cyrilzakka/clinical-trials huggingface dataset:
TRIAP: Is Triage by Healthcare Mini-teams Effective to Improve Efficiency in Primary Health Care?

Background: With new challenges for healthcare, there is a clear consensus among experts on the need to introduce changes in the organization of care in health centres to address the problems of over-attendance, bureaucratization and other emerging issues that require growing amounts of attention. However, there has been insufficient research into possible models and the impact of their adoption.

The objective is to assess the feasibility and effectiveness of the TRIAP intervention, a new organizational model based on triage and healthcare mini-teams (two general practitioners/pediatricians, two nurses and one member of the administrative staff) compared to the current model, aiming to achieve a correct classification of the healthcare needs of the primary care population and direct them to the most suitable professional.

In addition, the implementation research objective is to identify the facilitators for and barriers to the implementation of the intervention in the context of primary care.

Methods/ design: This is a quasi-experimental controlled clinical trial to be performed in 14 healthcare mini-teams (7 intervention and 7 control groups) from 8 health centres in the Basque Healthcare Service (Osakidetza) Interior Health Region.

The results will be assessed using the data on morbidity-adjusted attendance of users to their family doctor, number of referral, addition of new activities to the portfolio of services, and patient perception and professional satisfaction. All the variables will be measured at baseline and at the end of the intervention, 24 months later.

Using covariance analysis models, the investigators will estimate the effect attributable to the intervention by analyzing differences in changes between the two groups, and calculating the 95% confidence interval, adjusting the comparisons for baseline values. The investigators will also adjust for potential confounding and effect-modifying variables.

Nominal groups will be held at the end of the intervention with the participation of all the agents involved in intervention centres to identify the facilitators for and barriers to the implementation of the intervention.

Discussion: There is a need to develop new forms of organization in primary care services to respond to new healthcare demands. To pursue this aim, changes have to be introduced in the organization of healthcare within health centres, redefining the roles of primary care professionals and refocusing their activity towards population health needs, seeking greater efficiency in health services.


Eligibility Criteria:
Inclusion Criteria:

* The study populations are patients of the seven mini-teams established, these professionals being responsible for the GP lists in the health centres of San Miguel in Basauri, Miraballes and Ondarroa, and the paediatric list in Etxebarri health centre. The control units are from the health centres of Basauri-Ariz, Arratia, Amorebieta and Bermeo, all located in the Interior Health Region.

Exclusion Criteria:

-
Diagnostic Power Comparison Between VOCs and CTCs

Early diagnosis of malignant tumors is pivotal for improving their prognoses. Circulating tumor cells (CTC) in peripheral blood and Volatile organic compounds (VOCs) in exhaled breath are newly developed diagnosis method. Due to the low percentage of CTCs in peripheral blood of cancer patients and the surface structure of lymphocytes (especially megakaryocytes) is often confused with tumor cells, CTC has a high false positive and negative rate. In recent years, the detection of volatile organic compounds (VOCs) in exhaled breath as a simple and noninvasive method has shown broad application prospects in the diagnosis of various diseases. A series of studies of VOCs diagnosing solid tumors the investigators had conducted in the past decade show that VOCs can not only distinguish different types of tumors, but also can make a distinction between different stages. This study was to compare CTC and VOCs with clinical samples. Predictive models will be built employing discriminant factor analysis (DFA) pattern recognition method. Sensitivity and specificity will be determined using leave-one-out cross-validation or an independent blind test set.

200 patients with definitive diagnoses will be enrolled and the alveolar exhaled breath samples and peripheral venous blood will be collected. Two blood samples and two breath samples will be collected from each patient. One blood sample will be send to CTC tests for a blind test and the other will be used for headspace VOCs analyses. One breath sample was used for analysis with the Nano-sensors array, and the other was used for gas chromatography coupled with mass spectrometry (GC-MS) analysis. The VOCs samples were collected using sorbent tubes at a total flow through sorption trap of 200ml/min, then will be send to Israel Institute of Technology for further test.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years
* Definitive diagnosis of gastric cancer, breast cancer,benign breast disease and gastric lesions
* ECOG(Eastern Cooperative Oncology Group) scores ≤ 2

Exclusion Criteria:

* Other palliative chemotherapy and radiotherapy for this cancer
* Other cancer
* Diabetes, Fatty liver
* Autoimmune disease
* Pulmonary ventilation dysfunction
SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

The purpose of SIBYL is to generate clinical validity data for the ability of a future version of Guardant360 developed by Guardant Health to measure response to systemic therapy in patients with unresectable advanced solid tumors. It is necessary to collect clinical data points and treatment outcomes in order to demonstrate clinical validity for longitudinal monitoring with ctDNA and correlation of ctDNA dynamics with therapeutic response, as evaluated by standard methods, including RECIST 1.1 and CT scan measurements.


Eligibility Criteria:
* Will be treated with a first- or second-line systemic and/or oral standard of care regimen at the enrolling site
* Patient is either treatment naive and has not yet commenced first line SOC therapy OR patient has completed a prior line of SOC therapy and will commence subsequent line of SOC therapy
* Provide written informed consent to participate in the study
* Diagnosed with an unresectable advanced solid malignancy and have a histologically confirmed cancer that qualifies for inclusion, defined as:

  * Non-small cell lung cancer (stage III-IV)
  * Colorectal adenocarcinoma (stage III-IV)
  * Breast Cancer (stage III-IV)

Exclusion Criteria:

* History of a prior solid or hematological malignancy within 5 years of enrollment
* Life expectancy \< 12 weeks
* Unable to collect baseline blood sample prior to starting SOC regimen
* Is participating in an interventional clinical trial or another observational study that is evaluating the performance of another genomic test for detecting/predicting clinical response/progression
Multicentre Prospective Cohort Study of Patients With Chronic Alcoholic and/or Metabolic Liver Disease

Chronic alcoholic and metabolic liver diseases are the two main liver diseases in France. The long-term prognosis of these two diseases are not well known because main studies are retrospective and with only alcoholic patients. The knowledge of the natural history of these diseases should improve the management of patients with such diseases.

The aim of this prospective cohort is to describe the natural history of patients with chronic liver disease due to alcohol or metabolic disease and to identify factors associated with complications of these liver diseases (cirrhosis, hepatocellular carcinoma, ascites. ..).

In 2010, the two most frequent chronic liver diseases are alcoholic and metabolic disease. The natural history of these two diseases is not well known. Indeed, most of the studies were retrospective and evaluated alcoholic disease or metabolic disease but never both diseases. However, these two diseases have the same histological lesions and can be associated. The knowledge of the natural history of these diseases could improve the management of patients in order to decrease complications and improve survival. The aim of this prospective study is to describe the natural history of chronic liver disease due to alcohol and/or metabolic syndrome and to identify factors associated with complications (ascites, encephalopathy, death, complications of obesity, diabetes or chronic alcohol abuse). All patients will be followed every 6 months for 3 years with clinical, biological and morphological parameters.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* chronic liver disease (liver biopsy with bridging fibrosis or cirrhosis) or non-invasive markers of fibrosis (fibrotest \> 0.58, FibroScan \> 7.9 kPa)
* no decompensated cirrhosis
* chronic alcohol use and/or metabolic syndrome (at least 3 criteria of metabolic syndrome)
* Written informed consent
* Patient covered by the French health insurance system

Exclusion Criteria:

* short term life threatening disease
* Other cirrhosis causes
* Impossibility of regular follow-up
* Under guardianship major Patient
* Presence of focal hurt suggestive of CHC
* pregnant women
* cirrhosis complication
* Child-pugh score superior or equal to 7
A Study of Balapiravir in Patients With Dengue Virus Infection

This randomized, double-blind, multiple-dose, placebo-controlled study will evaluate the safety, tolerability and efficacy of balapiravir in adult male patients with confirmed dengue virus infection whose symptoms began within the 48 hours preceding the first administration of balapiravir. Patients will be randomized to receive either balapiravir or placebo, orally twice daily for 5 days. Anticipated time on treatment as in-patient is 7 days, with an out-patient follow-up to week 12. Target sample size is \<200


Eligibility Criteria:
Inclusion Criteria:

* male patients, 18-65 years of age
* dengue virus infection (confirmed by NS1 strip test) with symptom onset \</=48 hours before first study drug administration
* patients and their partners of childbearing potential must use 2 forms of contraception until 3 months after receiving the last dose of study drug
* BMI between 18 and 35

Exclusion Criteria:

* positive test at screening for HIV using point of care test, or known HIV infection
* history of any disease known to cause significant alteration in immunologic function or autoimmune disease
* patients taking steroid or other immuno-suppressive therapies
* positive test for drugs of abuse or alcohol using point of care test
* clinically significant abnormal laboratory test results which are deemed unassociated with dengue infection or, alternatively, are diagnostic of dengue shock syndrome
Effect of Low Frequency Ultrasound on Kidney Function

The purpose of this study is to find out what effect, if any, Low Frequency Therapeutic Ultrasound (LOTUS) has on kidney function in patients with chronic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Must be \>/= 18 years of age
* Must have documented Stage 3 to Stage 4 (eGFR 15 - 59) chronic kidney disease
* Females with childbearing potential must not be pregnant at the time of study
* Subject must provide written informed consent

Exclusion Criteria:

* Unable or unwilling to cooperate with study procedures
* Currently enrolled in another clinical study for which the follow-up period is not complete
An Efficacy, Safety and Pharmacokinetics Study of Beloranib (ZGN-440 for Injectable Suspension) in Obese Subjects

The purpose of this study is to evaluate weight reduction, safety and pharmacokinetics for certain doses of beloranib (ZGN-440 for injectable suspension) administered as twice-weekly subcutaneous injections for 12 weeks.

This protocol is designed to test the safety and efficacy of a drug called beloranib (ZGN-440 for injectable suspension). It is to be tested for its ability to reduce weight in obese subjects. The study will provide information on how much ZGN-440 gets into the blood, how long it stays in the body, and how it affects other biological markers.

Eligibility Criteria:
Inclusion Criteria:

* Obese volunteers weighing ≥ 50 kg
* BMI ≥ 30 and ≤ 50 kg/m2
* Stable body weight during the past 2 months
* Type 2 diabetes mellitus is allowed

Exclusion Criteria:

* Use of weight loss agents in the past month
* Current, clinically significant eating disorder
* Type 1 diabetes mellitus
Arimoclomol in Amyotropic Lateral Sclerosis

A multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of arimoclomol in amyotropic lateral sclerosis (ALS)

Screening up to 4 weeks Treatment up to 76 weeks

Eligibility Criteria:
Inclusion Criteria:

* Subject meets revised El Escorial criteria for clinically possible, clinically probable / clinically probable ALS laboratory-supported, clinically definite ALS or clinically definite familial ALS laboratory-supported
* 18 months or less since first appearance of weakness (e.g. limb weakness, dysarthria, dysphagia, shortness of breath)
* ALS Functional Rating Scale-Revised (ALSFRS-R) equal to or above 35 and erect (seated) Slow Vital Capacity (SVC) % predicted equal to or above 70% at Screening

Exclusion Criteria:

* Tracheostomy or use of non-invasive ventilation for more than 2 hours during waking hours at the time of Screening and Baseline
* Pregnant or breast-feeding
* Current or anticipated use of diaphragmatic pacing
* Any other relevant medically significant condition which could present risk to the subject or interfere with the assessment of safety or has an increased risk of causing death during the trial
Oxidative Stress and L-CBMN Cytome Assay in Obese After 3 Weeks VLCD

Obesity leads to physiological imbalance resulting in hyperglycemia, dyslipidaemia and inflammation and can generate systematic oxidative stress through multiple biochemical mechanisms. Oxidative stress (OS) can induce DNA damage and inhibit DNA repair mechanisms. Very low calorie diet (VLCD) have rapid positive effect on weight loss, glucose homeostasis, insulin resistance, inflammation and OS. The aim of this study is to determine the effect of a three-week VLCD on anthropometric, biochemical and genomic parameters in individuals with BMI ≥ 35kg/m2.

Obesity is a complex chronic multifactorial disease associated with concomitant or increased risk for chronic inflammation, insulin resistance, dyslipidemia, oxidative stress, type 2 diabetes, cardiovascular disease, stroke and multiple cancer types. Oxidative stress (OS) can cause permanent DNA damage which could be detected with lymphocytes cytokinesis-block micronucleus (L-CBMN) cytome assay. Weight loss and improvement of dietary habits in people with obesity can affect genome stability and have beneficial effects on insulin sensitivity, inflammation and OS. Effects of very low calorie diet (VLCD) on DNA damage are scarce. The aim of this study is to determine the effect of a three-week VLCD used in Special Hospital for extended treatment of Duga Resa in patients with BMI ≥ 35kg/m2 on permanent DNA damage, lipid profile, insulin resistance, inflammation and anthropometric parameters.

Eligibility Criteria:
Inclusion Criteria:

* body mass index ≥ 35 kg/m2

Exclusion Criteria:

* pregnancy
* actual tumor diseases
* recent diagnostic or treatment exposures to ionizing radiation in the period of one year
* individuals not willing to stay 3 weeks under supervision under full 24 h surveillance from the medical stuff
The Effectiveness of Isometric Exercise on the Management of Chronic Shoulder Pain

The aim of this study was to evaluate the influence of the intensity of Isometric Contraction of shoulder external rotators, comparing the effect of a high-level IC (80% maximal voluntary isometric contraction) versus a low-level Isometric Contraction (20% maximal voluntary isometric contraction) on pain intensity, pain thresholds, and function in chronic pain shoulder patients.

This was a single-blinded, randomized parallel study. Eighty-two patients presenting chronic musculoskeletal shoulder pain were allocated to two groups. Patients in group 1 (n= 41) received a five-series Isometric Contraction of shoulder external rotators at 20% maximal voluntary isometric contraction, while patients in group 2 (n= 41) received similar protocol but the intensity of contraction was set at 80% maximal voluntary isometric contraction. In both cases, each series of IC was done until exhaustion or up to a maximum of 5 minutes. Patients received five sessions of treatment during a two-week period. Outcome measures included muscle pain sensitivity (pressure pain thresholds) and pain intensity (pain intensity numerical rating score), and shoulder function (Constant Score).

Eligibility Criteria:
Inclusion Criteria:

* Male or female having a chronic shoulder soft-tissue injury of at least 3 month duration resulting in a mild to moderate level of disability (Constant score scale), pain intensity score between 3 and 8 points (pain intensity numerical rating scale), and age between 18 and 65 years.

Exclusion Criteria:

* Participants were excluded if they had any contraindications related to the application of isometric exercise, neurological problems (central or peripheral), concomitant physiotherapy or chiropractic treatment, fibromyalgia or general systemic disease conditions, had participated in any moderate or vigorous physical activity in the las 72 hours previous the outcome assessment.
Effect of GLP1 Receptor Agonists on Physical Function, Body Composition, and Markers of Aging in Older Adults

Semaglutide is a medication approved by the US Food and Drug Administration (FDA) as an antihyperglycemic (a drug that reduces glucoses in those with diabetes) and for weight management. This new study will help find out what effects, semaglutide has on people who take the drug and the drug's effect on physical function, body composition, and aging.


Eligibility Criteria:
Inclusion Criteria:

* Older than 65
* Have prediabetes or diabetes
* BMI ≥ 27.0 kg/m2
* Living independently (not in assisted living or nursing home)

Exclusion Criteria:

* Have heart disease
* Have liver disease
* Smoke
HOrmone Therapy Immediately After Histological Diagnosis of Breast Cancer

Breast Cancer is a public health issue worldwide. The time from diagnosis to treatment initiation varies from country to country and regionally within a country. Early diagnosis and prompt treatment initiation are key factors in patient survival rates.

Currently there is a rising trend, with a high percentage of patients with "Luminal" like breast cancer only undergoing adjuvant endocrine therapy.

Authors argue that tumor biology alterations after introducing very early endocrine therapy might have a prognostic and therapeutic impact and should be studied.

Selected patients of female gender, above 50 y.o, and after a biopsy of Luminal-like Breast Cancer will go under aromatase inhibitor, from the diagnosis day till the surgical therapy to be decided (if so).In this study are going to be included patients that refuse surgical treatment, remaining this way in an "active surveillance". This last group is going to be randomised in order to recieve hormontherapy plus placebo vs hormontherapy plus acetolisalicilic acid.

In this way, authors want to investigate if:

1. st This approach influences the tumor biology
2. nd This approach influences tumor pathologic response and progression free survival.
3. rd It is a valid approach and in which grade, for patients that refuse surgical treatment

Eligibility Criteria:
Inclusion Criteria: Menopausal woman of equal or above 50 y.o. with breast biopsy of Luminal like breast carcinoma

Exclusion Criteria:

* informed consent
* \<50 y.o.
* Pre-menopausal state
Three Methods for Best PEEP Determination Compared With PEEP Determination Guided by Adult Respiratory Distress Syndrome (ARDS) Network

To compare the best Positive End Expiratory Pressure (PEEP) as determined by one of three commonly used clinical approaches for best PEEP determination, with PEEP guided by the ARDS network algorithm.

The determination of optimal level of Positive End Expiratory Pressure (PEEP) in patients with acute hypoxemic respiratory pressure remains elusive and controversial.

Several approaches with different algorithms exist. Among them, Low PEEP algorithm approach and High PEEP algorithm approach. These approaches are characterized by a generalized application of certain level of PEEP according to a predefined algorithm. However, these algorithms fail to account for inter-individual variations between patients with different diseases and with different severities of the same underlying process. Therefore, we advocate for an individualized application of PEEP. Whereby, PEEP will be determined individually for each patient based on familiar and well established physiological parameters.

Eligibility Criteria:
Inclusion Criteria:

20 Man and women older than 18 years will be recruited. Patients with acute respiratory failure of any cause who are mechanically ventilated according to the ARDS network recommendations will be considered for inclusion to the study.

To be included in the study a prerequisite of high peak Inspiratory pressure (plateau pressure of 25 to 30 cmH2O) has to be present, and at least one of the following four severity inclusion criteria has to be met.

1 - Low Total Respiratory system compliance (CT), defined as less than 50ml/cmH2O. 2 - PaO2 /FIO2 ratio of less than 300. 3 - Need for a PEEP greater than 10 cmH2O to maintain arterial oxygen saturation (SaO2) of \> 90%.

4 - carbon dioxide partial pressure (PCO2) over 60 mmHg, or PH less than 7.2 that is attributed to respiratory acidosis.

Exclusion Criteria:

Patients with any of the following will be excluded from the study. Previous lung or chest wall surgery, previous esophageal surgery, known Achalasia or any other esophageal motility or spasm disorder, presence of chest thoracostomy tube, and any significant chest wall abnormality such as kyphoscoliosis.