cyrilzakka/clinical-trials huggingface dataset:
Ecological Momentary Mental Assessment

Suicide is a major health problem that causes annually a million death worldwide. Suicide and suicide attempts are preventable.

A history of self-injuries or suicidal attempts are known to be the most important risk factor for death by suicide. Suicidal ideation is also strongly correlated with suicide attempts.

The development of Smartphones applications offers new possibilities for data collection and transmission.

Moreover, the online help function, when a suicidal crisis occurs, is the most effective strategy for prevention of suicidal behavior.

Specific technologies have been developed to analyse behaviors and experiences of patients in a natural environment, in real life.

That is the goal of Ecological Momentary Assessment.

The aim of the study is to develop an algorithm to assess and predict the risk of suicidal event occurrence, in order to detect as soon as possible the signs of suicidal crisis.

EMMA will be the first application in French, meeting the recommendations for health applications, developed by experts on suicidal behavior and in collaboration with patients which aims to predict suicidal risk.

A subsequent study, conducted on a larger population, should allow to validate the predictive algorithm of EMMA.

Long-term goal is to improve the care of patients at risk for suicidal behavior.

100 patients having recently attempted suicide or having suicidal ideation will be recruited. They will be asked to use the application EMMA during 6 months and will be followed up during this period.

An optional qualitative study conducted on 25 patients will allow to evaluate more finely their subjective experience of the use of the application.

Initial visit (inclusion) : clinical, biological and neuropsychological assessment and installation of the application EMMA.

First visit (1st month) and second visit (3rd month) : clinical assessment

Last visit (6th month) : clinical, biological and neuropsychological assessment and optional qualitative interview.

Eligibility Criteria:
Inclusion Criteria:

* Recent suicidal attempt (\< 8 days) or suicidal ideation score ≥ 2 (IDSC-30 scale)
* More than 18 years old
* Able to understand nature, aims, and methodology oh the study
* To own a smartphone

Exclusion Criteria:

* Refusal to participate
* Patient on protective measures (guardianship or trusteeship)
* Deprived of liberty subject (administrative decision)
* Subject in exclusion period for another protocol
* Not affiliated to a social security agency
* Unable to understand and/or answer a questionnaire
Extracorporeal Membrane Oxygenation (ECMO) and Coronavirus Disease (COVID) 19

The role of ECMO in the treatment of patients with severe COVID-19 (Acute Respiratory Distress Syndrome (ARDS) and/or acute refractory heart failure) is not yet known. The present study will aim to report the results of the ECMO management of the most severe forms of COVID-19 through the first French ECMO registry.

The main objective of this study is to evaluate the hospital survival of COVID-19 patients supported by venovenous or venoarterial ECMO in a multicenter registry.

The secondary objectives are to describe the characteristics of COVID-19 patients who have received ECMO support, to identify the risk factors associated with hospital mortality, to analyze the outcomes after ECMO weaning including survival at day 28 and day 90, and to analyze the utility of a circulatory support mobile unit in a severe pandemic

Inclusions are both prospective and retrospective in order to collect data over the whole pandemic

Eligibility Criteria:
Inclusion Criteria:

* All COVID-19 patients, adults or children,
* Tested positive by RT-PCR for SARS-CoV2 (nasopharyngeal swabs, sputum, endotracheal aspiration, bronchoalveolar lavage or stool sample) and / or with a diagnosis made on chest CT findings,
* Supported by venovenous or venoarterial ECMO

Exclusion Criteria:

* Temporary legally protected Adults over a set period or waiting for protection supervision, guardianship
* Patients or proxies who express their opposition to study participation
The Detection of Circulating Tumor Cells (CTCs) in Patients With Colorectal Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment

Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in colorectal cancer could play an important role in diagnosis, predicting the risk for tumor recurrence, and providing novel target therapy biomarkers. In view of these facts, the investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting human tumor cells of colorectal cancer in normal peripheral blood after cryosurgery with or without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR) method.

1 day before and 2 days after cryosurgery with or without DC-CIK treatment，approximately 17-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients with colorectal cancer and healthy volunteers. The blood of the healthy volunteers will be used to evaluate the sensitivity and specificity and as negative control cells. To avoid contamination with skin cells, 2 mL blood will be discarded before the study samples will be taken.Briefly, the mononucleate cells will be separated from the blood over Ficoll- Paque for 20 min with 1800g at 4℃. The interface cells will be removed and washed, and the red blood cells(RBCs) will be removed using a lysis buffer followed by a repeated wash. The mononuclear cells will be counted and aliquot for RT-PCR and multiparameter flow cytometry on the basis of at least 2-3×106 cells for each methodology. The cell pellet will be resuspended in phosphate-buffered saline for multiparameter flow cytometry and in Trizol reagent for RT-PCR. Aim : Identification of CTCs may lead to better diagnosis and prognosis and could help to choose an adequate therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age:18-75
2. Karnofsky performance status \>60
3. Diagnosis of colorectal cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive cryosurgery and/or DC-CIK treatment
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except colorectal cancer
2. History of coagulation disorders or anemia
Effectiveness of Rifaximin on Preventing Postoperative Recurrence in Crohn's Disease

Some studies have shown that rifaximin is effective in the management of Crohn's Disease. Meanwhile, its adverse effect is tolerable. But no study has been conducted to assess its effect on preventing postoperative recurrence. Thus, we conduct a randomised controlled study to assess the effect of rifaximin on preventing postoperative endoscopic recurrence in Crohn's disease. The primary endpoint is the rate of endoscopic recurrence at 6 months.


Eligibility Criteria:
Inclusion Criteria:

1. Consecutive patients with Crohn's disease undergoing intestinal resection of all macroscopic diseased bowel, with an endoscopically accessible ileocolic anastomosis;
2. Enrolled patients without risk factor for the development of postoperative recurrence including penetrating disease behaviour, prior bowel resection, and active smoking.

Exclusion Criteria:

1. Severe comorbidities;
2. With a stoma;
3. With malignancy;
4. Pregnancy;
5. With contraindication of using rifaximin.
AZ, MZ, and the Pulmonary System Response to Hypoxia

The purpose of this proposal is to compare the physiological effects of acetazolamide (AZ) and methazolamide (MZ) on the control of breathing and hypoxic pulmonary vasoconstriction. The first objective is to assess the effects of AZ and MZ on the control of breathing in normoxia and hypoxia. To achieve this the ventilatory interaction between oxygen and carbon dioxide will be measured and effects compared between placebo, AZ, and MZ conditions. In addition, the isocapnic and poikilocapnic hypoxic ventilatory response and hypercapnic ventilatory response will be measured with each drug. The second objective is to assess the effects of AZ and MZ on the control of the pulmonary vasculature during hypoxia. Pulmonary pressure and cardiac output will be measured during 60 minutes of poikilocapnic hypoxia.


Eligibility Criteria:
Inclusion Criteria:

* 18-40 years of age
* regularly physically active
* male

Exclusion Criteria:

* ex-smokers
* pulmonary function \<80% of predicted
* contraindications to carbonic anhydrase inhibitors (eg. severe or absolute glaucoma, adrenocortical insufficiency, hepatic insufficiency, renal insufficiency, sulfa allergy or an electrolyte imbalance such as hyperchloremic acidosis)
* Obese (BMI\>30Kg/m2)
* diuretic medication use
* blood thinner use
* anti-platelet drug use.
Integrated Hypertension and Diabetes Mellitus Type II Treatment and Care Among People Living With HIV/AIDS

This project was a facility-based program intervention for People Living with HIV (PLHIV) aged 18 years and above who attended a Care and Treatment Center (CTC) in Dar es Salaam, Tanzania. Clients received preventive, diagnostic, and treatment services for Hypertension (HTN) and Type Two Diabetes Mellitus (T2DM). The primary health outcomes were all-cause mortality, disease-specific morbidity, HTN, and T2DM control rates. Secondary outcomes included access to care, retention in care adherence, and quality of care. Results obtained can be used to strengthen Non-Communicable Diseases (NCDs) care delivery in HIV/AIDS care in CTC in Tanzania.

A cohort of patients who were diagnosed with hypertension and diabetes was created and followed up for 6 months. Patients were required to attend clinics on a monthly basis. At the first visit short interview using the STEPwise approach of the STEPS surveillance tool for NCDs from the World Health Organization (WHO) was conducted. On subsequent visits, hypertension and blood sugar levels and cholesterol levels will be measured and adherence to medication were assessed. The patient registry was developed following recommendations from the HEARTS (Healthy lifestyle, Evidence-based protocols, Access to essential medicines and technology, Risk-based Cardiovascular Disease (CVD) management, Team-based care Guidance Systems for monitoring)technical package of WHO with some modifications if needed. A simple surveillance system was developed for all patients diagnosed with hypertension and diabetes so that there is continuous evaluation and monitoring of all patients attending NCDs care at the HIV clinic.

Eligibility Criteria:
Inclusion Criteria:

All PLHIV who attended CTC 18 years and above

Exclusion Criteria:

* Pregnant women living with HIV/AIDS
* Patients with mental diseases.
Closed-Loop Insulin Delivery in Children Less Than 7 Years of Age

The investigators are conducting this study to find out whether a new device can control blood sugar levels in children who have Type 1 diabetes. In Type 1 diabetes, children have high blood sugar levels because they do not make enough insulin. The standard treatment is to give insulin either by shots or using an insulin pump. A new device, called closed-loop insulin therapy, uses a continuous glucose monitor (CGMs) linked to an insulin pump by a computer. The CGM will send the sugar levels to a computer which automatically figures out how much insulin to give and then gives that amount of insulin through the insulin pump. It will give the child insulin to bring sugar levels down if they are high, and will give less insulin if the child's blood sugar is getting lower. Earlier research using closed-loop insulin therapy has shown the ability for it to improve diabetes care in adults and older children, but there has been no research of closed-loop insulin therapy in young children. This study will compare children's current insulin therapy with the closed-loop system. The knowledge that the investigators gain from this research will help us to figure out whether closed-loop therapy can work in young children, hopefully leading to better Type 1 diabetes care.

We will perform a randomized cross-over study of semi-closed-loop insulin therapy in children less than 7 years old with type 1 diabetes. Subjects will be admitted to the inpatient clinical research center for 48 hours. They will receive their standard home insulin therapy for one day and semi-closed-loop insulin therapy for the other day.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 7 years old
* Type 1 Diabetes (as diagnosed by outpatient endocrinologist) with duration greater than 6 months
* Treated with insulin pump therapy for greater than 6 weeks

Exclusion Criteria:

* Any other chronic medical condition
* Weight below 10 kg as this is the minimal required weight for the amount of blood being drawn
Text-based Intervention to Minimize the Time Burden of Routine Cancer Care

The primary objective is to test whether a text-based e-triage can safely minimize the time associated with routine cancer care by identifying patients who can proceed directly to their immunotherapy infusion without a preceding in-person office assessment.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Initiating singe agent PDL-1/PD-1 targeted immune checkpoint blockade for any solid malignancy at Penn's Abramson Cancer Center
* Access to a mobile phone with texting capabilities
* ECOG performance status less than or equal to 2

Exclusion Criteria:

* Non-English speaking
* Unable to perform informed consent
Efficacy and Safety of Birch Pollen Immunotherapy in Local Allergic Rhinitis

Local allergic rhinitis (LAR) is relatively new disease. The question of effect of allergen specific immunotherapy on LAR is open. The randomized, double blind placebo controlled trial of birch subcutaneous AIT on LAR were performed in twenty eight patients. The therapy was performed during 24 months in proportion 15 patients with AIT and 13 placebo. The primary endpoint was decreased of symptoms medication score (SMS). Additionally monitoring serum specific IgE, specific IgG4 and nasal specific IgE (nsIgE) to Bet v1 and parameters of safety and quality of life were provided.

Local allergic rhinitis (LAR) is still an under diagnosed and under treated disease. It is characterised by local production of IgE during natural exposure to aeroallergens. These patients have negative skin prick tests and serum-specific IgEs but have positive nasal provocation tests for aeroallergens. More than 50% of patients with chronic non-allergic rhinitis may have a problem with lack of LAR diagnosis. Misdiagnosis can lead to mistakes in the treatment as well as inefficiencies.

Besides on only local IgE-mediated reaction, allergen immunotherapy (AIT) could be a potential way of treatment such patients. However, there are only sufficient data that the AIT is effective in allergic rhinoconjunctivitis and asthma to pollens and house dust mites and some animal.

The aim of this study was to assess the safety and efficacy of AIT for birch pollen allergens in patients with local allergic rhinitis and a confirmed birch pollen allergy.

Eligibility Criteria:
Inclusion Criteria:

* well document symptoms of rhinitis during birch pollen season
* positive nasal provocation test to birch
* negative results of skin prick tests to inhalant allergen including: D. pteronyssius, D. farinae, grass pollen, birch, hazel, alder Alternaria, and cat.
* negative results of serum total and allergen specific IgE against mentioned allergens.

Exclusion Criteria:

* diagnosis of bronchial asthma, non-allergic rhinitis (especially senile or vasomotor rhinitis) and severe non-stable diseases. All subjects were required to abstain from anti-allergy drugs and glucocorticoid nasal drops for at least 6 weeks prior to the start of the study.
Evaluation of a Procedure for Identification and Brief Intervention of Lifestyle Advice Assisted by Application in a Care Setting

Chronic diseases share similar risk factors associated with four daily behaviours: unbalanced diet, sedentary lifestyle (physical inactivity and time spent sitting down), smoking and alcohol consumption. These diseases are responsible for 74% of deaths worldwide. Despite the frequency with which practitioners witness these bad habits in their patients, little time is devoted to lifestyle advice during medical visits, and even less to using effective techniques to discuss their behaviour. Yet medical and paramedical consultations could be an essential educational opportunity to promote a healthy lifestyle. But advice is often limited during medical check-ups, due to a lack of time and suitable tools, and is often focused on a particular risk factor. To date, there is no procedure for screening and behavioural intervention to deal with harmful lifestyle habits in patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Treated for a stabilised chronic disease OR person treated for localised cancer, after the end of heavy treatment during the follow-up period within 5 years of the date of diagnosis of the cancer.
3. Contactable by telephone
4. Affiliated to a social security scheme
5. Having signed a free, informed and written consent.

Exclusion Criteria:

1. Requiring psychiatric assessment
2. Suffering from eating disorders
3. Undergoing dietetic treatment or therapeutic education for dietetic purposes (at least two consultations at the same facility in the previous year)
4. Suffering from a life-threatening condition within 5 years
5. Suffering from a disabling condition (reduced activity with major restrictions)
6. Unable to read
7. Taking part in another psycho-behavioural nutritional intervention study
8. Protected person (adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty, pregnant woman (declaratory), breast-feeding woman and minor).
Cuff Pressure in Patients: Manometer vs Invasive Pressure Monitoring Setup

This is a prospective study looking at ways to measure the cuff pressure of cuffed endotracheal tubes (ETTs). We will be comparing a hand-held manometer (MM) to the transducer of an invasive pressure monitoring setup (IPMS), which is commonly used for arterial or central venous pressure monitoring. The investigators previously did this study in vivo with ETTs in polyvinyl chloride (PVC) "tracheas" and we found that there is good correlation between the pressure readings using the MM and the IPMS. The purpose of the current study is to validate the in vitro findings in clinical situations.


Eligibility Criteria:
Inclusion Criteria:

* Intubation of trachea with a cuffed endotracheal tube.

Exclusion Criteria:

* None
The Importance of Patient Education - A Randomised Controlled Trial

Modification of individual life style factors and fall prevention programmes may have significant positive effects on fracture incidence. Also, a large number of studies have demonstrated that pharmacological therapy of osteoporosis is effective; however non-adherence to such therapy is a well recognized problem. Few studies, however, have examined the effect of particular patient education programmes on knowledge and adherence to therapy.

We hypothesised that a group-based, multi-disciplinary, education programme increases the total quality of treatment for patients with osteoporosis, Patients' knowledge on osteoporosis and adherence with pharmacological therapy ect.

A total of 300 patients, recently diagnosed with osteoporosis and started on specific treatment, were randomised to either the "school" or "control" group. In the school-group, patients attended four classes with 8-12 participants during four weeks (a total of 12 hours). Teaching was performed by nurses, physiotherapists, dieticians, and doctors and was based on dialogs and situated learning. The classes covered "facts on osteoporosis", "fractures and pain", "diet", "preventive measures", "balance and exercise", and "medical treatment". Teaching was designed to increase empowerment. The control group were offered the department's standard treatment including follow-up visits.

All 300 patients received questionnaires regarding "Knowledge about Osteoporosis", "Level of Adherence", "Quality of life", "Dietary calcium intake", "Level of physical activity", "Falls events" registered every month by postcard, at inclusion and after 3, 12, and 24 month. BMD was examined by DXA-scan at inclusion and after 12 and 24 month. The last patient will answer the questionnaires first of May 2007.


Eligibility Criteria:
Inclusion Criteria:

* Men and female age 45-80,
* Diagnosed with osteoporosis and started medical treatment

Exclusion Criteria:

* Severe illness,
* Cognitive dysfunction,
* Not able to speak or read Danish
The Intestinal Function in People With Prader-Willi Syndrome

The projects aim is to investigate the intestinal function of patients suffering from Prader-Willi Syndrome. The methods used are ultrasonographic measurement of the rectal diameter and gastrointestinal transit time

Prader-Willi Syndrome (PWS) is a congenital genetical disease characterized by moderate retardation, food-seeking behavior and a serious risk of developing health threatening overweight, low stature, abnormal body composition and a lack of growth- and sex-hormones. They can not live an independent life and are reliant of help from care personnel.

People with PWS react abnormally to signals from their own bodies. E.g. they have a reduced sense of pain and can have a lacking urge to urination despite a full bladder. Most of the patients also have a relatively slow pulse, which can be consistent with a dysfunction in the nervous system (the parasympathetic nervous system) which also has large significance for the bladder- and bowel function.

The Intestinal function in people with PWS is a sparse described subject, which has not been systematically examined in scientific context. We therefore want to examine whether the bowel function in people with PWS are different from the bowel function in healthy people.

The subject is elucidated by a medical examination, a questionnaire, a registration of toilet habits, a measurement of the rectal diameter by an ultrasound scan and a measurement of the colonic transit time.

The results will be compared to findings in normal healthy people. Because no normal material exists for rectal diameter measured by ultrasound, we will establish one.

The result of the project will increase our knowledge of possible bowel dysfunctions such as constipation, in people with PWS and can immediately lead to improved care for and optimized treatment of the patients.

Eligibility Criteria:
Inclusion Criteria:

* age above 18
* \>14 days since last antibiotic treatment
* \>14 days since last laxative treatment
* PWS confirmed genetically

Exclusion Criteria:

* previous abdominal surgery (except appendectomy or haemorrhoidectomy
* patient not capable of understanding the information
* treatment with eltroxin or antipsychotic medication
* pregnancy