cyrilzakka/clinical-trials huggingface dataset:
Pilot Study on Community Gardens and Food Purchases in Deprived Neighborhood (Marseille, France)

The pilot study aims to investigate the place of fresh garden produce in the food supply and food practices of women in community gardens of deprived neighborhoods of Marseille, reputed to be among the poorest in the European Union. We hypothesized that access to a community garden in these neighborhoods could help instigate the adoption of healthier food patterns by gardeners and their households, and in particular, increase their consumption of fruits and vegetables.

Urban community gardening was explored in terms of (i) food production, (ii) nutrition and economics, and (iii) cultural, social, and symbolic dimensions, by social and nutritional science approaches, involving informative questionnaires, semi-structured interviews, and a nutritional and economic analysis of household food supplies.

Eligibility Criteria:
Inclusion Criteria:

* Having access to a community garden in deprived neighborhoods of Marseille
* Willingness to be involved in the study
* Be in charge of the household food purchases

Exclusion Criteria:

* None
Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain

The aim of the study is to assess tolerability and activity of oxycodone and pregabalin in combination for the treatment of oncological neuropathic pain with two different strategies.

Neuropathic pain is frequently diagnosed as a complication of cancer pain. While opioids are the mainstay of cancer pain management,their efficacy in neuropathic pain seems to be less then optimal,and adjuvant drugs, mainly anticonvulsants and antidepressants,are often combined with opioids in the analgesic regimen of patients with neuropathic cancer pain. This approach is suggested by well-established guidelines, but the analgesic benefit and the safety of pregabalin and oxycodone in combination is not yet documented.

The aim of this study is to assess the activity and tolerability of the addition of pregabalin to oxycodone in the treatment of patients with neuropathic pain due to neoplasm.

Eligibility Criteria:
Inclusion Criteria:

* instrumental and clinical diagnosis of every malignant neoplasm
* presence of pain with a neuropathic component in the opinion of the physician
* presence of pain \>=4(NRS)
* PS ECOG \<3
* written informed consent

Exclusion Criteria:

* serum creatinine \>2mg/ml or creatinine clearance \<40 ml/min
* mild or severe hepatic insufficiency
* iatrogenic neuropathy caused by chemotherapeutic agents
* previous allergic reactions to oxycodone and pregabalin
* pregnancy or breastfeeding
Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study

The main purpose of this study is to determine if it is safe to use the study drug, clavulanic acid, in combination with cocaine. In this study, subjects will receive intravenous (i.v.) cocaine and the study drug, clavulanic acid. The safety of clavulanic acid is being studied so future studies can be done to find out if this drug is helpful in treating cocaine dependence. Currently, there is no available medication treatment for cocaine dependence.

This is a prospective, placebo controlled inpatient crossover safety study of 3 doses (250 mg/day, 500 mg/day, 750 mg/day) of CLAV with an intravenous infusion of cocaine 40 mg. Subjects will be non-treatment seeking experienced cocaine dependent adults, ages 18-65 (N=12 completers, 21 estimated to enroll). Subjects will undergo a washout of the study drug for 5 half-lives between study drug administration sessions.

The primary objective will be to determine whether there are clinically significant adverse interactions between CLAV (250 mg/day; 500 mg/day; 750 mg/day) and intravenously administered cocaine in healthy, non-treatment seeking adults with cocaine use disorder.

Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual of Mental Disorders Fifth Edition criteria for cocaine use disorder, moderate to severe.
* Be a non-treatment seeking cocaine user.
* If female and of childbearing potential, must have a negative pregnancy test within 48 hours of beginning the study and be willing to use acceptable contraception or be abstinent for 14 days prior to study, through the entire study and 30 days after study participation.

Exclusion Criteria:

* Be seeking treatment for substance abuse.

(For full inclusion/exclusion criteria or for more information, please contact the site directly.)
Polysomnographic Titration of Non-invasive Ventilation in Motor Neurone Disease

A two-arm, individual participant randomised controlled, assessor-blinded trial in 7 MND care centres across Australia will be undertaken.

Non-invasive ventilation (NIV) is a treatment that uses positive pressure delivered via a face mask or mouthpiece to assist a person to breathe. It can be used as a long-term treatment for people whose breathing is failing - usually due to chronic conditions that produce weakness of the respiratory muscles such as motor neurone disease / amyotrophic lateral sclerosis \[MND/ALS\]chronic obstructive pulmonary disease). Most people with MND/ALS use NIV at night initially. Even though NIV may improve survival and function, many are unable to use it for more than 4 hours per day (which is considered a threshold amount of use in order to gain a benefit) and many others are unable to tolerate it at all. Our team has recently provided evidence that specific and individualised titration of NIV leads to better outcomes in people with MND. This previous trial determined that the use of a sleep study (also called 'polysomnography') can improve the way people are initially set up with NIV. This study will replicate and extend the single site study in a large, multi-centre randomised controlled trial (RCT) across multiple sites This multi-centre RCT will also include a 12-month follow-up period to evaluate longer-term outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Clinical indication to commence long term NIV
* Confirmed clinical diagnosis of underlying condition

Exclusion Criteria:

* Medically unstable
* Hypoventilation attributable to medications with sedative/respiratory depressant side- effects
* Use of NIV for more than 1 month in the previous 3 months
* Inability to provide informed consent
* Previous intolerance of NIV
Probiotic on Psychological and Cognitive Effects

This study will determine whether supplementation of probiotic Lactobacillus Rhamnosus GG improves psychological status in middle age and older adults through a 12-week, randomized, double-blind, placebo-controlled clinical trial. Secondary analyses will be conducted to examine the possible benefits of probiotic supplementation on cognitive function and markers of physical health.


Eligibility Criteria:
Inclusion Criteria:

* Age 55-75 years
* Able to speak and read English

Exclusion Criteria:

* History of neurological, developmental, or severe psychiatric disorder (e.g. dementia, stroke, schizophrenia);
* Antibiotic use in the past 30 days;
* History of significant stomach or GI surgery (e.g. gastric bypass, cholecystectomy);
* History of alcohol or illicit drug dependence;
* History of severe heart, kidney, or liver problems (e.g. heart failure, liver failure);
* Regular use of an acid-blocking medication in the past 30 days (i.e. proton pump inhibitor, H2 blocker);
* Likely immunosuppression (e.g. chemotherapy treatment);
* Regular use of other pre- or probiotic supplements in the past 30 days;
* Severe gastrointestinal conditions including celiac disease, Crohn's disease, or diverticulitis.
DDX17 Orchestrate Septic Vascular Endothelial Pyroptosis by Controlling Gasdermin D Pore Formation

Objective: To investigate the correlation between plasma levels of DDX17 and GSDMD with vascular endothelial dysfunction and prognosis of in sepsis patients.

Design: A single center, prospective, observational research. Participants: Patients with sepsis who are hospitalized to Southeast University Affiliated Zhongda Hospital and meet the diagnostic criteria for sepsis 3.0.

Inclusion criteria:1. There is a potential or clear infection; 2. Sequential organ failure score (SOFA score) increases by more than or equal to 2 points compared to the baseline value; 3. Sign informed consent form.

Exclusion criteria: Age\<18 years old or\>80 years old, pregnant women, tumor patients, including diseases that may be complicated with vascular endothelial damage: hypertension, acute and chronic hepatitis (hepatitis caused by virus), liver cirrhosis, PT prolongation after liver transplantation, acute myocardial infarction, chronic tubular nephritis, chronic renal insufficiency/maintenance hemodialysis, renal transplantation, interstitial pneumonia, acute pancreatitis, active phase of systemic lupus erythematosus Ulcerative colitis, Crohn's disease, HELLP syndrome.

Primary outcome: 28-day mortality. Secondary outcome: Plasma levels of DDX17 and GSDMD, and their correlation with vascular endothelial injury, severity, and prognosis in sepsis patients.

Data collection:Recording the population information, including name, sex, BMI, and past history. Recording disease-related information's, including diagnosis, infection site, pathogens, organ dysfunction, SOFA and APACHE II scores. Recording treatment measures of patients, including whether to use vasopressor, invasive mechanical ventilation, and continuous renal replacement therapy. Recording laboratory examination results, including leukocyte count, PCT and hs-CRP on D1, D3 and D7, respectively. All patients were followed up to 28 days. Patients were distributed to survival group and non-survival group according to the 28-day survival.

Sample collection: 3 mL of the patient's peripheral blood were drawn on Day1, 3, and 7, and the plasma was centrifuged and kept at -80 °C. ELISA content detection of DDX17 and GSDMD.

Eligibility Criteria:
Inclusion Criteria:

* There is a potential or clear infection;
* Sequential organ failure score (SOFA score) increases by more than or equal to 2 points compared to the baseline value;
* Sign informed consent form.

Exclusion Criteria:

* Age\<18 years old or\>80 years old
* pregnant women
* tumor patients
* including diseases that may be complicated with vascular endothelial damage: hypertension, acute and chronic hepatitis (hepatitis caused by virus), liver cirrhosis, PT prolongation after liver transplantation, acute myocardial infarction, chronic tubular nephritis, chronic renal insufficiency/maintenance hemodialysis, renal transplantation, interstitial pneumonia, acute pancreatitis, active phase of systemic lupus erythematosus Ulcerative colitis, Crohn's disease, HELLP syndrome.
Mechanisms of Glucose Counterregulation in Pancreatic Islet Transplantation

Pancreatic islet transplantation improves glucose counterregulation and stabilizes glycemic control in patients with type 1 diabetes mellitus prone to severe hypoglycemia even if insulin independence is not achieved. However, the extent and underlying metabolic pathways of this improvement are unknown. Investigators therefore compare systemic glucose turnover including lactate gluconeogenesis and muscle glucose utilization, between insulin-requiring islet transplant recipients, matched type 1 diabetic subjects who did not receive islet transplantation, and matched healthy non-diabetic subjects.

Subjects (n=12 each group) undergo a hypoglycemic and a euglycemic hyperinsulinemic clamp in a randomized fashion. Systemic and skeletal muscle glucose and lactate kinetics are assessed using a combination of isotopic and forearm balance techniques.

Eligibility Criteria:
T1DM/ITX+

Inclusion Criteria:

* Type 1 Diabetes
* Pancreatic islet transplantation

Exclusion Criteria:

* Type 2 Diabetes
MetaNeb® Chest X-ray Study

To study objective is to evaluate the impact of use of The MetaNeb® System in clearance of atelectasis, as demonstrated by improvement in chest x-rays. This is a a non-randomized open label study, with all subjects receiving treatment with The MetaNeb® System. Subjects who qualify for enrollment in the study will receive therapy with The MetaNeb® System following the labeled instructions for the device. Details of the treatment including duration and frequency will be defined in treatment procedures.

Study Population:

Post-surgical (thoracic, cardiac or abdominal surgery) non-mechanically ventilated patients with significant atelectasis as documented by chest x-ray results.

Duration of treatment:

Duration of treatment with The MetaNeb® System will be a minimum of 48 hours, or until the subject is discharged from the hospital (if discharge is earlier). Enrolled subjects will remain in the study through Day 4 or until the subject is discharged from the hospital, whichever occurs sooner.

Eligibility Criteria:
Inclusion Criteria:

* Post-surgical (thoracic, cardiac or abdominal surgery)
* Age ≥ 18 years
* Significant atelectasis by chest x-ray
* Patient meets indication for therapy intervention as defined by Recruitment and Airway Clearance Protocol (Respiratory Department Policy and Procedure)
* Signed informed consent

Exclusion Criteria:

* Cause of atelectasis suspected to be infectious or solid mass
* Requirement for mechanical ventilation
* Requirement for chronic supplemental oxygen
* Hemodynamically unstable, as defined by need for vasopressor therapy
* Anticipated need for mechanical ventilation or other poor clinical outcome, unrelated to atelectasis or secretion retention
* Contraindication to MetaNeb® therapy (untreated tension pneumothorax)
* Inability to perform MetaNeb® therapy using a mouthpiece
* Anticipated hospital discharge within 24 hours
Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301

Aim of study is to collect long term safety and tolerability data on enteric-coated mycophenolate sodium with regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of study CERL080A301 study, patients who previously were on enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert from MMF to enteric-coated mycophenolate sodium.


Eligibility Criteria:
Inclusion Criteria:

-First cadaveric, living unrelated or human antigen mismatched living related donor kidney transplant recipients who completed study CERL080A301

Exclusion Criteria:

* Other protocol-defined inclusion/exclusion criteria may apply.
Biomarkers in Bone Marrow Samples From Pediatric Patients With High-Risk Acute Myeloid Leukemia

This pilot research trial studies biomarkers in bone marrow samples from pediatric patients with high risk acute myeloid leukemia. Studying samples of bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PRIMARY OBJECTIVES:

I. To provide a detailed, molecular map of pediatric high risk acute myeloid leukemia (AML).

II. To identify mutations, expression profile, gene copy number, loss of heterozygosity (LOH) status and genomic methylation patterns in order to identify novel changes associated with pediatric AML.

III. To generate fibroblast cell lines in order to obtain germline nucleic acids from marrow specimens from AML patients with induction failure.

IV. To identify genomic alterations contributing to induction failure in childhood AML.

OUTLINE:

Banked bone marrow samples from diagnosis and remission are used to develop a detailed molecular map of pediatric high-risk acute myeloid leukemia. Analysis includes genome single nucleotide polymorphism (SNP) genotyping, expression, and methylation profiling.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute myeloid leukemia

  * High-risk disease
* Treated on COG-AAML03P1 or COG-AAML0531
* Meets the following criteria:

  * Initial remission with no known adverse risk factors
  * High quantity and quality of ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) available
  * Highly enriched specimens with \>= 50% blast available
Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients

Study safety of longterm immunosuppressive protocol with Sirolimus plus Prednisolone, and Calcineurin inhibitor withdrawal.

Sirolimus with Cyclosporine minimization is the standard protocol for kidney transplantation in Chulalongkorn University. The investigators published the safety of this regimen in Transplantation Proceeding 2008; 40: 2206-8.

The investigators now further study in those patients who doing well with this regimen more than 1 year. The patients will be asked for kidney biopsy to evaluate and make sure they don't have subclinical rejection. The patients who don't have subclinical rejection will discontinue cyclosporine and continue with only sirolimus and prednisolone.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant with Sirolimus plus Cyclosporine plus Prednisolone more than 1 year

Exclusion Criteria:

* history of acute rejection, or subclinical rejection
Maastricht IBS Cohort

To set up a cohort of at least 400 IBS patients in order to identify different patient subgroups according to phenotypical and genotypical patterns and

To set up a biobank for future translational studies on the pathophysiology of IBS, in order to identify genetic factors to unravel the pathogenesis of IBS and to provide novel therapeutic targets.

Aim of the present study is to set up a large cohort of IBS patients in order to identify different disease characteristics as well as aetiological and pathophysiological factors in (sub)groups of patients with this heterogeneous disorder. Various phenotypical and genotypical markers will be evaluated. For this purpose, blood and faecal samples as well as symptom questionnaires will be collected and visceral perception and intestinal permeability will be measured. In order to increase the sensitivity of the barostat procedure, a pilot study will be performed by measuring patients and healthy controls under meal stimulated and fasting conditions. We aim to set up a biobank for studies on the pathophysiology of IBS, in order to identify genetic factors that may help unravel the pathogenesis of IBS and provide novel therapeutic targets. Consent will be asked to collect data from questionnaires, to store serum samples, DNA, stool and, when endoscopy is performed for clinical reasons, also biopsy specimens.

Eligibility Criteria:
Inclusion Criteria:

* IBS-patients

Exclusion Criteria:

* Severe co-morbidity hindering a rectal barostat procedure, according to the gastroenterologist's perception.
* Abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy or hysterectomy.
* Inability to stop medication that can influence gastrointestinal motility or perception (like loperamide, butylscopolamine, psylliumsead (metamucil), duspatal, metoclopramide, domperidon, erytromycin and serotonin reuptake inhibitors), for at least 3 days before tests.
Diabetes-Related Discrimination at Workplace and by Insurances

Diabetic subjects often report of problems at the workplace or when contracting insurances because of their diabetes.

By distributing a self-report questionnaire to insulin-treated Type 1 and Type 2 diabetic subjects we wanted to analyse the frequency of work- and insurance-related discrimination. Furthermore we wanted to detect socio-demographic and diabetes-related factors which are associated with increased discrimination at workplace and by insurances. We hypothesized that diabetes-related discrimination at workplace and by insurances exists and that certain factors like having severe hypoglycaemic events, being type 1 diabetic or being overweight would be associated with more problems at work or with insurances.

Our self report questionnaire included 83 items to assess treatment goals, quality of life and discrimination at workplace or by insurances. 636 questionnaires were distributed and were answered and returned. Anonymity was ensured. Patients were recruited from the diabetes outpatient clinic of the University of Basel Hospital, 5 regional hospitals, specialist practices and general practitioner practices.

The aims of this study are to investigate the prevalence of discrimination at workplace and by insurances due to diabetes mellitus. Furthermore we want analyse if socio-demographic factors (age,gender,origin) show an impact on diabetes-related discrimination at workplace and by insurances. We hypothesize furthermore that certain diabetes-related factors like having severe hypoglycemias, being type 1 diabetic, having diabetic complications or being overweight/obese is associated with more problems at work and with insurances.

Data will be analysed by a multiple ordinal regression analysis. We will correct data for age, gender, employment status and diabetes type.

Eligibility Criteria:
Inclusion Criteria:

* german-speaking insulin-treated diabetic patients

Exclusion Criteria:

* none
Prospective Comparison of Incidence of Heavy Menstrual Bleeding in Women Treated With Direct Oral Anticoagulants

Prospective comparison of the incidence of heavy menstrual bleeding (HMB) in women of reproductive age treated with direct oral anticoagulants (DOACs)

Patients will be treated as standard of care, no randomization schedule, no blinded investigational product (IP).

The decision which DOAC will be given is made before the subject will enter the trial. The DOAC has to be taken at least for seven days.

The registry is non-interventional (NIS) with routine blood draw at baseline and at month 4 after inclusion. The prospective follow up will be up to four months. Three consecutive menstrual bleeding cycles will be documented by the participating patients at home. One baseline data reporting and one follow up reporting after four months are planned in the participating coagulation centers.

The primary aim is the comparison of the frequency of heavy menstrual bleeding in female patients of reproductive age anticoagulated with DOACs using a modified pictorial blood loss assessment chart.

Secondary aims are the prevalence of von Willebrand disease in young anticoagulated female patients and correlation of HMB with age, International Society of Thrombosis and Hemostasis bleeding assessment tool at inclusion, Blood group, anatomical reasons i.e. underlying uterine pathologies, i. e. presence of uterine fibroids, endometrial polyps and/or adenomyosis, occurrence of iron deficiency, hemoglobin level and intermittent use of non-steroidal anti-inflammatory drug (NSAID).

Eligibility Criteria:
Inclusion Criteria:

* Women with venous thromboembolism
* Age: 18 - 50 years
* Regular menstrual bleeding
* Treatment with DOACs for at least 7 days before inclusion
* Full therapeutic anticoagulation with rivaroxaban 1 x 20 mg, apixaban 2 x 5 mg, edoxaban 60mg once daily or dabigatran 2 x 150mg for at least the next four months
* Written informed consent

Exclusion Criteria:

* Hysterectomy or ovariectomy
* Known heavy menstrual bleeding
* Hormonal contraceptives
* Hormone replacement therapy
* Use of hormone releasing intrauterine System (IUS)
* Contraindications to treatment with DOACs
* Treatment with rivaroxaban 15 mg twice daily (first three weeks after diagnosis of venous thrombosis) or apixaban 10 mg twice daily (first week after diagnosis of venous thrombosis)
* Treatment with rivaroxaban (10 mg or 15 mg once daily) or apixaban (2,5 mg twice daily) in reduced therapeutic dosages
* Participation in any other trial