cyrilzakka/clinical-trials huggingface dataset:
The PROspective German NOn-CF bronchiectaSIS Patient Registry

The purpose of this study is to study the epidemiology of non-CF bronchiectasis (NCFB) and to provide an estimate of the distribution (prevalence) of NCFB etiologies across all different levels of health care as well as real-life data regarding the current management of NCFB in Germany.

* To study the epidemiology of non-CF bronchiectasis (NCFB) and to provide an estimate of the distribution (prevalence) of NCFB etiologies across all different levels of health care as well as real-life data regarding the current management of NCFB in Germany
* To establish feasible investigational strategies in order to establish the etiology of NCFB
* To perform observational research into bronchiectasis, particularly in areas where single center datasets are underpowered, such as in rare etiologies or determining markers of prognosis
* To promote collaborative clinical, basic and translational research in NCFB between German (and European) centers
* To provide a registry of well phenotyped patients with NCFB in clinical centers potentially eligible for enrolment into clinical trials
* To track access to healthcare and cost of caring for patients with NCFB over time

Eligibility Criteria:
Inclusion Criteria:

* A clinical history consistent with bronchiectasis
* (High resolution) computed tomography (CT) scan of the chest demonstrating bronchiectasis affecting 1 or more lobes

Exclusion Criteria:

* Bronchiectasis due to known cystic fibrosis (CF)
* Age \<18 years
* Interstitial lung disease
* Prior lung or heart-lung transplantation
Multicentric Cohort of Melanoma Patients in Ile de France Area

This is a multicentric prospective cohort of all stage melanoma patients from AP-HP ,the largest consortium of University hospitals over Europe. 7 investigation sites (7 dermatological services of AP-HP) in Ile de France region are involved. 1300 patients will be enrolled and be followed during 10 years.

Melan-Cohort should constitute the first multicentric cohort with various objectives: prognostic, therapeutic, cognitive and medico-economical studies on melanoma. Patients will be recruited in all of the dermatology departments of APHP (dermatology departments from AMBROISE PARE, Saint-Louis, BICHAT-Claude Bernard,Henri-Mondor, Cochin-Tarnier, and Tenon hospitals). For all included patients, a standard file is filled comprising all anatomy-clinical useful data and epidemiologic ones, including sun exposures. Blood is harvested to collect DNA, RNA, serum, plasma at inclusion and at regular intervals and in case of progressive disease. Procedures for sentinel lymph node biopsies have been homogenized. An informed consent is obtained for each patient included in the cohort. A steering committee meets on a regular basis, and genetics or pathology subgroups have been constituted. An electronic CRF is available using the Intranet of APHP hospitals. Specimens are stored using high quality standards.

Eligibility Criteria:
Inclusion criteria :

* age ≥ 18 years
* an informed consent is obtained
* patients with anatomy-pathologically proved melanoma
* the tissue sample of melanoma is available
* the primary melanoma is treated according to the international standard
* absence of a progressive non neoplastic pathology involving life-threatening
* patient living in Ile de France region.
* time limit to entry in the cohort must be:
* within 3 months after Surgical resumption of primary melanoma;
* within 3 months after curative surgical treatment;
* with one month after diagnosis of a transit metastasis or a distant metastasis.

Exclusion criteria :

* refusal of the patient
* pathology sample isn't available
* primary melanoma not being treated according to the international standard
* patient living too far to follow regular visits
* patient diagnosed with a progressive non neoplastic pathology involving life-threatening
* too late to entry and lack of useful stored specimens to research.
Helicobacter Pylori Genome Project (HpGP)

Helicobacter pylori is a common bacterial infection. It can lead to severe stomach problems, including stomach cancer. Researchers want to look at samples of the bacteria. These H. pylori strains will be taken from chronically infected people. They want to identify the genetic and epigenetic differences in H. pylori strains. This could help predict which people who get infected with the bacteria will get stomach cancer. This could lead to the cancer being detected earlier. It could also mean less people get stomach cancer.

Objectives:

To study genetic variations of H. pylori strains based on samples from chronically infected people. To identify the features of strains that might lead to severe stomach problems or stomach cancer.

Eligibility:

People ages 30-70 years who need an upper endoscopy or who were recently diagnosed with stomach cancer

Design:

Participants will be screened by the doctor who does their procedure and a study nurse.

Participants who have endoscopy will have \~6 biopsies removed. These are tissue samples. They are about the size of a grain of rice. Participants will allow the study team to access reports from their stomach exam.

Participants with stomach cancer will donate some of the tissue that will be removed during their clinical care. They will allow the study team to access reports of their surgery. They will also allow them to access the microscope slides of their stomach.

Helicobacter pylori, a Gram-negative bacterium associated with a spectrum of benign and malignant gastric conditions, is one of the most genetically variable pathogens. Variations in a few genes have been associated with risk of inflammation and carcinogenesis, but to date no systematic study has evaluated the entire bacterial genome. We propose a multicountry study to establish and analyze an informative international collection of H. pylori clinical isolates from residents of defined geographic areas. Molecular characterization will be conducted at the NCI/DCEG. Our hypothesis is that genetic and epigenetic variations in H. pylori strains among chronically infected individuals may affect risk of progression to gastric cancer. Findings from this study may help to characterize the differential virulence among H. pylori isolates and suggest predictive biomarkers for early diagnosis of cancer. The bacterial isolates and databases from this study will also provide a foundation for further elucidation of H. pylori pathogenesis.

Eligibility Criteria:
INCLUSION CRITERIA:

H. pylori strains collected from:

1. Adult aged 30 to 70 years old.
2. Patients who need upper endoscopy (examination of the lining of their stomach with a flexible tube).
3. Patients with stomach cancer.
Pharmacokinetics/Pharmacodynamics (PK/PD) of Caspofungin in Intensive Care Unit (ICU) Patients. An Open Observational Study for Antifungal Treatment's Optimization

PK of Caspofungin in ICU septic patients might be changed as compared to healthy volunteers due to sepsis-related pathophysiology.

Sub-optimal plasma and tissue concentrations might be achieved in these patients when drugs are administered at the same dosage/regimen suggested for healthy volunteers.

Open non randomized, non controlled single center study on the pharmacokinetics of caspofungin in 20 consecutive ICU patients with severe sepsis or septic shock, requiring caspofungin therapy and PK-PD evaluation for the optimization of caspofungin therapy. The aim of this study is to describe the Caspofungin PK-PD alterations in a cohort of critically ill septic patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult ICU patients (\>18 yrs)
* Severe sepsis or septic shock
* Caspofungin therapy based on clinical judgement (empiric therapy) or microbiological result (targeted therapy).

Exclusion Criteria:

* Concomitant ciclosporin or rifampicin therapy.
* Pregnancy
* Continuous renal replacement therapy
* Severe Liver failure (Child Pugh score \> 6)
The Impact of Oxidative Stress on Erythrocyte Biology

This study will address if red blood cells transfused to a sickle cell patient from a donor with a glucose-6-phosphate-dehydrogenase (G6PD) enzyme deficiency have a different lifespan as measured by the percentage of red blood cells that survive post-transfusion compared to red blood cells transfused to a sickle cell patient from a donor without a G6PD enzyme deficiency.

This prospective, phase II, crossover, single-blind, randomized transfusion order study will address if red blood cells from donors with a G6PD enzyme deficiency have a different lifespan once transfused into a patient with sickle cell disease than red blood cells from an otherwise normal donor. Results of this critical study will guide future research and donor testing policies to ensure that patients receive the most appropriate units of blood for their condition. Each patient randomized to the study will receive 2 blood transfusions, one from a G6PD deficient donor and one from an otherwise normal donor. Half the patients (8) will receive G6PD deficient blood first while the other half (8) will receive non-G6PD deficient blood first. Patients will have a wash-out period of at least 4 months before receiving the opposite type of blood transfusion. The blood transfusion order will be randomized. There is currently no standard of testing in place to screen blood donations for G6PD enzyme deficiency. It is believed that up to 10% of the antigen-matched donors for patients with sickle cell disease are G6PD deficient, and the lifespan is unknown in the sickle cell population.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years
* Has diagnosis of sickle cell disease
* Steady state (no pain or baseline pain and ≥1 month from any hospital admission)
* Receiving chronic transfusions (i.e., regular transfusion every 4-8 weeks).

Exclusion Criteria:

* History of transfusion reactions not adequately managed by antihistamines
* Does not have crossmatch compatible red cells
* Known G6PD deficiency
* Hepato- or splenomegaly
* Participation in another therapeutic trial
* Pregnant or nursing
* HIV positive
* At investigator discretion for uncontrolled inter-current illness or social situation limiting compliance with study requirements.
* Inability to speak and/or read English
Cross Sectional CFAR HIV/COVID-19 Study

The main purpose of this research study is to learn the rate of SARS COV-2 on HIV infected children, adolescents, and youth receiving their primary HIV care at the University of Miami Miller School of Medicine.


Eligibility Criteria:
Inclusion Criteria:

* Being a patient to the Pediatric or Adolescent clinic located at Batchelor Children Research Institute (BCRI)
* Being diagnosed with HIV infection by the time of enrollment
* At enrollment, 3 to \< 26 years

Exclusion Criteria:

* Patient will be excluded from the study if any of the following are identified:
* Patients under legal age and in the State's custody
* Participant or legal guardian unable to sign Informed Consent forms
* Participant unable to complete study visits
Proof-of-concept Study to Assess the Efficacy and Safety of SRX246 in Adults With PTSD

18-week, crossover, double-blind, randomized, placebo controlled proof-of-concept study to assess the efficacy and safety of SRX246 (160 mg bid) vs placebo in 52 adult veterans and civilians with a primary diagnosis of PTSD. Subjects will be randomly assigned in a double-blind fashion to 2 groups in a crossover design. The first group will receive SRX246 for 8 weeks followed by 8 weeks of placebo, while the second group will receive placebo for 8 weeks followed by 8 weeks of SRX246. Both groups will engage in a 7-day washout period between treatments. Subjects will be assessed at baseline and then every 2 weeks during the trial using the CAPS.


Eligibility Criteria:
Inclusion Criteria:

* Medically stable, current diagnosis of PTSD

Exclusion Criteria:

* Medically unstable
Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum, Phase 2

Cantharidin is cited in the dermatology and pediatric literature as a valuable treatment option. Treatment is often available in private practice offices, where a prescribing physician may offer a non-FDA approved treatment on an individualized basis. The situation is different in many hospital and academic settings, such as our own for example, where the formulary is defined through a FDA-approved indication. The absence of an indication precludes its addition to many hospital formularies, thus limiting the options available to a prescribing physician and denying patient access to a treatment offered in the private practice setting. An indication and formulary status require controlled clinical trials on the safety and efficacy of cantharidin in MC. The objective of this trial is to see if this commercially-viable cantharidin formulation has a comparable safety and efficacy profile as formulations previously studied under conditions which most closely match the what has been historically done in the clinic.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of MC by the Principal Investigator.

Maximum of 50 lesions on locations including the face, trunk, back, left or right arm, left or right leg, hands, feet, buttocks, and groin.

Execution of Informed Consent and or assent forms

Exclusion Criteria:

Patients with immunosuppression, including organ transplantation, HIV infection.

Patients utilizing immunosuppressive agents (including oral corticosteroids) will be excluded except for patients using inhaled corticosteroids, such as those utilized for asthma or allergic rhinitis.

Females who have reached menarche and are sexually active as well as pregnant patients will be excluded as the effects of this drug have not been evaluated in pregnancy.

Patients who have greater than 50 MC lesions will also be excluded from the study.
Frailty Intervention Trial in End-Stage Patients on Dialysis

The proposed investigation for this study aims to; 1) understand the prevalence and outcomes associated with frailty among haemodialysis patients; 2) ascertain the best frailty assessment tool for haemodialysis patients, and; 3) design a clinical study to explore the feasibility of facilitating, recruiting and executing a multi-disciplinary clinical and psychological intervention to improve frailty status among haemodialysis patients.

Work package 1: Firstly, there is a need to understand the prevalence and spectrum of frailty in a UK haemodialysis cohort and what impact frailty has for haemodialysis patients. To investigate this, the investigators will approach every patient on haemodialysis within the local catchment of haemodialysis units and, after informed consent, clinically phenotype their frailty status (pre- and post-haemodialysis for calculation of variability). The frailty phenotyping will encompass a number of frailty assessments (including the Edmonton Frail Scale, Clinical Frailty Scale from Rookwood score and Fried Frailty scale) to identify the ideal frailty assessment tool. All patients in this observational cohort study will be prospectively monitored for clinical/biochemical outcomes using an informatics-based approach for up to 60 months.

Work package 2: Building upon the work conducted in work package 1, work package 2 will aim to recruit 50 patients clinically phenotyped with pre-frailty from work package 1 into a feasibility study exploring a multi-disciplinary intervention to improve frailty status. Eligible patients, after informed consent, will be randomised into active or passive intervention. The active intervention will involve a dietitian and physiotherapist who have been trained and accredited with cognitive behavior intervention, utilising established behavioral intervention frameworks, to deliver a multi-disciplinary clinical intervention targeting multiple components of frailty.

The FITNESS project will therefore answer some important unanswered questions regarding frailty among the haemodialysis population and help in the design of a large multi-disciplinary intervention study if deemed feasible.


Eligibility Criteria:
Inclusion Criteria:

* On hemodialysis

Exclusion Criteria:

* Inability to give consent
Assessment Study of Faciocraniosynostosis by Craniofacial Osteodistraction

Context. Faciocraniosynostoses present with an insufficient growth of the craniofacial skeleton due to premature fusion of skull and facial sutures. There are prenatal conditions with functional (risk of raised intracranial pressure) and morphological consequences (exorbitism, and impairment of upper respiratory airways), the severity of which justifies an early surgical treatment based on craniofacial osteotomies and osteodistraction techniques.

Distraction techniques were started in our unit eleven years ago, and never ceased to be modified: Recent improvements allowed better correction of exorbitism and therefore reduction of visual risks. But the improvements of the respiratory function remain insufficient. The initial evaluations of the respiratory functions were based on blood oxygenation monitoring, and showed real improvement. But we have routinely screened our patients with complete polysomnography examinations for the past year, and this has always revealed the existence of severe sleep apnea syndromes that we fail to correct completely, although there were slightly improved.

The aim of this PHRC protocol is :

* the qualitative and quantitative improvement of the respiratory status with a reinforced task force group including the specialists in genuine multidisciplinary approach.
* A modification of the surgical technique including modifications of the existing distraction devices, an increased number of implanted devices, and maybe a change in the surgical strategy.

Study design. This is a monocentric study, the patient being its own control. Due to the extremely low incidence of these conditions, it is foreseen to include twelve patients per year, during two years, which represent 24 patients in total with a minimum follow-up of one year.

Evaluation criteria. The main evaluation criteria are the polysomnography variables (sleep apnea index, characterization of obstructive versus central respiratory events, the oxygenation pattern through the night), which will be performed before and after surgery (6 and 12 months post-op). The secondary criteria are the exorbitism correction analysed with the globe protrusion index and the rate of infections. A multidisciplinary task force group has already been structured in Necker Hospital.

Expected results. We expect to analyze and correct all the sleep apnea syndromes. Many modifications could be made on the distractors, including removal of the activation rods, bioresorbable parts, as well as the modification of the surgical techniques.

Eligibility Criteria:
Inclusion Criteria:

* age under 18 years
* faciocraniosynostosis
* surgery indication to craniofacial osteotomies
* informed consent
* social security

Exclusion Criteria:

* no possibilities of follow-up during one year post-surgery
* history of radiotherapy
* acquired or hereditary immunodeficiency syndromes
* mental retardation
* bone conditions could not support distractors
Melatonin and Cardiac Outcome After Major Surgery

The purpose of this study is to assess whether treatment with melatonin can reduce cell damage and inflammatory stress response and thereby occurrence of myocardial injury after abdominal aortic surgery.

Abdominal aortic surgery is associated with a significant increase of oxidative and inflammatory stress response. Aortic surgery is also associated with elevated troponin which is a sensitive and specific marker for myocardial injury. The severity of oxidative stress is correlated with elevated troponin. Melatonin, which is a hormone produced in brain, seems to modify cell damage and inflammation. On the other hand we know, that melatonin production first night after surgery is disturbed. The purpose of this study is therefore to determine whether treatment with melatonin can reduce cell damage and inflammation, and thereby occurrence of myocardial injury associated with abdominal aortic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Indication for elective abdominal aortic aneurism surgery or periphery atheroscleroses with indicated protheses operation
* Patients between 18 and 80 years old

Exclusion Criteria:

* Patients with ASA class \> 3
* Anticoagulation therapy (marevan and marcoumar)
* Preoperative therapy with opioid, anxiolytic and hypnotic medication
* Renal insufficient (preoperative creatinin \> 200 mmol/l)
* Well-known liver insufficient
* Alcohol consumption (more than 5 drinks)
* Compliance (language difficulty, mental problems etc.)
* Pregnancy and breast-feeding
* Lack of written consent
Probiotics as Adjuvant Therapy in the Management of Irritable Bowel Syndrome

Studying the effects of adding probiotics to the drug regimen of patients with diarrhea predominant IBS

Irritable bowel syndrome (IBS) is a common highly prevalent functional gastrointestinal (GI) disorder that places an enormous burden on resource-challenged healthcare systems. Although many drugs have been advocated in the treatment of IBS, including psychotropic agents, antispasmodics, bulking agents, and 5-HT receptor antagonists. However, in the vast majority of instances, these medications have failed to provide adequate symptom alleviation, presumably due to the disease's diverse pathophysiology. Probiotics are "live bacteria that confer a health benefit on the host when administered in suitable doses". In IBS, a decrease in Bifidobacterium and Lactobacillus species, as well as an increase in Gamma-proteobacteria species (a family of pathogens), has been described in IBS studies. Therefore, the ability of probiotics to repair dysbiosis (qualitative and quantitative changes in the microbiota) or stabilize the host microbiota is the reason for their use in the treatment of IBS.

Eligibility Criteria:
Inclusion Criteria:

1. Age 16-55
2. Both genders
3. Patients diagnosed clinically with IBS based on Rome's criteria
4. IBS-Diarrhea only with pain \& distention
5. Duration of symptoms 6 months

Exclusion Criteria:

1. Age \> 55
2. Celiac disease
3. Inflammatory bowel disease (ulcerative colitis \& Crohn's)
4. Thyroid disease
5. Colonic CA
6. Lactose intolerance
7. Alarming features (anemia, blood in the stool, weight loss, abdominal masses, dysphagia, family history of GIT malignancy)
8. Preexisting use of antibiotics in the previous 3 months.
9. Preexisting systemic diseases