cyrilzakka/clinical-trials huggingface dataset:
Microbial Infection and AMR in Hospitalized Patients With Covid 19

To detect microbial infection and AMR associated with COVID 19 infection.

To correlate risk factors of COVID 19 patients with microbial infections and their effects on disease.

The most common type of infection among ICU patients was bacterial or fungal pneumonia; bloodstream and urinary tract infections were also noted. Organisms cultured from patients included pandrug-resistant Acinetobacter baumannii, Klebsiella pneumoniae carbapenemase-producing K. pneumoniae, extended-spectrum β-lactamase (ESBL)- producing K. pneumoniae, ESBL-producing Pseudomonas aeruginosa, Enterobacter cloacae, Serratia marcescens, Aspergillus fumigatus, Aspergillus flavus, Candida albicans, and Candida glabrata .

Eligibility Criteria:
Inclusion Criteria:

* Patients with Covid infection

Exclusion Criteria:

* Patients without covid 19
A Non-interventional, Post Marketing Surveillance (PMS) Study of Tresiba® (Insulin Degludec) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India

This study is conducted in Asia. The aim of the study is to evaluate long term safety and efficacy of Tresiba® (insulin degludec) in patients with diabetes mellitus in routine clinical practice in India.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study-related activities (Study related activities are any procedure related to recording of data according to the protocol). The historical data including the data before informed consent obtained (e.g. glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG), severe hypoglycaemia before the start of Tresiba® therapy) can be used for baseline data
* Patients with insulin requiring diabetes mellitus and who is scheduled to start treatment with Tresiba® based on the clinical judgment of their treating physician

Exclusion Criteria:

* Known or suspected allergy to Tresiba®, the active substance or any of the excipients
* Previous participation in this study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Patients who are or have previously been on Tresiba® therapy
* Patients who are participating in other studies or clinical trials
* Patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months
Self-Efficacy Enhancing Interviewing Techniques Study

Patient self-efficacy, or confidence in one's ability to take the necessary steps to achieve a goal, has been shown to influence a number of important health behaviors and outcomes. However, current ways of increasing patient self-efficacy are time and labor intensive and occur away from doctor visits, where most health care is delivered. We developed, and are testing in a study the effectiveness of a new way of teaching doctors how to talk to patients during office visits in a way that will boost their patients' self-efficacy for changing important health behaviors.


Eligibility Criteria:
Inclusion Criteria:

* Family medicine or internal medicine residents in training at the University of California Davis Medical Center

Exclusion Criteria:

* None
A Study Comparing Irinotecan and Cisplatin (IP) With Etoposide and Cisplatin (EP) Following EP/TRT for LD-SCLC

To evaluate the role of 3 cycles of irinotecan and cisplatin for patients with limited-stage small-cell lung cancer who received one course of etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic irradiation.

The Japan Clinical Oncology Group (JCOG) previously conducted a randomized phase III trial comparing irinotecan and cisplatin (IP) with EP in patients with extensive-stage SCLC. The response rate and overall median survival were significantly better for IP, i.e. 84.4% and 12.8 months with IP, versus 67.5% and 9.4 months with EP, respectively. The 2-year survival rates were 19.5% for IP and 5.2% for EP (7). These encouraging results prompted us to explore the use of IP in LSCLC.

Eligibility Criteria:
Inclusion Criteria:

1. cytologically, histologically proven small-cell lung cancer
2. limited disease
3. age 20-70 years old
4. performance status of 0-1
5. measurable disease
6. no prior treatment for small-cell lung cancer
7. no history of chemotherapy
8. adequate organ functions
9. written informed consent

Exclusion Criteria:

1. pericardial effusion
2. active concomitant malignancy
3. pregnant or lactating women
4. interstitial pneumonia/active lung fibrosis on chest x-ray, watery diarrhea, intestinal obstruction or paralysis, uncontrolled heart disease or a history of myocardial infarction within the previous 6 months, uncontrolled diabetes mellitus, active infection, psychological disease deemed unacceptable for inclusion to the study, long-term steroid treatment.
Dietary Supplements for Reduction of Intestinal Permeability Levels

A randomised and controlled trial, in which the effect of a dietary supplement is evaluated for reduction of intestinal permeability levels of subjects with high levels of zonulin in feces

Randomized clinical trial, with masking of the statistician and the evaluator, to assess the effect of a food supplement, composed of substances that promote intestinal mucosa repair, on the levels of zonulin in feces and consequently on intestinal permeability. A control group of subjects not receiving any type of supplementation will be used to compare the effectiveness of the treatment.

The main objective of this study is to determine if the use of a dietary supplement composed of glutamine, butyrate and lion's mane, among others, corrects the levels of zonulin in feces.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between 18 and 65 years of age with elevated levels of zonulin in stool (greater than 80 ng/ml).

Exclusion Criteria:

* Taking any type of antibiotic in the last month
* Taking prebiotics or probiotics products in the last month.
* Taking laxatives in the last month.
* Undergoing any medicinal treatment
* Pregnancy
* Subject with a history of current gastrointestinal pathology or disorder such as: acute colon pathology, acute haemorrhagic colitis, suspected digestive perforation, recent abdominal surgery, severe arterial hypertension, abdominal hernia, colon neoplasia, history of cardiac syncope, renal failure, liver cirrhosis, epilepsy, severe psychiatric illness (psychosis), necrosis due to abdominal irradiation, severe anaemia, severe neurovegetative lability.
Outreach and Choice in Colorectal Cancer Screening

The primary objective of this clinical trial will be to compare overall colorectal cancer (CRC) screening participation between an active choice (fecal immunochemical test \[FIT\] or colonoscopy) and a sequential choice (FIT offered first, then colonoscoscopy offered in those still unscreened) arm. Secondarily, we will (1) compare the proportions of FIT vs. colonoscopy per arm, (2) compare active choice vs FIT only in the initial 3 months of the study, (3) characterize changes in physician knowledge and attitudes regarding CRC screening before and after an educational seminar delivered at the launch of the initiative, (4) characterize perceptions regarding the effect of the intervention on clinical practices, and (5) compare detection rates of CRC, adenomas and SSLs per arm, and the operational results of the outreach program across arms.


Eligibility Criteria:
Inclusion Criteria:

1. Adults 45-75 years of age not up to date with CRC screening, and without precancerous polyp history (i.e. not in post-polypectomy surveillance; ascertained based on problem list or colonoscopy results letter).
2. The assessment of screening status will happen monthly, on a rolling basis.
3. Definition of being up to date with CRC screening includes any one of the following:

   i) FIT or guaiac-FOBT within 1 year, OR

ii) Colonoscopy within 10 years, OR

iii) Sigmoidoscopy within 5 years, OR

iv) CT colonography within 5 years, OR

v) Cologuard within 3 years

Exclusion Criteria:

1. Age outside the 45-75 range.
2. History of precancerous polyps requiring colonoscopy surveillance.
3. Already being up to date with CRC screening, as defined above.
4. Evidence of total removal of the colon which would eliminate the need for screening.
The Impact of Arts-Based Interventions on Patient Hospital Experience

nuts and bolts

interventions and timing of interventions

Eligibility Criteria:
Inclusion:

* Inpatient on either Bone Marrow Transplant ICU or High Risk Obstetrics Unit
* Estimated length of stay 2 or more weeks
* Age \>18
* Patients who will potentially benefit from the AIM experience

Additional Inclusion Criteria:

* For the High Risk Obstetrics Unit group (hand-sewing), patients should be physically able to participate in hand-sewing activity.
* For the Bone Marrow Transplant IUC group (story-telling/poetry), patients should be physically able to participate in story-telling/poetry activity.

Exclusion:

* Patient too ill
* Complex medical condition that requires therapies which would not allow time for participation
* Declined to participate
* Age \<18
Study of the Efficacy of 532nm Laser and 1064 nm Laser in the Treatment of Cutaneous Lupus Erythematous Versus Topical Corticosteroids Alone

This study aims to compare the efficacy of 532nm Potassium Titanyl Phosphate (KTP) laser and 1064 nm Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) laser as adjuncts to topical corticosteroids in the treatment of cutaneous lupus erythematosus versus topical corticosteroids alone.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adult 18 years of age or older
* Ability to rate level of pain
* Ability to rate visual satisfaction
* At least 2 active lesions of CLE

Exclusion Criteria:

* New or change in systemic medication for cutaneous lupus in past 6 months
* Allergy to triamcinolone or betamethasone dipropionate cream
* Pregnancy
* Currently a prisoner
* Unable to read and speak English since consent will only be available in English
Dry Needling, Manual Therapy and Exercise for Neck Pain Management

Since neck pain is the fourth highest disabling condition (with an estimated point prevalence of 20%, lifetime prevalence up to 70% and high recurrence rates), dry needling targeting myofascial trigger points in neck muscles has been proposed as an effective treatment for reducing pain and disability in patients with chronic neck pain.

A recent meta-analysis reported whether dry needling could be recommended for this population. Low to moderate evidence suggests that dry needling can be effective at the short-term, but its effects on pressure pain sensitivity or cervical range of motion are limited.


Eligibility Criteria:
Inclusion Criteria:

* To be between 18 and 65 years old
* To have been experiencing unilateral neck pain for at least 3 months
* To have a Neck Disability Index (NDI) score \>8
* To have a Visual Analogue Scale (VAS) score \>3
* To have at least one active MTrP located in the upper trapezius or cervical multifidus muscles

Exclusion Criteria:

* History of whiplash injury
* Previous cervical surgery
* Cervical radiculopathy or myelopathy
* Diagnosis of fibromyalgia
* Additional analgesic treatments during the study (e.g. physiotherapy or drugs)
* Psychiatric disorders
* Any contraindication to the interventions proposed (e.g. fear of needles or anticoagulants)
Optimisation of Antipsychotic Drug Use in Older People

Drugs such as amisulpride, known as antipsychotic drugs, are used to treat troublesome and distressing symptoms in older people. Although these drugs can be beneficial, they are associated with side effects, particularly in patients with dementia and schizophrenia- like illness. There is an urgent clinical need to understand why this is the case, to guide treatment strategies.

This study aims to utilise brain imaging techniques that measure the action of antipsychotic drugs in the brain to explore the causes of this susceptibility in older people with dementia and schizophrenia-like illness, and translate these findings into direct patient benefit.

The aim of the study is to investigate and compare the relationship between the action of amisulpride at brain sites during the first 10 weeks of amisulpride treatment in two patient groups - Alzheimer's disease and schizophrenia-like illness. Imaging data will be combined with data on drug dosage, levels of drug in the bloodstream and clinical response (symptom reduction and motor side effects) during dose titration.Dose-response modelling will be carried out in both groups to establish the minimum clinically effective dose of amisulpride, optimum dose range and impact of variability and covariates on exposure-response relationships


Eligibility Criteria:
Inclusion Criteria

Treatment and Control (antipsychotic free) Group

Schizophrenia

* meet diagnostic criteria for schizophrenia-like illness
* aged between 60 and 95 years of age
* score \<6 on the Geriatric depression scale

Alzheimer's

* meet diagnostic criteria for AD
* score \<=4 on the Modified Hachinski Ischaemia Scale
* score \< 8 on a modified version of the UPDRS
* aged between 60 and 95 years of age
* score \<6 on the Geriatric depression scale

Exclusion Criteria

Treatment Group

Schizophrenia

* current or past history of addiction, traumatic brain injury or epilepsy
* prescribed any drug that interferes with brain dopamine in past 2 weeks (6 weeks if depot antipsychotic medication).
* medical conditions that might affect Ability to tolerate a brain scan
* unable to give informed consent

Alzheimer's

* current or past history of psychiatric illness, traumatic brain injury or epilepsy
* prescribed an antipsychotic or other oral drug that interferes with brain dopamine function within the past 2 weeks (6 weeks if depot antipsychotic medication).
* medical conditions that might affect a person's ability to tolerate a brain scan

Control (antipsychotic free) Group

Schizophrenia

* Prescribed psychotropic medication
* unable to give informed consent

Alzheimer's

• Prescribed psychotropic medication
BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test

To explore the efficacy and safety of four BAY1003803 formulations by means of a within subject comparison in an open Psoriasis Plaque Test


Eligibility Criteria:
Inclusion Criteria:

* Male and female (non-childbearing potential) volunteer with stable plaque-type psoriasis, but otherwise healthy
* Age: 18-64 years

Exclusion Criteria:

* Severe disease within the last 4 weeks prior to the first study drug administration as determined by the investigator
* Any topical antipsoriatics on plaques potentially to be treated in this trial (including corticosteroids, vitamin D analogues, immunomodulators, retinoids, dithranol and tar, except for salicylic acid (Pretreatment) in the 4 weeks before first treatment and/or planned during the trial, except for allowed topical treatment on the face, ears and scalp
* Systemic treatment depending on kind of treatment within 4 weeks and 6 months prior and/or planned during the trial
* Treatment with concomitant medication that may affect and provoke or aggravate psoriasis, e.g. antimalarial drugs, lithium, beta-blockers or angiotensin-converting-enzyme inhibitors (AEC inhibitors) unless on a stable dose for 3 months before study medication initiation
* Clinico-chemical parameters of clinically significant deviation
Postoperative Delirium After Kidney Transplantation

This project is a retrospective evaluation of the routine data of patients who underwent a kidney transplant at the Charité Campus Mitte between January 2015 and December 2019 (until the corona pandemic).

Post-anesthetic complications such as delirium can occur in patients after kidney transplantation. We would therefore like to characterize pathophysiological changes after transplantation of the kidneys and, if necessary, gain diagnostic and therapeutic knowledge. The purpose is to study postoperative delirium after kidney transplantation.

Eligibility Criteria:
Inclusion Criteria:

* All patients 18 years and older who underwent kidney transplantation and who were admitted to Post-intensive care unit or to an Intensive care unit at the Campus Charité Mitte

Exclusion Criteria:

* Incomplete data records of the parameters to be determined
* Underage Patients
Acute Coronary Syndrome in Patients With COVID-19

The aim of this study was to find a clinical or laboratory parameter, that would help in distinguishing between COVID-19 patients with myocardial infarction (MI), who have an infarct-related artery (IRA) and therefore, require immediate revascularization, and those, who have no IRA.

The coronavirus pandemic has hit the world with its vast contagiousness, high morbidity, and mortality Apart from the direct damage to the lung tissue, the corona virus infection is associated with multiple organ damage, including the heart. Emerging evidence reveals a direct correlation between COVID-19 and cardiovascular complications, such as heart failure, myocarditis, arrhythmias, conduction abnormalities and acute coronary syndromes. The SARS-CoV-2 infection can frequently induce coagulation abnormalities that are associated with cardiopulmonary deterioration and death as a possible complication in all patients, despite presence or absence of concomitant risk factors and diseases. In addition, many patients with severe COVID-19 undergo thromboembolic events, which seem to be related to this particular coagulopathy. One of the most unpleasant and life-threatening types of thromboembolism is the one involving the coronary circulation, thus causing a heart attack. Many additional problems arise due to this condition e.g., access to a Cath lab, exposure of additional medical personnel, more complications and increased mortality for the patients.

Invasive angiography for COVID-19 patients is logistically challenging and, in some cases, there is no intervention target, since microcirculatory disease and thrombosis is common in this group. Therefore, the investigators studied in detail the case series of 10 patients referred for primary percutaneous coronary intervention (pPCI) for MI in our catheterization laboratory during the course of COVID-19 infection. And the investigators set themselves the purpose to evaluate if there are some factors or parameters that could predict the presence of an interventional target - infarct related artery (IRA), prior to catheterization, and to determine their sensitivity and specificity.

Eligibility Criteria:
Inclusion Criteria:

* Acute coronary syndrome (ACS)
* COVID-19 infection

Exclusion Criteria:

* No combination of ACS and COVID-19 infection
Effects of Intranasal Corticosteroid and Montelukast On Nasal Allergen Challenges*

This study will be a randomized, double blind, placebo-controlled, parallel group study and will include subjects with ragweed-induced seasonal allergic rhinitis.

The primary goal of this proposal is to assess the ability of an intranasal corticosteroid, fluticasone, and montelukast to affect the upper airway and systemic physiologic, biologic and clinical parameters occurring after an early and late upper airway allergic response to ragweed in ragweed allergic rhiniticsThe assessment of early allergy responses in the nose has been fairly well established in our laboratory and we will use methods detailed in previous publications (21, 23 24). One potential challenge will be to sample upper airway mediators and cytokines without affecting clinical parameters such as symptom scores and acoustic rhinometry readings. Moreover, we will need to sample at time points throughout six or more hours in order to accurately determine the effects on late phase allergic responses. Nasal filter paper sampling is a technique that we are currently engaged in using, and we will work with Roche to elute the samples and measure multiple mediators and cytokines.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 19-60 years.
* Females of child bearing potential must use appropriate birth control throughout the study and urine pregnancy tests must be negative prior to dosing at each study visit.
* Subjects with a documented history of ragweed-induced seasonal allergic rhinitis requiring pharmacotherapy during the preceding 2 allergen seasons.
* Subjects with a positive skin prick test to short ragweed (Amb a 1) extract, defined as \>3mm wheal larger than saline control
* Subjects spirometry FEV1 must be \> 80% predicted prior to each allergen challenge
* Subjects average post diluents nasal congestion score must be \< 1 at admission for each study visit

Exclusion Criteria:

* Subjects with evidence or history of clinically significant medical illnesses other than changes related to allergic rhinitis. Subjects with some stable chronic medical conditions not expected to interfere with the conduct or safety of the study may be eligible to participate based on the investigator's discretion.
* Subjects with a history of asthma or urticaria, or a screening FEV1 prior to allergen challenge of \<80% of predicted. in FEV1 compared to pre-diluent FEV1 baseline at either screening visit.
* Subjects with significant nasal deformity, recent nasal surgery nasal polyps or chronic rhinosinusitis.
* Subjects who have smoked in the last 6 months or have a history of \>10 pack years.
* Subjects who are taking or have taken restricted concomitant medications that could confound the safety or efficacy assessments including those shown below.
* Subjects who have history or evidence of alcohol or drug abuse.
* Subjects exposed to cat and have a positive skin test to cat.
* Subjects that have a positive skin test to dust mite (D pteronyssinus/ D farinae) requiring pharmacotherapy
Fecal Microbiota Transplantation in Pediatric Crohn's Disease

This study will test the safety and effectiveness of fecal microbiota transplantation (FMT) plus partial enteral nutrition (PEN) in refractory pediatric Crohn's disease (CD) who have failed conventional treatment

Recent studies have suggested that gut imbalance and deregulation of immunological responses plays a pivotal role in the disease development of Crohn's disease (CD), and that FMT could be a useful treatment. Our study is aims to repeated and multiple FMTs plus PEN in the treatment of refractory pediatric CD. In the induction stage of CD, standard therapy remained unchanged, FMT and PEN were added, and FMT was given 1-2 courses, 3-6 times per course. In the maintaining stage, FMT was performed every 3 months, with the same 3-6 times of FMT treatment for each course, and the withdrawal of conventional drug therapy was gradually reduced. Refractory CD was defined as refractory to standard therapy (e.g., steroids, immunomodulators, cyclosporine, tacrolimus, or anti-TNF agents).

Eligibility Criteria:
Inclusion Criteria:

Aged 2-16 years and without genetic diseases; All refractory pediatric with mild-to-moderate CD; Mild-to-moderate CD, defined by the pediatric Crohn's disease activity index (PCDAI) \>10 and ≤40 and Simple Endoscopic Score for CD (SES-CD) \> 3 were enrolled in the study; refractory CD, defined by children who failed conventional treatment (hormone, immunosuppressant, biologics)

Exclusion Criteria Children who were treated by PEN (80%) less than 8 weeks; follow up less than 3 months; known contraindication to all FMT infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy, enema and Fecal capsule; unwilling to give informed consent/assent