cyrilzakka/clinical-trials huggingface dataset:
Use of the xCELLigence System for Quantification of Bacterial Biofilm's Real Time Formation and Antibiotics Selection.

The aim of the study is to develop an in vitro model of growth of oral biofilms, and validate xCELLigence system for the selection of an effective antibiotic treatment for each patient.

Periodontitis in a chronic disease caused by bacteria present in the subgingival flora, which induces an inflammatory response of periodontal tissues. It has been suggested that some periodontal pathogens may be inaccessible to mechanical periodontal therapy due to its ability to invade the gingival tissues and evade defense mechanisms of the host. Therefore, it is conceivable that coadjuvant administration of antimicrobials may improve the outcome of mechanical therapy. There are several techniques to monitor periodontal pathogens and determine antibiotic therapy. But the most important disadvantage of conventional laboratory methods is that they are indirect, based on the molecular detection of 3 to 10 bacterial species, without analyzing whether the biofilm as a whole is sensitive or resistant to treatment, being a possible cause of failure and / or recurrence of the disease, in addition to the risk of development of antimicrobial resistance.

The investigators hypothesis is that the specific selection of antimicrobial treatment with the xCELLigence system allows better improvements in clinical parameters than indirect laboratory methods.

Materials and methods:

A randomized double-blind clinical trial will be launched. Samples of subgingival plaque will be taken with paper tips. Subjects included in the study will be randomized to one of 3 treatment groups: scaling and root planing combined with systemically administration of antibiotic suggested by the xCELLigence system; scaling and root planing combined with systemically administration of antibiotic suggested by 'Echevarne' laboratory and scaling and root planing combined with systemically administration of antibiotic suggested by 'Origen' laboratory.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects of 40-70 years.
2. No smokers or smokers of less than 10 cigarettes a day.
3. Patients with periodontitis stages III and IV grades A-B.
4. Presence of 20 natural teeth, including at least three molar teeth.
5. Presence of at least 4 sites with at least 6 mm probing depth.
6. Good general health

Exclusion Criteria:

1. Smokers of more than 10 cigarettes a day.
2. Patients who have received periodontal treatment in the previous 12 months.
3. Patients who have used antibiotics in the last 6 months.
4. Routine use of oral antiseptics and / or during the previous 3 months.
5. Systemic conditions that required antibiotic premedication.
6. Women pregnant or nursing.
7. Medications that could influence the outcome of periodontal therapy.
8. Any known allergies to the test antimicrobial agents.
9. Diabetics.
Evaluation of Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) Compared to Placebo and Oxis in Patients With Severe COPD

The purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

* \>=40 years of age
* diagnosed COPD with symptoms \>= 2 years
* pre-bronchodilatory FEV1 \<=50% of PN

Exclusion Criteria:

* Current respiratory tract disorder other than COPD
* history of asthma or rhinitis
* significant or unstable cardiovascular disorder
Calcium: Magnesium Balance, Microbiota, and Necroptosis and Inflammation

Transient receptor potential melastatin 7 (TRPM7), a magnesium (Mg) -regulated chanzyme possessing both ion channel and kinase activities, has a much stronger affinity to Mg2+ than calcium (Ca)2+. We previously reported that individuals with the TRPM7 GA/AA genotype and consumed diets high in Ca:Mg ratio had an increased risk of colorectal polyps. The TRPM7 gene was also observed to possess "driver" mutations that contribute to developing multiple cancers. However, the molecular mechanism remains unclear.

To identify if the gut microbiota plays a role in this association, we will investigate whether optimizing Ca:Mg intake ratios to 2.3 altered the abundance of the microbes (e.g. associated with TRPM7 genotype and the risk of metachronous polyps) at the genus level in at least one sample type among stool, swab and tissue in a double-blind 2x2 factorial (TRPM7 genotype and Ca:Mg ratios) randomized trial (Personalized Prevention of Colorectal Cancer Trial, NCT01105169).


Eligibility Criteria:
Inclusion Criteria:

• Participants from the parent study (Personalized Prevention of Colorectal Cancer Trial, NCT#01105169, IRB#100106)

Exclusion Criteria:

• Participants did not provide any stool/swab/rectal biopsy sample in the parent study
Bronchoscopy Registry

This monocentric, non-interventional observational registry study was designed in order to obtain data of patients with the indication for a flexible bronchoscopy to control and optimize a guideline conform therapy of these patients.

Aims of this registry study are documentation of the characteristics of all patients with an indication for a flexible bronchoscopy who are attended at the University Hospital Aachen (UKA) to obtain new knowledge concerning safety and patient comfort using different medications for sedation.

Therefore a routine flexible bronchoscopy is carried out, whereat the choice of analgosedation medication is for the investigators decision, independent from the study.

Subsequently the following data are collected:

* duration of medical examination
* medication (e.g. midazolam, fentanyl, propofol, lidocain)
* vital signs at the end of the examination
* complications

Furthermore the patient should be asked concerning the general tolerance for the procedure and different symptoms like emesis, feeling of suffocation, cough and pain (0 = no stress, 100 = intolerable). In addition to that the grade of amnesia and the acceptance for later bronchoscopies should be asked.

Analyzing this data will optimize the internal quality control concerning the conducted examination, collect all complications related to the analgosedation and enhance the patients comfort during a flexible bronchoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Written declaration of consent
* Patients with the medical indication for a flexible bronchoscopy

Exclusion Criteria:

* Patients who are not fulfilling the inclusion criteria or:
* Pregnant or breastfeeding women
* Participation in other studies
* Sponsor-dependent patients or patients who are working with the sponsor
* Patients without mental ability or capacity to understand and follow the instructions of the investigator
Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC

Taxane efficacy in metastatic prostate cancer is modest due to resistance development. Several clinical phase III studies in metastatic castration-naïve prostate cancer (mCNPC) patients have shown that adding an androgen receptor signalling inhibitor (ARSi) to patients receiving a taxane and androgen deprivation therapy (ADT) improves survival endpoints. Adding ARSi darolutamide to docetaxel+ADT in mCNPC patients resulted in a robust OS benefit (HR 0.68). Importantly, the combination of a taxane and darolutamide is not prone to a drug-drug interaction, while there is a detrimental CYP3A4 inducing effect in the case of enzalutamide, resulting in a significant and clinically relevant reduction of cabazitaxel plasma concentrations. The investigators have previously reported preclinical data showing that addition of an androgen receptor signaling inhibitor (ARSi) improves cabazitaxel efficacy, even in metastatic castration-resistant prostate cancer (mCRPC). As treatment options for mCRPC) patients are scarce and patients often develop drug resistance relatively early, a new treatment regimen for this population to delay drug resistance is highly desired. The investigators propose a randomized phase II trial to investigate the efficacy of docetaxel or cabazitaxel plus darolutamide compared to docetaxel or cabazitaxel monotherapy in men with metastatic CRPC, who have progressed on an ARSI.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. A confirmed diagnosis of progressive mCRPC (progression according to Prostate cancer Working Group (PCWG) 3 criteria, castration defined as castrate levels of testosterone of \<0.5 ng/mL) with an indication for docetaxel or cabazitaxel.
3. Patients should have had disease progression previously on at least one ARSi (abiraterone, apalutamide, darolutamide or enzalutamide). ARSi administration is allowed both in the mCNPC and in the mCRPC setting. Previous co-administration of docetaxel in mCNPC (triplet-therapy) is allowed, if patients will receive cabazitaxel in this study.
4. WHO performance ≤ 2
5. Able and willing to sign the Informed Consent Form prior to screening evaluations
6. Adequate haematological, renal and liver function and chemistry.

Exclusion Criteria:

1. Impossibility or unwillingness to take oral drugs
2. Hypersensitivity to taxanes
3. Known serious illness or medical unstable conditions that could interfere with this study requiring treatment (e.g. HIV, hepatitis, Varicella zoster or herpes zoster, organ transplants, kidney failure, serious liver disease (e.g. severe cirrhosis), cardiac and respiratory diseases)
4. Symptomatic peripheral neuropathy CTCAE grade ≥2
5. Docetaxel-rechallenge.
A Real-world Study of Cardiac Ablation for PSVT Using ST Catheter

Paroxysmal supraventricular tachycardia known as PSVT includes atrioventricular reentrant tachycardia (AVRT) and atrioventricular nodal reentrant tachycardia (AVNRT).

This study is multicenter, retrospective, cohort study. This study will collect real world data of AVNRT and AVRT cohorts retrospectively to evaluate the effectiveness and safety in real world clinical practice. 300 subjects with PSVT will be consecutively enrolled backwards since 02 Nov 2017, and at least 100 subjects for each cohort.

Cohort one: AVNRT Cohort two: AVRT, including Wolff-Parkinson-White syndrome（WPW）


Eligibility Criteria:
Inclusion Criteria:

1. Waiver of informed consent is approved by Ethics Committee, or follow methods approved by Ethics Committee to get patient's informed consent (such as get informed consent by telephone contact, etc.).
2. Patients diagnosed as atrioventricular reentrant tachycardia (AVRT), atrioventricular node reentrant tachycardia (AVNRT) after surgery/discharge, and the existing source records must include 1) at least 1 copy of preoperative ECG or intraoperative electrophysiological examination results;2) Information about the acute procedure outcome.
3. Patients were ablated by ST catheter.
4. Adult patients 18 years or older.

Exclusion Criteria:

1. Contraindications for the use of ST catheters, including:

   1. Ventriculotomy or atriotomy was performed within 8 weeks before the procedure;
   2. Presence of myxoma or intracardiac thrombus;
   3. fitted with artificial valves;
   4. Active systemic infection;
   5. Atrial septal patch.
2. Pregnant women
Deep Learning Model for Diagnosis and Contour of Cervical Lymph Node for Nasopharyngeal Carcinoma

The diagnosis of cervical lymph node in nasopharyngeal carcinoma is difficult. Magnetic resonance imaging based deep learning model may be a noninvasive and rapid diagnostic method for cervical lymph node. Thus, the investigators aimed to develop and externally validate a deep learning model to assist in the diagnosis and localization of metastatic lymph nodes in nasopharyngeal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of nasopharyngeal carcinoma; Cervival lymph nodes confirmed by pathology

Exclusion Criteria:

* a history of cancer
Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects

The purpose of this study is to evaluate the best timing for administering pneumococcal vaccine (PV) to HIV-infected adults that have CD4 cell counts of more than 200 and are not yet receiving combination antiretroviral treatment (ART). Participants in this study will be assigned by chance to receive vaccination with PV prior to starting ART or after at least 6 months of ART. Antibody levels to components of the PV will be measured at 6 months and 12 months after vaccination. The results will tell us if patients that receive PV after 6 months of ART have better response to the vaccine than those that get vaccinated prior to treatment.


Eligibility Criteria:
Inclusion Criteria:

* HIV infected
* CD4 count \>200
* no acute illness
* no pneumococcal vaccination within 3 years
* naive to treatment or if previously on treatment, no antiretroviral treatment for at least 6 months
* willingness to start antiretroviral treatment as recommended by current guidelines

Exclusion Criteria:

* prior pneumococcal vaccination within 3 years
* prior AIDS diagnosis based on opportunistic disease
* acute illness
TESS Shoulder Arthroplasty Data Collection

This observational study intends to collect efficacy and safety data on TESS shoulder system

The T.E.S.S.® shoulder system has been developed to provide a complete solution for all the indications for Shoulder Arthroplasty, Arthritis, Rotator Cuff Arthropathy, Proximal Humeral Fracture, minimising bone resection and restoring the natural anatomy of the patient.

Eligibility Criteria:
Inclusion Criteria:

* A pre-operative level of pain and function the same as for conventional joint replacement
* A likelihood of obtaining relief of pain and improved function
* Full skeletal maturity
* Ability to follow instructions
* Good general health for age
* Willing to return for follow-up evaluations

Exclusion Criteria:

* Glenohumeral joint infection, osteomyelitis
* Neuro-muscular complications
* Inability to co-operate with and complete the study
Antidepressant Monotherapy on Depressive and Anxiety Symptom in Chinese Patients

The primary objective is to evaluate the improvement of antidepressant monotherapy on depressive and anxiety symptom in Chinese patients who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for the comorbidity of major depressive disorder (MDD) and generalized anxiety disorder (GAD)

To evaluate the improvement of the quality of life of antidepressant monotherapy on Chinese patients who meet DSM-5 criteria for the comorbidity of MDD and GAD. To monitor adverse events (AEs) and serious adverse events (SAEs) of antidepressant monotherapy

Eligibility Criteria:
Inclusion Criteria:

1. First episode outpatients in department of psychiatry, aged 18-65 years
2. Comorbidity of MDD and GAD according to DSM-5 criteria Hamilton Depression score (HAMD) of ≥18 at screening
3. HAMA≥14 at screening
4. Medically stable
5. Provision of written, informed consent.

Exclusion Criteria:

1. Suicide ideation
2. Use antidepressants within at least 14 days before study begin
3. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence)
4. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse within 4 weeks prior to enrolment
5. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension, renal or hepatic dysfunction, cerebrovascular disease ) as judged by the investigator
6. Women in pregnancy or lactation
7. Medical conditions that would affect absorption, distribution, metabolism or excretion of study treatment.
8. Medical history with seizure disorder, except for febrile convulsion
9. Participation in another clinical study within 4 weeks (or longer time according to the local requirement)
10. Receive Electroconvulsive therapy (ECT) before study begin
SMART Stimulation: Precision Neuromodulation of Cognition in Older Adults

The current study will investigate methods for enhancing cognitive training (CT) effects in healthy older adults by employing a combination of interventions facilitating neural plasticity and optimizing readiness for learning. A pilot randomized clinical trial will examine the individual and combined impact of pairing cognitive training with transcranial direct current stimulation (tDCS). A precision dosing algorithm will be used to determine the appropriate levels of current and location of electrodes to deliver current using tDCS.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Age: 65 to 89 years
* English speaking
* Physically mobile
* Working memory function between 0-75th percentile determined by screening results on the POSIT Baseline Cognitive Training computerized tasks.

Exclusion Criteria:

* Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury).
* Evidence of dementia (NACC UDS scores of 1.5 standard deviations below the mean for age, sex and education adjusted norms in a single cognitive domain on the task).
* Past opportunistic brain infection
* Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis or severe major depression and/or suicidality.
* Unstable (e.g., cancer other than basal cell skin) and chronic (e.g, severe diabetes) medical conditions.
* MRI contraindications (e.g., pregnancy, claustrophobia, metal implants that are contraindicated for MRI).
* Physical impairment precluding motor response or lying still for 1 hr and inability to walk two blocks without stopping.
* Certain prescription medications may possibly reduce effects otherwise induced by the tDCS stimulation protocol.
* Hearing or vision deficits that will not allow for standardized cognitive training stimulation; ie colorblindness, inability to hear through headphones (with or without hearing aids), macular degeneration or other significant diseases that cause severe loss of vision. If vision is corrected with lenses to appropriate levels, then participant will be eligible.
* Left handedness, as those with left-handedness have a higher percentage rate of atypical functional lateralization for brain functions, which would significantly interfere with interpretability of brain data.
* Participants with precision tDCS dosage of \>4.0mA required will be excluded due to limitations of tDCS device (maximum output of 4.0 mA). The maximum output of 4.0 mA reflects a technical limitation of the device design rather than a safety threshold.
A Clinical Study of MK-1084 in Participants With Renal Impairment (MK-1084-010)

The goal of this study is to learn what happens to MK-1084 levels in a person's body over time. Researchers will measure what happens to MK-1084 levels in the body when it is given to people with moderate or severe renal impairment (RI) (meaning the kidneys do not work properly) as compared to people who are in good health. Researchers also want to learn about the safety of MK-1084 when it is given to people with RI and if people with RI can tolerate it.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

All participants:

- Has a BMI ≥18.0 and ≤40.0 kg/m\^2

Participants with severe or moderate RI:

* With the exception of RI, is sufficiently healthy for study participation
* Has stable renal function with no clinically significant change in renal status at least 29 days prior to dosing and is not currently or has not been previously on dialysis for at least 1 year

Participants with normal renal function:

- Is medically healthy

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

All participants:

* Has a history of cancer (malignancy)
* Has positive results for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus
* Has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing

Participants with severe or moderate RI:

* Has a history or presence of renal artery stenosis
* Has a renal transplant or nephrectomy
A Randomized Multicenter Study of Daylight Mediated Photodynamic Therapy (PDT)

A randomised, multi-center study of daylight mediated photodynamic therapy (PDT) with Metvix in patients with multiple actinic keratosis on the face and/or scalp.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older, 5 AK in face and scalp

Exclusion Criteria:

* immunosuppression
Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients

The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.

This is a combined analysis using 81 patients randomized and treated in CRAD001A2419 (NCT00154284) with 33 randomized and treated in CRAD001A2423 (NCT00170807). This approach is reflected in the protocol amendments for each study, and the one clinical study report for both.

Eligibility Criteria:
Inclusion Criteria:

* Recipients of a first renal transplant from a primary cadaveric or non-HLA identical living related donor.
* Renal cold ischemic time \< 36 hours.
* Age of donor \< 65 years.

Exclusion Criteria:

* Patients who have received an investigational drug within 4 weeks of baseline period.
* Patients who are recipients of multiple organ transplants, including any organ other than kidney.
* Recipients of non-heart beating donor organs.

Other protocol-defined exclusion criteria may apply.
Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation

To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation (NVAF)and to obtain information on pharmacokinetics and pharmacodynamics (anti-thrombotic potential) in the target population


Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible for the study if all of the following apply:

* Subject has paroxysmal permanent or persistent NVAF
* Subject has INR of 2.0 or below and an aPTT ≤ 1.5 times the upper limit of normal at the baseline visit.
* Legal minimum age requirement (country-specific).
* Written informed consent has been obtained.

Exclusion Criteria:

* History of heart valve disorders
* History of rheumatic fever.
* History of stroke and/or systemic embolism (including TIA).
* History of Acute Coronary Syndrome (ACS).
* Indication for warfarin other than NVAF.
* Known hemorrhagic disorder and/or coagulation disorder.
* Active bleeding or any condition associated with increased risk of bleeding.
Sleep and Type 1 Diabetes

The primary goal of the study is to determine whether insufficient sleep is associated with poor glycemic control in type 1 diabetic children. Secondary goals aim to determine whether salivary amylase could be an easily accessible and non-invasive biomarker of sleep loss and somnolence, and whether insufficient sleep is linked to body composition. Sleep characteristics, glycemic control, salivary amylase and body composition will be assessed 3 times, at 3-4 months intervals, in 82 type 1 diabetic children.


Eligibility Criteria:
Inclusion Criteria:

- Female and male type 1 diabetic children and adolescents who are followed at the Woman, Mother and Child's Hospital (Hôpital Femme Mère Enfant : HFME) of Bron, France.

Exclusion Criteria:

* Refusal of consent of the parents or the child or the adolescent
* Pregnancy
* Concomitant pathology that severly impacts sleep
* Implanted electrical stimulation device
* Diagnosis of type 1 diabetes \<1 year