cyrilzakka/clinical-trials huggingface dataset:
Preoperative Magnetic Resonance (MR) Imaging of Prostate Cancer

The investigators want to evaluate if preoperative MRI improves the surgical results, especially in respect to surgical margins. The impact on the surgical procedure will be evaluated.

In addition the investigators will examine the accuracy of tumor detection, localization and staging.

Background:

During the last two decades, Magnetic Resonance Imaging (MRI) of the prostate has evolved to become a promising tool in preoperative evaluation of prostate cancer. Several studies have evaluated the radiological and histopathological correlation. However, the sensitivity and specificity in regard to staging have shown wide ranges and poor reproducibility. These discrepancies can be explained by difference in patient selection, MRI methods, and criteria used for diagnosis. More studies are therefore needed to evaluate the clinical impact of preoperative MRI in patients with prostate cancer.

Aims of the study:

To evaluate 1) detection rate of tumor 1-3 (tumor 1 = index tumor), size of tumor 1-3, possible extraprostatic extension and predict presence of Gleason grade 4 and 5 tumor, 2) the influence of preoperative MRI on the surgical decision process with respect to the operative procedure for removal of the gland and pelvic lymph node dissection, and 3) the impact of preoperative MRI on the rate of positive surgical margins and functional results.

Material and method:

A prospective study including 400 consecutive patients referred to robot assisted laparoscopic prostatectomy randomised to preoperative MRI (intervention group) and no MRI (control group). The prostatectomy specimens will be histopathologically examined, and TNM classification will be performed according to 2002 AJCC standard.

Eligibility Criteria:
Inclusion criteria

* All patients suitable for surgery.
* Positive biopsy (Gleason grade \>3).
* Informed consent.

Exclusion Criteria:

* Patients who do not sign the consent paper for any reason or do not accept the study premises.
* Patents who want to withdraw for any reason during the study.
* Patients with contraindications to MRI (pacemaker, claustrophobia etc) and/or surgery.
* Patients who have undergone a high quality MRI examination of the prostate at another radiological center. In this situation the MR examination is evaluated together with the surgeon but the patient is not included in the study. (In case of a low quality examinations, we will disregard the findings, and include the patient).
* If the surgeon finds it unacceptable to perform RALP without MRI, because of various reasons (eg. patient demand, too high risk etc) the patient will not be included in the study.
* If preoperative MRI reveals extensive tumor invasion into adjacent organ (T4) or skeletal metastases (M1), as these cancer stadiums do not benefit from RALP.
EndoClot for Preventing Rebleeding After Endoscopic Mucosal Resection (EMR)

Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment techniques of gastrointestinal small lesions. Postoperative rebleeding is one of the common complication following EMR. Several endoscopic hemostasis methods are currently in use. EndoClot® absorbable polysaccharide hemostat (PAPH) as a new hemostasis material was previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic application remains unknown. This study has been designed to observe the effect of rebleeding prevention after EMR.


Eligibility Criteria:
Inclusion Criteria:

* consecutive cases of colorectal polyps and submucosal lesions with anticipated complete removal endoscopically by EMR.

Exclusion Criteria:

* severe cardiovascular diseases, liver and kidney dysfunction;
* platelet and coagulation dysfunction (PLT \< 50\*109/L, INR \> 2);
* cases that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 1 month before the procedure;
* cases unavailable for follow-up.
Video-Interpreting in an Emergency Trauma Room Setting - a Feasibility Trial

Background: Global migration increases the likelihood of language barriers. In medical situations language barriers have a negative effect on quality of treatment and thus endanger patient safety.

In-hospital settings feasibility of video-translation has been demonstrated, yet there is lack of evidence in emergency trauma rooms. There, the physicians have to deal with time-critical decisions. Aims: This feasibility trial aims to investigate technical feasibility, usability as well as the impact on decision-making (e.g. alteration of treatment strategies). Methods: In this study 50 responsive patients with language barriers will be included. The anesthesiologic emergency physician will start video-translation via a tablet. Feasibility, quality of communication, usability as well as changes in diagnosis and treatment will be gathered and analyzed.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, at least 18 years old
* awake, responsive patients
* language barrier (Albanian, Dari, Romanian, Turkish, Modern Standard Arabic, Arabic, Farsi, Russian, Hungarian, Bosnian-Croatian-Serbian, Kurdish (Kurmanci), Slovakian, Bulgarian, Polish, and Czech)

Exclusion Criteria:

* unconscious patients
* cardiac arrest patients
* delay of treatment due to e-translation
* refusal of video-translation by the patient
Study of Therapeutic Monitoring of Mycophenolate Mofetil (MMF/CellCept) After Kidney Transplantation

This three-arm study will evaluate the efficacy and safety of various dosing regimens of MMF combined with various dosing regimens of calcineurin inhibitor (CNI), either cyclosporine or tacrolimus, in participants who have undergone kidney transplantation. Participants will be randomized to one of three dosing regimens to receive concentration-controlled MMF with reduced CNI, concentration-controlled MMF with standard CNI, or fixed-dose MMF with standard CNI. Participants will be followed for 20-24 months after randomization.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 13-75 years of age
* Single organ recipient (kidney only) from living (related or unrelated) or cadaveric heart-beating donors
* Receiving first or second kidney transplant

Exclusion Criteria:

* Immunosuppressive therapy (except for 48 hours prior to transplantation and corticosteroid treatment) within previous 28 days for a first transplant and 3 months for a second transplant
* History of malignancy in last 5 years (except successfully treated localized non-melanoma skin cancer)
A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)

This is a prospective, observational, non-interventional, multicenter, post-marketing surveillance study to mainly collect safety information from subjects with locally advanced and recurrent/metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) treated with cetuximab based on the locally approved label.

Cetuximab is an immunoglobulin G1 (IgG1) monoclonal antibody that enhances the effects of some common chemotherapy agents and radiotherapy and demonstrates minimal overlapping toxicities with these approaches. This prospective, observational, non-interventional and multi-centric post marketing surveillance study is being conducted to collect safety information from subjects with locally advanced or recurrent/metastatic SCCHN treated with cetuximab based on the locally approved label. Study plans to enroll 200 to 300 subjects, who are eligible for cetuximab treatment according to the indication in the approved label of cetuximab by Taiwan Health Authority. Data related to subjects' demographics, relevant tumor history, and laboratory information (hematology, biochemistry) will be captured and analyzed descriptively.

OBJECTIVES

Primary objective:

• To obtain safety information on the use of cetuximab in subjects with SCCHN according to the regulatory approved label and in a regular clinical setting

Secondary objectives:

• To gather clinical efficacy information of the treatment

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven Stage 3-4 locally advanced SCCHN (oropharynx, hypopharynx, larynx) or recurrent and/or metastatic SCCHN
* Age greater than or equal to 18 years
* Signed informed consent

Exclusion Criteria:

* Subjects with known severe (Grade 3 or 4; National Cancer Institute Common Toxicity Criteria Version 4.03) hypersensitivity reactions to Cetuximab
* Subjects with contraindications for concomitantly used chemotherapeutic agents or radiation therapy, identified before initiation of cetuximab combination treatment
Clinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis

The purpose of this study is to evaluate the clinical efficacy of a probiotic lozenge containing Limosilactobacillus reuteri as an adjunct to the periodontal non-surgical treatment of patients with stage II, grade A, B and C, generalized periodontitis.

The main purpose of this study is to assess the effect on disease progression of the probiotic Limosilactobacillus reuteri as an adjunct in the non-surgical periodontal treatment in patients with stage II, grade A, B and C, generalized periodontitis: evaluated by Bleeding on Probing (BoP) - Lindhe, 1972. The secondary purpose is to evaluate the effect of this probiotic on the values of Plaque Index (PI) - Silness \& Löe, 1964; Gingival Index (GI) - Löe \& Silness, 1963; Probing Pocket Depth (PPD), Clinical Attachment Level (CAL) - Ramfjord, 1959, when compared to a negative control product.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old, who intend to voluntarily participate in the study and:

  * Have a definitive diagnosis of stage II, grade A, B or C, generalized periodontitis (2018, World Workshop);
  * Have at least 3 natural teeth maintained per quadrant.

Exclusion Criteria:

* • Patients unable to understand the instructions necessary to participate in the study or unable to give informed consent;

  * Patients who have received any type of periodontal treatment 2 months prior to the start of study participation;
  * Pregnant or breastfeeding patients;
  * Patients with associated systemic pathology, such as diabetes, HIV, asthma, hyperthyroidism, immune system pathologies, lichen erosive or other pathologies treated with corticosteroids or immunosuppressants;
  * Patients undergoing therapy with drugs that may interfere with the response of the gingival tissues: anti-inflammatory drugs, anticonvulsants (phenytoin and sodium valproate), immunosuppressants (cyclosporin-A and tacrolimus) and antihypertensives (nifedipine and verapamil hydrochloride);
  * Patients undergoing anticoagulant therapy;
  * Patients allergic to both lidocaine, articaine and mepivacaine;
  * Patients who require antibiotic prophylaxis for bacterial endocarditis;
  * Patients who have had antibiotic therapy within 2 months of study participation;
  * Patients using chlorhexidine, or other mouthwashes or elixirs;
  * Patients undergoing orthodontic treatment.
Memory Problems Perceptions Among Patients and Accompaniers During Diagnosis Process :

This study aims to prospectively examine the memory problem perceptions of patients with memory complaints \[MCs\] and their accompaniers during the diagnostic process.

Through the french adaptation of the "illness perception questionnaire memory", this study aims to prospectively examine the memory problem perceptions of patients with memory complaints \[MCs\] and their accompaniers during the diagnostic process. The investigators plan to recruit 125 patients with MCs who come for the first time at the Research and Resources Memory Center in Nancy, France. Participants have to express MCs and must be free of dementia diagnosis at the first visit. Participants also need to be accompanied by an accompanier and both have to be fluent in French. This study has been approved by our local Ethics Committee (Committee for the Protection of Persons) and the French Health Security Agency. After giving their informed consent, patients and accompaniers are followed up throughout the diagnostic process with three visits : at their first visit, at one month after the first visit, and at six months after the diagnosis disclosure.

Eligibility Criteria:
Inclusion Criteria:

For patients with memory complaints:

* Age over 18 years
* Have a memory complaints with a QPC score greater than or equal to 3
* Be accompanied by a next of kin
* Folstein MMSE greater than or equal to 15/30
* Have given their written consent after receiving clear and intelligible oral and written information
* Social security coverage

For Accompaniers :

* Age over 18 years
* Consent to participate at the study with the patient
* Have given their written consent after receiving clear and intelligible oral and written information
* Social security coverage
* Be in contact with the patient at least 8 hours per week. It could be physical contact or telephone contact.

Exclusion Criteria:

For patients with memory complaints:

* Sensory deficit interfering with the completion of the questionnaires
* Level of French insufficient to complete the questionnaires
* Legally protected person
* Diagnosis of neurocognitive disorders already established
* Treatment for Alzheimer Disease
* Refusal or inability to obtain written informed consent form from the patient
* Included in another experimental study at inclusion visit

For Accompaniers:

* Sensory deficit interfering with the completion of the questionnaires
* Level of French insufficient to complete the questionnaires
* Refusal or inability to obtain written informed consent form from the accompanier
A Dose Escalation Study in de Novo Renal Transplantation

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.


Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand the study requirements and provide written informed consent before and study assessment is performed.
* Male or female patients ≥ 18 to 70 years of age.
* Recipients of a de novo renal allograft from a heart-beating deceased, living unrelated, or non-HLA identical living related donor.
* Recipients of a kidney with a cold ischemia time (CIT) less than 30 hours.

Key Exclusion Criteria:

* Multiple-organ transplant recipients
* Subjects who have received a kidney allograft previously
* Recipient of a kidney from an HLA identical living related donor
* Recipient of a kidney from a donor after cardiac death
* Subjects at high immunological risk for rejection
Cyclosporine and Prognosis in Acute Myocardial Infarction (MI) Patients

Infarct size is a major determinant of prognosis after Acute Myocardial Infarction (AMI). The investigators recently reported that cyclosporine A, when administered immediately prior to percutaneous coronary intervention (PCI), can significantly reduce infarct size in STEMI (ST Elevation acute Myocardial Infarction) patients. The objective of the present study is to determine whether cyclosporine can improve STEMI patient clinical outcome. Nine-hundred and seventy two patients with ST elevation MI will be entered into a multicentre, randomized, placebo-controlled, double-blinded study. They will receive one single injection of cyclosporine A (CicloMulsion, verum) or an equivalent volume of placebo prior to reperfusion therapy by PCI. The incidence of the combined endpoint (mortality, hospitalization for heart failure, left ventricular (LV) remodeling) will be assessed at one year and three years after treatment.


Eligibility Criteria:
Inclusion Criteria:

Eligibility criteria (for screening before hospital admission):

1. All (male and female) patients, aged over 18, without any legal protection measure,
2. Having a health coverage,
3. Presenting within 12 hours of the onset of chest pain,
4. Who have ST segment elevation ≥0.2 mV in two contiguous leads,
5. For whom the clinical decision was made to treat with percutaneous coronary intervention (PCI).

   And (further inclusion criteria to be confirmed by the admission coronary-angiography):
6. The culprit coronary artery has to be the LAD
7. The LAD artery has to be occluded (TIMI flow grade 0-1) at the time of admission coronary angiography.
8. Preliminary oral informed consent followed by signed informed consent as soon as possible.

Patients undergoing either primary PCI or rescue PCI are eligible for the study. Patients with previous AMI, PCI or coronary artery bypass surgery (CABG) are eligible for the study.

Exclusion Criteria:

1. Patients with loss of consciousness or confused
2. Patients with cardiogenic shock
3. Patients with the left circumflex or the right coronary artery (RCA) as the culprit artery, or with evidence of coronary collaterals to the risk region
4. Patients with an opened (TIMI \> 1) LAD coronary artery at admission on initial (admission) coronary angiography
5. Patients with 5.2. known hypersensitivity to cyclosporine 5.3. known hypersensitivity to egg, peanut or Soya-bean proteins 5.4. known renal insufficiency (either known creatinin clearance \< 30 ml/min/1.73m² or current medical care for severe renal insufficiency) 5.5. known liver insufficiency 5.6. uncontrolled (treated or untreated) hypertension (\> 180/110 mmHg)
6. Patients treated with any compound containing Hypericum perforatum (St.-John's-worth) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine
7. Female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis).
8. Patients with any disorder associated with immunological dysfunction more recently than 6 months prior to presentation 8.2. cancer, lymphoma 8.3. known positive serology for HIV, or hepatitis
Effects of Food on the Pharmacokinetics of DWJ1458 in Healthy Adults

The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers.

The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers: Randomized, open-label, oral, single-dose, crossover study

Eligibility Criteria:
Inclusion Criteria:

* Age 19 to 55 years
* BMI 18.5≥ and ≤27.0 kg/m²
* Female subjects must be menopause or surgically infertility.
* Male subjects must consent to contraception for at least 60 days after the study period and the final administration of the study drug.
* Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.

Exclusion Criteria:

* History of hypersensitivity to investigational product
* Participation in a clinical drug study or bioequivalence study 6 months prior to the present study
* The subject who is judged to be unsuitable as a test subject in a screening test.
* The subject who is judged to be unsuitable for participation in a clinical trial due to other reasons determined by the investigators.
Radiotherapy - Anastrazole Concomitant : Evaluation of the Side Effects

This study is a description of the radiation effects on the healthy tissues in patients receiving Anastrozole, sequential or in association with radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal woman without superior age limit
* No metastatic breast cancer, stade I-II, estrogen receptor positive or progesterone receptor positive, treated by conservative surgery or total mastectomy and requiring additive treatment by radiotherapy and hormonotherapy
* The patients including in another clinical trial can be include in this observatory
Efficacy of a Whitening Dentifrice on Tooth Discoloration

The purpose of this study was to compare the whitening effect of a toothpaste containing blue pigment with a conventional toothpaste and with at-home tooth bleaching; evaluate the subject's perception about tooth color improvement and; and evaluate the safety and acceptability of these products.

The study was approved by local Ethical Committee under protocol number CAAE: 035541412.7.0000.5188, and each volunteer signed an informed consent form prior to enrollment in the study.

The sample size calculation was carried out based on a previous study. To detect the bleaching effect with a power of 80% and a one-tailed alpha error of 5%, a sample size of 20 subjects in each treatment group was necessary to detect a 20% difference between groups in shade change. A 20% addiction in subjects' number, taking into consideration potential loss or refusal, gave a total sample size of 75 subjects (25 in each group). The individuals were invited to participate in this clinical trial through advertisement exposed at the Federal University of Paraíba, Brazil.

Basing on eligibility criteria, 75 volunteers were selected to the trial and randomized to one of the three groups of treatment: G1- brushing teeth with a conventional toothpaste; G2- brushing teeth with a silica whitening dentifrice containing blue pigment; and G3 - at-home tooth bleaching with 10% carbamide peroxide. The treatments will be detailed in another section. It was used a simple randomization to allocate the subjects, and a randomization table was prepared in the Excel Program by a member, not directly involved with the clinical part of the study.

To mask the products used in the treatment groups, each toothpaste type was enveloped with an adhesive tape of a different color and the seal of the bleaching gel syringe was removed. The same examiner responsible for subject allocation did this procedure. Thus, testing with the toothpastes was double-blinded, where both evaluator and subject did not know which toothpaste was being used.

The outcomes evaluated were: tooth shade, subjects' perception about tooth color appearance, and safety and acceptability of products tested, which were measured at baseline, 2-weeks, 3-weeks and 4-weeks of the beginning of treatments.

For statistical analysis, data were checked for normal distribution using the Kolmogorov Smirnov test, and then it was applied the appropriated parametric or non-parametric tests. Differences were considered statistically significant when p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* To have six maxillary anterior teeth with a mean shade of C1 or darker (Vitapan Classical, Vita Zahnfabrik, Bad Sackingen, Germany),

Exclusion Criteria:

* With active caries or periodontal disease,
* Presenting non-vital anterior teeth,
* Previous hypersensitivity,
* Under orthodontic treatment,
* With structural defect in the enamel,
* Who had used tooth whiteners within the previous 3 years,
* Smokers,
* Pregnant or lactating