cyrilzakka/clinical-trials huggingface dataset:
In Vivo Preoperative Skin Preparation Persistence Evaluation

Evaluate persistent antimicrobial effectiveness of chlorhexidine gluconate containing products on abdominal and inguinal sites following a saline and wipe challenge.

Persistent antimicrobial effectiveness was evaluated by measuring the regrowth of normal skin flora at 48 hours, 72 hours and 96 hours, and the suppression of regrowth relative to post-prep (10-min) at 48 hours, 72 hours and 96 hours.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of any race
* Subjects in good health
* Minimum skin flora baseline requirements on abdomen and groin

Exclusion Criteria:

* Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test area
* Topical antimicrobial exposure within 14 days prior to screening and treatment days
* Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days
A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer

The purpose of this study is to assess the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation.


Eligibility Criteria:
Inclusion Criteria:

* Histologic confirmation of adenocarcinoma of the prostate without small cell features
* Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
* Documented prostate cancer progression per Prostate Cancer Working Group (PCWG3) criteria within 6 months prior to screening
* Chemotherapy-naïve for metastatic castration-resistant prostate cancer (mCRPC), with 1 to 2 prior second generation hormonal therapies in the recurrent non-metastatic setting and/or metastatic setting, and no more than 1 second generation hormonal therapy in the mCRPC setting. Must have progressed during or after second generation hormonal therapy or have documented intolerance to second generation hormonal therapy
* Participants must meet one of the following criteria regarding tissue submission: Sufficient tumor samples from a newly obtained ("fresh") biopsy (obtained during screening); or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides. For participants with bone-only disease or inaccessible soft tissue lesions or if the biopsy procedure would pose an unacceptable clinical risk for the participant, submission of tumor tissue obtained from a fresh biopsy is not required.
* Men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Active brain metastases
* Active, known, or suspected autoimmune disease
* Condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids or adrenal replacement steroid doses are permitted in the absence of active autoimmune disease
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
* Prior treatment with docetaxel or other chemotherapy for mCRPC. Prior docetaxel for metastatic castration-sensitive prostate cancer is permitted if at least 12 months have elapsed from last dose of docetaxel

Other protocol-defined inclusion/exclusion criteria apply
Necessity for Lipid Lowering Therapy in Type 2 Diabetes Patients

Purpose:

To assess prior need for lipid lowering therapy in patients with type 2 diabetes.

Background/Hypothesis:

At present, lipid lowering therapy, usually with a HMG-CoA reductase inhibitor or "statin", is recommended therapy for selected patients with type 2 diabetes mellitus (DM). The use of statins for primary prevention of CVD is not clear. Some primary prevention studies have found a statistically significant benefit but others have not (CARDS and ASPEN).

Although low-density lipoprotein (LDL) has traditionally been a key marker of cardiovascular disease risk (CVD) risk and thus a guide to statin treatment, in recent years apolipoprotein B (apoB) has emerged as an independent risk factor for CVD.

In a recent study, Tildesley H. et al. showed that in 500 patients with type 2 DM not on lipid lowering therapy there was discordance between LDL and apoB values. Specifically, it was found that among patients who fail to achieve the LDL-C target, 13% of men, 24% of women less than 50 and 13% of women greater than 50 meet the apoB target. In other words, while the LDL level would indicate treatment, the apoB level would not.

Objectives:

The investigators propose to measure lipid parameters during lipid lowering therapy and compare this with lipid parameters at one and two months after discontinuation of therapy in selected patients with type 2 DM at low risk for CVD. Lipid parameters to be measured include: high-density lipoprotein (HDL) - cholesterol, LDL-cholesterol, triglycerides, total cholesterol, total cholesterol: HDL-cholesterol ratio and apoB. As well, A1C will be measured.


Eligibility Criteria:
Inclusion Criteria:

* LDL \< 2.5 mmol/L and total cholesterol: HDL-cholesterol ratio \< 4.0
* Blood pressure ≤ 130/80 mmHg
* No personal or family history of CVD
* No history of proteinuria or renal failure
* Taking atorvastatin (lipitor) with a dosage ≤ 10 mg, equivalent dosages for other statins follow this requirement (Simvastatin ≤ 20 mg, pravastatin ≤ 40 mg, rosuvastatin ≤ 5 mg, fluvastatin ≤ 40 mg and lovastatin ≤ 40 mg)
* Calculated by the UKPDS Risk Engine to be low risk (risk is less than 15%) for Coronary Heart Disease (CHD), fatal CHD, stroke and fatal stroke (the UKPDS Risk Engine provides risk estimates in individuals with type 2 diabetes not known to have heart disease (1), calculating the patient's risk involves considering risk factors such as age, sex, incidence of smoking and lipid levels)

Exclusion Criteria:

* Patients who do not meet the above criteria or are not willing to participate will not be included in the study
Postoperative Analgesia in Bilateral Knee Arthroplasties

To observationally compare the analgesic efficacy of LIA and S-FICB techniques and to record the pain scores of patients who underwent bilateral knee operations in the postoperative period.


Eligibility Criteria:
Inclusion Criteria:

* Planned elective bilateral knee arthroplasty under spinal anesthesia
* American Society of Anesthesiologists (ASA) risk score I-II
* Patients aged 18-75 years

Exclusion Criteria:

* Those receiving general anesthesia,
* Those with epidural catheters,
* Those who refused to participate in the study,
* Those whose spinal anesthesia failed and returned to general anesthesia,
* Those with a body mass index (BMI) \>30 kg/m2,
* History of chronic opioid or corticosteroid use,
* Patients with psychiatric or neurological problems that would not allow assessment of pain using a visual analog scale (VAS) will be excluded.
* In addition, patients whose surgery lasted \<40 minutes or \>120 minutes will also be excluded to keep the data homogeneous.
Imaging Perilymphatic Fistulas After Barotrauma

Our objective is to validate the CT / MRI combination of non-injected rock for the rapid positive diagnosis of perilymphatic fistulas.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18
* Clinical suspicion of perilymphatic fistula
* Patient having undergone a rock scan or MRI of the middle ear at the Strasbourg University Hospital with surgical confirmation of the diagnosis (or reversal)

Exclusion Criteria:

- Refusal of the patient to participate in the study
Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis

Cardiovascular disease is a leading cause for morbidity and mortality in general population. The incidence of cardiovascular disease and their poor outcome is well documented in a broad spectrum of connective tissue diseases, especially in rheumatoid arthritis (RA). The risk of incident CVD is increased by 48% in patients with RA compared to the general population.

RA is associated with 50% increase in the mortality in patients with cardiovascular disease (CVD). One reason is the more frequent cardiovascular risk factors in RA patients compared with the general population. Patients with RA have a high risk of premature cardiovascular disease (CVD). The aim of the present study is to assess whether there are non-invasive measures that might predict arteriosclerosis in RA patients.


Eligibility Criteria:
Inclusion Criteria:

1. 18-70 years old (except for women till 75 years old)
2. Absence of established CVD:

   * Myocardial Infarction p/h
   * PCI with balloon and/or stent
   * Intermittent claudication
   * PAD / intervention
   * CAS /intervention
3. Signed informed consent form
4. Documented diagnosis of rheumatoid arthritis

Exclusion Criteria:

1. Known CVD
2. Pregnancy
State of Play of Physiotherapy in the Postoperative Management of Prostate Cancer (PREduKiné)

In France, a considerable number of radical prostactectomy for cancer is carried out every year.This number was estimated at 20.000 in 2016.This surgery may have negative impact on the continence's subjects and their quality of life. The rehabilitation, preoperative or postoperative, practiced by a physiotherapist, can reduced those side effects. The rehabilitation techniques are many and their efficacy may differ.

No study where found about the clasification and evaluation of those rehabilitation techniques.

Investigator aim to create homogeneous clusters of subjects according to the rehabilitation techniques they have received during the preoperative or postoperative period, using a survey replied 6 months after the surgery.

To achieve that goal, invesgator will call subjects conduct two interviews. The first interview will take place around one month after the radical prostatectomy and the second around 6 month after the surgery.

During those interviews, investigator will question subjects about the rehabilitation techniques practiced on them, about their continence and quality of life. To evaluate the continence investigator will use the survey ICIQ-SF. To evaluate the quality of life, investagator will use the survey KHQ-HR Qol.

Eligibility Criteria:
Inclusion Criteria:

* men who has undergone a radical prostactectomy to treat a prostatic adenocarcinoma
* having a follow up postoperative consultation between one and two month after the surgery
* being able to answer to respond the questions during the interviews
* agreeing to participate by signing informed consent form

Exclusion Criteria:

* undergoing an adjuvant therapy as radiotherpy, chemotherapy and hormone therapy
* Refusing to take part in the study
Phase 3 Clinical Trial with Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients

Recent trials have demonstrated positive renal outcomes of sodium-glucose co-transporter-2 inhibitors (SGLT2i) additive to angiotensin-converting-enzyme inhibitors (ACEis) in adult patients with diabetic and non-diabetic chronic kidney disease (CKD). These trials included no children. The hypothesis of DOUBLE PRO-TECT Alport is to demonstrate superiority of the SGLT2i dapagliflozin in preventing progression of the chronic kidney disease Alport syndrome in children and young adults at early stages of disease. Preventing the rise of albuminuria by dapagliflozin would result in a very significant delay of end-stage kidney failure (ESKF) and improved quality of life. If successful, DOUBLE PRO-TECT Alport will change the treatment recommendations for children with CKD, who have a very high unmet medical need.


Eligibility Criteria:
Key inclusion criteria:

Early stages of CKD with established diagnosis of Alport syndrome at visit 1 (screening)

* adolescents ≥ 10 to \< 18 years with albuminuria (UACR ≥ 300mg/g creatinine) AND
* eGFR ≥ 30 ml/min/1.73 m2 OR
* adults ≥ 18 to \< 40 years with albuminuria (UACR ≥ 500mg/g creatinine) AND
* eGFR ≥ 60 ml/min/1.73 m2

  1. Molecular-genetic diagnosis or diagnosis established by kidney biopsy
  2. Stable RAS blockade as background therapy.
  3. Signed and dated written informed consent.

Key exclusion criteria:

1. Medical history that might limit the individual's ability to take trial treatments.
2. Treatment with any SGLT2 inhibitor or within 4 weeks prior to Visit 1.
3. eGFR\<60 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis or after kidney-transplantation
4. Uncontrolled arterial hypertension (blood pressure above 145/95 mmHg).
5. Known hypersensitivity or allergy to the investigational products.
6. Any previous or current alcohol or drug abuse.
7. Participation in another trial with an investigational drug ongoing.
8. Women, who are nursing or pregnant, or who are not practicing an acceptable method of birth control.
Fluid Balance and Clinical Outcomes

This study is about investigating the relationship of postoperative fluid balance, inflammation and acute kidney injury. This is a non-interventional study (no drug administration). The investigators will collect baseline demographic data, postoperative fluid balance status by Intake-output data, follow routine labs and collect 1 blood sample (0.5ml) with morning lab draws on day 1 and 5ml urine samples on day 1 and 2.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older, and
* Undergoing elective cardiothoracic surgery(s), alone or in combination with other procedures/surgery(s): thoracic aortic aneurysm, cardiac valves, coronary artery bypass grafting, abdominal thoracic aneurysm, and other cardiovascular surgery.

Exclusion Criteria:

* Pregnancy
* History of any organ transplant
* Preoperative intra-aortic balloon pump (IABP)
* Current use of natriuretic peptides
* ESRD patients on dialysis
* Estimated GFR \< 30ml/min using MDRD equation.
Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation in Early Breast Cancer

Hypofractionation with simultaneous integrated boost has been investigated in a few trials and appears to be safe and feasible.

Investigators initiated this multicenter two-armed phase III prospective trial to analyse the non-inferiority of hypofractionation with simultaneous integrated boost in patients with early breast cancer in comparison to standard fractionation.

Control Arm:

Conventionaly fractionated radiotherapy of the breast 28 × 1.8 Gy = 50.4 Gy followed by a tumor bed boost sequentially 5 to 8 × 2.0 Gy = 10.0 Gy to 16.0 Gy, total dose 60.4 Gy to 66.4 Gy.

or Conventionaly fractionated radiotherapy of the breast 28 × 1.8 Gy = 50.4 Gy with simultaneous integrated boost to the tumor bed, total dose 28 × 0.3 Gy or 0.45 Gy= 8.4 Gy or 12,6 Gy, total dose 58,8 Gy to 63.0 Gy.

or Hypofractionated radiotherapy of the breast 16 × 2.66 Gy = 42.56 Gy followed by a tumor bed boost sequentially 5 to 8 × 2.0 Gy = 10.0 Gy to 16.0 Gy, total dose 52.56 Gy to 58.56 Gy.

Experimental Arm:

Hypofractionated radiotherapy of the breast 16 × 2.50 Gy with simultaneous integrated boost to the tumor bed, total dose within the boost volume 16 × 3.00 Gy.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins independently of further risk factors (positive or high-risk negative lymph node status, estrogen- or progesterone receptor status, Her-2/neu status uPA/PAI-1 criteria) and postoperative systemic therapy (chemotherapy, endocrine, antibody or bisphosphonate therapy were permitted when indicated)
* Indication to adjuvant radiotherapy including boost radiotherapy
* Clearly identified primary tumor region preferably by radiopaque clips
* Primary wound healing after breast conserving therapy without signs of infection
* Age ≥ 18 years
* ECOG ≤ 2 Performance Status
* Written informed consent
* Compliance regarding treatment appointments and toxicity
* Linguistic and cognitive ability to understand the questionnaires

Exclusion Criteria:

* Patients operated by mastectomy
* No indication for boost radiation (e.g. status after IORT)
* double sided breast cancer
* Resection margins positive for disease or insufficient identification of the boost volume
* Indication for radiotherapy of the regional lymph nodes
* History of prior breast or thoracic radiotherapy
* Extended postoperative seroma at the beginning of radiotherapy
* Previously administered radiotherapy not allowing the required dose
* Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception
* treatment history of other cancer or participation in another clinical trial testing radiotherapy or drugs within 4 weeks of the start of treatment.
* Patients with serious, uncontrolled, physical or cerebrovascular disorders(e.g. myocardial infarction within the last 12 months) or neurologiy or psychiatric disorders thought to adversly affect treatment compliance
Study of the Effect of SR57667B on the Progression of Symptoms in Patients With Parkinson's Disease

The primary objective is to assess the effect of SR57667B at the dose of 4 mg/d on the progression of Parkinson symptoms in patients with early PD. The primary outcome will be the time to progression of disability warranting initiation of L-dopa or a dopamine agonist. Secondary outcomes will comprise assessments of symptoms, activities of daily living and global clinical status.

Multinational, multicenter, randomized, parallel-group, double-blind, phase II study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients.
* Age \>=35 years at screening.·
* Diagnosis of Parkinson's syndrome, on at least two of the three key Parkinson's symptoms, i.e. resting tremor, bradykinesia and rigidity.
* Duration of the disease of less than 3 years since diagnosis·
* Modified Hoehn and Yahr stage \<= 2.5.
* Untreated patients.
* Generally healthy and ambulatory.
* Patient has given his informed written consent and is capable of following study procedures.

Exclusion Criteria:

* Any indication of forms of parkinsonism other than PD.
* Severe resting tremor.
* Presence of either dyskinesia, fluctuations, or loss of postural reflexes·
* Treatment with L-Dopa, dopamine agonist, amantadine, anticholinergics, catechol-o-methyltransferase (COMT ) inhibitors, selegiline, dopamine receptor antagonists, catecholamine depleters, indirect dopamine agonists or alphamethyldopa.
* Electroconvulsive therapy (ECT).
* Use of CYP3A4 strong, and moderate inducers or inhibitors.
* Participation in another clinical trial with an investigational drug within two months prior to randomization.
* Dementia, uncontrolled depression, psychotic disorder.
* History of substance-related disorders including alcohol or other substance use disorders.
* Females of child bearing potential.
* Evidence (detected by history, physical examination and/or laboratory/ECG tests) of any clinically significant or unstable medical disorder that could interfere with the patient's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug.
* Alterations of laboratory tests or ECG findings of potential clinical significance.
Maximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD)

The purpose of this study is to examine the efficacy of exercise in comparison to wellness education to determine if they can improve the effects of prolonged exposure therapy (PE) in reducing symptoms of anxiety associated with Post-traumatic Stress Disorder (PTSD). In addition, the two strategies (i.e., exercise and wellness education) will be compared in terms of improvements in sleep as well as levels of brain-derived neurotrophic factor (BDNF). BDNF is a protein that helps to support the survival of existing neurons and stimulate the growth new neurons and synapses. BDNF is important to learning and memory in general and therefore may be associated with the learning and memory as it relates to PE and corresponding symptom PTSD improvement.


Eligibility Criteria:
Inclusion Criteria:

* You have PTSD
* You are between the age of 18 and 54 if female or between ages 18 and 44 if male.
* You have written physician approval/medical clearance to participate in an exercise protocol.
* Are currently taking no psychotropic medications or are able and willing to discontinue these medications prior to the first PE session.

Exclusion Criteria:

* You are currently participating in a structured exercise program
* You have severe depression
* You have any history of bipolar disorder, psychotic disorder, or obsessive compulsive disorder;
* You have a diagnosis of eating disorder, or substance abuse or dependence (excluding nicotine) within the past six months
* You have any history of a suicide attempt, or are at significant risk of self-harm or harm to others
* You have ever been diagnosed with organic brain syndrome, mental retardation, or other cognitive dysfunction
Evaluation of Safety and Efficacy of Using Lipsus Device for Oral Wetting

Following waking up from surgery performed under general anesthesia, patients are suffering from discomforting oral dryness, and moreover, they are not allowed drinking for 24 hours. The current management involves the wetting of patient's lips using wet bandage. This action is dependent on the presence of a family member or a nurse, which is not always possible. Many patients describe the oral dryness as a suffering, added to the suffering anyway entailed by surgery.

The investigated Lipsus device is intended for oral wetting, relieving patient's suffering and minimizing the dependence on continuous presence next to patient's bed.


Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled for surgery under general anesthesia.
* Male/female age 18 and up.
* Subject able to comprehend and give informed consent for participation in this study
* Subject must sign the Informed Consent Form.

Exclusion Criteria:

* Subjects who have any form of suspicious lesion in treatment target area.
* Pregnant or lactating Subjects
* Subjects with any infection / abscess / bleeding / blister / crack / edema / fissure / ulcer / pain in treatment target area.
* Eczema or dermatitis in treatment target area
* Subjects on drugs or psychologically determined unsuitable for the study.
* Subject is suffering extreme general weakness.
* Subject objects to the study protocol.
* Concurrent participation in any other clinical study
* Physician objection