cyrilzakka/clinical-trials huggingface dataset:
Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort

The goal of this clinical trial is to evaluate the incidence and severity of postoperative catheter-related bladder discomfort after robot-assisted radical prostatectomy.

The main question it aims to answer is to evaluate incidence of CRBD immediately after extubation in resuscitation.

A total of 20ml of 2% lidocaine and 1μg/ml sufentanil or 20ml normal saline was injected into the bladder of the participants through the catheter. After drug injection, the catheter was clamped for 20 minutes, and then 100ml normal saline was injected into the bladder through the catheter to flush out.

Then, the incidence of CRBD was compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

1. aged 18-79 years, ASA class I-II
2. participants undergoing robot-assisted radical prostatectomy under general anesthesia
3. signed informed consent and volunteered to participate in the experiment

Exclusion Criteria:

1. urethral stricture, difficulty in inserting catheter or urethral bleeding during catheterization
2. a preexisting bladder disease such as an overactive bladder, bladder outflow obstruction, and neurogenic bladder
3. cognitive impairment or communication disorders
4. severe heart, lung, liver, kidney and immune system diseases
5. confirmed or suspected allergy to this trial drug
Simultaneous Integrated Boost in Malignant Glioma Patients Treated With Chemoradiation

Simultaneous integrated boost (SIB), a field-in-field escalation technique, has been introduced to deliver higher radiation dose to the certain part of target with the same fractionation scheme. The aim of this study was to investigate the value of chemoradiation (CCRT) using SIB in glioblastoma and the correlation with surgical extent.

The SIB technique provides the higher radiobiological effect with the same fractionation scheme, i.e. 69 Gy over 6 weeks, which might increase the loco-regional control. Besides, the co-registration with magnetic resonance imaging (MRI) strengthens the precision of target delineation as well as higher possibility to spare adjacent normal brain tissue.

In this protocol, the newly diagnosed, primary glioblastoma patients received SIB 69 Gy/30 fractions to preoperative tumor bed and surgical cavity, while 60 Gy/30 fractions were covering preoperatively edematous area. To determine the status of surgical extent, postoperative CT scan and MRI was acquired within 72 hours and at 4th week after surgery. During the period of chemoradiation, acute neurotoxicity and hematological toxicity was assessed as well.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or above
* newly diagnosed, tissue-proven glioblastoma
* pre-radiotherapy Karnofsky performance score (KPS) ≧60.

Exclusion Criteria:

* any previous history of chemotherapy or radiotherapy
* receiver of any investigating agents
* recurrent GBM
* any second malignancies.
MED Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous WCK 5222 (Zidebactam and Cefepime) in Healthy Volunteers

Study to evaluate the safety, tolerability and pharmacokinetics of multiple escalating doses of intravenous WCK 5222 (Zidebactam and Cefepime) in healthy adult human subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Have a body mass index of 18 to 30 kg/m2 (both inclusive) calculated as weight (kg)/height(m2).
2. Resting supine blood pressure of 90 to 139 (systolic)/40 to 89 (diastolic) mmHg and a resting pulse rate of 40 to 100 beats per minute.
3. Calculated creatinine clearance ≥80 mL/min (Cockcroft-Gault method).
4. All values of hematology, serum chemistry, coagulation, and urinalysis showing no clinically significant deviations from normal as judged by the Principal Investigator.

Exclusion Criteria:

1. Participation in another investigational drug or device study or treated with an investigational product within 30 days or 5 half-lives, whichever is longer, before investigational product administration in this study.
2. History/evidence of clinically relevant pathology related to the cardiovascular system, central nervous system, respiratory tract, gastrointestinal tract, endocrinology, immunology, hematology or any other systemic disorder/major surgeries, that in the opinion of the Principal Investigator would confound the subject's participation and follow-up in the study.
3. History of clinically significant food or drug allergy, including known hypersensitivity to cefepime or any other related drugs.
4. History of Clostridium difficile induced diarrhea or infection within 1 year before screening.
5. Prior exposure to zidebactam.
A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial

Holmium laser enucleation of the prostate (HOLEP) has proven to be efficacious and safe for the treatment of benign prostatic hypertrophy (BPH). New laser technologies such as the Moses Pulse laser system provide for improved energy delivery which may decrease blood loss and operative time. We seek to evaluate Moses technology for enucleation of the prostate in the setting of BPH.

This is a single-center, prospective, double-blinded, randomized controlled trial comparing MOLEP to HOLEP. Inclusion criteria included all symptomatic BPH patients desiring enucleation with prostate sizes \> 80ccs based on cross-sectional imaging. Patients are randomized in a 1:1 fashion and the study is powered to evaluate for a difference in operative time (i.e. alpha=0.05,N=21 per group). All surgeries will be performed with a 550 μm fiber. At the start of each case, a laser technician would be notified of randomization via envelope and randomize the settings to either Moses or traditional mode. The surgeons and patients were blinded to which mode was used. All surgeries will be performed using a two lobe technique and laser settings between 2J and 20-40Hz. Further recorded endpoints include change in blood loss, reduction in International Prostate Symptom Score (IPSS), improvement in uroflow parameters, and complications postoperatively at 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Any man with clinical symptoms fo BPH requiring surgery who has a prostate sized at greater than 80 grams

Exclusion Criteria:

* Anyone actively on anticoagulation perioperatively
Fear of Other's Judgment, Self-esteem and Use of Social Networks Among Students

Fear of being judged negatively by others can lead to avoidance of social situations or even social isolation. If the intensity of this fear is excessive and results in significant impairment of functioning or significant suffering, the subject may suffer from social anxiety.

The considerable growth of social networks in a decade has led to the emergence of new behaviors among young people. Individuals spend on average 2 hours and 27 minutes per day with differences in usage: time spent, social network used, function sought. The use of these networks may be reasonable and moderate but may also be excessive and abusive (Amnon, 2014). Some authors even talk about addiction or dependence on social networks (Perales and Billieux, 2020) even if the existence of this disorder is not consensus.

People who fear being judged negatively by others may be more at risk of misuse of social networks. Indeed, the use of social networks would compensate for their existing problems (Kardefelt-Winther, 2014) and would thus be a new emotional management strategy. It would also reduce dreaded social situations such as face-to-face exchanges (Weidman and Rodebaugh, 2012; Yen and Ko, 2012). Self-esteem is defined as a subjective judgment of oneself in relation to one's values and vision of the real and ideal self (Rosenberg. 1979). The greater the gap between the vision of the real self and the ideal self, the lower the self-esteem.

The objective of the study is to study the influence of self-esteem on the association between the fear of being judged negatively by others and the use of social networks.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* students at a French school or university
* using social media
* agreeing to participate in the study

Exclusion Criteria:

* Protected by law
* Refusing to participate in the study
Use of a Hypochlorous Acid Spray Solution in the Treatment of COVID-19 Patients : COVICONTROL Study .

The objective is To evaluate the efficacy and safety of nasal spray and mouth spray application with hypochlorous acid-containing solution versus placebo as a curative treatment for hospitalized SARS-CoV-2 positive patients And for symptomatic SARS-CoV-2 positive patients followed as outpatients

The COVICONTROL study is a prospective, multicenter study . It is a randomized, controlled, double-blind study.

The COVICONTROL study will be conducted in Tunisia at the COVID patient management centers in the emergency departments of Monastir (Fattouma Bourguiba) and Sousse (Hospital Of Sahloul).

After initial medical evaluation, every patient who meet the inclusion criteria, will receive randomly either A spray of solution containing hypochlorous acid or Placebo as detailed above according to the predetermined randomization.

For each patient included, one nasal spray in each nasal nostril /3 hours and two oral sprays/3 hours either by a solution of hypochlorous acid (NEED DEFENDER) or by a placebo. for 5 days None of the treating physician or nurses are aware about the nature of medication receive. In both arms, patients can receive antipyretics, antibacterials, antivirals, antifungals and anti-inflammatories at the discretion of the treating physician.

\* Patients follow-up :

During the study , a research member maintains contact (face-to-face if hospitalized or by telephone if ambulatory) at D2, D3, and D5 with participating patients to ensure compliance with treatment and report on disease progression: disappearance or persistence of symptoms, need for hospitalization, need for intensive care, duration of hospitalization, need for respiratory assistance (CPAP, NIV, Optiflow, VM), duration of respiratory assistance, survival or death.

At day 3 :a nasopharyngeal swab will be taken to check the viral load using quantitative RT PCR.At D10 and D30, data on disease progression will be collected one last time.

Eligibility Criteria:
* Inclusion Criteria :

  * Patients with symptoms of COVID who are over 18 years of age and whose nasal swabs have been positive for SARS-CoV-2 based on RT-PCR testing less than 3 days .
  * Patients must have the ability to understand and be willing to sign a written informed consent document from the patient or legal representative.
  * The patient must be able and willing to comply with the requirements of this study protocol.
* Exclusion Criteria:

  1. History of allergy to hypochlorous acid solution .
  2. Oral lesions contraindicating the use of hypochlorous acid solution.
  3. Patients receiving any other investigational agent in a clinical trial.
  4. Intubated patient on mechanical ventilation or with uncontrolled disease : congestive heart failure, IDM, uncontrolled epilepsy or psychiatric illness.
  5. Uncertain patient follow-up during the study.
Diagnosis of Lynch Syndrome Based on Next-generation Sequencing in Colorectal Cancer

The purpose of this study is to determine the proportion of patients diagnosed with Lynch syndrome in colorectal cancer patients with the loss of staining by immunohistochemistry (IHC) of any of the mismatch repair (MMR) proteins. Besides, this study aims to test the specificity and the sensitivity of detecting microsatellite instability (MSI) by next-generation sequencing, and to find out the consistency between IHC and MSI in colorectal cancer patients in China. In addition, researchers want to analyze the clinical characteristics and germline mutation of Lynch syndrome in Chinese population.

1. Detect microsatellite instability (by next-generation sequencing and PCR capillary electrophoresis) and germline mutation (by next-generation sequencing) in probands.
2. Analyze the test outcome with clinical and family information to evaluate the germline mutation status preliminarily: likely pathogenic germline mutation, variant of uncertain significance, non-pathogenic germline mutation.
3. Verify the germline mutation in blood relatives whose proband has known likely pathogenic germline mutation or variant of uncertain significance.
4. Diagnose pathogenic germline mutation and non-pathogenic germline mutation based on clinical characteristics, family information and germline mutation test outcomes (including the outcomes of probands and blood relatives). Diagnose Lynch syndrome and the pathogenic germline mutation carriers in the included population.
5. Analyze the specificity and the sensitivity of detecting microsatellite instability (MSI) by next-generation sequencing; and analyze the consistency between IHC and MSI.
6. Analyze the clinical characteristics and germline mutation of Lynch syndrome in Chinese population.

Eligibility Criteria:
For probands, the inclusion criteria:

All of the following four points should be satisfied:

* Histological diagnosis of colorectal cancer;
* With the loss of staining by immunohistochemistry of any of the mismatch repair (MMR) proteins (MLH1, MSH2, MSH6, PMS2);
* With sufficient tumor tissue and normal tissue to test;
* Agree to provide basic information, clinical information and family history of cancer information.

For probands, the exclusion criteria:

* With at least one blood relative with known pathogenic germline mutation(s).

For blood relatives verifying germline mutation, the inclusion criteria:

All of the following three points should be satisfied:

* First- to second-degree blood relatives of probands with germline mutation(s).
* With Sufficient tumor tissue and normal tissue to test.
* Agree to provide basic information, clinical information and family history of cancer information.

For blood relatives verifying germline mutation, the exclusion criteria:

* Blood relatives who refuse to test.
RHPRG4 FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)

rhPRG4-GVHD-001 is a prospective multi-center study conducted in Australia to evaluate the safety and efficacy of topically-applied rhPRG4 in subjects with moderate to severe dry eye secondary to chronic GVHD.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis and Main Criteria for Inclusion:

All to be queried and checked at the screening visit (V1):

1. Subjects 18 years of age or older;
2. Subjects diagnosed with oGVHD for at least 3 months (current use of artificial tears for the treatment of GVHD);
3. VAS Eye Dryness (100-point scale) score ≥ 60 mm;
4. Tear Osmolarity ≥ 312 in either eye;
5. Corneal staining score with fluorescein ≥ 2 using the Oxford scale in the worst performing eye; staining must include quadrants beyond only inferior or superior staining;
6. Only subjects who satisfy all Informed Consent requirements may be included in the study.

Exclusion Criteria:

Diagnosis and Main Criteria for Exclusion:

1. Evidence of an active ocular infection in either eye;
2. History or presence of ocular surface disorders not related to oGVHD in either eye, including but not limited to significant conjunctivochalasis, superior limbic keratoconjunctivitis, limbal stem cell deficiency, allergic conjunctivitis, giant papillary conjunctivitis, atopic keratoconjunctivitis, anterior basement membrane dystrophies, neurotrophic keratitis, corneal dystrophy, exposure keratitis and moderate to severe blepharitis;
3. History of any ocular surgery (including laser or refractive surgical procedures) in either eye within 90 days before study enrollment. Ocular surgery will not be allowed during the study treatment period and elective ocular surgery procedures should not be planned during the duration of the follow-up period;
4. Initiation of new therapeutic modalities within 30 days of recruitment;
5. Artificial rescue tears are allowed as long as they are recorded in a diary;
6. Known hypersensitivity to one of the components of the study or procedural medications;
7. Participation in another clinical study at the same time as the present study or within 60 days of screening/baseline visit;
8. History of drug, medication or alcohol abuse or addiction;
9. Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions:

   1. are currently pregnant or,
   2. have a positive result on the urine pregnancy test at the Screening/Baseline Visit or,
   3. intend to become pregnant during the entire course of and 30 days after the study treatment periods, or,
   4. are breast-feeding or,
   5. not willing to use highly effective birth control measures, such as: Hormonal contraceptives - oral, implanted, transdermal, or injected and/or mechanical barrier methods, during the entire course of and 30 days after the study treatment periods.
Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint

As recommended allowance of oral vitamine D are unable to ensure the recommended serum concentration of vitamine D, the purpose of this study is to show that a dose of vitamin D3 higher than the recommended allowance may slow the cognitive decline of patients with a memory complaint.


Eligibility Criteria:
Pre-Inclusion Criteria :

* Patients aged 60 years or older,
* Who report to a memory centre with symptoms of memory complaint,
* Having a Mini-Mental State Examination (MMSE) score strictly \> the 5th percentile for sociocultural level of the patient (GRECO standards for elderly patients),
* Having visual, hearing abilities (authorized equipment) and an oral or written expression sufficient for the suitable realization of the tests,
* Who accept participation in the study and are able to sign the informed consent of the - Affiliated to the French social security system.

Inclusion Criteria:

* Insufficient 25 OH D serum level : 25 OH D \< 50 nmol/L (20 ng/ml),
* Normal corrected plasma calcium concentration,
* Normal kidney function (cockcroft \> 30 mL/mn)

Exclusion Criteria:

* Alzheimer's disease or other dementia,
* Parkinson's disease treated,
* Epilepsy treated,
* Huntington's disease,
* Brain tumor,
* History of a progressive disease which may have consequences for the central nervous system (blood pressure, higher or equal to 180/100 mmHg, chronic pulmonary disease with hypoxia; cerebrovascular accident of less than 3 months, cranial traumatism with persistent neurologic deficit, subdural hematoma, brain surgery),
* Antecedent of alcoholism or chronic drug-addiction with an obvious or documented consequence on cognition,
* Severe depression : score Montgomery Asberg Depression Rating Scale (MADRS) \> 18,
* Psychotropic drug therapy (at the discretion of the clinician),
* Hypercalcaemia or treatment for a hypercalcaemia,
* Known hypersensitivity to the vitamin D,
* Granulomatous disease,
* Treatment of vit D at doses higher than the current recommendations,
* History of calcium urinary lithiasis of less than 1 year,
* Nonsteroidal antiinflammatory drug (NSAID) chronic treatment,
* Severe medical or surgical affection of less than 3 months,
* Unstable health, severe hepatic or renal deficiency,
* Deprivation of liberty, under judicial protection,
* Institutionalization (EHPAD),
* Illiteracy,
* Participation in another biomedical research. A diagnosis of MCI (Mild Cognitive Impairment) of less than 6 months is not a criterion of non-inclusion.
Special Investigation For Renal Cell Carcinoma (RCC) Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan)

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

All the patients whom an investigator prescribes the first sunitinib malate(Sutent) should be registered.

Eligibility Criteria:
Inclusion Criteria:

* Patients need to be administered sunitinib malate (Sutent) in order to be enrolled in the surveillance.

Exclusion Criteria:

* Patients not administered sunitinib malate (Sutent).
Asymmetric Targeted DBS for PD With PIGD

The purpose of this study is to compare the effectiveness of the deep brain stimulation of asymmetric targets \[subthalamic nucleus (STN) in the right hemisphere while globus pallidus interna (GPi) in the left\] versus the bilateral STN for the treatment of Parkinson's disease (PD) with postural instability/gait difficulty (PIGD) in a randomized, double-blinded manner.

This is a double-blinded, randomized, controlled trial aiming at comparing the efficacy of asymmetric targets and bilateral STN DBS in treating PD with PIGD.

After being informed about the study and potential risks, enrolled patients giving written informed consent will be screened to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized into two groups in a 1:1 ratio using a minimization randomization method in a double-blinded manner, and later undergo bilateral DBS surgery. One group of patients will receive stimulation of left GPi and right STN, while the other will receive STN stimulation bilaterally. The follow-up period will be one year, with corresponding clinical assessments completed at six months and one year postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of idiopathic Parkinson's disease
* postural instability/gait difficulty (PIGD) phenotypes in the on-medication condition

Exclusion Criteria:

* Atypical parkinsonism
* History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with intracranial surgery
* Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent
* Presence of anatomical abnormalities in the target region
* Clinically significant medical history that would increase pre-/post-operative complications
* Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data