cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of the Addition of Alanyl-Glutamine-Dipeptide to Dialysis Solution in Peritoneal Dialysis

Peritoneal dialysis (PD) is a cost effective and safe form of renal replacement therapy in patients suffering from end stage renal disease.

However currently available PDF (peritoneal dialysis fluids) are not biocompatible for the peritoneal cavity and its cells. Acute cytotoxic effects of the majority of the current glucose-based PDF are caused by low pH, lactate, high glucose and its degradation products (GDP).

Toxic effects of PDF can thus be extended to suppression of mesothelial HSR (heat shock reactions) following PDF exposure resulting in increased susceptibility of mesothelial cells against PDF exposure: PDF inherent stress factors fail to adequately induce HSP as effectors of the cellular stress response - the adequate HRS rather seems to be blocked.

Hence, therapeutic approaches to activate and enhance the HSR will reduce peritoneal damage and organ failure and improve the survival of organisms.

Preclinical results demonstrated that supplementation of PDF with pharmacological doses of alanyl-glutamine restored HSP expression and increased the resistance of mesothelial cells in in-vitro models of PD and preserved peritoneal integrity in in-vivo models of PD.

After these positive preclinical results, this study shall now clarify, whether the addition of alanyl-glutamine to the most commonly used glucose-based PDF is safe and tolerable. Therefore PDFs will be drained in a randomized cross-over study. Main outcomes measures will be total HSP expression in peritoneal cells and changes of the peritoneal transport kinetics and the presence/absence/severity of side effects.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure
* Male and female patients aged ≥ 19 years old
* Chronic renal failure; 2 months stable on PD
* no peritonitis within the previous 2 months
* Without severe concomitant disease
* Negative pregnancy test in female patients of childbearing potential and adequate contraception in female patients of childbearing age

Exclusion Criteria:

* Known hypersensitivity to study medication
* Treatment with another investigational drug within 1 month prior to start of study medication
* Malignancy requiring chemotherapy or radiation
* Pregnancy or nursing,
* Presumed non-compliance
* Limited efficacy of peritoneal dialysis due to anatomical anomalies or severe intra-abdominal adhesions
* Clinical significant inflammatory parameters
* Less than 50 kg body weight
* Immunosuppressive therapy
The Consciousness Variation of Deep Brain and Transcranial Magnetic Stimulation for Disorders of Consciousness Patients

Aims:To explore the consciousness stimulation role of DBS (Deep Brain Stimulation) and TMS (Transcranial Magnetic Simulation) for DOC (Disorders of Consciousness) patients.

Methods:Seventy-five DOC patients will be randomised into three groups: DBS group, TMS group and Control group. Three months after treatments, the result will be analysed and concluded.

To explore the consciousness stimulation role of DBS (Deep Brain Stimulation) and TMS (Transcranial Magnetic Stimulation) for DOC (Disorders of Consciousness) patients. Seventy-five DOC patients will be randomised into three groups: DBS group, TMS group and Control group. These patients will be recorded the conscious level, fMRI (functional magnetic resonance imaging) and EEG evaluation before treatment of research, and three months later the prognosis was also recorded. Finally, the variation of consciousness, prognosis, fMRI and EEG index for three groups will be analyzed and compared. Hopefully, there will be a conclusion for these treatments to DOC patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ages 14 to 65 years old;
2. DOC patients, including vegetative state and minimally consciousness state.
3. With normal body temperature, stable vital signs, spontaneous breathing without extra oxygen supply, no tracheotomy using metal trachea cannula, and feasible for magnetic resonance inspectors;
4. Written informed consent from patient families

Exclusion Criteria:

1. History with nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
2. Patients with V-P shunt or ommaya implantation, which may effects magnetic resonance scan signal analysis;
3. Body temperature is abnormal, vital signs is not stable, still need ventilator to support breathing; Plentiful sputum needed suction during MRI scans.
Tandem Predictive Low Glucose Suspend Inpatient Feasibility Study

The goal of this study is to assess the functionality of an integrated predictive low glucose suspend system designed to minimize the incidence and duration of hypoglycemia by suspending insulin delivery if hypoglycemia is projected.

This protocol is designed to test the functionality of a predictive low glucose suspend system under supervised conditions where basal insulin rates are manually increased until a system generated suspension occurs. The study will collect data that will be used for planning a pivotal study, and the study data are intended to be used to support a Premarket Approval (PMA) application.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 diabetes requiring insulin therapy for at least 12 months
* Insulin pump therapy for at least 6 months
* Age ≥18.0 years
* Subject demonstrates stable insulin regimen including basal rates, insulin sensitivity factor and insulin:carbohydrate ratio for at least 3 months

Exclusion Criteria:

* Pregnant (female subjects must have negative urine or serum pregnancy screening test)
* Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment
* Diabetic ketoacidosis in the month prior to enrollment
* A current condition that would prevent the use of a CGM sensor or insulin pump, or in the judgment of the investigator is a contraindication to study participation
* Use of acetaminophen during study participation
* Current use of any medication intended to lower glucose other than insulin including naturaceuticals, oral or non-insulin injectable medications
Prehospital Management of Hypotensive Trauma in HEMS

Up to today, inadequate evidences and knowledge exist about the best prehospital management of hypotensive trauma patients and its clinical consequence on the in-hospital recovery and mortality.

Also new emerging therapies such as prehospital blood transfusion and REBOA (resuscitative endovascular balloon occlusion of the aorta) are lacking strong evidences in, eventually, reducing hospital mortality and improving outcomes.

Moreover, prehospital emergency medicine is throughout Italy an heterogeneous system that has no unique standard operating procedures and, even among HEMS (helicopter emergency medical service), management and therapies on complex trauma patients may vary upon local policies.

With this study we aim to enroll hypotensive trauma patients and study factors of prehospital rescue that can be associated with in-hospital mortality and recovery, eventually even with hospital outcome. For each patients data as demographic, kind of trauma (mechanism, injury scores), therapies and maneuvers will be recorded and then analyzed in comparison with in-hospital data such as need for transfusion, ABG parameters, length of stay (in-ward and ICU), need of therapies like invasive ventilation and renal replacement therapy, recovery and outcome


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Witnessed traumatic event managed by HEMS
* Shock at first evaluation (Systolic blood pressure \< 90 mmHg)
* Suspect or obvious ongoing haemorrage

Exclusion Criteria:

* Patients in cardiac arrest at HEMS arrival in which resuscitation is not started or interrupted by HEMS crew
The Flipped Classroom Approach in Ophthalmology Residency

This study aims to evaluate the flipped classroom approach compared to the traditional classroom approach in teaching horizontal strabismus in ophthalmology residency didactics.

Ophthalmology residents (post-graduate years 2-4) from 11 institutions were invited to participate. Participating residents were taught esotropia and exotropia topics sequentially, randomized by order and classroom style (flipped classroom vs. traditional lecture) one to three weeks apart. Participants were assigned a pre-class video lecture prior to the flipped classroom in-class case-based activity. The traditional classroom included a preparatory reading assignment and an in-person lecture delivered by the same instructor. Participants completed three identical 5-question content assessments (pre-test, post-test, and 3-month retention) and opinion surveys following each classroom.

Eligibility Criteria:
Inclusion Criteria:

* Ophthalmology residents of all levels (PGY2-PGY4) from 11 residency programs were invited to participate in this study

Exclusion Criteria:

* Those who did not complete both classroom styles were excluded from the survey data
* Those who lost their study-IDs were excluded from the results analysis
Osteoarthrosis on 7.0T Magnetic Resonance Imaging

This clinical trial studies the use of 7-Tesla (7T)and 3T magnetic resonance imaging (MRI) in detecting osteoarthrosis. 7T MRI has increased detection sensitivity, including more accurate lesion delineation, higher inter-rater agreement. Diagnostic procedures such as 7T MRI may help ultimately improved diagnostic and therapies confidence to inform decision making than standard 3T MRI.

7T MRI increased detection sensitivity, attain superior anatomic resolution, higher spatial and spectral specificity of advanced quantitative techniques, and shorter scan times than 3T MRI. When applied clinically, these benefits translate to increased detection sensitivity, and ultimately improved diagnostic and therapies confidence to inform decision making. This study aim to detect the image characteristics and diagnostic accuracy of osteoarthrosis on 7T MRI.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18 and ≤80
* Having no contraindications against MRI
* Clinically stable

Exclusion Criteria:

* Age#18 or #80
* Pregnancy and other contraindication to MRI scan
* Informed consent not obtained
Study of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Solid Tumors

This study is dose escalation study to evaluate the tolerability and safety of ONO-7914 alone and in combination with ONO-4538 in patients with advanced or metastatic solid tumors


Eligibility Criteria:
Inclusion Criteria:

1. Patients with advanced or metastatic solid tumor
2. Patients with ECOG performance status of 0 or 1
3. Patients with a life expectancy of at least 3 months

Exclusion Criteria:

1. Patients with severe complication
2. Patients judged to be incapable of providing consent for reasons such as concurrent dementia
Esketamine on Postpartum Depression in Cesarean Section Women

This study was to explore the preventive effect of esketamine on postpartum depression (PPD) in cesarean section, and to evaluate the safety of the drug

Studies have shown that esketamine can treat clinical refractory depression, the drug takes effect quickly, can quickly eliminate the patient's suicide intention, low-dose maintenance treatment is conducive to the stability of the patient's condition, and less adverse reactions, is the current hot spot of antidepressant drug research. Esketamine has been approved by FDA for the treatment of refractory and suicidal depression, but can it effectively prevent and treat postpartum depression? It is not clear. Based on this, this study aims to explore the preventive effect of prophylactic administration of esketamine on postpartum depression in cesarean section, and evaluate the safety of the drug.

Eligibility Criteria:
Inclusion Criteria:

* Elective cesarean section;
* 18-40 years;
* Primipara;
* Singleton pregnancy;
* Sign informed consent.

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) grade III and above;
* Intracranial hypertension;
* Hypertension;
* Severe heart disease;
* Hyperthyroidism patients without treatment or insufficient treatment;
* Liver and kidney dysfunction;
* Preeclampsia or eclampsia;
* Mental disorder, mental retardation;
* Drug abuse and alcoholism;
* Contraindication of intraspinal anesthesia;
* The preoperative EPDS score ≥10;
* Participated in other clinical studies.
A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis

This single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered.


Eligibility Criteria:
Inclusion Criteria:

* chronic kidney disease stage 3 or 4, with chronic renal anemia, not requiring dialysis;
* continuous stable subcutaneous maintenance Erythropoietin-Stimulating Agent (ESA) therapy during previous month.

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months;
* significant acute or chronic bleeding;
* poorly controlled hypertension.
Adjuvant Immunotherapy Combined With Chemoradiation for Patients With High-risk reseCtable Extrahepatic chOlangiocaRcinoma and gallblaDder Cancer

The study is a multicenter phase II randomized controlled trial. The purpose is to investigate the efficacy and safety of adjuvant immunotherapy combined with chemoradiation for patients with high-risk resectable extrahepatic cholangiocarcinoma and gallbladder cancer.

The trial will recruit 92 patients, and they will be randomized (1:1) into two groups (chemoradiation+immunotherapy group, observation group) after operation. Patients in chemoradiation+immunotherapy group will receive camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal. After 1 or 2 courses of camrelizumab, patients went on to receive capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week) concurrent with radiotherapy (45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed). Patients in observation group will not receive any anti-cancer therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-70 years;
2. Primary resectable extrahepatic cholangiocarcinoma and gallbladder cancer proved by pathology which underwent radical surgery;
3. Pathology indicates R0 with T2-4 or N1; or R1;
4. ECOG PS 0-1;
5. Adequate hematologic, hepatic and renal function: ANC ≥ 1.5x10\^9/L, Hb ≥ 80g/L, PLT ≥ 100 x10\^9/L, albumin ≥ 28g/L, total bilirubin \< 1.5×ULN, ALT and AST \< 2.5×ULN, CREA\<1.5×ULN;
6. At least 6 months of life expectancy.

Exclusion Criteria:

1. Pregnant or breastfeeding women, or expecting to conceive or father children within the projected duration of the trial;
2. Received previous anti-cancer therapies;
3. With purulent, infected or delayed healed wounds;
4. Have risky bleeding events requiring transfusion, operation or local therapies, continuous medication in the past 3 months;
5. Have thromboembolism in the past 6 months, including myocardial infarction, unstable angina, stroke or transient ischemic attack, pulmonary embolism, deep vein thrombosis;
6. Have taken aspirin (\>325mg/day) or other antiplatelet drugs continuously for 10 days or more within 2 weeks before enrolment;
7. Uncontrollable hypertension, systolic pressure\>140mmHg or diastolic pressure\>90mmHg after best medical care, or history of hypertensive crisis or hypertensive encephalopathy;
8. Symptomatic congestive heart failure (NYHA class II-IV). Symptomatic or badly-controlled arrhythmia. Congenital long QT syndrome or modified QTc\>500ms upon screening;
9. Have active autoimmune diseases that require systemic treatment within 2 years before enrolment;
10. Active tuberculosis, having antituberculosis therapy at present or within 1 year;
11. Have a known history of prior invasive malignancies within 5 years before enrolment;
12. Have other uncontrollable comorbidities;
13. Infection of HIV, known syphilis requiring treatment;
14. Allergic to chemotherapeutics.
Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy

The purpose of this clinical study is to evaluate BackStop, a polymer-based device that is intended to be used during ureteroscopic lithotripsy to prevent retrograde stone migration. It is a water soluble polymer with reverse thermosensitive properties; the polymer exists as a liquid at low temperature (below 17 C) and rapidly transitions to a high viscosity gel at body temperature (i.e. in the ureter). BackStop is injected above the stones in the ureter and is intended to prevent retrograde migration of stones during ureteroscopic lithotripsy. Upon completion of the lithotripsy procedure, BackStop dissolves naturally or by irrigation.

The study hypothesis is that a greater proportion of patients will experience no retropulsion of a kidney stone when BackStop is used versus no anti-retropulsion device when undergoing intracorporeal lithotripsy.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a solitary, radio-opaque ureteral stone in the proximal ureter.
* Clinical indication for treatment by ureteroscopic lithotripsy.
* Minimum 18 years old (or any institutional age limits for participation in clinical study).
* Patients must be willing and able to participate in any follow-up visits, as required.
* Patients must provide informed consent.

Exclusion Criteria:

-
Retrospective Study on the WalkOn AFO in Children or Teenagers with Neurological Pathologies

The goal of this observational study is to assess the interest of prefabricated carbon fiber ankle foot orthoses (AFO) in children and teenagers with central or peripheral neurological pathologies. The main question it aims to answer is:

Does prefabricated carbon AFO improve gait and provide user satisfaction? In current practice, all patients with gait impairments were fitted with this orthosis and had a 3D gait analysis with and without AFO. Biomecanical and follow-up data collected in current practice are analysed in this study in order to answer the question.


Eligibility Criteria:
Inclusion Criteria:

* Patient, child or adolescent, whose gait is affected by central or peripheral motor impairments
* Patient who has carried out a one-off trial of a WalkOn AFO (Ankle-Foot Orthosis) within the last 3 years prior to the beginning of the study (inclusion period)
* Patient whose quantified gait analysis with the WalkOn AFO and without orthosis is available in the medical file and whose date is within the inclusion period
* The investigator has verified that the patient and the parental authorities have received the information note concerning the study
* The investigator has verified that the person and the parental authorities do not object to the processing of data necessary for the study

Exclusion Criteria:

• Patients or holders of parental authority objecting to the processing of data within the framework of the study
Calprotectin in Chronic Prosthetic Joint Infection

A bacterial infection of an artificial joint is a serious complication that often requires additional surgery to exchange the arthroplasty. It is also difficult to recognize an infected joint, as the symptoms caused by the infection are very similar to those of other problems with arthroplasties, such as loosening of the implant. To improve the ability to diagnose prosthetic joint infections, this study compares the levels of calprotectin, a specific inflammatory protein, in the joint fluid of infected joints and joints with other complications. The underlying hypothesis is that the level of calprotectin in infected joints is significantly higher, thus facilitating the diagnosis of prosthetic joint infection.


Eligibility Criteria:
Inclusion Criteria:

* scheduled arthroplasty exchange for any of the following reasons:
* infection
* loosening
* instability
* malalignment
* periprosthetic fracture

Exclusion Criteria:

* acute prosthetic joint infection
Gynaecological Follow-up of a Subset of 580299/008 (NCT00122681) Study Subjects

This study is designed to provide up to four years of annual oncogenic HPV DNA testing and cervical cytology examination for NCT00122681 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their last NCT00122681 study visit (Visit 10, Month 48).

This follow-up study will also be offered to subjects who were pregnant at their last NCT00122681 study visit (Visit 10, Month 48) so that no cervical sample could be collected at that visit.

The objectives \& outcome measures of the primary phase (study 008/580299) are presented in a separate protocol posting (NCT00122681).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from the subject prior to enrolment.
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* A subject previously enrolled in the study NCT00122681 and who fulfils either of the following criteria:

  * displayed normal cervical cytology but tested positive for oncogenic HPV infection at her last NCT00122681 study visit (Visit 10, Month 48).

or

- was pregnant at her last visit of the NCT00122681 study (Visit 10, Month 48) so that no cervical sample could be collected at that visit.

Exclusion Criteria:

* A subject who displayed normal cervical cytology and who was negative for oncogenic HPV infection at her last NCT00122681 study visit (Visit 10, Month 48).
* A subject who had a cervical lesion at her last NCT00122681 study visit (Visit 10, Month 48) or who had a cervical lesion that required treatment at the NCT00122681 exit colposcopy.
* A subject for whom the cervical cytology results from the last NCT00122681 study visit (Visit 10, Month 48) were unavailable for reasons other than pregnancy.

If at the time of enrolment the subject experiences heavy bleeding (menstruation or other) or heavy vaginal discharge, or is pregnant, the pelvic exam cannot be performed. The subject's first study visit will be deferred until condition is resolved according to investigator's medical judgment.