cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE)

The primary objective of the study is to evaluate the safety, tolerability and Pharmacokinetics (PK) of Epratuzumab in Japanese subjects with moderate to severe general SLE as add on to standard of care treatment during the trial.


Eligibility Criteria:
Inclusion Criteria:

* Positive Anti-nuclear Antibody (ANA) at Screening (Visit 1)
* Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria
* Active moderate to severe SLE activity as demonstrated by British Isles Lupus Assessment Group Index (BILAG)
* Active moderate to severe SLE disease as demonstrated by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score on stable SLE treatment

Exclusion Criteria:

* Subjects who are breastfeeding, pregnant, or plan to become pregnant
* Subjects with active, severe SLE disease activity which involves the renal system and active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A
* Serious infections
Intraoperative Fluid Therapy for Deceased Donor Renal Transplantation

Delayed graft function (DGF) is defined as requirement for dialysis in the first week following kidney transplantation. DGF is a common complication occurring in 39% of the deceased donor renal transplants at the investigators' institution with significant cost and outcome implications. The 3 major risk factors for DGF are donor graft characteristics, recipient factors and perioperative management. The most easily modifiable of these factors is perioperative management, in particular intraoperative fluid therapy. The investigators propose to compare the amount of fluid administered using the current standard of care with the fluid administered when optimizing the cardiac output (CO) using Esophageal Doppler Monitoring (EDM) to guide fluid therapy. EDM measures blood flow in the descending aorta, optimizing stroke volume (SV) and cardiac output (CO) by indicating when fluid administration fails to produce an increase in CO.


Eligibility Criteria:
Inclusion Criteria:

* age greater than 18 years
* signed informed consent
* listed for deceased donor transplantation.

Exclusion Criteria:

* esophageal surgery or cancer
* esophageal stricture, varices or diverticulum
* upper airway surgery
* coarctation of the aorta
* significant valvular heart disease
* clinically significant cardiac arrhythmias
* patient randomized to other trials with an outcome variable of delayed graft function or early graft function will also be excluded
Safety,Tolerability, and Pharmacokinetic of KPCXM18 for Injection

to assess the safety,Tolerability, and pharmacokinetic of KPCXM18 for injection in healthy subjects

To explore the safety, tolerance and pharmacokinetic of KPCXM18 for injection in healthy subjects by intravenous administration of different doses in single and multiple administration safety, tolerance and pharmacokinetic tests, and to obtain the safe dose range of the test drugs, thus providing dose design basis for phase II clinical trials.

Eligibility Criteria:
Inclusion Criteria:

1. BMI between 19 and 26 kg/m2；male body weight not less than 50.0kg,female body weight not less than 45.0kg ；
2. General physical examination and physical and chemical examination are qualified.
3. Volunteers can communicate well with the investigator, understand and comply with the relevant requirements of the study, understand and sign the informed consent；

Exclusion Criteria:

1. Any condition that might interfere with the procedures or tests in this study;
2. Drinking（more than 14 units of alcohol per week） in 6 months ;
3. Smoking (more than 10 cigarettes per day or equal amount of tobacco) within 3 months (90 days) ;
4. Have special requirements on diet, or cannot follow a unified diet ;
5. Used a clinical trial drug within 3 months prior to administration ;
6. Positive blood pregnancy test of female subjects ;
7. Subjects may not be able to complete the study for other reasons or the investigator considers that they should not be included .
Turkish Version of the Neurogenic Bladder Symptom Score Questionnaire: a Cross-cultural Adaptation, Reliability and Validity Study

Turkish version of the Neurogenic Bladder Symptom Score questionnaire: a cross-cultural adaptation, reliability and validity study

Turkish version of the Neurogenic Bladder Symptom Score questionnaire: a cross-cultural adaptation, reliability and validity study in spinal cord patients.

Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury patients
* aged \> 18 years old

Exclusion Criteria:

* spinal shock patients
* urinary tract operation in the last month
* Quality of life changes in the last month
* urinary tract infections in the last month
* bladder management changes or drug changes in the last month
Electrical Impedance Tomography for Quantification of Pulmonary Edema in Acute Respiratory Distress Syndrome Patients

Evaluation of pulmonary edema is a key factor in monitoring and guidance of therapy in acute respiratory distress syndrome (ARDS) patients. To date, methods available at the bedside for estimating the physiologic correlate of pulmonary edema, extravascular lung water(EVLW), often are unreliable or require invasive measurements. The purpose of the this study is to develop a novel approach to reliably assess extravascular lung water by electrical impedance tomography(EIT).


Eligibility Criteria:
Inclusion Criteria:

Patients will be included in this study if the following criteria have been met:

1. Males and females \> 18 years old and \<85 years old (non-pregnant, non-lactating females).
2. Patients fulfilled the Berlin diagnostic criteria of ARDS
3. Signed written informed consent has been obtained
4. Patients had monitoring system Pulse-Induced Contour Cardiac Output (PiCCO)

Exclusion Criteria:

1. Females who are pregnant or lactating.
2. Patients with contraindication of EIT(Skin abrasions or wounds in the chest area.Patients with pacemakers or paced EKG rhythms.Thoracic deformity. Severe subcutaneous emphysema)
3. Patients \<18 years old or \> 85 years old
4. Patients Without monitoring system Pulse-Induced Contour Cardiac Output (PiCCO)
5. Patients with Cardiac function of grade 4 or patients with acute myocardial infarction or acute coronary syndrome
Cognitive Therapy Plus Dietary Intervention for Obesity Treatment

This randomized clinical trial was carried out from January 2017 to December 2017 at the facilities of the Catholic University of Murcia. Written informed consent was required from each patient. The protocols of the present clinical trial follow the CONSORT standards. To measure the impact of cognitive training on weight loss in overweight / obese subjects, a double-blind study (de facto masking) was designed.

Both the participants and the statistical assessors were unaware of the study hypothesis. Participants were unaware of treatments and possible assignments between groups, and only those subjects who were randomly assigned to the cognitive training group were informed that such training was part of dietary therapy.

The principal investigator of the present study (J.J.H.M.) carried out the randomization, with the assistance of the Microsoft Excell program, with the help of a macro designed in Visual Basic® for that purpose.

The randomization divided the subjects into two groups, as they were treated with a hypocaloric diet plus 12 nutrition education sessions (CONTROL group) or a group that were treated with a hypocaloric diet plus 12 sessions of cognitive training (COGNITIVE group).

In order to obtain a similar size in both groups, a randomization in blocks with a 1: 1 allocation ratio was performed.

Cognitive performance measures were performed before and after training. One week before the beginning of the cognitive and dietary intervention, the participants performed a series of cognitive tests. After 12 weeks of both dietary and cognitive intervention, participants were reexamined to measure performance on neurocognitive tests.


Eligibility Criteria:
Inclusion Criteria:

* Present a BMI\> 27 kg / m2, and want to be part of the study voluntarily

Exclusion Criteria:

* subjects with diabetes mellitus type 2
* subjects with a history of a cardiovascular event (acute myocardial infarction, intermittent claudication, etc.)
* subjects with kidney or liver failure or some other significant pathology (cancer)
* subjects under pharmacological treatment that could affect body weight (corticoids, thyroxine, etc.)
* subjects who were on a diet or had been on a diet at least 6 months before their participation in the study were also excluded.
High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in Prostate Cancer

This is an Investigator Initiated, non-commercial, single center, non-randomized, single arm, open label pilot study on 194 patients. The patients are affected by prostate cancer but in two different clinical settings. The first group is characterized by patients who are going to be operated of radical prostatectomy and they will undergo the study imaging preoperatively. The second group experiences biochemical relapse after primary treatment.

Novel, sensitive tools, such as 68Ga-PSMA PET imaging, have great potential for very early disease detection and open the possibility of early curative local salvage treatment (with surgery, radiotherapy or a combination of both). This project will moreover provide important insights into the biodistribution and dosimetry of 68Ga-PSMA, opening possibilities of 90-Yttrium or 177-Lutetium-PSMA-based radionuclidetherapy of patients with metastatic PC in the future.

The study consists of 2 work units (WU):

Work-unit 1: Patients at high risk for nodal involvement prior to radical prostatectomy with extended lymph node dissection Work-unit 2: Biochemical recurrence after initial treatment with curative intent

Eligibility Criteria:
Inclusion criteria

Work-unit 1

* age \< 75 years of age, with histologically proven invasive adenocarcinoma of the prostate
* a risk of equal or more than 5% of lymph node metastasis (intermediate to high risk disease), according to the Briganti nomogram (1)
* scheduled to undergo radical prostatectomy with extended lymph node dissection

Work-unit 2

* histologically proven diagnosis of prostate cancer
* biochemical relapse (two consecutive PSA≥0.2 ng/ml) of prostate cancer following radical local prostate treatment
* WHO performance state 0-1
* age \> 18 years old

Exclusion criteria

Work-unit 1

* involvement of pelvic lymph nodes assessed by multi-parametric MRI
* evidence for bone metastasis assessed by bone scan (if PSA \> 20 ng/ml)
* WHO performance status \> 2
* previous pelvic irradiation or radical prostatectomy.
* other malignancy except adequately treated basal cell carcinoma of the skin diagnosed during the last 5 years
* any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Work-unit 2

* serum testosterone level \<50ng/ml
* symptomatic metastases
* local relapse on MRI
* PSA rise while on active treatment with LHRH-agonist, LHRH-antagonist, Anti-androgen, Complete androgen blockade, Oestrogen-antioestrogen therapy
* previous treatment with cytotoxic agent for PCa
* treatment during the past month with products known to influence PSA levels (e.g. fluconazole, finasteride, corticosteroids,...)
* disorder precluding understanding of trial information or informed consent
A Study Evaluating the Safety, Tolerability, and Range of Biologically Active Doses of ICM-203 in Mild to Moderate Knee Osteoarthritis

The purpose of this study is to determine the safety, tolerability, and activity of ICM-203, a recombinant adeno-associated viral (AAV) vector that expresses a therapeutic gene that promotes cartilage formation, reduces joint inflammation and pain, as well as improves joint physical function, by injecting escalating doses of ICM-203 or matching placebo into the knee of subjects with mild to moderate knee osteoarthritis (OA).


Eligibility Criteria:
Inclusion Criteria:

1. Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive, at the time of screening.
2. Kellgren-Lawrence grade 2 or grade 3 OA of target knee.
3. Target knee pain between 4 and 9, inclusive, on an NRS ranging from 0 (no pain) to 10 (worst pain imaginable).
4. KOOS function in daily living score \>25, a measure of knee function ranging from 0 (extreme problems) to 100 (no problems).
5. A stable treatment regimen for symptomatic relief of OA, including NSAIDs, for 4 weeks prior to screening.

Exclusion Criteria:

1. History of rheumatoid arthritis, psoriatic arthritis, gout, pseudogout, autoimmune OA, chondrocalcinosis, hemochromatosis, villonodular synovitis, and synovial chondromatosis or other disorder that in the opinion of the Investigator could cause inflammation of the knee.
2. Injection of steroid, hyaluronate or other agent, into the target knee less than 90 days prior to day 1.
3. Major injury to the target knee, such as torn ligament or severe sprain, within 12 months of screening.
4. Disability so severe that the subject cannot comply with the study requirements, including knee symptoms that result in significant difficulty or inability to walk.
5. Surgery on the target knee within 180 days prior to day 1
6. Total knee arthroplasty or other knee surgery planned in the next 12 months.
7. Active joint infection or other concurrent medical (diabetes, uncontrolled hypertension, severe osteoporosis, glaucoma) or psychiatric condition that, in the opinion of the Investigator, would make the subject unsuitable for the study.
The Alternative Position for the SedLine® Sensor

SedLine® Brain Function Monitoring provides real-time insight into a patient's depth of anesthesia with bilateral data acquisition and processing of electroencephalogram (EEG) signals. Four active EEG leads collect data from the frontal lobe with a sensor position on the patient's forehead.

Whenever a frontal approach for neurosurgical procedures is required or the frontal placement of the EEG is not indicated, it would not be possible to place the SedLine® .

Numerous studies have analyzed the change of position and the application of alternative positions for other devices used in assessing the depth of anesthesia. Albeit, yet to date, there is no study that analyzed the application of alternative positions for the SedLine® sensor.

The purpose of study is to compare the standard forehead placement versus a nasal placement of SedLine® sensor for neuromonitoring.

The hypothesis is that placing the central sensors in the montage approximately 2 cm below the standard recommended placement, across the nasal bridge and then running under the eyes to the normal temporal leads placement would put the entire montage out of the operative field and would still have corresponding values and EEG signals.

The primary outcome measure is to monitor and compare processed electroencephalograph (EEG) values (PSi- Patient State Index, SEFL- Spectral Edge Frequency Left, SEFR- Spectral Edge Frequency Right, SR-Suppression Ratio, EMG-Electromyography, ARTF-Artifact) and EEG waveforms, on both sensors (standard-Forehead and alternative-Nasal)

Other parameters that will be measure are patient demographics (age, sex, surgery, ASA status, weight, height, BMI).

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age, both genders.
* Patients undergoing simple or complex surgery.
* American Society of Anesthesiologists Classification (ASA) score I to III.

Exclusion Criteria:

American Society of Anesthesiologists Classification (ASA) score IV and V.

* Emergency cases
* Cognitive/Mentally impaired or unable to provide consent
* Previous neurological problems affecting EEG
* Dementia
* Use of sedative or drugs that can alter EEG readings
* Patients under head and neck surgery
Relationship Between Magnesium Depletion Score and Extraction Socket Healing

The surgical extraction of an impacted tooth is one of the most common procedures in oral surgery. Following extraction, the tissue undergoes repair and regeneration through a process known as socket healing (SH).

SH is a complex and highly regulated biological process. Several local, surgical, and systemic factors can influence SH. This study aimed to evaluate the impact of the magnesium depletion score (MDS) on the socket healing following tooth extraction.

The surgical extraction of impacted teeth is one of the most commonly performed procedures in the field of oral surgery. According to the American Dental Association (ADA), surgical extraction involves "the removal of a tooth that has either erupted or not into the mouth, which includes the removal of a mucoperiosteal flap and the trimming of a portion of the tooth and/or bone." Complications related to post-extraction wound healing-such as pain, swelling, bleeding, and infection-can pose significant challenges for both patients and surgeons. Optimal healing depends not only on the tissue itself but also on various local, surgical, and systemic factors, including but not limited to the patient's stress levels, oral hygiene, age, sex, overall health status, and nutrition, many of which may be beyond intervention or control. Consequently, there is growing interest in treatments that can enhance wound healing. Recent studies indicate that magnesium consumption may have a beneficial effect on the healing process.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy adult participants who were scheduled to undergo surgical extraction of lower impacted third molars.

Exclusion Criteria:

* Refusal to consent
* Presence of chronic diseases
* Use of medications that affect wound healing (steroids, bisphosphonate, or immunosuppressives)
* Prior radiotherapy in the head and neck area
* Pregnancy
* Inability to self-evaluate, and inability to communicate verbally or in writing.
Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants

Pain will bring early and long-term adverse reactions to infants. The investigators need to pay attention to whether there is pain in infants after surgery. Since infants cannot self-report pain,The investigators need to use appropriate pain assessment scale to evaluate the pain of these infants, so as to understand the status of postoperative pain in children. The result of pain score not only enables investigators to understand the pain status of children, but also helps investigators to give corresponding intervention and treatment according to the pain degree of children. Postoperative pain management is one of the core contents of ERAS. Effective pain management is beneficial to the early postoperative recovery of infants and reduces the adverse reactions caused by pain. Sveral studies have confirmed that the combination of acetaminophen and opioids could reduce the use of opioids after surgery. But even if opioid use is reduced, it still causes many side effects for children. This study evaluated the safety and efficacy of acetaminophen alone for postoperative analgesia in infants.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent was obtained from parents of children;
* Infants aged 0-12 months;
* Children who underwent abdominal and perineal surgery in the Department of Neonatal Surgery, Children's Hospital Affiliated to Nanjing Medical University and returned to the unaccompanied ward after removal of tracheal intubation.

Exclusion Criteria:

* No informed consent was obtained from parents;
* known allergy or intolerance to acetaminophen;
* Children with liver function impairment (alanine aminotransferase/aspartate aminotransferase (ALAT/ASAT) more than three times the reference value;
* Children with renal insufficiency (urea and creatinine values exceeding the upper limit of reference values);
Recurrences After Standard EMR vs Plus Thermal Ablation EMR

The primary objective of this trial is to investigate whether thermal ablation EMR with soft tip snare coagulation (STSC) reduces the recurrence rate of lateral spreading or sessile polyps ≥20mm compared to standard EMR.

Rationale:

Lowering the EMR recurrence rate will potentially lead to fewer colonoscopies resulting in less additional costs, less compliance burdens and less exposure to possible procedure related risks.

Objective:

To investigate whether thermal ablation EMR with snare tip soft coagulation (STSC) reduces the recurrence rate of lateral spreading or sessile polyps ≥20mm compared to standard EMR.

Study design:

This study entails a patient-blinded multicenter prospective randomized controlled trial that will be conducted between January 2022 and May 2025 in 1 academic and 7 non-academic hospitals in The Netherlands and it will take place in the outpatient clinics of the participating centers.

Study population:

All patients aged ≥ 18 years with proven colorectal sessile of lateral spreading polyps (Paris classification 0-IIa/b/c, Is) with a diameter of ≥ 20mm requiring piecemeal resection with EMR are eligible for inclusion.

Intervention:

Snare tip soft coagulation of the entire EMR margin is a technique for the removal of potential residual adenoma.

Main study endpoint:

Polyp recurrence after 6 months follow up. Recurrence is evaluated histologically and endoscopically with biopsies taken during follow up colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Proven colorectal sessile or lateral spreading polyps with a diameter of ≥ 20mm requiring piecemeal resection with EMR.

Exclusion Criteria:

* Previously attempted intervention
* Polyps with any signs of invasive malignancy
* Presence or suspicion of inflammatory bowel disease
* En bloc resection
* Incomplete resection
A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Patients With AIDS and AIDS-Related Complex

To determine the safety profile and maximum tolerated dose (MTD) of recombinant soluble human CD4 (rCD4) therapy in patients with AIDS or AIDS related complex (ARC). To assess pharmacokinetic properties of rCD4 in humans. To obtain a preliminary indication of the antiviral effects of rCD4 in patients with AIDS and AIDS related complex (ARC).


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV-1 seropositivity.
* Diagnosis of AIDS or AIDS related complex (ARC).
* Failure to tolerate or respond to zidovudine (AZT) or decided to decline AZT therapy.
* The ability to sign a written informed consent form prior to treatment.
* A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.
* A life expectancy of at least 3 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Serious active opportunistic infections.
* Malignancies other than Kaposi's sarcoma.

Concurrent Medication:

Excluded:

* Zidovudine (AZT).
* Corticosteroids.
* Nonsteroidal anti-inflammatory agents (NSAI).
* Other experimental therapy.

Patients with the following are excluded:

* Serious active opportunistic infections.
* Malignancies other than Kaposi's sarcoma.

Prior Medication:

Excluded within 3 weeks of study entry:

* Zidovudine (AZT).
* Chemotherapy.
* Immunomodulators.
* Other experimental therapy.