cyrilzakka/clinical-trials huggingface dataset:
Pre-therapeutic 68Ga-PSMA PET AI Based Dose Prediction for 177Lu-PSMA Targeted Radionuclide Therapy

Targeted Radionuclide Therapy (TRT) is a contemporary approach to radiation oncology, aiming to deliver the maximal destructive radiation dose via cancer-targeting radiopharmaceutical. Radioactive ligands for the prostate-specific membrane antigen (PSMA) have emerged for the treatment of metastatic castration-resistant prostate cancer (mCRPC).Normal organ and tumor dose can be assessed by a series of cross-sectional whole-body SPECT scans, however, these require a large amount imaging time and are often not feasible in routine clinical practice.

An alternative is to generate a 3D time integrated activity (TIA) map per patient based on the PBPK and the pre-therapy imaging

Despite the early success of TRT, concerns have been raised about the risks of inadequate trade-off between therapeutic dose and side effects. Currently, the protocols for administering the radiopharmaceuticals are assessed on a population basis, and the activity to administer was determined for a specific patient group based on preceding studies . However, the European Council Directive (2013/59 Euratom) mandates that TRT treatments should be planned according to the optimal radiation dose tailored for individual patients, as has long been the case for external beam radiotherapy (EBRT) or brachytherapy. An essential requirement of TRT treatment planning is to estimate the absorbed dose in advance of therapy.

Prior knowledge of the biodistribution of the therapeutic agent via the pre-therapy imaging assists to optimize the trade-off between tumor destruction and irradiation of healthy tissues. Concepts, such as physiologically based pharmacokinetic (PBPK) modeling, have been proposed to estimate the spatiotemporal pharmacokinetics of imaging agents and then extrapolate to the treatment agents.

An alternative is to generate a 3D time integrated activity (TIA) map per patient based on the PBPK and the pre-therapy imaging. The TIA gives the information about number of decays that take place in each voxel during the total duration of the therapy. PBPK is an organ-based model, then the calculation of the 3D TIA raises the issue of organ segmentations on the pre-therapy nuclear imaging, which must be robust, automatic, and accurate. The absorbed dose to the patient can be estimated before the treatment using the 3D TIA and the patient anatomy (CT image) using Monte Carlo (MC) simulation. . This project will address two main challenges: (a) the robust and accurate metabolic segmentation in nuclear medicine for the 3D TIA calculation, and (b) the fast dose prediction based on MC and deep-learning approach.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received at least one dose of 177Lu-PSMA and for whom a 68Ga-PSMA PET/CT was performed as part of IVRT in the "pre-treatment" assessment

Exclusion Criteria:

* Patient opposition to the use of their data as part of this research.
Tissue-engineered Construct Based on Buccal Mucosa Cells and Matrix From Collagen and Polylactoglycolide Fibers

This study investigates safety and efficacy of surgical treatment of patients with anterior urethral stricture using a tissue-engineered construct based on autologous buccal mucosa cells and matrix from reconstituted collagen and reinforcing polylactoglycolide fibers. This is a single arm study with no control. Success will be assessed via objective and subjective methods; complications will be tallied in a standardized fashion. Outcomes will be measured at five years.

Treatment of urethral strictures longer than 2 cm is an actual clinical challenge. In this case, the common method is replacement surgery using a buccal mucosa graft. However, the main disadvantage of this method is associated with limited donor resources and donor site morbidity.

The aim of this study is to assess safety and efficacy of surgical treatment of patients with anterior urethral stricture using a tissue-engineered construct. The construct consists of autologous buccal mucosa cells and matrix from reconstituted collagen and reinforcing polylactoglycolide fibers. Patients will be followed up for 5 years within this study. The follow-up regimen includes retrograde and pericatheter urethrography, voiding cystourethrography, uroflowmetry, biopsy, and quality of life monitoring. Telephone follow-up will take place in between these assessments.

The data obtained from this study will have practical implications for the urethral stricture treatment and will be based on the principles of evidence-based medicine.

Eligibility Criteria:
Inclusion Criteria:

* Patient signed informed consent form
* Diagnosed anterior urethral stricture longer than 2.0 cm and shorter than 4.0 cm
* At least one prior internal optical urethrotomy and/or urethral bougienage

Non-inclusion Criteria:

* Acute infectious diseases
* Patient with decompensated heart and renal failure
* Patient with non-compensated diabetes mellitus
* Patient with malignant tumor
* Patient with polyvalent allergy
* Mental disorders
* Post traumatic urethral strictures
* Subtotal and total urethral strictures
* Sexually transmitted infections
* Hypersensitivity to any components of tissue-engineered constructs
* Any clinical state which does not ensure the safe implementation of study procedure (investigator's view)
* Other associated urethral strictures
* Laboratory markers of active urethritis

Exclusion Criteria:

* Patient's refusal from the further participation in trial
* Confirmed syphilis, HIV, hepatitis B or C infections
* Patient who cannot be regularly examined due to any circumstances
Inflammation and Glycation in a General Adult Population

Background. Obesity, insulin resistance and type 2 diabetes are closely associated with chronic inflammation characterized by abnormal cytokine production. Some authors have found discordances between glycated hemoglobin (HbA1c) and other measures of glycemic control, suggesting that a "glycation gap", defined as the difference between the HbA1c concentration and that predicted by the fructosamine concentration, could explain the excess interindividual variation in HbA1c.

The present study was aimed to examine the association between inflammation, sociodemographic (age, gender) and lifestyle factors (diet, exercise, alcohol, and tobacco consumption), and common diseases. In addition, we also examine levels of blood glucose, HbA1c, fructosamine and "glycation gap" determining the prevalence of "high glycators" in a general adult population and their association with lifestyles and prevalent diseases.

Methods. Selection of a random sample of the general adult population from a single municipality (A-Estrada, Pontevedra, Spain), stratified by age. The initial sampling includes 3,500 subjects. Considering approximate 67% participation rate, the final study population would include more than 2,000 individuals. The standard workup includes structured questionnaires, skin prick test, periodontal examination, psychological tests, physical examination and blood determinations to allow for categorization of participants in terms of basic demographics, profession, education level, socioeconomic level, quality of life, physical activity, diet, alcohol consumption and smoking, atopy, obesity, diabetes, metabolic syndrome, hypertension, cardiovascular disease, and liver disease. We determine blood levels of inflammation markers, HBA1c, fructosamine and glucose. We will collect a urine sample for microalbuminuria determination. In addition, blood will be drawn to be stored at the Biobank of our Hospital. One half of participants (\~1000 individuals) will undergo continuous glucose monitoring. The design is cross-sectional, followed by a longitudinal study using population registries for the determination of events (mortality).

Discussion. This comprehensive study in a general adult population provides an excellent opportunity to determine serum concentrations of inflammation and glycation markers and how they can vary widely with age, sex, common habits, metabolic abnormalities, and chronic diseases. The findings from this study should also help to find out the relationship between glucose profiles and HbA1c and fructosamine concentrations with diet and inflammation markers.

Keywords: Inflammation, glycation, glycated hemoglobin, glycation gap, continuous glucose monitoring, obesity, allergy, periodontal diseases, depression, metabolic diseases.


Eligibility Criteria:
Inclusion Criteria:

* Female or male
* 18 years and older
* No evidence of acute illness, fever, undue stress

Exclusion Criteria:

* Unable to give informed consent
* Pregnant
* Dementia
* Terminal cancer
* Allergy to adhesives
* Any concomitant medical condition that would likely affect the evaluation of device performance
Hemodynamics During Induction of General Anesthesia After Prophylactic Ephedrine, Phenylephrine or Norepinephrine.

In this trial the investigators want to examine if there is any difference in hemodynamic stability when giving equipotent prophylactic injections of ephedrine 0,1 mg/kg, phenylephrine 1 microg/kg, norepinephrine 0,1 microg/kg or sodium chloride (NaCl) 9 mg/ml during induction of general anesthesia with propofol and remifentanil.

The LiDCOplus monitoring system (Lithium Dilutional Cardiac Output (LiDCO) Ltd., Cambridge, United Kingdom) is a minimally invasive monitor for measuring stroke volume (SV) using two different algorithms. The PulseCO (PulseCO ™, Cambridge, United Kingdom) is based on analyses of the the arterial pressure wave giving nominal values. The LiDCO uses lithium-dilution for calibration to give absolute values. In this trial, the investigators will use the PulseCO looking at relative changes in uncalibrated hemodynamic variables. Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (CO) and systemic vascular resistance (SVR) will be measured.

Earlier studies have shown that propofol 2.5 mg/kg induction without opioid reduces CO (-15%), SV (-5 %), MAP (-33%) and SVR (-11%) and a slight reduction i HR. High-dose remifentanil anesthesia (2 microg/kg/min), in coronary patients reduced cardiac index (-25%), SV (-14%) and MAP (-39%) in a similar manner as propofol/remifentanil (propofol target 2 microg/ml and remifentanil 0.5 microg/kg/min), but systemic vascular resistance index decreased (-14%) in propofol/remifentanil combination.

Several procedures have been proposed to minimize the negative hemodynamic changes during induction. Administration of a crystalloid or a colloid did not prevent the decrease in MAP after induction of general anesthesia with propofol and fentanyl.

The hemodynamic effects in propofol-fentanyl anesthesia of preoperative ephedrine 0.07-0.15 mg/kg vs phenylephrine 1.5 microg/kg in valve surgery and concludes that ephedrine 0.07-0.1 mg/kg is safe and effective in counteracting hypotension. A dose of 0.15 mg/kg ephedrine is suggested for preventing hypotension during anesthesia induction with propofol 2.5 mg/kg and remifentanil 3 microg/kg.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women
* Age 18-50 years
* Gynecological procedures
* General anesthesia

Exclusion Criteria:

* Pre-existing hypertension
* Diabetes for several years
* Ischemic heart disease
* Cerebrovascular disease
* Heart valve disease
* Verified cardiac arrhythmia
* Anaemia
* Kidney or hepatic disease
* Hypersensitivity for soya, eggs or peanuts
* Pregnancy
* Poor health state
* Illicit substance use
* BMI \<20 or \>35 kg/m2
* SBP \>150 mmHg
* HR \>100 beats/min
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.

This Protocol Posting has been updated following Protocol amendment 1, October 2009. The impacted section are the study design section, the outcomes measures section and the intervention section.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
* Children, male or female, aged between 3 and 17 years at the time of the first study vaccination.
* Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
* Healthy children as established by medical history and clinical examination when entering into the study.
* Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
* Clinically or virologically confirmed influenza infection within six months preceding the study start.
* Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
* Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
* Acute disease and/or fever at the time of enrolment
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
* Previous administration of any H1N1 A/California-like vaccine.
* Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
* If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
* Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
* Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
* Child in Care.
Loratadine for the Reduction of G-CSF Induced Bone Pain in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization

This early phase I trial studies how well loratadine works in reducing granulocyte-colony stimulating factor (G-CSF) induced bone pain in patients with multiple myeloma who are undergoing stem cell mobilization. Loratadine is an antihistamine that may help to reduce or control bone pain during the process of stem cell collection in patients with multiple myeloma.

PRIMARY OBJECTIVE:

I. To evaluate the efficacy of the second-generation antihistamine, loratadine, as prophylaxis for filgrastim (i.e., Neupogen, Zarxio) induced bone pain during stem cell mobilization in multiple myeloma patients.

SECONDARY OBJECTIVES:

I. To examine the frequency and quantity of supportive analgesic medications needed in addition to loratadine or placebo for filgrastim induced bone pain.

II. To identify risk factors associated with developing filgrastim induced bone pain.

OUTLINE: Patients are randomized to 1 of 2 cohorts.

COHORT I: Beginning 5 days before the first dose of standard of care filgrastim, patients receive loratadine orally (PO) once daily (QD). Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity.

COHORT II: Beginning 5 days before the first dose of standard of care filgrastim, patients receive placebo PO QD. Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be able to provide informed consent
* Patients with confirmed diagnosis of multiple myeloma
* Able to swallow and retain oral medication
* All ethnic groups are eligible

Exclusion Criteria:

* Non-English speaking person
* Patients undergoing haploidentical allogeneic hematopoietic stem cell transplant
* Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds
* Any medical complications or conditions that would, in the investigator's judgement, interfere with full participation in the study
* On therapeutic dose of aspirin (doses greater than 81 mg) within 7 days prior to the start of the study
A Study of BNC210 in Elderly Patients With Agitation

This is a Phase II randomised, double-blind, placebo-controlled study assessing the effects of BNC210 on agitation in hospitalised elderly patients as measured by the Pittsburgh Agitation Scale (PAS). Safety and tolerability of BNC210 will also be assessed.

The secondary objectives of the study include evaluation of the effects of BNC210 on global function in patients with agitation as assessed by the Clinical Global Impression Scale (CGI-S/I).

Participants will receive 5 days of blinded treatment followed by 2 days of follow up.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female elderly patient admitted to hospital and under the care of a specialist Geriatrician
* Determined to have agitation requiring intervention in addition to standard of care behavioural management, as assessed by the Investigator or delegate, after at least 24 hours following admission to hospital.

Key Exclusion Criteria:

* Severe Alzheimer's Dementia (stage 7) as assessed by the Functional Assessment Staging Test (FAST).
* Diagnosed with Severe Parkinson's Disease.
* Premorbid psychotic illness as assessed by the Investigator.
* Evidence of severe organ dysfunction
* Confirmed metastatic malignancy.
Effectiveness and Safety of Breeded Leech for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint

In this trial the investigators want to prove the efficacy and safety of a one-time topical leech application at patients with symptomatic primary arthrosis of the first carpometacarpal joint in comparison to the standard therapy with topical diclofenac.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 35 to 85 years
* Pain intensity in the region of the thumb base in pain phases ≥ 40 mm on the VAS of 0 to 100 mm (relative to the last 24 hours)
* Complaints for at least 3 months
* X-ray Stadium Eaton I-IV at least once secured

Exclusion Criteria:

* Anticoagulation (Marcumar, Heparin)
* Haemophilia, V. Willebrandt Jürgens syndrome, thrombocytopathy and other blood anomalies
* Combination therapy of ASA and thienopyridines
* Pain medication with opioid analgesics
* Systemic medication with corticoids or immunosuppressants
* Intraarterticular injections or RSO within the last 3 months
* Past or planned surgery on the affected joint in the next 2 months
* Pregnancy, lactation
* Insulin-dependent type I diabetes mellitus
* Acute psychotic disorders
* Severe comorbidity
Evaluation of Dexketoprofen in Total Knee Arthroplasty

Pain is a global public health issue and represents the most common reason for both physician consultation and hospital admissions. Dexketoprofen is a new NSAID treating acute postoperative pain. The purpose of this study is to evaluate the analgesic effect when it is given intravenously or as part of the local infiltration analgesia in patients under spinal anesthesia undergoing unilateral total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* unilateral total knee arthroplasty
* accept to enter the study
* ASA score I or II
* hospitalization for at least 2 days

Exclusion Criteria:

* allergy in any given medications
* active gastrointestinal bleeding or other active bleeding
* history of peptic ulcer
* renal failure
* hepatic failure
* chronic heart failure
Study to Evaluate the Effect of Bimosiamose on Ozone Induced Sputum Neutrophilia

The purpose of this study is to evaluate the safety, tolerability and efficacy of repeated inhalative doses of Bimosiamose on ozone induced sputum neutrophilia in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Able to produce sputum with normal sputum neutrophil levels at screening (\< 65% of non-epithelial cells).
* Ozone responsive, defined as ≥ 20% relative increase in sputum neutrophils cell count after 3 h ozone challenge.
* At screening FEV1 at least 80% of predicted.

Exclusion Criteria:

* Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports of a recent tobacco use and/or who has a urine cotinine ≥ 500 ng/mL.
* Significant illness within two weeks prior to dosing (e.g., infection).
* Recent (within the last three years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
Comparison of Self-inflicted Deep Wrist Injuries to Traumatic Deep Wrist Injuries

Self-inflicted wrist injuries require special psychiatric knowledge and tactical skills. There is no protocol for treating such injuries. We analyze self-inflicted wrist injuries and compare them to traumatic wrist injuries.

Self-inflicted wrist injuries are regularly treated in hand surgery centers. These injuries involve risks that require special psychiatric knowledge and tactical skills. There is no protocol for treating such injuries. Therefore, the investigators analyze self-inflicted wrist injuries and compare them to traumatic wrist injuries.

Eligibility Criteria:
Inclusion Criteria:

* Deep wrist injury from 2008-2018
* Treated in University Hospital Schleswig-Holstein
* Agreed to retrospective analysis, questionnaires and hand function assessment

Exclusion Criteria:

* Non-compliance
The Impact of Diaphragm Training on Dysphagia in Bulbar Palsy After Ischemic Stroke

This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding. The observation group will be given Diaphragm Training Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.

Dysphagia in patients after stroke continues to be a challenge. This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding. The observation group will be given Diaphragm Training Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years;
* meeting the diagnostic criteria of Bulbar Palsy After Ischemic Stroke;
* any degree of dysphagia at admission;
* steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
* clear mind.

Exclusion Criteria:

* complicated with other neurological diseases;
* damaged mucosa or incomplete structure in nasopharynx;
* tracheostomy tube plugged;
* unfeasible to the support of parenteral nutrition;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.