cyrilzakka/clinical-trials huggingface dataset:
A Single Centre Open Label Comparison of [I-123]-Ortho-Iodohippuric Acid (OIH) With [Tc-99m]-Mercaptoacetyltriglycine (MAG3) for Assessment of Renal Tubular Function

Iodine-123 labelled ortho-Iodohippuric Acid (\[I-123\]-OIH) was used in the early 1970's as a kidney imaging agent or tracer that "lights-up" inside your body when scanned, but over the years its use has declined. The most commonly used tracer is Technetium-99m labelled Mercaptoacetyltriglycine (\[Tc-99m\]-Mertiatide or \[Tc-99m\]-MAG3). However, long-term shortages may threaten the supply of the radioactive substance Tc-99m in Canada and the world. As a result of such shortages, there is a need to identify other types of tracers that can be used for imaging. \[I-123\]-OIH may be an alternative.

The purpose of this study is to examine the diagnostic performance characteristics of \[I-123\]-OIH in comparison to \[Tc-99m\]-MAG3.

This study is being conducted to compare two imaging agents (tracers): \[I-123\]-OIH and \[Tc-99m\]-MAG3 using gamma camera imaging in participants with different levels of kidney function. Gamma camera imaging is a non-invasive nuclear scan that is used to look at organs and tissues inside the body. An imaging agent or tracer is a radioactive chemical intravenously injected into your body which lights up cells, tissues and organs. The study will evaluate the safety of a single injection of \[I-123\]-OIH and compare the imaging results and the calculated renal function values (using blood tests) to those of \[Tc-99m\]-MAG3 . 90 participants are required to complete this study.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Provide signed informed consent.
* Documented stable renal impairment with an eGFR \< 60/mL/min/1.73m\^2 by two eGFR measurements within 3 months that are within ± 15% of each other or healthy prospective kidney donor with an eGFR ≥ 60 mL/min/1.73m\^2.

Exclusion Criteria:

* Females who are pregnant, planning to become pregnant or are lactating.
* Clinically relevant abnormal findings that could, in the opinion of the investigator, interfere with the safe completion of the study.
* Unable, in the opinion of the clinician or investigator, to tolerate fluid intake required for radionuclide renography.
* Participation in any clinical trial involving an investigational product within 30 days prior to the first injection.
* Not using an adequate method of family planning unless the participant, or the male participant's partner, has had a hysterectomy, a tubal ligation, is postmenopausal or is not at risk of pregnancy.
* Unable to lie still in a supine position for at least 30 minutes.
* Unable to complete study procedures, including follow-up safety assessments.
* Medical or psychological conditions that on assessment by the principal investigator make the participant unable to complete the procedure.
* History of allergic reaction to iodine or iodine compounds, inclusive of iodinated x-ray contrast media.
* Any other conditions that may impact the participant's ability to complete the study.
Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells

This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.

Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.


Eligibility Criteria:
Inclusion Criteria:

* Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored or Celgene alliance partner-sponsored trial, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable.
* Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.

Exclusion Criteria:

Not Applicable

Other protocol-defined inclusion/exclusion criteria apply
Effectiveness of Three Times of Starting Antibiotic Prophylaxis in Patients With Asymptomatic Bacteriuria.

Asymptomatic bacteriuria (AB) is the isolation of a bacterium in a sample of urine appropriately collected from a person who does not have signs or symptoms of urinary infection. It is common in diabetic women, in pregnant women, in men over 60 years and in patients with spinal cord injury.

There is clinical evidence that AB should be treated in patients who will be operated on with urologic surgery because of the risk of presenting infectious complications; however, the timing of initiating antibiotic therapy has not been established, even in some studies the prophylaxis has been considered from one to seven days prior to the procedure, without determining the differences in the outcome for each one of the interventions and causing an undue and risky use of antibiotics.

A randomized, parallel-design, single-masked clinical trial will be performed to compare and analysis the bloodstream infections, surgical site infections, readmissions and hospital stay in three intervention groups, 1) those receiving antibiotics during the previous 5 days to the procedure; 2) 3 days prior to the procedure; and 3) those who receive only a single dose of antibiotic on the day of the procedure.

The main expected result is to identify the timing of initiation of antibiotic prophylaxis in urological procedures in patients with asymptomatic bacteriuria, with the purpose of diminishing the bloodstream and of the surgical site infections. If it is scientifically demonstrated that those patients who receive a single dose of antibiotic on the same day of the procedure, have the same safety and effectiveness compared to the other two groups, would reduce hospital stay, surgical waiting time and indiscriminate use of antibiotics that generate multidrug-resistant microorganisms, thus generating an impact on Public Health and on the quality of care.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients with asymptomatic bacteriuria identified with a urine culture prior to the surgical procedure and with a microorganism that meets the following criteria: 1) gram-negative bacteria in the enterobacterial family and non-fermenting bacilli; 2) Bacteria with resistance profile has a therapeutic option that reaches therapeutic concentration in urine.
* Patients scheduled for urological procedures, such as: transurethral resection of the prostate, open prostatectomy, cystoscopy, extracorporeal lithotripsy and flexible ureterorenoscopy.
* Informed consent

Exclusion Criteria:

* Patients with chronic renal failure; with immunosuppressive status secondary to glucocorticoid consumption, haematological or solid organ neoplasms undergoing chemotherapy or radiation therapy or neutropenia.
* Patients with active infection or clinical criteria of urinary infection.
* Patients who voluntarily do not want to participate in the study.
* Patients who can not give informed consent under reasonable or vulnerable conditions.
* Patients who present type I allergy to penicillin.
* Patients who have scheduled surgeries combined with a discipline different to urology.
Ventral Mesh Hernioplasty : Laparoscopic Versus Open Sublay

To compare between laparoscopic ventral hernia repair and open sublay technique (recurrence ,operative time ,bleeding ,rate of complication and injury , seroma, post operative pain)

A hernia usually happens in abdomen or groin, when one of your organs pushes through the muscle or tissue that contains it. Most hernias eventually will need surgical repair.

sublay mesh repair has the lowest recurrence and surgical site infection in open anterior abdominal hernia repair it is a perfect choice for the repair of ventral abdominal hernia the principles included two main steps: (1) mesh placement deep into the recti muscles and (2) mesh extension beyond the hernia defect.

Laparoscopic ventral hernia repair (LVHR) has established itself as a well-accepted option in the treatment of hernias. Clear benefits have been established regarding the superiority of LVHR in terms of fewer wound infections compared with open repairs. Meticulous technique and appropriate patient selection are critical to obtain the reported results.

• In the laparoscopic technique, a prosthetic mesh is inserted through a trocar into the abdominal cavity and fixed against the abdominal wall. After reducing the hernia contents, the hernia sac is left unresected, and most surgeons do not place additional sutures for closing the hernia orifice. A specific risk of laparoscopic hernia repair lies in freeing adhesions between intestine and abdominal wall, which may result in (sometimes unrecognised) bowel perforation . The mesh should overlap the hernia orifice by at least 5 cm and is anchored to the abdominal wall with tacks, transfascial sutures, or a combination of the two methods. In laparoscopic abdominal hernia repair, mesh placement methods are generally classified into intraperitoneal onlay mesh (IPOM), transabdominal abdominal preperitoneal (TAPP)

Eligibility Criteria:
Inclusion Criteria:

* All cases of midline ventral hernia fit for surgery

Exclusion Criteria:

1. Surgically unfit cases
2. Complicated hernia (obstructed ,irreducible, strangulated)
3. incisional ,massive ,recurrent hernias
Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed metastatic colorectal adenocarcinoma
2. Not amenable to surgery or radiation therapy
3. Eligible for first or second line chemotherapy

Exclusion Criteria:

1. Brain metastases or spinal compression
2. Last prior chemotherapy discontinued within 4 weeks before start
3. Last dose radiotherapy within 4 weeks of start
Algae and Cholesterol Absorption

The primary objective of this study is to investigate the effects of wakame and spirulina consumption on intestinal cholesterol absorption.

Objectives:

Secondary objectives are to investigate the effects of wakame and spirulina consumption on fasting markers for lipid metabolism, glucose metabolism and blood pressure.

Study design:

This study is a double-blinded, randomized, placebo-controlled, crossover intervention trial consisting of three intervention periods of 17 days each, separated by a minimum washout period of 14 days.

Study population:

The study population will consist of 37 healthy, non-hypercholesterolemic men and women aged between 18 and 70 years.

Intervention:

All subjects will receive wakame, spirulina and placebo capsules in randomized order. Subjects will be asked to consume 12 capsules per day for 17 days, which is equal to 4.8 grams of wakame or spirulina a day.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 70 years;
* BMI between 18 and 30 kg/m2;
* Non-smoking;
* No elevated serum triacylglycerol concentrations (\< 4.5 mmol/L);
* Willing to comply to the study protocol during the study;
* Agreeing to be informed about medically relevant personal test-results.

Exclusion Criteria:

* Not willing to abstain from any algae and/or seaweed consumption or algae/seaweed containing products two weeks before the start and during the trial;
* Use of plant-sterol/stanol-enriched foods (e.g. Becel Proactive) or supplements in the four weeks prior to the screening and/or during the study;
* Use of cholesterol or lipid-lowering medications (e.g. statins, bile-acid sequestrates, cholesterol absorption inhibitors);
* Use of any kind of medication or a medically prescribed diet, which can interfere with the study;
* Use of oral antibiotics in 40 days or less prior to the start of the study;
* Use of food supplements that might interfere with study measurements (judged by the principal investigator) in four weeks or less prior to the start of the study;
* Indications of treatment according to the Standard for Cardiovascular Risk Management from the Dutch General Practitioners community;
* Any medical condition that might interfere with study (measurements), judged by the principal investigator, including cardiovascular diseases or events (e.g. acute myocardial infarction or cerebro-vascular accident), diabetes, asthma, COPD, rheumatoid arthritis, and gastro-intestinal diseases (e.g. inflammatory bowel disease);
* Unstable body weight (weight gain or loss \> 3 kg in the past 3 months);
* Females who are pregnant, breast feeding or who may wish to become pregnant during the study;
* Consumption of \> 14 (males) or \> 10 (females) alcoholic consumptions a week;
* Reported intense sporting activities \> 10 hours a week;

  ￼• Abuse of drugs;
* Participation in any other biomedical trial four weeks prior to the screening visit;
* Having donated \>150 ml blood within 1 month prior to the screening visit, planning to donate blood during the study or within one month after finishing the study;
* Impossible or difficult to puncture as evidenced during the screening visit.
Correlation of Measured and Calculated Serum Osmolality During Hyperosmolar Drugs Infusion in Patients After Craniotomy

Osmotherapy has been used as the medical treatment for brain edema and intracranial hypertension in critically brain injured patients. Measurement of serum osmolality during osmotherapy is of clinical importance to determine clinical efficacy, adjust dosage and avoid side effect. Serum osmolality is often measured in laboratory by cryoscopic technique as the reference method. However, in clinical setting, routine measurement of serum osmolality is not feasible at bedside, either in intensive care unit (ICU) or neurosurgical ward. Therefore, clinicians usually estimate serum osmolality by using equations derived from serum osmoles that can be measured by bedside blood gas analysis or routine laboratory chemical analysis, such as sodium, potassium, urea, and glucose. In present study, mannitol or hypertonic saline will be used in patients after craniotomy, and serum osmolality will be measured before and during drug infusion. Investigators hypothesize that the correlation of measured and calculated serum osmolality is better during infusion of hypertonic saline than mannitol.


Eligibility Criteria:
Inclusion Criteria:

* adult patients after elective craniotomy, requiring hyperosmolar agents for prevention or treatment of brain edema

Exclusion Criteria:

* age younger than 18 yr or older than 65 yr
* history of diabetes
* unstable hemodynamic condition
* presence of renal failure
Danger Response in Polytrauma Patients

The NTF_PT_2014 multicenter study aims to collect, store, and analyse plasma and serum from polytrauma-patients (injury severity score ≥25) and corresponding clinical data to address 1) how trauma modulates the release of danger molecules, inflammatory mediators, coagulation factors and novel biomarkers, 2) how the specific injury pattern affects the posttraumatic response and regenerative potential on an organ-, cell, and molecular level, and 3) how could a specific organ- and immune-monitoring predict the clinical outcome.

Polytrauma is worldwide a major socio-economic problem. Especially the polytrauma-induced complications, such as systemic inflammatory response, sepsis, organ dysfunction remain associated with a high morbidity and mortality rate. The underlying posttraumatic pathophysiology remains poorly understood, especially since the polytrauma patients present a highly variable patient cohort with complex injury patterns, comorbidities and different therapeutic strategies.

Therefore, the present "NTF_PT_2014" multicenter study of the Trauma Research Network (NTF) of the German Society for Orthopaedics and Trauma (DGOU) with its established national Polytrauma-serum-bank aims to collect, store, and analyse plasma and serum from polytrauma-patients and corresponding clinical data to address:

1. how trauma modulates the release of danger molecules, inflammatory mediators, coagulation factors and novel biomarkers?
2. how the specific injury pattern affects the posttraumatic response and regenerative potential on a organ-, cell, and molecular level?
3. how could a specific organ- and immune-monitoring predict the clinical outcome?

Blood will be drawn from anticipated 1000 patients with an injury severity score ≥ 25 at the time of hospital admission (in the emergency room), 8 h, 24h, 48, 120 h, and 240 h post injury. The biochemical and immune-monitoring data will be correlated to corresponding clinical data and data from the German Trauma Registry (TraumaRegister DGU®).

Blood from age- and sex matched healthy volunteers (n=200) will serve as a control group.

The study will provide a detailed picture of the molecular danger response after multiple injury and may reveal novel therapeutic targets for posttraumatic complications.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18
* healthy

Exclusion Criteria:

* age \< 18
* gravidity
Aspects of Breast-conserving Surgery

Prospective study of cosmetic outcome and quality of life for women undergoing breast cancer surgery using patient a reported outcome measure (BREAST-Q) and a computer program validated to assess cosmetic outcomes after breast cancer surgery (BCCT.core) at baseline and on 1-year follow-up.

This is a clinical study with the aim to investigate how breast cancer patient's quality of life changes after breast cancer surgery, as well as looking at the cosmetic outcomes for the same patient group. The study is conducted prospectively, with patients being included forward in time when they are diagnosed with breast cancer in Kristianstad hospital, Sweden. The study started in January 2019 and is expected to continue enrollment for two years, with the aim of recruiting 300 patients. The patients fill out a quality of life questionnaire (Breast-Q) at baseline, which is defined as time of diagnosis, and second Breast-Q questionnaire 1-year post surgery. Photos are also taken of the breasts both preoperatively and postoperatively and the photos are assessed by a computer program validated to assess cosmetic outcomes after breast cancer surgery, called BCCT.core, and secondly the cosmetic results of the breasts are evaluated by the surgeon and patient herself on a 10-grade scale. In addition study specific items covering for example psychiatric comorbidity, BMI and smoking are retrieved.

The study hypothesis is that patients undergoing breast cancer surgery overall have a good quality of life 1-year after their diagnosis, especially if they are treated with a surgical approach that takes into account both the best oncological treatment as well as the best surgical technique for cosmetic outcome, so called oncoplastic surgery. The other hypothesis is that cosmetic results will be overall favorable for the group of patients who are operated with breast-conserving techniques, and most favorable in those patients who have undergone oncoplastic surgery. Secondly the study aims to see if there are other patient related variables that affect the quality of life or cosmetic outcome, for example cytostatic treatment, a high body mass index, smoking or psychiatric history prior to diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Women with breast cancer diagnosed in Central Hospital of Kristianstad from 1/1 2019

Exclusion Criteria:

* Patients who lack the ability to read and write Swedish
* Patients that are not able to understand the information given
* Palliative care patients
CysLT1-r Expression Following Allergen Exposure in Asthma and Allergic Rhinitis

Cysteinyl leukotrienes (CysLTs) play an important role in asthma. CysLTs exert most of their bronchoconstrictive and pro-inflammatory effects through activation of the CysLT1-r. As allergic rhinitis appears to be a predisposing factor in the development of asthma and as CysLT-receptors seem to be implicated in the first steps of asthma manifestations, we think it would be of interest to determine if the CysLT1-r is a key mediator in the progression from allergic rhinitis to asthma. We believe it would be interesting to study the expression of the CysLT1-r

Our goal is to assess baseline, as well as variations following allergen bronchoprovocations, in the expression of the CysLT1-r in mild asthmatic subjects compared with non asthmatic subjects with allergic rhinitis.

Our hypothesis is that there will be a higher baseline expression of the CysLT1-r in asthmatic subjects compared with allergic rhinitis subjects and that allergen bronchoprovocations will induce an increase in the expression of the CysLT1-r in both groups.

We will recruit mild allergic asthmatic subjects and non asthmatic subjects with allergic rhinitis. On a baseline visit, allergy skin prick tests, spirometry, methacholine bronchoprovocation and induced sputum (IS) with differential leukocyte count will be obtained.

In a second step, mild asthmatic subjects will undergo conventional bronchial allergen challenge. IS will be obtained at 6h (corresponding to the late asthmatic response) and 24h following the challenge. The rhinitic subjects and asthmatic subjects will undergo a 4-day low dose allergen bronchial challenge as well as a nasal allergen challenge. Sputum samples will be obtained following days 2 and 4 of the low dose challenge and one week later, and 24h following nasal challenge.

Induced sputum will be analyzed for differential cell count. Total mRNA will be extracted from IS cells and used for RT-PCR.

Eligibility Criteria:
Inclusion Criteria:

* To have a positive reaction to one or more allergen on prick tests.
* Non smokers
* No respiratory track infection for at least one month prior to the study.
* Asthmatic subjects using only inhaled beta-2 agonists on an as needed basis for their asthma treatment.
* Asthmatic subjects with a history of asthma of at least 6 months.
* Asthmatic subjects with PC20 methacholine lower or equal to 8 mg/ml.
* Allergic rhinitic subjects never experienced any asthma symptoms or took any asthma medication in the past.
* Allergic rhinitic subjects with a PC20 methacholine higher than 16 mg/ml.

Exclusion Criteria:

* Smokers or ex smokers less than 6 months or more than 10 pack-years.
* Asthmatic subjects using or used in the past 3 months inhaled or oral corticosteroids.
Growth and Adiposity in Newborns: The Influence of Prenatal Docosahexaenoic Acid (DHA) Supplementation

The purpose of this study is to learn if participants in the ADORE study (NCT02626299), who took a DHA supplement during pregnancy, see favorable body fat in their infants from birth to 24 months, and if excessive or appropriate weight gain during pregnancy impacts this result.


Eligibility Criteria:
Participants for this study are invited from the parent study, ADORE. Eligibility listed reflects criteria for the ADORE study.

Inclusion Criteria:

* Agree to consume study capsules and a typical prenatal supplement of 200 mg DHA
* Available by telephone

Exclusion Criteria:

* Expecting multiple infants
* Gestational age at baseline \<12 weeks or \>20 weeks
* Unable or unwilling to agree to consume capsules until delivery
* Unwilling to discontinue use of another prenatal supplement with DHA that contains ≥ 200 mg DHA
* Women with allergy to any component of DHA product (including algae), soybean oil or corn oil