cyrilzakka/clinical-trials huggingface dataset:
Assessing Ultra-low Dose PET/CT and CT-less PET Using a Long Axial Field-of-view PET/CT System

Latest generation extended axial field-of-view (FOV) PET/CT systems offer the potential for substantial reductions in applied radiopharmaceutical necessary for a clinical scan. However, such low-dose examination protocols have yet to be robustly tested or demonstrated to be non-inferior. Furthermore, extended FOV scanners offer the potential for CT-less attenuation correction of the PET emission data, making clinically acceptable ultra-low dose examination protocols with radiation exposures of \< 1 millisievert possible for the first time. The aim of this study is to demonstrate the clinical acceptability of such low and ultra-low dose scanning protocols in a head-to-head prospective study against a full-dose scan using a regular FOV system

The first installation of a long-axial field-of-view (LAFOV) PET/CT system occurred in October 2020 at the department for nuclear medicine in Bern. This scanner along with recently introduced total-body scanners (TB-PET/CT) represent a substantial step forward in terms of nuclear medicine imaging technology. In conjunction with recent improvements in time-of-flight resolution and fully-digital detection technology, such systems offer surpassed sensitivity with improvements in image quality, lesion detection and diagnostic certainty. In contrast to LAFOV systems, standard axial field of view (SAFOV) scanners suffer from limited detection efficiency, where 90% of emitted photons go undetected owing to the ability to capture signal from only a small portion of the body (termed "bed position" or "bp").

However, while a number of studies are able to simulate lower applied radiopharmaceutical activities through the re-sampling of PET-sinogrammes or the rebinning of list-mode data, few studies adequately test the application of lower radiopharmaceutical activities, where limited data are available to justify the deviation from clinical routine. The clinical acceptability of such low-dose scans, in terms of lesion detection, image quality and lesion quantification is yet to be determined, which this study aims to address.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years) able to provide informed consent for inclusion, willing and able to undergo a PET/CT for the detection or staging of cancer.
* Individuals undergoing a PET/CT with 18F-FDG for the investigation of known or suspected NSCLC.
* Upper fasting plasma glucose levels of \<8.3 mmol/L (\<150 mg/dL) (as measured \>30 mins prior to the administration of the radiopharmaceutical).

Exclusion Criteria:

* Patients who are unable to consent to a second study-specific examination
* Patients with claustrophobia requiring medication.
* Patients who commence active treatment of a cancer or other pathology between scans.
* Patients who have not fasted for \> 4 hours prior to the study.
* Insulin dependent diabetics.
Cortical Representation of Hyperalgesia Induced by Nerve Growth Factor

Intraepidermal injection of nerve growth factor results in a non-inflammatory hyperalgesia for thermal and mechanical stimuli. This hyperalgesia is similar to the pathological ailments of patients with neuropathic pain. The mechanisms of the cognitive modulation of pain and hyperalgesia are not yet understood in this group of patients. The investigators plan to use NGF injection as a model of non-inflammatory neuropathic pain in healthy subjects to investigate the underlying neuronal mechanisms of this hyperalgesia using functional magnetic resonance imaging and resting state network analysis.


Eligibility Criteria:
Inclusion Criteria:

* no acute or chronic disease
* no acute or chronic pain
* age: 18-60 years
* male
* no medication use

Exclusion Criteria:

* metallic parts in the body
* claustrophobia
* drug or substance abuse
Vaginal Estrogen With Pessary Treatment

Patients presenting with pelvic organ prolapse will be offered the use of a pessary. Vaginal estrogen cream treatment with the pessary will be randomized amongst the patients and patient satisfaction and complication rates will be assessed during follow-up.

This will be a double-blinded, placebo-controlled, randomized controlled trial. Eligible patients presenting to the urogynaecology clinic with pelvic organ prolapse will be offered management with a pessary and participation in the study

Patients who agree to participate in the study will be given a consent form

Patients in the study and thus those who have opted for pessary use will be randomized between two groups:

1. Treatment group - will be given instructions for use and prescription for Premarin vaginal cream 2g at bedtime twice weekly
2. Control group - will utilize pessary with an inactive placebo cream

Both the patient and the investigators will be blinded to patient treatment.

If a patient has expressed willingness to participate in the study over the phone, the research assistant will issue a study number to the patient and pick up the corresponding cream from the LHSC pharmacy to give to the patient at their next clinic visit. The cream will be provided to the patient once they have read the letter of information and signed the consent form.

For follow-up visits, the research assistant will monitor appointment bookings to ensure that the cream is ready in the clinic when the patient has their next follow-up visit.

Patients of both groups will be fitted with a pessary. Pessary fitting will be individualized due to differences in pelvic size and shape and degree of prolapse. Patients may return to the clinic for subsequent fittings until a successful fit has been achieved. An unsuccessful fitting is defined as discontinued pessary use due to discomfort or expulsion.

Patients will be assessed for satisfaction and complications 6 wks, 18 wks, 36 wks and 60 wks after the successful fitting.

To determine patient satisfaction and complications, patients will complete a compilation of validated questionnaires assessing urinary symptoms, sexual function and quality of life at each follow-up.

At each follow-up, a vaginal exam will be done and a vaginal swab and urine sample (for urinalysis and culture and sensitivities) will be taken to assess vaginal bleeding and infections.

Eligibility Criteria:
Inclusion Criteria:

* Any patient presenting to the clinic with pelvic organ prolapse will be offered management with a pessary and will be offered participation in the study.

Exclusion Criteria:

* have a contraindication to the use of estrogen cream or products
* have any allergy to the use of estrogen cream or products
* have a past medical or family history of breast cancer
* have a past medical history of thromboembolism, myocardial infarction and stroke or are pregnant
* have previously used Premarin vaginal cream
* are currently using oral estrogen
* are not competent to consent
Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic

This protocol is a study of the effects of Lactobacillus reuteri in 45 healthy infants with colic. The study is being conducted in order to prove treatment dose with probiotic (Lactobacillus reuteri) in a clinical setting is safe in healthy infants with colic.

This study will evaluate the safety and tolerability of Lactobacillus reuteri in healthy infants with colic. Patients will be randomized to receive either L. reuteri at one dose orally for a total of 42 doses. The doses will be 5x108 (5 drops) during a satisfactory assessment of safety and tolerability. The time on study treatment is 6 months, and the target sample size is 45 healthy infants.

Secondly, the investigators aim to gather evidence supporting hypothesis of safety and tolerability of Lactobacillus reuteri by administering a physical examination and testing of complete blood count, liver tests, and serum electrolytes over a forty-two day period.

Eligibility Criteria:
Inclusion Criteria:

* Full-term babies with colic (21-90 days old, who cry/fuss \> 3h daily x \> 3d wk)
* baby must have more than 3h crying for enrollment

Exclusion Criteria:

* severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk \> 8 times daily, projectile, bilious or bloody emesis)
* failure to thrive
* intrauterine growth retardation
* hematochezia (blood in the stools)
* diarrhea (watery stools that takes the shape of a container \> 5x daily)
* fever (38.2 degrees)
* Premature infants (\<37 wk gestation)
Efficiency of a Whole Body Vibration Training Program in Adult Renal Transplanted Patients

Evaluate the effectiveness of a Whole body vibration training program on quadriceps muscle strength, functional capacity and respiratory muscle strength in adult renal transplant recipients

The study will be a randomized controlled clinical trial involving adult renal transplant recipients, who will be recruited through eligibility criteria at Nephrology outpatient clinics of the Kidney Transplantation Centers of the Hospital das Clínicas of the Federal University of Pernambuco (HC-UFPE). Individuals will be randomized and assigned to one of the following groups: Platform Group, which will perform 12-week whole body vibration training or Platform SHAM Group that will receive treatment without the therapeutic effect of the platform. Afterwards, the patients will be submitted to an evaluation, a form with sociodemographic data, the clinical history of the disease and the laboratory tests will be completed, after which the pulmonary function, respiratory muscle strength, quadriceps muscle strength and thickness, postural balance , Functional capacity, quality of life, risk of falls and level of physical activity.

Eligibility Criteria:
Inclusion Criteria:

* patients with more than 1 year of kidney transplant surgery
* stable graft function (creatinine \<1.8 mg / dL)
* hemoglobin\> 8g / dL
* age range 18 And 59
* both sexes

Exclusion Criteria:

* PAS\> 160mmHg and PAD\> 100mmHg
* Patients with neurological, diagnosed or pulmonary heart disease
* Involved in some physiotherapeutic program
* With hospitalization history for 3 months
* Pregnant
* Current or previous smokers
* That use pacemaker, screws and / or pins in the body
* Presence of acute migraines, labyrinthitis
* History of thrombosis
* Body weight greater than 120Kg
* Cognitive, visual and / or auditory deficits
* Osteomioarticular diseases that would impair evaluation procedures and / or training
Neuropeptide Y and Sympathovagal Balance

Neuropeptide Y (NPY) activates the sympathetic and vagal nervous systems through the Y1 and Y2 receptors. This double-blind placebo-controlled crossover study investigated the sympathovagal balance during three exercises on a cycloergometer in healthy volunteers treated with saxagliptin (DPP4 inhibitor).

Pharmacological studies indicate that NPY has a role as a co-transmitter associated with catecholamines to maintain cardiovascular homeostasis. The development of a selective and sensitive assay of NPY1-36 (vasoconstrictor) and NPY3-36 (vasodilator) by LC-MS/MS will confirm this modulating role of NPY in sympatho vagal balance in healthy young subjects. This project should lead to a better understanding of the contribution of NPY to exercise physiology through a double-blind randomized study using a DPP4 inhibitor (Saxagliptin) used for the treatment of type 2 diabetes, blocking the formation of NPY3-36 and thus enhancing the effect of NPY1-36. The interest of this study will be to find targets other than adrenergic receptors in the regulation of sympathetic and parasympathetic systems during exercise.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects aged between 18 and 30 years.
2. Non smoking
3. Practicing at least 3 hours physical activity per week
4. Absence of significant findings in the medical history and physical examination as judged by the Investigator, especially for cardiovascular, pulmonary, haematological and nervous systems
5. Ability to understand the procedures, agreement to participate and willingness to give written informed consent
6. Co-operative attitude and availability for scheduled visits over the entire study period.

Exclusion Criteria:

1. Use of any medication the week prior to study. Paracetamol is permissible before and during study as a concomitant medication but only with Investigator's permission.
2. History of major cardiovascular, pulmonary, hepatic, immunological, renal, haematological, gastrointestinal, genitourinary, neurological, or rheumatologic disorders
3. rhinosinusitis
4. Urinary tract infection
5. Hypertension defined as supine blood pressure \>150/90 mmHg or recurrent hypotensive events considered as clinically relevant or documented orthostatic hypotension
Effects of Sleep Hygiene Education and Lavender Oil Inhalation on Sleep Quality, Fatigue, Quality of Life

Self-care non-pharmacological methods can help reduce the negative health effects of sleep problems or insomnia. This trial aims to investigate the effects of sleep hygiene education and lavender oil inhalation alone and in combination on sleep quality, fatigue, and health-related quality of life in adults with a stoma.

This study has been planned as a randomized controlled clinical trial and will use a 2x2 factor design in which an equal number of participants meeting the inclusion criteria will be randomly allocated to one of four groups. The study population will comprise 120 adult patients who have undergone ostomy surgery in a city hospital in Turkey. Lavender oil inhalation together with sleep hygiene education will be applied in the first group (n=30), only sleep hygiene education in the second group (n=30), only lavender oil inhalation in the third group (n=30), and no intervention in the fourth group (n=30). The sleep quality of the groups will be evaluated using the Pittsburgh Sleep Quality Index, their fatigue levels with the Chalder Fatigue Scale, and their quality of life with the Stoma Quality of Life Scale.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older,
* At least three months having passed after ostomy,
* Having a clear level of consciousness and no disease or medication use that can negatively affect the level of consciousness,
* Being able to communicate in Turkish,
* Providing informed written consent to participate in the study.

Exclusion Criteria:

* Lavender allergy,
* Respiratory tract infections such as sinusitis and pneumonia,
* Body mass index (BMI) of \>40,
* A diagnosis of sleep disorder and/or medication use for sleep problems.
Antibody Response Against SARS-CoV-2 in Dialysis Patients During COVID-19

Determination of IgM and IgG antibodies against SARS-CoV-2 in dialysis patients by continous monitoring in the period from March 2020 to december 2020

Blood samples are collected every 14 days

Eligibility Criteria:
Inclusion Criteria:

* Dialysis

Exclusion Criteria:

* Not willing to give consent
Carboxyamidotriazole in Treating Patients With Advanced Kidney Cancer

RATIONALE: Carboxyamidotriazole may stop the growth of kidney cancer by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of carboxyamidotriazole in treating patients who have advanced kidney cancer that has not responded to biological therapy.

OBJECTIVES: I. Determine the disease free progression at 6 months in patients with locally recurrent or metastatic renal cell cancer (refractory to immunotherapy) treated with carboxyamidotriazole. II. Evaluate the progression free survival rate and response rate in these patients on this regimen. III. Evaluate the toxic effect of this regimen on these patients.

OUTLINE: Patients receive oral carboxyamidotriazole daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with stable disease may discontinue therapy after 6 courses. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and every 12 months thereafter until death.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 20 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven advanced renal cell cancer Locally recurrent or metastatic lesions not amenable to current resection Progressive disease defined as 25% increase from last measurement or new lesions Bidimensionally measurable disease No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 OR Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT and/or SGPT less than 2 times upper limit of normal Renal: Creatinine less than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No other serious medical illness or active infection that would preclude chemotherapy compliance No other prior malignancy unless curatively treated and disease free for the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy At least 1 (but no more than 2) prior biologic regimen(s) (i.e., interleukin-2, interferon alfa, or combination) and recovered Regimen defined as at least 8 weeks of treatment Prior sargramostim allowed Chemotherapy: No prior chemotherapy Endocrine therapy: At least 4 weeks since prior hormonal therapy (i.e., megestrol or tamoxifen) and recovered Radiotherapy: No prior radiotherapy to study lesions At least 4 weeks since prior radiotherapy and recovered No concurrent palliative radiotherapy Surgery: Prior nephrectomy allowed Recovered from any recent surgery
Safety and Efficacy of Topical TolaSure on Skin Punch Biopsies in Healthy Participants

TolaSure is a topical gel for the promotion of wound healing. This phase I study will assess the safety, tolerability and clinical effect of TolaSure when applied to skin wounds created by punch biopsy in healthy participants. A total of 26 healthy volunteers, males and females ages 18 years or older, will be enrolled. Subjects will monitored for safety and efficacy over the course of 2 weeks following daily topical administration of TolaSure.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Males and Females \> 18 years of age
* Health history review
* Physical exam
* Blood and urine clinical chemistries
* Pregnancy test
* Drug screen

Exclusion Criteria:

* Acute or chronic skin disorders (e.g. acne, psoriasis, dermatitis)
* Prone to keloids or hypertrophic scarring
* Topical or systemic antibiotics within 4 weeks of study enrollment
* Subjects with mental illnesses
* Diagnosed with Diabetes Type I/II
* Surgery within the previous 3 months (except for minor cosmetic or dental procedures)
* History of severe vitamin or mineral deficiency
* History of drug or alcohol abuse (as defined by the Investigator)
* Smoking/Vaping
* HIV/AIDS
* Consistently taking steroids and/or non-steroidal anti-inflammatory drugs
* Cancer diagnosis in the last year
* Currently receiving chemotherapy or radiation
* Women who are pregnant, nursing or planning a pregnancy
* Hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields
* Symptoms of a clinically significant illness in the four weeks before treatment application that may influence the outcome of the study
* Treatment with any investigational agent within one month before treatment application for this trial
* Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule
* Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment
Immediate Implants in the Aesthetic Zone

The use of immediate implants in the aesthetic area is a technique widely used in modern implantology. The characteristics of the patient, the implant, and the surgical procedure used may influence the final results. The aim was to assess whether the implant design affects primary (PS) and secondary stability (SS), bone level (BL), and PES/WES evaluation.

20 implants with two different designs (n=10) were immediately placed in the upper anterior maxilla with no grafting material. ISQ, BL, and PES/WES were evaluated. Results will analyze with the Wilcoxon-Mann-Whitney test (p\<0.05).

The random distribution is made prior to assignment following the internet prgram https://www.random.org

Eligibility Criteria:
Inclusion Criteria:

* Patients who presented aa vertical fracture in an upper incisor that can not be treated conservatively and ended in the extraction, and the treatment needed is a unitary implant.
* Good systemic health status (ASA I or II).
* Oral hygiene index of \< 2 (Löe and Silness).
* A minimum of 2 mm of attached mucosa.
* A minimum of 8 mm of vertical bone.
* A minimum of 7 mm of bucco-lingual bone.

Exclusion Criteria:

* Traumatic or complicated incisor extraction.
* Pregnant or women in the lactation period.
* Use of any medication that contraindicates implant treatment.
* A history of alcohol or drug abuse.
* A requirement for guided bone regeneration.
* A requirement for tissue graft augmentation.
* Failure to comply with the study protocol.
Efficacy and Mechanism of Action of Methenamine Hippurate (Hiprex™) in Women With Recurring Urinary Tract Infections.

The purpose of this study is to measure the concentration of formaldehyde in the urine of women with recurrent urinary tract infections on Hiprex; and then, assuming its urinary presence is confirmed at the proper acid urinary pH, evaluate if such a therapy has favorable effects in decreasing the rate of recurrent urinary tract infections over time.


Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Age 50 - 85
3. Have RUTIs (at least 2 UTIs within the past 6 months or 3 within the past year) -

Exclusion Criteria:

1. Being on antibiotics at baseline (i.e. suppressive therapy or antibiotic therapy for urinary or non-urinary infections)
2. Neurogenic bladder condition
3. Using urinary catheters (including Foley catheter, intermittent catheterization, and suprapubic catheter)
4. Uncontrolled diabetes (HbA1c \> 9)
5. Chronic renal failure defined as serum creatinine \> 1.5 mg/dL
6. History of liver disease
7. Patients from out of town, in whom follow-up will not be possible
8. Pregnancy
9. Allergy to Hiprex
10. Inability to take Hiprex reliably at home, such as having psychosis, dementia, or swallowing disorders
11. Non-English speakers -
Dural Puncture Epidural Vs Standard Epidural Technique in Parturient Receiving Continuous Labour Epidural Infusion

The goal of this study is to evaluate the quality and safety of labor analgesia by comparing the use of Dural puncture epidural technique to Standard epidural technique while maintaining labor analgesia by means of continuous epidural infusion in parturient. The main questions it aims to answer are

* Effectiveness and quality of labor analgesia
* Frequency of catheter adjustments
* Need for catheter replacements
* Incidence of failed regional anesthesia requiring conversion to general anesthesia


Eligibility Criteria:
Inclusion Criteria:

* Nulliparous / Multiparous women
* Age \>18 years
* ASA 1 \& 2
* Singleton vertex presentation
* Gestational age 37-42 weeks
* Parturient with established labor and pain score ≥ 3

Exclusion Criteria:

* Major cardiac disease
* History of chronic pain
* Chronic opioid user
* Platelet count \< 70 x 109/L
* spinal cord anomalies
* Use of anticoagulants
* Allergic to local anesthetics
* Patients with preeclampsia/ eclampsia
* Known fetal anomalies