cyrilzakka/clinical-trials huggingface dataset:
A Prospective, Bicentric Evaluation of Fluciclovine PET-imaging in Patients with Prior Negative or Inconclusive PSMA-ligand PET

The REFINE study is evaluating whether a fluciclovine (18F) PET/CT scan can detect recurrent prostate cancer in patients whose previous PSMA PET/CT was negative or inconclusive.

The REFINE study is a prospective, bicentric observational trial conducted at two specialized nuclear medicine centers in Germany to evaluate the technical performance of fluciclovine (18F) PET/CT imaging in a real-world clinical setting. Patients with prostate cancer recurrence after definitive treatment who previously underwent a negative or inconclusive PSMA PET/CT are enrolled and observed for 12 months. Each participant undergoes a fluciclovine PET/CT scan as part of their normal clinical routine, with all images pseudonymized and stored in a central database where three independent nuclear medicine physicians, blinded to the local site's interpretation, review each scan. In addition to the initial imaging, follow-up assessments are conducted at one month and 12 months to validate scan findings; a questionnaire sent to the referring physician at one month helps capture any changes in the intended treatment plan, while comprehensive follow-up data-including additional imaging studies, PSA levels, treatment outcomes, and histopathological findings when available-are collected at 12 months. This follow-up information serves as a composite reference standard to distinguish true positive lesions from false positives, with criteria based on changes in lesion size, response to treatment, and confirmatory imaging or biopsy results, as well as to identify any false negatives.

Eligibility Criteria:
Inclusion Criteria:

* Patient is male and aged \>18 years old.
* Patient with a history of localized adenocarcinoma of the prostate with prior curative intent treatment, experiencing BCR of hormone sensitive PCa, following prior treatment with one or more of the following: a) RP, b) RP plus adjuvant therapy, c) RT and/or androgen deprivation therapy \[ADT\].
* An elevated PSA, clinically suspicious for biochemically recurrent disease, that meets one of the following conditions: 1) Following RP with or without adjuvant therapy: PSA ≥0.2 ng/mL followed by a subsequent confirmatory PSA value ≥0.2 ng/mL and within the total range of 0.2 and 2 ng/ml. PSA must be measured at least 6 weeks after RP. 2) Following RT (e.g. radical radiotherapy or brachytherapy) as the primary treatment: nadir +2 ng/mL and within the total range of 2 and 4 ng/ml

Exclusion Criteria:

* Patients with any medical condition or circumstance (including receiving an investigational product) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements.
* Current or recent androgen deprivation therapy (ADT) within 3 months prior to the start of the study, which includes surgical orchidectomy, continuous or intermittent LHRH agonist/antagonist, and first-/second-generation anti androgen alone or combined with LHRH agonist/antagonist.
Symbiotic & Colonization

The clinical trial aims at showing efficacy of prebiotics and the probiotic on microbiota balance. Together, the prebiotic solution in combination with the probiotic is expected to harmonize the microbiota of formula fed neonates with the microbiota of breast fed neonates and to allow a greater diversity of Bifidobacteria species in comparison with a formula non-supplemented with pre and probiotics.

The infants will be recruited and randomized between 0 and 14 days. The intervention period, in terms of data necessary for the primary outcome, will be until they reach 3 months old. Measurements will be collected on three separate occasions during this period, i.e. 2 and 6 weeks and 3 months. Stools will be collected, on 3 separate occasions, i.e. 4-5 day, 6 weeks and 3 months of life.

Eligibility Criteria:
Inclusion Criteria:

* Healthy newborn infant
* Full term infant (≥ 37 weeks gestation; ≤ 42 weeks gestation)
* Age of infant is between 14 days at the time of enrollment
* Birth weight between 2500g and 4500g
* For the Formula fed groups: The infant's mother has elected, before the 14th day of their child's life, not to continue breastfeeding (no breastfeeding after the 14th day of the child's life) For the Breastfed group: The infant's mother has elected to fully breastfeed her baby, from enrollment to at least 3 months of age
* Having obtained his/her legal representative's informed consent

Exclusion Criteria:

* Congenital illness or malformation that may affect normal growth
* Significant pre-natal and/or post-natal disease
* Re-hospitalization for more than 2 days in the first 14 days of life. (Exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study).
* Newborn who have received antibiotics during the first 14 days of life
* Receiving infant formula containing pro and/or prebiotics at the time of enrolment
* Newborn whose parents / caregivers cannot be expected to comply with treatment
* Newborn currently participating in another clinical trial
Early Life Exposures Among Children with Sickle Cell Disease

This study is being conducted to determine the relationship between early childhood exposures, such as Adverse Childhood Experiences, Social Determinants of Health and nutrition/breastfeeding, among children with sickle cell disease, and behavioral interventions aimed to reshape psychological resilience and lifestyle factors towards positive health outcomes.

During year 3 of the award period, 20 mother-infant dyads will be randomly assigned to either a community-based breastfeeding support group or observation. Acceptability to enrollment, intervention adherence for at least 6 months and preliminary effectiveness will be captured. Biomarkers of inflammation, development of asthma and incidences of pain and/or acute chest syndrome will be compared among the intervention and control groups.

Eligibility Criteria:
Inclusion Criteria:

* mother of infant with sickle cell disease
* resides within the city of Birmingham, Alabama or in close proximity

Exclusion Criteria:

* prescribed teratogenic medications
* no/limited internet access
Use of Arthroscopy in Treatment of Acute Pediatric Septic Hip Infection

Acute septic hip infection in pediatric population is a true orthopedic surgical emergency that require early diagnosis and prompt management. Open surgical debridement and drainage of the hip through lateral approach is the gold standard method of treatment. Usage of hip arthroscopy in the treatment of such condition has been in clinical practice for more than 30 years. However, literature is still lacking in actual prospective comparison about the outcome of both methods.

The study will divide the children presented with acute septic hip infection into two groups; the control group in which the child will undergo traditional open surgical debridement and drainage of the hip via lateral approach, and the intervention group in which arthroscopic drainage and debridement of the hip will be done. The outcomes of both methods will be recorded and compared. The research hypothesis is that arthroscopic management of acute pediatric septic hip infection is as effective as open surgery; with fewer complications and faster recovery.

Eligibility Criteria:
Inclusion Criteria:

* Age 10 months - 14 years _unilateral or bilateral acute septic hip arthritis

Exclusion Criteria:

* Children with pre-existing other pathology of the affected hip, whether he / she has surgery for management of this pathology or not.

  * Patients whose parents refuse to participate in the study
Effect of Nervous System Mobilization on Athletes' Performance

This study aims to compare the effects of two diferente doses of nervous system mobilization on athletes performance.

It is anticipated that 60 athletes will be randomly allocated to receive either 4x10 (n=30) or 8x10 (n=30) repetitions of neural mobilization .

Data on flexibility (knee extension test) and lower limb strength and motor control (hop tests and vertical jump test) will be collected at baseline and after the neural mobilization.

Statistical analysis will be performed using a mixed-methods ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* Healthy athletes

Exclusion Criteria:

* Nerve damage
* Arthritis
* Tumors
* Vascular conditions
* Spinal cord injuries
* Any sistemic condition
* Surgery in the past 6 months
* Injury in the last 3 months
* A knee angle of \<10º
Let's be Well Red: Efficacy of Gudness Bars in Improving the Hemoglobin and Hematocrit Levels of Anemic Subjects

To test the efficacy of Gudness Bars in improving the hemoglobin and hematocrit levels of anemic subjects longitudinally.

To quantify the demographics of subjects attending anemia testing camps through LBWR and to explore correlations with the demographics data.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Ages 18-35 years age

Exclusion Criteria:

* Known allergy towards nuts.
Clinical and Urodynamic Evaluation of Surgical Repair of Pelvic Organ Prolapse Associated With Lower Urinary Tract Symptoms

To assess the urinary symptoms and urodynamic findings concomitant with Pelvic organ prolapse before and after surgical treatment and to define the role of urodynamic study in treatment decision making.

Pelvic organ prolapse (POP) is a prevalent problem that affects women's quality of life women with POP may present with a variety of lower urinary tract symptoms (LUTS).

For POP patients with concomitant urinary symptoms, urodynamic (UDN) testing is proposed for proper evaluation of cases and identification of the pathophysiologic events in each case individually.

In this prospective study, the investigators aim to describe the urinary symptoms and urodynamic findings concomitant with POP before and after surgical treatment of POP. We also aimed at defining the role of UDN in decision-making regarding the treatment of POP when associated with LUTS.

Eligibility Criteria:
Inclusion Criteria:

* women with anterior pelvic organ prolapse (POP) associated with Lower urinary tract symptoms

Exclusion Criteria:

* Patients with POP less than POP-Q grade II, POP not in need for surgical repair, neurological diseases that could possibly affect voiding functions, pelvic infections, congenital bladder disorders, history of urinary fistula, history of malignancy, and patients on current medical treatment for voiding dysfunction.
Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain

The primary objectives of this placebo-controlled clinical trial are to evaluate the analgesic efficacy and safety of bicifadine at three oral dose levels compared with placebo in patients with moderate to severe chronic low back pain.

The secondary objectives are to investigate the dose-response relationship of three dose levels of bicifadine, to evaluate the clinical meaningfulness of bicifadine efficacy, to evaluate the effect of bicifadine on function and general quality of life, to describe the population pharmacokinetics of bicifadine in patients with chronic low back pain, and to evaluate safety following discontinuation of bicifadine treatment.


Eligibility Criteria:
Main Inclusion Criteria:

* Patients with low back pain assessed as Class 1, Class 2 or Class 3 according to the Quebec Task Force Classification for Spinal Disorders and without detectable leg weakness on neurological examination.
* Patients must have required on average daily analgesics for the treatment of low back pain for at least 3 months prior to dosing.

Main Exclusion Criteria:

* Patients may not have moderate or severe pain in a location other than the lower back (with the exception of radiation to the lower extremity).
* Patients must not have had lower back surgery within 6 months prior to baseline, nor epidural corticosteroid injections within 3 months prior to baseline.
* Patients may not have an unstable medical condition.
Orthodontic Treatment With Clear Aligner

Three-dimensional Assessment of Root Resorption following treatment with clear aligners using Cone Beam Computed Tomography Design: A randomized, controlled, crossover, double-blind clinical study including twenty six adult , aged 18-25 years old.

Orthodontically induced root resorption is one of the common undesirable sequalae of orthodontic treatment. one third of the patients treated with fixed appliances showed more than 3 mm of root resorption whereas at least 2% of orthodontic patients showed more than 5 mm of root resorption.

There is a controversy in the literature regarding the effect of clear aligners on apical root resorption. One previous study reported that some kinds of removable aligners may have the potential of minimizing orthodontic ally induced root resorption due to the studied piezoelectric property by these materials Till now, the degree of apical root resorption following treatment with (in house) aligners has not been reported in the literature.

Eligibility Criteria:
Inclusion Criteria:

The Clinical Diagnosis the age of patients ranges between 18-25 years, medium crowding between 3-6 mm in the area of the upper anterior teeth according to Little irregularity index 20,class1 according angel classification healthy patient No previous orthodontic treatment vital teeth with periodontal tissue without root absorption,

Exclusion Criteria:

Previous history of orthodontic or orthopedic treatment. Presence of craniofacial anomalies. Presence of any signs and symptoms of gingival and periodontal diseases. Presence of significant medical history (including drug allergy). Pregnant and lactating women
Ramadan and Energy Expenditure Study

Ramadan fasting entails abstinence from eating and drinking between dawn and sunset. During this month major changes in meal times and patterns, sleeping times and activity occur. Starvation is known to lead to a compensatory reduction in energy expenditure. However, the Ramadan fast is not synonymous with starvation as it involves intermittent periods of fasting followed by gorging. People who fast during Ramadan feel less energetic. However, little is known about the effects of this religious practice on energy metabolism. .

The aim of this study is to assess energy dynamics before and/or after and during Ramadan fasting in non-obese participants. Resting metabolic rate (RMR), thermic effect of food (TEF), active energy expenditure (AEE) and total energy expenditure (TEE) in free-living conditions will be measured . Indirect calorimetry will be used to assess RMR and TEF, doubly labeled water will be used to measure TEE and activity monitors will measure physical activity. In addition, body composition analysis will be performed by bio-electrical impedance. Blood sample will be taken to exclude medical factors affecting energy metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Willing to participate.
* Age (18-70) years.
* BMI (20-30 kg/m2).
* Physically and mentally healthy.
* Consent form signed.

Exclusion Criteria:

* Any patients with significant health problem.
* Pregnant and lactating females.
* Smokers.
* Consumption of caffeine before tests.
* Patients who have had vigorous exercise for the last 12 hours before visit.
* Patients with diabetes treated with drugs known to alter the metabolic rate.
* Patients who had bariatric surgery.
* Patients with eating disorders.
* Patients with conditions known to affect energy expenditure
* Patients on medication know to alter EE (Thyroxine, anti-thyroid drugs, certain cold remedies)
Decision Making Tool for Firearm Storage

This is a one-arm pilot study testing the feasibility and acceptability of a decision aid about safe firearm storage.

This pilot study will test the feasibility and acceptability of a decision aid about safe firearm storage with firearm-owning persons with early dementia and/or depression

Eligibility Criteria:
Inclusion Criteria:

* Medical record documentation of early dementia and/or depression
* Internet or mobile device access
* Access to firearm(s)

Exclusion Criteria:

• Active suicidality
In Vitro Follicle Activation in Patient With Premature Ovarian Failure Under 36 Years Old

This is a clinical trial that the investigators aim to validate In-vitro Activation (IVA) treatment protocol, which was previously defined by Kazuhiro Kawamura (MD) and Aaron Hsueh (PhD), in Turkish patient with Premature Ovarian Insufficiency (POI) under age 36.

The objectives of the study is as following;

* Validation of the previously defined In-Vitro Activation Protocol approach in Turkish patients under 36 years old with Premature Ovarian Insufficiency (POI).
* Giving an opportunity to young POI patient in Turkey for having genetically own baby.
* Primary outcome measure would be live birth.
* For activation of primordial follicles, phosphatase and tensin homolog (PTEN) inhibitor and protein kinase B (AKT) stimulator will be used.

Eligibility Criteria:
Inclusion Criteria:

* Patient with POI
* Short amenorrhea period (1 - 2 years)

Exclusion Criteria:

* Having been treated with chemotherapy and/or radiotherapy;
* Having been diagnosed with advanced stage of endometriosis (endometriomas)
* Having been diagnosed with the chronic diseases such as diabetes, cardiac failure, kidney insufficiency, morbid obesity etc..
* Presence of chromosomal abnormality (Turner, Fragile-X etc.)
* Previous multiple laparotomies
* Menopause \>10 years
* Accompanied azoospermia
Improving the Impact of Calorie Labeling Policies

Increased consumption of fast-food may be a contributing factor to the obesity epidemic. Posting calories on menus in fast-food restaurants is an important public health initiative and may help consumers to make lower calorie, healthier choices. This study will develop and test an intervention to improve the impact of calorie labeling policies. Further, the study will examine potential barriers to using posted calorie information

By the year 2030, 50% of American adults could be obese. Increasingly, Americans are consuming more foods away from home and most of these foods are consumed in fast-food restaurants. Menu calorie labeling provides calorie information at the point of purchase in fast-food restaurants and is one strategy employed to promote lower calorie, healthier food choices. Initial studies of the impact of calorie labeling, however, suggest that posting calories may only affect calories purchased in a minority of consumers.

The Patient Protection and Affordable Care Act (PPACA) mandates that calorie labeling be implemented nationally and fast-food restaurants throughout the U.S. will begin to post calorie information. With an overarching goal of improving the impact of calorie labeling policies; this proposal will develop and pilot test a brief intervention that is complementary to the posted calorie information, and will explore potential barriers to reducing calories among an urban clinic population. The study aims are: (Aim 1) To develop the Complementary Calorie Labeling (CCL) intervention, an individual single-session intervention that can be delivered in primary care settings. Semi-structured interviews will be conducted among 40 overweight or obese participants to guide development of intervention components and materials. (Aim 2) To conduct a pilot randomized controlled trial of the CCL intervention among 188 overweight or obese participants. The CCL intervention will be compared to a control group that receives an educational brochure about calories. The primary outcome will be weekly calories purchased at fast-food restaurants as measured by fast-food receipts and food logs. (Aim 3) To examine whether calorie knowledge, health literacy, numeracy, and motivation are barriers to using calorie information and whether these variables moderate intervention efficacy.

The proposed study will be conducted in a primarily low-income, minority clinic population in the Bronx NYC. NYC was the first major city to implement calorie labeling. Preliminary data from NYC suggest that fast-food consumers in the Bronx may be less likely to reduce their calories purchased when calorie information is posted, compared to other consumers in NYC. Developing interventions that may improve the impact of calorie labeling policies within this population will have important implications as these policies are implemented in urban communities throughout the U.S.

Eligibility Criteria:
Inclusion Criteria:

* Eats at Fast-food restaurant at least once per week BMI\>25

Exclusion Criteria:

* inability to keep food logs or fast-food receipts
A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer

The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer.

The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix assisted TURB compared to standard white light TURB.

The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer.

Patients will be followed 4, 8 and 12 months after the initial TURB. This follow-up regimen is according to standard clinical practice in Denmark.

Recurrence of non-invasive bladder cancer is frequent, and this study is designed to investigate whether Hexvix assisted TURB can reduce the early recurrence compared to standard TURB

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspicion of non-invasive bladder cancer indicated for a transuretheral resection of the bladder
* Above 18 years
* Written informed consent obtained

Exclusion Criteria:

* Gross hematuria. (Note: Gross hematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy. Where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy).
* Patient with porphyria.
* Known allergy to hexyl aminolevulinate hydrochloride or a similar compound.
* Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
* Pregnant or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and use the contraceptive pill or intrauterine device (IUD) during the treatments and for at least one month thereafter).
* Conditions associated with a risk of poor protocol compliance.