cyrilzakka/clinical-trials huggingface dataset:
18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer

PyL, also known as \[18F\]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted PET imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. Its ability to image metastatic prostate cancer sites was comparable to 68Ga-PSMA with high tumor-to-background ratios.Additionally, \[18F\] PyL demonstrated higher mean tumor-to-background ratios when using kidney, spleen, or parotid as reference organs. However, the role of \[18F\] PyL in tumor response to therapy has not been evaluated, specifically the potential to serve as a predictive biomarker of response. Given the high cost of current therapeutic agents in mCRPC, there is a need for an early response biomarker to stratify which patients will benefit from therapy and which will not. This will also allow for earlier change in management of patients who will not response to these therapies, potentially improving patient outcomes.

The investigators will conduct a prospective phase II/III study of 300 men diagnosed with prostate cancer with a rising prostate-specific antigen (PSA). Upon enrollment, subjects will undergo standard of care imaging (defined as a CT or MRI of the chest, abdomen, and pelvis, and 99mTc bone scans) if not obtained within 45 days of enrollment. Subjects will have standard of care laboratory evaluations and undergo 18F- DCFPyL PET/CT.

\[18F\]DCFPyL will be used for study imaging.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of prostate cancer
2. PSA ≥ 0.2ng/ml
3. Age ≥ 18 years of age
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (karnofsky ≥ 60%)
5. Ability to understand and willingness to sign a written informed consent document
6. Wiling to comply with clinical trial instructions and requirements
7. Willing to cover the cost of PyL PET/CT imaging if funds are not available

Exclusion Criteria:

1. History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin
2. Presence of prostate brachytherapy implants unless approved by the PI
3. Administration of another radioisotope within five physical half-lives of trial enrollment
4. Radiation or chemotherapy within 2 weeks prior to trial enrollment
5. Serum creatinine \> 3 times the upper limit of normal
6. Serum total bilirubin \> 3 times the upper limit of normal
7. Aspartate transaminase (AST) or alanine aminotransferase (ALT) \>5 times the upper limit of normal
8. Inadequate venous access
A Research Study Looking at How a Single Dose of the Medicine NNC0194-0499 Behaves in Chinese Men

This study looks at how a new study medicine called NNC0194-0499 behaves in the body of Chinese men. Three different dose levels will be tested. Participant will get only one of the three different dose levels of NNC0194-0499. Which dose participant will get will be decided by chance. NNC0194-0499 is a medicine under clinical investigation. It means that the medicine has not yet been approved by the health authorities. Participant will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on stomach. The study will last for a maximum of 64 days. Participant will not be able to take part in the study if the study doctor considers there is a risk for participant's health.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Chinese male aged 20-55 years (both inclusive) at the time of signing informed consent.
* Body mass index (BMI) between 23.0 and 34.9 kilograms per meter square (kg/m\^2) (both inclusive).
* Body weight greater than or equal to 60 kg.
* Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Known or suspected hypersensitivity to study intervention or related products.
* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China

The study will assess the safety of Pentaxim® vaccine as a three-dose primary vaccination at 2, 3, and 4 months of age in order to meet the regulatory requirements for the license renewal as for any other product registered in China, and to generate additional clinical data using the three-dose primary vaccination schedule in some other Chinese provinces.

Primary Objective

* To describe the safety after administration of PENTAXIM® at 2, 3, and 4 months of age in the study population.

Each study participant will receive an injection of PENTAXIM® at 2, 3, and 4 months of age and will be monitored for safety through the entire study period.

The duration of each participant in the trial will be approximately 3 to 4 months.

Eligibility Criteria:
Inclusion Criteria:

* Aged 2 months (60 to 74 days) inclusive on the day of the first study visit
* Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
* Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

* Participation or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth, or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
* Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
* Clinically significant illness, according to investigator judgment, at a stage that could interfere with trial conduct or completion
* Evolving encephalopathy
* Receipt of immune globulins, blood or blood-derived products since birth
* Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection
* Receipt of any other vaccine in the 14 days preceding the first trial vaccination or planned receipt of any vaccine in the 14 days following the first trial vaccination
* Acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
* Contraindications to vaccination according to PENTAXIM® summary of product characteristics (SPC) or leaflet
* In an emergency setting, or hospitalized involuntarily
* Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
Testing the Potential Metabolic Effect of the Human Gut Bacterial Peptide, RUCILP, in Healthy Men

The goal of this randomized, double-blinded and placebo-controlled clinical cross-over trial is in healthy men to explore the potential metabolic effects of the naturally occurring gut bacterial polypeptide, RUCILP. This bacterial peptide is produced by commensal strains of Ruminococcus torques in the human gut microbiota.

In preclinical studies of rodents, RUCILP lowers blood glucose and stimulates release of plasma insulin, glucagon-like peptide-1(GLP-1) and Peptide YY (PYY) but induces a decline of glucose-dependent insulinotropic polypeptide (GIP).

In the present trial, the investigators want to explore potential effects of intraduodenally delivered RUCILP on release of plasma concentrations of GLP-1, GIP and PYY.

In addition, the investigators will test for potential effects of intestinal RUCILP infusion on plasma concentrations of glucose, insulin and metabolome.

Participants will have a duodenal tube placed into which RUCILP or placebo will be infused over 3 hours after an initial standardized liquid meal infusion into the duodenal tube.

Participants will on different days and in a randomized order receive either placebo or RUCILP infusion into the tube.

Safety is acutely monitored under the intervention and postintervention safety is monitored by clinical biochemistry measures of hematology, and liver and kidney functions. The study participants will further keep a diary of any experienced adverse effects during the week after the intervention.

Primary OUTCOMES: a composite of changes in plasma concentrations of GLP-1, GIP and PYY.

Secondary OUTCOMES: changes in plasma glucose, plasma insulin and plasma metabolome profile.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 35 years
* Self-reported good health
* Caucasian
* Normal body mass index (18.5 to \<25)

Exclusion Criteria:

* Any known disorder/disease that could interfere with study results or is seen as compromising to the study (as assessed by the investigator), for example diabetes, cancer or cardiovascular or kidney disease.
* Use of any daily medication as well as p.r.n. (pro re nata; not taken regularly) medication that cannot be discontinued during the trial
* Use of antibiotics during the recent three months
* Acute or chronic gastrointestinal symptoms
* Lactose intolerance
* Smoking
* Alcohol or drug abuse
* Use of creatine as dietary supplement during study period
* Plasma creatinine concentration above the normal range (\>105 μmol/L)
* Known significant liver disease or plasma ALAT concentration ≥ 3 × normal value
* Values for hemoglobin, leukocytes, or thrombocytes outside of the normal ranges
Pan Facial Volume Restoration

The aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction further to pan-facial volume restoration with a new cross-linked hyaluronic acid dermal filler containing lidocaine 0.3%.

Clinical hypothesis: The global approach of the subject pan-facial dermal volume depletion and face soft-tissue contour defects correction using specific dermal filler for all indications to be injected will satisfy both subjects and investigators.

This device will be used for full face correction of volume loss: chin, temporal areas, jawline, cheek, cheekbones, deep to very deep nasolabial folds (only if cheekbones are injected concomitantly).

Study duration will be up to 19 months. Injections will be performed at baseline. If necessary, investigator will perform touch-up injections at the following visit (3 weeks after baseline injection).

Eligibility Criteria:
Inclusion Criteria:

* Subjects seeking treatment for correction of volume loss.
* Subjects presenting a score of at least 2 (visible depression or descent) for whole face on the volume loss scale and at least 2 indications affected by volume loss among the following: chin temporal areas, jawlines, cheeks, cheekbones, deep to very deep nasolabial folds (severity score 4 at least on Lemperle rating scale) if cheekbones are injected.

Exclusion Criteria:

* Subjects at risk in term of precautions, warnings and contraindication referred in the package insert of the study device,
* Subjects who underwent previous injection of permanent filler in the injected area.
Exercise and Diet Intervention Attenuated Inflammation Through ASC Gene and Inflammatory Markers in Obese Adults

Background: Obesity is one of the most important health problems worldwide, several factors related to lifestyle as physical inactivity and unbalanced diets increase their development. This condition is characterized by low-chronic inflammation by excess of adipose tissue. The apoptosis-associated speck-like protein containing a caspase recruitment domain (ASC) protein is part of NLRP3 inflammasome, a complex related to inflammation and metabolic alterations.

Purpose: The aim of this study was to evaluate the effect of physical exercise program on ASC gene expression and inflammatory markers in obese adults.

Methods: 37 obese individuals were randomized to exercise-diet group or diet-group during a 4-month follow-up period. The dietary evaluation was analyzed by Nutritionist Pro software. Body composition was evaluated by bioimpedance (InBody 370). All biochemical determinations were analyzed by dry chemistry (Vitros 350). ASC messenger ribonucleic acid (mRNA) expression was performed by real-time polymerase chain reaction (PCR) using Taqman probes and by the 2-ΔΔcq quantification method. Cytokine levels was performed using the Bio-PlexPro™ HumanTh17Cytokine Assays (MagPix) panel. Statistical analysis was performed with Statistical Package for the Social Sciences (SPSS) v.22 software.

A randomized clinical trial was conducted in the Institute of Translational Nutrigenetics and Nutrigenomics, Department of Molecular Biology in Medicine, Health Sciences Center, at the University of Guadalajara, Guadalajara, Jalisco, Mexico, from February of 2018 to February of 2019. All participants were recruited through flyers and social media invitations. Sample size was determined according to the mean difference formula for clinical trials. To achieve a statistical power of 80% and an alpha of 5%, a sample size of 13 participants in each study group was required. However, 37 obese individuals who met the selection criteria were randomized in exercise-diet group or diet-group. Blood sample, height and weight were measured after 8-12 hour fast and wearing light clothes. The participants in the exercise-diet group were cited in the Respiratory Unit of the University of Guadalajara with the indication of not consuming caffeine, tobacco or energy drinks 24 hours before the test, and not having eaten food at least two hours before the Astrand-rhyming Test. This study was approved by the Ethics and Biosafety Committee of the Health Sciences Center, University of Guadalajara (registry number CUCS/CINV/0476/18). The procedures were in accordance with this institution's guidelines and all the participants signed a written consent-informed.

Eligibility Criteria:
Inclusion Criteria:

* BMI greater than 30 kg/m\^2
* Sedentary individuals
* Both genres
* Waist circumference greater than 80 centimeters in women and greater than 90 centimeters in men

Exclusion Criteria:

* Pregnant or breastfeeding women
* Diagnosis of any metabolic disease or cancer
* Alcohol or tobacco consumption
* Muscle or joint injury
Effect of Mirror Therapy on Unilateral Neglect for Patients After Stroke

This is a single-blinded randomized controlled trial to investigate the effects of mirror therapy (MT), with reference to sham mirror (a glass wall) and control (a covered mirror), in reducing unilateral neglect for patients with stroke in 2 centres.

Twenty-one subacute inpatients with left unilateral neglect after right-hemispheric stroke, recruited from 2 hospitals - Hong Kong and Guangzhou, in 1 and a half years, were randomly assigned to three groups; mirror therapy, sham therapy (in the form of a transparent glass wall), and control (covered mirror). The treatment programme for all groups consisted of 12 sessions (4 per week for 3 weeks) movement practice for the hemiplegic arm involved 5 table-top tasks graded according to the severity of patients' arm impairments. Blinded assessments were administered at baseline, 3-week postintervention, and 3-week follow-up upon completion of training.

Eligibility Criteria:
Inclusion Criteria:

* ischemic or hemorrhagic stroke, confirmed by medical diagnoses compatible with a unilateral right lesion involvement (i.e. left hemiplegic), exhibited left visual field inattention or unilateral neglect by obtaining a total score of star cancellation subtest in the conventional battery of the Behavioural Inattention Test ≤ 51 (out of 54);
* stroke with onset of neurological condition ≤ 6 months previously;
* have normal or corrected-to-normal visual acuity better than 20/60 (6/18) in the better eye;
* with hemiplegic upper extremity functional levels 3-7 as rated by Functional Test for the Hemiplegic Upper Extremity and is able to move against gravity;
* ability to understand and follow simple verbal instructions, with Mini-mental State Examination ≥ 21;
* ability to participate in a therapy session lasting at least 30 minutes;
* consent to participant in the study

Exclusion Criteria:

* prior neurological or psychiatric disorders;
* severe spasticity (Modified Ashworth Scale \>3) over paretic arm;
* history of recent Botox injection or acupuncture to the paretic arm within the past three months;
* participation in another clinical study elsewhere apart from the study site during recruitment
Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment

The purposes of the study is to determine whether blood sugar control is different between Lantus and a third oral anti-diabetic agent when added to patients who fail a thiazolidinedione and sulfonylurea or metformin combination.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 - 79 years of age
* With diagnosed type 2 diabetes for at least a year treated with stable doses of two oral antidiabetic drugs of which one is either Avandia or Actos for at least three months

Exclusion Criteria:

* Major cardiovascular events

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
ICBT for Depression - A Factorial Investigation of Kinds of Therapist Support and Self-/Expert-selected Content

The study is a factorial randomized controlled trial investigating the efficacy of difference versions of internet-administered cognitive behavioral therapy.

The study is a 2 x 2 design. The first factor thought to be of relevance for the efficacy is the whether the content is selected by the participants themselves or by a therapist. The second factor consists of two levels: regular, continuous weekly support from a therapist or guidance on demand by a health care team consisting of a physician, a nurse, a clinical psychologist, an IT-technician and the principal investigator of the study.

Eligibility Criteria:
Inclusion Criteria:

* Current depressive symptoms equivalent to a score of at least 5 on Patient Health Questionnaire 9 and a minimum of 10 points on Becks Depression Inventory.
* 18 years or older.
* Adequate ability to understand and speak Swedish.
* Access to the internet and a smartphone/computer.

Exclusion Criteria:

* Other ongoing psychological treatment or counselling.
* Recent (within the past 3 months) changes in the dose of psychotropic medication.
* Prior diagnosis of psychosis, bipolar disorder, or substance dependence.
RESPOND EDGE Post Market Study

The purpose of the RESPOND EDGE post market study is to collect real world clinical and device performance outcomes data with the Lotus Edge™ Valve System used in routine clinical practice to demonstrate that the commercially available Lotus Edge Valve System is a safe and effective treatment for patients with severe calcific aortic stenosis.

The RESPOND EDGE study is a prospective, open label, single arm, multi-center, observational post market study designed to collect real world clinical and device performance outcomes data of the commercially available Lotus Edge Valve used in routine clinical practice for the treatment of severe calcific aortic stenosis. Approximately 200 real-world, consecutive subjects will be enrolled at up to 20 study centers. The study duration for each subject is expected to be approximately 2 years. Implanted subjects will be contacted for follow-up at 30 days, 1 and 2 years post index procedure. Subjects who are enrolled but not implanted with a Lotus Edge valve will be followed for safety through 30 days after the initial attempted index procedure.

Collection of safety events will include any serious adverse event (SAE), serious adverse device effect (SADE), adverse device effect (ADE), unanticipated serious adverse device effect (USADE), and all Valve Academic Research Consortium (VARC) events regardless of seriousness and device relationship through 2 year follow-up.

Eligibility Criteria:
Subjects will be evaluated for eligibility by the clinical center's heart team per the local standard of practice in accordance with the Directions for Use.
Identification of Markers (Klotho-FGF23 Axis) as Determinant in the Evolution of Arterial Stiffness During the First Year of Renal Transplant

The primary objective is to show that the contribution of Klotho by the renal graft is an independent determinant of the evolution of the recipient's central arterial stiffness during the first year of renal transplant. The contribution of Klotho by the graft will be estimated by: its circulating concentrations assay, its urinary excretion assay, and, indirectly, by the circulating concentrations of FGF23. The recipient's central arterial stiffness will be estimated by the measure of the carotid-femoral pulse wave velocity, noninvasive reference method for measuring aortic stiffness in human.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman 18 to 70 years old
* Renal transplant
* Dead donor or alive donor
* Immunosuppression including a calcineurin inhibitor
* Written consent

Exclusion Criteria:

* MultipleTransplant
* Morbid Obesity (Body Mass Index (BMI)\> 40 kg/m2 sc)
* Cardiac Arrhythmia
* Lower limbs occlusive arterial disease
* Impossibility to understand the information form
Collecting and Storing Tissue and DNA Samples From Patients Undergoing a Donor Stem Cell Transplant

RATIONALE: Collecting and storing samples of blood, urine, and tissue from patients undergoing a donor stem cell transplant to test in the laboratory may help the study of graft-versus-host disease in the future.

PURPOSE: This research study is collecting and storing tissue and DNA samples from patients undergoing a donor stem cell transplant.

OBJECTIVES:

* To establish a DNA bank from donor and recipient (prior to transplant) peripheral blood for SNP studies.
* To establish a tissue bank for gene expression studies using donor and recipient (post-transplant) peripheral blood samples.
* To establish a tissue bank for proteomic studies using donor and recipient blood and urine samples.
* To establish a tissue bank for various studies using biopsy specimens.
* To establish a tissue bank for flow cytometric studies using recipient (post-transplant), and sample from stem cell product.

OUTLINE: Peripheral blood samples are collected from donors prior to stem cell mobilization and from patients prior to starting preparative regimen. Samples are studied by single nucleotide polymorphism (SNP) analysis, SNP array, proteomic analysis, gene expression, and other immunological laboratory methods. Blood, urine, and tissue samples are preserved for future studies. Extra skin biopsies and gastrointestinal biopsies are performed at diagnosis of graft-vs-host disease and preserved in a tissue bank for flow cytometric studies.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Approved for allogeneic stem cell transplantation
* Sample of the stem cells from donor must meet 1 of the following criteria:

  * Total peripheral blood stem cell dose \> 5 X10\^6 CD34+ cells/kg
  * Marrow cell dose \> 3 X 10\^8 nucleated cells/kg

PATIENT CHARACTERISTICS:

* Platelet count \> 50,000/mm³ (for patients undergoing endoscopic biopsies)
* INR \< 1.5 (for patients undergoing endoscopic biopsies)

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics