cyrilzakka/clinical-trials huggingface dataset:
68Ga-labeled NY104 PET Imaging in Patients

This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY104 PET Imaging in patients with Renal Cell Carcinoma


Eligibility Criteria:
Inclusion Criteria:

1. Patients voluntarily signed informed consent;
2. Age 18-75, male or female;
3. Patients diagnosed with renal cell carcinoma confirmed by histopathology or cytology;
4. At least one measurable solid lesion has been examined according RECIST1.1 standard;
5. ECOG score 0\~3; Life expectancy of at least 3 months;

Exclusion Criteria:

1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
2. Patients with systemic or locally severe infections, or other serious coexisting diseases;
3. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
4. Patients with autoimmune diseases, including rheumatoid arthritis;
5. Inadequate control of arrhythmias, including atrial fibrillation;
6. Uncontrolled hypertension;
7. Patients with allergies or allergies to any component of the imaging agent or antibody;
8. Patients who cannot undergo PET/CT imaging scan;
9. Syphilis, HBV, HCV, or HIV positive subjects;
10. Male and female subjects of reproductive age cannot take effective contraceptive measures;
11. Pregnant or lactating women;
12. Patients with a history of mental illness or related conditions;
13. Other subjects considered unsuitable by researchers.
Periodontal Disease Prevention Study

This study is one component of a program to improve the maintenance of good dental health and the prevention of disease by use of risk stratification methods to efficiently guide increased preventive services to adult dental patients who are at increased risk for the major dental diseases, caries and adult periodontitis.

The investigators will use a retrospective cohort model to analyze a large dental claims database to determine if the frequency of preventive services influenced the periodontal disease outcomes and to determine if periodontal risk assessment information can be used to stratify dental patients into "high risk" and "low risk" categories that influence the effect of preventive services on periodontitis outcomes.

Primary Objective To evaluate whether dental patients who are classified as "low risk" for periodontal disease progression, based on history of periodontitis (claims history), smoking, diabetes, and IL-1 genetic variations, have different primary and secondary endpoints if they had two dental cleanings per year compared to one cleaning per year.

Secondary Objectives To evaluate whether dental patients who are classified as "high risk" for periodontal disease progression, based on a history of periodontitis, smoking, diabetes, and IL-1 genetic variations, have different primary and secondary endpoints if they had two dental cleanings per year compared to one cleaning per year.

To evaluate whether dental patients who have had one dental cleaning per year have different primary and secondary endpoints if they are classified as "low risk" for periodontal disease compared to patients who are classified as "high risk." To evaluate whether dental patients who have had two dental cleaning per year have different primary and secondary endpoints if they are classified as "low risk" for periodontal disease compared to patients who are classified as "high risk."


Eligibility Criteria:
Inclusion Criteria:

* Study may include all participants who are 34-55 years old in 1992 (48-68 years old in 2010) and who have at least a 15-year dental claim history with Delta Dental.

Exclusion Criteria:

* Organ transplant recipients are excluded.
Cohort of Patients Presenting Unexplained Recurrent Miscarriages and Identification of Early Miscarriage Recidivism Factors

About 1 to 3% of women of childbearing age have repeated early spontaneous miscarriages (RCF) defined by at least 3 fetal losses before 14 weeks of gestation. RCFs may be related to parental chromosomal abnormalities, congenital or acquired uterine abnormalities, hormonal causes (e.g. type 1 and 2 diabetes, ovarian failure), infectious etiology, constitutional or acquired thrombophilia or sickle cell disease.

The presence of antiphospholipid antibodies, antithyroid and anti-transglutaminase antibodies in approximately 10% of cases suggests an autoimmune origin for these fetal losses. The role of other antibodies, in particular unconventional antiphospholipid antibodies, remains to be established. Indeed half of RCF cases would be due to an immunological dysregulation of the mother leading to a decrease in tolerance to the fetus. Several studies have shown immune abnormalities, such as an imbalance of pro and anti-inflammatory cytokines, an increase in cytotoxic cells and a defect in regulatory cells in the blood of patients. The assessment of these immune abnormalities is not currently carried out routinely in France in women with recurrent early miscarriages.

When one of these known causes is excluded, it is unexplained RCF which represents 50% of RCF. In these women with unexplained RCF, slightly more than half could be linked to aneuploidies and primary recurrent spontaneous abortions. The evaluation of the degree of aneuploidy and the genetic origin of fetal losses remains difficult, the examination of the sample of tissue from the miscarriage being rarely available, due to the spontaneous nature of the loss.

The constitution of a prospective cohort of patients with RCF is an essential step in exploring the factors associated with the success of treatment.

On the day of inclusion, if the patient accepts the ancillary study, a blood sample will be taken for the biological collection If the patient becomes pregnant during the follow-up period, the blood sample for the ancillary study will be repeated each trimester of pregnancy (if applicable).

At the inclusion visit and during pregnancy, the patient will complete a Baecke questionnaire and a questionnaire to measure perceived stress

The study population will be followed as part of usual care, identical to all patients presenting with RCF.

As part of the routine care of the internal medicine department of Saint Antoine, patients with RCF have a complete check-up in the day hospital (complete blood test, stomatologist consultation, ECG) and are seen in consultation twice a year.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 50 years
* Patients with at least 3 recurrent miscarriages
* Signed consent form

Exclusion Criteria:

- Patients who don't accept the use of their data
Comparison of Holmium Laser Enucleation Prostatectomy and Open Transvesical Prostatectomy in Large Prostate

comparison of holmium laser enucleation prostatectomy and open prostatectomy regarding safety and efficacy in men with prostate larger than 80 grams


Eligibility Criteria:
Inclusion Criteria:

* American Urological Association Symptom Score of eight or higher,
* Maximum urinary flow rate of 10ml/s or less,
* Post void residual urine volume of 50 ml or more,
* And a total prostate volume of 80 ml or more in transrectal ultrasound (TRUS).

Exclusion Criteria:

* A previous prostate or urethral surgery
* And non-BPH related voiding disorders
* Prostate cancer patients
Study of Meningococcal B Vaccine and ACWY Conjugate Vaccine in Healthy Adults

The study involves the measurement of immune response to vaccination with three doses of a meningococcal B vaccine and a single dose of a meningococcal ACYW conjugate vaccine in healthy adults (Laboratory workers). The study will be completed at the Manchester Medical Microbiology Partnership in the UK and will enrol staff who may be at potential occupational exposure to meningococci. Blood samples will be taken before and after each vaccination and used to determine if the vaccines induce protective responses.

Laboratory staff at the Manchester Medical Microbiology Partnership may be at potential occupational exposure to meningococci. No licensed vaccine is available against serogroup B meningococci and the available plain polysaccharide serogroup ACYW vaccine is poorly immunogenic. Novartis Vaccines have developed an investigational serogroup B vaccine and a conjugated ACYW vaccine. This study will investigate these vaccines ability to induce a protective response in laboratory staff from the Manchester Medical Microbiology Partnership. Three doses of the meningococcal B vaccine will be administered at 0, 2 and 6 months and a single dose will be administered at 0 months. Blood samples will be taken before and after each vaccination and functional antibodies determined.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years of age
* Who have given written informed consent after the nature of the study has been explained.
* Who work within the Manchester Medical Microbiology Partnership and may be at potential occupational exposure to meningococci.

Exclusion Criteria:

* The possibility of pregnancy
* A serious chronic disease including progressive neurological disease or seizure disorder.
* Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
* Have a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component.
* Have received another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study.
Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time.

Mitral regurgitation (MR) for degenerative disease is nowadays routinely treated with valve repair with excellent short and long term results in experienced centers. However, repair durability can varies according to the characteristics of the initial lesion, and better long term durability in isolated lesions of the posterior leaflets compared to anterior or bi-leaflets prolapse has been shown. A commissural MR can be caused by lesions of the anterior, posterior or both leaflets and several surgical techniques have been proposed to treat these lesions. However, long term outcomes of mitral valve repair (MVr) for isolated commissural flail or prolapse remain poor defined. In San Raffaele Hospital cardiac surgery, commissural lesions are usually treated with a functional approach, by means of edge-to-edge approximation of the anterior and posterior leaflet at the commissural area (commissural closure). The investigators previously reported the short and mid-term outcomes of this technique with satisfactory results. With this study the investigators aim to analyze the very long term clinical and echocardiographic results of isolated commissural lesions treated with commissural closure.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients;
* Patients underwent mitral valve repair for flail or isolated commissural prolapse, of posterior, anterior or bileaflet origin;
* Patients operated on with median sternotomy or left minithoracotomy;
* Patients in whom the commissural MR has been treated with commissural closure and annuloplasty;
* Patients operated on at the Cardiac Surgery department of San Raffaele Hospital from January 1997 to December 2007.

Exclusion Criteria:

* Patients underwent a mitral valve replacement
A Trial Investigating the Effect of Probenecid and Ciclosporin on the Concentrations of SNAC in Healthy Subjects

The aim of the study is to investigate the effect of the medicines, probenecid and ciclosporin on the concentrations of SNAC. SNAC is an ingredient of the semaglutide tablets. Participants will get 3 different treatments (that is 3 treatment periods): 1) a single dose of 3 mg semaglutide, 2) a single dose of 600 mg ciclosporin with 3 mg semaglutide, 3) 500 mg probenecid twice a day for 3 ½ days with a single dose of 3 mg semaglutide on the last day.

The sequence of treatments participants get is decided by chance. Probenecid and ciclosporin are available medicines. They are given by doctors. Semaglutide contains SNAC. It cannot be prescribed yet.

The study will last for up to 125 days. Participants will have 17 to 18 visits at the study centre. This includes short visits at the centre for blood sampling only. Participants will have several blood draws.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of non-childbearing potential, aged 18-64 years (both inclusive) at the time of signing informed consent.
* Body mass index between 18.5 and 29.9 kg/sqm (both inclusive).
* Body weight greater than or equal to 50.0 kg.
* Considered to be generally healthy 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:

- Use of tobacco and nicotine products, defined as: A. Smoking more than 1 cigarette or the equivalent per day B. Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house period(s).

* Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
* History (as declared by the subject) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
* Known glucose-6-phosphate-dehydrogenase deficiency (as declared by the subject).
Impact of the Puncture of the RP6 Point on the Ampliation and Injuries of the Perineum During Childbirth

During the study period, any patient who enters labour and reports to the maternity ward and meets the inclusion and non-inclusion criteria is offered to participate in the study by the midwife acupuncturist present.

After signing the informed consent, a numbered envelope with the randomization arm is assigned to the patient. The acupuncturist midwife does not perform the delivery herself. At the time of the expulsive efforts, she punctures the point drawn at random. The patient's participation in the study ends when she leaves the labour room after the birth.

During the study period, any patient who enters labour and reports to the maternity ward and meets the inclusion and non-inclusion criteria is offered to participate in the study by the midwife acupuncturist present. She's responsible for explaining the purpose and practicalities of the study orally and issues a written information document. The information provided is the same regardless of the midwife present. If she agrees to participate in the study, the patient signs the consent form.

After signing the informed consent, a numbered envelope with the randomization arm is assigned to the patient. The acupuncturist midwife does not perform the delivery herself. At the time of the expulsive efforts, she punctures the point drawn at random. She collects the clinical Research Form from the time the patient signs the consent form until she leaves the labour room after the birth.

The patient's participation in the study ends when she leaves the labour room after the birth. No further follow-up is planned.

Eligibility Criteria:
Inclusion Criteria:

* primiparous or multiparous women who have never given birth vaginally
* term patients (after 37 weeks of amenorrhea)
* patients delivering a fetus in cephalic presentation
* patients speaking and understanding French.

Exclusion Criteria:

* patients suspected of having a fetal macrosomy (greater than the 97th percentile) on the last ultrasound
* patients with twin pregnancies
* excised patients
* patient who has made an acupuncture preparation during pregnancy
* patients with fetal death in utero
* patients requiring medical termination of pregnancy
Is There Any Relation Between Serum Anti-p53 Antibody and TLG, MTV and SUV as PET Parameters in Lung Cancer Patients?

p53 is a tumor suppressor gene which plays an important role in controlling normal cell proliferation regulation that is located on the chromosome 17 (17p13.1). It is the most common goal of genetic alteration in many tumors. Serum p53 protein is presence in normal healthy individuals. However p53 antibody is extremely rare. Mutations in this gene cause an accumulation of non-functional proteins and development of anti-p53 antibodies, which can be detectable in tissues, slouhed cells, blood and other body fluids. Some studies have reported that, p53 mutations are highly common in leukemia, lymphoma, lung, esophagus, stomach, liver, bone, bladder, ovarian, and brain cancers. Lung cancer is the most common cause of cancer-related deaths and the survey is low after the initial diagnosis. Accurate staging is important for determine the choice of treatment and predict prognosis. 18F-FDG PET/BT has important value for initial staging and it is the most advanced imaging technique developed all over the world for determine of the characterization of the metabolic tumor volume. Maksimum Standardized Uptake Value (SUVmax) which was acquired by PET imaging is commonly used in clinical practice as a criterion for malignancy. Due to the development of new software programs recently studies have shown that metabolic tumor volume (MTV) and total lesion glycolysis (TLG) may be useful quantitative parameters for the prognostic evaluation. Viable tumor volume could be estimate with this programs.The purpose of this study was to assess the relation between serum anti-p53 antibody level and quantitative PET parameters as SUVmax, SUVave, MTV and TLG.


Eligibility Criteria:
Inclusion Criteria:

* patients who were referred to our department with the purpose of 18F-FDG PET/CT imaging for staging due to lung cancer diagnosis
* patients who were performed 18F-FDG PET/CT for diagnosis in the cause of the suspected pulmonary nodule/lesion in thorax CT but not detected pathologic FDG accumulation
* In the control group, healthy subjects with no history of cancer and without any complaint

Exclusion Criteria:

* Patients had operated for lung cancer, received prior chemotherapy or radiotherapy for lung cancer, with no definitive histological diagnosis, and a blood glucose level greater than 150 mg/dL
Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients

The purpose of EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin in hypertensive patients at low/moderate cardiovascular risk.

EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin on vascular function protection in hypertensive patients at low/moderate cardiovascular risk.

Eligibility Criteria:
Inclusion Criteria:

* All patients must meet the hypertension with low or moderate cardiovascular risk following 2010 Guidelines for prevention and treatment of hypertension in China

Exclusion Criteria:

* Secondary Hypertension
* Women who are pregnant or lactating
* History of mental instability, or major psychiatric illness not adequately controlled and stable on therapy
* Type 2 Diabetes
* Active liver disease or impaired liver function tests
* Impaired renal function
* Uncontrolled cardiac arrhythmia
* Patient who is unable to give informed consent
* Any condition or situation, which in the opinion of the investigator, might pose a risk to the patient or confound the results of the study
Tourniquet Use in Anterior Cruciate Ligament Repair

The purpose of this study is to assess the intra-operative and post-operative effects of tourniquet use during ACL reconstruction. We hypothesize that:

1. Limited tourniquet use will not significantly impact arthroscopic visualization nor the time it takes to complete an ACL reconstruction.
2. Limited tourniquet use will lead to significantly less patient pain intra-operatively and in the immediate peri-operative period.
3. Patients who undergo an ACL reconstruction with limited tourniquet use will have earlier return of quadriceps functions as compared to those undergoing reconstruction with the use of a tourniquet.

Type of Study Double-blinded randomized controlled clinical trial

Group 1 (Control): Patients undergoing patellar bone-tendon-bone autograft ACL reconstruction with a tourniquet used for the duration of the case.

Group 2 (Treatment/Intervention, if applicable): Patients undergoing ACL reconstruction with a tourniquet used only during patellar bone-tendon-bone autograft harvest, for a maximum of 20 minutes.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing an arthroscopic assisted ACLR using a bone-tendon-bone patellar tendon autograft.
2. 18 years or older
3. English speaking

Exclusion Criteria:

1. Concomitant procedures (e.g., osteotomy or other ligamentous reconstructions) other than chondroplasty, partial meniscectomy or meniscal repair
2. Medical contraindications to epinephrine or TXA use.
3. Hemophilia or other predisposition for bleeding
4. Does not follow study protocol in regard to regional anesthesia, TXA, epinephrine use in the arthroscopy fluid and post-operative rehabilitation.
5. Participation in physical therapy at any facility other than the OrthoCarolina Randolph, Matthews or South Park locations
Microscopic-spectroscopic Examination for Urothelial Tissue Characterization

To evaluate the possibility to properly discriminate between healthy bladder tissue and BCa with a multimodal fiber optic spectroscopy (MFOS) technique, in order to possibly introduce a more objective way to detect BCa, thus reducing inter-observer variability and maybe to determine urothelial carcinoma stage and grade with a comparable accuracy, specificity and sensibility of the current gold standard histopathological analysis

Observational single center study on human biological samples to evaluate the possibility to discriminate between healthy and tumor tissue on urothelial bladder samples. Aim of the study is to provide a fast, reliable and label free aid/alternative to current histopathology

Eligibility Criteria:
Inclusion Criteria:

* willingness to participate,
* legal age,
* full capacity to sign informed consent
* eligibility for each surgical operation according to the best clinical practice and the urological guidelines

Exclusion Criteria:

* concomitant use of Hexaminolevulinate (Hexvix®)
* concomitant ongoing UTIs,
* concomitant bladder stone presence,
* recent catheterization or persistent bladder catheterization at time of surgery,
* concomitant presence of other pelvic cancer (both prostate, urethral, uterine),
* previous chemotherapy or radiotherapy of the pelvis,
* patient refusal at informed consent.
Mental Imagery Enhances Proprioception in Patients With Low Back Pain

Mental imagery has been used in a variety of pathological instances in support to classical therapeutic treatments. The aim of the present study was to observe the effect of internal Kinesthetic and external Visual Imagery to improve proprioceptive feedback in low back pain. Fifty-five subjects with a history of low back pain were included in two experimental groups who used mental imagery and one control group who did not. The results showed the effectiveness of the Internal Kinesthetic Imagery to improve the accuracy of repositioning of lumbo-sacral spine that may subsequently improve the quality of the proprioceptive input. The possibility to use effectively mental imagery, as a part of proprioceptive rehabilitation process, is the principal outcome of this study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects suffering from common non-specific low back pain

Exclusion Criteria:

* Recent history of inner ear infection causing associated balance or coordination problems
* History of cerebral trauma followed by unresolved neurosensory symptoms
* Recent history of vestibular disorder and previous spinal surgery
* An involvement in specific balance or stabilization training during the 6 months prior testing. Patients taking pain medication were excluded from the study.