cyrilzakka/clinical-trials huggingface dataset:
Unfavorable MRI But Favorable 68Ga-PSMA PET/MRI for Primary Prostate Cancer Detection

This perspective cohort study aims to assess the detection rate of prostate cancer through prostate biopsy within suspicious patients harboring unfavorable multiparametric MRI but favorable 68Ga-PSMA PET/MRI who have had no prior prostate biopsy.

Multiparametric MRI (MpMRI) is currently regarded as the best imaging method to noninvasively identify and characterize prostate cancer (PCa) with the Prostate Imaging Reporting and Data System (PI-RADS) v2. However, there are diagnostic difficulties for suspicious patients with PI-RADS score 3 and not all PCa are equivalently visible on mpMRI. For such patients, other alternative imaging techniques are required to properly characterize and detect PCa.

It has been widely reported that 68Ga-PSMA PET imaging offers excellent performance in detecting primary PCa and is able to noninvasively characterize the aggressiveness of PCa. Recently, integrated PET/MRI, which combines the strengths of both modalities, has been shown to have great potential for influencing clinical practice by providing a more certain map of localized PCa to aid targeted biopsies and therapy.

This perspective cohort study aims to assess the detection rate of PCa through prostate biopsy within suspicious patients harboring unfavorable mpMRI but favorable 68Ga-PSMA PET/MRI who have had no prior prostate biopsy.

Eligibility Criteria:
Inclusion Criteria:

1. Men more than 18 years old with clinical suspicion of prostate cancer;
2. Serum prostate-specific antigen (PSA) \> 4 ng/ml within the previous 3 months;
3. PI-RADS score no more than 3 or normal mpMRI of prostate;
4. Suspicious lesion(s) within prostate on 68Ga-PSMA PET/MRI;
5. no evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
6. Able to provide written informed consent.

Exclusion Criteria:

1. Prior prostate biopsy or prostate surgery;
2. Prior treatment for prostate cancer;
3. Contraindication to MRI or PET (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min);
4. Contraindication to prostate biopsy.
Perinatal Covid-19 Infection, NO Pathway, and Minipuberty

Some evidence exists that SARS-COV-2 may infect pituitary axis, and therefore may alter hypothalamic function. Whether perinatal COVID-19 is associated with alterations in the maturation of the Hypothalamic-Pituitary-Gonadal (HPG) axis, and specifically with its transient activation occurring during infancy, namely minipuberty, is a major concern. Among the various pathogenic features related to COVID-19, altered minipuberty could be a key factor underlying many multimorbidities later in life, suggesting that they could involve a common causative mechanism that occurs within this short and critical period of time following birth. Altered minipuberty together with NO deficiency seem to be key factors underlying many of these multimorbidities, suggesting that they involve a common causative mechanism that occurs within this short and critical period of time following birth


Eligibility Criteria:
Inclusion Criteria:

* Group 1 : Newborn infants (24 to 41 weeks gestational age) or young infants (\< 3 months) admitted at the maternity ward or at the Department of Neonatology at Jeanne de Flandre Hospital, CHU of Lille with perinatal COVID-19 infection defined by:

  * Antenatal COVID-19 infection: pregnant women with positive PCR test at any time of the pregnancy;
  * Post-natal COVID-19 infection: newborn or young infants (\< 3 months) with positive PCR test in pharynx or stools as part of their treatment.
* Group 2 : Newborn infants (24 to 41 weeks gestational age) or young infants (\< 3 months) admitted at the maternity ward or at the Department of Neonatology at Jeanne de Flandre Hospital, CHU of Lille for severe cardiorespiratory diseases requiring inhaled NO treatment.
* Group 3 : The control group without perinatal COVID-19 infection and no inhaled NO treatment will be matched to the two other groups on age at birth (± 2 weeks of gestation), on postnatal age (± 3 weeks), on respiratory failure (yes/no).
* No inclusion in another ante- or post-natal trial;
* Written consents from both parents.
* Social security affiliation

Exclusion Criteria:

* Preterm birth less than 24 weeks gestational age.
* Severe brain lesions: bilateral and extensive periventricular leukomalacia, intracranial hemorrhage grade 3 or 4;
* One or both of the parents is unable to read or understand French language, or refuse to participate
Compassion Meditation for Older Adults

Some older Veterans with psychological distress may under-utilize mental health services due to perceived stigma of symptom-focused interventions. This study was designed to examine the feasibility of a strengths-based compassion training intervention with Veterans ages \> 55 years with anxiety or depressive symptoms. Although this study was focused on feasibility if successful, this line of research could open the door to a novel and effective treatment that widens acceptance by older Veterans with psychological distress.

Many older Veterans in VA primary care clinics experience anxiety and depressive symptoms, but only a minority of these Veterans seek care through VA mental health services. Research suggests that some older Veterans with psychological distress under-utilize mental health services due to perceived stigma of treatments focused on mental health symptoms. However, prior research with civilians, including one study of Veterans with PTSD, suggests a strengths-focused intervention that provides group training in compassion meditation may be effective in reducing negative emotions and increasing positive emotions and well-being. This project was designed to examine the feasibility of this approach with Veterans ages \> 55 years with anxiety or depression. The study was designed to guide and support development of a future larger-size, more definitive follow-up project. . If successful, this line of research could open the door to a novel and effective treatment that widens acceptance by older Veterans with psychological distress.

Eligibility Criteria:
Inclusion Criteria:

* VA San Diego Healthcare System (VASDHS) patient
* current mild-to-moderate anxiety or depressive symptoms as defined by scores between 5 and 14 on the Patient Health Questionnaire (PHQ-9) and or Generalized Anxiety Disorders scale (GAD-7).
* stated intention to attend the 10 group sessions at the scheduled times at the VASDHS in addition to the baseline and follow-up study assessment visits, as well as to complete the outside homework assignments
* provides written informed consent for participation

Exclusion Criteria:

* no active suicidality/homicidality in the preceding six months
* untreated alcohol or substance use disorders
* changes to psychiatric medications within six months prior to the baseline evaluation
* medical and/or psychiatric instability interfering with current ability to engage in the group sessions and outside homework assignments
Non-Surgical Treatment Approaches in Patients With Newly Diagnosed Lateral Epicondylitis: A Randomized Clinical Trial

Lateral epicondylitis (tennis elbow) is a painful musculoskeletal condition, which is considered to be due to overuse, over-stress or over-exertion of the wrist extensors of the forearm, especially extensor carpi radialis brevi.

The aim of this study is to The compare the short-term effects of different physiotherapy approaches on pain, function and grip strength in the rehabilitation of patients with lateral epicondylitis.

Lateral epicondylitis (tennis elbow) is a painful musculoskeletal condition, which is considered to be due to overuse, over-stress or over-exertion of the wrist extensors of the forearm, especially extensor carpi radialis brevi. Different treatment approaches are described in the literature. The primary aim of the treatment approaches are decrease the pain and improve the functional level in patients with lateral epicondylitis. Thus, decreasing pain and regaining the functional performance in the daily living activity is essential in early diagnosed patients.

The aim of this study is to compare the short-term effects of different treatment approaches on pain, function and grip strength in the rehabilitation of patients with lateral epicondylitis.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with tennis elbow,
* and the duration of symptoms was between 8 and 10 weeks,
* and pain over the lateral epicondyle, pain during grip strength testing, and pain with one of the following tests: extensor carpi radialis test (i.e., resisted middle-finger extension), resisted wrist extension, or passive stretch of the wrist extensors.
* Furthermore, the participants had to agree to abstain from any other form of treatment during their involvement in this study

Exclusion Criteria:

* patients with inflammatory, autoimmune, endocrine or kidney diseases, cubital tunnel syndrome, carpal tunnel syndrome, radiculopathies due to cervical disc pathologies, additional shoulder-hand-wrist pathologies, inflammatory arthritis, upper extremity operations or traumas,
* allergies to adhesive tape,
* and the patients who received corticosteroid injection due to lateral epicondylitis within the last 3 months
Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma

Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology.

Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for reccurrence of bladder cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with incident or recurrent urothelial cell carcinoma and undergoing surveillance monitoring for urothelial cell carcinoma
* Has all urothelial cell carcinoma tumor resected within the past 12 months
* Has a plan for cystoscopic surveillance

Exclusion Criteria:

* Planning to undergo radical cystectomy or chemotherapy-radiation for UCC
Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure

The purpose is to evaluate the renal denervation system (PRDS-001) for controlling sympathetic nerve over-activation in patients with heart failure, and for its safety in such patients.


Eligibility Criteria:
Inclusion Criteria :

* Patients aged 18 years or older and younger than 85 years at the time of informed consent
* NYHA (New York Heart Association) class II-III
* More than 6 weeks have passed since onset of acute heart failure or acute exacerbation of chronic heart failure
* Washout rate of MIBG \[3 (meta)-iodobenzylguanidine\] scintigraphy-cardiac is more than 35%
* Patients having continued treatment of heart failure with the same dosage and administration for 4 weeks before obtaining informed consent

Exclusion Criteria :

* Patients with type1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (HbA1c: ≥ 8%)
* Patients whose eGFR (estimated glomerular filtration rate) is less than 40 mL/min/1.73 m\^2 (estimation formula by Japanese Society of Nephrology)
* Patients with concomitant or previous autoimmune or inflammatory bowel disease
* Patients with a history of serious lung disease
* Patients with a history of heart transplantation or VAD \[ventricle-assist device\]
* Patients receiving reserpine, tricyclic antidepressants, and labetalol hydrochloride (can be used for up to 5 half-lives before informed consent is obtained)
* Patients being treated for Parkinson's disease or Lewy body dementia
* Patients with a history of any severe cardiovascular event (myocardial infarction, coronary artery bypass graft surgery, acute heart failure requiring hospitalization) or severe cerebrovascular event (stroke, transient ischemic event, cerebrovascular accident, etc.) within 3 months before obtaining informed consent
* Patients with persistent atrial fibrillation
* Patients using active implantable medical devices
* Patients with coronary or carotid artery diseases who were deemed necessary by the principal investigator / sub investigator to undergo surgery or PCI (Percutaneous Coronary Intervention) within 6 months after obtaining informed consent
* Patients with contraindications, unacceptable anaphylactic reactions, or uncontrollable allergies to contrast media
* Female patients who are pregnant or breastfeeding
* Patients whose office blood pressure (systolic) is 100mmHg or lower at the time of screening test
Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction

To prove pregabalin's efficacy and safety in Thai patients scheduled for arthroscopic ACL reconstruction

Only eligible patients with willingness to join this study are included. Eligible patients are those aged 18-65 years of either sex, American Society of Anesthesiologists (ASA) physical status I \& II, and body mass index (BMI) between 16-35. The exclusion criteria are patients who are allergic to pregabalin, with impaired hepatic and renal functions, alcohol or substance abuse, chronic pain (except pain in the knee joint) or daily intake of analgesics, uncontrolled medical disease (hypertension and diabetes mellitus) and inability to operate patient-controlled analgesia (PCA) device.

Data analysis

* Student t-test for continuous data with normal distribution
* Mann-Whitney U test for continuous data with non-normal distribution
* Chi-square test for categorical data

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients are those aged 18-65 years of either sex,
* American Society of Anesthesiologists (ASA) physical status I \& II, and body mass index (BMI) between 16-35.

Exclusion Criteria:

* patients who are allergic to pregabalin,
* impaired hepatic and renal functions,
* alcohol or substance abuse,
* chronic pain (except pain in the knee joint) or daily intake of analgesics, uncontrolled medical disease (hypertension and diabetes mellitus)
* inability to operate patient-controlled analgesia (PCA) device
Traditional PT v Internet Based PT After Total Knee Arthroscopy

Knee arthroscopy results in significant improvements in functional outcomes, pain relief and quality of life for patients suffering from mechanical symptoms associated with meniscal tears. Patients are able to return to their activities of daily living, occupation, or sport without significant limitations. Traditionally, patients have undergone formal physical therapy (PT) after knee arthroscopy to regain function. There is a significant cost and time commitment associated with traditional outpatient physical therapy. An internet based therapy program allows patients to perform therapy at home on their own time schedule. A recent study demonstrated that patients who undergo internet based PT after total knee arthroplasty performed as well patients receiving traditional physical therapy. These findings have not been studied in the knee arthroscopy patient population. The goal of this study is to compare traditional outpatient physical therapy rehabilitation to Internet-based rehabilitation in patients undergoing knee arthroscopy for partial meniscectomy.

The purpose of this study is to compare functional outcome, and patient satisfaction, internet-based rehabilitation program vs. standard outpatient physical therapy after unilateral knee arthroscopy for meniscal tear.


Eligibility Criteria:
Inclusion Criteria:

* Any patient undergoing unilateral primary knee arthroscopy for meniscal tear
* Any patient 18 years or older

Exclusion Criteria:

* Patients without access to the Internet
* Post-traumatic osteoarthritis
* Patients with ligamentous injury
* Patients with full thickness cartilage defects
* Patients with osteoarthritis or inflammatory arthritis
* Revision or conversion knee arthroscopy
* Patients receiving workers compensations
* Patients discharged to a rehabilitation unit or other form of respite care such as a skilled nursing facility, acute rehabilitation center, convalescent home, long-term care facility or nursing home.
Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin

This trial will be conducted in Africa, Asia, North America and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec) with sitagliptin, as add-on to subject's own current oral antidiabetic (OAD) treatment, in subjects with type 2 diabetes inadequately controlled with 1-2 OADs (metformin, sulphonylurea, glinides or pioglitazone).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes (diagnosed clinically) for at least 6 months
* Ongoing treatment with 1 or 2 of the following OADs (metformin, insulin secretagogue (sulphonylurea or glinides) or pioglitazone) in any combination with unchanged dosing for at least 3 months prior to Visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination)1500 mg or maximum tolerated dose (at least 1000 mg daily) -Insulin secretagogue (sulfonylurea or glinide): minimum half of the maximal daily dose according to local labelling -Pioglitazone: minimum half of the maximal daily dose according to local labelling or maximum tolerated dose
* Body Mass Index (BMI) below or equal to 40.0 kg/m\^2
* HbA1c 7.5-11.0 % (both inclusive) by central laboratory analysis

Exclusion Criteria:

* Use within the last 3 months prior to Visit 1 of: exenatide, liraglutide, rosiglitazone or acarbose
* Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
* Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
* Cancer and medical history hereof (except basal cell skin cancer or squamous cell skin cancer)
Management of Nausea and Vomiting in Pregnancy and Hyperemesis Gravidarum: Evaluation of Clinical Practices in Five Maternity Hospitals in Île-de-France

This clinical trial aims to evaluate the adequacy of healthcare professionals' clinical practices regarding nausea and vomiting in pregnancy (NVP) and hyperemesis gravidarum (HG) with the recommendations of the National College of French Obstetricians and Gynecologists (CNGOF). The study involves 117 participants and follows an observational, cross-sectional, multicenter study design conducted in five maternity hospitals in Île-de-France.


Eligibility Criteria:
Inclusion Criteria:

* Midwives, obstetrician-gynecologists, and gynecology-obstetrics interns working in the labor and delivery units, high-risk pregnancy units, and obstetric-gynecological emergency units of the five selected maternity hospitals.

Exclusion Criteria:

* Midwives or doctors in training (student midwives or medical externs)
* Midwives and obstetrician-gynecologists working in private practice
Lipid Testing After Myocardial Infarction at the Montreal Heart Institute

Because treatment decisions are usually based on a single measurement of the lipid panel at the time of an admission for an MI, the overarching objective of this project is to evaluate whether the measurement of LDL, non-HDL, and apoB values are reliable through all the duration of the hospitalization.

It will be a single-center, prospective, observational study will be conducted, including consecutive patients hospitalized for myocardial infarction at the Montreal Heart Institute.

Every patient at the Cardiac Care Unit will undergo non-fasting lipid panel testing at day 0 of their admission for Myocardial Infarction during the study period. Patients who consent to participate will have a 2nd non-fasting lipid panel drawn at day 2 of their admission.

Thereafter, the levels of the different lipid values from the panel will be compared between day 0, day 2, and 4-6 weeks after discharge.

We hypothesize that LDL, non-HDL, and apoB values are highest at time of admission and more reflective of the true patient's values, and lower near the time of discharge. Therefore, the timing of testing for the lipid panel during an admission for MI can impact the intensity with which dyslipidemia is treated (i.e. intensity of pharmacologic therapy at discharge), and followed (timing of subsequent lipid panel testing).

The objective of this project is to evaluate whether the measurement of LDL, non-HDL, and apoB values are reliable through all the duration of the hospitalization, from day 0 to day 2.

It will be a single-center, prospective, observational study will be conducted, including consecutive patients hospitalized for myocardial infarction at the Montreal Heart Institute.

Every patient at the Cardiac Care Unit will undergo non-fasting lipid panel testing at day 0 of their admission for Myocardial Infarction during the study period. Patients who consent to participate will have a 2nd non-fasting lipid panel drawn at day 2 of their admission.

The proportion of patients who undergo a repeat lipid panel, and the proportion with a LDL, non-HDL, or apoB value above the intensification threshold, at 4-6 weeks post-discharge, will be assessed. There will be no contact with participants after discharge.

A sample size of 80 to100 patients is aimed for in this exploratory study, based on feasibility and convenience. This sample size is however likely to provide enough power for the primary objective of comparing LDL levels on day 0 and day 2.

Statistical analysis will be conducted at the two-sided 0.05 significance level and performed with SAS.

LDL levels at day 0 and at day 2 will be compared using a paired Student t-test. The changes in LDL from day 0 to day 2 will be estimated and presented with a 95% confidence interval. Results will also be graphically displayed in a bar graph.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥18 years old
* Hospitalized at the Cardiac Care Unit for Myocardial Infarction (either NSTEMI or STEMI)
* Lipid panel performed on day 0 of admission
* Willing to provide informed consent

Exclusion Criteria:

* None
Kinetics of Biomarkers in Acute Pyelonephritis

The objective of this study is to explore the kinetics of biomarkers in 30 adult female patients with uncomplicated acute pyelonephritis.

We will measure c-reactive protein, procalcitonin, pyuria and a new blood biomarker (Signature TM) everyday till normalization of these markers in 30 adult female patients with uncomplicated acute pyelonephritis.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* Flank/loin pain or tenderness, or both and fever \> 38°C during the last 48 hours and pyuria

Exclusion Criteria:

* Pregnancy
* Presence of indwelling catheters
* Known polycystic kidney disease or any malformation of the urinary tract, or single kidney; renal transplant recipients; acute or chronic renal failure requiring dialysis
* Recent discharge from hospital (during the last 10 days); ongoing antibiotic treatment
* Known severe immunosuppression: Receiver of solid-organ or hematopoietic stem cells transplants; neutropenia ( \< 1 G neutrophils / L); chronic (more than 14 days) use of systemic glucocorticoids (\>10 mg/d of prednisone); active use of immunosuppressive therapy for the treatment of auto-immune or inflammatory disease; HIV infection with \< 350 CD4+ cells / ml or unknown CD4+ status
* Pyelonephritis initially identified as complicated: obstruction of urinary tract, urinary stone; history of renal infection in the last 15 days
* Patient with severe sepsis or septic shock