cyrilzakka/clinical-trials huggingface dataset:
PYLARIFY® PET/CT or PET/MRI in Men with Favorable Intermediate Risk (FIR) Prostate Cancer

The purpose of this study is to learn whether PYLARIFY PET imaging (study scan) can safely and accurately detect the presence or absence of prostate cancer growing beyond the prostate gland in men with favorable intermediate risk prostate cancer.

Participants will receive a single dose of PYLARIFY injection followed by a single whole-body PET/CT or PET/MRI scan acquired at 1 to 2 hours after PYLARIFY injection. Participants with positive study scan results that are suspicious for prostate cancer outside of the prostate gland may be asked to undergo additional diagnostic test(s) and/or recommend certain treatment(s) for prostate cancer within 2 to 90 days after the study scan. Participants will be monitored for up to 12 months to collecting information about treatment they receive for prostate cancer and results of regular PSA blood draws if ordered by doctors for up to 12 months after the study scan.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must have the ability to understand and sign an approved informed consent form (ICF)
2. Patients must have the ability to understand and comply with all protocol requirements
3. Patients must be ≥ 18 years of age
4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
5. Patients with life expectancy of at least 13 months as determined by the investigator
6. Patients must have confirmed favorable intermediate risk (FIR) adenocarcinoma of the prostate per 2023 NCCN guidelines. FIR risk group confirmation includes all the following:

   * 1 intermediate risk factor (cT2b-cT2c or ISUP Grade Group 2 or PSA 10-20 ng/mL)
   * ISUP Grade Group 1 or 2
   * \<50% biopsy cores positive (e.g., \<6 of 12 cores)

Note: Date of the prostate biopsy should be no sooner that 2 weeks and no later than 3 months prior to PYLARIFY PET imaging

Exclusion Criteria:

1. Patients administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1 (PYLARIFY imaging)
2. Previous Prostate cancer treatment including radiation, androgen deprivation therapy, brachytherapy, surgery, prostate ablation, hormonal therapies or investigational therapy
3. Known hypersensitivity to the components of PYLARIFY or its analogs
4. Patients with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or complete the study
5. Patients who have any radiographic evidence of T3, N1 or M1 disease on SOC imaging (if performed)
The Effect of Head Positioning on the Cross-sectional Area of the Subclavian Vein.

In the present study, the cross-sectional area of subclavian vein, the distances of subclavian vein \~ subclavian artery and subclavian vein \~ pleura are assessed in different head positions (neutral, rotation to ipsilateral or contralateral sides) in spontaneous breathing adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Medication affecting vascular elasticity
* History of central venous catheterization or clavicle fracture
* History of lung surgery, operation of chest cage
Effect of Cocoa Consumption in Cardiovascular and Immune Parameters

Arterial hypertension is one of the most preventable risk factors for stroke, cardiovascular and renal disease. Cocoa is rich in a subclass of flavonoid called flavanol this increase nitric oxide production and is involved in controlling blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 65 years old
* Resides in Medellín City
* Attached from the contributive regimen of Colombian Health System
* Essential Arterial Hypertension, stage I. Diagnosis less than 3 months.
* Medically indicated non-pharmacological therapy.
* Voluntary desire to consume 50 grams of chocolate per day for 12 weeks.
* Voluntary desire to participate in the trial and sign informed consent.

Exclusion Criteria:

* Suspect of secondary hypertension
* Suspect of injury in target organ
* Presence of diabetes mellitus
* BMI (Body Mass Index) major or equal to 30
* Present smoker or with less than four weeks of abstinence of tobacco
* Consume antiplatelet substances
* Regular consumption of antioxidants, multivitamins, anti-inflammatory medications, drugs for nasal congestion and sibutramine
The Prevalence and Characteristics of Adrenal Incidentaloma

To investige the prevalence, characteristics and prognosis of adrenal incidentalomas in Chinese adults.

With the development of imaging detection technology and its wide application in clinic, the detection rate of adrenal incidentaloma (AI) has been greatly improved. Most AI are benign and do not have the function of autonomic hormone secretion, but about 20% of them have function and can secrete adrenal hormone autonomously. Studies based on biopsy reports show that the prevalence of AI is about 2%, and the prevalence of AI detected by CT scan is 1% - 4.5%. However, most of these studies are retrospective, and there may be selection bias and other confounding factors. There is no large sample prospective study on the prevalence of AI in the general population. The purpose of this study is to prospectively include patients with adrenal incidentaloma in community physical examination population, and evaluate their function and prognosis. The research results will provide new evidence for standardized diagnosis and treatment of adrenal incidentaloma in the future.

Eligibility Criteria:
Inclusion Criteria:

·On weekdays, the first 100 individuals, aged 18 to 78 years, taking health checkup in the Community Health Examination Center were invited to take part in the study.

Exclusion Criteria:

* with known adrenal diseases;
* with continuous steroids or drug treatment that might influence cortisol secretion ordexamethasone metabolism and could not be stopped
* refuse to participate in the study.
Stroke Volume Analysis During Aortic Valve Replacement Trial

Compromised peripheral tissue oxygenation during surgery may lead to worse patient outcome, mainly due to post-operative infections or heart failure. Insufficient stroke volume and/or cardiac output due to hypovolemia or cardiac defects play a central role in causing poor peripheral tissue oxygenation. In order to assess stroke volume, there are numerous invasive and non-invasive methods available. Up to the present date it is unknown, if these methods may by used interchangeably in patients with severe cardiac defects like aortic stenosis.


Eligibility Criteria:
Inclusion Criteria:

* scheduled transcatheter aortic valve implantation
* signed patient consent form
* aged 18 or older by time of surgery
* no participation in other clinical trials

Exclusion Criteria:

* pregnant or breast-feeding women
* emergency surgery
Role of Chest Ultrasound in Diagnosing and Follow-up of Pneumonia

The study of a large number of patients (at least 200 patients) from several European centres aims to investigate the value of chest ultrasound in diagnosing and checking the course of pneumonia as compared to a chest X-ray film in two planes and - in case of a controversial X-ray finding- as compared to low-dose CT.

An X-ray finding is regarded controversial, if infiltrates cannot be reliably excluded or not reliably represented and if a definite diagnosis is, thus, not possible. A low-dose CT is indicated even in case of a positive chest ultrasound and negative X-ray finding. Sonographic recording and characterization of pneumonic infiltrates is performed both at the time of diagnosing and in the further course under therapy.

The primary target criterion is

• Assessing the sensitivity of chest ultrasound in diagnosing pneumonia.

Secondary target criteria comprise

* Assessing specificity, negative and positive predictive value of chest ultrasound at the time of diagnosing,
* Characterizing pneumonic infiltrates at the time of diagnosing and further course,
* Describing the association between clinical, X-ray and sonographic findings in the course of pneumonia.

The tertiary target criterion includes

• Characterizing the range of pathogens detected by microbiological examination.

Eligibility Criteria:
Inclusion Criteria:

Patients with clinically suspected CAP who received no antibiotic treatment yet

* Patients in whom a chest X-ray in 2 planes was already performed, can be included in the study, if chest ultrasound is performed within 24 hours after X-ray and if the X-ray finding is neither available to nor known to the examiner doing the ultrasound examination.
* Age \> 18 years
* Patient's declaration of consent is available.

Exclusion Criteria:

* Patients with HAP
* Age \<18 years
* Patients in whom the time difference between chest ultrasound and chest X-ray in 2 planes is more than 24 hours
* Patients whose X-ray findings are with the examiner doing the ultrasound or are known to him
* Pregnancy and lactation
* Missing declaration of consent by the patient.
Access to Maternity and Risk Factors in a Non-consultant Population (PROXIMA)

Characterize the psychic and medical disorders related to pregnancy and motherhood in a group of primiparous and primigratic women.


Eligibility Criteria:
Inclusion Criteria:

* primiparous and primigest women,
* Singleton pregnancy
* Consultant at the University Hospital of Besançon in gynecology / obstetrics department - initial consultation
* 25 to 45 years old,
* European culture and speaking French,
* Living in a relationship with the spouse
* Spontaneous pregnancy, without medical help
* Having agreed to the use of this medical data as part of this research and the completion of the self-questionnaires.
* Patients who benefit from a social security scheme

Exclusion Criteria:

* Termination of pregnancy or non-progressive pregnancy
* Prematurity of the child (Childbirth before 37 weeks)
* Maternal pathologies acquired during pregnancy
* Fetal diseases acquired during pregnancy
* Pregnancy of twins or triplets
* Any type of medical difficulties occurring during pregnancy (gestational diabetes, high blood pressure, threat of preterm delivery, preeclampsia, ...)
* Any type of difficulty occurring during childbirth for example, hemorrhage of maternal deliverance
* Birth by cesarean section Birth necessitating the use of instruments that led to the transfer of the baby to the neonatology unit or to the kangaroo unit
* At birth, baby's Apgar less than 7.
* Fetal death
* Childbirth that did not occur at the CHU maternity ward
Effectiveness of HPV Vaccine Among Adolescents and Reproductive Women

To assess the effectiveness of HPV vaccine 2 doses or less to prevent HPV high risk infection among adolescents and adults. We conduct the test-negative control study including 12-45 women who interest to do a check-up pap smear. Cases were women who met the inclusion criteria and tested positive for HPV DNA, and controls were defined as women who met inclusion criteria but tested negative. For the proposed HPV VE study, we will enroll nine controls for each enrolled case. The participants will be interviewed about their demographics and vaccine histories. Potential confounders data will be collected by interview or self- report questionnaire. HPV DNA test will be done by urine or self-cervical sampling (optional). In case the participant has previous HPV test result within 1 year, the result will be recorded and analysed without repeating the test.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 12-45 who willing to do HPV test check-up.
* Subject has provided written informed consent prior to performance of any study-specific procedures and is willing and has means to be contacted and to contact the investigator during the study.
* Based on clinical judgment, the participant with underlying chronic disease who has stable and well-controlled medical conditions.

Exclusion Criteria:

* Participant with history of total hysterectomy and loop electrosurgical excision procedure.
* Participant who received 3 doses HPV vaccine.
* Any condition that might confound the interpretation of vaccine effectiveness by investigator
Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

Multicenter, open-label, exploratory, phase II clinical trial to evaluate the efficacy and safety of PM01183 in previously treated patients with advanced solid tumors

Patients with relapsed small cell lung cancer (SCLC), head and neck carcinoma (H\&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing's family of tumors (EFTs) will be enrolled in nine different cohorts. Up to 25 evaluable patients are planned to be enrolled in each cohort (50 in the endometrial carcinoma and 100 in the SCLC cohort).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Voluntary signed informed consent (IC)
* Pathologically proven diagnosis of any of the following malignancies:

  * Small cell lung cancer (SCLC).
  * Head and neck carcinoma (H\&N). Salivary glands tumors are excluded.
  * Neuroendocrine tumors (NETs), grade 2 and grade 3 according to World Health Organization classification.
  * Biliary tract carcinoma.
  * Endometrial carcinoma.
  * BRCA 1/2- associated metastatic breast carcinoma
  * Carcinoma of unknown primary site.
  * Germ cell tumor (GCTs), excluding immature teratoma, or teratoma with malignant transformation.
  * Ewing's family of tumors (EFTs)
* Prior treatment. Patients must have received:

  * SCLC, endometrial carcinoma: one prior chemotherapy-containing line.
  * H\&N, NETs, biliary tract, CUP: one or two prior chemotherapy-containing lines
  * GCTs: no limit of prior therapy
  * EFTs: no more than two prior chemotherapy-containing lines in the metastatic/recurrent setting.
  * BRCA 1/2-associated metastatic breast carcinoma: at least one but no more than three prior chemotherapy-containing lines.
* Performance status ≤ 2 \[Eastern Cooperative Oncology Group (ECOG)\]
* Adequate major organ function
* At least three weeks since the last chemotherapy
* Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry

Exclusion Criteria:

* Prior treatment with PM01183 or trabectedin
* Prior or concurrent malignant disease unless in complete remission for more than five years
* Known central nervous system (CNS) involvement
* Relevant diseases or clinical situations which may increase the patient's risk
* Pregnant or breastfeeding women and fertile patients (men and women) who are not using an effective method of contraception
Assessment of Penile Vibratory Stimulation Using the Viberect in Men With Mild-Moderate ED

The primary objective of this study is to assess the safety, acceptability, and satisfaction of penile vibratory stimulation in treatment of erectile dysfunction (ED). The secondary objective is to demonstrate subjective physiological response (erection, rigidity, orgasm) after four weeks of frequent device use and the satisfaction of penile erection and sexual intercourse with partner.

ED is the inability to develop and maintain an erection for satisfactory sexual intercourse or activity. ED is a highly prevalent medical condition often associated with multiple causes. It is estimated that more than 50 million American men suffer from mild/moderate to severe ED. Roughly 50% of men in their 50's, 60% of men in their 60's, and 70% of men in their 70's suffer from ED. The economic impact of ED is in the billions of dollars. More than 5 billion dollars a year are spent on the pro-erectile medications currently in the market.

Penile vibratory stimulation mimics rapid and repetitive manual/hand stimulation of the penis. Vibratory stimulation of genitalia is considered safe by the medical community with important benefits including treatment of orgasmic dysfunction and stress urinary incontinence. No significant physical or emotional side-effects have been reported in the medical literature. A recent epidemiological study of the use of vibrators by American women and men has shown no complaints, and generally high satisfaction and improvement in sexual response.

Penile erection is controlled by spinal autonomic centers, the activity of which is dependent on input from supraspinal centers and the genitalia. From a neurophysiological viewpoint, scientists believe that penile erection is a culmination of multiple successful nerve reflexes that initiate a vascular event. Simultaneous vibratory stimulation of both surfaces of the penis at high frequency (70-110 Hz) for 7-10 minutes can lead to gradual filling of the penis with arterial blood within minutes by activating the pudendo-cavernosal reflex. Additional physiological effects include progressive rhythmic contraction of the perineal muscles via the bulbocavernosus reflex, which helps in strengthening rigidity of erection. This will prepare the user for successful sexual intercourse. Subsequent orgasm and ejaculation can be very strong and amplified due to stronger contraction of the bulbospongiosus muscle and activation of higher ejaculatory centers.

This study will assess daily or on-demand ease of use, safety, satisfaction, and efficacy of the home use of the Food and Drug Administration (FDA) cleared Viberect device by men with mild to moderate ED

Eligibility Criteria:
Inclusion Criteria

* mild-moderate erectile dysfunction based on International Index of Erectile Function (IIEF) erectile function score 13-25

Exclusion Criteria

* Men with neurological disease
* IIEF score less than 13
* Spinal cord injury
* History of priapism
* Pelvic neuropathy
* Post-prostatectomy
* Penile skin lesions or ulcers
* Inability to understand and demonstrate device use instructions
Evaluation of Sarcopenia in Elderly at the Emergency Department

The goal of this observational study is to evaluate in elderly patients for the frequency of sarcopenia and its relationship with mortality in a university hospital.

The main questions it aims to answer are;

1. What is the frequency of sarcopenia in elderly patients at emergency department?
2. Is sarcopenia associated with mortality in an elderly patient admitted to the emergency department?


Eligibility Criteria:
Inclusion Criteria:

1. Above the age of 65 admitted to the emergency department
2. Able to walk without support
3. No lower extremity fracture
4. No disease with neuromuscular involvement

Exclusion Criteria:

1. In the presence of a cerebrovascular event
2. Those in need of critical intervention when applying to the emergency department
3. Unconscious patients
Validation of Artificial Intelligence Enabled TB Screening and Diagnosis in Zambia

Tuberculosis (TB) is a global epidemic and for many years has remained a major cause of death throughout the developing world. Zambia is among the top 30 TB/HIV high burden countries. Chest X-ray (CXR) is recommended as a triaging test for TB, and a diagnostic aid when available. However, many high-burden settings lack access to experienced radiologists capable of interpreting these images, resulting in mixed sensitivity, poor specificity, and large inter-observer variation. In recognition of this challenge, the World Health Organization has recommended the use of automated systems that utilize artificial intelligence (AI) to read CXRs for screening and triaging for TB. In this study, we primarily evaluate the performance of our AI algorithm for TB, and secondarily for Abnormal/Normal.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are 18 years and older with a known HIV status or are willing to undergo HIV testing if unknown HIV status and meet the following criteria will be included in the study:

  * Presumptive TB patients defined as having any of the following:

    ○ Cough, Weight loss, Night sweats, Fever
  * Household /close TB contacts regardless of symptoms
  * Newly diagnosed HIV regardless of symptoms.

Exclusion Criteria:

* Individuals who do meet the above inclusion criteria will be excluded. In addition, individuals with history of TB treatment within 365 days prior to enrolment will be excluded.
Improving Glycaemic Control With L-carnitine

A characteristic of Type 2 diabetes is a high blood glucose level, which is partly caused by the inability of insulin to stimulate glucose uptake into our muscles (insulin resistance). Insulin resistance can be caused by the accumulation of fat within muscle of overweight individuals. The aim of the present research is to test whether a novel nutritional intervention containing L-carnitine can increase the amount of carnitine within muscle of individuals recently diagnosed with Type 2 diabetes. Carnitine is essential for 'burning fat' within our muscles and it is hoped that increasing the amount of carnitine within muscle can increase fat burning, lower muscle fat, reverse insulin resistance and ultimately lower blood glucose levels and wellbeing. We also aim to investigate the cellular mechanisms underlying any observed effects in a hope to identify further targets to lower muscle fat.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) 27-37 kg/m2
* Male
* Age 18-60 years old
* Type 2 diabetes mellitus reasonably well controlled (HbA1c less than or equal to 58 mmol/mol) on diet therapy or metformin alone
* Not taking anti-diabetes medication other than metformin
* Understand verbal and/or written explanation of the study requirements

Exclusion Criteria:

* Malignancy (excluding localised basal and squamous cell skin cancer)
* Metabolic diseases (stable treated hypothyroidism allowed)
* Active cardiovascular disease (current angina, myocardial infarct, or coronary artery surgery/angioplasty within 12 months)
* Primary muscle disorders
* Cerebrovascular disease
* Neurological disease e.g. epilepsy, Parkinsons disease
* Active respiratory disease
* Active gastrointestinal or liver disease
* Renal impairment (eGFR \<60 ml/min)
* Clotting dysfunction
* Anti-diabetes medication other than metformin
* Other medications that may affect glucose tolerance (e.g. corticosteroids), muscle metabolism, or safety (e.g. anticoagulants)
* Any other conditions in addition to the above that the investigators consider may affect study measurements or safety
Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.

Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated tablets.


Eligibility Criteria:
Inclusion criteria:

healthy males and females, aged 18-50years, BMI 18,5-30

Exclusion criteria:

History of hypersensitivity or allergy to IMP
Effects of COVID-19 on the Elderly

The goal of this observational study is to learn about in former COVID-19 patients. The main questions it aims to answer are:

* are there any association among pain, fear of falling, fall frequency, and physical activity level
* are there any difference between former COVID-19 elders and non-COVID-19 elderly population


Eligibility Criteria:
Inclusion Criteria:

* Being 65 years or older
* Being cooperative

Exclusion Criteria:

* Refusing to participate in the study
* Having significant vision and hearing problems
* Not completing the study questions