cyrilzakka/clinical-trials huggingface dataset:
Prostate Cancer Detection Screening MRI Protocol

Whether a quantitative detection specfic magnetic resonance imaging (MRI) protocol improves prostate cancer (PCa) detection in biopsy naïve men is not adequately studied.

This will be a 2 arm prospective clinical trial. Men with clinical suspicion for PCa but no prior prostate biopsy will be enrolled from the University of Illinois (UI) Health Urology clinics. All eligible men will be screened and enrolled by the clinical research coordinator. Enrolled men will undergo detection protocol MRI at the UIC Advanced Imaging Center (AIC) prior to diagnostic biopsy. The MRI will be processed by the study team and evaluated for areas suspicious for high grade PCa by a board certified clinical radiologist. Subjects with MRI with no suspicious areas for high grade PCa will undergo standard of care (SOC) core transrectal ultrasound (TRUS) biopsy. Subject with MRI suspicious for high grade PCa will have 2-4 biopsies guided toward each suspicious lesion using MRI/TRUS fusion biopsies (maximum of 12 cores). All biopsies will undergo SOC histologic processing and interpretation in pathology. Biopsy results will be communicated to the patients by the Urologist performing the biopsy and all additional management will be SOC. This visit will signify the end of the study

Eligibility Criteria:
Inclusion Criteria:

* Adult men between 18 and 80 years of age
* Suspected PCa as defined by elevated PSA ≥4 ng/mL and ≤20 ng/mL and/or abnormal DRE as determined by a physician
* Ability to provide informed consent

Exclusion Criteria:

* Prior prostate biopsy
* Prior diagnosis of PCa
* MRI incompatible implanted medical devices or foreign bodies
* Rectal anatomy incompatible with TRUS biopsy
* Life expectancy \<10 years as determined by the treating urologist
Postmarketing Surveillance Study With MOBEC®

The aim of the study is to investigate

* the indication for MOBEC in a dose of 15 mg per day
* the treatments patients were receiving before switching to 15 mg MOBEC
* how treatment with 15 mg is assessed compared with previous treatment
* how effective and safe treatment with 15 mg MOBEC is considered


Eligibility Criteria:
Inclusion Criteria:

* An indication for a treatment with 15 mg MOBEC of at least four weeks

  * the symptomatic short-term treatment of osteoarthritis
  * the symptomatic long-term treatment of rheumatoid arthritis (chronic polyarthritis); restriction: the recommended dose for long-term treatment of elderly patients is 7.5 mg)
  * the symptomatic treatment of ankylosing spondylitis

Exclusion Criteria:

* Treatment with MOBEC prior to the start of the study
* Patients with any of the general or specific contraindications of MOBEC
In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter

The purpose of this study is:

* To study the components of the gastroesophageal junction high-pressure zone individually and as a group, by pharmacologically eliminating or accentuating the pressure profile generated by the smooth muscle components.
* To differentiate the gastric sling fibers from the clasp fibers based on the spatial orientation of these muscle groups.

The purpose of this research study is to examine and evaluate a part of the digestive system (gastrointestinal tract). The specific part the study team will look at is called the "lower esophageal sphincter complex." This complex is located where the esophagus (food pipe) meets the top of the stomach. The lower esophageal sphincter complex involves a group of muscles, and the study team hopes to better understand how they work.

The study team hopes that, by studying the lower esophageal sphincter complex, it may be possible to discover how it functions and what causes it to fail. When a complex fails, this can lead to reflux and heartburn. So learning more about the lower esophageal complex may help doctors' better treat future patients with reflux problems.

We plan to study these functions in normal control subjects, in patients with GERD (heartburn symptoms), and in patients with Barrett's esophagus (a change in the lining of the esophagus due to chronic reflux). The doctor performing the study procedure has previous experience with and is skilled in performing these procedures.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for GERD patients are:

* Symptomatic heartburn
* Regurgitation
* Chest pain or water brash

Exclusion Criteria:

Exclusion criteria for normal volunteers include:

* Medications-Subjects on any medication which could effect the gastroesophageal junction high-pressure zone will be excluded, this includes use of antacids, H2 blockers, proton pump inhibitors, prokinetic agents, erythromycin type antibiotics and anticholinergics.
* GI symptoms, conditions and disorders

In addition exclusion criteria will include a history of:

* Esophagitis
* Gastrointestinal symptoms such as abdominal pain
* Heartburn
* Reflux
* Regurgitation
* Chest pain
* Difficulty swallowing
* Pain on swallowing
* Dysphagia
* Abdominal surgery involving the stomach or esophagus
* Nausea or vomiting
* Diabetes
* Scleroderma
* Esophageal motility disorders
* Non cardiac chest pain
* Achalasia and current pregnancy.
Comparison of Different Treatment Methods in Lumbal Disc Herniation Treatment

The aim of this study is to determine the effectiveness of three different treatment methods which consists spinal decompression, deep friction massage and exercise. The patients were separated three groups Group one received non-surgical spinal decompression therapy, group two received non-surgical spinal decompression, lumbar stabilization exercises and manual therapy, group three received manual therapy and lumbar stabilization exercises. All groups completed 15 sessions of therapy. In each session, pain severity was assessed with numeric analog scale, straight leg raise test applied and the degree of the hip flexion where the patient reported pain were recorded, respectively. Static, dynamic muscle strength-endurance tests were applied before the treatment sessions started, after the treatment sessions ended, six weeks after and three months after the study. Oswestry Disability Scale (ODI), Back Performance Scale (BPS), Lanss Neuropathic pain Questionnaire, Fear-Avoidance-Beliefs Questionnaire (FABQ) and McGill Pain Questionnaire were applied before the treatment sessions started, after the treatment sessions ended and three months after the study. Gradient of disc height and thickness of the herniation were assessed segmentally with magnetic resonance imagination (MRI) before the study and three months after the study.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of lumbar disc herniation without strengthening loss

Exclusion Criteria:

* clinical diagnosis of osteoporosis
* have scoliosis and spondylolisthesis
* any surgery related spine
* any neurological diseases causes sensory loss
Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease

A pilot, single-center, prospective, interventional study. The objective is to demonstrate that catheter-based renal denervation using carbon dioxide renal angiography in patients with moderate to severe chronic kidney disease can be performed for treatment of uncontrolled hypertension.

Renal sympathetic denervation has been shown to be safe and effective in patients with uncontrolled hypertension and estimated Glomerular Filtration Rate (eGFR)\>45 mL/min per 1•73 m². However, the safety and efficacy of this has not been studied in patients with more severe renal impairment. The investigators aim to examine safety and efficacy of renal denervation (RDN) in patients with eGFR between 44 and 15 ml/min/1.73 m2 (CKD 3b \& 4) in a pilot study which may be a precursor of a large observational study in the future. Moreover, the current imaging protocol and procedure protocol for renal sympathetic denervation requires the use of iodinated contrast, which can have deleterious effects on renal function. The investigators have a proven track record for the use of carbon dioxide angiography in renal artery intervention. The investigators would like to use carbon dioxide angiography in this study to minimize contrast induced deterioration in renal function in this cohort which may again be a precursor of a farther larger study.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-75 years with a clinic systolic blood pressure of 140 mm Hg or more despite compliance with three or more antihypertensive drugs,
* eGFR\<45 and \>15 mL/min per 1.73 m².

Exclusion Criteria:

* eGFR \<15 mL/min per 1.73 m²,
* Type 1 diabetes,
* Substantial stenotic valvular heart disease,
* Pregnancy or planned pregnancy during the study,
* A history of myocardial infarction, unstable angina, or cerebrovascular accident in the previous 6 months.
Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients

The investigators have demonstrated the crucial role of the liver-lung axis in the distant metastasis of NPC. Furthermore, the investigators have identified a potential therapeutic approach to improve outcomes in NPC patients by identifying those most suitable for anticoagulant therapy. Further, the combination of anticoagulant therapy and anti-IL6R therapy has shown promising results in enhancing the prognosis of NPC patients. These findings highlight the significance of targeting the liver-lung axis and utilizing personalized treatment strategies for NPC.

Distant metastasis accounts for nasopharyngeal carcinoma (NPC)-related mortalities. Recently, extracellular vesicles (EVs) have been widely explored as key mediators of bidirectional tumor-host cell interactions by mediating pre-metastatic niche (PMN) formation. However, considering the complexity of the human body, multiple organ studies of tumor metastasis remain poorly understood. Here, the investigators have demonstrated the crucial role of the liver-lung axis in the distant metastasis of NPC. The investigators demonstrated mechanistically that hepatocellular derived EVs can be specifically taken up by the lung to form a hypercoagulable pre-metastatic microenvironment associated with IL6.Furthermore, the investigators have identified a potential therapeutic approach to improve outcomes in NPC patients by identifying those most suitable for anticoagulant therapy. Further, the combination of anticoagulant therapy and anti-IL6R therapy has shown promising results in enhancing the prognosis of NPC patients. These findings highlight the significance of targeting the liver-lung axis and utilizing personalized treatment strategies for NPC.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of NPC with distant metastasis
* Must be able to swallow tablets

Exclusion Criteria:

* Liver disease
* Blood disease
* Long-term use of anticoagulants
Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support

Hormonal milieu during implantation is crucial to embryo-endometrium interaction and to the viability of the conceptus. Alterations in the peri-implantation environment are considered to impair perinatal outcomes in intracytoplasmic sperm injection (ICSI) therapy. GnRH-a is a new and promising modality for LPS. Regimens for using GnRH-a in LPS, including single mid-luteal bolus or the addition of a GnRH-a to progesterone supplementation, have been recently suggested. The aim of this study is to evaluate the impact of addition of mid-luteal single-dose or multiple-dose GnRH agonist to the routine luteal phase support in patients undergoing ICSI cycles using GnRH antagonist protocol.


Eligibility Criteria:
Inclusion Criteria:

1. Patient age ≤ 38 years.
2. BMI ≤ 30.
3. Basal follicle stimulating hormone (FSH) level ≤ 10 IU/L.
4. Anti-Müllerian hormone (AMH): ≤ 5 ng/ml.

Exclusion Criteria:

1. Endometriosis.
2. Polycystic ovarian syndrome (PCOS).
3. Uterine pathology or anomaly.
4. Evidence of hydrosalpinx by hysterosalpingography or ultrasound.
5. Comorbidities: Diabetes mellitus, hypertension, immune diseases.
Long Term Extension Study is Designed to Monitor Long-Term Efficacy and Safety of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Subjects With Chronic Hepatitis C Virus Genotype 1 Infection

Long Term Observational Extension Study Designed to Monitor Long-Term Efficacy and Safety of Miravirsen Sodium in Combination with Telaprevir and Ribavirin in Subjects with Chronic Hepatitis C Virus Genotype 1 Infection


Eligibility Criteria:
Inclusion Criteria:

- Participated in Study SPC3649-205 (this would include those who completed study SPC3649-205, those who discontinued or terminated the study early for whatever reason (including treatment failure) and those who opted to receive approved therapy for the treatment of HCV infection).

Exclusion Criteria:

* Those unwilling to provide informed consent for participation in this study.
* Subjects who have received investigational drug therapy after discontinuation, termination, or successful completion of Study SPC3649-205.
Efficacy of Daratumumab to Overcome Platelet Transfusion Refractoriness in Patients with Aplastic Anemia

This is a phase 1, prospective, single-arm, open-label study. The aim of this study is to evaluate the transfusion responses of platelet increment by using Daratumumab among aplastic anemia patients with platelet transfusion refractoriness.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of aplastic anemia (AA)
* Dependent on platelet transfusions, characterized by either PLT\<10×10\^9/L, or PLT\<20×10\^9/L with bleeding events.
* Diagnosed with platelet transfusion refractoriness, characterized by Corrected count increment (CCI) \<7500/ul at 60 min, or CCI \<4500/ul at 24 hrs.
* Male or female age ≥ 12 years
* ECOG performance status ≤2
* Willing and able to comply with the requirements for this study and written informed consent.

Exclusion Criteria:

* The inherited bone marrow failure syndromes
* The presence of hemolytic PNH clone
* Combination of either radiotherapy or chemotherapy for solid tumors in recent 3 years, excluding the local tumor diagnosed 1 year ago and cured by surgical resection.
* Cytopenia caused by other diseases, including liver cirrhosis, active rheumatic connective tissue disease, and persistence of infectious diseases, etc.
* Uncontrolled infection
* HIV, HCV or HBV active infection
* The presence of any of the following bleeding events:

  * Gastrointestinal bleeding
  * Respiratory tract hemorrhage
  * Central nervous system bleeding
* Abnormal liver function: ALT or AST \> 2 ULN, or TBil \> 2 ULN after treatment.
* Abnormal kidney function: Creatinine clearance \< 30 ml/min
* Heart failure (NYHA class III or IV)
* Poorly controlled diabetes, characterized by fasting blood glucose \> 8.8mmol/L or post-meal blood glucose \> 11.1mmol/L after therapy with insulin or oral hypoglycemic agents
* History of congestive heart failure, unstable angina pectoris, myocardial infarction, arterial or venous thrombosis
* Pregnant or breast-feeding patients
* Had a history of any psychiatric diseases, cerebrovascular disease or cognitive sequelae of head injury.
* Participation in another clinical trial within 4 weeks before the start of this trial
* Have an allergy to Daratumumab or any other part of this medicine.
* Previously treated with Daratumumab
* Previously treated with ATG/ALG within 4 months before the start of this trial
* Previously treated with the anti-CD20 monoclonal antibody within 2 months before the start of this trial
* Currently treated with TPO-RA except for a minimum of 4 weeks for washout before the start of this trial
* Patients considered to be ineligible for the study by the investigator for reasons other than above
Central Sensitization and Physical Activity in Adolescents With HSD/hEDS

Hypermobility Spectrum Disorder and hypermobile Ehlers-Danlos Syndrome (HSD/hEDS) is under-recognized and poorly understood and its management is therefore not clear.

The goal of this study is to better understand pain and its impact on function in the daily activities of adolescents with Hypermobility Spectrum Disorder and/or hypermobile Ehlers-Danlos Syndrome.

This study will explore the presence of the pain sensitivity status after physical exercise as well as movement behaviour in adolescents with HSD/hEDS compared to a healthy control group.

All participants will be asked not to undertake physical exercise at least 48 hours before the measurements, and to refrain from consuming caffeine, alcohol or nicotine. For ethical reasons, the patients are allowed to take non-opioid pain medicine as described in the first step of the World Health Organization analgesic ladder (COX-inhibitors and paracetamol), however the patients will be asked to abstain from these medications during the 24 hours period before the measurements.

Eligibility Criteria:
Inclusion criteria for the HSD/hEDS group:

* Able to read and understand Swedish
* Diagnosed with HSD or hEDS

Exclusion criteria for the HSD/hEDS group:

* Pregnancy and one year postpartum.
* Other syndromes with hypermobility such as the Marfan syndrome, Osteogenesis Imperfecta or other types of EDS.
* Co-morbidity with neurological disorders

Inclusion criteria for the control group:

* Able to read and understand Swedish
* Healthy
* Pain free at time of investigation (Numerical Rating Scale score \<3/10).

Exclusion criteria for the control group:

* Pregnancy and one year postpartum.
* Past or present signs of rheumatic, neurologic, musculoskeletal, metabolic diseases.
* Chronic pain.
Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With CLL and NHL

The purpose of the First-In-Human study was to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of JBH492 as single agent.

This was a FIH, open-label, phase I/Ib, multi-center study, which consisted of a dose escalation part of JBH492 as a single agent, followed by an expansion part. The escalation part was conducted in patients with relapsed/refractory chronic lymphocytic leukemia (r/r CLL) and Non-Hodgkin's Lymphoma (r/r NHL). Once the maximum tolerated dose/recommended dose (MTD/RD) of single agent JBH492 was determined, the study continued with an expansion part with single agent JBH492 in defined patient populations.

Eligibility Criteria:
Inclusion Criteria:

For patients with CLL:

• Confirmed diagnosis of chronic lymphocytic leukemia (CLL)

For patients with NHL:

* Histologically confirmed diagnosis of B- or T-cell non-Hodgkins lymphoma (NHL).
* Must have a site of disease amenable to biopsy, and be suitable and willing to undergo study required biopsies at screening and during therapy.

Exclusion Criteria, applicable to both CLL and NHL:

* History of anaphylactic or other severe hypersensitivity/infusion reactions to ADCs, monoclonal antibodies (mAbs) and/or their excipients such that the patient in unable to tolerate immunoglobulin/monoclonal antibody administration
* Any prior history of treatment with maytansine (DM1 or DM4)-based ADC
* Known intolerance to a maytansinoid
* Patients with any active or chronic corneal disorders
* Patients who have any other condition that precludes monitoring of the retina or fundus
* Patients with active CNS involvement are excluded, except if the CNS involvement has been effectively treated and provided that local treatment was completed \>4 weeks before first dose of study treatment. Patients that have been effectively treated for CNS disease and are stable under systemic therapy may be enrolled provided all other inclusion and exclusion criteria are met. Patients who received prophylactic intrathecal treatment are eligible, if treatment discontinued \>5 half-lives prior to the first dose of study treatment
* Impaired cardiac function or clinically significant cardiac disease
* Known history of Human Immunodeficiency Virus (HIV) infection
* Active HBV or HCV infection. Patients whose disease is controlled under antiviral therapy should not be excluded. Patients who are anti-HBcAb positive should be HBsAg negative and HBV-DNA negative to be eligible

Other inclusion and exclusion criteria may apply.
Menthol Mouth Rinsing and Performance Responses of Elite Football Referees in the Heat

Ten male football referees will be recruited to perform two intermittent football protocols , separated by at least 7 days (wash-out period). After passing the eligibility criteria, the participants will be randomly assigned, according to a computer-generated allocation schedule, to 1 of 2 beverages sequences: (1) intervention - menthol solution 0.01% (room temperature) and (2) placebo - noncaloric berry-flavoured solution (room temperature). The participants will be provided with one of the 2 beverages before warm-up (pre-cooling) and at the half-time (per-cooling). The trials will follow a randomised counterbalanced crossover design, blinded to the participants, and will take place in indoor facilities, where WBGT exceed 30◦C, at the same time of the day, to control for circadian variations. Each trial involves an exercise protocol (SAFT-90), lasting 90 minutes, separated into two 45-minute parts. The first half will be preceded by a warm-up and the second half by a 15-minute break.

The results of this study are expected to determine whether mouth rinsing a menthol solution, before a football exercise protocol performed in the heat, will help to alleviate physiological strain and improve performance parameters, comparing to a non-cooling strategy, in elite male football referees. Thus, we can be closer to defining nutritional strategies of internal cooling, that will be an advantage for the performance of the football referees, concretely in the competitions carried out under adverse environmental conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Male football referees aged over 18 and under 45 years;
2. With normal weight (BMI ≥ 18.5 and ≤ 24.9 kg/m2);
3. Availability to participate in the introductory meeting, familiarization session and 2 experimental sessions;
4. Ability to read and sign the informed consent.

Exclusion Criteria:

1. Under the influence of any medications that may affect urinary parameters, thermoregulation mechanisms, circulatory system, thyroid and pituitary function or metabolic status;
2. Injury, diabetes, autoimmune disease, cardiovascular disease or obstructive disease of the gastrointestinal tract (e.g., diverticulitis, inflammatory bowel disease);
3. Schizophrenia, bipolar disorder or other psychotic disorders;
4. Eating disorders;
5. MRI scans scheduled within 48 hours after familiarization session or any of the experimental trials.
Prevalence of NAFLD in T2DM Patients

To determine the prevalence of non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Having type 2 diabetes mellitus (T2DM)
* Written informed consent obtained

Exclusion Criteria:

* Excessive alcohol use
* Exclusion of other causes of liver disease and secondary causes of steatosis