cyrilzakka/clinical-trials huggingface dataset:
MRI and Biomarkers in Prostate Cancer

Prostate cancer has been the most common neoplastic disease in men in Finland over the last ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate cancer. However, PSA has a limited sensitivity and specificity for prostate cancer detection. Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS) guided biopsy. Because of the low accuracy of TRUS a systematic biopsy is usually performed instead of targeted TRUS biopsy. As biopsy carries a significant risk of complications, there is an increasing interest in developing more accurate non-invasive imaging modalities.

This prospective multi-institutional study will enroll 400 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 2.5 ng/ml and/or abnormal digital rectal examination. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 1.5/3 Tesla (T) magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer. Targeted TRUS guided biopsy based on MRI findings will be performed in addition to routine twelve core TRUS biopsy. Moreover, selected serum and urine biomarkers as well as biomarkers extracted from fresh biopsy sample will be collected and correlated with the presence or absence of prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 85 years
* Clinical suspicion of prostate cancer, based on: serum level of PSA from 2,5 ng/ml to 20 ng/ml in two following measurements and/or abnormal digital rectal examination
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

* previous prostate biopsies within 6 months
* previous diagnosis of prostate carcinoma
* previous prostate surgeries, e.g. TURP (transurethral prostatic resection)
* symptomatic of acute prostatitis
* contraindications for MRI (cardiac pacemaker, intracranial clips etc)
* uncontrolled serious infection
* claustrophobia
* hip replacement surgery or other metal implants in the pelvic area
Pharmacodynamic Drug Interaction Between Warfarin and Amoxicillin-clavulanic Acid

Several case reports indicate that the use of the antibiotic combination amoxicillin and clavulanic acid (AM-CLAVAC) can interact with warfarin pharmacodynamics. However, fever per se might also be responsible of these warfarin overdose reports, as well as the use of high dose paracetamol.

The aim of the present study is to determine if AM-CLAVAC can increase the pharmacodynamics of warfarin among patients at steady state Double blinded cross over controlled study vs placebo performed in 12 evaluable patients treated with warfarin with an INR target 2 to 3 and a stable INR and a stable dose.

Double blinded cross over controlled study vs placebo performed in 12 evaluable patients treated with warfarin with an INR target 2 to 3 and a stable INR and a stable dose

One period : seven consecutive days of amoxicillin(2g twice daily)- clavulanic acid (125 mg twice daily) association Wash out period of at least 4 weak with the return to a stable INR and warfarin dose One period : seven consecutive days of placebo twice daily

Main outcome INR delta Day7-Day

Eligibility Criteria:
Inclusion Criteria:

* patients treated with warfarin (target INR 2 to 3)
* stable anticoagulation (3 consecutive INR in the target)
* stable dose
* no infection
* normal CRP
* age \>18 years
* normal transaminase levels

Exclusion Criteria:

* drug allergy
* penicillin allergy
* Alzheimer
* cancer
* thyroid disease
* gastro intestinal chronic disease
* frequent nausea or vomiting
* Cirrhosis
* chronic renal failure (GFR\<60 ml/min)
* frequent intake of paracetamol or NSAID
* addict to drugs or alcool
* St John's wort treatment or grapefruit juice intake
* concomitant drugs (amiodarone, cimetidine, SSRI, clofibrate, fenofibrate, diltiazem, fluconazole, itraconazole, isoniazide, voriconazole, métronidazole, miconazole , omeprazole, glucocorticoids, zileuton, ritonavir, rifampicin, carbamazepine, phenytoin, phenobarbital)
* antibiotic use during the 3 last weeks
* pregnancy
A Clinical Study on the Efficacy and Safety of the Treatment of Hyperplasia of Mammary Glands With Xiaoru Sanjie Capsule

The purpose of this study is to evaluate the efficacy and safety of Xiaoru Sanjie capsule in the treatment of cyclomastopathy.

This is a multicenter, randomized, open and parallel controlled clinical study.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old female patients with cyclomastopathy who signed a written informed consent.
* The subjects voluntarily entered the clinical observation whom are hospitalized patients or outpatients with good compliance.
* They have specific symptoms, such as distending pain of the breast, stabbing pain, dull pain and radiating pain.
* They have specific physical sign, for example, we can touch block gland, granular, nodular or cord like glands and etc..
* Breast ultrasound or molybdenum target show I-III class by Breast Imaging Reporting and Data System.

Exclusion Criteria:

* Women who are pregnant or lactating, and who has the history of periarthritis of shoulder.
* Excluding breast fibrocellular tumor, breast cancer and other breast diseases.
* Patients with poor self coordination, mentally retarded patients, or have cardiovascular and cerebrovascular disease, severe organic disease, as well as the hematopoietic system disease or mental illness.
* Be judged as over middle degree depression by the Hamilton's depression scale.
* Allergic constitution patients, and people who are allergic to a variety of drugs.
* Any medical history which may interfere with the test results or increase the risk of patients according to the investigators.
* Patients who have received treatment of other diseases, and those treatment methods and targets may have an impact on the indicators of this study.
Role of Cytosorb in Left Ventricular Assist Device Implantation

Mechanical circulatory support, specifically implantable continuous flow left ventricular assist device (CF-LVAD) therapy has been established as a viable treatment for rapidly deteriorating patients suffering from end stage heart failure either as bridge or alternative to heart transplantation. However, a large proportion of these patients experience severe complications in the early postoperative period including right ventricular failure or multi organ failure leading to increased mortality. The leading theory explaining these complications involves exaggerated systemic inflammatory response prior to, during and early after CF-LVAD insertion. Among the cytokines IL-6 appears to play a major role. There is increasing demonstration of the efficacy of a cytokine haemoadsorption (HA) technology in attenuating cytokine response and particularly IL-6 in various inflammatory states and emerging data on the safety of the Cytosorb® device in routine and complex cardiac surgery.

The study team hypothesizes that Cytosorb® treatment is feasible and safe in heart failure patients undergoing LVAD insertion and that it is effective in attenuating IL-6 secretion with benefit in the wider inflammatory and metabolic response to this high-risk surgery.

The principle objectives of this study are:

1. To investigate the efficacy of Cytosorb® treatment in attenuating perioperative changes in IL-6 during CF-LVAD implantation
2. To investigate the feasibility, and safety of Cytosorb® treatment during CF-LVAD implantation.
3. To pilot the effect of Cytosorb® treatment on vasoplegia and organ dysfunction with specific focus on right ventricle failure, liver failure and acute kidney injury (AKI).
4. To establish a collaborative biobank of patient's biological samples to allow extensive characterisation of patient phenotype prior to CF-LVAD implantation and their individual inflammatory and metabolic responses to surgery and perioperative management.

Eligibility Criteria:
Inclusion Criteria:

Adult patients (≥18 years), but ≤70 years; Scheduled for elective LVAD implantation with the use of cardiopulmonary bypass; Written informed consent for participation

Exclusion Criteria:

* Poor spoken and/or written language comprehension
* Declined or missing informed consent
* LVAD implant planned without use of CPB
* Total Artificial Heart implantation
* Planned CPB temperature \< 32 °C
* AIDS with a CD4 count of \< 200/μL
* Severe thrombocytopenia (PLT \<50000
* Application of contrast medium on the day of surgery
* Immunosuppressive therapy or long-term therapy with corticosteroids
* Contraindication to anticoagulation with heparin
* Participation in another clinical intervention trial
Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia (CML) Patients With Complete Cytogenetic Response After Imatinib as First Line Therapy

Rationale: At present, virtually no evidence exists regarding mid to long-term patient-reported health outcomes (e.g., health related quality of life-HRQOL) of CML patients treated with Imatinib.

Purpose: the results of this research will provide preliminary evidence-based data on an number of issues from the patients' perspective, including adherence to therapy issues.

OBJECTIVES:

Primary: to investigate a number of mid to long-term HRQOL issues in Chronic Myeloid Leukemia (CML) patients with complete cytogenetic response treated with Imatinib as First Line Therapy.

Secondary evaluation of:

* Psychological wellbeing.
* Fatigue.
* Adherence to therapy issues.
* Symptom burden.
* Possible association between social-demographic and clinical variables with patient reported health outcomes.

OUTLINE:This is a multicenter study.

SAMPLE SIZE:

Sample size estimation has not been performed considering the nature of the study and the lack of preliminary data to hypothesize the number of possible eligible patients in each center.

DURATION OF THE STUDY:

The recruitment period is estimated in approximately 6 to 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years.
* CML patients meeting the following criteria:

  * Started IM therapy in the early chronic phase (ECP).
  * Have been undergoing treatment with IM, as first line therapy, for at least three years regardless of the current prescribed dose of IM.
  * In complete cytogenetic response (CCgR) and no clinical evidence of disease progression to accelerated phase (AP) or blast crisis (BC).
* Able to read and write Italian.
* Freedom from psychiatric conditions that may confound HRQOL evaluation.
* Informed consent provided.

Exclusion Criteria:

* CML patients who were initially diagnosed in the AP or BC or those who started therapy with IM in the late chronic phase (LCP).
* Having received any kind of treatment prior to IM therapy (except for hydroxyurea and/or anagrelide).
* Patients with a new primary malignancy.
Psychosis TMS Study

The main goal of this study is to investigate the neural mechanisms of working memory function in patients with early psychosis using Transcranial Magnetic Stimulation (TMS) in conjunction with functional MRI. TMS is a noninvasive method used to modulate brain activity via changing magnetic fields applied over the surface of the scalp.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of psychosis, psychosis not otherwise specified, schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder with psychosis, and schizophreniform disorder within first ten years of onset of psychotic symptoms.
* Ability to provide informed consent

Exclusion Criteria:

* TMS incompatibility including metallic implants in head and neck, cardiac pacemakers, history of seizures, pregnancy.
* MRI-incompatibility including implanted aneurism clips, cardiac pacemakers, metal implants, intrauterine devices, tattoos containing metal ink, pregnancy, and claustrophobia
* Severe substance abuse within 3 months (nicotine allowed)
* Unstable medical or neurologic illness that would preclude participation in study procedures
Traditional Chinese Medicine for Severe COVID-19

In December 2019, a new type of pneumonia, COVID-2019 outbroke in Wuhan ,China, and currently the infected has been reported in more than at least 75 countries.

Patients with severe COVID-19 have rapid disease progression and high mortality rate. This may attribute to the excessive immune response caused by cytokine storm. Strategies based on anti-virus drugs and treatments against symptoms have now been employed. However, these managements can't effectively treat the lethal lung injury and uncontrolled immune responses, especially in the elderly with severe COVID-19. Traditional Chinese Medicine (TCM), which treats the disease from anther perspective, has achieved satisfactory results. National Health Commission of China released a series of policies to enhance the administration of TCM prescriptions.

This study is aimed to evaluate the efficacy and safety of Traditional Chinese Medicine as an adjuvant treatment for severe COVID-19.


Eligibility Criteria:
Key Inclusion Criteria:

1. Patients were diagnosed as severe COVID-19 according to the Coronavirus disease (COVID-19) Treatment Guidance (Six edition)
2. Patients received a combined treatment of TCM and conventional therapy, or only conventional therapy.

Key Exclusion Criteria:

1. Age \>85 years
2. After cardiopulmonary resuscitation
3. Patients combined with other organ failure or conditions need ICU monitoring and treatment, such as severe liver disease, severe renal dysfunction, upper gastrointestinal hemorrhage, disseminated intravascular coagulation.
4. Respiratory failure and need mechanical ventilation
Use of COLD-fX to Prevent Respiratory Infections in Community Dwelling Seniors

Seniors are a population vulnerable to respiratory infections. It is hypothesized that regular use of COLD-fX following an influenza vaccination would potentially augment immune response in the elderly. Use of COLD-fX may also provide additional protection again respiratory infection and reduce the incidence and severity of respiratory infections in otherwise healthy seniors.

Eligible seniors will be randomly placed into three groups to receive 400 mg/day, 800mg/day or a placebo for a period of six months beginning in October. Daily dosing will be recorded as well as any symptoms not related to having a respiratory infection. For seniors who experience a respiratory infection, they are asked to call a study nurse who will take a nasopharyngeal swab. The seniors are also asked to record on a diary card the severity of their symptoms on a scale from 0-3 (none, mild, moderate, severe). Symptoms include cough, fever, runny nose, stuff nose, aches and pains, headache, chills, sneezing, ear aches and fatigue.The swab will be taken to the lab for testing for upper respiratory viruses.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years of age and older
* current season influenza immunization
* available for follow-up visits
* willing and able to sign written informed consent

Exclusion Criteria:

* HIV infection
* malignancy (under active observation or treatment)
* unstable cardiovascular diseases
* renal abnormalities (serum creatine \>200umol/l)
* pulmonary disease (chronic bronchitis, emphysema, or asthma requiring treatment in the last 3 months with oral steroids - prednisone \>10mg/day, other chronic respiratory illness)
* acute or active chronic liver disease
* neurologic or psychiatric disease (progressive or currently under treatment
* active tuberculosis
* multiple sclerosis
* bleeding disorders
* planned surgery over the course of the trial
* on immunosuppressive therapy
* taking oral steroids at dose = to prednisone 10 mg/day or more
* taking phenelzine, pentobarbital, haloperidol, warfarin, heparin
* use of natural health products(except the study product and vitamins and minerals with a dose \<600 mg/day of vitamin E and containing no vitamin K) including echinacea or ginseng-containing products (tea, capsules, extracts, tablets)
* current alcohol/drug abuse
* major surgery in the past 6 months
* allergies to ginseng
Photodynamic Therapy (PDT) Trial for Palliation of Cholangiocarcinoma

This research study is a phase III double arm, multicenter, randomized controlled clinical trial comparing endoscopic retrograde cholangiopancreatography (ERCP) and stenting plus photodynamic therapy (PDT) versus ERCP with stenting alone in adult patients with unresectable cholangiocarcinoma.

The study objectives are to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time of patients with unresectable cholangiocarcinoma and to assess the effect of PDT on both cholestasis and health-related quality of life (HRQoL).

The study objectives are to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time of patients with unresectable cholangiocarcinoma and to assess the effect of PDT on both cholestasis and health-related quality of life (HRQoL).

Eligibility Criteria:
Inclusion Criteria:

* Patient is age 18 years or older
* Patient is diagnosed with non-resectable cholangiocarcinoma, as determined by CT within 30 days of enrollment and CT shows Bismuth Tumor Stage as: IIIa, IIIb, IV (Bismuth tumor stage I and II are not eligible to participate)
* Patients must have adequate organ and marrow function as defined below:

  * Patient's INR ≤ 2 within 30 days of treatment
  * Patient's platelets \> 50,000/cmm within 30 days of treatment
  * Patient's Absolute Neutrophil Count (ANC) \> 1,500/cmm within 30 days of treatment
  * Patient's creatinine ≤ 3 mg/dL within 30 days of treatment
* Patient has the ability to understand and the willingness to comply with the study procedures and provide written informed consent to participate in the study

Exclusion Criteria:

* Patient was diagnosed with cholangiocarcinoma more than 3 months ago
* Patient has any metastatic disease
* Patient has acute porphyria
* Subjects exhibiting neurologic or cutaneous symptoms will undergo urinary delta-aminolevulinic acid and porphobilinogen dosage tests to determine severity.
* Patient is pregnant (Women of child bearing age must have a negative pregnancy test prior to registration and must agree to use adequate contraception during study therapy)
* Patient has a concurrent non solid malignancy
The Efficacy of Acupuncture in Treating Chemotherapy Side Effects in Breast Cancer Patients

The goal of this study is to determine if acupuncture improves multiple symptoms associated with chemotherapy on the MD Anderson Symptom Inventory (MDASI): nausea, vomiting, fatigue, anxiety, anorexia, pain, disturbed sleep, shortness of breath, dry mouth, depression, and peripheral neuropathy (see statistical section). The investigators hypothesis is that acupuncture will result in lower MDASI scores over the course of chemotherapy for the acupuncture group vs. control group.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* English speaking/reading/writing
* Breast cancer stages I through III
* Any performance status suitable for chemotherapy as determined by the physician
* Primary or secondary chemotherapy, but enrolling patients prior to a chemotherapy regimen regardless of previous radiation therapy exposure and/or previous mastectomy.
* Scheduled to receive either of the following two regimens:
* Adriamycin (60 mg/m2), Cytoxan (600 mg/m2), Taxol (175 mg/m2)
* Adriamycin (60 mg/m2), Cytoxan (600 mg/m2), Taxol (80 g/m2)
* Taxotere (75mg/m2), Cytoxan (600 mg/m2)
* Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose)

Exclusion Criteria:

* History of narcolepsy
* Sleep apnea requiring continuous positive airway pressure (CPAP)
* Other acupuncture treatment within one month of enrollment
* Acupuncture treatment for chemotherapy in the past
* Current participation in any other research studies
European Serrated Adenoma Classification Score

The aim of the study is to develop a score system in order to differentiate adenomatous polyps, hyperplastic polyps and serrated adenomas on the basis of optical features. Endoscopic images of colorectal polyps will be collected from a prospectively managed database. Histopathological diagnoses are available for all polyps. Histopathological diagnoses serve as gold standard in this study.

In the first phase of the study optical features of serrated adenomas are extracted from the database. Discriminators are then defined on the basis of the extracted features. In the second phase a test set of high quality pictures are provided to both novices and experts of colorectal endoscopy. Participants are asked to use the above named discriminators in order to rate pictures and to classify polyps into three classes (adenomatous polyps, hyperplastic polyps and serrated adenomas). In the third phase of the study accuracy of optical bases diagnoses is calculated by comparing optically derived diagnoses with histopathological diagnoses (gold standard).


Eligibility Criteria:
Inclusion Criteria:

* indication for colonoscopy
* patients \>= 18 years

Exclusion Criteria:

* pregnant women
* indication for colonoscopy: inflammatory bowel disease
* indication for colonoscopy: polyposis syndrome
* indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
* contraindication for polyp resection e.g. patients on warfarin
The Impact of Local Analgesia for Postoperative Analgesia in Posterior Thoracolumbar Operation

Posterior thoracolumbar operation always chooses general anesthesia. Due to surgical trauma and rich periosteum and joint capsule innervation, patients after general anesthesia immediately feel acute pain.The use of appropriate postoperative analgesia in patients with thoracolumbar surgery is beneficial to postoperative recovery. Infusions of local anaesthetic via multilumen catheters that deliver directly to wound sites have been used for postoperative analgesia in procedures. Reducing the morbidity from both pain and nausea will make the mode of analgesia a better tolerated and more palatable option for patients. The aim of this study is to examine the effects of using local anaesthetic infusion catheters following posterior thoracolumbar surgery, and compares the outcomes of patients managed using intravenous analgesia pump infusion of systemic opioids.

All 71 adult patients were prospectively included and randomized to either the local (L) group (n=35) or the intravenous (V) group (n=36) by using a random number table: the test group were treated with local analgesia infusion pump of 0.33% ropivacaine through the wound for postoperative analgesia, while the control group were treated with intravenous analgesia pump infusion of flurbiprofen axetil,palonosetron, pentazocine. At 2, 4, 6, 12, 24, 36, 48 hours after operation, postoperative pain visual analogue scale(VAS) scores and sedation Ramsay scores were used to evaluate the level of pain and sedation, and investigators documented the comprehensive evaluation of patients with pain control system, and the incidence of adverse reactions. At 24, 48 hours investigators observed the wound whether inflammation and exudation or not, and the removal of penetration catheter sent to clinical laboratory for bacterial culture. Investigators also recorded the length of time to discharge and called to ask pain conditions at the first 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. ASA Ⅰ \~ Ⅱ patient undergoing elective posterior thoracolumbar operation
2. between 18 and 70 years of age

Exclusion Criteria:

1. A history of cardiopulmonary disease, liver and kidney dysfunction, abnormal coagulation
2. Preoperative use of analgesic drugs
3. A allergy history of ropivacaine and polyurethane material