cyrilzakka/clinical-trials huggingface dataset:
Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound for the Treatment of Prostate Cancer

The investigators aim to evaluate cancer control, genitourinary, rectal and overall health-related quality of life outcomes and effectiveness of focal therapy for localised prostate cancer using High Intensity Focused Ultrasound (HIFU).


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven prostate cancer on trans-rectal or transperineal template prostate biopsies
* Template biopsy:

  * unilateral disease (Gleason ≤4+3)
  * bilateral disease: presence of clinically significant cancer in both sides (Gleason ≤4+3) OR clinically insignificant disease with a burden of \>50% of biopsy cores taken on that side, OR bilateral clinically insignificant disease and \<50% of biopsy cores positive on any one side but with dominant disease burden on one side
* Stage T1-T2cN0M0 disease, as determined by local guidelines (radiological T3a permitted)
* Serum PSA ≤15
* Life expectancy of ≥10 years
* Signed informed consent by patient
* An understanding of the German language sufficient to understand written and verbal information about the trial and consent process

Exclusion Criteria:

* Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer
* Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
* Men with an inability to tolerate a transrectal ultrasound
* Men with latex allergies as the HIFU probe is covered with a latex condom sheath prior to insertion into the back passage
* Men who have undergone prior significant rectal surgery preventing insertion of trans-rectal HIFU probe (decided on the type of surgery in individual cases)
* Men who have had previous HIFU, cryosurgery, thermal or microwave therapy to the prostate.
* Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within 6 months. These patients may be included within the trial if deferred from consenting and screening until at least 6 months following the TURP.
* Men not fit for major surgery as assessed by a Consultant Anaesthetist
* Men unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant etc likely to contribute significant artefact to images)
* Presence of metal implants/stents in the urethra
* Presence of prostatic calcification and cysts (on transrectal ultrasound) whose location will interfere with effective delivery of HIFU therapy
* Men with renal impairment with a glomerular filtration rate of \<35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI).
"Hepafast" in Non-alcoholic Fatty Liver Disease (NAFLD)

The purpose of this study is to investigate whether a weight reduction with "Hepafast" in combination with raw food and vegetables for two weeks followed by a meal substitution with "Hepafast" and a calorie restriction in accordance with the Low Glycemic and Insulinemic Diet (LOGI) for 10 weeks is superior regarding improvement of non-alcoholic Fatty Liver Disease (NAFLD) compared to a conventional weight reduction in accordance with the LOGI diet without use of "Hepafast" for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 30-40 kg/m2
* suspected or diagnosed non-alcoholic fatty liver disease (NAFLD)

Exclusion Criteria:

* other liver diseases
* kidney failure
* pregnancy, lactation
* diabetes mellitus which is treated with insulin
* alcohol abuse
* several drugs
Financing Strategies of Influenza Vaccination in China

This trial focuses on influenza vaccination among three recommended groups in China. Data concerning the economic burden of influenza-like illness (ILI), vaccine hesitancy, discrete choice experiment, immunization records and willingness to pay for vaccines will be collected via questionnaires, and the financing strategies of influenza vaccines in China will be further analyzed. Besides, the knowledge, attitude/belief and practice (KAP) of medical staff will also be asked in a supplementary questionnaire.

This trial focuses on influenza vaccination among three recommended groups in China, including children (aged between 6 to 59 months), the elderly (aged 60 years old or above), and adult patients with chronic diseases (aged below 60 years old).

The questionnaires will collect data on the economic burden of influenza-like illness (ILI), vaccine hesitancy, discrete choice experiment, immunization records and willingness to pay for vaccines, and the financing strategies of influenza vaccines in China will be further analyzed accordingly.

Besides the three recommended groups, vaccination and health care personnel will also be asked about their knowledge, attitude/belief and practice (KAP) in a supplementary questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* (For children group) children aged between 6 to 59 months.
* (For the elderly group) the elderly aged 60 years old or above.
* (For chronic disease patient group) adult patients with chronic diseases aged below 60 years old.
* (For medical staff) general practitioners and vaccination staff.
* Interviewees with informed consent.

Exclusion Criteria:

* Those cannot be surveyed for physical reasons.
* Those with communication barriers.
* Those who do not agree to participate in the survey.
Urodynamic Evaluation in Patients After Spinal Cord Injury

Retrospective study, which analyzed 100 medical histories of patients who were admitted o the Neurological Rehabilitation Ward of the Rehabilitation Clinic in the Orthopedic-Rehabilitation Hospital in Poznan in years 2010-2019.

All patients considered for the study underwent routine testing: blood counts, urinalysis, urine culture, and sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* incomplete spinal cord injuries,
* the results of the urodynamic testing (conducted by the same urologist) by admission,
* urine culture test by admission.

Exclusion Criteria:

* complete spinal cord injury
* without urodynamic test in medical documentation by admission,
* without urine culture test by admission,
* with symptomatic urinary tract infection in urodynamic test
Loop Diuretic Therapy in Acutely Decompensated Heart Failure

DiurHF is a prospective, multicenter, observational, study that compares continuous with intermittent infusion of furosemide in patients admitted with a diagnosis of ADHF. Previous pilot study design was planned to anticipate a larger multicenter trial able to definitively evaluate the optimal loop diuretic use strategy in patients with ADHF.

The use of intravenous loop diuretics is a cornerstone of therapy for acutely decompensated heart failure (ADHF); significant concerns have been raised regarding risks and benefits of loop diuretics, particularly about dosage and administration regimen.

Recent guidelines recommend the use of these drugs to reduce left ventricular filling pressure, avoid pulmonary edema, and alleviate peripheral fluid retention.

Some studies have provided guidelines for the administration of these drugs in clinical practice, but data interpretation remains challenging due to the frequent exclusion of patients with kidney disease from major ADHF clinical trials. Therefore, it is not clear if continuous infusion is better than intermittent boluses in terms of decongestion, maintenance of renal filtration function and prognosis.

On the other hand, continuous administration should provide a more constant delivery of the drug into the tubule, potentially reducing these phenomena.

The aim of the study is to evaluate the better loop diuretic intravenous administration in terms of renal function, congestion signs, BNP and outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years;
* Patients with diagnosis of ADHF(dyspnea, orthopnea, peripheral edema or major fatigue and at least two clinical signs including rales, hepatomegaly, pulmonary congestion on chest radiography, jugular vein dilatation, or a third heart sound);
* Blood BNP \> 100 pg/mL;

ADHF: Acute Decompensated Heart Failure; BNP: B-type Natriuretic Peptide; IV: IntraVenous; LVEF: Left Ventricular Ejection Fraction.

Exclusion Criteria:

* Patients who receive more than 40 mg of IV furosemide;
* End-Stage renal disease or renal replacement therapy;
* Recent myocardial infarction (within thirty days of screening);
* Systolic blood pressure \< 80 mmHg;
* Creatinine levels \> 4 mg/dL;
* Patients affected by sepsis, liver diseases, inflammatory diseases or neoplastic diseases.
SCOOT: Sample Collection for DART

The study will use a blood sample collected from participants to:

* Develop new ways of finding and diagnosing lung health problems, such as lung cancer.
* Develop tools which make it easier to screen people with possible lung health problems, diagnose problems earlier and with fewer tests, and start the best treatment faster.
* Help improve the early diagnosis of lung cancer, as finding lung cancer early means that it can be treated more easily and successfully.

The results from this study will be linked with the data from the DART study (also collecting data through the Lung Health Check programme) to develop new ways of using computer technology (artificial intelligence) to improve lung health care. The studies use computer programs (called 'algorithms') which can be trained to analyse medical samples. Once developed, these algorithms can be used to support doctors by increasing their speed and accuracy of diagnosing issues.

Eligibility Criteria:
Patient suitability will be assessed against the below criteria by the clinical teams managing the patients.

Inclusion Criteria:

1. Patients with a pulmonary nodule or nodule(s) detected on a CT scan performed as part of Lung Cancer Screening from the Lung Health Check centres, that require further investigation with a PET-CT scan, and / or biopsy, and / or resection
2. Willing and able to give informed consent

Exclusion Criteria:

* None -
Evaluation of Complications in Airway Management

In the current study researchers aim to evaluate the rate of the complication due to airway management (during intubation or placement of supraglottic airway devices)

Airway management is one of the most important subject of anesthesia practice. Airway devices ,helping anesthesiologists to maintain airway safety have many complications. 4 th national audit project (NAP 4) study was designed to evaluate the incidence of the major complication of airway management. Accordingly in current study authors aim to determine the complications and incidence of the complications during airway management.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing general anesthesia
* Patients to whom airway devices will be inserted

Exclusion Criteria:

* Patients who undergo surgery under regional anesthesia
* Patients who undergo surgery under sedation
Study of Patients With Chronic Hepatitis C Infected With HCV LVL G1 and Effect of Peg-Intron Plus Rebetol Treatment (Study P04793)

To determine the relapse rate at 24 weeks follow up in Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) patients treated for 24 weeks with Peg Intron and Rebetol who are Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) negative at treatment week 4 and week 24. To determine the proportion of patients (%) with sustained virological response at 24 weeks post follow up treatment.

Approximately 500 patients from about 100 sites to be identified as HCV LVL G1 patients

Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate
* 18 years or older, either gender, any race
* Must have Hepatitic C Virus Low Viral Load \[LCV LVL\] (positive, but \<600,000 IU/mL on the assay used by the individual study site. Only Hepatitis C Virus-Ribonucleic acid/quantitative polymerase chain reaction \[HCV-RNA/qPCR\] assays with results in IU/ml are acceptable) AND been diagnosed with Genotype 1
* Subject considered suitable for treatment per local label
* Investigator considers suitable and subject consents to be treated

Exclusion Criteria:

* Does not show negative polymerase chain reaction \[PCR\] at week 4
* Pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant
* Subject does not qualify based on contra-indication, special warning, special population, and/or pregnancy \& lactation section of the Summary of Product Characteristics \[SmPC\]
Investigate the Effect of AZD1656 on the Pharmacokinetics of Sitagliptin in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the effects of AZD1656 on Sitagliptin pharmacokinetics and vice versa in patients with Type 2 Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed type 2 diabetes mellitus for at least 2 months and treated with metformin.
* Body mass index between ≥19 and ≤42 kg/m2.

Exclusion Criteria:

* Intake of another investigational drug within the last 30 days prior to enrolment.
* Clinically significant illness or clinically relevant trauma.
Study Safety/Efficacy of AmBisome Loading Dose Regimen Versus Standard AmBisome Regimen for Initial Treatment

To evaluate and compare two AmBisome dosing regimens for the initial treatment of invasive aspergillosis and other filamentous fungal infections diagnosed by modified EORTC criteria in immunocompromised patients, as determined by overall response rates at end of course of treatment.

To evaluate and compare two AmBisome dosing regimens for the initial treatment of invasive aspergillosis and other filamentous fungal infections diagnosed by modified EORTC criteria in immunocompromised patients, as determined by overall response rates at end of course of treatment.

Determine and compare the following parameters for the two treatment arms:

* Safety and tolerability
* Survival rates and the rates of infection relapse at 4 weeks Post Treatment.
* Survival rate at 12 weeks after study entry.
* Time to favorable overall response and time to End of Treatment for patients with favorable overall response.
* Cumulative dose of study drug given through End of Treatment.

Eligibility Criteria:
Inclusion Criteria:

* Immunocompromised due to hematologic malignancies, chemotherapy-induced neutropenia, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy (greater than or less than 20 mg of Prednisone or equivalent for greater than or less than 3 weeks), treatment with other immunosuppressant medications, or other acquired or hereditary immunocompromising conditions that place the patients at risk for IFI. Evidence of Proven, Probably or Possible IFFI by modified EORTC criteria. Continued treatment with study drug is contingent upon confirmation of diagnosis of Proven or Probable IFI within 4 working days after study entry.

Exclusion Criteria:

* Life expectancy of less than 30 days; chronic IFI (defined as signs/symptoms of IFI present for less 4 weeks preceding entry into study;prior systemic therapy of greater than or less than 4 days with any polyene anti-fungal agent within 14 days of study enrollment;prior systemic therapy of greater than or less than 4 days with non-polyenes for the current, documented IFI. Use of another investigational, unlicensed drug within 30 days of screening or concurrent participation in another clinical trial using an investigational, unlicensed drug; serum creatinine greater than 2 x upper limit of normal (ULN), serum ALT or AST less than 5 x ULN; pregnant or lactating women; history of allergy or serious adverse reaction to any polyene anti-fungal agent.
Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer

The purpose of this study is to learn about the effect of the investigational agent tivozanib on the control of the tumor growth in hepatocellular (liver) cancer. The investigators also plan to collect information on the likelihood to develop side effects while on this treatment. Tivozanib is an oral medication (pill) taken once a day. This medication is designed to stop the tumor from developing new blood vessels.

Angiogenesis is the formation of new blood vessels. Angiogenesis is driven by cytokines including vascular endothelial growth factor. Tivozanib is an oral medication that inhibits vascular endothelial growth factor preventing tumor from developing new blood vessels.

The purpose of this study is to evaluate the effects of tivozanib on hepatocellular (liver) cancer. Participants in the study take tivozanib daily at a dose of 1 mg for 1month. if doing well the dose would be increased to 1.5 mg per day. Patients are monitored for response using CT or MRI scans every 2months. In addition, patients will have blood draws to evaluate the effects of tivozanib on blood vessels.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with measurable, histological diagnosis of hepatocellular carcinoma (HCC) and whose disease is not amenable to surgical or regional therapy.
2. Prior allowed therapy:

   * Surgery including hepatic resection

     1. Minimum of 4 weeks since any surgical procedure.
     2. Patients must have adequately recovered from surgery.
   * Regional therapy

     1. Includes transarterial chemoembolization (TACE), drug-eluting bead \[DEB\]-TACE, percutaneous ethanol injection, radiofrequency/cryo ablation, Yttrium-90 radioembolization.
     2. More than 2 weeks must have lapsed from therapy.
     3. There must be an indicator lesion outside the treated area or clear evidence of progression in the treated lesion, not amenable for further local therapies.
     4. Concomitant sorafenib with regional therapy is allowed as long as no evidence of progression on sorafenib.
   * Prior adjuvant sorafenib is allowed, if completed more than 6 months prior to disease recurrence.
3. Adequate hematological, liver and metabolic organ function.
4. Signed informed consent.

Exclusion Criteria:

1. Patients with mixed histology or fibrolamellar variant.
2. Prior systemic therapy for metastatic disease.
3. Uncontrolled hypertension (HTN).
4. Symptomatic heart failure.
Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Breast Cancer

This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic capecitabine and in patients with a HER2-positive tumour in combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases from breast cancer.

Only patients without extrahepatic disease are included.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age \> 18 years
* Performance status 0-1; expected survival ≥ 3 months
* Patient with histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the breast
* Liver metastases not suitable for local treatment
* Extrahepatic disease should be excluded by PET-CT-scan.
* No progression on treatment with capecitabine.
* Prior treatment with taxane (adjuvant or for metastatic disease)
* Metastases \< 70 % of the liver
* Neutrophile granulocytes \> 1.5 x 109/l og thrombocytes \> 100 x 109/l
* Bilirubin \< 2.0 x UNL (upper normal limit).
* Creatinine-clearance \> 30 ml/min.
* INR \< 1.6.
* If the patient is HER2-positive:Baseline LVEF ≥ 50 %.

Exclusion Criteria:-

* History of chemotherapy within the 4-week period prior to the start of trial medication
* Other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.
* Previous treatment with oxaliplatin
* Cytotoxic or experimental treatment within a 14 days period before start of trial medication
* The patient is not allowed to participate in other clinical trials.
* Any clinical symptoms suggesting peripheral neuropathy \< or equal to grade 2 or CNS metastases (In case of clinical suspicion on CNS metastases a MR or CT scan should be performed within 4 weeks before inclusion
* Other severe medical conditions e.g. severe cardial disease or AMI \< 1 year
* Presence of diseases which prevent oral therapy. • Patients with uncontrolled infection
* Pregnant or lactating women
* Women capable of childbearing not using a sufficient non-hormonal method of birth control
* Patients not able to understand the treatment or to collaborate.
* Prior serious or unsuspected reaction after treatment with fluoropyrimidine
* Known prior hypersensitivity reactions to the agents.

If the patient is HER2-positive:

• Dyspnoea in due to complication related to malignant disease e.g.lung metastases with lymphangitis or other conditions with need of supportive oxygen.
Efficacy of AirGLovE in Difficult Venous Access

To determine whether Airglove™ warming device dilates upper limb veins to the same degree as the warm water immersion (WWI) method.

Failure to cannulate to gain intra-venous access is a common occurrence in patients undergoing chemotherapy, obese patients, intravenous drug users and those with chronic medical problems leading to peripheral venous collapse. Difficulty in gaining IV-access is a serious medical consequence since important life-saving drugs, fluids, blood transfusions, and other medication are usually given via the intravenous route. Most chemotherapy units in the UK rely on venous dilation by immersing the forearm of patients with "difficult to cannulate veins" (DTCV) into a bucket of warm water. There are however, limitations in this method such as controlling water temperature and ensuring proper sterility.

A new device Airglove™ has been developed which directs warm air over the forearm in a polythene sleeve causing venodilation. Preliminary studies in chemotherapy patients suggest that the Airglove™ causes venodilation to the extent of the warm water immersion technique, however further evidence is required with testing on normal healthy volunteers.

Aims and Objectives:

To determine whether Airglove™ warming device dilates upper limb veins to the same degree as the warm water immersion (WWI) method.

Eligibility Criteria:
Inclusion Criteria:

* Participants \> 18 years old
* Able to give written informed consent
* Able to understand and complete questionnaire forms independently

Exclusion Criteria:

* Participants \< 18 years old
* Participants with cancer and/or undergoing chemotherapy
* Participants with difficult to cannulate veins (DTCV)
* Participants with lymphoedema in either hand
* Participants with pre-existing Raynaud's disease
* Participants with Diabetes (Type 1 \& 2)
* Participants with generalised anxiety disorder
* Participants with diagnosis of hypertension
* Participants with any cardiovascular disease, previous stroke, episodes of DVT, recent treatment for venous thromboembolism (VTE), recently administered heparin, participants on warfarin or any anticoagulant treatment (including NOACs).
* Participants not able to give written informed consent
* Participants not able to comprehend or complete questionnaire forms independently