cyrilzakka/clinical-trials huggingface dataset:
Radiofrequency Interstitial Tissue Ablation in Treating Patients With Localized Renal Cell Carcinoma (Kidney Cancer)

RATIONALE: Radiofrequency interstitial tissue ablation may kill tumor cells by heating tumors to several degrees above body temperature.

PURPOSE: This phase II trial is studying radiofrequency interstitial tissue ablation to see how well it works in treating patients with localized renal cell carcinoma (kidney cancer).

OBJECTIVES:

Primary

* Evaluate the efficacy of radiofrequency interstitial tissue ablation in terms of tumor destruction or slowed tumor growth rate in patients with localized renal cell carcinoma.

Secondary

* Assess the toxicity of this treatment regimen in these patients.

OUTLINE: Patients undergo percutaneous radiofrequency interstitial tumor ablation (RFA). Patients are offered laparoscopy-assisted percutaneous RFA in the operating room if their tumors are not safely accessible. Intra-operative ultrasound is used to confirm probe placement and to monitor treatment delivery. If the target temperature or impedance are not reached, treatment is repeated no more than twice. No more than 5 tumors are treated per kidney.

All patients are followed at 2 to 3 months, 6 months, and then at 1 year.

Patients with tumors greater than 2 cm in diameter are followed every 6 months for up to 5 years. Patients whose tumors become greater than 3 cm are recommended for surgery and removed from study if surgery is performed.

PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Localized renal cell carcinoma, meeting both of the following criteria:

  * Enlarging renal tumors on imaging studies over a minimum of 12 months
  * Tumor size between 0.5-4.0 cm in diameter at time of treatment

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Creatinine less than 2.0 mg/dL OR
* Creatinine clearance greater than 60 mL/min

Other:

* Not pregnant
* Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specifed

Radiotherapy

* Not specified

Surgery

* Not specified
No Need for Neuromuscular Blockade in Daycase Laparoscopic Surgery

This study analyse the need for neuromuscular blockade in consecutive routine laparoscopic procedures without standard use of neuromuscular blockade in an ambulatory laparoscopic surgery setting and analyse specific reasons for using neuromuscular blockade in individual patients. Furthermore, the study report the analgesic use in postoperative care unit and the discharge rate.

The study is retrospective, including consecutive patients in an unrestricted referral of patients undergoing laparoscopic cholecystectomy, umbilical and inguinal hernia repair. Inclusion period was from 01.04.2013 to 31.03.2015. All patients received general anesthesia using propofol (2 mg/kg) and remifentanil (1 μg/kg/min) for induction. In patients where tracheal intubation was required, this was done without use of neuromuscular blocking drug; otherwise a proseal laryngeal mask was used. For the maintenance of anesthesia, additional continuous infusion of propofol (3-5 mg/kg/h) and remifentanil (0.3-0.5 μg/kg/min) was used. Data were derived from a prospective local database on demographics, anesthetic methods and supplements (i.e. need for neuromuscular blockade) and postoperative needs for supplementary analgesics besides the postoperative standard analgesic regimen, number of hours stayed in the ambulatory surgery department, and discharge rate (including reasons for hospital admittance).

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing laparoscopic cholecystectomy, umbilical and inguinal hernia repair

Exclusion Criteria:

* None
Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

Heartburn, a burning sensation in the chest or throat, occurs in many patients when acidic stomach contents move into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg once a day in treating frequent heartburn.


Eligibility Criteria:
Inclusion Criteria:

1. Experiencing heartburn at least 2 days per week over the past month.
2. Having heartburn that responds to heartburn medication.
3. Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.

Exclusion Criteria:

1. Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy).
2. Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study.

Other protocol-defined inclusion or exclusion criteria may apply
Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer During Radiation or Chemoradiation Therapy

The impact of sonifilan on the quality of life in patients with cervical cancer during radiation or chemoradiation therapy

1. Primary endpoint : Quality of life
2. Secondary endpoint : complications related to Sonifilan, treatment effect of Sonifilan

Study design Prospective randomized controlled trial

Study period Protocol registration approval date - may/31/2016

Study drug Sonifilan(Sizofiran)

Study population

1. Cervical cancer FIGO stage IA2-IVA patients will be participated.
2. Squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma
3. age 20-75 year

Treatment Fron the day of radiation therapy started, Sonifilan 20mg, 1amp IM/week for 8weeks

Concurrent therapy Chemo \& radiation therapy

1. Cisplatin 40mg/m2, day 1, 8, 15, 2, 29, 36
2. External whole pelvic irradiation 3000-3500 cGy / 6 fractions in high dose rate

Assessment

1. Pre-study assessment (within 4weeks before participation) a medical history b informed consent c ID number assignment d life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI e basic information collect
2. On-study assessment (during study) a complication check b life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI

3. Post-study assessment (1week after study finished) a MRI b PAP smear c HPV test d life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI

4 Follow-up assessment (every 3 month for 1 year) a Pelvic exam b PAP smear c HPV test d MRI (if needed) e PET (if needed) f life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI 93, 6, 12, 24 month after study finished)

Eligibility Criteria:
Inclusion Criteria:

* Cervical cancer FIGO stage IA2 - IVA
* Histologic type : SCC, Adenocarcinoma, Adenosquamous carcinoma
* GOG performance status 0-2

Exclusion Criteria:

* past radiation therapy history
* Neuroendocrine carcinoma
* concurrent other cancer
* uncontrolled medical disease
* ulcerative disease history
* current pregnancy and lactation
Effect of the Computer Aided Diagnosis with Explainable Artificial Intelligence for Colon Polyp on Optical Diagnosis and Acceptance of Technology

The goal of this clinical trial is to learn if computer-aided diagnosis with deep learning and computer-aided diagnosis with explainable AI work to optical diagnosis performance and acceptance of technology in endoscopists. The main questions it aims to answer are:

Do computer-aided diagnosis with deep learning and computer-aided diagnosis with explainable AI improve optical diagnosis performance in endoscopists?

Does experience using deep learning-based computer-assisted diagnosis and explainable AI-based computer-assisted diagnosis improve endoscopists' acceptance of computer-aided diagnosis as a technology?

Participants will:

Conduct a survey on acceptance and use of technology about computer-aided diagnosis.

Perform a test to estimate the pathologic diagnosis on 200 NBI still images without the aid of computer-aided diagnosis.

More than 1 month later, perform a same test to estimate the pathologic diagnosis on 200 NBI still images with computer-aided diagnosis with deep learning or explainable AI.

Conduct a survey on acceptance and use of technology about computer-aided diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Endoscopists with colonoscopy experience

Exclusion Criteria:

* Who can not perform colonoscopy
Comparison Amongst Scleral, Corneal and Amniotic Membrane Grafts to Restore Scleral Thinning

The purpose of this study is to evaluate the use of preserved scleral, corneal and amniotic membrane graft for the surgical repair of scleral thinning of different sizes in patients underwent surgery of pterygium with associated beta therapy .

Scleral thinning may occur secondary to different ocular surface conditions, especially in rheumatologic diseases and after surgeries as in pterygium. There are different methods to treat this condition, as to use scleral, corneal and more recently amniotic membrane graft.

Eligibility Criteria:
Inclusion Criteria:

* Patients with corneal scleral defects that have persisted for 1 years or longer, regardless of their cause. These patients will have received corneal-scleral or amniotic membrane transplant in order to correct scleral thinning
* Patients with history of pterygium surgery associated with beta therapy followed by scleral thinning

Exclusion Criteria:

* Ocular infection
* Acute ocular inflammatory condition
* Previous ocular surgery in the eye study
* Non-controlled systemic disease such as rheumatoid arthritis
Application of Amide Proton Transfer-weighted Imaging in Predicting Pathological Complete Response After Neoadjuvant Therapy of Rectal Cancer

The goal of this observational study is to learn about the amide proton transfer-weighted imaging for rectal cancer response assessment after neoadjuvant therapy. The main question it aims to answer is:

• Does amide proton transfer-weighted imaging predict the cancer response before surgery? Participants will underwent amide proton transfer-weighted imaging as part of their regular MRI examination.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced rectal cancer(cT3-4, or cN+), resectable, histologically confirmed rectal adenocarcinoma
* Received neoadjuvant therapy before surgery
* Complete radical resection of rectal cancer and postoperative pathological examination
* Informed consent and signed the informed consent form

Exclusion Criteria:

* Poor image quality, such as severe artifacts
* Complicated with intestinal obstruction, intestinal perforation and other cases requiring surgical treatment
* The interval between preoperative MRI and surgery was more than 2 weeks
* Prior treatment for rectal cancer
* History of other malignant tumors
* Patients who cannot undergo MRI examination due to contraindications or relative contraindications
* Patients were lost to follow-up or voluntarily withdrew from the study due to adverse reactions or other reasons
A Food Effect Study of 60mg ER Torsemide

This study will evaluate the effects of a high-fat meal (food effect) on the bioavailability and pharmacokinetics of 60mg ER Torsemide tablet after single dose oral administration in healthy volunteers. The study will be conducted as a two-sequence to period crossover study to compare 60mg ER Torsemide ER bioavailability under fed and fasting conditions. 60mg ER torsemide is a new strength and dosage form.

Immediate Release (IR) Torsemide is a highly effective natriuretic drug but its short duration of action is a major drawback, which allows significant post-dose sodium retention, and as consequence, limits salt loss in patients with heart failure unless dietary salt intake is severely restricted. Extended Release (ER) torsemide is being developed to address this drawback by prolonging the duration of action to increase sodium excretion even in patients who consume high salt diet. Since 60mg ER torsemide is a new strength and dosage form, this study will test 60mg ER torsemide for a food effect in healthy volunteers who are either fasting or consuming a high-fat meal (fed). The primary endpoint of the study is full pharmacokinetics measurements after a single dose of 60mg ER torsemide. The secondary endpoints are 24h sodium excretion and total urinary excretion.

Eligibility Criteria:
Inclusion Criteria:

* healthy male or female
* non-smoker
* weight ≥ 50 kg for male and ≥ 45 for female
* clinically acceptable laboratory profiles with ECG and chest x-ray performed within 6 months

Exclusion Criteria:

* participation in bioavailability/bioequivalence studies in past six months
* history of drug abuse or alcohol dependence
* history of allergies, known hypersensitivity to Torsemide and related drugs
* presence of clinically significant disorder
* suffer from high/low blood pressure (\<90 and \>140 mm Hg)
* positive urine drug screening, and
* history of incontinence
Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial

This study is intended to compare the new Carnation patch monitoring system with the Zio patch, which represents the current standard for continuous recording of the ECG over extended periods.

The purpose of this research is to confirm the clinical value of a new P-wave sensitive recording vector combined with an easy-to-use long-term cardiac rhythm monitoring patch system, the CarnationTM Ambulatory Monitoring (CAM) System. The P-wave is a critical aspect of the electrocardiogram and a key finding for proper arrhythmia diagnosis. The CAM system is optimized for both ease of use and for maximum P-wave clarity for arrhythmia diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Syncope of uncertain etiology or
* Pre-syncope of uncertain etiology or
* Palpitations of uncertain etiology or
* Management of known AF/SVT patients

Exclusion Criteria:

* Any dermatitis or infected skin over the sternum (Carnation patch) or left upper anterior thorax (Zio patch).
* A sternal or thoracic incision that extends under the patch within 3 months from the date of enrollment
Study of Adoptive Transfer of iNKT Cells Combined With TAE/TACE to Treat Unresectable HCC

Hepatocellular carcinoma (HCC) is a common disease with high mortality. More than 80% patients receive a diagnosis when their tumors are too advanced for curative approaches and have a dismal prognosis. invariant Natural Killer T (iNKT) cell exhibit antitumor activity against malignant tumors through producing high levels of cytokines. iNKT cells are abundant in the liver, but their function is defective in liver cancer. After expansion and restored function in vitro, iNKT cells can home to liver, then they play key antitumor function. We have finished a phase I study of adoptive transfer of autologous iNKT cells for treating patients with unresectable HCC. Safety and feasibility of iNKT infusion was proved. The purpose of this study was to verify the effectiveness of iNKT cell infusion in patients with unresectable HCC who had previously failed transcatheter arterial embolization (TAE) / transcatheter arterial chemoembolization (TACE).

Patients with unresectable HCC will be enrolled and divided into two groups. Patients in trial group will be treated with combination of TAE/TACE and adoptive transfer of autologus iNKT cells. TAE/TACE will be performed at 0th and 4th week. iNKT cells will be infused at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy. Patients in control group will be treated with TAE/TACE at 0th and 4th week. Overall survival (OS) time, progression-free survival (PFS) time, objective response rate(ORR), disease control rate(DCR) will be monitored.

According to JSH guidelines, TAE/TACE failure is defined as an insufficient response after ≧2 consecutive TAE/TACE procedures that is evident on response evaluation computed tomography or magnetic resonance imaging after 1-3 months, these patients do not respond sufficiently to TAE/TACE.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years.
* Patients with hepatocellular carcinoma (BCLC, stageB/C) proved by histopathology or proved by CT or MRI imaging system, relapsed after previous therapy and no effective therapies known at this time.
* Life expectancy of ≥ 12 weeks.
* WBC\>3.0×10\^9/L, LYMPH\> 0.8×10\^9/L, Hb\>85g/L, PLT\>50×10\^9/L, Cre\<1.5×the upper limit of normal value.
* iNKT\>10 cell/mL in peripheral blood mononuclear cell (PBMC).
* Able to understand and sign the informed consent.

Exclusion Criteria:

* Any uncontrolled systematic disease: hypertension, heart disease, and et al.;
* Portal vein tumor thrombus, central nervous system tumor metastasis, or combined with other tumors;
* Receiving radiochemotherapy, local therapy, or targeting drugs within 4 weeks prior to this treatment;
* Unstable immune systematic diseases or infectious diseases;
* Combined with AIDS or syphilis;
* Patients with history of stem cell or organ transplantation;
* Patients with allergic history to related drugs and immunotherapy;
* Patients with complications associated with liver diseases: moderate or severe pleural effusion, pericardial effusion, ascites, or gastrointestinal hemorrhage;
* Pregnant or lactating subjects;
* Unsuitable subjects considered by clinicians.
Impact of Decision Quality by Using Question Prompt List

To investigate the effects of a question prompt list (QPL) on a shared decision-making consultation among facing decision for dialysis in end-stage renal disease (ESRD) patients. A randomized controlled trial was conducted at the university medical center of North Taiwan. Subjects were randomized assigned to QPL group or usual care group. Decisional quality and decision control preferences were assessed with questionnaires. Measurements were performed at before the counseling (T0), immediately after counseling (T1), and evaluate decision regret at one month after treatment.

The aim of this study was to investigate the effectiveness of decisional quality and decisional control preferences by using a specific question prompt list (QPL) during a shared decision-making consultation among facing decision for dialysis in end-stage renal disease (ESRD) patients. A randomized controlled trial was conducted at the university medical center of North Taiwan. Recruit subjects are those who are about to receive the nurse-led coaching of shared decision-making (SDM) for patients with ESRD and attend the program. By using blocked Randomization design, the investigators assigned participants to QPL group or usual care. Prior to a clinic visit to discuss treatment, two-pages ESRD QPL leaflets are provided to QPL group, while usual care group without receiving provision of QPL. Measurements of outcome included decision quality (decision conflict, decisional self-efficiency) and decision control preference at before the counseling (T0), immediately after counseling (T1), and evaluate decision regret at one month after treatment (T2), at this time the patient has decided and started to accept the selected treatment (hemodialysis, peritoneal dialysis or conservative treatment). All statistical analyses were performed in SAS statistical software, version 9.4 (SAS, Cary, NC). The effects of the intervention were assessed by generalized estimating equation (GEE) analysis with the coefficient of interaction ( group × time) term. Statistical tests were two-sided with a significance level of 0.05. Hierarchical Linear Model was used to detect the impact of nested within physician.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stage 5 chronic kidney disease who facing decision for dialysis;
* normal cognitive functions;
* be able to read, communicate in Mandarin or Taiwanese;
* ability to express willingness;

Exclusion Criteria:

* vision or hearing function impairment;
* Severe illness;
* Urgent to dialysis for extend life;
* Dialysis modalities Already decided.
Study to Assess Blood Levels of Itraconazole During a Two-Week Period

The objective of this clinical trial is to document the steady state pharmacokinetics and safety of a new itraconazole 200 mg film coated tablet.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.0 and 28.0 kg/m2
* Good physical and mental health status, determined on the basis of the medical history and a general clinical examination.
* Vital signs (blood pressure and heart rate) in supine position within the normal range
* Electrocardiogram (12 lead) considered as normal
* Non-smoker.
* Able to swallow pills
* If subject is a woman of childbearing potential (WOCBP), must agree to use adequate birth control as defined by the protocol

Exclusion Criteria:

* Any disease or physical condition which, in the opinion of the investigator, could impact the pharmacokinetics of the drug
* History or presence of drug abuse or consumption of alcohol
* History of sensitivity or allergy to azoles or related drugs
* Any requirement to be on other drug treatment (except acetaminophen and for WOCBP, hormonal contraceptives)
* Unsuitable veins for repeated venipuncture.
* Clinically significant abnormal ECG
* Nursing mothers and pregnant women, or women of childbearing potential not using adequate contraceptives.
Cardiac Magnetic Resonance Predictors of Outcome of Rhythm Control in Patients with Atrial Fibrillation/Flutter

evaluate the impact of various features in CMR on the mid-term/long-term success rate of rhythm control for paroxysmal atrial fibrillation/flutter .

* Atrial fibrillation/flutter are widely prevalent.
* Reported antiarrhythmic drug efficacy to restore \& maintain sinus rhythm is 52% which is far from optimal.
* On the other hand, 5-year arrhythmia-free survival after catheter ablation was previously reported to be 63%.
* Therefore, there is a need for better characterization of the underlying atrial substrate, to improve treatment outcomes in terms of efficacy and safety

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years.
* Patients undergoing successful cardioversion (pharmacologic or electric) for atrial fibrillation/flutter, OR symptomatic patients with paroxysmal atrial fibrillation/flutter scheduled for trans-catheter ablation.
* Index cardioversion OR Index ablation procedure.

Exclusion Criteria:

* LA thrombus on TEE or CMR.
* Contraindications to CMR.
* Contraindications to Gd-based contrast.
Role of Interleukin-6 in Exercise

The purpose of the study is to understand the role of interleukin-6 during physical activity in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion criteria:

* Obesity group: BMI 30-40 kg/m2, fasting plasma glucose \<6.4 mmol/l.
* Diabetes group: Type 2 diabetes according to American Diabetes Association criteria

Exclusion criteria:

* Anti-diabetic drug other than metformin
* Diabetes duration of more than 5 years
* Inflammatory diseases
* Current infection
* Liver disease (transaminases \>2x upper normal range)
* kidney disease (creatinine \>1.5 mg/dl for men and 1.4 mg/dl for women)
* pregnancy or breast-feeding, women of child bearing potential not using an acceptable form of contraception
* immunosuppressive disease
* corticosteroid use
* regular non-steroidal antinflammatory drug usage
* history of carcinoma
* history of tuberculosis
* anemia, bleeding disorders
* obstructive pulmonary disease.