cyrilzakka/clinical-trials huggingface dataset:
The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC74647 in HCV-infected Subjects

The goal of this study is to assess the tolerability, pharmacokinetics and antiviral activity of HEC74647 in HCV treatment naïve subjects with genotypes 1-6.

All subjects will be receive QD doses of HEC74647 or the matching placebo for 3 days to assess the the tolerability, pharmacokinetics and antiviral activity at specified time-points during the study.All subjects also will be monitored for up to 8 days post-dose to determine the persistence of viral mutations.

Eligibility Criteria:
Inclusion Criteria:

* Able to comprehend and sign the ICF voluntarily prior to initiate the study;
* Able to complete the study according to the protocol;
* Agree to use protocol defined precautions against pregnancy
* Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 30 kg/m2, inclusive;
* HCV treatment-naïve adult subjects with GT1-6 HCV infection
* HCV RNA level ≥ 5 log10 IU/mL at screening
* FibroScan score within 6 months≤12.5 kPa or Liver biopsy results within 12 months proved Non-cirrhosis

Exclusion Criteria:

* Smokers, who smoke more than 5 cigarettes/day within 3 months before the study;
* Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
* Donated blood or massive blood loss within 3 months before screening (\>450 mL）;
* Have any disease that increases the risk of bleeding, such as acute gastritis or stomach and duodenal ulcers;
* Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days prior to screening;
* Have taken any drug that inhibit gastric acid secretion, such as H2 receptor antagonist famotidine and proton pump inhibitor omeprazole;
* Have participated in any clinical trial or taken any study drug within 3 months before dosing;
* Positive test result of HBV,HIV or syphilis;
* Solid organ transplanters
Comparing Efficacy of Postoperative Oral Antibiotic Use in Trans-Oral Thyroidectomy

Transoral endoscopic thyroid surgery is a emerging surgical technique for thyroid surgery. This study to investigate the need for postoperative antibiotics in transoral endoscopic thyroid surgery.

To prevent possible infection from the oral cavity flora, most surgeons prescribe postoperative oral antibiotics more than 3 to 7 days after surgery. Currently, there's no clinical evidence that postoperative oral antibiotics is necessary or not in transoral endoscopic thyroid surgery. The investigator will conduct randomization after transoral thyroid surgery with two groups : postoperative oral antibiotics group versus no oral antibiotics group.

Eligibility Criteria:
Inclusion Criteria:

* Patients who planned to Transoral endoscopic thyroidectomy
* Age between 20 to 70
* Voluntarily consenting to the study and study agreement
* No local invasion or distant metastasis
* Normal vocal cord function in laryngoscopic exam
* No significant abnormalities in preoperative laboratory tests

Exclusion Criteria:

* Take aspirin or antiplatelet drugs within 7 days before admission
* Uncontrolled hypertension, diabetes, chronic renal failure, or coagulation disease
* History of cardiovascular disease (angina pectoris, heart failure, myocardial infarction, history of coronary artery disease, stroke, transient ischemic attack)
* Substance abuse and alcohol abuse
* History of esophageal and airway diseases
* Patient was participated in other clinical trials within 30 days
* History of neck irradiation or surgery
* History of drug allergies
* Pregnant or lactating women
Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair

Objective of the present study is to compare endovascular repair versus surveillance and, eventually delay treatment in patients with small abdominal aortic aneurysms (AAA), with respect to patient survival, AAA rupture and AAA related death risks.

The study will include patients with small AAA (diameter 4.1 to 5.4 cm defined by Computed Tomographic scan) suitable for endovascular repair (EVAR).

Randomization is designed with equal probability of assignment to each of the two groups (ie, immediate endovascular repair or surveillance group) by means of a computer-generated -random-number list . After eligibility is verified, assignment will be made using a computer database held at the Coordinating Centre.

In the immediate repair group, endovascular repair with introduction of an aortic endograft (Cook Zenith) will be performed within six weeks from randomization.

In the surveillance group, patients are followed without repair until the aneurysm reaches 5.5 cm in diameter, or enlarges at least 1.0 cm in one year, or until patient develops symptoms that are attributed to the aneurysm by the attending investigator. When one of these criteria is met, endovascular repair (if the patient remains a candidate for EVAR), or open repair will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Patients of 50-80 years of age
* Non symptomatic infrarenal AAA of 4.1 to 5.4 cm in diameter measured by CT performed within 3 months before randomization
* Adequate infrarenal aortic neck (length \> 15 mm diameter \< 30 mm) and other anatomical configurations suitable for EVAR
* Patients have a life expectancy of at least 5 years
* Signed informed consent

Exclusion Criteria:

* Ruptured or symptomatic AAA
* AAA maximum diameter \>= 5.5 cm
* Suprarenal or thoracic aorta aneurysm of more than 4.0 cm
* Patient unsuitable for administration of contrast agent
* Severe heart, lung, liver or renal disease (serum creatinine \>= 3mg/dl)
* Need for adjunctive major surgical or vascular procedures within 1 month
* High likelihood of non compliance with follow-up requirements
Advanced Translational Research on Childhood Leukemia

Prognosis of children with leukemia, the most common pediatric cancer, has improved markedly. Yet, relapse still occurs in 15-40% of patients with a probability of survival of \<50%, which is unlikely to be boosted by intensification of standard chemotherapy due to overwhelming toxicity. The advent of effective and safe targeted therapies for high-risk cases is therefore imperative. This study constitutes two research projects aiming at driving therapeutic advances.

The first part of the study aimed to investigate genomics and drug sensitivity profiling of childhood leukemia and its potential application for precision medicine.

The second part of the study aimed to develop novel antibody for treatment of childhood leukemia by animal model experiments.

Design:

Project 1: Whole-exome and RNA sequencing will be performed on children with leukemia (ALL, AML, MPAL, JMML, MDS) prospectively recruited in the Hong Kong Children's Hospital. Samples will be screened for their sensitivity to preselected, clinically accessible targeted agents in an ex vivo culture system. Results for the high-risk patients will be subjected to the tumor broad for evaluation.

Project 2: Fully human antibody candidates identified by phage display will be engineered into therapeutic forms, and assessed for efficacy and safety in patient-derived xenografts of relapsed/refractory B-ALL and in transgenic mice. The mechanisms of action will be identified by single-cell RNA sequencing.

Significance:

Implementation of functional genomics could identify leukemia patients who will benefit from targeted therapies and enable tailoring of precision medicine. The invented antibodies could be moved forward into clinical trials for salvaging high-risk pediatric B-ALL. Immediate and long-term impact on therapy of childhood leukemia is foreseen.

Eligibility Criteria:
List of inclusion criteria:

1. acute lymphoblastic leukemia (ALL) or
2. acute myeloid leukemia (AML) or

3 .mixed phenotype acute leukemia (MPAL) or

4. juvenile myelomonocytic leukemia (JMML) or

5. myelodysplastic syndromes (MDS) or

6. normal bone marrow donor

List of exclusion criteria:

1. This study will not recruit subjects who are unable to understand English or Chinese.
2. Patient or parent refusal
Certican (Everolimus) for Recipients of Kidney From HLA-identical Living Donors

Recipients from living donors kidneys HLA-identical were lower risk for acute rejection, graft loss or death. There is no clear definition of what is ideal immunosuppressive regimen for this population.

Everolimus (EVR) was associated with lower incidence of viral infections and also the lowest incidence of neoplasms. Furthermore, immunosuppressive regimens based everolimus allow the reduction or elimination of calcineurin inhibitors reducing cardiovascular risks associated with chronic use of these agents. Moreover, the use of EVR is associated with increased incidence of proteinuria, which associated mechanism has not been fully elucidated. Knowing that proteinuria may be the first indication of recurrence of the underlying renal disease, detailed information about the patient's medical history and histological analysis of the graft may contribute with additional knowledge in this area.

The aim of this prospective, open, single arm study that will be performed only in the Hospital do Rim e Hipertensão, is investigating the outcomes of kidney transplantation in recipients of HLA identical living donor, receiving an everolimus-based immunosuppressive regimen. This will include 100 recipients of first or second kidney transplant from a living donor HLA identical to the Kidney and Hypertension Hospital, which will be followed by a period of 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Adult candidates of first or repeat kidney transplant HLA identical living donors;
2. Patient who signed the informed consent form to participate in this study;

Exclusion Criteria:

1. Patients were excluded if they had been receiving immunosuppressive therapy before transplantation;
2. Patients who received an investigational medication within the past 12 months;
3. Patients with suspected or known to have an infection or were seropositive for hepatitis B surface antigen (HBsAg), antibody against hepatitis B core antigen (anti-HBcAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);
4. Patient who had had cancer (except nonmelanoma skin cancer) within the previous 2 years.
5. Pregnant women, nursing mothers, and women of childbearing potential who were not using condoms or oral contraceptives were excluded.
Assessment of Indocyanine Green as a Near-Infrared Fluorescent Contrast Agent for Image-guided Liver Surgery

This is a prospective, monocentric, non-randomized, phase I-II study. The goal is to assess the faisability and the capabilities of fluorescence imaging in hepatic surgery, and specially to help the surgeon while performing liver surgery.

This study will be performed on patient intended to undergo a liver cancer surgery.It will contain three steps, assessing the following items:

* Step 1: to assess the faisability of the use of the Fluobeam, in actual clinical surgical conditions and validate the data obtained in the preclinical phase,
* Step 2: to assess the ability of the combination of ICG and Fluobeam to mark hepatic lesions,
* Step 3: to assess the ability of the combination of ICG and Fluobeam to help in guiding per-hepatectomy.

  3 to 6 patients will be enrolled in the first step, 20 in the second step and 20 in the third step.

Patients will be followed during 4 weeks after the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Affected of hepatic cancerous lesions whatever they are
* Requiring a one or two steps hepatectomy by laparotomy
* ECOG performance status (PS)≤ 2
* Mandatory affiliation to health security insurance
* Written informed consent

Exclusion Criteria:

* With a contraindication or hypersensitivity to ICG administration in medical history
* Having already undergone a major hepatic surgery (more than three segments) or major biliar surgery (context of major iterative hepatic surgery)
* Unable to be followed during the duration of the study, for social, family, geographical or psychological reasons
* Pregnant or breast-feeding woman (urinary strip must be negative at the time of the inclusion in the study for women in age to procreate)
The Effect of SHOTBLOCKER

This study was conducted as a randomized controlled experimental cross over study to examine the effect of injection pain, anxiety and comfort level with the use of Shotblocker in geriatric patients undergoing subcutaneous injection. The study was defined on 80 patients who were inpatients in the internal wards of a hospital, and the experimental and control groups, which provided the appropriate conditions for the study, included the same people. Ethics committee approval, institutional permission and written informed consent forms were obtained from the individuals. Data were obtained by the researcher using Personal Information Form, Visual Analog Scale (VAS), State and Trait Anxiety Scale, Comfort Scale, Visual Patient Satisfaction Scale and Shotblocker.

This study was conducted as a randomized controlled experimental cross over study to examine the effect of injection pain, anxiety and comfort level with the use of Shotblocker in geriatric patients undergoing subcutaneous injection. The study was defined on 80 patients who were inpatients in the internal wards of a hospital, and the experimental and control groups, which provided the appropriate conditions for the study, included the same people. Ethics committee approval, institutional permission and written informed consent forms were obtained from the individuals. Data were obtained by the researcher using Personal Information Form, Visual Analog Scale (VAS), State and Trait Anxiety Scale, Comfort Scale, Visual Patient Satisfaction Scale and Shotblocker.

Eligibility Criteria:
Inclusion Criteria:

Voluntary participants in the study, Over 65 years of age, Cognitive ability to answer the questions, Body Mass Index (BMI) 18.5- 29.9 kg / m2, No communication problems, Subcutaneous injection in the treatment, No bleeding coagulation disorder, Platelet, INR and APTT values within normal limits, No scar tissue, incision or infection findings in the injection area, No history of allergy

Exclusion Criteria:

Patients with amputation in the right/left arm area to be studied, Patients with any scar tissue, incision, lipodystrophy or signs of infection in the injection area in the arm area, Patients receiving hemodialysis treatment and having a dialysis catheter, Patients who underwent mastectomy surgery and should not undergo any application/treatment on the arm on the operated side were excluded from the study.
Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)

The purpose of this study is to assess the safety, efficacy, and durability of up to two REACT injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with T1DM or T2DM and CKD.

The objective of this study is to assess the safety, efficacy, and durability of up to two REACT injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with T1DM or T2DM and CKD:

* Cohort 1: Two scheduled REACT injections given 3 months (+60 days) with at least 18- month follow-up
* Cohort 2: One scheduled REACT injection with a possible second REACT injection, no less than 3 months after the first one, within 30 days (+30 days) of meeting a renal function redose trigger (triggered up to 15 months following the first REACT injection).

Both cohorts will be followed for 18 months after the final REACT injection. If a Cohort 2 subject does not meet a trigger, the subject will be followed for at least 18 months after the first injection.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 30 to 80 years, inclusive, on the date informed consent is signed.
2. Clinical diagnosis of T1DM or T2DM, controlled per institutional standard of care.
3. The subject has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy).
4. The subject has a serum glycosylated hemoglobin (HbA1c) level less than 10% at the Screening Visit.
5. The subject has a documented clinical diagnosis of an eGFR between 20 and 50 mL/min/1.73m² inclusive not requiring renal dialysis.

Exclusion Criteria:

1. The subject has a history of renal transplantation.
2. The subject has a mean systolic blood pressure greater than or equal to 140 mmHg and/or mean diastolic blood pressure greater than or equal to 90 mmHg at screening.

   Subjects with blood pressure outside of this range prior to biopsy/injection may continue if approved by the Medical Monitor.
3. The subject has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization.
Deformable Registration of Multi-parametric MRI to Intra-operative Transrectal Ultrasound for Prostate Brachytherapy

Objective:

To focus the high dose radiation to the gross tumor in the prostate while maintaining adequate dose for control of microscopic disease elsewhere in the prostate.

In order to test the incorporation of the robust MRI and TRUS fusion algorithm in the clinical setting the investigators planned a study of Focused therapy with a primary endpoint of accurate localization of the high risk region. This is a pilot study of dose painted permanent I-125 seed implant to verify absence of tumor cells outside a high risk region using multi-parametric MRI and deformable TRUS registration. The high risk region will be dose painted to 160 Gy and the rest of the prostate will receive the normal prescription dose.

Primary end-point:

Feasibility of dose painting will be determined by the absence of tumor outside the high-risk region on an intra-operative trans-perineal biopsy.

Frozen sections will not be obtained, however on receipt of the final pathology 2-4 weeks after the procedure 2 possible scenarios arise:

1. There is no evidence of cancer: this confirms the accuracy of the TRUS MRI registration.
2. There is evidence of tumor on the stereotactic biopsy: In this case a regular dosimetric check (this is performed in the Standard of care procedure and is known as post-operative dosimetry) will be performed to determine whether adequate dose was delivered. If not, as the involved needle position was recorded in the treatment plan and labeled with co-ordinates, the regular possibility of accurately adding radioactive seeds is possible.

Eligibility Criteria:
Inclusion Criteria:

* Men suitable for monotherapy with permanent Iodine 125 implant

  * Age \> 50 yrs
  * PS 0-2 (WHO)
  * Histologic diagnosis of prostate adenocarcinoma made on transrectal guided prostate biopsy with no fewer than 12 cores taken
  * No more than 50% of cores involved (summary)
  * MRI of Prostate with Diffusion Weighted Imaging and Dynamic Contrast Enhancement with demonstrable lesion compatible with biopsy result
  * Gleason sum no greater than 3+4 =7 in any core
  * Clinical T stage no higher than T T (tumor) 2A
  * Prostate volume ≤60 cc
  * Serum prostate-specific antigen (PSA) no higher than 15 ng/mL
  * No prior history of malignancy except non-melanoma skin cancer
  * Must be suitable for general or spinal anesthesia

Exclusion Criteria:

Have anesthesia surgical assignment category IV or greater

* Cannot cease anti-coagulant therapy
* Had a malignancy, other than prostate or skin cancer (except malignant melanoma), within 5 years
* urethral stricture
* Prior prostate cancer therapies
Anatomical Radiofrequency Ablation for Small Hepatocellular Carcinoma

The aim of this study is to investigate therapeutic outcomes of anatomical radiofrequency ablation for peripherally located small hepatocellular carcinoma using combined energy delivery mode and triple cooled-wet electrodes.


Eligibility Criteria:
Inclusion Criteria:

* Child-Pugh class A or B7.
* Presence of chronic hepatitis B or liver cirrhosis.
* Patients with hepatocellular carcinomas diagnosed by histopathology or noninvasive imaging-based diagnosis according to the Korean Liver Cancer Association-National Cancer Center Korea guidelines.
* Patients with viable hepatocellular carcinoma after locoregional treatment diagnosed by the Liver Imaging Reporting and Data System.
* Tumor location is less than 5 cm from liver capsule.

Exclusion Criteria:

* The number of tumor is three or more.
* Tumor size is over 3 cm.
* Tumor location is over 5 cm from liver capsule.
* Child-Pugh class B8-9 or C.
* Presence of macrovascular invasion and/or distant metastasis.
* Platelet count \< 50,000 mm3, or international normalized ratio \> 1.5 (prothrombin time \>1.5 × normal).
Anorexia and Personality Traits in Elderly Individuals

The aim of this study is to evaluate the relationship between age-related anorexia and personality traits in elderly individuals with comorbidities.

There is no study in the literature investigating the relationship between personality traits and age-related anorexia. The aim of this study is to evaluate the relationship between age-related anorexia and personality traits in elderly individuals with comorbidities.

Eligibility Criteria:
Inclusion Criteria:

* Being 65 years or older,
* Volunteering to participate in the study,
* Being conscious and not having communication problems,
* Having a Charlson comorbidity index of 1 or higher and/or a diagnosis of hypertension,
* Being fed orally.

Exclusion Criteria:

* oropharyngeal dysphagia,
* Presence of neurological or muscular disease that prevents swallowing,
* Being fed by nasogastric tube, percutaneous endoscopic gastrostomy or intravenous nutrition,
* Using drugs that affect appetite (corticosteroid, cancer chemotherapy digoxin, opioids, serotonin reuptake inhibitors, topiramate),
* Using appetizers (megestrol acetate, dronabinol, mirtazapine, growth hormone analogue),
* Having an active cancer disease,
* Major neuro-psychiatric disease (Alzheimer's, dementia, major depression, mania, psychosis, etc.),
* Presence of acute infection,
* Not having sufficient communication skills (Mini Mental Test score below 24 points).
Standardization of Laparoscopic Hernia Repair

Incisional hernias are one of the most frequent complications in abdominal surgery. Laparoscopic repair is widely used but even not standardized. Existing data from different study designs show no representative data resulting in a lack of comparability and evidence. Therefore the standardization of operative techique has been proposed by the LIPOM-study group and will be assessed in a prospective manner.

Data are scheduled for publication.

Eligibility Criteria:
Inclusion Criteria:

* Primary incisional hernia
* Hernia size EHS W 1-2
* Hernia location EHS M 1-5, L 1-3
* Clinical symptoms or progressive growth of hernia

Exclusion Criteria:

* Recurrent incisional hernia
* Ventral hernie
* Hernia size \> EHS W 2
* Hernia location EHS L 4, ASA \>3
* Prospective mesh overlap \< 5 cm
* Malignant disease