cyrilzakka/clinical-trials huggingface dataset:
Effects of Statin on Hepatocellular Carcinoma Recurrence After Liver Transplantation

This study aims to investigate whether statin therapy can help prevent recurrence of hepatocellular carcinoma (HCC) in transplant recipients who had liver transplantation for HCC. Multiple logistic regression analysis will be performed to evaluate the association between statin therapy and the risk of HCC recurrence after LT.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received LT at the Severance Hospital from 2006 to 2016.

Exclusion Criteria:

* early postoperative mortality (defined as death within 2 months after LT without signs of tumor recurrence)
* patient with distant lymph node metastasis confirmed within 1 month after LT
* Patients younger than 20 years of age
* patients who had LT for cirrhosis without confirmed HCC
A Research Study on the Effects of NNC0537-1482 in Healthy Individuals When Injected Under the Skin

The study is testing a new medicine to potentially treat people with heart failure. The main purpose of the study is to see if the new study medicine is safe and how it works in the body. It is the first time NNC0537-1482 (the new study medicine) is tested in humans and will be tested in healthy individuals (men and postmenopausal women). Participant will either get NNC0537-1482 or placebo (a "dummy medicine" without any active ingredients). Which treatment the participant get is decided by chance and the participant will only get either the study medicine or placebo on one occasion. It will be injected under the skin of the stomach by the study staff and the number of injections will depend on the cohort participant is assigned to. NNC0537-1482 cannot be prescribed by doctors. The study consists of 6 cohorts (groups) with 6 different dosing levels. The study will last for about 9 months. Participation in the study will last up to 42 days (depending on the cohort participant are assigned to) with an additional screening period that can be up to 28 days. Participant will have up to 10 visits to the clinic during the study period. However, the total number of visits depend on which cohort participant is assigned to.


Eligibility Criteria:
Inclusion Criteria:

* Male or postmenopausal female.
* Age 22-55 years (both inclusive) at the time of signing the informed consent.
* Body Mass Index (BMI) between 18.5 and 30.0 kilogram/meter per square (kg/m\^2) (both inclusive) at screening.
* Considered eligible and generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Known or suspected hypersensitivity to study intervention(s) or related products.
* Use of prescription or non-prescription medicinal products, including herbal medications, within 14 days before screening. Occasional use of over-the-counter vitamins, or paracetamol or Non-steroidal anti-inflammatory drugs (NSAIDs) at their labelled doses for mild pain is permitted.
* Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Orthostatic hypotension, defined as a decrease in systolic blood pressure greater than or equal to 20 millimetres of mercury (mmHg) or a decrease in diastolic blood pressure greater than or equal to 10 (mmHg) from supine to standing after 3 minutes, at the screening visit.
* Any laboratory safety parameters at screening outside the below laboratory ranges for:

  * Alanine Aminotransferase (ALT) greater than (\>) Upper normal limits (UNL) plus (+) 10 Percentage (%)
  * Aspartate Aminotransferase (AST) \> Upper limit normal (ULN) +20%
  * Bilirubin \> ULN + 20%
  * Creatinine \> ULN + 10%
COVID-19 Effectiveness Study in the Philippines

This is a multi-site, observational, prospective test negative design case-control study which primarily aims to determine the protective effectiveness of 2 doses of an inactivated COVID-19 vaccine at least 14 days after the second dose, against hospitalized virologically-confirmed SARS-CoV-2 infection.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Aged 18 years of age and above
* Residing in the catchment area of the participating hospital
* Admitted to the participating hospital with an acute respiratory illness
* Able and willing to provide a naso- and oro-pharyngeal swab for RT-PCR testing

Exclusion Criteria:

* 6.2.2.1 Refusal to participate
Investigation of Gait Parameters in Health and Neurological Disease Under Varying Locomotor Conditions

In the cross-sectional component of this study, our overall objective is to gather a large pool of data from which we can generate gait "profiles". These profiles will consist of a constellation of gait (+/- electrophysiological) parameters associated with a particular neurological diagnosis or specific lesion(s) in neuroanatomical systems. Once developed, these profiles can be compared for differences and similarities; allowing insights into the specificity of the effect on gait of a given diagnosis or lesion in the case of the former and redundancy of neuroanatomical systems in that of the latter. A longitudinal component of the study will look at the evolution of gait parameters over time in a group of patients with spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* age 18 - 80
* written, informed consent
* one of the following established diagnoses: unilateral stroke affecting motor system, Parkinson syndrome, cerebellar disease, vestibular dysfunction, spinal cord injury, multiple sclerosis
* Brain and whole spine T1, T2 \& FLAIR magnetic resonance imaging performed within the last four months and available for study purposes or no contraindications to performing these scans

Healthy subjects:

* age 18 - 80
* written informed consent

Exclusion Criteria:

Patients:

* Colour-blindness
* Known to be pregnant or breastfeeding
* Body mass index (weight in kg/height in metres squared) \>40 Unable to walk 50m within 6 minutes (with or without walking aids) Inability to undertake any component of the trial protocol
* Terminal diagnosis with life expectancy less than six months
* Cognitive disturbance defined as MMSE \< 25 Clinically significant comorbidities such as severe cardiovascular, pulmonary or malignant disease

Healthy subjects:

* Colour-blindness
* Known to be pregnant or breastfeeding
* Body mass index (weight in kg/height in metres squared) \>40 Unable to walk 50m within 6 minutes
* Reliance on walking aids / prostheses for mobilisation
* Significant neurological or orthopaedic diagnosis with potential impact on gait // Previous operations on the lower limbs or spine with potential impact on gait Inability to undertake any component of the trial protocol Clinically significant conditions such as severe cardiovascular, pulmonary or malignant disease
Monitoring of Anaesthesic Depth in the Cerebral Cortex Using Bispectral Bilateral System.

This is a prospective, observational study, aimed to establish changes of bispectral bilateral system in both cerebral hemispheres during a total intravenous anaesthesia during breast surgery in the woman. By placing two Bispectral bilateral sensors (BIS), one on both frontal lobes, and another on both parietal lobes, we wanted to evaluate differences between frontal and parietal areas, when the patient is awake and during the anaesthetic procedure.


Eligibility Criteria:
Inclusion Criteria:

* Aged more than 18 years old.
* Scheduled for general anaesthesia.
* Agree to participate(signed inform consent).

Exclusion Criteria:

* Neurological disease.
* Cognitive impairment.
* Egg allergy.
* Severe disease or condition that could potentially interfere with interpretation of tests.
Screening Test Accuracy of Gynocular™, HR-HPV Testing, VIA for Detection of Cervical Neoplastic Lesions, in Women Living With HIV

Cervical cancer in HIV-positive women is largely preventable through regular screening. The World Health Organization (WHO) recommends cervical screening for HIV-positive women every three years. Currently the least costly method for screening and the most viable option for many countries is visual inspection after application of acetic acid (VIA). Alternative testing methods are HPV testing and assessment with a portable magnification device. The investigators plan to assess and compare the screening test accuracy of these screening tests in women living with HIV. All women will receive histopathology reference standard.

The simplest and least costly method for cervical cancer screening is visual inspection after application of acetic acid (VIA). However, the ability of this screening method to correctly identify precancerous lesions (sensitivity) and women free from these lesions (specificity) is limited. The investigators aim to identify alternative screening methods which maximize sensitivity and specificity, particularly in HIV-infected women in receiving care in Southern Africa. The investigators will evaluate the screening test accuracy of a new portable magnification device , the Gynocular™ with Swede score assessment, in women who are HIV-positive and eligible for cervical cancer screening. The investigators will assess the accuracy of the device when used as a stand alone test, as well as when used subsequent to positive VIA or HPV tests. The investigators will make comparisons with current screening practices (VIA alone), as well as, recommended screening practices (HPV testing). The investigators will enrol 450 HIV-positive women receiving care for HIV/AIDS at the Centre for Infectious Disease Research in Zambia, in Lusaka, Zambia. Consenting women will be screened with VIA, HPV testing and visual assessment with Gynocular™. All women undergo biopsy (reference standard) and receive treatment as indicated and in accordance with national guidelines.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-infected women confirmed through medical records
2. Women residing within Lusaka district and plans to stay in this area for the next 6 months
3. Women between 18 and 65 years of age (age bracket as per Zambian guidelines for cervical cancer screening)
4. Able and willing to consent
5. Willing to undergo a pelvic examination and cancer screening
6. Has had sexual intercourse before
7. Agrees to have follow-up appointment in 6 months

Exclusion Criteria:

1. Women with a history of cervical cancer or previous hysterectomy (where the cervix was also removed)
2. Pregnant women or women who plan to get pregnant within the next 6 months
3. Women who have been vaccinated against HR-HPV
A Study of R1507 in Combination With Multiple Standard Chemotherapy Treatments in Patients With Advanced Solid Tumors

This study will evaluate the safety and tolerability of R1507 in combination with 12 distinct standard chemotherapy drug regimens and an additional R1507 monotherapy arm in patients with advanced malignant neoplasms.The 12 regimens will be tested in parallel. There are 3 subsets of patients who are eligible for the study: untreated, treated and requiring further treatment, or treated and failed and for whom adding R1507 represents a suitable treatment for their disease. All regimens will first test doses of R1507 which are less than the maximally administered dose, and if tolerated, the dose will be escalated in subsequent patients. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* malignant neoplasms;
* failed prior standard curative therapy;
* ECOG performance Status of 0 or 1;
* adequate bone marrow, hepatic and renal function;
* life expectancy greater than 8 weeks.

Exclusion Criteria:

* chemotherapy within 2 weeks of start of therapy;
* prior irradiation within 4 weeks prior to start of therapy;
* prior treatment with agents targeting IGF-IR inhibition, or other investigational agents;
* major surgery or significant traumatic injury within 2 weeks prior to study start;
* patients receiving concurrent antibody or immunotherapy;
* other exclusion criteria are related to specific treatment regimens.
Effect of Ulinastatin on Postoperative Renal Function in Patients Undergoing Robot-assisted Laparoscopic Partial Nephrectomy

Ulinastatin reduces systemic inflammatory responses and protects organs from ischemia/reperfusion-induced injury. The aim of this study is to evaluate the effect of ulinastatin on postoperative renal function in patients undergoing robot-assisted laparoscopic partial nephrectomy. Seventy patients, aged 20 to 79 years, scheduled for robot-assisted laparoscopic partial nephrectomy will be divided into ulinastatin (n=35) and control (n=35) groups. Randomly selected patients of the ulinastatin group are given ulinastatin. In contrast, patients in the control group receive an equivalent volume of normal saline as a placebo. The primary endpoints are postoperative renal function measured by serum creatinine, cystatin C, and urine output.


Eligibility Criteria:
Inclusion Criteria:

* patients who are scheduled to undergo robot-assisted laparoscopic partial nephrectomy with an American Society of Anesthesiologists (ASA) physical status I-III

Exclusion Criteria:

* Subjects are ineligible if they have severe respiratory or cardiovascular disease, renal insufficiency before operation, cognitive dysfunction, are unable to communicate or speak Korean
Use of Laser Assisted New Attachment Procedure and Low Level Laser Therapy for Periodontitis Patients

In this study, it is evaluated the effects of laser assisted new attachment procedure (LANAP) and low level laser therapy (LLLT) and on clinical, biochemical and radiographic parameters in addition to non-surgical periodontal treatment (NSPT).

The study was designed as a randomized-controlled, single-blind and parallel design consisting of 80 patients with chronic periodontitis. Study consists of 4 groups, with 20 patients in each group. Group 1 received only NSPT, Group 2 received NSPT+LANAP, Group 3 received NSPT+LLLT, and Group 4 received NSPT+LANAP+LLLT. Clinical measurements of patients and gingival crevicular fluid (GCF) were taken before treatment and after 1 and 3 months. In GCF, interleukin-1beta, interleukin-10 and vascular endothelial growth factor were analyzed. Standard periapical radiographs were taken for radiographic measurements.

In moderate (4-6 mm) and deep pockets (7 mm and above), it was found that all groups treated with laser significantly decrease pocket depth (PD) and clinic attachment level (CAL) compared to Group 1. Group 3 caused significantly less gingival recession than all other groups. There was no statistical difference between the groups in biochemical markers. Radiographic analysis revealed that only Group 2 achieved significant bone filling compared to Group 1.

Bot LANAP and LLLT application in the deep pockets provide an additional contribution to NSPT. It has been found that LLLT administration leads to decrease in PD by creating a minimum recession.

Eligibility Criteria:
Inclusion Criteria:

* periodontitis of periodontal stage II, III, or IV with grades B
* with at least 12 teeth in the mouth and had ≥4 teeth but not all of them in the same quadrant
* with Probing depth of ≥5 mm, Clinical attachment level of ≥4 mm
* radiographic evidence of alveolar bone loss

Exclusion Criteria:

* smoking
* pregnancy and lactation
* using antibiotics in the last 6 months and anti-inflammatory drugs in the last 3rd months,
* having the systemic disease and the use of the drug that will affect the periodontal condition, having restoration of the adjacent tooth to be collected gingival crevicular fluid
Detection of Plasma Circulating Tumor DNA in Gastric Cancer

The aim of this study is to develop a protocol for detection of circulating tumor DNA (ctDNA) in plasma of patients with early stages of gastric cancer.

Gastric cancer (GC) is the fifth most common cancer worldwide and the third leading cause of cancer deaths. Earlier detection of GC can dramatically increases the five-year survival rate up to \> 90%. The current endoscopy and tissue biopsy remain excessively expensive for middle-income nations, in addition to being fairly invasive, with possible complications. Additionally, most of serum-based biomarkers such as carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), carbohydrate antigen 72-4 (CA72-4), and carbohydrate antigen 125 (CA125) are not recommended for detection of GC due to the limit of specificity and sensitivity in the early stages of GC. Thus, it is essential to identify new biomarkers for diagnosis of early stages of GC. In this study, the investigators develop an ultradeep massive parallel sequencing (MPS) assay to detect tumor derived mutations (TDM) in plasma of early stages of GC. This study provides proof-of-principle for eventual clinical employment of circulating DNA, via liquid biopsy, for detection of early stages of GC.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female patients aged 18 years and older
2. Histologically proven stage (I, II and IIIA) gastric adenocarcinoma
3. Naivety to treatment.
4. No known other concomitant cancer diagnosis
5. Signed informed consent

Exclusion Criteria:

1. Pathologically late stage (stage IIIB and IV) or metastatic gastric adenocarcinoma
2. Underwent any type of treatment
3. Unable to undergo biopsy
Pain Neuroscience Education and Exercise

This study examined the effects of pain neuroscience education plus exercise when compared with exercise only in university students with chronic idiopathic neck pain.

This study examined the effects of pain neuroscience education plus exercise when compared with exercise only in university students with chronic idiopathic neck pain.

University students with chronic neck pain were randomly allocated to receive pain neuroscience education and exercise or exercise only and assessed at baseline, after the intervention and at 3 months follow up. Outcome variables were pain intensity (primary outcome), disability, fear of movement, catastrophizing, knowledge of pain neurophysiology, pressure pain thresholds and neck and scapular muscle endurance.

Eligibility Criteria:
Inclusion Criteria:

* Participants could enter the study if they had chronic idiopathic neck pain, defined as pain felt in the neck at least once a week in the previous 3 months and for which no cause had been established. Furthermore, they were required to have a minimum pain intensity in the previous week of 2 in the visual analogue scale.

Exclusion Criteria:

* Participants were excluded if they had had physiotherapy for their neck pain in the 6 months previous to the study, if they had rheumatic, nervous, cardiac and/or respiratory pathology that could prevent or make it difficult to do the exercises. Exclusion criteria were ascertained by self-report.
Safety of Cat-PAD in Cat Allergic Subjects

Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy. This study will investigate the safety of Cat-PAD administered as increasing single doses.

This study is designed as a two centre, randomised, placebo-controlled, escalating single dose study in up to 88 cat allergic subjects. Cohorts of 8 subjects will be enrolled. Each cohort will undergo screening 14-28 days before treatment and a baseline challenge for EPSR and LPSR to cat allergen injected into the arm 7 days before treatment. On the treatment day, subjects will be injected either intradermally (into the skin) or subcutaneously (under the skin) with a single dose of Cat-PAD or placebo and safety observations made for 8 h. After 21 days, subjects will again have cat allergen injected into the arm and the EPSR and LPSR will be recorded. The dose of Cat-PAD will be increased in successive cohorts, provided that the previous dose tested was well tolerated.

Eligibility Criteria:
Inclusion Criteria:

* A reliable history of rhinoconjunctivitis (sneezing, rhinorrhoea, nasal blockage, itchy/red/sore/watering eyes) or controlled asthma (GINA (2006) classification 1) on exposure to cats for at least 1 year.
* Late-Phase Allergic Skin Reaction (LPSR) to 0.010 HEP units Leti cat allergen eight hours after intradermal injection of greater than 25mm diameter response on single arm.

Exclusion Criteria:

* Subjects with asthma falling under GINA(2006) classification 2 (partly controlled) and 3 (uncontrolled).
* A history of anaphylaxis to cat allergen.
* Subjects with a cat specific IgE \>100 kU/L.
* Subjects with an FEV1 \<80% of normal.
* Subjects with an acute phase skin response to cat allergen with a weal diameter \> 30mm.
* Subjects who suffer from hay fever, and cannot complete the clinical study outside the pollen season.
* Allergen immunotherapy during the last 5 years or Cat Dander immunotherapy ever.
* Use of the following therapies for the periods specified prior to the screening visit will make the subject ineligible for the study: corticosteroids: (depot: 90 days; systemic: 30 days; dermatological, intranasal, inhalational: 15 days); cromones (14 days); antihistamines other than loratadine (nasal and long-acting oral: 10 days; short-acting oral, ocular: 7 days); leukotriene inhibitors (10 days); anticholinergics (7 days); alpha-adrenergic agonists (7 days); tricyclic antidepressants (14 days). If it becomes a medical necessity for a subject to use one of these contraindicated medications during the study this will become an individual stopping criteria.
* Subjects for whom administration of adrenaline is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
* Subjects being treated with beta-blockers
Registry-based Biobank Development and Integrative Physiological Analysis

The purpose is to develop a registry-based biobank for integrative physiological analysis based on biological samples (blood, urine, interstitial fluid and muscle) from subjects enrolled in the Section registry, using multivariate and data-mining approaches that includes also clinical and demographic parameters


Eligibility Criteria:
Inclusion Criteria:

* able to perform fatiguing exercise

Exclusion Criteria:

* severe mental or physical handicap
* chronic disease deemed by the M.D. to preclude inclusion
* use of prescription medicine deemed by the M.D. to preclude inclusion
Tolerability of Pentasa Sachet in Patients With Ulcerative Colitis

Confirmation of safety profile


Eligibility Criteria:
Inclusion Criteria:

* treatment of Ulcerative Colitis

Exclusion Criteria:

* hypersensitivity to mesalazine
* severe liver or renal impairment