cyrilzakka/clinical-trials huggingface dataset:
Investigation of the Safety, Dosing Frequency and Anti-Scarring Potential of Two Concentrations of Intradermal Avotermin (Juvista)

The purpose of this study is to investigate the dosing frequency, wound healing (re-epithelialisation) and anti-scarring effects of one, three and five applications of two concentrations of intradermal RN1001 in healthy male subjects.

Subjects were randomised into two cohorts, to receive either 5 ng avotermin doses or 50 ng doses, with a minimum of 21 subjects per cohort. Within each cohort subjects were randomised into one of three dosing groups (7 subjects per group).

Subjects were to receive four 3 mm punch biopsies, two on the upper-inner aspect of each arm. One treatment was randomly allocated to one biopsy on one arm, with the opposite biopsy on the other arm set to receive the same treatment. The other treatment was administered to the other two biopsies (one on each arm. This allowed for control of possible positional effects on healing.

Three subjects per group received intradermal avotermin to one of the biopsies on each arm and intradermal placebo to the other biopsies. A different three subjects received intradermal avotermin to one of the biopsies on each arm and standard care only to the other biopsies. The final subject per group received intradermal placebo to one of the biopsies on each arm and standard care only to the other biopsy.

On day 0 biopsy sites were marked on both arms and following local anaesthesia avotermin, placebo or nothing was injected intradermally into the allocated sites. Subjects in dosing frequency group 1 (DFG 1) were dosed only once (day 0), subjects in DFG 2 were dosed three times (day 0, 1 and 2) and subjects in DFG 3 were dosed five times (day 0, 1, 2, 3 and 4).

On Day 5, all subjects had their punch biopsy wounds on one arm only re-dosed as per Day 0 and then excised with a 5 mm surgical ellipse. Subjects in DFG2 and DFG3 received further re-dosing on their excised punch biopsies as before, i.e. three doses for DFG2 and five doses for DFG3.

Subjects returned for a first follow-up at day 14 and then at months 2, 4 and 6 to examine for anti-scarring effects. At month 6 all scars were excised for histological examination.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-Caribbean, male subjects aged 18-45 years inclusive
* Weight between 60-150 kg and a BMI within the permitted range for their height using Quetelet's index (15-45 kg/m(squared)) (weight (kg)/height (squared)(m))
* Subjects who have a previous history of surgery or minor injury and who have not developed any evidence of hypertrophic or keloid scar formation

Exclusion Criteria:

* Subjects who have a history or evidence of hypertrophic or keloid scarring
* Subjects with tattoos or previous scars in the area to be biopsied
* Subjects who have evidence of any past or present clinically significant disease, particularly coagulation disorders
Evaluation of Diagnostic Accuracy of MCG(Magnetocardiography) Scan in Suspected Coronary Artery Disease

This multicenter clinical trial is designed to evaluate the diagnostic accuracy of MCG scan in detecting significant CAD compared to the reference standard CAG.

This is multicenter, prospective, observational trial to evaluate the diagnostic accuracy of magnetocardiography(MCG) scan in detecting significant coronary artery disease(CAD) compared to the reference standard coronary arteriography(CAG). Chest pain patients scheduled for CAG will be offered to enroll in this clinical trial and provide informed consent to undergo with a rest/stress MCG scan prior to CAG. This MCG scan with a new 96 channel superconducting quantum interference device(SQUID) system is radiation-free, contactless and takes less than ten minutes to complete. Multiple studies have shown that the diagnostic accuracy of stress MCG scan is quite high in identifying patients with symptomatic CAD. Results will be interpreted and compared to the results of cardiac SPECT stress test, if available, and CAG. Participants will be followed up to 30 days via phone call or chart review. 30 day major adverse cardiac event(MACE) will be recorded and correlated with initial MCG scan results.

Eligibility Criteria:
Inclusion Criteria:

* Over 19 years of age at the time of enrollment
* Patient presenting for CAG
* Consents to having an MCG scan study

Exclusion Criteria:

* Patients unable to fit into MCG scan device
* Patients with implanted cardiac pacemakers/defibrillators
* Atrial fibrillation with rapid ventricular response
* Patients with other sustained or incessant arrhythmias
* Presence clinical suspicious of any acute coronary syndrome
Dendritic Cell Based Therapy of Malignant Melanoma

The aim of the study is to show if vaccination with autologous dendritic cells pulsed with peptides or tumor lysate in combination with adjuvant cytokines and Cyclophosphamide can induce a measurable immune response in patients with metastatic malignant melanoma, and to evaluate the clinical effect (objective response rate) of the vaccination regime.

Eligible patients receive vaccination with tumor antigen pulsed autologous monocyte-derived mature dendritic cells with a fixed interval. The dendritic cells are generated from leukapheresis products and frozen after antigen loading.

HLA A2 positive patients are treated with PADRE and oncopeptide pulsed DC; p53, survivin and telomerase peptides. HLA A2 negative patients are treated with KLH and tumorlysate pulsed DC; autologous or allogeneic. Each patient is given 6 immunizations with at least 5x106 peptide/lysate pulsed autologous DC. Vaccination 1-4 is given weekly and 4-6 at 2-week intervals. Those patients who exhibit stable disease, partial response or complete response after 6 injections will be given 4 more vaccinations at 2-week interval. The vaccine is applied by intradermal injection near the inguinal region.

IL-2 2 MIU s.c. day 2-6, Cyclophosphamide (Sendoxan®, Baxter A/S) 50 mg twice a day bi-weekly and 200 mg Celecoxib (Celebra®, Pfizer) daily are used. Scans and re-staging tests are performed at scheduled intervals throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven progressive metastatic or locally advanced melanoma
* No standard treatment indicated
* Age: \> 18
* WHO-Performance Status 0-1
* At least tone measurable tumor lesions according to the RECIST criteria.
* Life expectancy more than 3 months
* Acceptable CBC and blood chemistry results
* Written informed consent

Exclusion Criteria:

* Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).
* Patients with metastatic disease in the central nervous system (CNS).
* Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
* Patients with acute or chronic infection including HIV, hepatitis and tuberculosis.
* Patients who are pregnant.
* Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial.
* Patients who receive corticosteroids or other immunosuppressive agents.
* Baseline serum LDH greater than 2.5 times the upper limit of normal.
* Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice

This study evaluates the effectiveness and safety rotational atherectomy in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 19 years old
* Patients who received rotational atherectomy
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

* Life expectancy \<1y
VR-assisted Curriculum on Depression for Stigma Reduction

Two randomised controlled trials will be conducted to evaluate a virtual reality (VR) simulation designed to reduce stigma against depression. Qualitative interviews will also be carried out to evaluate the VR simulation.

The investigators examine the impact of a VR-assisted curriculum on stigma reduction towards individuals with depression. This is done through the development and evaluation of a VR-assisted curriculum that promotes stigma reduction towards depression among tertiary-aged students. Collection of data will provide insights about the effectiveness of VR's immersive quality in enhancing stigma reduction skills through measures of attitudes, beliefs and knowledge about depression. In the first study, VR is compared with traditional pamphlets in an information sharing booth about depression. In the second study, participants attend a 30-min session where they undergo an educational curriculum with either a VR or standard video as adjunctive tools.

Eligibility Criteria:
Inclusion Criteria:

* Tertiary students from NUS and Yale-NUS only

Exclusion Criteria:

* History of medical or psychiatric disorder; History of motion sickness, dizziness or epilepsy; (For reliability and safety of heart-rate monitoring) Tattoos near the wrist and/or nickel or acrylate allergies
Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China

To determine if duloxetine 60mg up to 120mg daily can work in treating pain from Diabetic Neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months.
* May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study.
* Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.

Exclusion Criteria:

* Glycosylated hemoglobin (A1C) \> 12%
* Severe hepatic disease
* History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
* Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis), kidney, respiratory, blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or likely to lead to hospitalization during the course of the study.
* Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study.
* Treatment of fluoxetine within 30 days of starting the study.
* Unstable blood sugar control and uncontrolled or poorly controlled hypertension.
Facilitating the Implementation of Interim Methadone to Increase Treatment Access

The primary aim of this study is to evaluate the effectiveness of Implementation Facilitation (IF) in promoting increased accessibility to methadone treatment.

This is a Type 3 implementation-effectiveness type study using a modified stepped wedge design. The study's purpose is to examine the effectiveness of Implementation Facilitation (IF) to prompt participating Opioid Treatment Programs (OTPs) to utilize interim methadone treatment and other approaches to reduce OTP admission delays. Interim methadone treamtent is an evidence-based practice permitted under federal OTP regulations to provide methadone treatment without routine counseling for individuals requesting methadone treatment who otherwise would not be able to be admitted to such treatment within 14 days of request. The study will be conducted at six OTPs in the US that are unable to admit individuals within 14 days of their request for methadone treatment. The OTPs will participate in a baseline Pre-Implementation Phase, an Implementation Phase, followed by a Sustainability Phase. OTPs will be randomly assigned in groups of two to the order in which they will initiate the Implementation Phase. IF will be delivered at the level of the OTP staff and their state health department official responsible for OTP oversight. OTP staff and state health department officials will be interviewed regarding facilitators and barriers to implementing interim methadone and other approaches to reduce admission delays. De-identified data will be gathered from the OTPs on the effectiveness of IF in prompting the implementation of interim methadone and reducing admission delays.

Eligibility Criteria:
Inclusion Criteria (Staff):

* OTP staff
* State health department staff responsible for OTP oversight

Exclusion Criteria:

* Unwilling to be interviewed

Inclusion Criteria (OTP applicants):

* requesting admission to OTP

Exclusion Criteria:

* None
Emergency Medicine Pharmacist Prescriptive Authority for Resolution of Outpatient Prescription Issues

The study aims to document the utility of Methodist Charlton Medical Center (MCMC's)Emergency Medicine Pharmacist (EMP) Collaborative Practice Agreement (CPA )utilization for the resolution of outpatient prescription issues. Evaluation of utility will involve describing all EMP-written prescriptions pursuant to resolution of prescription issues realized after discharge.

Use of an EMP CPA, which allows for broad prescriptive authority, will assist Emergency Department (ED )workflow by preventing a significant volume of new prescriptions needing to be sent by physician and mid-level providers. Will improve rates of ED re-visits. In addition, this Collaborative Practice Agreement (CPA) will not be associated with a large volume of new prescription errors.

Eligibility Criteria:
Inclusion Criteria:

* Patients at MCMC who had a prescription sent by an EMP between November 1, 2021 and June 30, 2023 and a progress note and documenting the reason for the call and action taken by the EMP.

Exclusion Criteria:

* CPA actions were misclassified as discharge prescription issue resolutions.
* Patients with prescriptions pursuant to late culture review, formulation changes not requiring a new prescription, prescription transfers to another pharmacy, or simple retransmission of prescriptions.
* Patients documented to have left the ED against medical advice.
Comparison of Efficacy of Different Dosages Vitamin K2

Vitamin K is a group name for a number of compounds: K1 is present in chloroplasts in green vegetables, K2 is of microbial origin. Lactic bacteria produce a mixture of higher menaquinones, including menaquinone-7, menaquinone-8, and menaquinone-9. Nothing is known yet about the efficacy of bacterial K2 vitamins for in vivo K function (carboxylation of essential proteins). Therefore, this study was undertaken to study effects of different dosages of bacterial vitamin K2 on carboxylation of extrahepatic proteins.

Vitamin K is a group name for a number of compounds: K1 is present in chloroplasts in green vegetables, K2 is of microbial origin. Lactic bacteria produce a mixture of higher menaquinones, including menaquinone-7, menaquinone-8, and menaquinone-9. Higher menaquinones not only have very long half-life times (over 3 days rather than 1 hour for vitamin K1); K2 vitamins are also transported to extra hepatic tissues such as bone and vessel wall whereas K1 is preferentially transported to the liver. Nothing is known yet about the efficacy of bacterial K2 vitamins for in vivo K function (carboxylation of essential proteins). This study describes a dose-response experiment for different dosages of bacterial K2 which are compared with one selected dose of K1 and placebo. The efficacy is concluded from the carboxylation of the bone Gla-protein osteocalcin and of the vascular Gla-protein matrix-Gla protein (MGP).

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women between 40 and 60 years old
* Subjects of normal body weight and height according to BMI \< 30
* Subjects of Caucasian race
* Subject has given written consent to take part in the study

Exclusion Criteria:

* Subjects with (a history of) metabolic or gastrointestinal disease
* Subjects presenting chronic degenerative and/or inflammatory disease
* Subjects presenting diabetes mellitus
* Abuse of drugs and/or alcohol
* Subjects receiving corticoϊd treatment including inhalators
* Subjects using oral anticoagulants
* Subjects using vitamin K containing multivitamins or vitamin K supplements
Switchability Study Between Brand and Generic Topiramate

The purpose of the study is to prove the bioequivalence of brand and generic topiramate.

Generic antiepileptic drugs (AED) achieve blood concentration similar to the brand AED. However, controversies exist about efficacy and safety of substituting generic AEDs. Because even minor absorption and kinetic differences can elicit a breakthrough seizure in patients who are changed to a generic AED from brand AED. Therefore, more ideal evaluation of interchangeability from the brand AEDs to generic formulation of the same drug is three-way or four-way crossover study, which can evaluate within-subject variability in pharmacokinetic and pharmacodynamic. Investigator designed four-way crossover study aimed to assess bioequivalence of brand and generic topiramate, to measure trough serum level , and to evaluate efficacy, tolerability and side effect of generic topiramate.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-65 years
* Patients with epilepsy who take by topamax 100mg bid or who need to take topamax 100mg bid

Exclusion Criteria:

* poor compliance
* subjects whose dose of antiepileptic drug are changed during the study
* subjects whose seizure is not well-controlled judged by neurologist
* history of any kind of drug allergy
* pregnancy or nursing
* existing or recent significant disease (cardiac, hepatic, or renal disease, severe diabetes mellitus, sepsis, etc.)
Randomized Controlled Trial for Retractor SPONGE Evaluation in Laparoscopic Colorectal Surgery

To achieve an adequate visual working field during laparoscopic colorectal surgery without disturbance of the small intestine, patients are positioned in Trendelenburg position. This position results in hemodynamic changes which may increase the risk of cardiopulmonary complications and prolonged hospital stay. Recently, an intraoperative retractor sponge was introduced as alternative for the Trendelenburg position during laparoscopic surgery.

Objective: To study the impact of use of an intraoperative retractor sponge on duration of hospital stay and risk of perioperative complications in patients undergoing laparoscopic surgery for colorectal cancer.

Study design: Randomized controlled trial, nested within a prospective cohort according to the 'cohort multiple randomized controlled trial' (cmRCT) design (clinicaltrials.gov NCT02070146).

Study population: Patients with colorectal cancer who undergo laparoscopic sigmoid of rectal resection, and who have given informed consent to be offered experimental interventions within the prospective cohort. Patient who require open surgery or patients with benign colorectal diseases are excluded for this study.

Intervention: Intraoperative use of the retractor sponge versus usual care, i.e. the Trendelenburg position.

Main study parameters/endpoints: The primary endpoint is hospital stay. Secondary objectives are operation time, blood-loss, fluid balance, body temperature, oxygen therapy and postoperative complications.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study will be conducted according to the cohort multiple Randomized Controlled Trial (cmRCT) design. Within the PLCRC cohort, we will identify all patients who are eligible for the experimental intervention and who have given informed consent to be invited for future experimental interventions. From this sub cohort, we will randomly select a group of patients to whom we will offer surgery with use of the retractor sponge, which they can accept or decline. Eligible patients from the sub cohort who were not randomly selected will undergo standard treatment, i.e. surgery in Trendelenburg position. We do not expect adverse events in patients in the intervention arm.

Eligibility Criteria:
Inclusion Criteria:

1. histologically confirmed distal colon (sigmoid) or rectal cancer,
2. planned for elective laparoscopic colorectal surgery,
3. performance status WHO 0-2
4. broad consent for randomization within ProspectIve data coLlection initiative on ColoRectal Cancer (PLCRC) cohort

Exclusion Criteria:

1. patients planned for open colorectal surgery or emergency colorectal surgery
2. patients with inadequate understanding of the Dutch language in speech and/or writing.
A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262)

A study designed to see if the study drug will increase blood levels of vitamin D, bone mineral density (BMD), improve biochemical markers of bone turnover, and reduce the number of falls as compared to women receiving standard care for osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Female
* 65 years or older
* Diagnosed with osteoporosis (Bone Mineral Density (BMD) T-score \<= -2.5 at spine or hip) or prior fragility fracture BMD T-score \<=-1.5 in at least one of the anatomic sites including lumbar spine, total hip, and femoral neck sites
* Postmenopausal
* Low levels of vitamin D as measured 25-hydroxyvitamin D
* Has fallen at least once within the past 12 months

Exclusion Criteria:

* Unable to stand or sit upright for at least 30 minutes
* Has a bone disorder other than osteoporosis
* Contraindication to the use of FOSAVANCE
Selenoprotein P and Non-alcoholic Fatty Liver Disease

The pathogenesis of nonalcoholic fatty liver disease has not been fully elucidated. The most widely supported theory implicates insulin resistance as the key mechanism leading to hepatic steatosis, and perhaps also to steatohepatitis.

Selenoprotein P(SeP) is a secretory protein primarily produced by the liver. Previous studies demonstrated that SeP, a liver-derived secretory protein, causes insulin resistance.

Therefore, the purpose of this study is to determine the different Sep levels between healthy normal group and NAFLD group.

Nonalcoholic fatty liver disease (NAFLD), a disease spectrum that includes simple steatosis, nonalcoholic steatohepatitis (NASH) and cirrhosis, has been increasingly recognized as the hepatic manifestation of metabolic syndrome. Both inflammation and insulin resistance are considered to be pivotal pathogenic mechanisms of NAFLD, as well as metabolic syndrome, type 2 diabetes, and atherosclerosis. There is mounting evidence implicating adipokines secreted from adipose tissue in the pathogenesis and progression of NAFLD, in addition to the development of insulin resistance and inflammation. Selenoprotein P (SeP) has recently been reported as a novel hepatokine that regulates insulin resistance and systemic energy metabolism in rodents and humans. Although previous studies have shown a close relationship among insulin resistance, inflammation, and NAFLD, as far as we know, there is no previous report evaluating the association between SeP and NAFLD. In the present study, we examined serum SeP levels in subjects with increased visceral fat area (VFA) or liver fat accumulation measured with computed tomography (CT). We evaluated the relationship between SeP levels and cardiometabolic risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers for visiting routine medical check in our clinic

Exclusion Criteria:

* History of cardiovascular disease(myocardial infarction, unstable angina, or cardiovascular revascularization)
* Diabetes
* Hypertension
* Malignancy
* Severe renal or hepatic disease
* Subjects taking medications that might affect body weight or body composition