cyrilzakka/clinical-trials huggingface dataset:
Trial of Adjuvant Chemotherapy for Gastric Cancer

This is a phase III randomized study designed to evaluate the efficacy of mitomycin, doxifluridine, and cisplatin compared to mitomycin and doxifluridine.

Stomach cancer is the most common cancer in Korea and one of the major health problems worldwide. The most effective treatment for gastric cancer is curative surgical resection of primary tumor. However, a substantial number of patients eventually die of recurrences after curative resection. A number of randomized trials investigating the role of adjuvant chemotherapy have been conducted. However, the efficacy of adjuvant chemotherapy is still controversial and varied between Western and Asian trials. Meta-analysis of Western trials didn't demonstrate the benefit of adjuvant chemotherapy after curative resection. Conversely, some Asian studies have demonstrated the efficacy of adjuvant chemotherapy after curative resection. In a previous study, mitomycin plus tegafur prolonged the survival in resected gastric cancer compared to no treatment.

This study is designed to evaluate the efficacy of mitomycin, cisplatin and prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven gastric adenocarcinoma
* Curative resection was done
* stage II, IIIA, IIIB, IV (including T4, lesions or N3, but excluding M1 lymph node metastasis)
* age: 18-69 years old
* Performance status: ECOG 0-2
* Adequate bone marrow function (WBC ≥ 4,000/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 10 g/dl)
* Adequate renal function (serum creatinine≤ 1.5)
* Adequate liver function (serum bilirubin ≤1.5 mg/dl, AST/ALT ≤ 3 x normal upper limit)
* Written informed consent was signed by the patient

Exclusion Criteria:

* Previous chemotherapy or radiotherapy
* Active ongoing infection which antibiotic treatment is needed
* Pregnant or lactating women
* Psychosis or convulsion disorder
* Ascites in preoperative abdomen CT
* Systemic disease which interfere the administration of chemotherapy
* Previous history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ
Pain Management of Pecto-intercostal Fascial Block Versus Intravenous Fentanyl After Pediatric Cardiac Surgery

Cardiac surgical patients often experience significant postoperative pain at the median sternotomy site.

In pediatric cardiac surgery, the recommended pre bypass dose of fentanyl to blunt the hemodynamic and metabolic stress response is 25-50 µg/kg Today lower doses are often used in order to achieve early extubation at such doses there is no guarantee that the stress response is completely abolished one way to overcome this problem is the use of the local anesthetic technique Regional anesthetic techniques reduce pain for up to 24 hours after cardiac surgery in children.

Pectointercostal fascial block was first described by de la Torre in patients undergoing breast surgery. This novel technique blocks the anterior cutaneous nerve which is a branch of the intercostal nerve that gives sensory supply to the skin.

The aim of the current study is to detect the effectiveness of pecto-intercostal fascial block in relieving postoperative pain in noncyanotic pediatric patients undergoing elective cardiac surgery the primary goal of this randomized study is to compare the postoperative pain score in the first postoperative 24 hours and to detect total dose of fentanyl requirements. The secondary goals are intraoperative hemodynamic stress response to surgical stimuli, analgesic consumption in the studied groups, cross-clamping and bypass time, time to extubation, intensive care length of stay, and postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* On pump
* Elective repair of congenital simple left to right intracardiac shunt
* Median sternotomy

Exclusion Criteria:

* Refusal of their guardians
* Redo cardiac surgery
* Previous back injury
* Previous back surgery
* Kyphoscoliosis
* Local infection of the skin and subcutaneous tissue at the site of needle puncture
* Hypersensitivity to local anesthetics
* Coagulation disorders
* Renal disease
* Hepatic disease
* Pulmonary disease
* Heart failure
* Moderate to severe pulmonary hypertension.
Study to Assess the Safety and Plasma Concentration of YM178 OCAS Tablet (Mirabegron) in Healthy Chinese Volunteers

To evaluate the safety and plasma concentration change of YM178 after single- and repeated-administration as oral absorption controlled tablet in healthy Chinese subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Body Mass Index (BMI) between 19 and 24, the weight is no less than 50 kg.
2. Good health status
3. The female subject must be either post-menopausal or surgically sterile. All women of child bearing potential will be required to use adequate contraception, must not be lactating, and must not be breastfeeding.

Exclusion Criteria:

1. The subject who has a known or suspected hypersensitivity to test drug or any of the constituents of the formulation used.
2. Drug abusers and alcoholics.
3. The subject who has consumed alcohol within 36 hours before administration.
4. The subject who is positive for hepatitis B surface antigen (HBs- Ag) or hepatitis C virus (HCV) antibody.
5. The subject who is positive for human immunodeficiency virus (HIV).
6. The subject who consumes more than 1L tea and coffee per day.
7. Smokers.
8. The subject who has donated or lost over 200 mL blood
9. The subject who has participated in other clinical trials
10. The subject who has taken other drugs that prototype and its main metabolites had not completely eliminated
11. The subject who has taken drugs repeatedly that may affect the metabolism of the test drug
12. Psychopath.
Non-Inferiority Study Comparing 3 Weekly Injections of SUPARTZ® vs 3 Weekly Injections of Euflexxa® for Knee OA

The purpose of this study is to demonstrate non-inferiority of three weekly intra-articular injections of SUPARTZ to three weekly intra-articular injections of Euflexxa for the relief of knee OA.

The purpose of this study is to demonstrate non-inferiority of three weekly intra-articular injections of SUPARTZ to three weekly intra-articular injections of Euflexxa for the relief of knee joint pain in subjects with osteoarthritis (OA) of the knee as measured by the VAS (0-100 mm) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale score Change from Baseline (CFB) over Weeks 3, 6, 12.

Safety will be accessed by recording adverse events, concomitant medications, physical examinations, and vital signs.

Eligibility Criteria:
Inclusion Criteria:

* Clinical evidence of symptomatic osteoarthritis of the study knee as classified according to Altman criteria.
* Symptoms in study knee for at least one year prior to the screening visit
* Verified OA of the study knee of Grade 2 or 3 according to a modification of the grading system of Kellgren-Lawrence (K-L) radiographic severity.
* Willingness to discontinue NSAIDs (systemic and topical) and non-acetaminophen analgesic use seven days or five half-lives prior to the first injection and throughout the study.

Exclusion Criteria:

* Inability to perform a 50 foot walk test.
* Subjects with rheumatoid arthritis, joint infection, other inflammatory and metabolic arthritis, Lupus or dermatologic disorder or skin conditions in close proximity to study knee that would preclude safe intra-articular injections.
* Prior hyaluronic acid injections into the study knee within six months of the screening visit.
* Intra-articular or intra-muscular steroid injections within three months of the screening visit or during study participation. Oral corticosteroids within four weeks of the screening visit or during study participation.
* History of surgical treatment to the study knee or arthroscopic intervention within three months prior to the screening visit.
* Clinically apparent tense effusion of the study knee on examination determined by either a positive bulge sign or positive ballottement of the patella (patellar tap).
* Subjects with clinically diagnosed symptomatic OA of the hip.
Hypodontia and Ovarian Cancer

The purpose of this project is to examine whether the risk of developing ovarian cancer is increased in Danish women with congenital missing teeth as a result of their failure to develop (hypodontia). Should this prove to be the case, these women could be offered regular clinical controls and prophylactic removal of their ovaries when menopause enters and the ovaries are no longer functional (producing hormones).

If there is a connection between congenital hypodontia and the development of different types of cancer, the investigators will perform a genetic screening in families with increased risk of cancer and hypodontia for changes in relevant genes, based on the current literature. The investigators hereby search for new genes, which in a changed form leads to an increased risk of cancer and thereby enables us to perform genetic screening in risk families.


Eligibility Criteria:
Inclusion Criteria:

* confirmed suspicion of ovarian cancer.

Exclusion Criteria:

* suspicion of ovarian cancer disproved.
Examining Heart Attacks in Young Women

Heart disease and heart attacks pose a serious health risk to young women, and women tend to experience less successful recoveries after a heart attack than men do. This study will examine various factors that may predispose women to heart attacks and to poor recovery after a heart attack. The differences between men and women in the medical care that they receive following a heart attack will also be studied.

Heart disease is one of the leading causes of death in women 55 years and younger, accounting for more than 8,000 deaths each year in the United States. Approximately 40,000 young women are hospitalized each year in the United States as a result of a heart attack. Research has shown that young women who have heart attacks are twice as likely to die in the hospital as young men who have heart attacks. While there has been an increase in awareness, little research has been conducted on understanding heart disease and heart attacks in young women. Specific biologic markers involved with inflammation, metabolic abnormalities, sex hormones, and genetics may indicate a predisposition to a heart attack and poor recovery. This study will analyze the biologic, demographic, psychosocial, environmental, and behavioral factors that may contribute to premature heart disease and to poor recovery after a heart attack in women. Researchers will examine if delays in receiving medical care following a heart attack can affect recovery and health outcomes for women. Gender differences in outcomes and the quality of medical care that is received following a heart attack will also be examined.

This study will enroll women and men who are hospitalized following a possible heart attack. At study entry, participants will be interviewed to collect information about symptoms, functioning, quality of life, and medical care. A medical record review will also occur. At 1 month after admission from the hospital, an interview will occur via phone and a blood sample will be collected when the participant returns to the hospital or alternatively be collected at a medical clinic convenient to the participant. Another telephone interview will occur at 12 months. Participants' blood samples will be stored for future biologic and genetic studies.

Eligibility Criteria:
Inclusion Criteria:

* Elevated cardiac markers within 24 hours of arrival at initial or enrolling institution
* Supporting evidence suggestive of a heart attack

Exclusion Criteria:

* Previously enrolled in the VIRGO study
* Does not speak English or Spanish
* Too ill to interview
* Current prisoner
Effect of a Low-glycemic-load and Milk-free Diet on Acne Severity

The objective of this study is to assess the effect of a low-glycemic-load and milk-free diet on acne severity.

IGF-1 and a phosphorylated product of the mTORC pathway (p70S6K) will be assessed in both groups to explore the mTORC signaling pathway, which is thought to be related to clinical improvement in previous studies.


Eligibility Criteria:
Inclusion Criteria:

* Mild, moderate or severe acne (GAGS score 15-44)
* Age: 14-20 years old
* Presence of acne for at least 2 months

Exclusion Criteria:

* Diabetes
* Polycystic ovary syndrome
* Use of hormonal contraceptives
* Previous use of oral retinoids
* Use of oral antibiotics or topical antibacterial or retinoid agents in the last 2 months
* Use of medications known to cause or exacerbate acne including lithium, oral or injected retinoids, some anticonvulsant drugs, medications containing iodides or bromides
* Drug or alcohol abuse.
* Active smokers
* Anticipated difficulty attending visits or fear of blood draws
Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures

Pilot study planned to demonstrate the safety and effectiveness of the use of BioTraceIO 360 for Planning, Monitoring and Assessment of liver tissue ablation procedures

Multi-center (up to 5 investigational sites) prospective single-arm clinical investigation.

Sample size - 30 subjects.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled and indicated for standard-of-care liver tumor ablation for either hepatocellular carcinoma (HCC) or metastatic liver tumor(s) microwave (MW) energy.
* Patient must have at least one prior CT or CECT scan (up to 6 months before enrollment).
* Tumor must be visualized on at least one diagnostic imaging modality (MRI or contrast-enhanced CT).
* Single tumor, or multiple tumors only if the distance between the ablated tumor and all other tumors allows for distinct separation between the necrotic zones.
* Distance between the tumor and the edge of any previous necrotic zones allows for distinct separation between the necrotic zones.
* At least 21 years of age.
* Able and willing to give informed consent.

Additional inclusion criteria for subgroup:

* Single ablation, using a single ablation needle, per tumor.

Exclusion Criteria:

* Planned ablation includes adjunctive means other than MW energy (e.g., ethanol, hepatic artery embolization, etc.).
* Planned ablation includes the use of more than two ablation needles, per tumor
* Ablation area cannot be visualized and monitored continuously using ultrasound throughout the entire ablation procedure.
* Pregnant or breastfeeding.
* Patient judged unsuitable for study participation by the physician for any other reason.
* Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period.
* Unable or unwilling to give informed consent.

Additional exclusion criteria for subgroup:

* Liver tumor that cannot be ablated with a single ablation needle, according to the investigator's clinical opinion.
* Planned ablation includes repositioning and/or overlapping ablations using a single ablation needle.
Clinical Evaluation of the Effect of LANAP as an Adjunct Treatment in Management of Patients With Chronic Periodontitis

this study evaluate the effect of LANAP (Laser Assisted New Attachment Procedure) as an Adjunct Treatment in Management of Patients With Chronic Periodontitis and assay the effect of LANAP on periodontal indexes like BOP, CAL, probing depth

this study evaluate the effect of LANAP (Laser Assisted New Attachment Procedure) as an Adjunct Treatment in Management of Patients With Chronic Periodontitis and assay the effect of LANAP on periodontal indexes like BOP, CAL, probing depth in a split mouth design before treatment and after follow up sessions.

Eligibility Criteria:
Inclusion Criteria:

* definite diagnosis of chronic periodontitis with at least two teeth with periodontal pocket depth more than 4 mm in each side

Exclusion Criteria:

* pregnant smoker systemic disease breast feeding
COVID-19 Vaccine Reactogenicity and Immunogenicity

Analysis of antibody kinetics after vaccination with mRNA-1273 and factors influencing the vaccine immunogenicity

We conducted a prospective study on healthy young adults who were to receive two doses of mRNA-1273 vaccine at 28-day intervals. After each dose, adverse events were prospectively evaluated, and blood samples were collected. The correlation between humoral immune response and reactogenicity after vaccination was determined. In addition, long-term anti-SARS-CoV-2 antibody kinetics will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* who were willing to receive the mRNA-1273 vaccine

Exclusion Criteria:

* previously diagnosed with laboratory-confirmed COVID-19
* history of autoimmune disease
* immunocompromised, pregnant, or breastfeeding
Promoting Healthier Food Purchases By Leveraging the Online-Grocery Environment

Rationale: Online-grocery shopping is predicted to be one of the "hottest" food trends of 2014, as national retailers such as Amazon, as well as start-up companies, venture into the e- commerce grocery sector. Importantly, the online-grocery environment could be uniquely manipulated to promote healthier food purchasing and help with weight control. Since consumers tend to choose items listed first on menus and buffet lines, the order of food products displayed on the grocer's website may impact purchasing. Furthermore, it's possible that in an online-grocery environment, nutrition information could be made more salient to consumers. For example, previous research has demonstrated that label color influences perceptions of the healthfulness of foods. The FDA also recently proposed a redesign of foods' nutrition facts panels, which would highlight calorie content in a larger font. Although implementing this label change on all food labels could take years, e-commerce sites could change the format of the nutritional information they display much more quickly.

Objectives: The proposed study intends to nudge consumers to make healthier grocery purchases through three distinct interventions: 1.) Manipulating the order of food items within grocery categories; 2.) Displaying product nutrition information in red or green; and 3.) Presenting calorie information in a larger font size. We propose to examine these concepts in adult consumers using a grocery e-commerce platform servicing socioeconomically and racially diverse communities in the northeastern U.S.


Eligibility Criteria:
Inclusion Criteria:

* Shopping on a Rosie grocery site

Exclusion Criteria:

* No exclusion criteria, all orders will be eligible
Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection as Adjunctive Therapy in Subjects With Internal Carotid Artery Hypoperfusion

The aim of this study is to evaluate the effectiveness, safety and tolerability of consistent dosages of the study drug (hydroxyethyl starch 130/0.4 and sodium chloride injection, Vuloven) administrated intravenously for 7 days.

This study will recruit 120 male and female patients between 18 and 75 years of age who are diagnosed with brain hypoperfusion within the unilateral arteries branching from the internal carotid artery with or without cerebral infarction. All subjects are taking up to routine treatment medications.

The purpose of the study is to evaluate the effectiveness, safety and tolerability of consistent dosages of the study drug (hydroxyethyl starch 130/0.4 and sodium chloride injection, Vuloven) administrated intravenously for 7 days.

Each patient who qualifies and chooses to participate in the study will be randomly assigned into treatment groups (consistent dose of hydroxyethyl starch 130/0.4 and sodium chloride injection of 500 ml/day, 1000 ml/day or 1500 ml/day) or control group (placebo control).

The parameters of clinic visits will include a medical history, physical exam, clinical laboratory tests, magnetic resonance imaging (MRI), using T1-weighted scan, T2-weighted scan and diffusion-weighted imaging (DWI), digital subtraction angiography (DSA), and computed tomography (CT) perfusion.

Eligibility Criteria:
Inclusion Criteria:

1. The degree of the branching arteries stenosis from the internal carotid artery is greater or equal to 70% confirmed by DSA.
2. Before hydroxyethyl starch 130/0.4 and sodium chloride injection-additional treatment, CT perfusion shows that time to peak (TTP) in lesion area is more than that in corresponding area of contralateral hemisphere.
3. If cerebral infarction appears, the time course should be less than 48h, NIH stroke scale: 3-20, and MRI+DWI shows ischemic stroke due to large artery atherosclerosis.

Exclusion Criteria:

1. Allergy to the components of Hydroxyethyl Starch
2. Chronic liver disease (ALT \> 120 or AST \> 120)
3. Chronic renal disease (Scr \> 150 μmol/L)
4. Severe heart failure which correspond to NYHA heart failure classification class III or IV, or serious arrhythmia, myocardial infarction
5. Hemorrhagic stroke
6. Pregnant and lactating women
7. Patients suffered from epilepsy or mental sickness
8. Alcoholism or drug abuse
9. hydroxyethyl starch or other artificial colloidal solution was used within 3 months.
10. Patients participate in other clinical trial within 6 months
11. Contraindication to CT perfusion imaging (i.e. contrast allergy, metformin use or Creatinine \>160 μmol/l)
12. Thrombus in lower limb vein
Pre-medication With Alfentanil vs Placebo During ECT

Hemodynamic changes associated with the conduct of electroconvulsive therapy may be minimized with the administration of alfentanil as part of their anesthetic regimen. This study proposes to compare the effects in a blinded fashion. Currently alfentanil is an FDA approved drug used on a daily basis by anesthesiologists on other surgeries so this is not a new indication.

Electroconvulsive therapy is associated with brief hemodynamic alterations that in some patients may be well outside the range of normalcy and potentially dangerous to the patient (Duma A, et al). This cardiovascular response is caused by activation of the autonomic nervous system and consists of an initial parasympathetic response rapidly followed by sympathetically mediated tachycardia and hypertension. The ultra-short acting synthetic opioid alfentanil has a rapid onset and duration of action that mirrors the duration of hemodynamic perturbation associated with Electroconvulsive Therapy (ECT) while having minimal or no effect on the duration or quality of the seizure. This drug may be effective in blunting the hemodynamic perturbations associated with ECT with a minimal amount of side effects.

Eligibility Criteria:
Inclusion Criteria:

* Age \> /=18 years
* Males or females
* Anticipating electroconvulsive therapy to treat refractory depressive disorder

Exclusion Criteria:

* Under the age of 18
* Allergy to alfentanil
* Allergy to other standard anesthetic medications utilized in the course of ECT (glycopyrrolate, methohexital, and succinylcholine)
* History of malignant hyperthermia
* History of severe airway obstruction, bronchospasm or laryngospasm
* History of recent myocardial infarction, ventricular arrhythmia
* Adverse reaction to ECT requiring premedication with lidocaine or atropine
* Non-English speaking
* Patients unable to consent for themselves
* Current pregnancy