cyrilzakka/clinical-trials huggingface dataset:
Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer

Background: It is shown that TS-1 as adjuvant chemotherapy after D2 resection in patients with gastric cancer can improve DFS and OS in one Japanese Trial. And TS-1 has become one of the standard therapies to these patients. But it is still unknown whether it would improve more to OS and DFS than single TS-1 after combined with oxaliplatin . This trial is designed to investigate the efficacy and safety of TS-1 plus oxaliplatin versus TS-1 single as adjuvant chemotherapy after D2 resection in patients with gastric cancer.

Patients and methods: In this study , patients with histologically confirmed gastric cancer who received D2 resection and staged II or III, aged from 18 to 70 years and with Eastern Cooperative Oncology Group performance status ≤2 and adequate organ function, are randomized 1:1 to oxaliplatin 100mg/m2 on day 1 and TS-1 40\~60mg twice everyday for 14 days in a 21-days cycle for total 6 cycles followed by TS-1 single with the same dose and frequency to the end of the 1st year postoperatively(SOX) , or TS-1 single 40\~60mg twice everyday for 14 days in a 21-days cycle to the end of the 1st year postoperatively (TS-1). The primary end point is overall survival (OS), and secondary end point is disease free survival(DFS) and safety. Final study analysis will be conducted in the end of the 5th year after the last patient's enrollment.


Eligibility Criteria:
Inclusion Criteria:

* informed consensus of patients
* be able to receive oral administration
* from 18 to 70 years old
* be proven to be primary adenocarcinoma of gastric cancer and staged II or III by pathological evidences
* without other chemotherapy and/or radiation against to the disease
* normal function of other organs including heart,liver ,kidney and so on
* Eastern Cooperative Oncology Group performance status:0\~2

Exclusion Criteria:

* history of other malignancy
* allergic reaction to S-1 or oxaliplatin
* be enrolling in other clinical trials
* abnormal GI tract function
* dysfunction of other organs
* female in pregnancy or lactation,or refuse to receive Contraception measures during chemotherapy
* other situation to be judged not adaptive to the study by investigators
Collection of Blood Samples From Patients With Relapsing MS Who Developed ITP After Receiving Lemtrada

Primary Objective:

To collect blood samples in a new cohort of Relapsing Forms of Multiple Sclerosis (RMS) participants who had developed immune thrombocytopenic purpura (ITP) after LEMTRADA treatment, for future Deoxyribonucleic acid (DNA) analysis as part of a global biomarker project assessing pre-identified candidate single nucleotide polymorphisms (SNPs) associated to the development of ITP after LEMTRADA treatment in RMS participants.

One to 70 days, as screening and inclusion visit(s) were performed the same day or on separate days with a maximum timeframe of 30 days apart. One visit was required for blood draw. However, if a second visit occured, it took place within 40 days of the first visit.

Eligibility Criteria:
Inclusion criteria :

* Male and female adult participants who had been treated with LEMTRADA, with development of ITP subsequent to treatment. Participants does not need to be currently on LEMTRADA treatment.
* Participants who had signed the study ICF.

Exclusion criteria:

- Not applicable

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Safety and Effectiveness of JUVÉDERM® VOLBELLA® With Lidocaine for Lip Enhancement in Chinese Adults

This study will evaluate the safety and effectiveness of VOLBELLA with Lidocaine injectable gel in Chinese adults seeking lip enhancement.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or older with an overall baseline Lip Fullness Scale (LFS) score of minimal, mild or moderate on the 5-point LFS scale.
* Has the ability to follow study instructions and is likely to complete all required visits

Exclusion Criteria:

* Has had any facial procedures or trauma that may interfere with the study procedures and results
* Is on anti-coagulation therapy or other contraindicated treatments
* Has current cutaneous inflammatory or infectious processes or lesions in the mouth area
A Study to Evaluate Pharmacokinetics (PK) of Etrumadenant Tablet and Capsule Formulations in Healthy Adult Participants

This study will compare the pharmacokinetics (PK) effect of single-dose etrumadenant tablet and capsule formulations in fasted conditions. The effect of food on single-dose PK of tablet formulation will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult, male or female (non-childbearing potential), 19-55 years of age, inclusive, at the screening visit.
* Body mass index (BMI) between 18.0 and 32.0 kilograms/m\^2 inclusive, at screening.
* Healthy as determined by medical history, physical examination, vital signs, and ECG assessed at the screening visit.
* Clinical laboratory test results clinically acceptable at screening and check in.
* Non-smokers or ex-smokers \[must have ceased smoking and stopped using nicotine containing products greater than (\>) 3 months prior to the first dosing\] based on participant self-reporting.
* Able to swallow multiple capsules or tablets.

Exclusion Criteria:

* Participants who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, rheumatological, dermatological, endocrine, connective tissue diseases or disorders, in the opinion of the PI or designee.
* Have a clinically relevant surgical history, in the opinion of the PI or designee.
* History of relevant atopy or hypersensitivity to etrumadenant or related compounds.
* History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
* History (within 3 months of screening visit) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 g of alcohol \[equivalent to approximately 8 oz of beer (5.5% alcohol); 1 oz of 45% alcohol; or 3.5 oz of wine (12% alcohol)\] based on self-reporting.
* Have a significant infection or known inflammatory process upon screening or check in, in the opinion of the PI or designee.
* Have acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, heartburn) at the time of screening or check in.
* Female participants of childbearing potential.
* Positive results for hepatitis B, C, HIV-1 or HIV-2.
* Clinically significant hypokalemia in the opinion of the PI or designee.
* Have been on a diet incompatible with the on study diet, in the opinion of the PI or designee, within the 30 days prior to the first dosing.
* Donation of blood or significant blood loss within 56 days prior to the first dosing.
* Plasma donation within 7 days prior to the first dosing.
* Participation in another clinical study within 30 days prior to the first dosing.
ABX-EGF (a Monoclonal Antibody) Given to Patients With Prostate Cancer With or Without Tumor in Other Parts of the Body

A clinical trial examining the safety and effectiveness of ABX-EGF when given to patients with prostate cancer with or without tumor in other parts of the body.

Patients will be treated for a maximum of 48 doses (6 treatment courses; 8 doses per course) or until evidence of progressive disease.


Eligibility Criteria:
Inclusion Criteria:

* Male 18 years of age or older
* Has tumor tissue available for diagnostics
* Failed front line luteinizing hormone-releasing hormone analogue (LHRH) such as leuprolide or goserelin, or failed orchiectomy, as evidenced by disease progression. Patients must continue on a LHRH analogue (unless the patient had an orchiectomy) throughout the course of the study
* ECOG score of 0 or 1

Exclusion Criteria:

* Any prior chemotherapy for prostate cancer besides hormonal therapy (including no prior EGFr targeting agent)
* Prior history of cancer other than prostate carcinoma within the past 5 years that has required treatment or been active (prior basal cell carcinoma is allowed)
* Known to be HIV positive
* Myocardial infarction within one year prior to entering the study
The Use of Rectal Balloons in Radical Pelvic Radiotherapy - a Feasibility Study

This study aims to test the hypothesis that insertion of an endorectal balloon into a patient receiving radical prostate radiotherapy by treatment radiographers is feasible without the patient experiencing undue discomfort. In addition this study will test the hypotheses that insertion of the rectal balloon prior to radiotherapy delivery stabilises rectal volume during radiotherapy treatment and minimises organ motion within the pelvis.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* ECOG performance status 0-2 (Patients with PS-2 as a result of comorbidity will be excluded).
* Patients with histologically confirmed diagnosis of prostate adenocarcinoma
* Patients who are going to undergo treatment with radical radiotherapy for prostate cancer.
* Patients must be able to receive and understand verbal and written information regarding the study and give written, informed consent
* Patients must be able to comply with trial requirements.

Exclusion Criteria:

* Patients must not have a history of previous bowel surgery involving the rectum or anus.
* Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial, as well as any other serious uncontrolled medical condition.
* Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
* Pre-existing anorectal disease, e.g. Haemorrhoids, active bleeding, anal irritation, inflammatory bowel disease.
* Patients who are unable to give consent.
* Patients in clinical trials of new investigational medicinal products or treatment regimens unless there is written, prior agreement that the patient can also consent to this study, and that clinical data can also be used for this study.
* Prior pelvic radiotherapy
Phase I/II Study of Oral S-1 Plus Docetaxel in Elderly Patients With Advanced Gastric Cancer.

To assess the usefulness of Docetaxel plus S-1 combination chemotherapy based on the antitumor effect and survival period by performing a phase I/II study of this combination in Elderly patients with inoperable or with postoperative gastric cancer.

A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on Elderly patients with histological stage IV gastric cancer given Docetaxel plus S-1. The usefulness of this regimens as 1st line therapy for gastric cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.

Eligibility Criteria:
Inclusion Criteria:

1. Histological diagnosis of gastric adenocarcinoma.
2. Measurable or assessable lesions(Except for Phase I).
3. Age: 76 \~ 80 years.
4. Performance Status (ECOG): 0 \~ 2.
5. No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period \>4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy.
6. No history of treatment with Docetaxel or S-1.
7. No history of radiotherapy to the abdomen.
8. Oral intake of S-1 is possible.
9. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5 times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine \<1.5 mg/dl (but if it is 1.0 \~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
10. Predicted survival for \>3 months.
11. Able to give written informed consent.

Exclusion Criteria:

1. Severe pleural effusion or ascites.
2. Metastasis to the central nervous system (CNS).
3. Active gastrointestinal bleeding.
4. Active infection.
5. Diarrhea (watery stools).
6. Uncontrolled ischemic heart disease.
7. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
8. Active multiple cancer.
9. Severe mental disorder.
10. Pregnancy, possible pregnancy, or breast-feeding.
11. Flucytosine treatment.
12. Judged to be ineligible for this protocol by the attending physician.
Assessment of Uterine Access, Uterine Patency and Intrauterine Adhesions Following Endometrial Ablation

The objective of this study is to gain information concerning the acute and longer-term morphological changes within the uterus following endometrial ablation. Hysteroscopic evaluation of the uterine cavity will be used to determine if physical access and the ability to systematically assess the post-ablation uterine cavity were preserved. The presence, location and severity of intrauterine adhesions will be documented in participants who are 3, 6 and 12 months from their standard of care endometrial ablation.

Prospective single center observational study. Up to 30 subjects will be enrolled (up to 10 subjects per time point). Patients who sign the Institutional Review Board (IRB) approved consent form who have undergone endometrial ablation within the prior 14 months from time of consent will be asked to participate in this study. Patients meeting all eligibility criteria will undergo either a 3, 6 or 12 month diagnostic second look hysteroscopy (SLH) as assigned by the Investigator depending on the duration of time between the ablation and the signature date of the informed consent (up to 10 subjects for each time point). A diagnostic SLH will be performed for scoring of intrauterine adhesions by the investigator and an independent reviewer. The ability to access the uterine cavity (or not) will be documented.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal female patients ≥ 18 years of age
* Patient has undergone endometrial ablation within the prior 14 months.
* There were no contraindications for endometrial ablation as specified in Ablation System labeling
* Patient agrees to undergo an SLH either at 3, 6 or 12 months post-ablation
* Patient abstained from any form of hormonal contraception including an IUD after the ablation and through the period that the SLH is performed.
* Patient has signed the IRB approved informed consent.

Exclusion Criteria:

* Additional intrauterine procedures performed between time of endometrial ablation and the SLH; e.g., endometrial and/or myometrial resection.
* IUD in situ
* Pregnant (positive urine pregnancy test) or lactating
* Active sexually transmitted infection or genital infection, or other clinically significant active and/or systemic infection per clinical or laboratory examinations at the time of endometrial ablation procedure or second look hysteroscopy (e.g., cervicitis, vaginitis, endometritis, or salpingitis).
* Systemic steroid within 1 week of endometrial ablation
* Previous adhesiolysis procedure or diagnosis of Asherman's disease.
* No noted clinically significant uterine anomalies at the time of the ablation (e.g., septate uterus or other anomalies that distorts the uterine cavity)
* Any other condition that in the opinion of the investigator could represent an increased risk for the subject, affect the primary outcomes of this study and/or impact the subject's ability to comply with protocol requirements.
* Participating or considering participation in a clinical trial of another investigational drug or device during this study
Bedside Ultrasound Assessment of Gastric Content and Volume

Patients undergoing gastroscopy will undergo two pre-procedure ultrasound scans of the stomach, once on arrival in the unit and on an empty stomach and a second time after consumption of a randomized amount of apple juice (0, 50, 100, 200, 300 or 400 mL). Immediately after ingestion and the second ultrasound scan, subjects will have their gastroscopy which will start by suctioning out the apple juice. Measurements of stomach fluid volume conducted by ultrasound will be compared to the actual volume removed during the gastroscopy procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Weight 50-100 kg
* height greater than 150 cm
* ability to provide informed consent

Exclusion Criteria:

* recent upper GI bleed (within 1 month)
* previous lower esophageal or gastric surgery
* not fasted for 8 hours
Influence of Bottle-Type of Infant Feeding Behavior

The objective this research is to conduct a within-subject, experimental study that will describe mothers' feeding practices during typical bottle-feeding conditions and will examine whether removal of visual cues related to the amount of milk/formula in the bottle will alter these feeding practices. The investigators hypothesize that mothers will show higher levels of infant-directed feeding practices and lower levels of mother-directed feeding practices when using opaque, weighted bottles compared to when using standard, clear bottles. The investigators also hypothesize that infants will consume less breast milk or formula when fed from opaque, weighted bottles compared to when fed from standard, clear bottles.


Eligibility Criteria:
Inclusion Criteria:

* Mothers must be 18 years or older
* Infants must be between 0-6 months of age
* Infants must be prior to the introduction of solid foods

Exclusion Criteria:

* Preterm birth
* Medical conditions that interfere with feeding
Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440

The objective is to investigate the immunogenicity of the Japanese Encephalitis vaccine IC51 (JE-PIV) single and concomitant with HAVRIX® 1440

This is a randomized, controlled, multi-center, single-blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years.

192 subjects will be enrolled at 2 sites in Europe.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the study period and 30 days after the last vaccination by practicing reliable methods of contraception
* Written informed consent obtained prior to study entry

Exclusion Criteria:

* History of clinical manifestation of any flavivirus infection
* History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer \>= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
* History of any previous Hepatitis A vaccination and infection
* Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
* Planned administration of another vaccine during the study period
* Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
* A family history of congenital or hereditary immunodeficiency
* History of autoimmune disease
* Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
* Any acute infections within 4 weeks prior to enrollment
* Infection with human immunodeficiency virus (HIV), Hepatitis B (HBsAg) or Hepatitis C
Endoscopic Ultrasound Plus Submucosal Injection for Early Esophageal Cancer

Preoperative accurately staging T1a or T1b in early esophageal cancer is vital for the choices of treatment. At present, the main diagnostic method for early esophageal cancer is endoscopic ultrasound (EUS). However, the accuracy of EUS alone is poor. Thus, it is necessary to improve endoscopic ultrasound examination methods. This project is concerning on the efficacy of EUS combining with submucosal injection of saline for staging T1a and T1b-esophageal cancer. Patients and methods: 80 cases of pathological confirmed early esophageal cancer were randomly divided into two groups: endoscopic ultrasonography group (EUS group) and EUS combining with submucosal injecting saline group (EUS+SIS group). All the cases will be performance by endoscopic or surgical resection; postoperative pathologic diagnosis will be obtained involving echo, depth, margin and other features. The EUS results of two groups of patients will be compared with pathologic results. From comparison, the efficacy and accuracy of EUS+SIS for staging T1a and T1b in esophageal cancer patients will be validated. Through this study, the investigators may develop a routine diagnostic and accurately staging method for early esophageal cancer patients.

Someone whom may concern our IPD are available to the PI, Jian-jun Li M.D. or at lijj@sysucc.org.cn

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years old, no gender limited;
* Patients with esophageal squamous cell carcinoma who be confirmed by ordinary endoscopy and pathologic biopsy;
* Patients who agree to accept endoscopic resection or surgical excision of the lesion in esophagus;
* patients with normal cardio-pulmonary function and normal coagulative function,are predicted to be tolerated anesthesia and surgery;
* patients who understand test purpose, volunteer to join these study and sign the consent inform.

Exclusion Criteria:

* Patients with stages of T2, T3, or T4 displayed by EUS;
* Patients who can't tolerate endoscopy and surgical treatment for various reasons;
* Patients who have distant metastasis, or multiple source of malignant tumors;
* Patients with blood coagulative disorder;
* Patients don't accept the endoscopic examination or surgical treatment;
* Patients with poor compliancy.
Variability of Healthy People and People After Stroke Results in the Box and Block Test

Main aim of the study is to find out how many attempts of each subtest in the Box and Block Test should be done in clinical practice during testing people after stroke who are 20-64 years old.


Eligibility Criteria:
Inclusion Criteria:

* people after stroke 20 - 64 years old
* signed Informed consent for probation with inclusion to research and Consent to the collection and processing of personal data during the study at the General University Hospital in Prague
* ability to sit independently for 15 minutes
* ability to grasp and move at least one 25 mm wide cube placed on a table using the dominant and then the non-dominant upper limb across the test partition
* ability to perform a simple task following verbal instructions
* retained ability to understand - according to psychological examination
* completion of testing during hospitalization in the Beroun Rehabilitation Hospital

Exclusion Criteria:

* severe hearing impairment not corrected by a hearing aid
* severe visual impairment not corrected by glasses
* severe comprehension impairment
* other reasons not allowing the completion of the entire testing using the Box and Block Test