cyrilzakka/clinical-trials huggingface dataset:
Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Gastric Cancer

The purpose of this study is to evaluate the safety and time to progression of HLA-A\*0201 restricted epitope peptides URLC10, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.

URLC10 has been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. In a prior study, it has been shown that URLC10 is upregulated in human gastric tumors. VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10-117 peptide (1mg), VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. The patients will also receive oral chemotherapy (S-1) simultaneously. Repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptide vaccines. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.

Eligibility Criteria:
Inclusion Criteria:

* Advanced or recurrent gastric cancer
* Resistant against conventional chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
* ECOG performance status 0-2
* Life expectancy \> 3 months
* HLA-A\*0201
* Laboratory values as follows 2000/mm3\<WBC\<15000/mm3 Platelet count\>100000/mm3 Bilirubin \< 3.0mg/dl Asparate transaminase \< 150IU/L Alanine transaminase \< 150IU/L Creatinine \< 3.0mg/dl
* Able to receive oral TS-1 therapy
* Able and willing to give valid written informed consent

Exclusion Criteria:

* Pregnancy (woman of childbearing potential:Refusal or inability to use effective means of contraception)
* Breastfeeding
* Active or uncontrolled infection
* Unhealed external wound
* Concurrent treatment with steroids or immunosuppressing agent
* Prior chemotherapy, radiation therapy, and/or immunotherapy within 4 weeks
* Uncontrolled brain and/or intraspinal metastasis
* History of allergy to Tegaful, Gimeracil and/or Oteracil
* Decision of unsuitableness by principal investigator or physician-in-charge
Ultra-Congruent(UC) Versus Posterior-stabilized(PS) Insert in Bilateral Total Knee Arthroplasty

Numerous studies have echoed the superior clinical outcomes of posterior-stabilized (PS) total knee arthroplasty compared to posterior cruciate-retaining (CR) total knee arthroplasty. The post-cam mechanism of posterior-stabilized (PS) total knee arthroplasty has been postulated to provide reproducible femoral rollback and increased flexion. However, posterior-stabilized (PS) total knee arthroplasty systems are purportedly limited due to several post-cam related problems, including post-cam dislocation, wear and breakage of post, and patellar clunk syndrome. Moreover, the post-cam mechanism requires additional bone resection and poses a risk for intercondylar fracture of the distal femur during box preparation. To overcome these issues, a fixed-bearing highly conforming ultra-congruent (UC) total knee arthroplasty was introduced.

This study aims to compare the clinical results of Ultra-Congruent(UC) and posterior-stabilized(PS) insert in bilateral total knee arthroplasty.

The objective of this work was to compare pain, stiffness, function and accuracy between groups at minimum 2 year postoperatively. The investigators hypothesized that the Ultra-Congruent(UC) insert would provide similar functional outcomes without increasing the incidence of adverse events.

The study design is a double-blind randomized controlled trial. Fifty patients planed to undergo simultaneously bilateral total knee arthroplasty are randomised to be used Ultra-Congruent(UC) insert on one leg and posterior-stabilized(PS) insert on the other. The clinical outcome is comparative preoperative, postoperative 6weeks, 3months, 6months and 1years. And clinical score consists of Range of Motion (ROM), WOMAC (Western Ontario and McMaster University Arthritis Index ) pain scale, Knee Society Score, Anterior and posterior stress view on X-ray.

Eligibility Criteria:
Inclusion Criteria:

* over 19 year old
* Patients for total knee arthroplasty of both knee
* having medicare insurance

Exclusion Criteria:

* Rheumatoid arthritis
* Other inflammatory arthritis
* Neuropsychiatric patients
* Hepatic insufficiency
* Renal insufficiency
* over 40 of body mass index
* Chronic opioid use (taking opioids for longer than 3 months)
Zalutumumab in Non-curable Patients With SCCHN

Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females age ≥ 18 years
2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
3. Failure to at least one course of standard platinum-based chemotherapy

Exclusion Criteria:

1. Three or more prior chemotherapy regimens
2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
3. Past or current malignancy other than SCCHN, except for certain other cancer diseases
Micronutrient-supplemented Milk Study in Women of Childbearing Age

The purpose of this study is to determine if consuming ANMUM Materna (a fortified milk product) over a 12-week period increases red blood cell folate concentrations in women of childbearing age in Singapore, compared to an equivalent amount of standard (unfortified) milk.

Folic acid (\~400 µg/day) taken around the time of conception significantly reduces the risk of a neural tube defect (NTD)-affected pregnancy. Strategies to reduce NTD with folic acid, include supplement use and food fortification. An attractive strategy for NTD prevention is the use of fortified foods targeted for use by women planning a pregnancy. Fonterra currently markets a fortified-milk (ANMUM Materna) in Asia, designed for use prior to and during pregnancy. This milk product, if consumed as directed, provides \~400 µg folic acid per day. It is not known whether ANMUM Materna will reduce NTD rate. However, in a case-control study the risk of NTD was inversely associated with maternal red blood cell (RBC) folate concentrations. Accordingly, if ANMUM Materna increases RBC folate, it could be expected to decrease NTD risk.

In this study, the ANMUM Materna fortified milk will be tested against a standard control (unfortified) milk over a 12 week period. The subjects will consume 75g of milk powder daily throughout the supplementation period.

Eligibility Criteria:
Inclusion Criteria:

* Female 21-35 years old.
* Able to understand the nature and purpose of the study, including potential risks and side effects.
* Willing to consent to study participation and to comply with study requirements.
* Negative Pregnancy test at screening

Exclusion Criteria:

* Consumption of vitamins and/or mineral supplements known to contain folate 6 months prior.
* Chronic disease.
* Milk and/or lactose-intolerant.
* Pregnancy in the last 12 months, or currently planning a pregnancy.
* Prior history of NTD-affected pregnancy
* Serum Folate deficiency
Telephone-based Treatment for Smoking Cessation

Aim: to assess the effect of adding Motivational Interviewing (MI) to the existing smoking cessation treatment protocol at the Swedish National Tobacco Quitline (SNTQ).

Methods: Experienced counsellors at SNTQ either received further training in the standard treatment (ST) protocol (including Cognitive Behavioural Therapy (CBT)) or a comprehensive regime of training in MI. 1309 clients were randomized to either the ST group or the group with MI added to the treatment protocol. In order to ensure treatment integrity among counsellors, MI skill was assessed using the Motivational Interviewing Treatment Integrity Code (MITI).


Eligibility Criteria:
Inclusion Criteria:

* Clients have to express a desire for support regarding smoking cessation
* Clients have to be willing to confirm their identity by answering a baseline registration questionnaire

Exclusion Criteria:

* Clients with obvious difficulties understanding Swedish
* Clients with obvious mental impairments
* Clients using tobacco products other than cigarettes (mainly smokeless tobacco, or "snus")
Safety, Tolerability and PK of Ensovibep (MP0420 - a New Candidate With Potential for Treatment of COVID-19)

This study will investigate how ensovibep is distributed throughout the body, the safety and the tolerability of ensovibep in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects between ages of 18-65 years
* Body mass index of 18.0-35.0 kg/m2
* Non-smokers for at least 3 months
* Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
* Agree to follow the contraception requirements of the trial
* Able to give fully informed written consent.

Exclusion Criteria:

* Positive tests for hepatitis B \& C, HIV
* Severe adverse reaction to any drug
* Drug or alcohol abuse
* Use of over-the-counter medication (with the exception of paracetamol \[acetaminophen\]) during the 7 days before the first dose of trial medication, or prescribed medication during the 28 days before first dose of trial medication
* Any vaccination within 4 weeks before dose of trial medication
* Participation in other clinical trials of unlicensed medicines within the previous 3 months
* Loss of more than 400 mL blood within the previous 3 months
* Vital signs outside the acceptable range
* Clinically relevant abnormal findings at the screening assessment
* Acute or chronic illness
* Clinically relevant abnormal medical history or concurrent medical condition
* Possibility that volunteer will not cooperate
* Females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception.
Alglucosidase Alfa Temporary Access Program

Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The objective of this expanded access study is to provide patients with Pompe disease in the United States (US), access to alglucosidase alfa produced from a scaled up manufacturing process for a limited time until production at this scale is approved for commercial use by the Food and Drug Administration.


Eligibility Criteria:
Inclusion Criteria:

* The patient or patient's legal guardian must provide signed, informed consent prior to performing any study-related procedures.
* The patient must reside in the US.
* The patient must have a confirmed diagnosis of Pompe disease defined as documented acid alpha-glucosidase (GAA) enzyme deficiency from any tissue source and/or GAA gene mutations.
* The patient must have/had documented clinical signs and symptoms of Pompe disease.
* The patient must have/had prior treatment with alglucosidase alfa produced at commercial scale OR be naive to enzyme replacement therapy (ERT) for the treatment of Pompe disease and meet at least 1 of the following criteria: require a wheelchair OR require some respiratory assistance for any number of hours (including night time) through non-invasive ventilation.
* The patient must be capable of complying with the required program schedule of assessments.

Exclusion Criteria:

* Females who are pregnant or lactating
* The patient has a clinical condition unrelated to Pompe disease that would interfere with program assessments.
* The patient is currently enrolled in any clinical studies.
Prospective Randomized Study Comparing One or Two High Dose Chemotherapy Regimen Followed by Autologous Stem Cell Transplantation

First randomization:

After inclusion Use of Daunorubicin (arm D) or Idarubicin (arm I) as anthracyclin during all courses of chemotherapy (induction, consolidation courses before ASCT)

Second randomization:

After achieving 1st CR: all patients received non intensive consolidation course Familial HLA typing required for all patients

Patients with HLA-identical sibling:

Patients with very good prognostic factors (CBF leukemias, WBC \< 30 giga/l at diagnosis, 1st CR after one induction course) = arm C: no allogeneic stem cell transplantation in 1st CR; received 2 more courses of intensive consolidation chemotherapy All others patients received an allogeneic transplant For patients aged less than 51 = arm M: upfront myeloablative conditioning regimen For patients aged over 51 and less than 61= arm m: intensive chemotherapy consolidation course.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 15 to 60 years
* Diagnosis untreated AML (FAB 0 to 2, 4 to 7): more than 20% marrow blasts according to WHO classification
* Signed informed consent required

Exclusion Criteria:

* AML3 subtype
* Previous diagnosis of myelodysplastic syndrome (MDS) or myeloproliferative disease; patients with previous chemotherapy or radiotherapy were eligible if they had no previous diagnosis of MDS
* Isolated extramedullary disease
* Inadequate performance status (≥ 3), cardiac function (LVEF \< 40%, severe arythmia or unstable coronary disease), renal function (creatininine \> 150 µmol/l), liver functional tests (bilirubin \> 35 µmol/l, liver enzymes \> 4 times normal values); life expectancy \< 3 months
* Informed consent refusal
Adaptive Design Study of NEST sTMS in Subjects With Major Depressive Disorder

This is a double-blind, sham controlled, multi-center study to confirm the safety and efficacy of synchronized transcranial magnetic stimulation (sTMS) for the treatment of patients currently experiencing an episode of depression who have failed to respond to at least one (1) antidepressant medication. Patients will be randomly assigned to either active or sham therapy and will undergo daily treatments for a period of time. Following completion of blinded treatments, patients may be eligible for a course of open label treatments.

Prospective, randomized, double-blind, sham-controlled, parallel group adaptive design study to confirm the safety and efficacy of sTMS in subject with Major Depressive Disorder (MDD) who have not responded to at least one antidepressant medication in the current episode. MDD was diagnosed according to DSM-IV criteria rendered by structured interview using the Mini International Neuropsychiatric Interview (MINI).

Subjects must have discontinued any antidepressant medication a minimum of 1 week prior to initiation of treatment with the active sTMS or sham device. Following wash-out of the antidepressant medication, an additional evaluation was performed to determine whether the protocol eligibility criteria were met before randomization and treatment.

Randomized subjects were treated 5 days per week for 6 weeks. Subjects who completed 6 weeks of double-blind treatment may have been eligible to receive up to 6 weeks of open-label treatment as clinically indicated during the follow-up phase of the study.

Follow-up evaluation visits were conducted during those six weeks, with frequency of the visits determined by the treatment choice during that time frame (open label subjects had weekly evaluation visits for 6 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Current episode of Major Depressive Disorder
* Inadequate response to at least one antidepressant medication in the current episode (Treatment Resistant Depression)
* Investigator able to identify IAF using EEG
* Willingness and ability to adhere to treatment schedule (5 treatments per week for six weeks)

Exclusion Criteria:

* Unable to unwilling to give informed consent
* Diagnosed with excluded conditions or treatment histories
* Currently hospitalized due to severity of depression symptoms
* Use of prohibited medications (as defined by protocol) within specified time frame of randomization
* Use of certain cardiac devices
* Use of certain intracranial devices
* Currently pregnant or unwilling to practice acceptable means of birth control, and women who are breastfeeding
Saturated Fatty Acids and HDL Metabolism

The purpose of this study is to determine whether palmitic acid (C16:0) and stearic acid (C18:0) have different effects on HDL metabolism during the fasted state.

Study design:

Double blind, randomized, cross-over study with two different diets: one diet will be high in palmitic acid (C16:0) and the other diet will be high in stearic acid (C18:0). Subjects will receive both diets for 4 weeks with a wash-out period of 4-6 weeks in between. Contrast in the intakes of palmitic acid and stearic acid is 6% of energy. A postprandial test will be carried out at the end of each dietary period.

Study population:

Accounting for a dropout rate of 20%, 40 healthy men and postmenopausal women, aged between 45 and 70 year, having a BMI (body mass index) between ≥ 18.0 and ≤ 30.0 kg/m2 will be recruited.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy men and post-menopausal women (post-menopausal for at least one year) as judged by study physician
* BMI ≥ 18.0 and ≤ 30.0 kg/m2
* Aged between 45 and 70 years
* Willing to comply to study protocol during study
* Having a general practitioner
* Agreeing to be informed about medically relevant personal test-results by a physician
* Informed consent signed
* Accessible veins on arms as determined by examination at screening

Exclusion Criteria:

* Having a medical condition which might impact study measurements
* Use of over-the-counter and prescribed medication, which may interfere with study measurements
* Use of oral antibiotics in 40 days or less prior to the start of the study;
* Use of food supplements or plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study;
* Reported alcohol consumption ≥ 10 units/week (female) or ≥ 14 units/week (male);
* Reported intense sporting activities ≥ 10 hours/week;
* Reported weight loss or gain of 3 kg or more during a period of 2 months prior to screening
* Regular smokers (at least one cigarette (or equivalent) daily or \>7 cigarettes (or equivalent) weekly. Smokers who cannot comfortably restrain from smoking for up to 2 days will also be excluded
* Reported dietary habits: medically prescribed diet, allergy/intolerance to test products that will be provided during the study
* Blood donation in the past 3 months
* Drug abuse
* Reported participation in another nutritional or biomedical trial 3 months prior to screening
* Fasting triacylglycerol concentrations at screening: ≥ 4.5 mmol/L
* Serum lipids: treatment recommended according to the "Multidisciplinary guidelines Cardiovascular risk management"
* Fasting HbA1c ≥ 48 mmol/mol (or 6.5%)
Trial of Community Health Worker-led Decision Coaching

Black men are disproportionately affected by prostate cancer, the most common non-cutaneous malignancy among men in the U.S. This randomized trial will evaluate the efficacy of a Community Health Worker-led decision coaching program to facilitate Shared Decision Making (SDM) and Prostate Specific Antigen (PSA) screening among Black men with regards to decision quality, the decision making process, patient-provider communication and PSA utilization for Black men in the primary care setting.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* Black
* Male
* Attending FQHC for routine primary care appointment

Providers:

* Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC)
* Caring for patients that fit inclusion criteria

Exclusion Criteria:

* Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC)
* Caring for patients that fit inclusion criteria
Serum Lactate Trend in Liver Resection

The study aimed to evaluate the correlation between the serum lactate concentration ed cumulative Pringle time after liver resection. In addition, the correlation between lactate clearance and clamping time was investigated.

During liver resection high serum lactate (sLac) concentration can be related to several clinical factors: impairment in lactate metabolism (i.e. extraction and utilization by the liver) or overproduction by splanchnic tissues; restrictive fluid regimen in order to limit the intraoperative back-flow bleeding; ischemia-reperfusion syndrome. However, the Pringle maneuver (temporary clamping of the hepatic hilum) seems having a sensible effect in inducing a significant increase in sLac levels during liver resection, particularly in the event of compromised liver function such as in cirrhosis.

Although the peak of sLac concentration may correlate with outcome, the lactate clearance (cLac) seems to be a better predictor. To date, this relationship has been mainly demonstrated in severe sepsis and shock septic. However, the effective correlation between the cumulative clamping time and cLac has not been clearly investigated. The correlation between cumulative hepatic ischemic time and sLac trend in the perioperative period after liver resection with intermittent PM was investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for liver resection for hepatic tumors

Exclusion Criteria:

* Patients who received blood transfusion or affected by chronic renal failure were excluded