cyrilzakka/clinical-trials huggingface dataset:
Cetuximab in Combination With Chemotherapy for Patients With Head and Neck Cancer

This is an open, multicenter phase II study. The purpose is to demonstrate the efficacy of cetuximab in combination with carboplatin and vinorelbine as second line treatment in patients with recurrent or metastatic head and neck cancer who have progressed during or after treatment with first line cisplatinum.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified squamous cell carcinoma of the head and neck where curatively intended local treatment is not possible.
* Measurable or non-measurable disease.
* Disease progression during or after first line palliative chemotherapy with cisplatinum or patients with recurrence \< 6 months after primary concomitant chemo-radiotherapy with cisplatinum.
* WHO Performance Status 0-2.
* Age ≥ 18 years.
* Neutrophil count (ANC) ≥ 1.5 x 10\^9/l and platelets ≥ 100 x 10\^9/l.
* Normal liver function with bilirubin \< 1.5 x UNL (Upper Normal Limit), no UNL for ALAT with liver metastases.
* Creatinin clearance ≥ 50 ml/min.
* Signed informed consent.

Exclusion Criteria:

* Other active malignant disease.
* Patients who are considered unable to follow the treatment plan or follow-up visits.
* Other serious disease (e.g. severe heart disease, myocardial infarction (MI) within 1 year, active infection).
* Any condition or treatment which after the opinion of the investigator may expose the patient to a risk or may influence the purpose of the trial.
* Pregnant or lactating women.
* Known hypersensitivity towards one or more of the components of the treatment.
* Prior treatment with either cetuximab or other inhibitors of EGFR.
Docetaxel With or Without Metronomic Cyclophosphamide as First Line Chemotherapy in Metastatic Breast Cancer

The purpose of this study is to evaluate the role of metronomic cyclophosphamide in addition to docetaxel in first line therapy in metastatic breast cancer.

Metronomic chemotherapy has been considered as an effective strategy for metastatic breast cancer. This trial is designed to evaluate the role of metronomic cyclophosphamide in addition to docetaxel in first line therapy in metastatic breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Females with age between 18 and 70 years old
2. ECOG performance between 0-1
3. Life expectancy more than 3 months
4. Histological proven unresectable recurrent or advanced breast cancer
5. No previous chemotherapy for metastatic breast cancer;suitable for monotherapy (Neoadjuvant or adjuvant docetaxel should be completed at least one year).
6. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST1.1)
7. No anticancer therapy within 4 weeks
8. Adequate hematologic, hepatic, and renal function,No serious medical history of heart, lung, liver and kidney
9. Provision of written informed consent prior to any study specific procedures

Exclusion Criteria:

1. Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound)
2. Women of child-bearing potential, unwilling to use adequate contraceptive protection during the course of the study
3. Treatment with an investigational product within 4 weeks before the first treatment
4. Symptomatic central nervous system metastases
5. Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
6. Patient having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
7. Uncontrolled serious infection
8. Patients with bad compliance
Validation of the Panic Screening Score in Patient With Unexplained Chest Pain

Panic-like anxiety ( panic attacks with or without panic disorder), a highly treatable condition, is the most prevalent condition associated with unexplained chest pain in the emergency department. Panic-like anxiety may be responsible for a significant portion of the negative consequences of unexplained chest pain, such as functional limitations and chronicity. However, more than 92% of panic-like anxiety cases remain undiagnosed at the time of discharge from the emergency department. The 4-item Panic Screening Score questionnaire was derived in order to increase the identification of panic-like anxiety in emergency department patients with unexplained chest pain.

The goals of this prospective cohort study are to (1) refine the Panic Screening Score; (2) validate the revised version of the Panic Screening Score; (3) measure the reliability of the revised version of the Panic Screening Score and (4) assess the acceptability of the instrument among emergency physicians.


Eligibility Criteria:
Inclusion Criteria:

Presenting unexplained chest pain as defined by:

* the absence of an identifiable cause (e.g., pneumothorax,pneumonia),
* the absence of chest trauma,
* the absence of new malignant cardiac arrhythmia, and
* a score of 2 or less on the modified version of the thrombolysis in myocardial infarction score.

Exclusion Criteria:

* presence of a terminal illness;
* presence of a severe communication problem that could interfere with the administration of the questionnaire;
* presence of a psychotic state, a major cognitive deficit or other condition that could invalidate the interview;
* being legally incompetent.
Exploring the Effect of Interactive Board Game Health Education on Improving Stroke Knowledge and Health Literacy in Community-Dwelling Adults

The purpose of this study is to explore the effectiveness between interactive board game health education and conventional health education in improving community-dwelling adults' stroke knowledge and self-reported stroke health literacy, including risk factors, symptoms, acute management of stroke, and 6 aspects of self-reported stroke health literacy. The intervention group will receive an interactive board game in a group (2\~6 individuals), while the control group was assigned to read the health education flier and watching the stroke prevention video. The follow-up period was set to be four weeks after the intervention, both control group, and intervention group.

Stroke is a major health problem and a known cause of death and disability. Approximately 13 million people suffered from stroke worldwide annually and it ranks fourth among the top 10 causes of death in Taiwan. In a recent survey of Taiwanese citizens on the World Stroke Day event (New Taipei City) in 2012, the public's stroke literacy was low, only 5.71% of them can reach "good stroke literacy". Generally, stroke education was mostly implemented in a one-way lecture way. Therefore, instead of one-way style health education, the investigators assume that interactive board games can increase stroke knowledge, stroke literacy, and self-reported stroke health literacy of community-dwelling seniors.

Eligibility Criteria:
Inclusion Criteria:

* Aged 50 years old or above.
* Cases with sanity and ability to communicate in Chinese or Taiwanese.
* No oral difficulties in daily life, able to fully express research-relevant narratives and readings.

Exclusion Criteria:

* Patients with a history of stroke diagnosed by a physician.
* Non-Republic of China (Taiwan) nationality.
* Worked as a medical staff in the past, in the fields of medical care or health educator.
* Those who cannot complete the assessment according to the guidance of the assessor.
Prospective Subtalar, Double, or Triple Arthrodesis Study With CCS Screws

The objective of this study is to prospectively evaluate the mid-term results and intraoperative and postoperative complication rate in patients who underwent double or triple arthrodesis using CCS screws.

This proposal is a collaborative effort of Medartis. This is a prospective investigation to evaluate the mid-term results and intraoperative and postoperative complication rate in patients who underwent subtalar,double or triple arthrodesis using CCS screws.The assignment of the device is at the discretion of the standard of care provider, not the study investigator.

Patients undergoing a double or triple arthrodesis in their foot using Aptus CCS screws will be asked to enroll in this study. After informed consent, the patients will be asked to complete the following patient reported outcomes questionnaires (standard of care for all patients in the Foot and Ankle section): VAS for pain, modified Coughlin rating scale, AOFAS, and FADI at each standard of care visit which includes preoperative, 6 weeks, 3 months, 6 months, 1 year, and 2 years post operative. Patients will also receive standard of care radiographs at these visits, and a standard of care CT scan at 6 months.

Patients will be identified in the clinic by an attending orthopaedic foot and ankle surgeon or his physician assistant based on clinical exam and radiographic findings. Inclusion criteria include anyone over age 18 who has Rheumatoid or posttraumatic osteoarthritis of the hindfoot with involvement of subtalar, talonavicular, and calcaneocuboid joints, and/or Symptomatic rigid pes planovalgus et abductus with end-stage posterior tibial tendon dysfunction, and/or Neuromuscular disease mediated hindfoot deformities, and/or Tarsal coalitions, and/or Indication for calcaneocuboid arthrodesis: severe degenerative changes in the calcaneocuboid joint and/or severe abductus deformity of the forefoot.and has failed nonoperative management. Typically, these patients have multiple medical comorbidities and therefore the only exclusion criteria will be patients who are not healthy enough to undergo surgery. Approximately 50 patients will be recruited for the study.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid or posttraumatic osteoarthritis of the hindfoot with involvement of subtalar, talonavicular, and calcaneocuboid joints (2;12).
* Symptomatic rigid pes planovalgus et abductus with end-stage posterior tibial tendon dysfunction (e.g. grade IV) (4;13-15).
* Neuromuscular disease mediated hindfoot deformities (16).
* Tarsal coalitions (17).
* Indication for calcaneocuboid arthrodesis: severe degenerative changes in the calcaneocuboid joint and/or severe abductus deformity of the forefoot.
* Between the age 18-75

Exclusion Criteria:

* Acute or chronic infection.
* Poor vascular status of the lower leg (relative contraindication for double arthrodesis through a single medial approach).
* Women that are pregnant.
Restrictive Versus Liberal Transfusion, Major Surgeries

Investigators aimed to compare the restrictive and liberal blood transfusion methods applied in major surgical operations performed in Anesthesiology and Reanimation Clinic and investigate their effects on postoperative transfusion needs, morbidity and mortality.

The test subjects consisted of 892 patients, who belong to ASA (American society of Anesthesiology) I -IV groups, underwent elective major surgery between the 01/01/2016-31/12/2016, and are over the age of 18 years. The demographic data (Age, sex, ASA (American society of Anesthesiology) scors, surgery type) were also recorded. we evaluated the value of Hemoglobin, platelet, APTT (activated partial thromboplastin time), INR (international normalized ratio) preoperatively and postoperatively. In this study, restrictive and liberal blood transfusion groups were investigated.restrictive and liberal transfusion hemoglobin threshold value respectively before perioperative transfusion was 8 g / dL. were defined as restrictive blood transfusion group and perioperative transfusion was over 8 g / dL were defined as liberal blood transfusion group. Adverse events (tachycardia, hypotension, the value of lactate and metabolic acidosis). Postoperatively, the amount of postoperative transfusion unit, duration of hospital stay, requirement of intensive care unit and mortality rate.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old patients,
* ASA I-II-III-IV,
* Major surgeries ( Intra-abdominal, intracranial, head and neck malignancy surgery, femur and vertebra surgery)

Exclusion Criteria:

* Emergency operation,
* Cardiovascular surgery,
* ASA V-VI
* Under 18 years old patients
Maternal Lipids and Offspring Adiposity at 5-7 Years

This study investigates the associations between measured maternal lipids (Total cholesterol, LDL-cholesterol , triglycerides and high-density lipoprotein cholesterol) at 28 weeks' gestation and offspring adiposity at 5-7 years. This was examined in a large observational study based in Belfast, UK.

The concept of fuel mediated teratogenesis, as proposed by Freinkel in his 1980 Banting Lecture, postulated that altered fuel metabolism during pregnancy had a long lasting metabolic effect on the offspring. Although in the intervening years the focus has largely been on maternal glucose as the principal fetal fuel, animal studies have documented that other nutrients such as lipids can also be transferred across the placenta. Furthermore, the latter part of pregnancy is associated with a significant hyperlipidemia including hypercholesterolemia and hypertriglyceridemia. Although the relation of maternal lipids during pregnancy to birth outcomes is well documented, few studies have examined this relation to longer term outcomes. Such an association, if present, would lend further support to the presence of developmental programming in the offspring based on fuel mediated teratogenesis.

Against such a background, the aim of this study was to examine the association between maternal lipids during pregnancy and later offspring adiposity controlled for relevant confounders including maternal body mass index (BMI), gestational glycemia and offspring birth weight.

The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study was an international multicentre epidemiologic study that examined the associations of hyperglycemia during pregnancy to adverse maternal/fetal pregnancy outcomes. Eligible pregnant women attended the Royal Victoria Maternity Hospital for an oral glucose tolerance test between 24-32 weeks gestation to assess glucose tolerance. An additional fasting serum sample for analysis of lipids was taken.

The mothers and their offspring were invited to return to the study 5-7 years later. At this visit, offspring weight, height and skin fold thickness measurements were taken.

Eligibility Criteria:
Inclusion Criteria:

* In a pregnant state in the first/second trimester
* Attending the Royal Victoria Maternity Hospital

Exclusion Criteria:

* Age younger than 18 years
* A plan to undergo delivery at another hospital
* An uncertain date of last menstrual period and no ultrasonographic estimation between 6 and 24 weeks of gestational age
* Inability to complete the oral glucose-tolerance test within 32 weeks of gestation
* Multiple pregnancy
* Conception by means of gonadotropin ovulation induction or in vitro fertilization
* Glucose testing before recruitment or a diagnosis of diabetes during the current pregnancy
* Diagnosis of diabetes before the current pregnancy and requiring treatment with medication
* Participation in another study that could interfere with the HAPO study
* Infection with the human immunodeficiency virus or hepatitis B or C virus
* Previous participation in the HAPO study
* Inability to converse in the languages used on centre forms without the aid of an interpreter
The Fifth-year Follow-up Study for the Phase IV Clinical Trial of Hepatitis A Vaccine in Healthy Children

The purpose of this follow-up study is to evaluate the five-year immune persistence of one injection of inactivated and attenuated alive hepatitis A vaccine in healthy children.

In the previous double-blind, randomized, phase IV clinical trial in 2008, 300 healthy Chinese children aged 18 to 35 months old were administered with one dose of inactivated and attenuated alive hepatitis A vaccine. Series of serum samples were taken for immunogenicity and immune persistence evaluation. Safety observations were performed after vaccination. This trial was also approved by Tianjin CDC Biomedical Ethics Committee in 2008.

This study is the fifth-year follow-up research for the previous clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* All subjects who received inactivated or attenuated alive HAV vaccine in the previous trial

Exclusion Criteria:

* Subjects who refused to continue in the follow-up study
Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)

The purpose of the UNIVERSAL study is to assess the safety, efficacy, cell kinetics, and immunogenicity of ALLO-715 with or without Nirogacestat in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen of ALLO-647 in combination with fludarabine and/or cyclophosphamide, or ALLO-647 alone.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (serum, urine, or free light chain \[FLC\]) per International Myeloma Working Group (IMWG) criteria
* At least 3 prior lines of MM therapy, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody (unless contraindicated), and refractory to the last treatment line.
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Absence of donor (product)-specific anti-HLA antibodies
* Adequate hematologic, renal, hepatic, pulmonary, and cardiac function

Exclusion Criteria:

* Current or history of Central Nervous System (CNS) involvement of myeloma or plasma cell leukemia
* Clinically significant CNS disorder
* Current or history of thyroid disorder
* Autologous stem cell transplant within the last 6 weeks, or any allogeneic stem cell transplant
* Prior treatment with anti-BCMA therapy, any gene therapy, any genetically modified cell therapy, or adoptive T cell therapy
* History of HIV infection or acute or chronic active hepatitis B or C infection
* Patients unwilling to participate in an extended safety monitoring period

Additional Exclusion Criteria for Nirogacestat plus ALLO-715 Cohorts

* Inability to swallow tablets
* Subject has known malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat
* Use of strong/moderate CYP3A4 inhibitors, and strong CYP3A4 inducers within 14 days before starting nirogacestat.
* Use of concomitant medications that are known to prolong the QT/QTcF interval
Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding

This study is performed to compare the efficacy of terlipressin, somatostatin, and octreotide in patients with variceal bleeding for the control of variceal bleeding in combination with endoscopic therapy.

In patients who are suspected to have variceal bleedings, pharmacologic therapy with vasoactive drugs such as terlipressin, somatostatin, and octreotide is recommended as soon as possible, even before endoscopy. However, it is still unclear whether the efficacies of these drugs are same or not. This study is performed to compare the efficacy of terlipressin, somatostatin, and octreotide in patients with variceal bleeding for the control of variceal bleeding in combination with endoscopic therapy.

Eligibility Criteria:
Inclusion Criteria:

* liver cirrhosis
* age between 16 and 75 years
* Patients who have upper GI bleeding symptoms (hematemesis or melena) within 24 hours before enrollment
* Patients whose systolic blood pressure \<100 mmHg or pulse rate \>100/min at the enrollment
* Patients who were not performed endoscopic or pharmacologic therapy for varices
* Signed informed consent

Exclusion Criteria:

* Pregnancy
* Positive anti-HIV Ab
* A history of severe side-effects or contraindications to study drugs
* Severe cardiovascular diseases: acute myocardial infarction, A-V block, congestive heart failure, ischemic heart disease, hypertension (systolic blood pressure \>170 mmHg or diastolic pressure \>100 mmHg)
* Chronic renal failure
* Hepatocellular carcinoma with protal vein thrombosis
* Coexisting malignancy except hepatocellular carcinoma
Safety, Feasibility and Cost-effectiveness of Genotype-directed Individualized Dosing of Fluoropyrimidines

In this study it will be determined whether the rate of severe toxicity associated with fluoropyrimidine treatment (capecitabine or 5-fluorouracil) can be significantly diminished by individualized dosing of fluoropyrimidines based on upfront genotypic assessment of dihydropyrimidine dehydrogenase (DPD) deficiency.

In addition to the genotyping, the DPD phenotype of all patients will be determined by measuring the baseline dihydrouracil/uracil (DHU/U) ratio, in order to investigate whether phenotype-guided treatment can further improve patient safety. In a subgroup of patients, other phenotyping methods will be tested: measuring the plasma levels of uracil after a uracil test dose and a uracil breath test after a dose of \[2-13C\] -labeled uracil. To validate these tests, these phenotyping results will be compared with the results of a DPD activity assay (which measures DPD enzyme activity in peripheral blood mononuclear cells), which is considered the gold standard in measuring DPD phenotype.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed malignancy for which treatment with a fluoropyrimidine is considered to be in the patient's best interest
2. Age ≥ 18 years
3. Able and willing to give written informed consent
4. WHO performance status of 0, 1 or 2
5. Life expectancy of at least 12 weeks
6. Able to swallow and retain oral medication
7. Able and willing to undergo blood sampling for pharmacogenetic and phenotyping analysis
8. Minimal acceptable safety laboratory values (ANC, platelet count, hepatic function, renal function)

Additional inclusion criteria for patients in subgroup of study:

1. Able and willing to undergo blood sampling and breath sampling at several time points
2. Able and willing to receive uracil for the test dose assay
3. Able and willing to receive \[2-13C\] -labeled uracil for the breath test

Exclusion Criteria:

1. Prior treatment with fluoropyrimidines
2. Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient's safety
3. Women who are pregnant or breast feeding
4. Both men and women who refuse to use reliable contraceptive methods throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms)
5. Patients with a homozygous polymorphic genotype or compound heterozygous genotype for DPYD