araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 14-year-old female with Li-Fraumeni syndrome; genetic feature: TP53

Clinical trial: Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating children who have advanced neuroblastoma or other solid tumors.

Detailed description: OBJECTIVES:
  -  Determine the response rates of patients with advanced neuroblastoma or other pediatric solid tumors treated with arsenic trioxide.
  -  Determine the toxicity of this drug in these patients.
  OUTLINE: Patients are stratified according to type of disease (neuroblastoma with progressive disease vs neuroblastoma with stable refractory disease vs other solid tumor).
  Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
  Patients are followed every 2-3 months for 1 year and then annually thereafter.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed neuroblastoma or other pediatric solid tumor (nonmyeloid and nonlymphoid) including the following:
  -  Ewing's family of tumors/primitive neuroectodermal tumor
  -  Retinoblastoma
  -  Nephroblastoma
  -  Osteosarcoma
  -  Rhabdomyosarcoma
  -  Desmoplastic small round-cell tumor
  -  Hepatoblastoma
  -  Germ cell tumors
  -  Medulloblastoma
  -  Relapsed from or resistant to prior standard anticancer therapy and/or no known standard therapy available
  -  Measurable disease (e.g., solid mass with definable dimensions) OR
  -  Evaluable disease (e.g., bone marrow involvement or malignant pleural effusion)
  PATIENT CHARACTERISTICS:
  Age:
  -  40 and under
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Bilirubin no greater than 2.5 times upper limit of normal (ULN)
  Renal:
  -  Creatinine no greater than 2.5 times ULN
  Cardiovascular:
  -  Absolute QT interval no greater than 460 msec in the presence of adequate potassium and magnesium levels
  Other:
  -  No pre-existing neurotoxicity/neuropathy grade 2 or greater
  -  No pre-existing convulsive disorder
  -  No active serious infections uncontrolled by antibiotics
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  More than 3 weeks since prior cytotoxic chemotherapy
  -  No other concurrent cytotoxic chemotherapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Concurrent radiotherapy allowed provided measurable or evaluable disease exists outside radiation field
  Surgery:
  -  Not specified
  Other:
  -  No other concurrent investigational agents

Relevance to patient case: not relevant
Patient case: 14-year-old female with Li-Fraumeni syndrome; genetic feature: TP53

Clinical trial: Acupuncture for Irritable Bowel Syndrome

Summary: Little is known about acupuncture's efficacy for Irritable Bowel Syndrome (IBS). This trial uses a manualized acupuncture treatment format that closely follows clinical practice and allows flexibility in designing individualized treatments. In addition, a second parallel qualitative study will follow a subgroup of patients throughout the trial to explore the relationships between patients' interpretations and understandings (what anthropologists call "meaning") of irritable bowel and their response to treatment. Cortisol levels (an important stress hormone) will also be assessed.
  This will be a 3-arm trial: Active acupuncture, placebo acupuncture, and wait list.


Eligibility: Inclusion criteria:
  Diagnosis of Irritable Bowel Syndrome based on Rome II criteria, including at least 12 weeks of abdominal discomfort or pain in the last 12 months with at least 2 of the following features:
  -  Relief with defecation
  -  Onset associated with a change in stool frequency
  -  Onset associated with a change in form/appearance of stool
  Exclusion criteria:
  -  History of severe or intractable IBS, defined as continuous, unremitting and several abdominal pain greater than 12 hours/day
  -  Previous acupuncture treatment
  -  Concurrent diagnosis of any bowel disturbance that would interfere with the assessment or safety of the study
  -  History of laxative abuse
  -  Previous abdominal surgery (uncomplicated appendectomy, hysterectomy or cholecystectomy at least 6 months prior to entry acceptable)
  -  History of metabolic or inflammatory disease that may affect bowel motility, eg.g., inflammatory bowel disease, diabetes mellitus, sarcoidosis
  -  Other significant illness as determined by Investigator
  -  History of drug or alcohol abuse w/in 2 years;
  -  Insufficient knowledge of English to complete self-assessments to participate in study

Relevance to patient case: not relevant
Patient case: 14-year-old female with Li-Fraumeni syndrome; genetic feature: TP53

Clinical trial: Antiphospholipid Syndrome Collaborative Registry (APSCORE)

Summary: Antiphospholipid Syndrome (APS) is an autoimmune disorder in which the body recognizes certain normal components of blood and/or cell membranes as foreign substances and produces antibodies against them. Patients with these antibodies may experience miscarriages and blood clotting disorders, including heart attacks and strokes. APS may occur in people with systemic lupus erythematosus and other autoimmune diseases, or in otherwise healthy individuals.
  The Antiphospholipid Syndrome Collaborative Registry (APSCORE) is a national registry and tissue repository for patients with APS. This registry will collect clinical information and blood samples from people with APS.

Detailed description: Registry participants will have a blood sample drawn and will be interviewed about their medical histories. Participants will be asked to return for a follow-up visit after two years. Clinical, demographic, and laboratory data will be collected. Registry resources will be made available to researchers and medical practitioners to support a broad range of research on the causes, diagnosis, mechanisms, and treatment of APS.
  The University of North Carolina at Chapel Hill is the coordinating center and an enrollment site for the registry. There are seven other enrollment sites: Ball Memorial Hospital, Muncie, IN; Duke University, Durham, NC; Hospital for Special Surgery, New York, NY; Johns Hopkins University, Baltimore, MD; Morehouse School of Medicine, Atlanta, GA; University of Texas Health Science Center, San Antonio, TX; and University of Utah Health Science Center, Salt Lake City, UT.

Eligibility: Inclusion Criteria:
  -  Antiphospholipid antibodies with or without associated clinical manifestations

Relevance to patient case: not relevant
Patient case: 14-year-old female with Li-Fraumeni syndrome; genetic feature: TP53

Clinical trial: Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)

Summary: Hypereosinophilic syndrome (HES) is a rare disease with broad clinical signs and symptoms which is diagnosed based on a persistent blood eosinophil count of greater than 1500 cells, various end-organ damages (including skin, heart, lung, nervous system and digestive system etc.), and with exclusion of known secondary causes of hypereosinophilia.
  HES has a high morbidity/mortality rate. The major treatment of HES has been systemic corticosteroid and other chemotherapeutic drugs (for example, hydroxyurea and interferon) with the intention to lower eosinophil counts and therefore to slow down the progression of disease. Even though corticosteroid and other therapies can effectively reduce eosinophilia in some patients, some may eventually become nonresponsive and intolerable to the amount of side effects of the long-term therapy with these medications.
  Mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5 (hIL-5) and inhibits its activity. Previous human experience has shown it has been effective in reducing blood eosinophilia in atopic and HES patients and has alleviated some HES clinical signs and symptoms. This study intends to further evaluate the corticosteroid-sparing and clinical benefit of mepolizumab in HES.

Detailed description: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase III Study to Evaluate Corticosteroid-reduction and -sparing effects of Mepolizumab 750 mg intravenously in Subjects with Hypereosinophilic Syndromes (HES) and to evaluate the Efficacy and Safety of Mepolizumab in controlling the Clinical Signs and Symptoms of HES over Nine Months

Eligibility: Inclusion criteria:
  -  Documented history of Hypereosinophilic Syndrome (HES)
  -  Eosinophil count greater than 1500 cells for 6 months
  -  Signs and symptoms of organ system involvement
  -  No evidence of parasitic, allergic or other causes of eosinophilia after comprehensive evaluation.
  -  Achieve and maintain a stable prednisone (corticosteroid) dose prior to starting study medication.
  -  Not pregnant or nursing.
  Exclusion criteria:
  -  Churg-Strauss Syndrome
  -  Wegener's Granulomatosis
  -  Lymphoma, hematological malignancy, advanced and metastatic solid tumors
  -  Chemotherapy, radiotherapy or interleukin 2 treatment.

Relevance to patient case: not relevant
Patient case: 14-year-old female with Li-Fraumeni syndrome; genetic feature: TP53

Clinical trial: Nursing Management of Irritable Bowel Syndrome:Improving Outcomes

Summary: The purpose of this study is 1) to determine whether a comprehensive self-management intervention is effective in a sample that includes men and women with irritable bowel syndrome, and 2) to determine whether the comprehensive self-management intervention is as effective when delivered over the telephone as compared to a face-to-face approach.

Detailed description: Randomization and Intervention Phase. Upon completing the baseline assessment phase, participants will be randomized to one of 3 treatment groups. A customized computer program will be used to do the randomization in an adaptive manner that ensures the 3 groups remain fairly balanced with respect to possible important predictors of outcomes: age, sex, predominant stool pattern (alternating, constipation-predominant or diarrhea-predominant), and severity of IBS symptoms and psychological symptoms at baseline. When each new participant is randomized, the program will adjust the probabilities of assignment to the three groups so that there is a higher probability of assignment to the group that results in the best balance.
  Intervention Groups. Face-to-Face Individualized Comprehensive Self-Management (CSM-FF) Group. Participants in the individualized CSM-FF group will be scheduled for 9 weekly sessions with the nurse therapist followed by post-intervention follow-up assessment.
  Telephone Individualized Comprehensive Self-Management (CSM-TEL) Group. Participants in the individualized CSM-TEL group will initially have 2 face-to-face meetings with the nurse therapist, 6 sessions over the phone and the final session face-to-face at 9 weeks.
  Usual Care Control Group (UC). Following randomization the participants in the control group will no receive any contacts during the comparable 9-week intervention in the treatment groups.
  Follow-up Phase. Participants in all 3 groups will be reassessed at 3-mo, 6-mo, and 12-mo post randomization. At this time the participants will complete questionnaires, a 4 week diary and collect 4 urines.

Eligibility: Inclusion Criteria:
  -  Irritable Bowel Syndrome
  Exclusion Criteria:
  -  GI pathology (organic disease)
  -  Co-morbid pain disorders

Relevance to patient case: not relevant
Patient case: 14-year-old female with Li-Fraumeni syndrome; genetic feature: TP53

Clinical trial: Cardiovascular Risk Evaluation in Clinical Practice in Metabolic Syndrome Patients

Summary: Metabolic syndrome is commonly defined as a set of risk factors and abnormalities that markedly increase the risk of cardiovascular events. Its relevance has been confirmed by a recent population-based survey of subjects aged 40-79 years indicating that the prevalence of metabolic syndrome in Italy is 34.1% if diagnosed using WHO criteria and 17.8% if diagnosed using the NCEP-ATPIII criteria.
  On the basis of the above considerations, the aim of this study is to promote the use of the SCORE algorithm for estimating cardiovascular risk, and to evaluate its evolution in patients with metabolic syndrome after the implementation of a multifactorial preventive strategy, with particular reference to the correction of lifestyle, hypertension and dyslipidemia.


Eligibility: Inclusion Criteria:
  -  Patients of both genders aged 40-65 years.
  -  A diagnosis of metabolic syndrome formulated on the basis of the criteria proposed by the NCEP - Adult Panel III: i.e. the presence of at least three of the following conditions:
  1. Waist circumference >102 cm in men and >88 cm in women
  2. Triglyceridemia 150 mg/dl
  3. HDL cholesterol <40 mg/dl in men and <50 mg/dl in women
  4. Sitting arterial pressure 130/85 mmHg
  5. Fasting glycemia 110 mg/dl
  -  A risk of cardiovascular death of >5% at the current age of the patient or >5% if projected to an age of 60 years, as calculated by means of the SCORE algorithm using the table based on the total/HDL cholesterol ratio relating to low-risk populations and appropriate for Italy.
  -  Written informed consent.
  Exclusion Criteria:
  -  Women who have not been in menopause for at least one year or are not surgically sterile, and do not use an effective contraceptive method, such as spermicidal barrier methods or intrauterine devices. The use of oral contraceptives is not allowed.
  -  Known or suspected hypersensitivity to valsartan and/or fluvastatin, or other contraindications to their use;
  -  A positive history of ischemic heart disease, peripheral artery disease or cerebral vasculopathy;
  -  Patients with an SBP of 180 mmHg and/or DBP of 110 mmHg.
  -  Patients with severe medical conditions which, in the judgement of the Investigator, contraindicate trial participation or significantly limit life expectancy;
  -  Treatment with drugs able to modify the lipid profile (ongoing or in the three months preceding trial entry);
  -  Patients unable to follow the planned protocol procedures or sign the informed consent form.

Relevance to patient case: not relevant
Patient case: 14-year-old female with Li-Fraumeni syndrome; genetic feature: TP53

Clinical trial: The Interaction Between Severe Acute Respiratory Distress Syndrome Viral Proteins and Monocytes

Summary: Severe acute respiratory syndrome (SARS) is a new threat to public health since November, 2002. The SARS is highly contagious and is believed to be transmitted by person-to-person through droplet and direct contact. The patients present with fever, chills, cough, myalgia, dyspnea, and diarrhea. The symptoms aggravate in the second week and nearly 40% of the patients develop respiratory failure that requires assisted ventilation. The mortality rate is reported as 6.5%-7%.
  After several months, the world scientists found the etiology to be a new coronavirus not belonging to the previous coronavirus group I, II and III. The new virus is called SARS associated coronavirus (SARS-CoV).
  Although the high morbidity and mortality of SARS occurred in adults, there was rare mortality reported in the children. The report from Hong Kong pointed out that the symptoms of SARS in younger children were milder and the clinical course was not as aggressive as in adults. Therefore, the aim of the project is to design the experiment to see the differences of immunological responses to SARS-CoV protein in healthy younger children, teenagers, and adults. The investigators hope that the result could explain the reason for milder disease in younger children and the immunological pathogenesis of SARS.


Eligibility: Inclusion Criteria:
  -  Healthy adults, children and cord blood

Relevance to patient case: not relevant
Patient case: 14-year-old female with Li-Fraumeni syndrome; genetic feature: TP53

Clinical trial: Morphology of the VMO in Patients With PFPS and Healthy Young Adults--A Sonographic Study

Summary: Background：Patellofemoral pain syndrome（PFPS） is a common knee disorder characterized by anterior or retropatellar pain associated with activities that load the patellofemoral joint. Previous studies reveal that the vastus medialis obliquus（VMO） is an important dynamic medial stabilizer of the patellar. Insufficiency of the VMO leads to lateral shift of the patella and the increases the patellofemoral contact force. An in vitro study conducted by Hubbard JK. et al. claimed that there were no significant relationship between several morphologic characteristics of the VMO and the extent of patellofemoral joint deterioration. We consider that the condition might be different in vivo, so we chose ultrasonogrphy as the measurement tool to examine the morphology of the VMO in PFPS patients and healthy controls. Purpose：To determine if there are significant differences in several morphologic parameters of the VMO between patients with PFPS and healthy controls under 50. Method：31 PFPS patients and 31 matched healthy adults under 50 were recruited for the study. The HDI 5000 ultrasonography machine was used to evaluate morphologic parameters of the VMO, including the percent of patella attachment, fiber angle, the volume attached to the patella, and the change of shape of the VMO.


Eligibility: Inclusion Criteria:
  1. under 50 years old.
  2. Have a diagnosis of PFPS.
  Exclusion Criteria:
  1. Diagnosis other than PFPS，such as meniscal lesion, ligamentous instability ,patellar tendon pathology, traction apophysitis, radiation pain, referred pain, ect.
  2. Knee operation within three month.
  3. X-ray findings (1)joint space narrowing (2)osteophyte formation

Relevance to patient case: not relevant
Patient case: 14-year-old female with Li-Fraumeni syndrome; genetic feature: TP53

Clinical trial: The Symptom Experience of Women With Perimenstrual Syndrome;Women's Health Related Quality of Life.

Summary: The purpose of these series research project is to investigate the prevalence, symptoms cluster and characteristic; establish the systemic symptom management nursing strategies (PMS-SMP); determine short-and long-term effectiveness of PMS-SMP. To enhance the health related quality of life of women with Perimenstrual syndrome. Simultaneously, the PMS-SMP offers a research and clinical based protocol to demonstrate the independent nursing role and practice care model. The 3-year series research process will include three research domains.

Detailed description: Symptoms are the most common reason people seek health care. Although the menstrual cycle, a normative process, but 10~15% of western women experience sever recurring symptoms associated with the menstrual cycle that can be considered a chronic illness. There are many interventional researches focus on this issue in western countries. There is not only lack of evidence base prevalence of perimenstrual syndrome, but also never found any nursing intervention project focusing on women with perimenstrual syndrome.
  The purpose of these series research project is to investigate the prevalence, symptoms cluster and characteristic; establish the systemic symptom management nursing strategies (PMS-SMP); determine short-and long-term effectiveness of PMS-SMP. To enhance the health related quality of life of women with Perimenstrual syndrome. Simultaneously, the PMS-SMP offers a research and clinical based protocol to demonstrate the independent nursing role and practice care model. The 3-year series research process will include three research domains.
  Content analysis, descriptive statistics(percentage, mode, medium, quartile, rank), Chi-square, One way ANOVA, MANCOVA, and Step-Wise regression will be applied to examine the research finding. Although focused on perimenstrual symptoms relief and improve the health related quality of life of women with perimenstrual symptoms, these strategies are generally health promoting and can be applied to other women’s health conditions.

Eligibility: Inclusion Criteria:
  -  female
  Exclusion Criteria:
  -  pregnancy,menopause,woman with breast-feeding

Relevance to patient case: not relevant
Patient case: 14-year-old female with Li-Fraumeni syndrome; genetic feature: TP53

Clinical trial: Steroids and Antiphospholipid Syndrome- Related Pregnancy Loss

Summary: Does the addition of steroids during the first trimester to the standard aspirin + heparin treatment reduce the miscarriage rates in women with antiphospholipid antibodies and recurrent first trimester miscarriage in those who had an unsuccessful pregnancy with aspirin + heparin?

Detailed description: Over the last decade, the APS has emerged as most important treatable cause of recurrent miscarriages. The pathogenesis of fetal loss in this condition is still remains obscure. Despite the success of aspirin + heparin treatment, some pregnant women with APS repeatedly miscarry even on treatment. The trial is designed to determine if addition of steroids has an success in these women. This is in view of recent in vitro data from our unit reporting that there is an increase decidual cytokine response in APS positive women.

Eligibility: Inclusion Criteria:
  History of 3 or more consecutive miscarriages and positive antiphospholipid antibodies on at least two occasions more than 6 weeks apart before becoming pregnant and an unsuccessful pregnancy with aspirin + heparin with a karyotype of miscarriage either unavailable or normal (46XX/ 46XY).
  Exclusion Criteria:
  Abnormal karyotype of women or partner, previous thromboembolism, SLE, diabetes mellitus, hypertension, sensitivity to aspirin, heparin and prednisolone, multiple pregnancy.

Relevance to patient case: not relevant
Patient case: 14-year-old female with Li-Fraumeni syndrome; genetic feature: TP53

Clinical trial: Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial

Summary: The purpose of this study is to determine whether daily use of a lower limb venous-return assist device, "Venowave', improves leg symptoms, ability to perform activities of daily living, and quality of life in subjects with severe PTS.

Detailed description: Eligible consenting patients will be randomly allocated to receive either the veno-device (active or placebo for 8 weeks and crossed over for a further 8 weeks (active or placebo) following a 4 week 'wash out' period.( A randomized controlled 'crossover' study}

Eligibility: Inclusion Criteria:
  -  Past History of objectively documented deep vein thrombosis
  -  Daily leg swelling with discomfort (i.e. report at least one of the following symptoms: heavy legs, aching legs and/or throbbing) for a minimum of 6 months
  -  Over 18 years of age (and of either gender).
  -  Villalta score of greater than 14(i.e.severe post phlebitic syndrome)
  Exclusion Criteria:
  -  Episode of objectively documented deep vein thrombosis occurred less than 6 months before recruitment
  -  Subjects report that their symptoms have been unstable (worsening, improving or variable over the previous month).
  -  Active venous ulceration
  -  Baseline leg circumference greater than 50 cm (cuff will not fit subject)
  -  Symptomatic peripheral arterial disease Peripheral neuropathy

Relevance to patient case: not relevant