cyrilzakka/clinical-trials huggingface dataset:
Studying DNA in Tumor Tissue Samples From Patients With Localized or Metastatic Osteosarcoma

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at DNA in tumor tissue samples from patients with localized or metastatic osteosarcoma.

OBJECTIVES:

* Determine the genomic expression profile in tumor tissue samples from patients with localized or metastatic osteosarcoma using transcriptome sequencing.
* Identify activating and loss of function mutations and gene rearrangement in these tumor tissue samples using transcriptome sequencing.
* Identify candidate genes that are important in osteosarcoma and tumorigenesis using genome partition strategies for genomic DNA sequencing.
* Identify which mutations are associated with outcome.
* Establish which mutations are also found in germ line DNA that predispose the patient to osteosarcoma.

OUTLINE: DNA and RNA from banked tumor tissue samples and DNA from paired blood samples are analyzed in sequencing studies using next-generation sequencing technology. The sequencing data from these tumor samples are matched to the Human RefSeq (for transcriptome sequencing) and normal human genome in the public databases and to the patient's germ line sequence to identify constitutional and somatic mutations.

Clinical information that is associated with each sample (i.e., age, tumor site, size, primary metastases, response to chemotherapy, surgical remission, follow-up time, and treatment protocol) is also collected, if available.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of localized or metastatic osteosarcoma
* Banked snap-frozen tumor tissue samples and paired blood DNA samples available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
A Study to Evaluate GLPG2222 in Ivacaftor-treated Subjects With Cystic Fibrosis

This clinical study is a phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate two doses of orally administered GLPG2222 in adult subjects with a confirmed diagnosis of CF harbouring one F508del CFTR mutation and a second gating (class III) mutation and on stable treatment with ivacaftor.

Up to 35 evaluable subjects are planned to be included in the study. Eligible subjects must be on stable treatment with physician prescribed ivacaftor (Kalydeco®) for at least 28 days at the baseline visit. They will be randomized in a 2:2:1 ratio to receive one of two active doses of GLPG2222 (150 mg q.d. or 300 mg q.d.) or placebo q.d. administered for 29 days. Subjects will be in the study for a minimum of 6 weeks and a maximum of 10 weeks, from screening until the follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject ≥ 18 years of age, on the day of signing the Informed Consent Form (ICF).
2. A confirmed clinical diagnosis of CF.
3. One F508del mutation on one allele in the CFTR gene, a gating (class III) mutation (one of the following: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R) on the 2nd allele in the CFTR gene (documented in the subject's medical record or CF registry).
4. Weight ≥ 40 kg.
5. Stable concomitant treatment for at least 4 weeks (28 days) prior to baseline (including physician prescribed ivacaftor (Kalydeco®) 150 mg b.i.d.).
6. Forced expiratory volume in 1 second (FEV1) ≥ 40% of predicted normal for age, gender and height at screening (pre- or postbronchodilator).

Exclusion Criteria:

1. History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator.
2. Unstable pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 4 weeks of baseline.
3. Need for supplemental oxygen during the day, and \>2 liters per minute (LPM) while sleeping.
4. History of hepatic cirrhosis with portal hypertension (e.g., signs/symptoms of splenomegaly, esophageal varices, etc).
5. Abnormal liver function test at screening; defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or alkaline phosphatase and/or total bilirubin (\>1.5 times ULN (CTCAE Grade 2) and/or gamma-glutamyl transferase (GGT) ≥ 3x the upper limit of normal (ULN), and/or total bilirubin (\>1.5 times ULN (CTCAE Grade 2).
6. Estimated creatinine clearance \< 60mL/min using the Cockroft-Gault formula at screening.
Ticagrelor Versus Clopidogrel for CMD in Patients With AMI: A Retrospective Study Based on the Angio-IMR

Coronary microvascular dysfunction (CMD) is increasingly recognized as an important indicator for long-term prognosis in patients with acute myocardial infarction (AMI). The angiography-derived index of microcirculatory resistance (angio-IMR) is a novel guidewire-free measure for CMD in patients with AMI. Ticagrelor has recently been suggested to have additional benefits on coronary microcirculation beyond its antiplatelet effect. This study was designed to compare the protective effects of ticagrelor and clopidogrel on CMD and prognostic impact in patients with AMI, using the angio-IMR as a novel assessment tool.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed with AMI, including STEMI and NSTEMI, and underwent successful PCI and routine follow-up coronary angiography at the Second Affiliated Hospital of Zhejiang University School of Medicine between June 1, 2017 and May 31, 2020.

Exclusion Criteria:

* 1) prior treatment with any P2Y12 inhibitor;
* 2) need for long-term oral anticoagulation therapy;
* 3) previous coronary artery bypass grafting (CABG);
* 4) chronic renal dysfunction with estimated glomerular filtration rate (eGFR) \<30 mL/ (min·1.73 m2) or on hemodialysis;
* 5) liver cirrhosis ≥Child-Pugh B class;
* 6) cancer;
* 7) adjustment of dual antiplatelet therapy (DAPT) during follow-up;
* 8) inadequate coronary angiographic images.
Precision Medicine in Cardiovascular Surgery Associated Acute Kidney Injury

The goal of this prospective observational study is to define a risk profile for cardiovascular surgery associated acute kidney injury (AKI), using clinical patient characteristics, operation parameters as well as blood and urine laboratory values.

The main question it aims to answer is:

• Does a combination of the factors mentioned above better predict patient outcome than classical factors used to date in clinical practice?

Participants of this study are adults aged 18 and above who are scheduled for elective heart or main artery surgery, and who have given written informed consent.

The difficulty of precisely predicting AKI following major surgery is a clinical challenge and unmet need as treatment should be introduced within 24-48 hours. In addition there is no available treatment to date apart from supportive therapy such as renal replacement therapy.

Therefore, early identification of patient-specific biomarkers and other clinical predictors could help to better understand the association with AKI and other patient outcomes. In addition to the "classical" risk factors (age, diabetes, pre-existing CKD), frailty might represent another important variable, as shown in previous observational studies. Importantly frailty is not unique to age, although it occurs in approximately 25% of those over 65 and affects more than half of the population aged 85 and older, as it has been shown to be highly prevalent in hospitalized patients and/or patients with CKD. Furthermore, in preclinical studies the serum protein Fetuin-A was identified as potential biomarker for vascular surgery associated AKI.

PEAK is a single center, prospective observational study involving several clinics at the University Hospital Bern. Besides from demographic data and perioperative parameters, blood and urine are collected with high granularity during and immediately after surgery (15min after the first cut, start and end of cardiopulmonary bypass (CBP) or aortic clamping (X-clamp), 4 hours after surgery) and at day 1, 2, 3, and 7 (or discharge) post-surgery. In addition renal function will be assessed at day 90. Furthermore, study participants will answer the Edmonton frailty questionnaire at baseline and at day 90.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective cardiovascular surgery, such as valvular replacement surgery, with or without combined coronary artery bypass graft (CABG), or thoracic or abdominal aortic surgery.
* Written informed consent obtained prior to surgery.

Exclusion Criteria:

* Patients with a kidney transplant or on renal replacement therapy
* Severe liver failure, defined by the presence of encephalopathy, Factor V \< 50% and INR \>1.5 on preoperative blood sample (within 4 weeks).
Effectiveness of Developed Interactive Play Mat In Pediatric Physical Therapy

The proposed study seeks to innovate by harnessing the potential of an interactive play mat, integrating haptic feedback and captivating sensory stimuli, to facilitate and expedite the motor skill development process in children with delayed milestones.

This research endeavors to contribute substantively to the field of pediatric therapy by providing an engaging, effective, and accessible intervention that aligns with the specific needs of this vulnerable population.

Eligibility Criteria:
Inclusion Criteria:

* Delayed Milestones, 2-5 Years of age

Exclusion Criteria:

* Spina Bifida, Hydrocephalus
Prospective Multicenter Registry of Hybrid Coronary Artery Revascularization Combined With Surgical Bypass and Percutaneous Coronary Intervention Using Everolimus Eluting Metallic Stents

This prospective multicenter registry evaluates the efficacy of hybrid coronary revascularization (HCR) combining coronary artery bypass surgery (CABG) and percutaneous coronary intervention (PCI) in the treatment of multivessel coronary artery disease. CABG is to be performed in the left anterior descending artery and the left circumflex artery using only arterial grafts, whereas PCI is to be conducted for the treatment of significant stenotic disease in the right coronary artery with everolimus-eluting stents (EESs). This research plans to involve patients scheduled for coronary revascularization for multivessel coronary artery disease who consent to participate in the registry.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stable angina, unstable angina, or non-ST elevation myocardial infarction.

  * Patients with multivessel coronary artery disease including significant stenotic lesion\* in the right coronary artery and also including left main stem disease.
  * Patients who will be referred for CABG.
  * Patients with significant stenotic lesion in the right coronary artery amenable to PCI.
  * Patients who can take DAPT medications.
  * Patients who provided written informed consent. \* Significant stenotic lesion means a condition where fractional flow reserve (FFR) is lower than 0.80 or visually confirmed stenosis is at least 75%.

Exclusion Criteria:

* • Patients with ST elevation myocardial infarction occurring within 24 hours before enrollment.

  * Patients who previously underwent CABG.
  * Patients who are at high risk of receiving CABG.
  * Patients who need simultaneous surgery such as valve surgery other than CABG.
  * Patients with a life expectancy of 1 year or shorter due to co-morbidities.
  * Patients with a history of cerebral infarction within the last 6 months.
  * Patients with congestive cardiac failure of NYHA 3 or higher.
  * Patients with unstable hemodynamics at enrollment.
  * Patients with right coronary artery disease that is chronic total occlusion and difficult to treat with PCI (J-CTO score of ≥ 23).
  * Patients receiving long-term dialysis.
  * Patients who are allergic to antiplatelet agent.
  * Patients who are critically allergic to contrast media.
  * Patients who are allergic to any DES component.
On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours

The current study aims to systematically investigate the diurnal variation in the optical quality of soft contact lenses on eye throughout the day. Subject reported quality of vision will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Habitual prescription +5.00 D to -6.00 D
* 18-35 years of age
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* Vertex corrected refractive cylinder must be -0.75 or less.
* Visual acuity best correctable to 20/25 or better for each eye
* The subject must read and sign the Informed Consent form.
* Mesopic pupil size \>5.00 mm.

Exclusion Criteria:

* active condition that would prevent contact lens wear
* history of issues of eye alignment or binocularity by self-report
* doctor diagnosed, self-reported accommodative or binocular vision issues
* doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
The Effectiveness and the Safety of Acupuncture for Symptomatic Care of Hemodialysis Patients: A Case-series

Purpose:

Hemodialysis-dependent patients with an end-stage renal disease (ESRD) suffer from a number of distressing symptoms, such as pain, poor mental health, fatigue, sleep disturbance and pruritus. These negatively influence health-related quality of life in ESRD patients, and some of them result in increased mortality and hospitalization. Acupuncture is a widely employed treatment on several chronic disease or condition. Adjunctive use of acupuncture with conventional treatment could be a possible therapeutic option to establish an optimal care for ESRD patients who experiences co-morbid conditions or complications of hemodialysis. Due to its non-pharmacologic feature, the effects of acupuncture without involving altered pharmacokinetics and drug-interactions in hemodialysis patients, might be another strong point compared to other pharmacological interventions. However, little information is available for the effects and the safety of acupuncture for symptomatic care of hemodialysis patients.

Thus, the investigators propose whether acupuncture could be a effective and safe therapeutic modality for a number of patient-reported symptoms in hemodialysis-dependent patients with ESRD.

This trial is a case-series, with a nested-qualitative study at the end of follow-up. Acupuncture treatment will be provided biweekly for 6 weeks, namely total 12 sessions, and follow-up period will be 4 weeks after the end of treatment. Changes of symptoms, quality of life and occured adverse events will be assessed during study procedure. Patients who agreed joining qualitative research will be interviewed about their experiences of acupuncture in detail.

Eligibility Criteria:
Inclusion Criteria:

* over 19 years old
* started hemodialysis at least 3 months ago
* receiving hemodialysis 3 times a week regularly
* equilibrated Kt/V ≥ 1.2
* willingness to participate in this study

Exclusion Criteria:

* acute/chronic liver disease
* events of life-threatening cardiovascular disease within 6 months
* events of life-threatening neurological disorder within 6 months
* current/past history of neoplasm
* hemorrhagic disorders
* drug abuse/alcoholism
* other infectious disease including active tuberculosis
* history of the use of acupuncture, moxibustion or herbs within 1 month
Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis

The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of patients with generalized myasthenia gravis despite treatment with various immunosuppressants, such as prednisone, methotrexate, Cellcept, cyclosporine, and cyclophosphamide, that are currently available.


Eligibility Criteria:
Inclusion Criteria:

* Generalized MG
* MGFA Clinical Classification Class II, III or IVa.
* QMG total score ≥12
* Minimum score of two (2) in four (4) or more test items in the QMG
* Able to give informed consent.
* Have failed at least two immunosuppressants after one year of treatment
* A positive serologic test for binding anti-acetylcholine receptor Abs at Screening and one of the following a) history of abnormal neuromuscular transmission test demonstrated by single-fiber electromyography or repetitive nerve stimulation, or b) history of positive anticholinesterase test, eg, edrophonium chloride test, or c) patient has demonstrated improvement in MG signs on acetylcholinesterase inhibitors as assessed by treating physician.

Exclusion Criteria:

* History of thymoma or other neoplasms of the thymus.
* History of thymectomy within 12 months prior to screening.
* Pregnancy or lactation
* Current or chronic use of plasmapheresis/plasma exchange
* IVIG treatment within 8 weeks prior to screening.
* Use of etanercept within 2 months prior to screening.
* Use of rituximab (RITUXAN®) within 6 months prior to screening.
* MGFA Class I, IVb, and V
* Crisis or impending crisis
A Mobile Intervention (txt4TKI) for the Improvement of Tyrosine Kinase Inhibitor Management in Patients With Chronic Myeloid Leukemia

This trial studies the feasibility and acceptability of a mobile intervention called txt4TKI for the improvement of tyrosine kinase inhibitor management in patients with chronic myeloid leukemia. Tyrosine kinase inhibitors (TKI) are associated with numerous potential side effects, including a decrease in bone marrow activity (myelosuppression), nausea, diarrhea, fatigue, and soft-tissue swelling (edema), especially in the face and lower legs, which are the primary reasons for patients to discontinue TKI medication. Using a mobile text messaging (TXT) intervention that emphasizes the importance of TKI compliance may improve TKI adherence in patients with chronic myeloid leukemia.


Eligibility Criteria:
Inclusion Criteria:

* PHASE 1: Patients diagnosed with chronic myeloid leukemia
* PHASE 1: Initiated tyrosine kinase inhibitors therapy for a year
* PHASE 1: Able to read and understand English
* PHASE 1: Able to provide informed consent
* PHASE 1: Have a mobile phone with TXT capability
* PHASE 1: Know how to use TXT
* PHASE 2: Patients diagnosed with chronic myeloid leukemia in the chronic phase
* PHASE 2: Starting tyrosine kinase inhibitors therapy or has been on tyrosine kinase inhibitors with anticipation of at least 6 month duration of use
* PHASE 2: Able to read and understand English
* PHASE 2: Able to provide informed consent
* PHASE 2: Have a mobile device with TXT capability
* PHASE 2: Willing to use a wireless pill bottle during study for 6 months
* PHASE 2: Know or willing to learn how to use TXT

Exclusion Criteria:

• Cognitive impaired document in the electronic medical record (EMR)
Safety and Efficacy Study for Various Skin Conditions

Characterizing safety and efficacy of Halo Laser Treatment for Various Skin Conditions.

The purpose of this study is to demonstrate safety and efficacy of Halo treatment as measured by changes in skin tone, texture and pigment.

Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin types I to IV
* Desires improvement of significant skin conditions on the face and/or neck
* Willingness to participate in the study by signing an informed consent form
* Will have limited sun exposure for at least two weeks prior to study screening and during the study, including the follow-up period
* Able to adhere to the treatment and follow-up schedule and post-treatment care instructions
* Post-menopausal or surgically sterilized female subjects.

Exclusion Criteria:

* History of Halo or resurfacing procedures in the treatment area within past six months
* Has tanned within the past thirty days or unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray, or cream
* Has tattoos, dysplastic nevi in the treatment area
* Pregnant and/or lactating
* Is planning to get pregnant within the study period
* Has a known history of photosensitivity
* Has used medication with photosensitizing properties within the past six months, e.g. isotretinoin
* History or evidence of chronic or recurring skin disease or disorder (e.g. psoriasis, --Netherton syndrome, etc.) affecting the treatment area
* Has open lacerations, abrasions, active cold sores, or herpes sores
* Has hormonal disorders
* History of keloid or hypertrophic scar formation or poor wound healing
* History of immunosuppression or immune deficiency disorder (including HIV infection or AIDS) or use of immunosuppressive medications
* History of bleeding disorder or taking anticoagulation medications
* History of skin cancer or any other cancer in the treatment area
* Has significant concurrent illnesses, such as diabetes, lupus, epilepsy, or cardiac disorders, which might be aggravated as a result of treatment
* Has participated in any clinical trial involving an investigational drug or cosmetic product or procedure within the past thirty days
* The investigator feels that for any reason the subject is not eligible to participate in the study
Fetal Lung Volume and Pulmonary Artery Resistance Index Measurement in Term Diabetic Pregnancy

The aim of this study is to determine cut-off values for fetal lung volume by VOCAL and pulmonary artery resistance index by pulsed Doppler in fetuses of diabetic mothers, and correlate the results with postnatal respiratory distress of the term neonates.

Research question:

Can the assessment of fetal lung volume by Virtual Organ Computed-aided Analysis (VOCAL) and pulmonary artery resistance index by pulsed Doppler predict neonatal respiratory distress syndrome in term fetuses of diabetic mothers?

Research hypothesis:

The assessment of fetal lung volume by VOCAL and pulmonary artery resistance index by pulsed Doppler can predict neonatal respiratory distress syndrome in term fetuses of diabetic mothers.

Eligibility Criteria:
Inclusion Criteria:

-Diabetic pregnant women 38 weeks gestation admitted for elective termination due to various obstetric indications

Exclusion Criteria:

1. Twins.
2. Pregnancy complicated by medical disorders other than Diabetes Mellitus (hypertension, pre-eclampsia, cardiac disorders, thyroid disorders, anemia with pregnancy...etc).
3. Autoimmune disorders.
4. Congenital fetal anomalies.
5. Macrosomia and intrauterine growth restriction (IUGR).
6. Intrauterine fetal death (IUFD).
7. Amniotic fluid index \<5cm or \>20cm.
8. Patients taking steroids within one week of measurement of lung volume.
A Clinical Trial of the Impact of Speed and Conventional Sintering on Ultra-thin, Highly Translucent, Multilayered Zirconia Laminate Restorations

A Minimally invasive esthetic restorative approach with the advancement of highly translucent multilayered monolithic zirconia ceramic can provide minimal thickness that affords high strength and esthetics without the need for layering porcelain. The effect of sintering conditions on yttria-partially stabilized zirconia is essential for the long-term success of such restorations.

The study aims to evaluate the clinical performance of speed and conventional sintering on ultra-thin, highly translucent, multilayered zirconia laminate restorations with minimum invasive tooth preparation.


Eligibility Criteria:
Inclusion Criteria:

* patients able to understand and sign the informed consent form.
* physically and psychologically able to undergo conventional restorative procedures.
* Good oral hygiene with no signs of periapical pathology or periodontal disease. (periodontal screening index 0-1).
* Slight malposition.
* Teeth with spacing.
* Teeth with discoloration.
* Patient having natural teeth as opposing dentition

Exclusion Criteria:

* Insufficient surface enamel (60%).
* Abutments with subgingival restorations or root caries.
* Parafunctional habits.
* Lack of opposite occluding dentition in the area intended for restoration.
* mandibular prognathism and maxillary retrognathism