cyrilzakka/clinical-trials huggingface dataset:
Family History in Prostate Cancer Patients in Taiwan

To investigate the prevalence of family history in prostate cancer patients in Taiwan and evaluate the association of variation of diseases and family history

We retrospectively reviewed the medical charts of prostate cancer patients at NTUH from 1978 to 2002. The initial presentations, systemic diseases, smoking habits, clinical stages, Gleason scores, pathological stages, treatments, and outcome were recorded. Post-hoc questionnaires were completed with OPD visits, admission visits, telephone interviews and mails. The questionnaires included the family histories of prostate cancer, colon cancer, breast cancer, hepatoma and so on. If patients is passed away, the first degree relatives will fill the vacant position. The prevalence of family histories of prostate cancers in these patients was determined. The associations of family histories and clinical presentations were analyzed. Besides, the characteristics of patients with and without responses were discussed.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer patients who were recorded at National Taiwan University Hospital from 1977 to 2002.

Exclusion Criteria:

* Patients or their family who refused our contact or were unable to be contacted
Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012

This is an open label, multicenter study for extended treatment of patients who have participated in the Immunex clinical study 016.0012. The primary objective of this study is to evaluate the long term safety of etanercept (TNFR:Fc) in patients with early stage rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria: - Previous enrollment in Immunex protocol 016.0012.

* No clinically significant adverse events thought to be due to etanercept (TNFR:Fc) during previous treatment.
* Negative serum pregnancy test not more than 14 days before the first dose of study drug in females of childbearing potential.
* No more than one NSAID at a dose not greater than the maximum recommended dose and stable for at least two weeks prior to administration of etanercept (TNFR:Fc). Exclusion Criteria:
* Previous receipt of etanercept (TNFR:Fc) (p55), antibody to TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein.
* Receipt of investigational drugs or biologics (other than etanercept (TNFR:Fc)) within interval between study drug in 016.0012 and this study.
* Receipt of DMARDs (e.g., hydroxychloroquine, oral or injectable gold, azathioprine, cyclosporin, D-penicillamine, sulfasalazine, minocycline, or leflunomide) other than MTX within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.
* Receipt of cyclophosphamide within 1 month prior to the first dose of etanercept (TNFR:Fc) in this study.
Betrnet Stem Cells and the Origins of Barrett's Esophagus Project 3 RF Ablation

The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus.

This Project is designed to identify biologically-based and clinically-useful biomarkers of tissue at risk for neoplastic progression as well as of response to ablation therapy. These results will result in improved risk stratification in BE and better targeting of resources for patients who are candidates for ablative therapy, while simultaneously providing key information regarding the origins of Barrett's esophagus.

Eligibility Criteria:
Inclusion Criteria:

* Barrett's esophagus with high grade dysplasia or intramucosal (early) adenocarcinoma.
* BE length ≥ 2 cm and ≤ 8 cm.
* Able to return every 3 months for one year after ablation

Exclusion Criteria:

* Patients who are unable to be compliant with follow-up endoscopies
* patients who cannot tolerate Proton Pump inhibitors
* pre-existing esophageal strictures
* pregnant or nursing women
The Effects of D-Fagomine on Glycaemic Response to Sucrose in Men

The aim of this study is to evaluate the effect of D-fagomine on glycaemic response to sucrose in men.

To determine and compare glycaemic response to sucrose of D-Fagomine and control in the timeframe of 180 minutes.

Eligibility Criteria:
Inclusion Criteria:

1. Males between the ages of 20 and 70 willing and able to provide written informed consent.

Exclusion Criteria:

1. LDL cholesterol levels higher than 189 mg/dl
2. Triglycerides higher than 350 mg/dl (the threshold level to determine c-LDL using the Friedewald formula)
3. Physical examinations and routine biochemical analysis shall be conducted to rule out pathologies.
4. Consumption of supplements or acetylsalicylic acid
5. Chronic alcoholism
6. Body mass index (BMI) greater than 30 kg/m2
7. Previous antihypertensive treatment at the start of the trial that has not finished at least 2 months before beginning the study
8. Diabetes mellitus (if the fasting blood glucose is higher than 126 mg/dl, the test should be repeated and confirmed)
9. Kidney disease (serum creatine levels above 1,4 mg/dl for women and above 1,5 mg/dl for men)
10. Acute infectious diseases, malignant tumors, severe liver failure, respiratory failure associated with chronic or endocrine diseases
11. Other conditions such as special dietary needs
12. To be participating or having participated in a clinical trial within the last 3 months
13. Inability to continue the study
14. History of gastrointestinal disease which may alter the absorption of nutrients
15. Depressive disorder or thoughts of self-injury
Assessment of Remote EEG Monitoring (REMI-EEG) in Pediatric Emergency and Adult Critical Care Units

The goal of this observational study is to compare clinical utility between Remote EEG Monitoring (REMI) and conventional EEG in patients (6 and older) that are undergoing EEG recording in a hospital as part of their routine clinical care. The main question\[s\] it aims to answer are:

* What is the concurrence of diagnosis made by epileptologist using REMI and full-EEG signals.
* What is the proportion of participants experiencing as seizure at the time of sensor placement, compared between REMI sensor placement and full-EEG placement.

Participants will wear REMI and conventional EEG electrodes at the same time.

Epitel has developed Epilog, a wireless wearable EEG sensor capable of transmitting EEG to a recording, display, and review platform called REMI (Remote EEG Monitoring). Epitel's REMI platform consists of the REMI tablet and four Epilog sensors. The REMI tablet requires connection to secure WiFi access, and Emergency Department and Intensive Critical Care's IT to open access to http://remi.epitel.com. The four epilog sensors communicate directly with the REMI tablet via Bluetooth connection. REMI synchronizes four Epilog sensors placed by hospital Emergency Department (ED) or intensive care unit (ICU) staff within minutes of patient arrival, thus allowing patients who are suspected of having encephalopathy to be evaluated quickly and prior to initial treatment. REMI securely transmits EEG data to its cloud server where data are processed in near real time using Persyst® Mobile software. Data can then be remotely reviewed by clinical team members.

The objective of this protocol is to demonstrate clinical utility of the Epilog EEG sensors with the REMI monitoring platform in children age 6 through adults in the pediatric emergency department and neurocritical care unit, respectively. Patients meeting entry criteria will be enrolled by a bedside clinical team member who is trained in Epilog sensor placement and use of the REMI platform. All participants will have four Epilog sensors placed, in addition to the standard of care full-EEG. The bedside clinician will be asked to make a "baseline" diagnosis based only on the clinical symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Clinical EEG has been ordered for suspected seizures
* Age 6 years or older

Exclusion Criteria:

* Cannot undergo EEG recordings because of severe head or other injury that prevents EEG recording.
* Transferred immediately for an operation
* Hemodynamically unstable (SBP less than 90 mmHg) at time of EEG placement
* Inability to place four REMI EEG sensors.
European Exposure Study

The current study was designed to determine the exposure of adult smokers and non-smokers to cigarette smoke constituents through evaluation of selected biomarkers of exposure.

The purpose of the study was to provide a greater knowledge about human exposure to cigarette smoke constituents by evaluating selected biomarkers of exposure in smokers and non-smokers. This was an observational, parallel-group study to be conducted at multiple centres in the UK, Germany, and Switzerland. It was planned to enrol sufficient subjects such that at least 1440 subjects complete the study.

Eligibility Criteria:
Inclusion Criteria:

Smokers: Subjects who smoked commercial cigarettes exclusively (less than or equal to 10 mg ISO tar yield in Germany and the UK; less than or equal to 12 mg ISO tar yield in Switzerland) with a regular consumption of at least 1 cigarette per day over the last 12 months without change in brand over the previous 3 months.

or

Non-smokers: Subjects who did not smoke commercial cigarettes, hand-rolled cigarettes, cigars, pipes, bidis, and did not use other nicotine-containing products (patch, gum, lozenges etc.) within 1 year prior to Visit 1 and throughout the study duration.

Exclusion Criteria:

* Female subjects with child-bearing potential were to be excluded if

  1. Subject was pregnant (or did not have negative pregnancy tests) or breast-feeding
  2. Subject did not agree to use an acceptable method of contraception
Critical Care and Palliative Care Medicine Together in the ICU

Will earlier palliative care medicine consultation in the ICU result in decreased length of stay in the ICU and hospital, as well as, increased patient and family satisfaction. Secondary questions to be answered is if this early consultation changes ICU and hospital death, discharge destinations, hospice admissions, code status changes, and withdrawal of life sustaining interventions.


Eligibility Criteria:
1. Age \>80 years
2. Apache II score \>14
3. SOFA score \> 9
4. Pre-existing functional dependency (admitted from ALF, SNF, LTAC, etc.)
5. Late stage dementia (bed-bound, nonverbal, incontinent, or unable to self-nourish/tube feed)
6. Stage 4 metastatic disease
7. Consideration to place permanent feeding tube or trach
8. Recurrent ICU admissions in the past year
9. Post-cardiac arrest
10. End-stage disease (lung, ESRD, ESLD)
11. ICU perceived need
Assessment of Left Ventricular Diastolic Function in Patients With Atrial Fibrillation

This study is a single-center, prospective cohort study to investigate non-invasive method to assess left ventricular diastolic function using echocardiography. Patients with AF who are referred radiofrequency catheter ablation (RFA) will be included prospectively. Transthoracic echocardiography will be performed during, immediately before RFA and with no cardiovascular medication taken between the exams so that the loading conditions during catheterization and echocardiography are as similar as possible. We will validate previously proposed echocardiographic parameters and creat an algorithm to identify the relationship between echocardiographic parameters of diastolic function and invasively measured LA pressure in patients with atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 19 year-old
* Patients who scheduled to perform radiofrequency catheter ablation for atrial fibrillation
* Patients who had paroxysmal, persistent, or chronic AF
* Patients provided with the written, informed consent to participate in this study

Exclusion Criteria:

* Patients with prosthetic valve
* Life expectancy \< 12 months
* Subject who the investigator deems inappropriate to participate in this study
S0106A, Biomarkers in Samples From Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Cytarabine-Based Chemotherapy

RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.

PURPOSE: This research study studies biomarkers in samples from patients with newly diagnosed acute myeloid leukemia treated with cytarabine-based chemotherapy.

OBJECTIVES:

* Training and testing of multiparameter flow cytometry-based cell signaling signature (FC classifier 1) associated with in vivo primary chemoresistance (i.e., non-complete response \[NR\]) to standard induction therapy in adult patients ≤ 60 years old with a newly diagnosed non-M3 acute myeloid leukemia (AML).
* Training and testing of multiparameter flow cytometry-based cell signaling signature (FC classifier 2) associated with complete continuous response at 1 year (CCR1) in adult patients ≤ 60 years old with a newly diagnosed non-M3 AML who are treated with cytarabine-based induction chemotherapy.
* Identification of signaling signature(s) associated with secondary chemoresistance (i.e., disease relapse) in adult patients ≤ 60 years of age who have longitudinally paired peripheral blood mononuclear cells (PBMC) or bone marrow mononuclear cells (BMMC) samples at diagnosis and at the time of first relapse. (Exploratory)

OUTLINE: Cryopreserved samples are incubated with cytokines (e.g., interleukins), growth factors (e.g., sargramostim \[GM-CSF\] and filgrastim \[G-CSF\]), chemotherapeutic agents (e.g., cytarabine, etoposide phosphate), and other modulators. Cells are fixed, permeabilized, and stained with antibodies that recognize extracellular markers in conjunction with intracellular activation-state specific epitopes of designated signaling molecules. Subsequently, cells are analyzed for multiparametric phospho-flow cytometry in a random manner (without knowledge of clinical variables and outcomes) to training and testing sets. Results are then compared with individual patient clinical outcomes.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Newly diagnosed non-M3 acute myeloid leukemia (AML)
* Pretreatment and relapsed and/or refractory cryopreserved bone marrow mononuclear cells (BMMCs) and peripheral blood mononuclear cells (PBMCs) available
* Have 2+ vials of pretreatment marrow cells and/or 2+ vials of pretreatment PBMCs in the Southwestern Oncology Group (SWOG) AML/Myelodysplastic Syndrome (MDS) Repository

  * Usable samples must contain approximately 1.6 ×10\^6 cluster of differentiation antigen 45+ (CD45+) cells post thaw.
* Eligible and evaluable patients who participated on SWOG-S0106 study

PATIENT CHARACTERISTICS:

* Did not refuse consent for this use of specimens

PRIOR CONCURRENT THERAPY:

* Not specified
The Effect of Whey Protein on Short-Term Food Intake and Post-Meal Blood Glucose Response in Young Men

The objective of this study was to describe relationships among whey protein when consumed before a meal on food intake and pre- and post-meal satiety, blood glucose in healthy young adults.

A randomized, cross-over design study was conducted. Whey protein preloads (10-40 g) were provided in 300 ml water. At 30 min following consumption, subjects were fed an ad libitum pizza meal. Satiety, and blood glucose were measured at baseline and selected intervals pre- (0, 15 and 30 min) and post-meal (50, 65, 80 and 95 min).

Eligibility Criteria:
Inclusion Criteria:

* healthy
* normal weight ( 18-24.9 kg/m²)
* young aged 20-27 year old

Exclusion Criteria:

* breakfast skippers
* smokers
* dieters
* individuals with diabetes (fasting BG ≥ 7.0 mmol/L) or other metabolic diseases
Long Term Metabolic Safety of Norditropin® Treatment of Small for Gestational Age (SGA) Subjects

The study is conducted in Europe. The primary aim of this observational study is to compare the insulin sensitivity in small for gestational age (SGA) subjects treated with Norditropin® with untreated small for gestational age (SGA) subjects and with average for gestational age (AGA) subjects.


Eligibility Criteria:
Inclusion Criteria:

* Norditropin® treated small for gestational age (SGA) group: Treated with Norditropin® for at least three years in the IUGR-1 or IUGR-2 trials
* Untreated small for gestational age (SGA) group: Birth length and/or weight less than -2 SDS for gestational age
* Average gestational age (AGA) group: Birth length and/or weight larger than -2 SDS for gestational age

Exclusion Criteria:

* Growth hormone deficiency defined as a peak growth hormone (GH) less than 20 mU/l
* Insulin like growth (IGF)-1 level less than -2 SDS
* Receipt of any investigational drug within four weeks prior to the trial
Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy

This study is a randomized, parallel, open-label, multicenter, phase IV clinical trial to assess the efficacy and safety of pregabalin and alpha-lipoic acid combination compared with each monotherapy in patients with diabetic peripheral neuropathy for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* aged 19 to 75
* type 2 diabetes mellitus with HbA1c (Hemoglobin A1c) ≤ 10 %
* peripheral (eg. hands, feet) neuropathic pain (eg. abnormal sensations, numbness, pain, etc.) within 3 months (12 weeks)
* diagnosed with diabetic peripheral neuropathy (DPN)
* VAS pain score ≥ 40 mm
* written informed consent

Exclusion Criteria:

* brittle diabetes mellitus
* ALT (Alanine Transaminase), AST (Aspartate Transaminase), CPK (Creatine Phosphokinase) level ≥ 3 times the upper limit of normal (UNL) or active liver disease
* severe renal impairment (eGFR (estimated glomerular filtration rate) \< 60 mL/min/ 1.73m2)
* treated with antiepileptic drugs within 1 week at randomization
* other nervous system or neuropathic disorders that may affect pain evaluation
* oral drug administration is not possible, or hypersensitive or allergic to pregabalin, r-thioctic acid tromethamine, thioctic acid, and other excipients
* pregnant, lactating, or childbearing potential
* alcoholics, drug abusers, and patients who are difficult to participate in clinical trials due to psychological and emotional problems
* have participated in other clinical trials within 30 days at screening
Study to Evaluate the Value of the Follow-up of CALCIneurin Activity to MOdulate Calcineurin Inhibitors-induced Immunosuppression in Lung Transplantation

The study is an interventional, multicentre, prospective, randomized, controlled, single-blind, comparative trial of two processes for adjusting the inhibitor of calcineurin (CNI) dosage in lung transplant recipients. Recipients will be stratified by transplant center and according to the underlying lung disease (affected with cystic fibrosis or not) and will be randomized to either evaluation of calcineurin activity (CN-a) in combination with CNI blood levels versus CNI blood levels alone in a 1:1 ratio. The objective is to compare the proportion of acute rejection that has required a specific curative treatment at 6 months after transplantation between patients in the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Patient placed on the national waiting list for lung transplantation
* First de novo lung transplantation (single or double LTx)
* Prevention of allograft rejection by a usual immunosuppressive regimen including CNI (cyclosporine or tacrolimus)

Exclusion Criteria:

* Previous lung transplantation or other solid organ transplantation
* Combined lung transplantation with either liver or renal transplantation
Effect of Nitrous Oxide on Intravenous Closed-loop Anesthesia

The main objective of the study is to analyze the influence of nitrous oxide on propofol and remifentanil requirements.

Nitrous oxide is a widely used anesthetic agent. The mechanism of its central action is not completely understood and its importance is questioned.

Total intravenous anesthesia can be driven by a computer using bispectral index as a controller. Such a system matches anesthetic agent requirements to the needs of each individuum and thus allows an unbiased evaluation of the influence of nitrous oxide. Two groups of patients are compared: one ventilated with a oxygen-air mixture and one with oxygen-nitrous oxide mixture. Anesthesia is provided by a "dual-loop" which adapts propofol and remifentanil target concentrations to maintain a bispectral index between 40 and 60 in both groups.

Eligibility Criteria:
Inclusion Criteria:

* General anaesthesia with controlled ventilation

Exclusion Criteria:

* Age lower than 18 years
* Pregnant woman
* Allergy to the propofol or to a muscle myorelaxant
* Patients receiving a psychotropic treatment
* Presence of a central neurological disorder or a lesion cerebral
* Patients having an anomaly of blood cells count preoperative biological assessment
* Patients having had an anaesthesia in the previous month
Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation

A randomised controlled clinical trial to assess efficacy of convergent ablation with the LARIAT procedure, as compared to standard endocardial catheter ablation in patients with long-standing persistent atrial fibrillation (AF).

Atrial Fibrillation is the commonest arrhythmia and is a major cause of morbidity and mortality, often causative in ischaemic strokes and compounded by heart failure. Treatment options are limited for persistent long-standing AF (PeAF), with pulmonary vein isolation by endocardial ablation being insufficient and further additive endocardial lesions with repeated ablations yield mixed results resultant in further atrial arrhythmias. Currently success rates for catheter ablation are moderate at 40 to 70% in a single procedure.

If this was improved, patient quality of life and readmission rates would significantly improve as well as a reduction in anti-arrhythmic drug use.

The Convergent procedure - is a two stage minimally invasive hybrid approach. The first stage employs surgical ablation to the posterior wall of the left atrium in combination with the LARIAT procedure to isolate the left atrium appendage (LAA). The second stage involves endocardial catheter ablation to confirm the surgical ablation lesions, and perform further endocardial catheter ablation to leverage both epicardial and endocardial lesions to create durable, transmural lesions.

Patients with long-standing persistent AF will be randomised in a 1:1 ratio to either the Convergent ablation with the LARIAT procedure or the standard endocardial catheter ablation.

This feasibility study would assess recruitment to the trial, safety and efficacy of the Convergent procedure, in combination with a left atrial appendage system.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years; \< 80 years
* Persistent AF \> 1-year duration
* Left atrium size \< 6cm
* Pts should be able to provide written informed consent.

Exclusion Criteria:

* Subjects currently enrolled in another investigational study except in case of observational registry with no associated treatments.
* Subject has a reversible cause of AF or transient AF
* Subject is absent of LAA or if the LAA is previously surgically ligated
* Subject has had previous cardiac surgery or abdominal surgery.
* Subject has contraindication to anticoagulation.
* Patients with hypertrophic cardiomyopathy.
* Patients with significant valve disease.
* Subject has had previous catheter or surgical ablation