cyrilzakka/clinical-trials huggingface dataset:
Superiority of Finger-sensor Monitoring: a Prospective Observational Study

This is an observational study investigating whether finger-sensor arterial pressure monitoring is superior to oscillometric arterial pressure monitoring in patients having non-cardiac surgery. Specifically, the investigators will test the hypothesis that the agreement between finger-sensor arterial pressure measurements and intraarterial arterial pressure measurements (mean arterial pressure, systolic arterial pressure, and diastolic arterial pressure) is better than the agreement between oscillometric mean arterial pressure measurements and intraarterial mean arterial pressure measurements in patients having low- to moderate-risk non-cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years
* scheduled for elective low- to moderate-risk non-cardiac surgery with general anesthesia
* planned intraarterial arterial pressure monitoring

Exclusion Criteria:

* systolic arterial pressure interarm differences \>20 mmHg
* heart rhythms other than sinus rhythm
* contraindications for finger-sensor arterial pressure monitoring (e.g., arteriovenous shunts, Raynaud's disease)
* pregnant patients.
EHRA-PATHS: Clinical and Health Economic Evaluation of New Care Pathways

In elderly atrial fibrillation (AF) patients, AF is usually a manifestation of risk factors and comorbidities not only limited to cardiovascular diseases. Especially in elderly often more than two comorbidities are present. The presence of comorbidities also affects outcomes in AF patients. Current healthcare systems are single-disease focused, which increases the risk of underdiagnosing, replicating diagnostic tests and adverse drug-drug interactions, placing a high burden on healthcare costs. Healthcare systems and hospitals are in need of new care pathways to address the complexity of multimorbid AF patients and to reduce costs. The EHRA-PATHS consortium set out to address this need for change in management for multimorbid, elderly AF patients in Europe through the development of new care pathways. The aim of this study is to evaluate the current management of risk factors and comorbidities, and subsequently implement the newly developed care pathways and evaluate if these pathways lead to better management of risk factors and comorbidities in multimorbid, elderly AF patients, compared to current standard care.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed atrial fibrillation (paroxysmal, persistent or permanent)
* ≥65 years of age
* Willing and able to participate and to attend the scheduled follow-up visits.

Exclusion Criteria:

* Atrial fibrillation episode was due to a trigger (i.e. postoperative, infection, hyperthyroidism etc.)
* Life expectancy of less than 1 year
* Participation in another clinical study (registry studies not included)
* Severe cognitive impairment / dementia (defined based on MMSE and CDR scoring systems)
Feasibility and Safety of a Dedicated Biliary Stent for Transmural EUS-guided Hepatico-gastrostomy: the FIT Study

One of the major roles of interventional EUS is biliary drainage (EUS-BD) as an alternative to ERCP-based biliary decompression.

In fact, even when performed by expert endoscopists, ERCP-based stenting fails in 5% of cases. In these cases, standard alternative approaches include surgical bypass and percutaneous transhepatic cholangiography and biliary drainage (PTBD). However, these procedures are associated with higher patient discomfort and prolonged hospital stay.

The most diffuse approach for EUS-BD are choledochoduodenostomy (CDS) or hepaticogastrostomy (HGS). As a matter of fact, since dedicate devices as lumen apposing metal stents (LAMS), have been adopted for CDS, we have been witnessing the escalation of such procedure.

On the other hand, the diffusion of EUS-HGS is still limited due to the complexity of the procedure and the lack of dedicated devices. However, recently a dedicated stent was conceived as asymmetrically covered and shaped in order to have its uncovered, tubular end into the intrahepatic ducts and the covered, flanged end into the gastric cavity, to reduce the risk of migration. The developement of such stent could further increase both the technical feasibility and the clinical outcomes of HGS in order to explore the whole potential of this procedure and to definitively find its role in biliary drainage algorithm.


Eligibility Criteria:
Inclusion Criteria:

• subjects with malignant bilio-pancreatic diseases with an indication to undergo biliary stent positioning for biliary drainage after ERCP failure.

Exclusion Criteria:

* Age \< 18 y
* Contra-indication for endoscopy or interventional radiology
* Unsigned informing consent form, ICF
* Pregnancy
Pharmacokinetic Study of Dexmedetomidine After Intra-Nasal and Buccal Dosing in Children

This research study is a continuation of a previous DEX PK study. It is examining the absorption of Dexmedetomidine (DEX) in the blood when given orally and as a nasal spray. This study will help us determine the best dosing amount for children undergoing sedation or anesthesia with DEX.

The study will be a prospective study of plasma concentrations after intranasal or buccal DEX to determine the early pharmacokinetics and bioavailability of a single dose via nasal or oral administration.

Dexmedetomidine sedation is commonly used at Cincinnati Children's Medical Center and other pediatric institutions. This compound is typically delivered intravenously or intranasally for sedation in children with or without congenital heart disease. Intranasal DEX is very effective for sedation although it has significant variability in the onset and peak effect. Patient care will be improved if factors that determine this variability can be determined. Investigators will determine the important clinical variables of peak plasma DEX concentration (Tmax and Cmax) of intranasal and buccal DEX in children.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 - 48 months (inclusive) scheduled to receive anesthesia for elective cardiac surgery
* The subject must be a candidate to receive Dex as determined by one of the study cardiac anesthesiologists
* The attending cardiac anesthesiologists for the case and the Chief of Anesthesia Cardiac Anesthesia will concur with or veto this decision
* The subjects legally authorized representative has given written informed consent to participate in the study

Exclusion Criteria:

* Post-natal age less than 6 months
* The subject is allergic to or has had a contraindication to Dex
* Severely depressed ventricular function on preoperative echocardiogram
* The subject has a high risk of cardiac conduction system disease in the judgement of the attending anesthesiologist or cardiologist
* The subject has a hemodynamically significant aortic coarctation or other left heart outflow obstruction
* The subject has received digoxin, beta-adrenergic antagonist, or calcium channel antagonist on the day of surgery
* The subject has received Dex within 1 week of the study date
* Patients who are to receive intranasal Dex are excluded if they have nasal/respiratory symptoms, which in the opinion of the study anesthesiologist, may affect intranasal drug absorption
Glycemic Excursion Minimization (GEM) to Outshine Health Disparities

The purpose of this study is to see if the GEM intervention is acceptable and helpful to Black adults with type 2 diabetes. The GEM intervention (coaching to reduce carbohydrate intake and increase physical activity after meals, with feedback from a continuous glucose monitor, CGM) might improve blood glucose levels, reduce diabetes distress, and increase empowerment and confidence in managing diabetes.

The purpose of the study is to test the feasibility, acceptability, and initial efficacy of the tailored GEM intervention among adult Black patients with type 2 diabetes, who are not on insulin or secretagogues.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* capable of making dietary and physical activity changes

Exclusion Criteria:

* on insulin or secretagogue
* on medications that impede weight loss (e.g., prednisone)
* pregnant or planning pregnancy in the next 2 months
* no history of moderate to severe hypoglycemia
Quality-of-Life Study of Patients With Previously Treated Ovarian Cancer

RATIONALE: Quality-of-life assessment of patients undergoing cancer treatment may help determine the intermediate- and long-term effects of treatment in patients with cancer.

PURPOSE: This clinical trial studies the quality of life in patients with previously treated ovarian cancer.

OBJECTIVES: I. Compare quality of life in terms of health status, sexual functioning, psychological/emotional well being, and social functioning in ovarian germ cell cancer survivors vs a matched healthy control group. II. Predict quality of life in these patients through the additive effects of cancer diagnosis and treatment, sociodemographic characteristics, other stressors, and social network variables.

OUTLINE: Patients identify up to 3 healthy acquaintance controls within 3 years of the same age. Patients and controls complete a written questionnaire, which takes about 30 minutes, and a telephone interview, which takes about 1 hour, to assess quality of life.

PROJECTED ACCRUAL: A total of 190 patients and 190 healthy controls will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: History of early or advanced ovarian germ cell tumors Continuously disease free for at least 2 years prior to study Must have been enrolled on GOG protocols 45, 78, 90, and 116 or similar protocols of cisplatin-based chemotherapy at M.D. Anderson Cancer Center

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Must be able to complete a written questionnaire and telephone interview in English

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified
Assessment of Myeloid Cell Constitution in the Follicular Fluid of Women Undergoing In-vitro Fertilization

The investigators will study the immune cell subpopulations in follicular fluid of patients undergoing In-Vitro Fertilization (IVF) treatment in our clinic. The investigators will corelate the presence of immature myeloid cells to the ovarian stimulation response as indicated by follicle stimulating hormone (FSH) and number of follicles or estradiol level developed on the day of human chorionic gonadotropin (hCG) administration.

The study will be an observational study using discarded material from patients undergoing IVF treatment. On the day of ovum pick up, the fluid aspirated from the first follicle in each ovary will be saved and analyzed for cellular content by fluorescence-activated cell sorter (FACS) analysis and cytokine and hormone by Enzyme-linked immunosorbent assay (ELISA) and quantitative polymerase chain reaction (qPCR). In addition, a total of 5cc of blood will be drawn from the patient when introducing the intravenous line for analysis of immune cell composition,hormones and cytokine levels. During the whole study number of oocytes retrieved,number of mature oocytes,number of fertilizations,implantation rates and clinical pregnancy rates will be documented as well.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing IVF treatment
* Infertility caused by one of the following : endometriosis, severe male factor, tubal occlusion, or unexplained.

Exclusion Criteria:

* An early follicular phase (day 2-4) FSH level \> 20 mIU/mL
* Abnormal uterine cavity
* Any contraindication for pregnancy
* Systemic disease
* History of alcohol or drug abuse
Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity

This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® PD01A vaccinations in patients with Parkinson's disease. Patients, who have already participated in AFF008 will be involved and will be receive one boost immunization with AFFITOPE® PD01A. One study site in Vienna (Austria) will be involved.

In addition, up to 8 patients will be offered participation within an untreated control group.


Eligibility Criteria:
Inclusion Criteria:

* Prior participation in AFF008 and AFF008E
* Written informed consent signed and dated by the patient and the caregiver (caregiver is not mandatory)
* In the investigator's opinion, does not have visual or auditory impairments that would reduce the patients' ability to complete study questionnaires or be unable to receive instructions for these
* Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method
* Stable doses of PD medications for at least 3 months prior to Visit 0 and during the entire trial period and of all other medications for at least 30 days prior to Visit 1 if considered relevant by the investigator

Exclusion Criteria:

* Women of childbearing potential without birth control or pregnant women
* Participation in another clinical trial (except AFF008E) within 3 months before Visit 0
* History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
* Autoimmune disease or allergy to components of the vaccine
* History of cancer (Exceptions: basal cell carcinoma, intraepithelial cervical neoplasia)
* Active infectious disease
* Immunodeficiency
* Significant systemic illness or psychiatric illness
* Alcoholism or substance abuse
* Prior treatment with experimental immunotherapeutics for PD including IVIG (with the exception of AFFITOPE ® PD01A), with immunosuppressive drugs or treatment with deep brain stimulation
* Venous status rendering it impossible to place an i.v. access
Study to Test the Accuracy of a Prototype Handheld PT/INR Device

The purpose of this study is to measure prothrombin time (PT) on an experimental device and a commercially available device on persons receiving coumadin (warfarin)treatment.

This study will require participants to have up to 2 finger-punctures taken and sample tested on a strip and meter system for both the experimental and commercially available devices.

Eligibility Criteria:
Inclusion Criteria:

* Currently taking coumadin (warfarin)
* Aged 18 years or older
* Able and willing to provide informed consent
* Can understand (read and write) English

Exclusion Criteria:

* None
Safety and Effectiveness Study of Duloxetine HCl in Women of Different Backgrounds With Stress Urinary Incontinence Who May Also Have Other Various Medical Conditions.

The purpose of the trial is to study the safety and effectiveness of duloxetine HCl in women of different backgrounds with stress urinary incontinence who may also have other various medical conditions.


Eligibility Criteria:
Inclusion Criteria:

* Women age 18 years or older who have for the 3 months prior to study entry at least 1 episode per week of stress urinary incontinence or stress predominant urinary incontinence defined as twice as many stress as urge urinary incontinence episodes per week.
* Women of non-childbearing potential by reason of hysterectomy, surgical or natural menopause. Women of childbearing potential should be using a medically accepted means of contraception.
* Must provide informed consent.
* Must not have urinary tract infection at screening.

Exclusion Criteria:

* Sensitivity to duloxetine
* Unstable medical conditions
* Pregnancy
* Acute liver damage
* Suicidal in the opinion of the investigator
A Multicenter Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Cyclosporin A Versus Cyclosporin A in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia （ITP）

The project was undertaking by Qilu Hospital of Shandong University and other 5 well-known hospitals in China. In order to report the efficacy and safety of recombinant human thrombopoietin combining with cyclosporin A for the treatment of adults with refractory immune thrombocytopenia (ITP), compared to cyclosporin A monotherapy.

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 120 steroid-resistant/relapsed ITP adult patients from 6 medical centers in China. One part of the participants are randomly selected to receive recombinant human thrombopoietin (given subcutaneously at a dose of 300 Units/kg for 14 consecutive days, following with a flexible dosage depending on platelet count until the 29th day), combining with cyclosporin A (given orally at a dose of 1.5-2.0mg/kg twice daily for 3 consecutive months, adjusted to maintain serum levels between 200-400 ng/ml and tapered by 50 mg/d per week if patients achieved a complete response). The others are selected to receive cyclosporin A monotherapy (given orally at a dose of 1.5-2.0mg/kg twice daily for 3 consecutive months, adjusted to maintain serum levels between 200-400 ng/ml and tapered by 50 mg/d per week if patients achieved a complete response). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of the combination therapy compared to cyclosporin A monotherapy for the treatment of adults with steroid-resistant/relapsed ITP.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.
2. Steroid-resistant/relapsed hospitalized patients, may be male or female, between the ages of 18-80 years.
3. To show a platelet count \< 30×10\^9/L, and with bleeding manifestations.
4. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.
5. Willing and able to sign written informed consent

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
2. Current HIV infection or hepatitis B virus or hepatitis C virus infections. 3.Severe medical condition (lung, hepatic or renal disorder) other than ITP. 4.Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)

5.Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.

6.Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.

7.Patients who are deemed unsuitable for the study by the investigator.
Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus

Study 0018 (NCT00107978) compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of one of the following complicated skin and skin structure infections with MRSA (Methicillin-resistant Staphylococcus Aureus) either suspected or confirmed as the major cause of the infection:

  * major abscess requiring surgical incision and drainage;
  * infected burn (see exclusion criteria for important qualifications);
  * deep/extensive cellulitis;
  * infected ulcer (see exclusion criteria for important qualifications);
  * wound infections
* Patients must be expected to require at least 7 days of intravenous antibiotic treatment.

Exclusion Criteria:

* Received more than 24 hours of potentially effective systemic (IV/IM or PO) antibiotic therapy
* Burns involving \> 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis.
Alternating Energy Intake and Blood Fat Content After a Meal

Increasing evidence suggests that meal timing affects metabolic health. For example, intermittent fasting (IF) may have positive effects on plasma glucose and lipid levels, insulin sensitivity, and blood pressure. However, IF protocols often result in significant weight loss. Therefore, it is not clear to what extent these beneficial metabolic effects are due to IF or to weight loss. Although the effect of IF independent of weight loss has been studied, daily energy intake in those studies did not differ between the days. Therefore, the investigators aim to examine the effect of alternating energy intake - i.e. standardised day-to-day fluctuations in energy intake - on metabolic health independent of weight loss.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy men and women as judged by study physician
* Abdominally obese males (waist circumference ≥ 102 cm) and females (waist circumference ≥ 88 cm)
* Aged between 18 - 75 years
* Stable bodyweight (weight gain or loss ≤ 3 kg in the past three months)
* Willingness to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
* No difficult venipuncture as evidenced during the screening visit
* Women should be pre- or postmenopausal
* Sedentary (light exercise \< 1 h per week) or moderately active (moderate exercise 1-2 h per week)
* Having a general practitioner
* Agreeing that the participant and general practitioner will be informed about medically relevant personal test results by a physician
* Willing to comply to study protocol during study
* Informed consent signed

Exclusion Criteria:

* Fasting plasma glucose ≥ 7 mmol/l
* Fasting serum triacylglycerol ≥ 4.5 mmol/l
* Fasting serum total cholesterol ≥ 8 mmol/l
* Blood pressure ≥ 160/100 mm Hg
* Current smoker, or smoking cessation \< 12 months
* Drug abuse
* Alcohol abuse (≥ 21 alcohol consumptions per week)
* Use of medication known to affect blood pressure, serum lipid metabolism, or glucose metabolism
* Having a medical condition or history which might impact study measurements, to be judged by the study physician (e.g. myocardial infarction, angina, thrombosis, stroke, cancer, familiar hypercholesterolemia, liver or bowel disease or diabetes)
* Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
* Use of an investigational product within another biomedical intervention trial within the previous 1-month
* Women who are perimenopausal, have an irregular menstrual cycle, or are pregnant
* Use of over-the-counter and prescribed medication, which may interfere with study measurements (to be judged by the principal investigator), e.g. weight loss medication
* Reported dietary habits: medically prescribed diets or slimming diets
* Reported participation in night shift work 2 weeks prior to screening and/or during the study. Night work is defined as working between midnight and 6.00 AM