cyrilzakka/clinical-trials huggingface dataset:
A Novel Non-interfering Arterial Blood Pressure Monitoring Device

The primary purpose of this investigation is to validate the performance and safety of the Investigational Device (ID) against a validated and legally cleared device for measuring Blood Pressure (BP). The secondary purpose is to validate the performance of the ID over a period of 24 hours against a validated and legally cleared device for Ambulatory Blood Pressure Monitoring (ABPM).

The clinical investigation is conducted as a controlled (subject as own control), prospective, randomised, comparative investigation in a population with a representative spread of BPs to ensure that the ID performs as good as current marketed and approved devices. The study will be conducted in compliance with the International Standard ANSI/AAMI/ISO 81060-2 - Non-invasive sphygmomanometers - Clinical validation of automated measurement type.

This clinical investigation will enrol up to 96 male and female subjects to ensure the recording of 85/35 evaluable datasets in accordance with the ANSI/AAMI/ISO standard \[11\]. All measurements will be paired and falls into 2 categories: Auscultatory measurements as gold standard reference, oscillometric measurements for clinical practise reference and further validation of ambulatory monitoring and pulse shape measurements.

Eligibility Criteria:
Inclusion Criteria:

* At least 30% of the subjects must be males (n=29)
* At least 30% of the subjects must be female (n=29)
* Age ≥ 18 years old
* Limb size circumference ≥ 17 cm
* Blood pressure distribution:
* At least 25 % of the subjects should be hypertensive
* At least 5 % of the subjects should be hypotensive

Exclusion Criteria:

* Breached skin
* Acknowledged pregnancy
* Pacemaker
* Diagnosed cardiac arrhythmia (tachycardia, bradycardia, atrial/ventricular fibrillation)
* Implanted metal in upper limb:

  * Elbow prosthesis
  * Shoulder prosthesis
  * Metal screws
  * Bone plates
  * Metal chips
  * Surgical clips
  * Implantable Cardiac Defibrillator (ICD)
  * Cardiac Resynchronization Therapy - Defibrillator (CRT-D)
  * Premature ventricular contractions (PVC)
  * Premature arterial contractions (PAC)
  * Sensitivity or allergy towards adhesives
* Presence of an arterial-venous shunt
* Recent axillary node dissection
Potential Allergens in Wine: Double-blind Placebo-controlled Trial

This study is designed to identify whether wines which are produced using the common potential food allergens such as proteins derived from fish, milk or egg are likely to contain sufficient food allergens to cause allergic reactions in susceptible individuals.

Recent international legislation requires labelling of wines made using potentially allergenic food proteins "casein", egg white, isinglass ( fish derived), milk or evaporated milk where "there is detectable residual processing aid". However it is not clear whether the final wine contains concentrations of residual added food proteins that can provoke allergic reactions.

Comparison:This study is a double blind, placebo-controlled trial to determine whether adults known to be allergic to eggs, fish, milk and/or nuts exhibit allergic reactions following consumption of Australian commercial wines fined with food allergens.

Eligibility Criteria:
Inclusion Criteria:

Individuals with IgE-mediated food allergy to milk, fish, egg or nuts Otherwise no major medical problems Able to drink wine -

Exclusion Criteria:

Major asthma or cardiac disease Unwilling or unable to participate

-
Rosiglitazone in Treating Patients With Liposarcoma

RATIONALE: Rosiglitazone may help liposarcoma cells develop into normal fat cells.

PURPOSE: Phase II trial to study the effectiveness of rosiglitazone in treating patients who have liposarcoma.

OBJECTIVES:

* Determine the clinical activity of rosiglitazone in patients with liposarcoma.
* Assess the impact of this regimen on markers of tumor proliferation and differentiation status in these patients using biologic and biochemical testing and correlative imaging.
* Determine the tolerance and safety of this regimen in these patients.

OUTLINE: Patients are stratified by histologic subtype (well differentiated vs dedifferentiated vs myxoid/round cell vs pleomorphic).

Patients receive oral rosiglitazone twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1-3 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 56-120 patients (14-30 per stratum) will be accrued for this study within 15 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven liposarcoma that is incurable with standard multimodality approaches (e.g., surgery and/or radiotherapy and/or chemotherapy)

  * Well differentiated OR
  * Dedifferentiated OR
  * Myxoid/round cell OR
  * Pleomorphic
* Measurable disease
* No clinically unstable brain metastases
* No progression on prior troglitazone therapy for liposarcoma

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* Absolute neutrophil count at least 1,000/mm3
* Platelet count at least 90,000/mm3

Hepatic:

* Bilirubin no greater than 2.0 mg/dL
* SGOT less than 5 times upper limit of normal

Renal:

* Creatinine no greater than 2.4 mg/dL

Cardiovascular:

* No poorly controlled atrial arrhythmias, symptomatic angina pectoris, or myocardial infarction within the past 4 months
* No symptomatic congestive heart failure, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within the past 3 months

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception

  * Oral contraceptives are not considered effective contraception
* No active retroviral disease
* No condition that would preclude informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics
* Prior chemotherapy allowed and recovered
* No concurrent cytotoxic therapy

Endocrine therapy:

* No concurrent hormonal therapy

Radiotherapy:

* See Disease Characteristics
* Prior radiotherapy allowed and recovered
* At least 6 months since prior radiotherapy to the sole site of measurable disease
* Concurrent localized radiotherapy to a single site of disease allowed if there are other sites of measurable disease

Surgery:

* Not specified
Inhibition of Gastric Acid is the Key to Satisfactory Relief of Symptoms With Esomeprazole in NUD Patients

Inhibition of gastric acid is the key to satisfactory relief of symptoms with esomeprazole in NUD patients

Enrolled patients will undergo 24h gastric pH monitoring and subsequently (if gastric pH drops below pH 4 during 24h monitoring) will be randomized to receive placebo (40 mg QD) or esomeprazole (40 mg QD) for 16 weeks of therapy. 24h gastric pH monitoring will be repeated 2nd and 3rd time in all participating patients at the end of 4th and 8th weeks of therapy. Additionally, in all participants NUD symptoms will be re-assessed at the end of 4th, 8th, 12th and 16th weeks of therapy.

Eligibility Criteria:
Inclusion criteria:

A. Males and females of age 18-55. B. A diagnosis of epigastric pain/discomfort (located in the upper abdomen) rated by the patient as moderate to severe in intensity (on a four-point categorical scale), which has been present at least 3 times per week for 12 weeks, unrelated to exercise.

C. Patients may have other symptoms of NUD including heartburn, regurgitation, bloating (abdominal distension), early satiety (feeling of fullness), belching (burping), or nausea; however, the dominant symptom must be epigastric pain/discomfort.

D. Capable of and willing to give informed consent and comply with all study requirements.

Exclusion criteria:

A. H. pylori positive serology. B. Regular use of NSAIDs or more than 100 mg of aspirin. C. Patients requiring chronic treatment with any medication inducing GI symptoms (e.g., certain antibiotics, codeine, etc.).

D. History or presence of endoscopic/radiological evidence of esophagitis. E. History or presence of chronic gastric or duodenal ulcer. F. History or presence of duodenal erosions. G. History or previous upper GI surgery. H. Presence of concomitant symptoms of irritable bowel syndrome (IBS) as assessed by three or more of the Manning or Rome criteria.

I. History or presence of other known organic disease that might explain the dyspepsia symptoms (e.g., symptomatic gallstones).

J. Pregnancy or lactation. K. Inadequate contraception. L. Regular consumption of greater than 2 fluid ounces of beverage alcohol (corresponding to 2 cocktails or 40 fluid ounces of beer or 16 fluid ounces of wine) per day.

M. History of substance abuse. N. Unwillingness or expected inability to tolerate absence of antisecretory medications (antacids, H2 receptor antagonists or Proton pump inhibitors (PPIs) or other GI pharmacotherapy for a period of time of study protocol (16 weeks maximum).
Pancreatoduodenectomy With or Without Ligamentum Teres Wrap Around Gastroduodenal Artery Stump for Prevention of Pancreatic Hemorrhage

To investigate, whether a prophylactic wrapping of the gastroduodenal artery stump with the ligamentum teres or falciform hepatic (embryological structures, covered with peritoneum that do not have relevant meaning for adults) can reduce the incidence of arrosion bleeding during surgery.

Thus a surgical technique is evaluated prospectively.

Pancreatoduodenectomy is a standard surgical procedure for resection of tumors of the pancreatic head and neck, and for selected patients with chronic pancreatitis. A postoperative pancreatic fistula (POPF) is a severe and frequent complication that may lead to a potentially letal arrosion hemorrhage from the stump of the gastroduodenal artery (GDA). Aim of the study is to evaluate the prophylactic wrapping of the GDA stump using the falciform hepatic ligament during the index operation. The null hypothesis is that prophylactic wrapping does not decrease the incidence of arrosion hemorrhage from the GDA stump. The study is designed as a randomized, single-blinded, controlled, multicenter trial.

Eligibility Criteria:
Inclusion Criteria:

* Indication for elective open pancreatoduodenectomy (pylorus-preserving or classic) with pancreatojejunostomy for tumors, or cystic lesions of the pancreatic head, tumors of the distal bile duct, duodenum or for chronic pancreatitis
* american society of anesthesiologists classification I-III
* age ≥18 years
* given informed consent

Exclusion Criteria:

* status post previous abdominal surgery with resection of the falciform ligament (e.g. hemihepatectomy)
* No reconstruction using a pancreatojejunostomy (e.g. pancreatogastrostomy)
* simultaneous visceral arterial resection
Evaluating the Diagnostic Validity of Inflammation-associated Markers for Tuberculous Pleurisy

1. To investigate the difference of PE inflammation/apoptosis-associated markers between TB pleurisy and non-TB pleurisy
2. To investigate the difference of neutrophil apoptosis in exudative PE between TB pleurisy and non-TB pleurisy
3. To investigate the change of apoptosis pattern of PE neutrophil, before and after TB antigen stimulation, and compare the difference between TB pleurisy and non-TB pleurisy
4. To investigate diagnostic aid of the inflammation/apoptosis-associated markers and apoptosis pattern of PE neutrophil for tuberculous pleurisy

Tuberculosis (TB) remains a global health problem even though it has nearly been eradicated in some developed countries. Because of variable manifestations and the difficulty in collecting clinical samples, extra-pulmonary TB is usually difficult to early diagnose. Tuberculous pleurisy (TP) is one of the most common extra-pulmonary infection and accounts for approximately 5% of all forms of TB. The gold standard for diagnosing TP is mycobacterial culture of pleural effusion (PE), pleura tissue, which requires weeks to yield. The treatment could thus be delayed, resulting in an increased mortality rate. In addition, mycobacterial culture is not so sensitive for PE and with positivity in less than two thirds of cases with TB pleurisy.

For diagnosing TP, PE biomarkers are required to be investigated in addition to traditional PE cell counting and biochemistry. In particularly, inflammation-associated cytokines and apoptosis-associated markers may be important because the two pathways involve in TB infection/defense mechanism. For inflammation-association markers, current literature is not comprehensive except IFN-gamma and IFN-gamma release assay (IGRA). However, the result of IGRA using PE is disappointed. We should study other PE inflammation markers such as IFN-induced protein-10, interleukin \[IL\]-2, IL-12 and so on. On the other hand, apoptosis suppression is one of escape mechanisms in TB pathogenesis. Macrophage, dendritic cell, and neutrophil are reportedly inhibited for apoptosis in TB infection. But the apoptosis of PE neutrophil are rarely studied. Moreover, the role of apoptosis-associated markers (Fas ligand \[FasL\], decoy receptor 3, lipoxin, prostaglandin E2, caspases) in PE has rarely been investigated in diagnosing TP except FasL. Therefore, we conduct a prospective study to investigate inflammation/apoptosis-associated markers in exudative PE and apoptosis of PE neutrophil to analyze their diagnostic usefulness for TP.

Eligibility Criteria:
Inclusion Criteria:

* patient older than 20 years old
* patients with exudative pleural effusion

Exclusion Criteria:

* refusal of enrollment
Sanofi Pasteur Quadrivalent Intradermal Influenza Vaccine Pregnancy Registry

The Sanofi Pasteur Fluzone Intradermal Quadrivalent vaccine (Fluzone QIV-ID) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes on pregnant women exposed to Fluzone QIV-ID vaccine.

Sanofi Pasteur will encourage registration of pregnant women exposed to Fluzone QIV-ID in the Sanofi Pasteur Pregnancy Registry by providing the registry's toll-free number, 1-800-VACCINE (1-800-822-2463), in the USPI. The toll-free number will also be available through the Sanofi Pasteur-sponsored Website for the Pregnancy Registry. Both the United States product insert (USPI) and Website will advise health care providers to register women who are pregnant or became aware they were pregnant at the time of Fluzone QIV-ID immunization.

Descriptive statistical methods will be the primary approach for summarizing data from the Fluzone QIV-ID Pregnancy Registry. No vaccine products will be provided or administered as part of this registry protocol.

Eligibility Criteria:
Inclusion Criteria:

Pregnant women will be enrolled in the registry prospectively (after exposure to a product but before the conduct of any prenatal tests that could provide knowledge of the outcome of pregnancy). If the condition of the fetus has already been assessed through prenatal testing (e.g., targeted ultrasound, amniocentesis, etc.), such reports will be considered retrospective reports. Retrospective reports are also eligible for the registry, but they will be analyzed separately from prospective reports.

Exclusion Criteria:

N/A
The Potency of Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension

The purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients with severe preeclampsia during caesarean section.

Preeclampsia, which affects 5% to 7% of patients, is a significant cause of maternal and neonatal morbidity and mortality. Because of constricted myometrial spiral arteries with exaggerated vasomotor responsiveness, though blood pressure in patients with preeclampsia are apparently higher than healthy patients, placental hypoperfusion is more common. Spinal anesthesia is still the preferred mode of anesthesia in patients with preeclampsia for cesarean section. In preeclampsia patients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. Even so, 17-26% patients with preeclampsia experienced postspinal anesthesia hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. As a potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction for use in patients undergoing cesarean section. However, the ED50 (prevent postspinal hypotension in 50% of patients) and ED90 of prophylactic norepinephrine bolus is still unknown. The purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients with severe preeclampsia during caesarean section.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* Primipara or multipara
* Singleton pregnancy ≥32 weeks
* American Society of Anesthesiologists physical status classification II to III
* Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

* Baseline blood pressure ≥180 mmHg
* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension
* Hemoglobin \< 7g/dl
* Fetal distress, or known fetal developmental anomaly
Peak Flow Monitoring in Older Adults With Asthma

Evaluate the incremental effectiveness of peak flow monitoring ove symptom monitoring as a management tool to enhance asthma control in adults \>= 50 years with moderate-severe asthma.

BACKGROUND:

We propose a five-year Demonstration and Education project to assess the incremental value of peak flow monitoring (PFM) over symptom monitoring (SM) as a management tool for asthma control in adults greater than or equal to 50 years with moderate-severe asthma. We will develop three parallel asthma education programs for older adults using as our base an existing asthma education program (AIR/Kaiser Adult Education Program) of demonstrated efficacy for adults ,50 years of age.

DESIGN NARRATIVE:

Primary outcome Frequency and cost of health care utilization for asthma, and asthma-specific quality of life

Key secondary outcomes Prebronchodilator FEV1; diurnal variability in PEF

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
Inclusions: Doctor-diagnosed asthma; \>=50 years; using asthma medications; \>12% increase in FEV1 after two puffs of inhaled beta-agonist; willing to participate in asthma meducation program and two-year follow up; likely to stay in Portland area; KPNW member for two years.

Exclusions: Unable to read, speak or understand English; no telephone; failure to keep two pre-randomization appointments; inability to reproducible FEV 1 maneuver; participation in pilot phase of study; concurrent participation in any other medical research study.
A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.

This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* female patients, \>=18 years of age;
* locally advanced, inflammatory or early stage invasive breast cancer;
* HER2 positive (HER2+++ by IHC or FISH/CISH+).

Exclusion Criteria:

* metastatic disease (Stage IV) or bilateral breast cancer;
* previous anticancer therapy or radiotherapy for any malignancy;
* other malignancy, other than cancer in situ of the cervix, or basal cell cancer;
* insulin-dependent diabetes;
* clinically relevant cardiovascular disease.
Short Intervention for Medication Overuse Headache (MOH) - Pilot

The purpose of the study is together with the BIMOH (NCT01314768) RCT study to evaluate whether training of GPs in the detection and treatment of medication overuse headache leads to improved care for these patients as compared to "business as usual".

The present pilot study focuses on testing the logistics and the methodology of short intervention on a pilot group of GPs and their patients.

Due to low recruitment and the pilot study focus on logistics and methodology, the study was changed to not include a control (business as usual) arm. The outcomes were evaluated as "before - after" data and qualitative comments on acceptability and utility of the method. Primary outcomes were changed to be the acceptability and utility (previously listed as secondary outcomes) while secondary outcomes were headache days and medication days (previously listed as primary).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with medication overuse headache

Exclusion Criteria:

* Other complicating pain condition
Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) to Treat Osteoarthritis

This registry study will compile information from patients that are scheduled to receive or have received Adipose Derived Regenerative Cells (ADRCs) prepared by the Celution device to treat osteoarthritis in the knee.


Eligibility Criteria:
Inclusion Criteria:

* Males or females \> 18 years of age
* Diagnosis of osteoarthritis in one or both knees with Kellgren Lawrence grade ≥ 2 at x-ray evaluation or MRI findings of degenerative changes
* Pain with or without swelling in the affected area for \>4 months

Exclusion Criteria:

* Know spine or disc disease or symptomatic nerve impingement contributing to pain in the affected limb
* History of documented nerve damage in the affected limb
* Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test prior to procedure.
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer (0683-008)

This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0683 in patients with advanced cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older
* Must agree to consume high fat meal and agree to fasting conditions
* Limit alcohol consumption

Exclusion Criteria:

* Patient has a history of drug or alcohol abuse within 5 years of start of study
* Patient is known to have HIV
* Patient has participated in another investigational study within 4 weeks of start of study
* Patient cannot stop taking certain medications or herbal remedies
* Patient will require immunologic, radiation, surgery, or chemotherapy during the study
* Patient requires frequent blood transfusions
* Female patient is pregnant or nursing
* Patient has an active Hepatitis B or C infection