cyrilzakka/clinical-trials huggingface dataset:
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026

The primary objective of this clinical investigation is to evaluate the accuracy of using Masimo's INVSENSOR00026 Pulse CO-Oximeter and Sensor to measure hemoglobin, as compared to hemoglobin measurements obtained from various lab analyzer(s) and point of care device(s).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Subject has given written informed consent to participate in the study

Exclusion Criteria:

* (\*) Pregnant or positive human chorionic gonadotropin (hCG) test
* (\*) Any severe coagulopathy, chronic bleeding disorders (i.e., hemophilia) or recent thrombolysis
* (\*) Hemoglobinopathies and synthesis disorders (i.e., sickle cell, thalassemias, etc.)
* (\*) Subjects who are currently taking anticoagulant medication
* (\*) Subjects with allergies to lidocaine, Pain Ease, latex, adhesives, or plastic
* (\*) Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as psoriasis, eczema, angioma, burns, scar tissue, substantial skin breakdown, nail polish, acrylic nails, infections, abnormalities, etc.
* (\*) Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
* (\*) Subjects with elevated blood pressure, skin or wrist abnormalities that may interfere with an arterial blood draw as determined by investigator or research medical staff.
* (\*) Subjects who intend on participating in heavy lifting, repetitive movement of their wrist (including riding a motorcycle) or exercise (working out, riding a bike, etc.), or any activity that will put additional stress on the wrist within 24 hours following a study involving an arterial blood draw
* Subjects deemed not suitable for the study at the discretion of the investigator or research medical staff

Note: (\*) May be self-reported by subject
Comparison Between Ticagrelor Versus Very Low Dose Rivaroxaban With Clopidogrel

A total of 50 participants diagnosed with ACS (group A ticagrelor 180mg/d, n=25), group B (clopidogrel 75mg + rivaroxaban 5mg/ d, n=25)) were consecutively enrolled and treated with study drugs on top of aspirin (100mg/d) for 1 month. VerifyNow® and Global thrombosis test were performed at day 2 and 1 month after administration of study drugs. The investigators compared aspirin reaction unit (ARU) and P2Y12 reaction unit (PRU), occlusion time (OT) which reflects shear stress-induced thrombotic activity, and lysis time (LT) which showed endogenous lytic activity between the two strategies at both time points.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed with acute coronary syndrome and underwent percutaneous coronary intervention

Exclusion Criteria:

* Patients administered with glycoprotein IIb/IIIa inhibitiors
* Patients with atrial fibrillation
* Patients with high risk of bleeding at the physician's discretion
* Patients with renal impairment (estimated GFR \<30ml/min)
Effect of Whole Body Vibration on Insulin Resistance in Females With Polycystic Ovarian Syndrome

The purpose of this study is to investigate the effect of whole body vibration on insulin resistance in females with polycystic ovarian syndrome

polycystic ovarian syndrome is a complex endocrine condition characterized by metabolic abnormalities such as insulin resistance, excess weight or obesity, diabetes, and an increased risk of cardiovascular disease.Despite previous studies reported that physical exercise improves insulin resistance in females with polycystic ovarian syndrome, there is no study yet investigate the effect of whole body vibration on insulin resistance

Eligibility Criteria:
Inclusion Criteria:

1. Females with polycystic ovarian syndrome.
2. Their ages will range from 20 to 35 years.

Exclusion Criteria:

* 1-Smoking. 2-History of chronic disease.
Nab-Paclitaxel in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer

This phase II trial studies the side effects of nab-paclitaxel in treating older patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic). Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

PRIMARY OBJECTIVE:

I. To evaluate the tolerability (grade 2-5 toxicity, neuropathy grade 2 or higher, need for dose reductions, or delays) of weekly nab-paclitaxel in older adults with locally advanced or metastatic breast cancer.

SECONDARY OBJECTIVES:

I. To evaluate the efficacy (response and time to progression) of weekly nab-paclitaxel in older adults with locally advanced or metastatic breast cancer using a stratification factor based on patient age (at least 5 patients age 75 years or older and no more than 15 patients age 65-70 years).

II. To explore predictors of the need for dose reduction, dose delays, or grade 2-5 toxicity and neuropathy grade 2 or higher based on a cancer-specific geriatric assessment.

OUTLINE:

Patients receive nab-paclitaxel intravenously (IV) over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic breast cancer
* Any estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth factor receptor 2 (Her2neu) status as long as the patient will receive nab-paclitaxel alone
* First or second line chemotherapy treatment for metastatic disease
* Karnofsky performance status (KPS) \>= 70%
* Resolution of grade \>= 2 toxicity from prior therapy (other than alopecia)
* Peripheral neuropathy =\< grade 1
* Absolute neutrophil count \>= 1,500/mm\^3
* Platelets \>= 100,000 cells/mm\^3
* Hemoglobin (Hb) \>= 9.0 g/dl
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x institutional upper limit of normal
* Alkaline phosphatase =\< 2.5 x upper limit of normal unless bone metastasis are present in the absence of liver metastases
* Bilirubin =\< 1.5 mg/dl
* Creatinine clearance (calculated or 24 hour) \>= 30 ml/min
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients may not be receiving any other investigational agents
* Untreated central nervous system (CNS) metastases or symptomatic CNS metastases requiring escalating doses of corticosteroids
* Known history of allergic reactions to paclitaxel
* Presence of any serious or uncontrolled infection
* Receipt of a taxane for adjuvant therapy or metastatic disease in the last 12 months
Efficacy and Safety of Kochujang Pills on Blood Lipids Profiles in Hyperlipidemia Subjects

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Kochujang pills on improvement of blood lipids. The investigators measured improvement of blood lipids parameters , including Total Cholesterol, LDL-C, Triglyceride and HDL-C, and monitored their blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 19-55 years old
* Total Cholesterol 200\~260 mg/dl or LDL-C 110\~190 mg/dl
* Able to give informed consent

Exclusion Criteria:

* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.
Zero Sodium Peritoneal Dialysate Protocol Pilot Study

The following pilot study will be undertaken to determine the effects of use of a zero-sodium peritoneal dialysate solution (10% dextrose in sterile water) on sodium removal as compared to a standard peritoneal dialysis solution.

While heart failure (HF) is generally regarded as the inability of the heart to pump sufficient blood, on a population level, volume overload is the primary driver of morbidity and hospitalization. The signs and symptoms of volume overload are driven by water accumulation, which is initially driven by sodium retention. This overall goal of this study is to investigate the ability to remove sodium through use of a zero-sodium solution in peritoneal dialysis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients actively undergoing peritoneal dialysis (PD) with a functioning PD catheter
2. PD vintage \< 3 years
3. As judged by treating nephrologist to be at or above optimal volume status (i.e., not dehydrated)

Exclusion Criteria:

1. Uncontrolled diabetes with frequent episodes of severe hyperglycemia
2. Systolic blood pressure \< 100 mmHg
3. Serum sodium \< 130 mEq/L
4. 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
5. Anemia with hemoglobin \<8 g/dL
6. Serum bicarbinate \< 18 mEq/L
7. Anuric renal failure
8. Inability to give written informed consent or follow study protocol
Pulse Oximetry With Automated Verbal Prompts

This study will evaluate the effectiveness of an automated voice prompting system on post operative hypoxia within the Postoperative Anesthesia Care Unit (PACU). This will be done to detect an improvement of the patient experience and provider care through a decrease in the number of peripheral capillary oxygen saturation (SpO2) monitor alarms via the patients own ability to follow the instruction and improve their SpO2 levels.

The investigators will examine and observe the patient's stay in the PACU and utilize the pulse oximetry software and data to analyze the ability to evaluate the difference in patient oxygenation levels and supplemental oxygen use with automated verbal prompted monitoring versus a standard care control group. As well as determine if automated verbal prompted monitoring leads to less monitor alarms and subsequent improvement of subjective alarm fatigue and patient satisfaction with their care versus standard care.

The pulse oximeter will have a finger probe that will be attached to the patient's middle finger to read the patient's SpO2 levels. Each time the participant's pulse oximetry value declines to 93% or less, an automated verbal prompt, created via the software, will generate as a soft prompt. This will be followed up by a hard prompt if no improvement is seen in their oxygenation level after a period of time. A positive feedback elicitation will be given if the participant's saturation levels increase above 93%. This automated verbal prompt guidance will take place during the entirety of the investigational group's PACU stay.

Eligibility Criteria:
Inclusion Criteria:

* planned general anesthetic
* ability to provide informed consent

Exclusion Criteria:

* use of regional anesthesia
* altered mental status
* hearing impairment requiring assistive devices
* inability to hear normal conversational voice during the consent process
* inability preoperatively to squeeze probe finger against thumb for any reason
* baseline SpO2 less than or equal to 93% (on room air or baseline home oxygen requirement)
* history of methemoglobinemia
* suspected or confirmed carbon monoxide (CO) poisoning
* planned admission to an intensive care unit
Skin Incision Adhesive in Pediatrics

The purpose of this study is to evaluate the effectiveness of on-label use of Surgiseal™ Tissue Adhesive, a cyanoacrylate-based Surgical Topical Skin Tissue Adhesive in wound closure of the topical skin in children presenting in the Emergency Department (ED).

Subjects had SurgiSeal™ applied to their topical skin incisions in the ED. Subjects' wounds were evaluated for bleeding and closure of the incision/wound before patient discharge and 48 hours after the procedure. Further follow up wound closure evaluations were conducted via telephone interview at 5-10 days and 14 days after the ED visit.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 5 and 18 years of age, inclusive
* Candidate for use of a topical surgical skin adhesive
* Informed consent by a parental guardian

Exclusion Criteria:

* A wound with evidence of active infection or gangrene or wounds of decubitus etiology
* Mucosal surfaces or across mucocutaneous junctions or skin that might be exposed to body fluids or dense natural hair
* Subjects with known hypersensitivity to cyanoacrylate or formaldehyde
Slow-release Tb4 Collagen and Chitosan Porous Sponge Scaffolds Skin Substitute Treatment is Difficult to Heal Wounds

Evaluation of slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitutes the effectiveness of clinical trials for the treatment of difficult to heal wounds and security.


Eligibility Criteria:
Inclusion Criteria:

1. Meet difficult had 1 month or more to heal the wound patients
2. Who signed the informed consent of men or women older than 17 (pregnancy)
3. Has the ability to care for, has the ability to self signed informed consent, 7 to 17 years old must be signed by the guardian informed consent
4. The process of mental stability, can finish the test

Exclusion Criteria:

1. Known allergic to bovine collagen or gao min physique
2. the wound is greater than the10cm×10cm
3. People with mental illness, drug abusers and or other items
4. Pregnant women,Prepare a pregnancy or breast feeding women 5.3 months participated in other similar experiment

6.Serious infectious disease not controller 7.With surgery, such as severe trauma stress situation 8.Can not meet the requirement of the long-term follow-up of patients
Naltrexone Plus Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder

To evaluate if naltrexone plus ketamine is effective in reducing depression and alcohol consumption.

The primary goal of this proposal is to test naltrexone plus repeated ketamine treatment for major depressive disorder and alcohol use disorder in an open-label trial.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 21-65 years old
2. Current major depressive disorder without psychotic features by DSM-5
3. Montgomery-Åsberg Depression Rating Scale (MADRS) ≥ 20
4. Current alcohol use disorder by DSM-5
5. Heavy drinking at least 3 times in the past month ('heavy drinking' defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks per day for women)
6. Abstinence from alcohol drinking for \> 5 days prior to ketamine infusion
7. Able to provide written informed consent

Exclusion Criteria:

1. Current substance use disorder by DSM-5 in the past 3 months (except alcohol, tobacco, or cannabis)
2. Current or past history of psychotic features or psychotic disorder
3. Current or past history of delirium or dementia
4. Current uncontrolled hypertension (systolic BP \> 170 mm Hg or diastolic BP \> 100 mm Hg)
5. Unstable medical condition or allergy to ketamine, naltrexone, or lorazepam---clinically determined by a physician
6. Imminent suicidal or homicidal risk
7. Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential
8. Positive opioid or illicit drug screen test (except marijuana)
9. Opioid use within 10 days prior to study medication (injectable naltrexone) or risks for opioid use during the study
10. Liver enzymes that are three times higher than the upper limit of normal
An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma

The study proposes to evaluate the safety and efficacy of PF-03715455 in moderate to severe asthma when added to standard of care and during staged withdrawal of background therapy.

Study terminated on 7th April 2015. The termination was due to business reasons. No safety or efficacy concerns contributed to the termination of the study

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a physician documented history or diagnosis of persistent asthma (according to GINA, 2014 definition of asthma),
* Pre bronchodilator FEV1 of greater than or equal to 50 and less that 80% of predicted.
* Subjects defined as GINA Step 4 on a stable dose of either fluticasone/salmeterol combination therapy, or budesonide/formoterol combination therapy or mometasone/formoterol combination therapy.
* Subjects who are defined as uncontrolled as evidenced by; Juniper Asthma Control Questionnaire (5 item version, ACQ) score greater than or equal to 1.5 and less than or equal to 3.0)

Exclusion Criteria:

* Subjects diagnosed with chronic pulmonary disease (COPD) and/or other chronic pulmonary diseases (eg, Occupational asthma, pulmonary fibrosis, bronchiectasis, Allergic bronchopulmonary aspergillosis (ABPA), pneumoconiosis, sarcoidosis, tuberculosis).
* Subjects who are current smokers.
Telemedicine on Metabolic Control in Type 1 Diabetes Mellitus Andalusian Patients (PLATEDIAN)

To assess the effect of a 6-month telemedicine program (DiabeTIC) in patients with type 1 diabetes mellitus (DM1) and regular metabolic control (HbA1c \<8%) in multi-dose insulin treatment (MDI) measured HbA1c vs. conventional medical care.

The substitution of face-to-face visits for telematics visits has a similar effect on glycemic control (measured by HbA1c) in patients with DM1 treated with multiple daily doses of insulin (MDI) and regular metabolic control (HbA1c \<8 %). It even saves costs and consumption of health resources, and improves the quality of life and satisfaction of subjects with DM1

To evaluate the effect of a 6-month Diabetic platform on telemedicine in patients with DM1 and regular metabolic control (HbA1c \<8%) on MDI treatment in the following parameters:

A) Glycemic control: Mean glycemia, number of mild hypoglycemia / week, number of severe hypoglycemia / 6 months, number of hyperglycemia greater than 250mg / dl / week, number of episodes of ketosis / 6 months, number of episodes of ketoacidosis / 6meses , Number of hospital admissions due to glycemic decompensation / 6 months.

B) Glycemic variability: Standard deviation, mean amplitude of glycemic excursions (MAGE).

C) Fear of hypoglycemia: scale FH-15. D) Quality of life: Diabetes Quality of Life Questionnaire (DQoL). E) Stress: DDS questionnaire.

F) Costs and consumption of health resources:

-Cost-effectiveness (HbA1C)

Eligibility Criteria:
Inclusion Criteria:

* Patients with DM1 over 2 years of evolution.
* Age ≥18 and \<65 years.
* HbA1c prior to inclusion of the study \<8% (the measure being valid in the month prior to inclusion in the study)
* Intensive insulin therapy with basal-bolus MDI.
* Patients living in Andalusian
* Patients candidates for telemonitoring.
* Patients who have received written informed consent.

Exclusion Criteria:

* Treatment with ISCI.
* Chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled).
* Pregnancy or pregnancy planning.
* Diabetes mellitus type 2.
* Severe psychological disturbances.
* Absence of collaboration (informed consent).
* Patients who are participating in other clinical studies.
INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP

Prospective, open-label, 1:1 randomized controlled trial of Basivertebral nerve (BVN) Ablation arm vs Standard Care Control for the treatment of vertebrogenic chronic low back pain (CLBP). Participants in the the BVN Ablation arm will receive radiofrequency ablation of the BVN using the Intracept procedure for treatment of up to 4 vertebral bodies (L3 to S1). Participants in the Standard Care Control arm will continue on non-surgical standard care and will be offered optional crossover after 12 months of follow-up with follow-up of 6 months post crossover treatment.

The study had a pre-specified Interim Analysis with stopping rules for superiority when approximately 60% of the randomized participants have completed their 3-month primary endpoint study visit. An independent Data Safety Management Board (DSMB) reviewed the interim analysis results and recommended stopping enrollments for superiority and offering early crossover to the control arm participants.

Participants in the BVN Ablation arm will be followed for 24 months following treatment. BVN Ablation arm participants will be approached to participate in a sub study of 3 additional years of follow-up at their 24 month visit (total of 5 years of follow-up).

Control arm subjects who were originally to be offered optional crossover treatment after the 12 month follow-up visit were offered crossover per the DSMB recommendation at a mean of 176.5 days.

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature subjects at least 25 years of age
* Chronic lower back pain for at least 6 months
* Failure to respond to at least 6 months of non-operative conservative management

Exclusion Criteria:

* Radicular pain
* Current or history of spinal infection
* Modic changes at vertebral bodies other than L3 to S1
* Contraindication to MRI
* Pregnant, lactating or plan to become pregnant in next year
* Has life expectancy of less than 2 years
* Compensated injuries or ongoing litigation regarding back pain/injury, or financial incentive to remain impaired
The Study of Giving Birth, a Study About Treatment of Labor Dystocia

Labor dystocia is an intransigent, high-profile issue in obstetric care, which causes significant maternal morbidity in low resource settings and maternal dissatisfaction, and increased healthcare costs worldwide. Amniotic fluid lactate, (AFL), values have recently been shown to reflect the metabolic status of the uterus and high levels have a strong association with subsequent need for operative intervention due to dystocia. In sports medicine, it is known that lactic acid can affect muscular performance but be decreased by bicarbonate given orally before physical activity. Main Outcome Measures: If an intake of bicarbonate, one hour before stimulation with oxytocin in cases with a high AFL value, changes the AFL levels and enhances delivery outcome in dystocic deliveries.

Design: Randomized controlled trial

Primary question: whether high AFL values (\>12mmol/l) in women with observed dystocic labor are best treated by

1. to handle childbirth according to the clinic's current guidelines in case of labor dystocia, i.e. with oxytocin stimulation
2. an intake of bicarbonate (Samarin) dissolved in water given 1 hour before the oxytocin is started Primary outcome variable A comparison of the frequency of spontaneous vaginal delivery in the observed two described intervention groups.

Eligibility Criteria:
Inclusion Criteria:

* dystocic labor with a need of oxytocin \>=34w of gestation

Exclusion Criteria:

* Nondystocic labors.
* Women who don't understand Swedish or English
* Premature deliveries (\<34w)
Study of ONO-1101 in Patients Scheduled for Coronary Angiography

The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients scheduled for coronary angiography, in a double-blind, randomized, placebo-controlled, parallel group, multi-center study.


Eligibility Criteria:
Inclusion Criteria:

* 20 years of age or older
* Heart rate less than 90 beats/min and more than 70 beats/min at entering the CT room

Exclusion Criteria:

* Previous allergic reactions to contrast agent
* Renal failure
* Asthma
* Concomitant beta-receptor blocking agent