cyrilzakka/clinical-trials huggingface dataset:
Gram Type Infection-Specific Sepsis Identification Using Machine Learning

The focus of this study will be to conduct a prospective, randomized controlled trial (RCT) at Cape Regional Medical Center (CRMC), Oroville Hospital (OH), and UCSF Medical Center (UCSF) in which a Gram type infection-specific algorithm will be applied to EHR data for the detection of severe sepsis. For patients determined to have a high risk of severe sepsis, the algorithm will generate automated voice, telephone notification to nursing staff at CRMC, OH, and UCSF. The algorithm's performance will be measured by analysis of the primary endpoint, time to antibiotic administration. The secondary endpoint will be reduction in the administration of unnecessary antibiotics, which includes reductions in secondary antibiotics and reductions in total time on antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* All adults above age 18 who are a member of one of the three subpopulations studied in this trial (patients with Gram-positive infection, patients with Gram-negative infection, and patients with mixed Gram-positive and Gram-negative infection) are eligible to participate in the study.

Exclusion Criteria:

* Under age 18
* No record of Gram infection
A Study of Different Forms of BGB-43395 and Food Effect in Healthy Participants

Study to determine the relative bioavailability of BGB-43395 solid dispersion tablet compared to salt tablet in healthy adult participants in Part 1 and the effect of food on the selected BGB-43395 formulation solid dispersion tablet or salt tablet in healthy adult participants in Part 2.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, of any race, between 18 and 65 years of age
* Body mass index between 18.0 and 32.0 kg/m2, inclusive
* In good health, as determined by no clinically significant findings from medical history
* Able to comprehend and are willing to sign the ICF and abide by the study restrictions

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator or designee.
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed)
* Confirmed systolic blood pressure \>140 or \<90 mmHg, diastolic blood pressure \>90 or \<50 mmHg, or pulse rate \>100 or \<40 beats per minute. If any parameter is out of range, measurements should be repeated twice. Participants will be excluded if the average of the 3 measurements are outside of the corresponding reference range.
* History of prolonged QT interval/QT interval corrected for heart rate, with QTcF \>450 ms for males and \>470 ms for females.
* History or current diagnosis of diabetes, with a HbA1c ≥6.5% or fasting blood glucose level ≥126 mg/dL at screening alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin \>1.5 × upper limit of normal (ULN) (except for participants with Gilbert's syndrome, where total bilirubin should not be \>2 × ULN) at screening and check-in.
* eGFR \<90 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) 2021)
* Hemoglobin \<lower limit of normal (LLN), white blood cell count \<LLN, absolute neutrophil count \<LLN, or platelet count \<LLN at screening and check-in.
* Positive hepatitis panel and/or positive human immunodeficiency virus test.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Allogeneic Umbilical Cord Blood Therapy for Stroke

This open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood (UCB) therapy for patients with stroke.

Stroke is one of the most common etiologies causing disability in developed countries. There remains no proven treatments except tissue plasminogen activator currently. Based on promising results of cell therapy in animal stroke models, efforts to apply cell therapy for patients with stroke has been made. UCB possess various stem or progenitor cells and is known to secrete neurotrophic factors to repair injured brain. This clinical research aims to determine the safety and efficacy of allogeneic UCB for stroke.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic or hemorrhagic stroke
* Onset duration over 12 months
* Hemisphere lesions except brain stem and cerebellar lesions
* National Institute Health Stroke Scale: 10 to 15

Exclusion Criteria:

* Possibility of hypersensitivity drugs used in this study
* Uncontrolled hypertension or cardiovascualr diseases
* Malignant cancer
* Renal or hepatic dysfunction (Consultation to specialist in nephrology or gastroenterology in case of renal or hepatic dysfunction)
* Severe pulmonary dysfunction
* Traumatic brain injury
* Lack of matched UCB
Clinical Trial of New Intermittent Single-use Catheter

A multi-centre, open-labelled, randomised, crossover design. The total study duration for the individual subject will be approximately 4 weeks, consisting of four site visits and two 2-week test periods at home. Visits 0 and 1 can be performed on the same day. For visit 2 and 3, 2 catheterisations will be performed in a hospital setting (one HCP catheterisation and one self-catheterisation) for bladder emptying and user experience assessments. Visit 1 and 2 are followed by a home-use test period, followed by visit 3 which terminates the study.


Eligibility Criteria:
Inclusion Criteria:

* Is Female
* Is at least 18 years of age and has full legal capacity
* Has signed an informed consent form
* Has used clean intermittent self-catheterisation (CISC) (CH12 or CH14) for at least one month up to inclusion
* Is using intermittent self-catheterisation for a minimum of 3 times per day for bladder emptying
* Has used a compact catheter 50% of the time (or more) for the last two weeks prior to entering the study
* Has the ability (assessed by investigator) and willingness to follow study procedures

Exclusion Criteria:

* Is participating in any other clinical study during this investigation
* Has previously participated in this study
* Has symptoms of urinary tract infection at time of inclusion, as judged by the investigator (if the patient recovers within the recruitment period, a second inclusion is allowed, under a different subject id)
* Is an individual with a history of - suspected to be - or showing signs of producing an excessive amount of mucus or large/clustered sediments or debris
* Has any known allergies towards ingredients in the investigational device
* Is pregnant
* Is breastfeeding
Validation of Salivary Proteomic Biomarkers for Early Detection of Oral Cancer in Egyptian Population

The present investigation was conducted on 100 individuals allocated into four groups; 25 healthy controls, 25 patients having OPMDs with dysplasia; 25 patients having OPMDs without dysplasia, and 25 oral cancer patients. Demographic data including data related to different risk factors, modified gingival index, oral hygiene level, in addition to salivary levels of IL-6, IL-8 and sCD44 were assessed.

Histopathologic evaluation:

Biopsy samples were obtained from all lesions to verify the diagnosis and establish the presence of dysplasia in the potentially premalignant lesions before allocating patients to their specific groups.

History and clinical assessment:

Demographic data as age and gender, medical history and habits as smoking and alcohol were obtained during patient interview. Modified gingival index (MGI), level of oral hygiene (OH) and the number of remaining natural teeth were also assessed. Subjects not willing to sign a written informed consent, pregnant females, lactating mothers, and patients with immunosuppressive disorders were excluded.

Modified gingival index (MGI) evaluates the presence and degree of gingival inflammation. A score of 0 means absence of inflammation. 1 indicates mild inflammation (slight redness) of any part of the gingiva. 2- mild inflammation of the whole gingiva. 3- moderate inflammation (moderate redness, edema, and/or hypertrophy) of the gingiva. 4-severe inflammation (marked redness and spontaneous bleeding) of the gingiva. Level of OH care was evaluated corresponding to the OH habits of the patient and efficiency of plaque removal. OH, level is scored as: 1- very good, 2- good, 3- fair, and 4- poor OH.

Collection of 1.0-2.0 mL of whole unstimulated saliva was obtained between nine and twelve in the morning, to evade diurnal alteration. Participants refrained from eating, smoking, brushing, and mouthwash use, 2 hours before to salivary sampling, which were stored at -70 ◦C till analyzed.

Quantification of salivary IL-6, IL-8, and sCD44 in all samples using an ELISA kit

List of abbreviations:

OSCC: Oral squamous cell carcinoma OPMDs: Oral potentially malignant disorders HNSCC: Head and neck squamous cell carcinoma MGI: Modified gingival index. OH: Level of oral hygiene ROC: Receiver operating characteristic

Eligibility Criteria:
Inclusion Criteria:

* patients above 18 years both males and females patients presenting with OPMDs
High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity

Hypoxia is the most common adverse event during gastrointestinal endoscopes sedated with propofol and sufentanil, especially in obese people. In the present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the incidence of hypoxia among obesity.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing gastrointestinal endoscopes
* age≥18 years old and ≤70 years old
* patients or family members signed informed consent form
* ASA classification I-II
* BMI≥ 28kg/m²

Exclusion Criteria:

* Coagulation disorders or a tendency of nose bleeding;
* An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months;
* Severe aortic stenosis or mitral stenosis;
* Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months;
* Acute myocardial infarction in the last 6 months;
* Acute arrhythmia (including any tachycardia - or bradycardia) with the fluid of hemodynamics instability;
* Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy);
* Increased intracranial pressure;
* ASA classification Ⅲ-Ⅳ ;
* Mouth, nose, or throat infection;
* Liver and kidney disease
* Fever, defined as core body temperature \> 37.5℃;
* Pregnancy, breastfeeding or positive pregnancy test;
* Emergency procedure;
* Patients or family members refused to participate
* Mental disorders and people without civil capacity
Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation

The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo in simulating Goblet Cell and Meibomian Gland function in adult subjects with DED.

This was a Phase 2, single-center, randomized, masked (including all subjects, investigators, and study site personnel), placebo-controlled study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in stimulating goblet cell and Meibomian gland function in in adult subjects with DED. Approximately 45 subjects at least 18 years of age with a physicians' diagnosis of DED and meeting all other study eligibility criteria were planned to be randomized to receive a single application of 0.2% (1.2 mg/mL) OC-01 or placebo

Eligibility Criteria:
Inclusion Criteria:

* Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to visit 1.

Exclusion Criteria:

* Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery (e.g. laser-assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or corneal implant) within twelve months of Visit 1
* Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed.
* Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
* Have a known hypersensitivity to any of the procedural agents or study drug components
* Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject
A Case Controlled Etiologic Study of Sarcoidosis (ACCESS)

To test specific hypotheses concerning environmental, occupational, lifestyle, and other risk factors for sarcoidosis. Also, to examine the familial aggregation of sarcoidosis and to test genetic hypotheses concerning its etiology. Finally, to describe the natural history of sarcoidosis, particularly in African-Americans who appear to be disproportionately affected, and to implement a system for storing biological specimens including blood cells, plasma, and serum.

BACKGROUND:

Sarcoidosis is a systemic granulomatous disorder of unknown etiology. While recognized as a distinct clinical entity for over a century, information on incidence, prevalence, risk factors, and natural history in the United States remains quite limited. Data available on the occurrence in the United States indicate that the incidence ranges from about 1 to 10 per 100,000 and prevalence from about 5 to 50 per 100,000. Incidence appears highest for young adults, ages 25 to 40, higher in females than males, and much greater in African Americans than other ethnic groups. Morbidity from this chronic disease is not well estimated by mortality data. In 1981, there were over 10,000 discharges from United States hospitals for sarcoidosis. Like mortality data, the hospital discharge information probably substantially underestimates the morbidity associated with sarcoidosis which is typically managed on an outpatient basis.

The Requests for Proposals were issued in September, 1994. Awards were made in June, 1995.

DESIGN NARRATIVE:

Each of ten clinical centers enrolled patients with sarcoidosis. Because population-based case-finding mechanisms have not been widely implemented for sarcoidosis, an institution-based rather than a population-based design was used. Participating institutions were located in geographic regions where the disease was known and ethnic and gender factors could be addressed. Several investigator-initiated studies were carried out.

In addition to etiology, ACCESS examined the socioeconomic status and clinical course of patients with sarcoidosis. Newly diagnosed cases of sarcoidosis were compared to age, sex, and race matched controls. Leads to the etiology of sarcoidosis have come from diverse sources: in clinical laboratory investigations, alveolitis has been found to precede granulomatous inflammation; in case control studies, familial aggregation has been identified; and in case reports, recurrence of granulomatous inflammation has been observed after lung transplantation.

Eligibility Criteria:
No eligibility criteria
The Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life With Adults on Hemodialysis

For the end stage renal disease (ESRD) patients undergoing hemodialysis treatment, specifically, reflex mediated calf muscle pump stimulation has the potential to significantly reduce the number and magnitude of hypotensive episodes thus enhancing the effectiveness of the dialysis process. Fewer hemodialysis complications during the patient's hemodialysis treatment, would allow treatment sessions to continue to the prescribed volume removal, with much reduced patient recovery time, and the costs associated with this recovery.

Recruit individuals who consistently miss their dialysis goal. Maintain the goal over a six week period of time. Utilize exogenous calf muscle pump stimulation during each dialysis session to enhance fluid return from the lower limbs with the objective of assisting the patient in reaching ultrafiltration goal.

Track number of hypotensive events during dialysis, as well as goal success.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older;
2. alert and oriented to time, place, and self;
3. able to read and speak the English language;
4. currently receiving hemodialysis treatment approximately 3-4 hour sessions, 3 times a week;
5. received hemodialysis treatments continuously for the several previous months; AND
6. consistently exhibits hypotensive symptoms during dialysis.

Exclusion Criteria:

1. receiving hemodialysis as a temporary treatment following a peritoneal dialysis complication or an episode of transplant rejection;
2. receiving hemodialysis at home; OR
3. if they have a Medical History of any the following conditions: deep venous thrombosis, uncontrolled hypertension, pulmonary embolus
A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis.

This 2 arm study will compare the hemoglobin maintenance with once monthly methoxy polyethylene glycol-epoetin beta (Mircera) administration versus epoetin beta or darbepoetin alfa in participants with chronic kidney disease on hemodialysis. Participants will be randomized to receive either monthly intravenous (IV) or subcutaneous (SC) methoxy polyethylene glycol-epoetin beta (at a starting dose of 120 or 200 micrograms, calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered), or standard therapy (IV or SC epoetin beta once, twice or thrice weekly, or IV or SC darbepoetin alfa once a week or twice a week).


Eligibility Criteria:
Inclusion Criteria:

* regular long term hemodialysis with same schedule for greater than or equal to (\>=) 12 weeks
* continuous IV or SC maintenance epoetin beta or darbepoetin alfa therapy, with the same dosing interval during the previous month, and no change in total weekly dose

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months
* significant acute or chronic bleeding
* poorly controlled hypertension requiring hospitalization or interruption of epoetin beta/darbepoetin alfa treatment in previous 6 months
* weekly dose of epoetin beta greater than (\>) 16000 international units (IU), or weekly dose of darbepoetin alfa \>80 micrograms during previous month
Nipple-Areola Complex Sensitivity After the Section of Periareolar Dermis in Breast Reduction

The purpose of this study is to evaluate the feasibility and sensitivity of nipple-areolar complex (NAC) prospectively due to the section of the dermis after decortication (Schwartzmann's maneuver), in 50 patients undergoing breast reduction surgery.

Preservation of the dermis after decortication regions of the areola and periareolar is considered relevant by most plastic surgeons.

In patients whose CAP should be mobilized through large distances in order to correct breast ptosis, or in cases of dense breasts where noted little slip of skin over the breast parenchyma, the periareolar dermis causes limitation on the mobility of the NAC.

In clinical practice, there is a greater mobilization of NAC when making a careful section of the dermis after decortication. In contrast, the appearance of partial necrosis in these cases has become a rarity, as no case of total necrosis was observed.

Given the technical benefit observed due to greater mobilization, there is no report in the literature about how behaves the sensitivity of the NAC in these cases.

To evaluate the sensitivity of the NAC will be used Semmes-Weisnstein's monofilament. Each point will be obtained five measurements. The largest will be scorned and the lowest value. The final value of each point corresponds to an arithmetic mean of the three remaining values.

Eligibility Criteria:
Inclusion Criteria:

* Patients who willingly seek the service requesting breast reduction or mastopexy;
* Patients who after consultation with the surgeon who led the research presents realistic expectation, being safe with the possible outcome of the surgery;
* Patients who undertake to comply with the protocol previously presented and discussed with them;

Exclusion Criteria:

* Patients with prior breast surgery;
* Patients with body mass index (BMI) greater than 34.9;
* Patients with severe anemia;
* Patients with neurological disease;
* Patients with impairment cardiovascular;
* Metabolic diseases - diabetes;
* Patients with autoimmune disease;
* Menopausal patients
* Patients with collagen disease;
* Patients with psychiatric disorders.
Effect of Short-term Theta Frequency Stimulation of the Vagus Nerve on Cognition in Patients With Refractory Epilepsy

The purpose of this investigation is data pilot study of the effect of theta frequency stimulation of the vagus nerve on cognitive performance in patients with refractory epilepsy. We will compare the effects of no stimulation, theta frequency (5 Hz), and 'standard' beta frequency stimulation (25-30 Hz) on cognitive measures. We hypothesize that theta frequency VNS will have a positive effect on memory retention. The goal of this study to provide initial data to inform the design of a larger clinical trial to examine the efficacy of theta VNS.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Refractory Epilepsy
2. Previously implanted vagal nerve stimulator
3. Willingness and ability to undergo temporary changes to their VNS device settings

Exclusion Criteria:

1. \<18 years of age
2. Adults unable to consent
3. Pregnant women
4. Prisoners
5. \>20 on the Beck Depression Inventory (BDI)
6. \<24 on the Montreal Cognitive Assessment (MOCA)
7. Adults with diagnosis of developmental delay, intellectual disability, or traumatic brain injury (TBI).
8. Adults with reported history of learning disability.
9. Adults unable to use a computer with their dominant hand.
10. Status Epilepticus within the past 6 months