cyrilzakka/clinical-trials huggingface dataset:
Population-centered Risk- and Evidence-based Dental Inter-professional Care Team

The main goal of the payment and delivery system reform is to reduce disparities in oral health and dental care access of low-income mothers and children living in rural Oregon counties. The target population is children, pregnant women and new mothers enrolled in Oregon Health Plan (OHP) in rural Oregon.

To implement a payment plan model based on global budgeting and Alternative Quality Contract (pay-for-performance) for dental providers within Advantage Dental Services, LLC with the goal of incentivizing implementation of delivery system changes aimed at reducing disparities in access and oral health for low-income mothers and children living in rural Oregon counties.

To implement delivery system changes where a team of dental providers (dentists, dental hygienists, case managers, community outreach workers and others) within Advantage Dental Services, LLC provide evidence-based screening, risk assessment and primary preventive care in non-conventional community settings (WIC, Head Start and similar settings) and seamless, timely and appropriate evidence-based care in Advantage dental clinics.

To evaluate and document the payment and delivery system changes to assess whether the changes result in (1) reductions in disparities in access for low-income mothers and children; (2) efficiency in allocation of limited resources with the application of evidence-based screening; (3) seamless and appropriate care for mothers and their child at high risk of dental caries

Eligibility Criteria:
Inclusion Criteria:

* Children less than 21 years old and women who are pregnant or up to 2 months-post-partum.
* Enrollment in Medicaid and assigned by Oregon Health Authority to receive dental care from Advantage Dental Plan.
* Home address is located in the selected counties.

Exclusion Criteria:

* None
Burden Comorbidities and Transcatheter Aortic Valve Implantation

The aim of the study is to determine whether the burden of comorbidities measured by CIRS-G (Cumulative Illness Rate Scale) is associated with a non-amelioration of the health related quality of life measured by questionnaire called "SF-36", six months after a transcatheter aortic valve replacement in older patients. During the comprehensive geriatric assessment realized before the valve implantation, the following data are recorded and their impact of the health related quality of life will also be analysed: comorbidity, age, depression, functional status, the cognitive impairment and malnutrition.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 75 years and older
* Patients referred for a transcatheter aortic valve implantation
* Patients who have a comprehensive geriatric assessment realized during the three months before the valve implantation
* Patients who provide informed written consent

Exclusion Criteria:

* Patients who refuse the study
* Patients with a legal guardian
Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery

The objective of the study is to determine the effectiveness of postoperative Tamsulosin in reducing the duration of acute postoperative urinary retention (POUR) following pelvic reconstructive surgery through a double blind, randomized placebo-controlled trial.

The primary objective is to determine the impact of Tamsulosin on duration of urinary retention following pelvic reconstructive surgery in women. Duration of catheterization via indwelling foley or clean intermittent self-catheterization (CISC), measured in days, will be compared between women receiving Tamsulosin versus placebo after diagnosis of postoperative urinary retention via standardized voiding trial. It is hypothesized that women receiving Tamsulosin will have a shorter duration of urinary retention, fewer urinary tract infections, and improved quality of life as compared with placebo. The Euroqol-5D (EQ-5D) will be used to compare physical, emotional, functional, and social/family well-being between women receiving Tamsulosin and placebo.

Upon diagnosis of POUR, women will be offered participation in the study. Once consent is obtained, women will be randomized to tamsulosin 0.4 mg or matching placebo capsules to be used daily until resolution of POUR or a 10 day course, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* willing and able to provide informed consent
* postoperative urinary retention as defined by a failed RGVT prior to hospital discharge
* Ability to speak and read English
* Tolerate pill ingestion

Exclusion Criteria:

* allergy/intolerance to Tamsulosin or sulfa drugs
* preoperative history of urinary retention as defined by preoperative post void residual of \>150mL
* current use of alpha antagonist medication for hypertension
* severe dementia
* end stage renal or liver disease
* history of severe heart failure or major cardiovascular event in the last 6 months
P2X7 Receptor, Inflammation and Neurodegenerative Diseases

Parkinson disease (PD) is a chronic degenerative disease characterized by a progressive loss of dopaminergic neurons in the substantia nigra. Its pathophysiological mechanisms are still partially unknown; a main role seems to be played by chronic neuroinflammation. A few reports have addressed the possible involvement of the inflammasome in PD, just describing the protective effect of P2X7 purinergic receptor (P2X7R) blockers in murine models of the disease and in microglial cells, where NLRP3 is activated by α-Synuclein, triggering a neuroinflammation that contributes to degeneration of dopaminergic neurons. It is still unclear whether, in addition to the increased brain expression and function of the nucleotide-binding domain, leucine-rich repeat, pyrin domain containing type 3 (NLRP3) inflammasome platform, a systemic activation of such complex might participate in the pathogenesis of PD, which could be the role of the P2X7R in this scenario, and whether such patterns undergo any specific epigenetic regulation. The present study has been designed to address these issues.

The day of the study patientes underwent a complete clinical evaluation and assessment of psycho-physical abilities using specific test such as Mini-Mental State Examination (MMSE), Cognitive Alzheimer's Disease Assessment Scale (ADAS-Cog), Clinical Dementia Rating Scale, Unified Parkinson's Disease Rating Scale (UPDRS). Blood samples were collected from an antecubital vein to assess serum and plasma aliquots for blood routine analysis and RNA and protein extraction from circulating lymphomonocytes.

To explore a putative epigenetic regulation of such complex scenario some circulating miRNAs likely involved in the pathogenesis of neurological diseases and neuro-inflammation will be measured.

Expression and functional activity of P2X7R-inflammasome complex will be measured by PCR and WB. Acute phase cytokines inflammasome-related levels will be determined by ELISA. Biochemical parameters (fasting glucose, lipid profile, serum creatinine, uric acid) will be measured by standard methods in the biochemistry laboratory of the University Hospital in Pisa. The same determinations will be repeated after one year from the first visit.

Eligibility Criteria:
Inclusion Criteria:

* newly-diagnosed PD or AD;
* no previous specific treatment;
* no systemic inflammatory or immunological disease and/or cancer;
* no anti-inflammatory drugs assumed in the three months preceding the enrolment;
* patients able to consent.

Exclusion Criteria:

* history of strokes or any neurological disease;
* patients assuming neuroleptic drugs;
* atypical symptoms at onset.
Analgesia After Knee Arthroscopy :Dexmedetomidine vs Fentanyl

The aim of this study is to evaluate analgesic effects Bupivacaine, Bupivacaine plus Dexmedetomidine and Bupivacaine plus Fentanyl in relieving pain after knee arthroscopic surgery.

Forty-five patients ASA I - II aged 21-45 years for elective knee arthroscopy were divided into 3 groups: Group B, BD and BF. Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline. Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).

Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug). The time of first request of analgesia and analgesic effect by VAS during the first 24 hr. postoperatively are recorded.

Eligibility Criteria:
Inclusion Criteria:

* Either sex,
* Age 21-45 years,
* American Society of Anesthesia (ASA) I - II for elective knee arthroscopy.

Exclusion Criteria:

* The patients with history of hepatic and renal diseases, psychiatric disorders,
* Prolonged intake of (NSAIDS, opioids and tricyclic antidepressant),
* Allergy to study drugs and patient who received analgesics up to 24 hr. before surgery were excluded from this study.
Treatment and/or Prevention of Urinary Tract Infections

The purpose of the study is to determine the effect of an investigational oral rinse in reducing uropathogens and treating uncomplicated urinary tract infections.

A 7-day treatment with a 28-day follow up has been designed as a "before and after" assessment of the clinical signs and symptoms of an uncomplicated urinary tract infection and the reduction/eradication of urinary pathogens. Enrollment is targeted to achieving 20 evaluable subjects by the end of the study. After enrolling in the trial at Day 0 (first day of dosing), participants will report back to the study site at Days 3, 7, and 28. At Day 3 or any time thereafter, worsening of symptoms and/or increases in quantitative bacteria counts will result in removal from the trial and prescription of a rescue medication, which will be selected based on microbial susceptibility testing.

Eligibility Criteria:
Inclusion Criteria:

1. Non-pregnant adult females;
2. 18 years of age or older;
3. Clinical signs with one or more symptoms of a UTI (e.g., dysuria, frequency, urgency, suprapubic pain) with onset of symptoms \< 72 hours prior to study entry;
4. One positive dipstick urine test positive either for leukocyte esterase or nitrates or have a urinalysis with \> 5 wbc/hpf.
5. A pre-treatment clean-catch midstream urine culture with ≥ 104 CFU/mL of a bacterial organism

Exclusion Criteria:

1. Males;
2. Women who are pregnant, nursing, or not using a medically accepted, effective method of birth control;
3. Three or more episodes of acute uncomplicated UTI in the past 12 months;
4. Known structural abnormality that would predispose the participant to reflux or urinary retention;
5. Patients with evidence of factors predisposing to the development of urinary tract infections, including calculi, stricture, primary renal disease (e.g., polycystic renal disease), or neurogenic bladder;
6. Patients with significant impaired immunity secondary to chemotherapy, oral corticosteroids, or HIV;
7. Patients with onset of symptoms \> 72 hours prior to entry;
8. Patients with a temperature ≥ 100°F, flank pain, chills, or any other manifestations suggestive of upper urinary tract infection;
9. Patients with purported hypersensitivity to iodine;
10. Patients with history of thyroid disease;
11. Patients who received treatment with other antimicrobials within 48 hours prior to entry;
12. Any significant medical or psychiatric condition that would render examination difficult or invalid or prevent the subject from active study participation; inability to use an oral rinse;
13. Use of concomitant medication that, in the opinion of the Study Directors, might interfere with the outcome of the study.
Effect of Topical Lidocaine on Warm and Cold Sensation in Healthy Individuals

The purpose of the present study is to systematically test the occurrence of paradoxical and illusory responses to cold and warm stimuli in healthy volunteers with artificial sensory loss.

Efficient thermal sensation is important for adequate behavioral response to cold or warm stimuli and early signs of neuropathy can be changes in the thermal sensation.

Alterations in thermal perception can results in paradoxical heat sensation (a warm perception when the skin is cooled) or a peculiar/burning sensation when the skin is stiumlated with simultaneous warm and cold (a "thermal grill").

Clarifying the occurrence of these paradoxical and illusory sensations, may help understanding early signs of peripheral neuropathy as well as thermal sensory perception.

The investigators plan to conduct a study on thermal sensory perception using a model of sensory loss in healthy volunteers and systematically test the occurrence of paradoxical heat sensations and responses to the thermal grill.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Age between 18 and 40 years
* Participant is able and willing to give informed consent.

Exclusion Criteria:

* Unable to understand and speak Danish
* Non-cooperative
* Chronic pain or acute pain the past week lasting more than 4 hours or pain on the day of investigation
* Pain medication within the last week
* Medication within the last week that can affect assessment
* Psychiatric or neurological disease and diseases that may affect the assessment
* Sensory disturbances
* History or symptoms of significant diseases (e.g. psychiatric or neurological disease, diseases that may affect the assessment, sensory disturbances, cancer, diabetes mellitus, liver diseases, kidney diseases, cardiovascular diseases)
* Pregnancy or lactation
* Jetlag or sleep deprivation
* Alcohol or drug abuse
* Consumption of cannabis the last 4 weeks and consumption of alcohol in the last 48 hours
* Any abnormality of the skin or of vascular origin at application site
* History of hypersensitivity to lidocaine, other amide-type anesthetics, or other contents of the lidocaine or vehicle
A Study to Evaluate the Single-Agent Lenalidomide in Subjects With Recurrent Non-Small-Cell Lung Cancer

Subjects who qualify will receive single agent lenalidomide once daily on days 1-21 of 28 day cycles. Subjects will continue until disease progression is documented.


Eligibility Criteria:
Inclusion Criteria:

1. Understand and voluntarily sign an informed consent form.
2. Age \>or = to 18 years at the time of signing the informed consent form
3. Able to adhere to the study visit schedule and other protocol requirements
4. Must have a histologically confirmed diagnosis of non small cell lung cancer that has recurred following at least two prior regimens. Those regimens must have contained both a platinum compound and a taxane either sequentially or in combination
5. Subjects must have measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter.
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (see Appendix II).
7. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.

WCBP must agree to have pregnancy tests every 4 weeks while on study drug (every 14 days for women with irregular cycles) and 4 weeks after the last dose of study drug.

Exclusion Criteria:

1. Any of the following laboratory abnormalities:

   1. Absolute neutrophil count (ANC) \<1,500 cells/mm3 (1.5 x 109/L)
   2. Platelet count \<100,000/mm3 (100 x 109/L)
   3. Serum creatinine \>2.5 mg/dL (221 mmol/L)
   4. Serum SGOT/AST or SGPT/ALT \>5.0 x upper limit of normal (ULN)
   5. Serum total bilirubin \>2.0 mg/dL (34 mmol/L)
2. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
3. Prior history of malignancies other than non-small cell lung cancer (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for \> or = to 1 year.
4. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
5. Pregnant or lactating females.
6. Prior \> or = grade 3 allergic reaction/hypersensitivity to thalidomide.
7. Prior \> or = grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
8. Prior use of lenalidomide.
9. Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
A Single Center Experience in the Management of Pilonidal Disease

Sacrococcygeal pilonidal disease (PND) is a common entity affecting the skin and subcutaneous tissue of the upper portion of the natal cleft of the buttocks. It is characterized by the presence of sinus tracts with recurrent inflammation and infection. It poses a significant healthcare problem due to its related morbidity, impaired quality of life, and financial costs.

This acquired disease is caused by negative suction of the hair present in the natal cleft region, leading to a foreign body reaction and subsequent granuloma . It affects 26 per 100000 people, and it mainly affects young men . Surgery for PND is frequently performed in Egypt by general surgeons, with no published data regarding its incidence or prevalence in the Egyptian population.

The PND patient may report different presentations ranging from asymptomatic disease to acute infection and abscess formation. Others may have a chronic disease with recurrent perianal inflammation and discharge.

Multiple surgical options have been described for chronic PND. However, no technique has been universally accepted. The idea of any procedure is to excise the pits with the related sinus tracts leaving healthy tissue as possible to decrease recurrence. The most commonly performed surgical techniques include excision with either primary closure, lay open, or flap-based reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes
* aging between 18- 60 years old
* who underwent surgical intervention for the pilonidal sinus (Either primary or recurrent)
* The surgical intervention includes excision with primary closure or lay open technique, Rhomboid flap and rotational flap.

Exclusion Criteria:

* surgically unfit due to commodities.
* those who lost follow up
Phase II Open Label Multicenter Study For Age Related Macular Degeneration Comparing PF-04523655 Versus Lucentis In The Treatment Of Subjects With CNV (MONET Study).

The aim of the study is to evaluate whether PF-04523655 is effective in the treatment of neovascular/wet AMD and at which dose.


Eligibility Criteria:
Inclusion Criteria:

* Males and females age 50 years or older with active primary or recurrent subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Active CNV is defined as any leakage detected on FFA or OCT. Note: Female subjects 50- 60 years of age must be amenorrheic for at least 2 years and have a serum FSH level within the laboratory reference range for postmenopausal women
* The total area of CNV (including both classic and occult components) encompassed within the lesion must be 50% or more of the total lesion area.
* The total lesion size ≤12 disc areas.
* Best corrected visual acuity using ETDRS protocol of 20/40 to 20/320 (letter score ≤73) in the study eye at the screening visit.
* Best corrected visual acuity score in the fellow eye of 20/400 or better (letter score of ≥19) at the Screening Visit. Note: Only one eye will be treated (study eye) through the duration of the study. In the event both eyes are eligible for study entry the study eye should be selected by the investigator and subject. The non-study eye may be treated with an approved AMD therapy
* Subject has retinal central subfield thickness ≥250µm measured using Stratus OCT.

Exclusion Criteria:

* Prior treatment with verteporfin photodynamic therapy, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
* Previous subfoveal focal laser photocoagulation in the study eye
* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Baseline
* History of vitrectomy, submacular surgery or other surgical intervention for AMD in the study eye
* Previous participation in any studies with investigational drugs or treatments administered 1 month preceding Baseline visit such as systemic glucocorticoids, ocular or periocular steroids (eg, triamcinolone, anecortave acetate), anti-angiogenic drugs such as pegaptanib (Macugen), ranibizumab (Lucentis), bevacizumab (Avastin) in the study eye
* Subretinal hemorrhage in the study eye that involves the fovea, if the size of the hemorrhage is either 50% or more of the total lesion area or 1 or more disc areas in size
* CNV in either eye of other etiology, eg, ocular histoplasmosis, trauma, or pathologic myopia
* Presence of subfoveal scarring
* Retinal pigment epithelial tear involving the macula in the study eye
Screening of Serum Exosomal miRNA as a Biomarker for Ocular Muscle Myasthenia Gravis

Ocular muscle myasthenia gravis (Ocular Myasthenia Gravis, OMG) has a high incidence and is difficult to diagnose. It is very necessary to find specific diagnostic indicators for OMG. By collecting peripheral blood of OMG, systemic myasthenia gravis and healthy people, extract miRNAs derived from exosomes in the serum and perform high-throughput sequencing, then use bioinformatics analysis methods to screen specifically expressed miRNAs as biomarkers for OMG diagnosis .

Part I: (1) Collect peripheral blood samples from patients with early-onset OMG, early-onset GMG and healthy subjects of age and sex matched who have been diagnosed for the first time and have not undergone any drug treatment. There are 6 cases in each group. Extract the secretion miRNA in serum and conduct high-throughput sequencing. Analyze and compare the differential expression miRNAs between OMG, GMG and healthy control groups by edgeR. The standard of differential expression is set as \| logFC \|\>1, p\<0.05. Use miRTarBase, TargetScan, and miRDB to predict target genes for differentially expressed miRNAs. Conduct GO enrichment and KEGG signaling pathway analysis on target genes. The STRING tool is used to construct the target gene protein interaction network (PPI). According to the importance of the target gene calculated by the maximum population concentration ratio (MCC) method, the top ten genes (hub genes) are selected and analyzed.

(2) Randomly collect peripheral blood samples from patients with early-onset OMG, early-onset GMG, and age-matched healthy subjects, with 10 samples in each group. The differentially expressed miRNAs obtained during the sequencing phase were validated using real-time fluorescence quantification (RT-qPCR). Construct a receiver operating characteristic curve (ROC) curve to evaluate the diagnostic efficacy of the identified miRNA.

Eligibility Criteria:
Inclusion Criteria:

* Clinical manifestations: fluctuating myasthenia;

  * neostigmine test positive; ③ AChR-Ab, Musk-Ab, LRP4-Ab antibodies positive; ④repetitive nerve stimulation or single fiber EMG Positive (comply with the first one of the above diagnostic criteria and any one of the other three, and at the same time exclude ophthalmoplegia caused by other diseases, the diagnosis can be confirmed).

Exclusion Criteria:

①Combined with other autoimmune diseases or other inflammatory diseases; ②Patients with tumorous diseases;

* Received targeted biologics, intravenous gamma globulin, plasma exchange therapy within three months before treatment; ④Pregnancy Status or lactation