cyrilzakka/clinical-trials huggingface dataset:
CATCH-UP Intervention in Increasing Cancer Screening and Prevention Care in Uninsured Patients at Community Health Centers

This randomized research trial studies the Community-based Health Information Technology (HIT) Tools for Cancer Screening and Health Insurance Promotion (CATCH-UP) intervention in increasing cancer screening and prevention care in uninsured patients at community health centers. The CATCH-UP intervention may contribute to increased rates of insurance coverage, leading to improved cancer screening and prevention rates in community health care settings, and general recommended preventive care.

PRIMARY OBJECTIVES:

I. Evaluate the effect of the CATCH-UP intervention on up-to-date status of cancer screening and preventive care received by patients.

II. Evaluate the effect of the CATCH-UP intervention on patients? insurance coverage rates.

III. Evaluate the intervention implementation process, patient and community health center (CHC) staff acceptance and use of the CATCH-UP tools, and the patient-, provider-, and system-level factors associated with successful implementation and sustainability of the tools, using mixed methods.

OUTLINE: CHC clinics are randomized to 1 of 2 groups. We compare between groups and with a matched-comparison group.

GROUP I (INTERVENTION ARM 1): Participants receive CATCH-UP tools which include a panel management/data aggregator system that identifies patients who may be eligible for public coverage but are not yet insured, or who are nearing coverage expiration, coupled with automated patient outreach and communication at baseline.

GROUP II (INTERVENTION ARM 2): Participants receive CATCH-UP tools which include a panel management/data aggregator system that identifies patients who may be eligible for public coverage but are not yet insured, or who are nearing coverage expiration, coupled with automated patient outreach and communication. Participants also receive additional implementation support such as trainings, assistance with workflows, and practice facilitation.

Matched-comparison group: A clinic-level matched comparison group will be derived from the OCHIN membership by using propensity score matching techniques. Comparison group clinics will not participate actively in any study activities but, as part of their member business associate agreement with OCHIN, have already agreed to provide data through OCHIN for pre- and post-implementation analysis in the study.

Eligibility Criteria:
Inclusion Criteria:

* Established patients at CHC sites
* Low-income
* Ethnically diverse populations with lower rates of cancer screening compared to national rates
* Uninsured patients
* Patients 18 to 64 years of age
* Clinics must be primary care sites, with greater than 1,000 adult patients in the past year, be located in a state that expanded Medicaid, and have implemented the OCHIN EHR prior to January 1, 2012
The Interaction Between Oxytocin and Serotonin

the study aims to explore whether there is an interaction between oxytocin and serotonin in the regulation of emotion-based behavior by using a between-subject randomized double blind pharmacological fMRI design during which 4 groups of healthy male subjects will receive combinations of oxytocin nasal-spray (versus placebo) and acute tryptophan depletion (ATD, versus placebo)

Convergent evidence from animal models and human studies suggests that both, serotonin and oxytocin are important regulators of social emotional behavior. Evidence is emerging that both systems interact in this domain. To determine the interaction of both systems on human social behavior, the present study aims to combine a randomized placebo-controlled administration of modulators of both systems (Oxytocin nasal-spray and acute tryptophan depletion, ATD) and their combination within a pharmaco-fMRI experiment. To determine effects on the neural networks engaged in social emotional processing, healthy male subjects will receive single doses of oxytocin (24IU) versus placebo and ATD (75.2g) versus placebo before fMRI measures of emotion perception and resting state will be acquired. To control for potential effects of pre-medication personality traits as well as effects of medicines on mood, subjects will be administered pre-treatment assessing relevant personality traits and post-treatment assessments of mood.

Eligibility Criteria:
Inclusion Criteria:

* health subjects without past or current psychiatric or neurological disorders
* Right-handedness

Exclusion Criteria:

* History of head injury;
* Medical or psychiatric illness.
* High blood pressure, general cardio-vascular alterations
* History of drug or alcohol abuse or addiction.
* Allergy against medications or general strong allergies
* Sleep disorders.
* Visual or motor impairments
Surface Roughness of Heat Cured Acrylic Resin Versus Acrylic Resin With Titanium Dioxide

Measurement of surface roughness of tow different material of denture base to find out which material is more hygienic by decreasing the amount of bacterial accumulation.

Using a denture base material as a standard value which is the rapid heat cured acrylic resin and compare it with a new material which is a conventional acrylic resin with addition of titanium dioxide nano particles in surface roughness and measuring it by a device called stylus profilometer this will be done on 20 patients this trial will take about 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Completely edentulous maxillary arch and fully dentate mandibular arch with adequate interarch space.
2. The edentulous ridges should be covered by firm healthy mucosa.
3. Angle class I maxillomandibular relationship
4. Healthy and co-operative patients

Exclusion Criteria:

1. Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than 10 cigarettes/day).
2. Previous history of radiotherapy or chemotherapy.
3. Any skeletal problem dictates surgical intervention
ASP8302 Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Subjects

The objective of this study is to evaluate the safety, tolerability and pharmacokinetic of single/multiple ascending oral doses of ASP8302 in non-elderly healthy Japanese male and female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body weight at screening: ≥ 50.0 kg and \< 80.0 kg for male, ≥ 40.0 kg and \< 70.0 kg for female.
* Body-mass index (BMI) at screening: ≥ 17.6 kg/m2 and \< 26.4 kg/m2 \[BMI = Body weight (kg) ÷ {Body height (m)2}\].

Exclusion Criteria:

* Subjects who participated or are scheduled to participate in any clinical trials or post-marketing studies within 120 days before screening test or during the screening test to the hospital admission (Day -2).
* Subjects who conducted or is scheduled to conduct any of the blood donation or blood drawing in designated period before Day -2
* Subject who received or is scheduled to receive any medications within seven days before the hospital admission.
* Any deviation from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram at screening or on the day of hospital admission (Day -1).
* Subject who meets any of the criteria for laboratory tests at screening or on the day of hospital admission (Day -2).
* Any deviation from the normal range of routine 12-lead electrocardiogram at screening.
* Subjects with a complication or history of drug allergies.
* Subjects who developed upper gastrointestinal symptoms within seven days before the hospital admission.
* Subjects with a complication or history of hepatic disease.
* Subjects with a complication or history of cardiac disease.
* Subjects with a complication or history of respiratory disease except for history of asthma in childhood.
* Subjects with a complication or history of gastrointestinal disease except for a history of appendicitis.
* Subjects with a history of gastrointestinal resection except for appendicitis.
* Subjects with a complication or history of renal disease except for a history of calculus.
* Subjects with a complication or history of endocrine disease.
* Subjects with a complication or history of cerebrovascular disease.
* Subjects with a complication or history of malignant tumor.
* Subjects who received ASP8302 previously.
* Subjects who have a habit of excessive smoking or drinking alcohol.
A Multi-center Prospective Observational Biomarker Study on EGFRm+ Non-small Cell Lung Cancer Patients With Leptomeningeal Metastasis

Leptomeningeal metastasis (LM) is one of the disastrous events when managing advanced Non-small cell lung cancer (NSCLC) due to a grave prognosis. Although intrathecal (IT) chemotherapy and brain and/or spinal axis irradiation show some effects for LM in advanced NSCLC, the prognosis is still poor with median survival less than 12-14 weeks. Epidermal growth factor (EGFR) tyrosine kinase inhibitors (TKIs) showed to be effective for LM in selected NSCLC patients in some retrospective research. Our single-center prospective research indicated that the incidence of EGFR sensitive mutations (EGFRm+) in NSCLC-LM patients was high and EGFR-TKIs showed a survival benefit for LM in EGFRm+ NSCLC patients. A multi-center prospective observational biomarker study will be started in 11 lung cancer center based on our single-center prospective research result. The aims of the study are to find predictive biomarkers for LM in advanced NSCLC, to establish EGFR-TKIs based comprehensive treatment for appropriate EGFRm+ LM cases, and to establish effective clinical assessment criteria for NSCLC-LM EGFR-TKIs treatment.


Eligibility Criteria:
Inclusion Criteria:

1. The cytological identification of malignant cells within cerebrospinal fluid (CSF).
2. Non-small cell lung cancer patients.
3. Tumor specimens or cytology specimens can be used for the EGFR gene mutation detection.
4. The entails examining cerebrospinal fluid could be obtained by lumbar puncture.
5. Expected survival time is greater than 1 month.

Exclusion Criteria:

Patients with radiologic evidence of LM not confirmed by positive CSF cytology.
Impact of in Utero and Breastfeeding Exposure to Tenofovir on Renal Function in HIV-exposed Uninfected Children

The goal of this project is to determine whether and how in utero exposure to Tenofovir affects renal function in HIV-exposed uninfected infants

There is a growing use of Tenofovir (TDF) in sub-Saharan Africa with the use of Option B+ for prevention of mother-to-child HIV transmission. TDF has been associated to renal function abnormalities both in macaques and HIV-infected adults and infants. Therefore concerns have been raised about its renal safety in exposed infants of women on Option B+. Data for HEU is sparse and routine measures of renal function (creatinine, proteinuria), may not be appropriate to detect TDF-associated renal injury early. The goal of our study is to assess whether TDF use in pregnancy and breastfeeding affects the function of the kidney function of the child. Pregnant women who consent during their first antenatal consultation to take antiretroviral drugs for PMTCT after testing positive, will be enrolled and followed till birth, for adherence using HPLC. Their terms infants who are HIV negative by DNA PCR at 6 weeks (HEU), will have urine collected at 1.5, 3, 6, 9 months. Using appropriate and more sensitive markers (RBP4, KIM1, NAG, β2M), proximal tubular function will be assessed in 159 HEU infants and same number of controls. Nutritional status and drug history data will be collected for both mother and child. RBP, KIM1, β2M will be measured using XMAP assay while ELISA will be used for NAG according to manufacturer recommendations. Creatinine, phosphates and urinary tract infection will be measured using standard methods. Values of these markers will be compared between the 2 groups. Results will confirm/infirm renal safety of TDF in pregnancy, improve prevention of long term renal injury through early detection, contribute to promote development of routine rapid diagnostic tests for acute renal tubular injury

Eligibility Criteria:
Inclusion Criteria:

* Mothers

  1. HIV seropositive pregnant women on Option B+ protocol containing TDF.
  2. HIV seronegative pregnant women
  3. Pregnant women who provide informed consent.
  4. Woman is living in Yaounde and is not planning to relocate in the next 2 years. Children

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  1. Children born to HIV-infected mothers (and HIV-uninfected mothers for controls).
  2. TDF- and HIV-exposed in utero (and age-matched unexposed controls).
  3. HIV negative after birth by DNA PCR 4.0 to 12 months of age (included in study at birth and followed up till 12 months)

Exclusion Criteria:

* Refusal of parent(s) to give consent
Pharmacokinetics of Ampicillin in Neonates With Moderate to Severe Hypoxic-Ischemic Encephalopathy

Controlled Hypothermia has become the standard of care for neonates with moderate to severe HIE. Ampicillin and aminoglycosides are drugs that are universally used for the treatment of suspected neonatal sepsis, which may or may not be responsible for the etiology of HIE. Currently, medication dosage regimens are not altered in the setting of CH. A better understanding of the effects of our interventions on this unique population may help us tailor our therapy to the specific circumstances of the patient

Hypoxic-ischemic encephalopathy (HIE) affects approximately 1 to 2 per 1000 live births and remains a cause of significant morbidity and mortality in the neonatal period. In response to an anoxic insult, perfusion to vital organs is preserved; however, when this injury is profound concomitant injury to nonvital organs is observed. Controlled hypothermia (CH) has been accepted as a neuroprotective therapeutic modality for neonates with moderate to severe HIE because of its role in attenuating secondary brain injury. Neonates exhibit varying degrees of multiorgan dysfunction after a hypoxic-ischemic insult, although the added beneficial and potential adverse effects that CH has in these babies have not been completely delineated or understood.

CH has been shown to alter normal physiologic functioning of several organ systems. Specific physiologic changes as a consequence of CH have been demonstrated in both animal and human models. The observed reduction in cardiac output and reflexive increase in systemic vascular resistance in response to CH alter renal perfusion and subsequently reduce glomerular filtration . Drugs that are renally cleared may develop a prolonged half-life in this setting. Finally, drug metabolism may further be affected by altered hepatic blood flow and temperature-dependent effects on hepatic enzyme activity . Collectively, the potential effects of CH on drug metabolism and clearance are significant warranting further investigation. The investigator aims to evaluate the combined effects of hypoxia and hypothermia on ampicillin clearance and excretion

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \> 36 weeks
* Birth weight \> 1800 grams
* Age \< 6 hours old at the time of admission to the NICU
* Cord gas or ABG/VBG with pH \< 7.0 or base deficit \> 16 within the first hour of life
* Presence of seizures or evidence of moderate to severe encephalopathy
* Presence of central line for lab draws

Exclusion Criteria:

• Infants admitted for CH without central intravascular access.
Impact of Body Weight on Outcomes of Patients Undergoing Coronary Artery Bypass Grafting

All consecutive patients who underwent isolated coronary artery bypass grafting (CABG) at our institution from 2014 to 2020 were included. Patients were divided into 6 groups according to body mass index (BMI): underweight (BMI \&lt;20.0 kg/m2), normal weight (BMI 20.0-24.9 kg/m2), overweight (BMI, 25-29.9 kg/m2), obesity class I (BMI 30-34.9 kg/m2), obesity class II (BMI 35-39.9 kg/m2) and obesity class III (BMI \&gt;40 kg/m2). The long-term mortality was analyzed as primary end-point. The univariable and multivariable analysis was performed using logistic regression modeling.

All consecutive patients aged above eighteen who underwent isolated CABG were enrolled. Patients operated on- and off-pump were included. We reviewed elective, urgent, emergency and salvage surgeries. Patients with any additional concomitant surgical procedures were excluded.

Patients were divided into 6 groups according to body mass index (BMI): underweight (BMI \&lt;20.0 kg/m2), normal weight (BMI 20.0-24.9 kg/m2), overweight (BMI, 25-29.9 kg/m2), obesity class I (BMI 30-34.9 kg/m2), obesity class II (BMI 35-39.9 kg/m2) and obesity class III (BMI \&gt;40 kg/m2).

The primary endpoint was long-term mortality. The secondary end-point was the rate of sternal wound infections.

Summary statistics were calculated. Continuous data are described as the median, with the interquartile range in parentheses, while categorical data are shown as numbers with percentages. Differences between groups for normally distributed, continuous variables were determined using the one-way analysis of variance with Holm-Sidak post-hoc test. The Kruskal Wallis test was used for the analysis of non-normally distributed continuous variables with Dunn's test for post hoc comparison. The chi-squared test was used for the analysis of categorical variables. Bonferoni's correction was used for post-hoc analysis. The univariable analysis was performed using logistic regression. For multivariable analysis a logistic regression model was performed, with mortality or wound infection as the dependent variable, and all other characteristics summarized in the table 1 as independent variables. The backward conditional selection was used for modeling with variables with score statistics \&lt;0.1 included in the model. Significance was assessed at p\&lt;0.05. Multiple imputation was not used to adjust for missing data. The number of valid entries for each variable and alterations in the sample size for specific analyses are described.

Analyses were performed using IBM SPSS Version 22.0 and MedCalc Version 19.4.1.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing isolated CABG

Exclusion Criteria:

any concomitant additional surgical procedures
Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism

This study will evaluate the fitting characteristics and physiological response of two toric lenses manufactured by Vistakon.


Eligibility Criteria:
Inclusion Criteria:

* Able to wear study lenses in parameters available.
* At least 18
* understand and sign informed consent
* willing to follow the protocol
* achieve at least 6/9 Visual Acuity (VA), both eyes (OU) with study lenses
* hyperopes: +2.00 to +4.00 with -0.75 D cylinder around 180, high myopes: -6.00 to -8.00 with -1.25 D cylinder around 180
* oblique axis: -2.00 to -4.00 with -0.75 D cyl around 45 or 135, have worn Soft Contact Lenses's within last 6 months

Exclusion Criteria:

* Any ocular or systemic disorder which may contraindicate Contact Lens (CL) wear
* any topical ocular medication
* aphakic
* corneal refractive surgery,
* corneal distortion from hard CL wear or keratoconus
* pregnant or lactating
* grade 2 or worse slit lamp signs
* infectious disease
* previous clinical study within 2 weeks
* don't agree to participate
Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.

To evaluate the efficacy and safety of diazepam in the management of refractory epilepsy in selected patients who require intermittent medical intervention for the control of episodes of acute repetitive seizures. In addition, to assess the support provided by caregivers who are not themselves or not under the direct supervision of health care professionals at the time of administration.


Eligibility Criteria:
Key Inclusion Criteria

For Patient:

* Older than 2 years of age and between 6 and 136 kg body weight
* Recipient of clinical diagnosis of epilepsy, taking a stable antiepileptic drug regimen for at least 2 weeks, and requiring intermittent medical intervention to control episodes of acute repetitive seizures (ARS)
* Experienced at least 2 episodes of ARS in previous year, one of which occurred in previous 6 months
* Has episodes of ARS that include complex partial or generalized seizures
* Has a responsible caregiver available to participate
* Is not pregnant or lactating and is practicing an acceptable method of birth control.

For Caregiver:

* Age of 18 years or older and has demonstrated responsibility as a caregiver through training to:

  * Recognize an episode of repetitive seizures for which the injection was intended,
  * Administer study drug
  * Count and record seizures and respiratory rate in the patient diary,
  * Monitor the patient and record observations in the patient diary for 12 hours following study drug treatment
  * Recognize the need for immediate medical attention.

Key Exclusion Criteria

For Patient:

* Petit mal status or petit mal variant status
* History of ARS consistently progressing to status epilepticus
* History of failure to respond to benzodiazepine treatment
* Hypersensitivity to diazepam
* Acute narrow angle glaucoma
* Alcohol and/or other substance abuse
* Has taken another investigational drug in previous 30 days
* Acute or progressive neurologic or severe psychiatric disease or severe mental abnormality.