cyrilzakka/clinical-trials huggingface dataset:
DPBRN Patient Satisfaction With Dental Restorations

The purpose of this study was to administer two questionnaires. The first, a Dental Satisfaction Questionnaire to assess patient satisfaction with a restoration visit using patients recruited from practices participating in the Dental PBRN "Reasons for replacement or repair of dental restorations" study. The second questionnaire (completed by the practitioner) was a brief single page questionnaire to evaluate the patient visit.

This study was to assess a comprehensive range of determinants of patient satisfaction following the restoration replacement or repair to study the relative contribution of each determinant towards overall patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* participants directly involved in this study were patients who sought dental treatment in the practitioner investigators' practices
* patient with replaced or repaired restorations placed in the treatment of permanent teeth who were also enrolled in the DPBRN "Reasons for replacement or repair of dental restorations"

Exclusion Criteria:

* children younger than 13 years of age were excluded from this study because of issues related to comprehension and validity of responses
Pharmacokinetic Profiling of Pembrolizumab and Nivolumab in Patients With Melanoma and/or Non-Small Cell Lung Cancer

This early phase I study collects blood samples and monitors the levels of pembrolizumab and nivolumab as they move through the body in patients with melanoma and/or non-small cell lung cancer. Pembrolizumab and nivolumab are a monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Studying samples of blood in the laboratory from patients receiving pembrolizumab and nivolumab may help doctors learn more about the effects of pembrolizumab and nivolumab on cells. It may also help doctors understand how well patients respond to treatment. Information from this study may be used in the future to guide physicians to make dosage adjustments based on serum concentrations of drug to minimize adverse side effects and maximize the effect of the drug.

PRIMARY OBJECTIVE:

I. To perform a steady-state PK study on patients who are taking monoclonal antibody therapy (25 patients starting pembrolizumab and 25 patients starting nivolumab for melanoma or non-small cell lung cancer).

II. Develop and validate a liquid chromatography tandem mass spectrometry (LC-MS/MS) assay to measure pembrolizumab and nivolumab in serum.

III. Measure patient samples for pembrolizumab/nivolumab at various clinical time points.

IV. Use the pharmacokinetic data (drug concentrations) to determine the area under the curve (AUC), maximum observed serum concentration (Cmax), clearance, half-life (t1/2), and trough steady-state drug concentrations.

V. Compare the data to the clinical efficacy (defined using Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 criteria)1, as well as, presence of auto-immune side effects using multiple variable regression modeling in Statistical Analysis System (SAS) version (v)9.4 or other statistical software.

OUTLINE:

Patients undergo collection of blood samples and have medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Adults who are at steady-state and taking monoclonal antibody therapy with pembrolizumab or nivolumab for melanoma or non-small cell lung cancer. Steady-state for pembrolizumab is week 21 or later and for nivolumab is week 14 or later from the initial infusion

Exclusion Criteria:

* Patients not taking pembrolizumab or nivolumab or taking pembrolizumab or nivolumab for other indications (not melanoma or non-small cell lung cancer).
Promoting Development in Toddlers With Communication Delays

Eighty parent-child dyads will be recruited and randomly assigned to either the experimental intervention or an active control condition. Subjects assigned to the experimental group will participate in 12 home-based intervention sessions.

The experimental intervention is manualized, follows an illustrated workbook for parents, and uses individualized video-feedback, modeling, and coaching strategies to help parents establish play interactions that promote communication. All participants take part in comprehensive baseline and post-intervention/post-active control assessments, as well as 6- and 12-month follow up assessments. Families in the active control group will also be invited to participate in an oral feedback session to discuss the results from these assessments. Children's involvement in other forms of intervention will be monitored using a validated intervention log so that the moderating effects of these treatments can be examined.

By targeting parent-child interactions, the current intervention ensures that new child behaviors generalize beyond the immediate context of the intervention and are maintained over time (Schreibman, 2000). In addition, by involving parents in the treatment of their children (e.g., by establishing a daily playtime routine), the current intervention ensures that the intervention strategies are implemented with sufficient intensity for causing developmental change (National Research Council, 2001).

Eligibility Criteria:
Inclusion Criteria:

* The child is between 15 and 30 months of age;
* The child scores at least one standard deviation below average on the Social Composite Score of the CSBS DP.

Exclusion Criteria:

* The child has been diagnosed with a known medical condition that has been linked to either autism or mental retardation (e.g., Fragile X, Tuberous Sclerosis, Cerebral Palsy, Hydrocephalus).
* The child has a severe visual, hearing, or motor impairment or fragile health condition that would prevent him/her from validly participating in the assessment procedures.
Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection

The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B treatment naive
* Compensated liver disease
Acute Viral Respiratory Infections in Elderly

This study is designed to assess the causes and impact of acute respiratory illness (common colds, flu, bronchitis, pneumonia) in adults age 65 and older. One of the ways to determine the virus causing a particular illness is to get a blood specimen when a person is sick and again later and look for the body's specific responses that identify the virus. Approximately 3000 subjects will be evaluated and their medical records assessed for details of recent illness and general health to help in understanding the subjects' current illness.

The purpose of this study is to determine the role of respiratory viruses in the etiology of medically attended acute respiratory illness in elderly populations and to assess the impact of these illnesses. Ambulatory elders presenting for health care with an acute respiratory illness will be recruited. Nose and throat swab specimens will be collected to test for one of the respiratory viruses, and acute and convalescent blood specimens will be collected to test for increases in specific antibody. Specimens will be collected within seven days of the onset of illness and then 1 month later for comparison specimens. A brief questionnaire will accompany the specimens, and more complete data on the illness and consequences will be obtained from the medical record. The pattern of illnesses by virus and their severity and duration will be determined.

Eligibility Criteria:
Inclusion Criteria:

1. 65 years of age or older
2. Presentation to the geriatric clinic with an acute respiratory illness of less than 7 days' duration.

Exclusion Criteria:

1. Presentation to the geriatric clinic with a history of a respiratory illness of greater than 7 days' duration.
2. Physician/physician assistant judgment that the respiratory complaints do not represent an acute infection.
3. Patient declines to permit specimen collection.
Perinatal Outcomes and Hematologic Parameters in COVID-19 Pregnancies

Complete blood count parameters are routinely evaluated cost-effective markers in diagnosis and clinical follow-up of infectious diseases.There is increasing number of studies to report the course of COVID-19 in pregnancy. The current study aimed to elucidate the changes in hematologic parameters in response to SARS-CoV-2 infection and whether there was an increase in adverse perinatal outcomes such as increased neonatal intensive care unit admission and lower APGAR scores in pregnancies with COVID-19.

The objective of this study is to evaluate the relationship between Coronavirus Disease 2019 (COVID-19) in pregnancy and adverse perinatal outcomes. The secondary aim is to analyze the diagnostic value of hematologic parameters in COVID-19 complicated pregnancies.The current study is conducted in a high volume tertiary obstetrics center burdened by COVID-19 pandemics, in Turkey, between March 20 and July 25, 2020. The study included a pregnant women cohort who had been regularly followed up and delivered in our clinics. The cohort was divided into two groups to reveal the impact of COVID-19 on the complete blood count cell indices and unfavorable obstetric and early neonatal outcomes in pregnant women. The clinically confirmed diagnosis of COVID-19 cases were included in Study Group (n=39) the healthy pregnant women without COVID-19 were included in Control Group (n=69). The study achieved a power of 0.89 and 0.98 with a 5% level of significance.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous pregnancy,
* Singleton pregnancy,
* Clinically diagnosed COVID-19 (SARS-CoV-2 positivity in real time-polymerase chain reaction)

Exclusion Criteria:

* Chronic maternal diseases (rheumatological diseases, renal failure, vascular malformations, hypertension, cardiac disease, diabetes mellitus, obesity, hypo-hyperthyroidism, congenital hematological disorders),
* Acute inflammatory conditions (acute pancreatitis, acute appendicitis),
* Pregnancy complications (gestational diabetes, PPROM, preeclampsia),
* Multiple pregnancies,
* Anticoagulant medication.
Efficacy of Balance Training by BBS on Gait Parameters and Balance in Patients With RLAS

This study will be conducted to find out the effect of adding balance training on gait parameters, balance, and Sensory Interaction

LAS are not benign injuries. As many as 4 in 10 individuals will develop chronic ankle instability (CAI) after a first-time sprain, More than half of patients with osteoarthritis (OA) of the ankle report a history of a sport-related ankle injury, and 85% of those are LAS.

Eligibility Criteria:
Inclusion Criteria:

* The patient will be referred to the outpatient clinic of the orthopedic department, Faculty of physical therapy, MTI University. with a confirmed diagnosis of recurrent Lateral ankle sprain grade II
* Subjects will be excluded if they had one of the following criteria:

Previous musculoskeletal injury to the lower limb or lumbar spine including a fracture, a sprain, or an unstable joint other than the injured ankle.
Sacubitril-Valsartan in Heart Failure with Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation

The main objective of this study is to assess the hemodynamic effects of sacubitril-valsartan in patients with heart failure with preserved ejection fraction and at least moderate atrial functional mitral regurgitation (AFMR), using a combination of cardiopulmonary exercise testing and stress echocardiography (referred to as CPETecho) at baseline and after six months of therapy. The patients included in this study will be randomly assigned to receive sacubitril-valsartan as an adjunct to standard medical care, as opposed to adhering solely to the standard of care which involves sodium-glucose cotransporter-2 (SGLT-2) inhibitor and mineralocorticoid receptor antagonist (MRA).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* New York Heart Association class II to IV.
* Written informed consent.
* Left ventricular (LV) ejection fraction ≥ 50%.
* Objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised LV filling pressures, including raised natriuretic peptides.
* ≥ moderate functional MR assessed by transthoracic echocardiography within the previous year.

Exclusion Criteria:

* Systolic blood pressure \< 100 mmHg.
* Potassium ≥ 5.2 mmol/L.
* Estimated Glomerular Filtration Rate ≤ 25 ml/min/1.73m².
* History of angioedema or unacceptable side effects during receipt of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB).
* Structural mitral valve disease and previous or planned mitral valve intervention.
* Already receiving angiotensin receptor neprilysin inhibitor (ARNI, sacubitril-valsartan) therapy.
* Severe comorbid condition limiting life expectancy \< 24 months or inability to perform a maximal CPETecho.
* Myocardial infarction, unstable angina, coronary revascularization within 12 weeks prior enrolment.
* Severe aortic, tricuspid or pulmonary valve disease.
* Pregnancy, lactation, or use of any method of contraception that is not highly effective.
Comparison of Standard Versus High Dose Urokinase for Dysfunctional Tunneled Dialysis Catheters in Haemodialysis Patients: a Randomized Controlled Trial

Tunneled dialysis catheters (TDCs) remain a frequent form of vascular access for patients undergoing long-term haemodialysis (HD). In our local setting, thrombolytic therapy with urokinase is used as first line therapy to restore catheter patency in patients who develop TDC dysfunction before considering a TDC exchange which is more invasive, requires hospital admission, and involves a higher cost. There are no published local data on the efficacy of Urokinase, though this is widely used in local practice as first line in the management of TDC dysfunction. Previous studies have also varied in terms of study methodology, dose and administration of urokinase in the form of systemic infusion or catheter lock therapy, with varying success rates of 78-97% (2,4-8). Overall, majority of these studies utilized higher doses of urokinase - some studies reported higher patency rates with high dose systemic infusion (4,5) or higher success rates when a higher dose was compared to a lower dose of urokinase lock (6-8). Bleeding events were very rare even in studies that use much higher doses or systemic infusion of urokinase (2,4-8). Our own preliminary data show lower lower success rates of around 52.5% compared to published reports, the question remains on how we can improve our patency rate and cost-effectiveness in treating TDC dysfunction without an increase in risk of adverse events. Therefore, we aim to answer the question as to whether an increase in dose of urokinase will achieve the above outcomes and result in a reduced need for TDC exchange.


Eligibility Criteria:
Inclusion Criteria:

All HD patients aged 21 or above with TDC dysfunction and able to provide informed consent and do not meet any exclusion criteria are eligible for enrolment in the study.

Catheters eligible for the study include:

(i) Incident catheters that have never received urokinase; including newly inserted catheters for previously enrolled patients are allowed.

(ii) Prevalent catheters that have not received urokinase for the last 6 months

Exclusion Criteria:

* Patients with TDC non-function, defined as no inflow and outflow from both arterial and venous ports upon catheter testing.
* Patients with contraindications to Urokinase including active internal bleeding; recent cerebrovascular accident (\< 2 months); recent intracranial or intraspinal surgery (\< 2 months); intracranial neoplasm, aneurysm or arteriovenous malformation; recent trauma, including cardiopulmonary resuscitation; recent gastrointestinal bleeding (\<2 months); known bleeding diathesis; severe uncontrolled hypertension; known hypersensitivity to Urokinase or any ingredient present in its formulation.
* Pregnancy.
* Tunneled dialysis catheter-related blood stream infection
The Prognostic Value of Anion Gap in Predicting Major Adverse Cardiovascular Events Among Patients With ST-Segment Elevation Myocardial Infarction

This study aims to evaluate the prognostic value of the anion gap in predicting major adverse cardiovascular events among patients with ST-segment elevation myocardial infarction. Researchers will collect information based on hospital registry as secondary data of in patient who had diagnosed as ST-segment elevation myocardial infarction and underwent primary percutaneous coronary intervention. The data consist of demographic data, clinical presentation, laboratory, and angiography result were collected from hospital registry by reviewing medical record. Then, the data was analyzed by using IBM SPSS Statistics v26.


Eligibility Criteria:
Inclusion Criteria:

* Adults with 18 - 70 years old with diagnosis of STEMI who underwent PPCI

Exclusion Criteria:

* History of heart failure due to any causes
* Cardiogenic shock before PPCI
* Any infection at the time of presentation
* Pregnant woman
* Other causes of high anion gap levels such as chronic kidney disease, metabolic acidosis, etc
Wellbeing in Pregnancy: Evaluating an Intervention to Improve Women's Emotional Wellbeing in Pregnancy

The Wellbeing in Pregnancy (WiP) project is an online pilot randomized controlled trial which aims to evaluate an intervention to improve women's emotional wellbeing in pregnancy.

It is estimated that mental health problems affect 10-20% of postnatal women. Many of these women do not seek help for their mental health for numerous reasons, including lack of awareness about symptoms, available treatments, and stigma. The Wellbeing Plan is a brief self-help leaflet developed by experts in perinatal mental health, and is designed to improve emotional wellbeing of women during and after pregnancy by providing information, raising awareness, helping a woman identify her own symptoms, provide coping strategies, and identify key people who can support the woman during this time. The Wellbeing in Pregnancy project is a online pilot randomized controlled trial which aims to evaluate the efficacy of the Wellbeing Plan in improving women's emotional wellbeing in pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* 26-38 weeks pregnant
* Sufficient proficiency in English to understand and complete the Wellbeing Plan

Exclusion Criteria:

* None
Effect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s)

The primary objective of this study is to compare the percentage of subjects who reach the target HbA1c level (\< or = 7.0% at endpoint) and do not experience symptomatic nocturnal hypoglycemia during treatment with insulin glargine or NPH human insulin.


Eligibility Criteria:
Inclusion Criteria:

* Insulin naïve subjects with type 2 diabetes treated with oral hypoglycemic agents
* Body mass index between 26 and 40 kg/m2
* HbA1c between 7.5% and 10.0%
* Fasting plasma glucose \>7.8 mmol/L and fasting C-peptide \> or =0.25 nmol/L
The Effects of 8-week Resistance and Aerobic Exercise on Anxiety, Depression, Sleep, Inhibitory Control in Young Adults With Smartphone Overdependence

The purpose of this study is to identify the effects of the resistance exercise and aerobic exercise on depression, anxiety, sleep, inhibitory control in young adult with smartphone overdependence


Eligibility Criteria:
Inclusion Criteria:

* Smartphone overdependent scale score of 24 ≥
* No regular exercise in the past 3 months

Exclusion Criteria:

* Unable to perform exercise
* Patients with musculoskeletal disorders
* Patients with cardiovascular diseases.
Therasphere® for Treatment of Unresectable Primary Liver Cancer and Metastatic Liver Cancer

The purpose of this protocol is to provide supervised and limited access to Therasphere® treatment for patients with primary liver cancer and chemotherapy refractory liver metastasis who cannot be treated by surgical removal of the affected part of the liver. Patient response to treatment and any side effects of Therasphere® treatment will be examined.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of primary or metastatic intrahepatic carcinoma
* The cancer must be unresectable with limited established treatment options
* ECOG Performance Status Score 0-2
* Age 19 years or older
* Able to comprehend and provide written informed consent

Exclusion Criteria:

* Any pre-treatment laboratory findings within 15 days of treatment demonstrating:
* Absolute granulocyte count ≤ 1,500/ul
* Platelet count ≤ 75,000/ul
* Serum creatinine \> 2.0 mg/dl
* Serum bilirubin ≥ 2.0 mg/dl
* Any of the following contraindications to angiography and selective visceral catheterization:
* History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine
* Bleeding, diathesis, not correctable by usual forms of therapy
* Severe peripheral vascular disease that would preclude catheterization
* Substantial venous shunt away from the liver
* Evidence of potential delivery of greater than 11 mCi (20 Gy absorbed dose) of radiation to the lungs on either 1) first Therasphere® administration; or 2) cumulative delivery of radiation to the lungs over multiple treatments
* Evidence of any detectable Tc-99 MAA flow to the stomach or duodenum, application of established angiographic techniques to stop such flow
* Significant extrahepatic disease representing an imminent life- threatening situation outcome
* Severe liver dysfunction or pulmonary insufficiency
* Active uncontrolled infection
* Significant underlying medical or psychiatric illness
* Pregnant women may not participate
Spanish Registry of Mohs Surgery

REGESMOHS (Registro Español de cirugía de Mohs) aims at describing effectiveness of Mohs surgery, and patient, tumor and technique factors related to adverse events and tumor recurrence.

REGESMOHS is a prospective cohort, including all patients considered for Mohs surgery in participating centers. All consecutive patients are included. The only exclusion criteria are being under 18-years-old or legally incompetent. Pre-planned follow-up is as required by common clinical practice, but at least once a year for the study period.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients considered for Mohs surgery

Exclusion Criteria:

* Under 18 years-old
* Legally incompetent
A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma

The purpose of the dose escalation part of the study is to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE) of ALN-BCAT as monotherapy and in combination with pembrolizumab. The purpose of the dose expansion part of the of the study is to evaluate the antitumor activity of ALN-BCAT as monotherapy and in combination with pembrolizumab; to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab.


Eligibility Criteria:
Inclusion Criteria:

* Has HCC confirmed histologically or cytologically, or, for patients with liver cirrhosis, clinically by the American Association for the Study of Liver Diseases (AASLD) criteria
* Has had at least one line of systemic therapy for unresectable advanced or metastatic disease
* Has at least one wingless-related integration site (WNT)-pathway activating mutation
* Child-Pugh class A or B7

Exclusion Criteria:

* Has fibrolamellar HCC, sarcomatoid HCC, or mixed cholangio-HCC tumors
* Has symptomatic extrahepatic disease
* Has received anti-cancer therapy or investigational drugs ≤3 weeks prior to the first dose of study drug

Note: other protocol defined inclusion / exclusion criteria apply