cyrilzakka/clinical-trials huggingface dataset:
Reducing Hypertension Disparities in Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a autoimmune disease associated with an increased risk of developing coronary artery disease (CAD) and premature death, particularly in Black patients. Traditional CAD risk factors like hypertension (HTN) are both very common and poorly controlled among Black RA patients. Disparities in RA disease activity further increase the risk of CAD in this population. Black patients face significant barriers when seeking RA care, and the investigators suspect similar challenges affect HTN care in this population. The goals of this project are to identify and address barriers to HTN care in patients with RA to reduce disparities in HTN and CAD outcomes for Black RA patients.

Interviews with Black RA patients, rheumatology providers, and primary care providers in the Duke University Health System will be conducted to describe barriers to HTN care in Black RA patients. Interviews will focus on access to care, patient-provider communication, coordination of care, and the challenges of managing HTN in patients with RA. These interviews will help us to develop an intervention that will focus on improving uncontrolled HTN in Black RA patients. The investigators plan to do this by empowering Black RA patients to actively participate in their HTN care, improving patient-provider communication, and improving coordination between primary care and rheumatology providers. If successful, our intervention has the potential to reduce rates of CAD and associated death for Black RA patients.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Race self-identified as "Black" or "African American"
* Uncontrolled hypertension
* History of rheumatoid arthritis
* Receive both primary care and rheumatology care from Duke Health System

Exclusion Criteria:

* Age less than 18 years old
* Other self-identified race
* Healthy volunteers without rheumatoid arthritis and hypertension
* Do not receive both primary care and rheumatology care from Duke Health System
* Cognitive impairment with lack the capacity to consent to study participation
* Pregnant women
* Prisoners
Assessment of Suicidality in Epilepsy - Rating Tools

This will be a cross-sectional study enrolling 200 outpatients/inpatients with treatment resistant partial epilepsy for at least two years, receiving 1-3 AEDS.

The study will consist of one or two visits, each lasting 1-2 hours. All subjects will complete Visit 1. Twenty five percent of the subjects will return for Visit 2. The study will assess the prevalence of depression and suicidal thoughts and the feasibility of using the proposed psychiatric rating scales in future epilepsy clinical trials. This study will also provide an estimate of the proportion of patients with epilepsy (PWE) who may be ineligible for future trials.

In light of the recent issues regarding antiepileptic drugs and suicidality, The Epilepsy Study Consortium is proposing a pilot study. Several scales to assess suicidality and screen for depression and anxiety disorders will be administered to a group of epilepsy patients with characteristics similar to patients who are usually enrolled in epilepsy clinical trials. The study will assess the prevalence of depression, suicidal thoughts, and behavior and the feasibility of using the proposed psychiatric rating scales in future epilepsy clinical trials. This study will also provide an estimate of the proportion of patients with epilepsy who may be ineligible for future trials because they have had active suicidal thoughts in the last 6 months, suicidal behavior in the last 2 years or a current major depressive episode.

Eligibility Criteria:
Inclusion criteria:

* Partial epilepsy for at least two years, confirmed with EEG studies
* Aged 18 to 70 years-old
* Proficient in English
* Having a minimum of a 4th grade reading level
* Having been on stable doses and type of AEDs for the previous two months
* Have at least 1 observable partial seizure (simple partial with motor component, complex partial or secondarily generalized tonic clonic seizure) per month for the past 6 months
* Is currently receiving 1-3 AEDs
* Has failed at least 2 AEDs (including current therapy)

Exclusion criteria:

* Non-epileptic seizures with or without comorbid epileptic seizures
* Subjects who currently carry a diagnosis of a major psychotic disorder
* Subjects who are currently taking an investigational medication
* Subjects with a known history of alcoholism, drug abuse, or drug addiction within the past 2 years
Effectiveness of Intracoronary Injection of Eptifibatide in Primary Coronary Intervention in STEMI Patients

The achievement of high local concentration of Eptifibatide, a GP 2b3a inhibitor,via direct intracoronary injection, promotes (in vitro) clot disaggregation. It remains unclear if it is of superior benefit than the routine intravenous administration of these agents.

In patients presenting with acute myocardial infarction, and undergoing primary coronary intervention, intracoronary administration of Eptifibatide may increase local drug concentration by several orders of magnitude and promote clot disaggregation with a minimal increase in systemic drug concentration, and in that way enhancing myocardial perfusion and survival.

Patients will be randomized, prospectively, single blinded into one of two arms:1)intravenous administration of Eptifibatide and 2) intracoronary administration. The primary end-point will be the angiographic achievement of TIMI 3 flow at the infarct related artery and TIMI myocardial perfusion grade (blush) and the electrocardiographic surrogate of myocardial perfusion the ST segment resolution.

The secondary end-points will be the occurrence of bleeding or hemorrhagic complication according to TIMI classification and the LVEF at one month compared with baseline

Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction candidate for primary coronary angioplasty, presenting within 12 hours of onset of pain and ability to clearly identified only one infarct related artery.

Exclusion Criteria:

* Contraindications for antiplatelet therapy such as bleeding disorders,
* Thrombocytopenia,
* Severe uncontrolled hypertension,
* Recent stroke (\<6 months),
* Intracranial hemorrhage at any time
* Patients after recent major surgery (\<30 days),
* Previous myocardial infarction
* Previous revascularization either by CABG or PCI and 9)patients presented with cardiogenic shock.
The Accuracy of Modified TTMB in the Spatial Distribution of Prostate Cancer

Investigators plan to use modified TTMB technology to puncture prostate of participants suspected prostate cancer, especially those with the first negative biopsy , but having a rising PSA.Then, Investigators will simulate the spatial distribution of prostate cancer in patients with positive biopsy before radical prostatectomy by way of the TPS software system . And after the radical prostatectomy ,Investigators will simulate the spatial distribution with the help of large tissue slice technique to compare with preoperative simulation ,which to verify the two simulations are consistent.

Investigators mainly plan to determine the accuracy of the modified TTMB technology in combination with the TPS system on the location of the tumor space distribution by comparing the two simulation, which is significant for the accurate focal thearpy.

Eligibility Criteria:
Inclusion Criteria:

1.Male patients;

2.18 yrs and older, and 90 yrs and younger;

3.Rectal examination reveal prostate nodules;

4.B ultrasound, CT or MRI find abnormal images;

5.PSA\>4ng/ml, abnormal f/t ratio and PSAD

Exclusion Criteria:

1. Abnormal coagulation function;
2. Severe urinary tract infection;
3. Serious cardiovascular and cerebrovascular disease
The Effect of Early Mobilization and Fluid Consumption on Bowel Movements After Cholecystectomy

Objective: The aim of this study was to determine the effect of early mobilization with consumption of tea, coffee, and warm water on bowel movements in patients who had laparoscopic cholecystectomy surgery.

Design: The study was a single-center, parallel, randomized, controlled trial. Setting: This study was carried out in the general surgery clinic of a university hospital in Türkiye.

Metod: The participants were randomized into four equal groups: tea, coffee, arm water and control. At the 4th hour postoperatively, the patients in the intervention group were first mobilized after drinking 200 ml of tea, coffee or warm water within 15 minutes. The first mobilization and oral intake of the patients in the control group started at the 8th hour. Bowel movements, mobilization time, first flatulence, first stool removal and hospital stay of the patients were followed up. Data were collected with "Patient Information Form", "Glasgow Coma Scale", "Patient Mobilization Follow-up Form" and "Patient Undergone Laparoscopic Cholecystectomy Surgery Follow-Up Form".

Hypothesis:

H0-a: Early mobilization and tea consumption have no effect on the first flatulence time in patients who have undergone laparoscopic cholecystectomy surgery.

H0-b: Early mobilization and coffee consumption have no effect on the first flatulence time in patients who have undergone laparoscopic cholecystectomy.

H0-c: Early mobilization and consumption of warm water have no effect on the initial flatulence time in patients who have undergone laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* To agree to participate in the study
* To be the age is between 18 and 65 years old
* To undergone laparoscopic cholecystectomy surgery
* To have American Society of Anesthesiologists (ASA) classification I or II

Exclusion Criteria:

* To have a history of cesarean section, hysterectomy, extensive intra-abdominal surgery
* To have metastatic disease, inflammatory bowel disease
* To use drugs that may affect intestinal functions due to systemic diseases
* To known allergy or sensitivity to coffee/caffeine
* To having difficulty swallowing
* To have mental disability or perception problems
* To have a barrier to communication
The Effect Of Low Back Pain on Paraspinal Muscles

Low back pain is frequently seen in the adolescent age group, with a prevalence approaching that of the adult age group. The most common type is non-specific, self-limiting low back pain. LDH is rare in children and adolescents and generally presents with low back pain, with or without radiculopathy. The condition is usually unilateral (especially L4-5 or L5-S1). LDH is also mostly central type. Although there are many studies that have investigated the relationship between paraspinal muscle volumes and LBP and/or LDH in the adult age group, there are very few studies in adolescents. The principal aim of this study was to compare MF, ES, and PM volumes in adolescents with LBP with and without LDH using magnetic resonance imaging (MRI) and to determine whether these two conditions cause paraspinal muscle volume loss.

The medical records of 229 patients who underwent MRI due to low back pain persisting for a minimum of twelve weeks between January 2018 and January 2020 were evaluated retrospectively. Twenty-four patients were excluded due to the presence of spondylolysis-listhesis, spinal alignment disorders including scoliosis and kyphosis, inflammatory diseases, or histories of spinal surgery and multilevel disc hernia. Two hundred five patients were finally enrolled. Age, gender, weight, and height were recorded, and BMI was calculated as weight/(height)². Participants were divided into two groups - with LDH (Group A) and without LDH (Group B). Right- and left-side PS, MF, and ES muscle volumes at intervertebral disc levels L4-L5 and L5-S1 were measured on Axial T2-weighted fast spin-echo sequences. All cross-sectional images at both levels (L4-5 and L5-S1) were generated by means of multiplanar reformat images. The muscles were identified by means of manual contouring at both disc levels. The fat components were then eliminated by application of the threshold technique, based on visual differences in pixel signal intensities. Volume measurement from cross-sectional images was based on the use of an automatic volume calculation tool.

Eligibility Criteria:
Inclusion Criteria:

* Aged 10-18
* LBP persisting for a minimum of twelve weeks

Exclusion Criteria:

* spondylolysis-listhesis
* spinal alignment disorders including scoliosis and kyphosis
* inflammatory diseases
* histories of spinal surgery
* multilevel disc hernia
NAC Trial for Anosmia

The purpose of this research study is to evaluate the use of NAC in the treatment of anosmia (a loss of the sense of smell). This drug is already approved by the Food and Drug Administration (FDA) for oral or pulmonary (lung) inhaled use for other medical conditions. However, there is research evidence that the medication may promote nerve recovery (help nerves work better after they are damaged). Since anosmia involves nerve problems, we believe the nasal spray may help treat anosmia. The medication has been in use for many years for other conditions, without safety problems.


Eligibility Criteria:
Inclusion Criteria:

* adults at least 18 years of age with documented microsmia or anosmia by University of Pennsylvania Smell Identification Test.
* patients must have no evidence of active sinonasal disease by nasal endoscopy or CT or MRI
* negative CT or MRI

Exclusion Criteria:

* adults unable to consent
* individuals who are not yet adults (infants, children, teenagers)
* pregnant women, prisoners, employees or subordinates,
* patients with known sensitivity to NAC or severe asthma
* patients with sinus or central disease on CT or MRI imaging.
Glycans Bound to Serum Haptoglobin: a Novel Gastric Cancer Tumor Biomarker

The purpose of this study is to evaluate sensitivity and specificity of newly defined tumor biomarker with gastric cancer pts and cancer-free healthy volunteers.

Measurements of specific glycosylation changes in serum haptoglobin.

Eligibility Criteria:
Arm1 (Gastric cancer patient)

1. Inclusion Criteria:

   * Male or female over 19 years
   * Patients with histologically Gastric Cancer (included Gastroesphageal junction)
   * Primary gastric cancer or/and metastatic gastric cancer.
   * Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
2. Exclusion Criteria:

   * Prior or present history of malignancies other than gastric cancer
   * Any condition that confounds the ability to interpret data from the study under the investigational confirmed.

Arm2 (Cancer-free healthy volunteers)

1. Inclusion Criteria:

   * Male or female over 19 years
   * Cancer-free status.
   * Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
2. Exclusion Criteria:

   * Prior or present history of malignancies (included gastric cancer)
   * Any condition that confounds the ability to interpret data from the study under the investigational confirmed
Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration

The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation via different injection routes in patients with treatment-naive sub-foveal choroidal neovascularization secondary to age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria include, but are not limited to:

* Diagnosed with sub-foveal choroidal neovascularization secondary to age-related macular degeneration
* Visual acuity of 20/50 to 20/200 in study eye

Exclusion Criteria:

* Any other ocular disease that could compromise vision in the study eye
* History of any prior treatment for choroidal neovascularization in the study eye
* Presence of other causes of choroidal neovascularization other than secondary to age-related macular degeneration
Post Market Study Using the Xoft Axxent System

The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.

The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System for the delivery of radiation therapy as part of breast conserving therapy in women with resected, early stage breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age \>50 years
* Tumor with Tis, T1, N0, M0 - (AJC Classification)
* Invasive ductal carcinoma or ductal carcinoma in situ
* Negative microscopic surgical margins of at least 1mm in all directions
* Adequate skin spacing between balloon surface and surface of the skin - (\> 7mm)

Exclusion Criteria:

* Pregnancy or breast-feeding - (During the treatment portion of the study, sexually active women of childbearing age will be asked to use pregnancy prevention)
* Scleroderma, systemic sclerosis and active lupus
* Infiltrating lobular histology
A Research Study to Evaluate the Safety and Effectiveness of MK0686 for the Treatment of Postherpetic Neuralgia (Also Known as PHN or Post Shingles Pain) (0686-005)

The purpose of this Study is to test the Safety and Effectiveness of MK0686 in relieving neuropathic (chronic) pain as experienced by patients with Postherpetic Neuralgia (Also Know as PHN or Post Shingles Pain).

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of postherpetic neuralgia with pain having lasted at least 6 months
* Able to complete study questionnaires, patient diary, and comply with daily study medication
* Patient is not satisfied with current treatment for pain control

Exclusion Criteria:

* Pregnant or nursing female
* History of evidence of a condition that in the opinion of the investigator, may interfere with the study results (e.g., diabetic neuropathy of fibromyalgia) or pose undue risk to undergo the course of medication required by the study (e.g., unstable heart disease, morbid obesity, kidney or liver disease)
Effect of Music on Emergence Delirium

The researchers are conducting a research study to see whether listening to music during an operation will have a positive effect on the way that children wake up from surgery/anaesthetic. It is a common phenomenon where children wake up unhappy, irritated and screaming (known as emergence delirium). Research have shown that music decreases anxiety and pain. The researchers want to see whether music can also influence a child's behaviour after emerging from anaesthesia. In other words whether they will be more calm and cooperative after listening to music while they are asleep during surgery. Should music have a positive effect, anaesthesiologists may use it in future to improve care of patients coming for surgery.

Children coming for certain elective surgeries, where pain has been excluded as a confounding factor, will have headphones placed on their ears after induction of anaesthesia. They will be randomised to two groups, one will receive music and the other just silence. The headphones will be removed just before waking the patient up. In the recovery room the child's behaviour will be observed and will be scored according to a validated score. The two groups will then be compared to see whether music makes a difference to the behaviour after anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Ages 2-7 years
* American society of anaesthesiologists class I and II patients
* Child has adequate hearing
* Surgery or procedure under general anaesthesia
* Receiving standardised anaesthetic
* Type of surgeries included: orthopaedic, urological, paediatric surgery and ophthalmology
* Minimum exposure to music must be 15minutes
* Child may not receive any premedication

Exclusion Criteria:

* American society of Anaesthesiologists class 3 and above
* Emergency cases
* Children with hearing problems
* Cognitive impairment
Soil-transmitted Helminth Reinfection Rates After Single and Repeated School Hygiene Education

Soil-transmitted helminth (STH) infections caused by Ascaris lumbricoides, Trichuris trichiura, or hookworm, affect approximately 1.5 millions individuals primarily in tropical and subtropical regions. STHs infections have been associated with delay in growth and development in children. The prevalence in Indonesia varied from 45% to 65%, but in poor sanitation areas the prevalence can increased to 80%. World Health Organization currently recommends mass treatment with benzimidazoles and health hygiene education to control the disease. In this study we evaluated the effectiveness of single and four-monthly health hygiene education to STH reinfection rates among school-aged children in Mandailing Natal district, North Sumatera province, Indonesia.

In this study we evaluate the prevalence of STH among school-aged children using Kato Katz examination prior to enrolment to the study. Two elementary schools in Mandailing Natal district, North Sumatera province, Indonesia have been selected and received either a single or repeated health hygiene education. Preliminary knowledge was also assessed using a questionnaire. Infected children received treatment of albendazole 400 mg for 3 days. Evaluation on reinfection status and STH knowledge is done at 4 month, 8 month and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Children who are negative for STHs infection on Kato Katz examination following 3 days treatment of albendazole

Exclusion Criteria:

* Parents who refused to participate in the study
* Severe malnutrition
* Co-infected with other helminth infections
GETNA2 Neoadj. TAX+Femara vs Femara in g I/II Breast Cancer

Primarily to evaluate the rates of clinical and radiological response in the 2 groups. Secondarily rate of histological response.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with breast cancer histologically proven by microbiopsy (14G or 16G) enabling confirmation of the diagnosis, and evaluation of the histological prognostic grade, hormonal receptors and HER2 status.
* Tumor T2 or T3, non-metastasized, non-inflammatory, unilateral
* Clinically or radiologically measurable lesion greater than 2 cm (ultrasound and/or mammogram)
* Receptors RE+ and/or RP+ (positive status determined according to the criteria of the investigating centers)
* HER 2 / neu status of 0, 1+ or 2+ in immunohistochemistry
* Histological grade I or II
* Menopausal patients aged greater than or equal to 60 years
* Patients with ECOG PS greater than or equal to 2
* Satisfactory hematological, hepatic and renal functions:
* Hemoglobin greater than or equal to 10 g/dL
* Platelet count greater than or equal to 100x109/L
* Polynuclear neutrophil count greater than 1.5x109/L
* Creatinine less than or equal to ≤ 1.5 ULN
* AST/ALT less than or equal to 1.5 ULN
* Alkaline phosphatases less than or equal to 2.5 ULN
* Patients able to be followed throughout the study
* Patient's consent obtained.

Exclusion Criteria:

* Inflammatory or T4 breast cancer
* T1 tumor
* Patients whose tumor is deemed by the doctor to be difficult to evaluate
* Tumor that is metastatic from the outset (M1) or locally advanced and inoperable from the outset
* RE and RP receptors negative or unknown
* HER 2/neu positive at 3 +
* Non-menopausal patients
* Surgical biopsy and/or ganglion dissection before neoadjuvant treatment
* Significant poorly controlled cardiac disorders, such as unstable angina pectoris, poorly controlled heart failure, arrhythmia requiring treatment, or myocardial infarction within the last 3 months
* Cardiovascular, hepatic, neurological or endocrine disease, or other major systemic disease that makes it difficult to conduct the protocol or to interpret the results
* Previous history of cancer that occurred within the last 10 years, with the exception of cervical cancers and basocellular skin cancers that were properly treated
* Allergy to polysorbate 80
* Hypersensitivity to docetaxel
* Participation in another clinical trial with one of the study medicinal products during the 30 days prior to entry in the study
* Patients who are unable to undergo medical monitoring for geographical, social or psychological reasons