cyrilzakka/clinical-trials huggingface dataset:
Safety Net Support Use in California

The investigator's goal is to promote equity by understanding the drivers of disparities in access to income support, particularly among urban and rural Latinx, African American, and white populations in California (CA). This study aims to capture levels of awareness, barriers to uptake, and the benefits of participation in the Earned Income Tax Credit (EITC), a tax credit for low- to moderate-income working individuals and families, among households with children ages 0-5 years old. To achieve this goal, the investigators will conduct a mixed-methods, cross-sectional, descriptive study in three diverse counties in California: Los Angeles (urban, nearly half Latinx), Alameda (urban, ethnically diverse), and Merced (rural, predominantly Latinx and white).

Using both focus groups and survey interviews, the investigators will recruit parents of young children (ages 0-5) eligible for the EITC (confirmed with screening questions regarding age, family size, marital status, and income) who either: 1) have utilized the program, or 2) have not utilized the program (do not file taxes or filed taxes but have not filed for EITC benefits). For the first group, the investigators will probe the value of the EITC benefits for their families, what experiences they had filing their taxes and receiving the benefit, how they spent the EITC benefits, and their thoughts about alternative approaches for benefit delivery that would better support their families. For the second group, the investigators aim to understand what they have heard of the program, why they may not have taken advantage of the benefits, and their recommendations for making the program more accessible. The investigators will also explore how EITC take-up varies by demographic variables, such as county of residence, income, and race/ethnicity, as well as children's and parents' characteristics, and enrollment in other programs designed to support low-income families with young children. The investigators will also ask questions about families' experiences with COVID-19 and related mitigation strategies (e.g. school closures, etc). As described in greater detail below, all data collection activities will be conducted in partnership with agencies such as WIC and Head Start, and through partnerships with the University of California Cooperative Extension program and other similar agencies.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children 0-6
* Lives in Alameda, Merced of Los Angeles counties
* Income below certain cut-offs

Exclusion Criteria:

* None
Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fed Conditions

The objective of this study was to prove the bioequivalence of Levetiracetam 750 mg Tablets under fed conditions


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Levetiracetam or any comparable or similar product.
Effect of Lavender Oil Inhalation in Colonoscopy Patients

Aim: In this study, it was aimed to determine the effect of lavender oil inhalation on the anxiety and comfort levels of patients who will undergo colonoscopy.

Material and Method: In this randomized controlled, prospective study, 73 experimental and 72 control group patients who will experience colonoscopy in a training and research hospital in western Turkey were included. While lavender inhalation was applied to the patients in the experimental group, routine care was applied to the patients in the control group. The short-form state-trait anxiety scale and general comfort scale were used to collect data before and after the procedure. p\<0.05 level was considered statistically significant.

Colonoscopy is a painful and uncomfortable procedure, and patients experience anxiety and restlessness / tension before colonoscopy. It is stated that aromatherapy, which is a non-invasive method and easy to apply, can be used to reduce these negative effects.

It is known that the fastest and easiest way of entry of essential oils into the body is inhalation. In addition, it is stated that it is safe to carry out these applications by inhalation; For this reason, studies are mostly carried out by inhalation of essential oils. In studies conducted in different fields, it is seen that lavender has positive effects on variables such as anxiety, pain, insomnia, comfort and vital signs. Looking at the literature; more music therapy and education are applied to patients who will experience anxiety and loss of comfort due to colonoscopy; As for aromatherapy interventions; In a study conducted in 2017 with Sunflower and Neroli (Orange Flower) oil, olive flower oil (Osmanthus fragrans) and grapefruit oil were used.

In this study, it was aimed to determine the effect of lavender essential oil, which has been found to have positive effects on many variables in various studies, on the anxiety and comfort levels that may be experienced in patients who will experience colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old, 65 years old and under,
* having colonoscopy,
* not having the risk of heart failure and cardiogenic shock (class III and IV),
* not having a history of asthma, eczema, and allergies to flowers and plants,
* not allergic to lavender,
* not having communicative/severe hearing or speech impairment,
* not using antidepressant, antihistamine, diuretic, hypnotic, benzodiazepine and narcotic derivatives
* having stable vital signs
* individuals who volunteered to participate in research

Exclusion Criteria:

- individuals who do not meet the inclusion criteria
Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation

Atrial fibrillation (AF) is the most common cardiac arrhythmia. In previous experimental studies, the investigators found that low-level vagus nerve (VN) stimulation (LLVNS), at voltages substantially below that which slowed the sinus rate, significantly suppressed AF inducibility and decreased AF duration. The investigators subsequently developed a non-invasive neuromodulatory therapy, in which LLVNS was delivered to the auricular branch of the VN located at the tragus, the anterior protuberance of the outer canine ear (low level tragus stimulation; LLTS). The anti-arrhythmic effects of LLTS were similar to those of LLVNS delivered to the cervical VN trunk. More recently, in a proof-of-concept study in humans, the investigators showed that in patients with drug-refractory AF undergoing AF ablation, LLTS for just one hour significantly shortened the AF duration and decreased inflammatory cytokines.

The overall objective of this proposal is to translate in ambulatory patients with paroxysmal AF the results of previous studies showing acute suppression of AF and inflammation in anesthetized canines as well as humans, in order to examine the long-term therapeutic effects of this approach. The investigators hypothesize that intermittent (1 hour daily) LLTS for 6 months may result in long-term decrease of AF burden and suppression inflammatory cytokines in patients with paroxysmal AF. Patients will be randomized to either active or sham LLTS. LLTS will be delivered through a transcutaneous electrical nerve stimulation (TENS) device for 1 hour daily over a 6-month period. AF burden will be defined as the percent of time spent in AF over a 2-week period, assessed by noninvasive continuous ECG monitoring at baseline and at 6 months. In addition, blood samples will be collected from patients at baseline, and at 3 and 6 months, for cytokine measurement. These investigations will establish the first evidence of the long-term effects of LLTS on AF suppression in patients with paroxysmal AF and may provide the basis for a potential expansion of the therapeutic targets of this treatment modality beyond AF.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients older than 21 year old
2. Paroxysmal AF

Exclusion Criteria:

1. Left ventricular dysfunction (Left ventricular ejection fraction \<40%)
2. Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases)
3. Recent (\<6 months) stroke or myocardial infarction
4. Severe heart failure (NYHA IV)
5. Left atrial dilatation (\>55mm)
6. Recurrent vaso-vagal syncopal episodes
7. Unilateral or bilateral vagotomy
8. Pregnancy or breast feeding
9. Sick sinus syndrome, 2nd or 3rd degree AV block, bifascicular block or prolonged (PR\>300ms) 1st degree AV block.
Patient Intake At the 'MOvement and REhabilitation (MO.RE.)

In recent years, there has been an exponential increase in studies regarding the benefits of physical activity in oncology, with significant results on improving both physical and psychological outcomes. When appropriately dosed, physical activity can help individuals with a history of cancer to cope with pain and Cancer-Related Fatigue, and improve their quality of life, both during and after cancer treatments.

Given the incidence and prevalence of cancer, along with the increase in survival due to advancements in cancer care, it is becoming increasingly important to promote an active lifestyle.

For this reason, in August 2022, the MOvement and REhabilitation (MO.RE.) clinic was opened by the S.C. of MFR, dedicated to individuals with a history of cancer at any stage of treatment, with the aim of offering consultations with an experienced physiotherapist to personalize a physical activity program that can help regain a good quality of life, return to daily activities, and prevent the onset of other diseases and recurrences.

The clinic also provides therapeutic education activities, following WHO guidelines, on proper lifestyle for wellness and secondary prevention.

The aim of our study is to retrospectively analyze the patients who requested a consultation at the MO.RE. clinic between August 2022 and June 2024, in order to describe and evaluate the appropriateness of access to the clinic, the expressed needs, and some clinical and rehabilitative data."


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of malignant tumor
* Access to the MO.RE. clinic for recommendations on exercise/physical activity
* Age over 18 years

Exclusion Criteria:

* Language barrier
* Conditions that prevent the individual from performing physical activity independently
Clinical Trial to Compare the PK of the Fixed-dose Combinations and Each Component of Gemigliptin/Dapagliflozin 50/10 mg

To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg

To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg Also we identify safety and tolerance of FDC and each component

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults who are 19 years \~ 50 years when they are screened
2. weight: 55.0 kg \~ 90.0 kg and BMI: 18.0 kg/m2 \~ 30.0 kg/m2
3. Volunteers who understand the procedures of clinical trial and signed informed consent form
4. Volunteers who are eligible decided by vital signs, physical examination, lab test and 12-lead ECG
5. Women of chlidbearing potential have negative results in pregnancy test

Exclusion Criteria:

1. Healtjy volunteers who don't have clinically significant disease such as liver disease, severe renal disease, acute pancreatitis... etc
2. Drug Allergy in aspirin, NSAID, Anti-bacterial drugs
3. GI tract diseases which affect PK results and safety such as ulceritis, GERD, chron disease...
4. Chronic urine track infection
5. Allergy history in sunset yellow 5 pigment and Fast green FCF (pigment)
6. galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
7. These resluts are appeared when screening

   * ALT, AST \>= 1.5 Upper limit of normal range
   * HbsAg, anti-HCV, HIV Ag\&Ab positive
   * MDRD equation: eGFR\< 60 mL/min/1.73m2
   * QTcB\> 450 ms
   * Fasting serum glucose \< 70mg/dL or \>110mg/dL
   * HbA1c\>6.5%
8. SBP\<90mmHg or \>150mmHg, DBP \<60mmHg or \>100mmHg
Mindset Interventions to Facilitate Taking Cold Showers

The primary objective of this trial is to determine whether mindsets sustain the feasibility of taking cold showers over a 3-month period. Secondary objectives are to determine potential effects on physical and mental well-being, sleep quality, skin and hair appearance, perceived illness, and related sickness absences from work.


Eligibility Criteria:
Inclusion Criteria:

The investigators will include

* healthy participants between 18 and 65 years of age,
* which do not take cold shower on a regular basis.
* As there are no known gender differences, participants of both female and male sex are included.

Exclusion Criteria:

The investigators will exclude

* pregnant or lactating women by self-report and
* subjects with cardiac, pulmonary or any other severe disease by self-report.
Refining and Testing the Diagnostic Accuracy of PAT-POPS

Increasing attendances by children (aged 0-16 years) at UK emergency departments (EDs) is putting pressure on the National Health Service (NHS). Health professionals make complex judgements on whether children attending EDs can be sent home safely or require admission. The Pennine Acute Hospitals (PAT) Paediatric Observation Priority Score (PAT-POPS) was developed as an ED-specific screening tool for this purpose. A preliminary study showed it to be a potentially effective tool for deciding admission of children from the ED. Therefore, the focus of this study is to refine the original screening tool.


Eligibility Criteria:
Inclusion Criteria:

* Children and young people aged 0-16 years of age who attend the Emergency Department

Exclusion Criteria:

* Patients who are confirmed dead on arrival at the Emergency Department
* Patients who attend the Emergency Department in cardio-respiratory arrest
The Value of a Convolutional Neural Network-Based Renal Artery Perfusion Model in Predicting Renal Function After Partial Nephrectomy: A Prospective Study

The goal of this observational study is to develop a CNN-based machine module to predict postoperative fractional renal function in people who are proposed to undergo partial nephrectomy. The main question it aims to answer is:

• Does this machine learning model accurately predict renal function after partial nephrectomy?

This prospective study is conducted to predict postoperative fractional renal function using the perfusion deficit method from a preoperatively established renal arterial perfusion model for people who are proposed to undergo partial nephrectomy. In this study, this prediction method will be compared with the true missing values of renal units on nuclear renal function, eGFR, and CTA. This study aims to evaluate the feasibility of applying the CNN-based model in predicting postoperative renal function after partial nephrectomy and provide high-level clinical evidence for the preoperative integrated diagnostic and treatment process of renal tumors, especially in terms of the functional evaluation.

Eligibility Criteria:
Inclusion Criteria:

* people with stage cT1 renal tumors confirmed by preoperative CT or MR
* people who are proposed to undergoing partial nephrectomy
* localized renal tumors without lymph node and distant metastases as defined by NCCN guidelines
* ECOG score of 0 or 1
* Life expectancy greater than 10 years

Exclusion Criteria:

* people with surgically unresectable lesions
* people with Abnormal preoperative renal function, eGFR(estimated by CKD-EPI)\<90ml/min/1.73m2
* people who receive preoperative molecular targeted therapy, immunotherapy, chemotherapy
* people with any contraindications to surgery
* people who convert to radical nephrectomy during surgery
* people who receive molecular targeted therapy, immunotherapy or chemotherapy during the postoperative follow-up period
* people with serious systemic disease
Genetics of Charcot Marie Tooth (CMT) - Modifiers of CMT1A, New Causes of CMT2

This project includes two projects. One is looking for new genes that cause Charcot Marie Tooth disease (CMT). The other is looking for genes that do not cause CMT, but may modify the symptoms a person has.

This project is to understand modifier genes and how they influence the severity of disease expression, along with identifying new forms of CMT which have not been genetically determined. Subjects who are eligible will either have CMT type 1A (CMT1A) or an unknown form of CMT. Blood will be drawn and sent to the University of Miami where they receive the coded sample and process it through exome sequencing. Subjects will be told that this is optional.

Eligibility Criteria:
Inclusion Criteria:

All patients must agree to take part in the study and sign a consent form. A teenager (age 13-17 years) considering enrolling must agree to take part in the study and sign an assent form (depending on local ethics committee requirements).

Additional inclusion criteria are described below.

Inclusion Criteria: CMT1A Gene Modifier Study

Patients must have at least one of the following:

1. Patient has a documented PMP22 duplication. AND/OR
2. Patient has a first or second degree relative (parent, child, sibling, half- sibling, aunt, uncle, grandparent, grandchild, niece, or nephew) with a documented PMP22 duplication AND a clear link between that family member and the affected patient AND a phenotype consistent with CMT1A.

i. A clear link is necessary for a second-degree relative. For example, if a grandparent is affected and has a PMP22 duplication, and the parent does not have any signs, symptoms, or electrophysiology consistent with CMT1A, there is no clear link.

ii. In cases where clear links are not available, genetic testing is required for the patient or the first degree family member who is not clearly affected.

Inclusion Criteria - Patients for CMT Exome Project

a. Patient has demonstrated neuropathy on nerve conduction studies or clinically diagnosed genetic neuropathy, in the opinion of the investigator or genetic counsellor.

Inclusion Criteria - Controls for CMT Exome Project

1. Person is a family member of a CMT patient who is enrolled in the CMT Exome Project.

   AND one of the following:
2. Person does not have a peripheral neuropathy, in the opinion of the investigator or genetic counsellor.

   OR
3. Person is suspected to have a peripheral neuropathy, but has not been examined at an INC site.

Exclusion Criteria

1. Patient does not wish to participate or does not sign a consent form.
2. For CMT Exome Project, patient has a genetically confirmed form of CMT (i.e. mutation in MFN2 causing CMT2A, mutation in GARS causing CMT2D, etc.).
3. Patients with known neuropathy from a non-genetic source, such as chemotherapies (i.e. Vincristine, Taxol, Cisplatin), diabetes, alcoholism will be evaluated independently so that genetic contributions to their effects on CMT1A phenotypes can also be analyzed.
The Pathogenesis of Terson Syndrome and the Role of CSF Tau / Amyloid-ß 40 and 42 in Patients With Aneurysmatic Subarachnoid Hemorrhage

Prospective clinical study to investigate the pathogenesis of Terson syndrome and the prognostic value of the CSF-biomarkers tau-protein and amyloid-β 40 and 42 in patients with aneurysmatic subarachnoid hemorrhage. Our two hypotheses are as follows:

1. The incidence of Terson syndrome correlates with the initial intracranial opening pressure (measured with extra ventricular drain)
2. The CSF-biomarkers correlate with the outcome assessed at discharge, 3-, 6- and 12-months postictally using Glasgow-Outcome-Scale-Extended (GOSE) and Euro-Qol-5 as well as with complications related to aneurysmatic subarachnoid hemorrhage such as cerebral vasospasm, delayed cerebral ischemia and re-bleed.

In this prospective clinical study the pathogenesis of Terson syndrome and the prognostic value of the CSF-biomarkers tau-proteine and amyloid-β 40 and 42 in patients with aneurysmatic subarachnoidal hemorrhage are investigated. Intracranial opening pressure will be measured in patients requiring CSF-diversion for acute hydrocephalus and correlated with the incidence of Terson syndrome tested by an opthalmologic exam (group A: Terson syndrome positive, group B: Terson syndrome negative). CSF samples from external ventricular drainages are obtained at day 0, 2 and 6 and concentration of tau-protein and amyloid-β 40 and 42 are determined and correlated to secondary outcome measures such as delayed cerebral ischemia, clinical vasospasm, re-bleed, necessity for surgical intervention secondary to raised intracranial pressure or CSF-diversion. Outcome in terms of Glasgow-Outcome-Scale-Extended and Euro-Qol-5 will be assessed at 3, 6 and 12 months.

CSF from patients undergoing diagnostic or therapeutic tapping of their internal ventricles for normal pressure hydrocephalus or shunt diagnostics serve as a reference for CSF-biomarkers concentration in healthy individuals.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* diagnosis of subarachnoid hemorrhage secondary to an intracranial aneurysm
* aneurysmatic subarachnoid hemorrhage must be the principal diagnosis for hospitalization
* an intracranial aneurysm must be confirmed by imaging (Computed tomography, magnet resonance tomography or angiography)
* Patients requiring diagnostic/therapeutic tapping of their internal ventricles for CSF-diversion (shunt) for normal pressure hydrocephalus or shunt diagnostics serve as a control group
* informed consent

Exclusion Criteria:

* younger than 18 years
* other diagnosis such as traumatic or perimesencephalic subarachnoid hemorrhage without an intracranial aneurysm