cyrilzakka/clinical-trials huggingface dataset:
Conventional Biopsies vs pCLE for Diagnosis of Superficial Gastric Neoplasia

Confocal endomicroscopy (CLE) allows real-time in-vivo high-resolution and high-magnification imaging of the gastrointestinal epithelium, which is comparable to histopathology. Previous studies have investigated the accuracy of pCLE for diagnosis and differentiated of colorectal polyps, Barrett's esophagus and pancreaticobiliary strictures. However, to date there are limited data exploring the application of pCLE to gastric lesions, and this is the first study comparing the diagnosis of conventional forceps biopsy with that of pCLE using the final specimens obtained from endoscopic resection as a reference standard. The aims of this study were (1) the accuracy of pCLE compared to conventional forceps biopsy using histopathology results following endoscopic resection as a reference, and (2) comparison of "real time" in-vivo pCLE diagnosis with that of blinded "off-line" pCLE diagnosis, and off-line interobserver agreement.


Eligibility Criteria:
Inclusion Criteria:

* Patients with biospy proven superficial gastric neoplasia, suitable for endoscopic resection.

Exclusion Criteria:

* Patients with uncorrectable coagulopathy,
* liver cirrhosis,
* acute gastrointestinal bleeding,
* pregnancy,
* breast feeding,
* documented allergy to fluorescein,
* patients with lesions that were deemed unsuitable for endoscopic resection, and
* patients without documented conventional biopsy results.
Evaluation of The Effect of Loratadine Versus Diosmin/Hesperidin Combination on Vinca Alkaloids Induced Neuropathy

All vinca alkaloids causes neuropathy. The incidence of peripheral neuropathy is 30 %-40 % in patients treated with vincristine. The incidence of long term neurological adverse events from vinblastine ranged from 50% to 97%. In this study, the investigators will study the effect of using either loratadine or diosmin 450mg/ hesperidin 50 mg combination on neuropathy caused by Vinca alkaloids therapy. This study is a prospective, controlled, randomized, interventional and open-label clinical trial.

Ninety patients will be randomly assigned to three groups as follows:

Group 1 (Control group): 30 patients will receive Vincristine 1.5 mg/m2 (maximum: 2 mg) or Vinblastine 6 mg/m2 according to treatment protocol.

Group 2 (Loratadine group): 30 patients will receive One tablet 10 mg orally once daily starting with vincristine or vinblastine administration for three cycles.

Group 3 (hesperidin 50 mg/diosmin 450mg group): 30 patients will receive 50 mg Hesperidin and Micronized purified flavonoid fraction (MPFF) 450 diosmin combination one film coated tablet orally twice daily starting with vincristine or vinblastine administration for three cycles .

Vincristine or Vinblastine dose will be adjusted as follows: Serum bilirubin 1.5 to 3 mg/dL or transaminases 2 to 3 times ULN or alkaline phosphatase increased: Administer 50% of dose.

Treatment allocation will follow a predefined randomization list and it will be computer generated.

Eligibility Criteria:
Inclusion Criteria:

1. Patients prescribed vincristine or vinblastine according to standard protocols.
2. Adult patients older than18 years.
3. Patients willing to participate in the study and sign the informed consent.
4. Adequate bone barrow function (platelet count\> 150 \*103per microliter, absolute neutrophil count\> 500 per microliter)
5. Eastern cooperative oncology group (ECOG) performance status Grade 0-2

Exclusion Criteria:

1. Hypersensitivity or contraindication to loratadine, hesperidin or diosmin combination or any component of the formulation.
2. Pre-existence or history of peripheral neuropathy due to a cause different from Vinca alkaloids induced neuropathy.
3. Receiving any other medication known to cause neuropathy.
4. Receiving medications with drug interaction grade X with Loratadine as Thalidomide, Tiotropium or Orphenadrine.
5. Women of childbearing potential not using an effective contraceptive method.
6. Pregnancy or breastfeeding.
7. Inability to understand patients' information and informed consent form.
8. Severe hepatic impairment.
STEPUP Clinical Trial

This study will test whether, among patients undergoing surgery for peripheral artery disease (PAD), the addition of an online multimedia patient education video to the current education regimen will improve PAD knowledge, activation, and self-care engagement. The study will randomize 150 participants to one of 2 groups: current education regimen vs. current education regiment with video. The primary outcome is stage of self-care engagement. Secondary outcomes are PAD knowledge, self-efficacy, and activation. A subset of participants will also be randomly selected to participate in semi-structured interviews. Study duration for participants is 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing surgery for PAD in Division of Vascular Surgery at Northwestern Memorial Hospital

Exclusion Criteria:

* Inability to provide informed consent
* Inability to complete study protocol
* Previously viewed the PAD education video
* Participation in pilot study
Efficacy of Square- Stepping Exercises in Individuals With Multiple Sclerosis

Square stepping exercises can promote correct foot placement, fast and coordinated step patterns, and sensory-motor interaction. The aim of this study is to examine the effect of square stepping exercises on mobility, balance and knee joint position sense in individuals with multiple sclerosis.

Multiple sclerosis (MS) is a chronic, inflammatory, autoimmune disease of the central nervous system that results in neurological disability. Complex gene-environment interactions play a role in the etiology of multiple sclerosis. Multiple sclerosis is more common in women than men, with a ratio ranging from 2:1 to 3:1.

MS is a very heterogeneous disease and it can have very variable clinical signs and symptoms, including motor, sensory, autonomic and cognitive disorders, depending on the region of the central nervous system. Balance and mobility disorders are the leading symptoms of MS. In addition, somatosensory disorders are frequently encountered as the initial symptom. Disorders in position sense, which is one of the components of somatosensory sense, is an important determinant of limitations during dynamic activities such as walking and balance. In order to reduce disability and improve function in individuals with Multiple Sclerosis, square stepping exercises protocol will be given to one group and a home exercise program protocol to the other group. Created by Shigematsu and Okura to improve balance and reduce the risk of falling, the square stepping exercises is performed on a thin exercise mat divided into 40 small squares of 250 cm x 100 cm. There are a number of step patterns that must be followed by the participants. Certain step patterns will be repeated 3-5 times to the participants and the participant will be asked to repeat the same pattern. As a home exercise protocol, a program consisting of frenkel exercises developed by Professor Heinrich Sebastian Frenkel for the treatment of gait, balance and coordination will be applied.

Square stepping exercises can promote correct foot placement, fast and coordinated step patterns, and sensory-motor interaction. The aim of this study is to examine the effect of square stepping exercises on mobility, balance and knee joint position sense in individuals with multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* Having a disability score of less than 4
* Being between 20-50 years old
* Not having an attack in the last month
* Patients without lower extremity spasticity according to Modified Ashworth Scale (MAS)

Exclusion Criteria:

* Having a neurological disease other than Multiple Sclerosis
* Having an Multiple Sclerosis attack during the study
* Having had orthopedic surgery affecting balance
* Presence of cognitive and psychiatric influences that will affect participation in the study
* Having a cardiovascular or pulmonary history that would inhibit participation in the study
* Have received steroid and/or immunosuppressive therapy in the past four weeks
A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis

The performance of the predictive models for the occurrence and severity of oropharyngeal mucositis established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory in nasopharyngeal carcinoma (NPC). Whereas the predictive model of a mucosal contouring method based on swallowing-induced breakthrough pain exhibited better overall performance in locally advanced NPC. Therefore, the investigators aimed to conduct a prospective, multicenter, real-world observational study to further assess the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC.

Swallowing-induced breakthrough pain as a prominent clinical challenge for radiation-induced oropharyngeal mucositis, occurs in almost all patients with nasopharyngeal carcinoma (NPC) undergoing radiotherapy, and has a significant impact on patients' quality of life and treatment outcomes. Radiation-induced oropharyngeal mucositis is closely related to the irradiated dose and volume, and the performance of the predictive models for its occurrence and severity established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory. Thus, it is difficult to carry out risk assessment, precise screening and early intervention through dosimetric parameters, thereby reducing the occurrence of severe radiation-induced oropharyngeal mucositis. The investigators defined a delineation method based on the mucosal areas of radiation-induced injury resulting in swallowing-induced breakthrough pain in locally advanced NPC, and our preliminary results demonstrated that the predictive model exhibited better overall performance. Therefore, the investigators aimed to conduct a prospective, multicenter, real-world observational study to further explore the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC.

Eligibility Criteria:
Inclusion Criteria:

1. Provide informed written consent.
2. Age ≥ 18 years.
3. Histologically confirmed as nasopharyngeal carcinoma, and currently undergoing radical radiotherapy or chemoradiotherapy.
4. Complete and continuous records of oral / oropharyngeal mucositis grading, and self-reported swallowing-induced breakthrough pain.

Exclusion Criteria:

1. Existence of poor oral hygiene, untreated dental or periodontal diseases, and metal dental restorations.
2. Current untreated or unresolved conditions like unstable heart diseases requiring treatment, and poorly controlled diabetes mellitus.
3. Body mass index (BMI) \<18.5.
4. Unsuitable to participate in current study, according to researchers' assessment.
Evaluation of Are You Ready?

The goal of this randomized trial is to learn if the Are You Ready? (AYR) intervention has a positive impact on the sexual and mental health behaviors of sexually active youth between the ages of 14 and 21 years old who are at risk for or involved in the juvenile justice and/or child welfare systems. The primary research questions it aims to answer are:

* Three months after being offered the intervention, does AYR impact youth's receipt of sexually transmitted infection testing in the past three months?
* Three months after being offered the intervention, does AYR impact youth's use of coping skills?
* Nine months after being offered the intervention, does AYR impact youth's frequency of having vaginal and anal sex without condoms in the past three months?

Researchers will compare participants randomized to receive AYR (treatment group) to participants randomized to receive a control condition that contains no sexual or reproductive health information (control group).

Participants randomized to the treatment group will be offered AYR as a virtual or in-person, 2.5 hour group session. Participants randomized to the control group will be offered a virtually delivered control condition.

This is an individual-level, randomized control trial to rigorously evaluate the impact of the Are You Ready? (AYR) intervention. Participant outcomes will be assessed using self-reported, individual-level data gathered using a structured questionnaire administered at three time points: baseline (enrollment); three months post-intervention (four months after baseline); and nine months post-intervention (ten months after baseline).

Eligibility Criteria:
Inclusion Criteria:

* At risk for or involved in the juvenile justice and/or child welfare systems
* Has had vaginal or anal sex in the past 3 months
* Comfortable reading, speaking, and writing in English

Exclusion Criteria:

- Has received other known sexual and reproductive health evidence-based interventions implemented in their local area.
A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects

This is a Phase 1 study to evaluate the PK profile of TXL oral formulations in healthy subjects

This is a Phase 1 study to evaluate the PK profile of different oral formulations of TXL following single dose administration in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age:18-55 Capable of giving written informed consent Capable of completing study requirements

Exclusion Criteria:

* History or medical condition which could impact patient safety History of drug or alcohol abuse within past 2 years Positive result for HIV, HBV, or HCV Participation in another clinical trial within the past 90 days
Mandibular Second Molar Protraction Assisted by Piezocision

This study was conducted to compare the rate of second molar protraction, level of Interleukin1-β in gingival crevicular fluid, periodontal health (gingival index, plaque index, and periodontal pocket depth) and perception of pain in patients treated by molar protraction with piezocision vs control (no piezocision).

Twenty-six subjects (39 Molars) who presented with at least one extracted mandibular first molar were selected to participate in the study. The subjects were subdivided into one of 3 groups as follows: group 1 consisted of 18 molars (13 molars from patients with bilateral first molar extraction space and 5 molars from patients with unilateral first molar extraction space) where piezocision was performed immediately before molar protraction; group 2 consisted of 21 molars (13 from patients with bilateral first molar extraction space and 8 molars from patients with unilateral first molar extraction space) where molar protraction was performed with no piezocision; group 3 consisted of 21 molars (group 2 subjects where piezocision was carried on after 3 months of molar protraction with no piezocision. After reaching 0.019X0.025" SS arch wire, NiTi coil spring was used for space closure (protraction force was 150g) attached from the lower second molar hook to the head of the mini-screw. Piezocision was performed by making 2 vertical incisions mesial and distal to the extraction space. Piezotome was inserted in the incisions previously made and bone cuts were done with a length up to mucogingival line and depth of 3 mm.

Gingival crevicular fluid (GCF) sample was obtained from the mesiogingival side of the lower second permanent molar with use of Periopaper. GCF sample was repeated 1 day, 1 week and 4 weeks after molar protraction with piezocision or with no piezocision. Pain was assessed using visual analog scale (VAS). Patients were requested to report the level of pain for 7 consecutive days.

Eligibility Criteria:
Inclusion Criteria:

* age range from 20 to 27 years
* at least one extracted mandibular first molar (first molar extracted more than one year ago and residual extraction space more than 5 mm)
* Class 1 malocclusion where molar protraction is indicated
* all permanent teeth are present except for the extracted mandibular first molar/molars.

Exclusion Criteria:-

* Ggingival index score \> 2
* Plaque index score \> 2
* Probing depth \> 4mm
* Previous orthodontic treatment
* Systemic disease and
* Smoker.
PD Frontline (Part of RAPSODI GD) Remote Assessment of People With Parkinson's

PD Frontline (part of RAPSODI GD) is an online study observational study with the goal of bringing People with Parkinson's to the frontline of research by getting them trial ready. To do this, participants are offered genetic sequencing for the GBA and LRRK2 gene with an at-home saliva collection kit.

PD Frontline is an online one-time questionnaire based study with the purpose of identifying potential candidates for gene targeted trials and observational studies.

Once the questionnaire is completed, the participant is sent a saliva collection kit in the post to provide a sample for genetic testing. The genes tested for are GBA1, the most common risk factor gene for Parkinson's, and LRRK2.

Once tested, the participant is informed of their results and kept up-to-date with any studies or trials for which they may be eligible.

Eligibility Criteria:
Inclusion Criteria:

* Formal diagnosis of Parkinson Disease

Exclusion Criteria:

* Confirmation that the individual carries a GBA variant (GBA positive). These individuals will be referred to sister-study, RAPSODI.
* History of Parkinsonism (progressive supranuclear palsy, multiple system atrophy, traumatic, manganese toxicity, postencephalitic, vascular PD; drug induced PD; corticobasal degeneration)
* Individuals with another neurological disorder including: dementia, movement disorders, and motor neurone disease.
* Individuals on drugs known to be associated with parkinsonism, including neuroleptic agents (Amisulpride, Chlorpromazine Hydrochloride, Flupenthixol, Fluphenazine Hydrochloride, Haloperidol, Methotrimeprazine, Levomepromazine, Olanzapine, Oxypertine, Pericyazine, Perphenazine, Pimozide, Pipotiazine, Prochlorperazine, Promazine Hydrochloride, Reserpine, Risperidone, Sulpiride, Thioridazine, Trifluoperazine, Zuclopenthixol acetate, Zotepine), plus Bupropion, , Lithium, Methyldopa, Metoclopramide and Sodium Valproate).
CTEPH DIAGNOSIS Europe - MRI

Phase III diagnostic trial to demonstrate that functional lung MRI can replace VQ-SPECT in a diagnostic strategy for patients with suspected CTEPH where positive findings are verified with catheter pulmonary angiography (CPA), or computed tomography pulmonary angiography (CTPA)

CHANGE-MRI is a prospective, multicentre, comparative phase III diagnostic study. The study aims to show via an in-place validation that MRI can replace VQ-SPECT as a screening test for chronic pulmonary embolism in the diagnostic algorithm for CTEPH. The diagnostic gold standard is catheter pulmonary angiography (CPA) or computed tomography pulmonary angiography (CTPA) with correction from the clinical outcome after 6-12 months.

Eligibility Criteria:
Inclusion Criteria:

* Transthoracic echocardiography indicates pulmonary hypertension
* Patients with clinical suspicion for CTEPH, scheduled for SPECT
* Provided informed consent for the study
* Age \>18y

Exclusion Criteria:

* Patient unable to undergo MRI (e.g. due to claustrophobia, cardiac pacemaker, hypersensitivity to MR i.v. contrast imaging agents)
* Women who are pregnant or breast feeding
Increasing the Number of Patients Receiving Information About Transition to End-of-life Care

Introduction: Honest prognostication and information for patients are important parts of end-of-life care. This study examined whether an educational intervention could increase the proportion of patients who received information about the transition to end-of-life care (ITEOL).

Method: Two municipalities (in charge of nursing homes) and two hospitals were randomized to receive an interactive half-day course about ITEOL for physicians and nurses. The proportion of patients who received ITEOL was measured with data from the Swedish Register of Palliative Care (SRPC). Patients were only included if they died an expected death and maintained their ability to express their will until days or hours before their death. Four hospitals and four municipalities were assigned controls, matched by hospital size, population, and proportion of patients receiving ITEOL at baseline.


Eligibility Criteria:
Inclusion Criteria:

* Hospitals and municipalities: Participation in the Swedish Register of Palliative Care.
* Patients: Reported from an included hospital or municipality during six months before to six months after intervention.

Exclusion Criteria:

* Hospitals and municipalities: Exclusion criteria were more than 40% patients receiving ITEOL at start of study, too large for an intervention due to practical reasons (university hospitals or municipalities with over 100 000 inhabitants), and hospitals not containing both internal medicine and surgery departments.
* Patients were excluded when death was unexpected, when a forensic post mortem examination was performed, or when the patients had lost their ability to express their will and take part in decisions concerning the content of medical care one week or more before death.
Risk Factor Analysis for Coronary Atherosclerosis Measured by MDCT

Coronary MDCT (multi-detector computed tomography) has been useful screening imaging modality for the coronary artery disease. Recently, novel adipokines and hepatokines as well as various inflammatory markers have been known as direct regulators of atherosclerosis. Therefore, the investigators examine the correlation of various metabolic risk factors including adipokines and hepatokines with coronary atherosclerosis measured by coronary MDCT in apparently healthy people.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy people who underwent medical routine check up in Korea Health Promotion Center.
* age \> 20 years

Exclusion Criteria:

* History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
* Diabetes
* Stage 2 hypertension
* Severe renal or hepatic disease
Effect of Bee-buzzy Vibrating Cold Application and Marionette Doll on Pain and Fear During Phlebotomy

Non-pharmacological methods are often used as a creative strategy to reduce pain and fear in children during a painful procedure such as phlebotomy. In this context, external vibratory cold application and a marionette doll are a commonly used as non-pharmacological distraction method to reduce pain and fear. In the literature, there are studies with cold application, vibrating devices and a marionette doll in bee appearance therefor this study is aimed to evaluate the effect of bee-buzzy vibrating cold application and marionette doll on pain and fear during phlebotomy among preschool children.

Pain is one of the negative experiences faced in pediatric patients due to various medical interventions and often causes fear and anxiety. Pain perception is affected by the child's age, cognitive development, communication skills, previous pain experiences, and pain beliefs. Severe and long-term pain resulting from interventions can cause behavioral and physiological problems. In this period, if the pain is not alleviated or eliminated with appropriate interventions, it may cause neurological and behavioral disorders in the future. Nurses are responsible for minimizing the pain felt by children exposed to painful interventions and helping them cope with it .

Eligibility Criteria:
Inclusion Criteria:

1. children and parents who agreed to participate in the study
2. children had successful phlebotomy in the first attempt.

Exclusion Criteria:

1. Children who are having a chronic disease
2. Mental disability or mental retardation
3. Taking analgesics in the last 24 hours
4. Undergone a surgical procedure,
5. Not having a successful phlebotomy on the first attempt,
6. The child and his/her family not being willing to participate in the study.