cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Analgesic Efficacy of Lidocaine and Diclofenac Spray in Radial Artery Blood Gas Sampling by Visual Analogue Scale and Perfusion Index

The aim of this clinical trial is to evaluate the analgesic efficacy of lidocaine and diclofenac sprays to be administered before the procedure in cases admitted to the emergency department and requiring radial artery blood gas sampling by means of visual pain scale (VAS) and perfusion index in comparison with placebo. The main questions it aims to answer are:

1. Is there a difference between the efficacy of two different sprays? 2. Is there a significant difference between the side effects of two different sprays? Researchers will compare diclofenac sodium, lidocain and placebo sprays. Treatments will;

1. be administered in same three spray bottles to ensure blinding in the groups.
2. Randomisation will be done by closed envelope method.
3. Numerical Pain Scale (NRS) will be used to evaluate the analgesic efficacy of the sprays. NRS scores will be recorded in both groups before starting blood gas sampling (baseline) and after blood gas sampling.
4. Any side effects due to medication will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65.
* Having clinical indication for radial artery blood gas sampling
* Being conscious, co-operative and orientated
* Those who approved the informed consent form

Exclusion Criteria:

* Being under 18 years of age.
* Being pregnant or breastfeeding.
* Not being conscious, co-operative and orientated (impaired consciousness)
* Being used painkillers in the last 24 hours
* Radial artery blood gas sampling on the same day (more than one application)
* Presence of cardiac arrhythmia
* Have a diagnosis of neuropathy (including diabetic neuropathy)
* Having a diagnosis of anxiety and panic disorder
* Using a sustained-release dermal analgesic patch (fentanyl)
* Patient unable to comply with the visual analogue pain scale (VAS) due to language barrier
* Presence of a condition such as dementia, etc. that may lead to a change in consciousness
* Allergy to lidocaine or diclofenac
Core Stability and Parkinson Disease

Patients with Parkinson's Disease frequently present impaired postural control that leads to loss of stability and increased risk of falls.Core system, includes passive structures of the thoracolumbar spine and pelvis that work as a unit to stabilize the body and spine against forces generated from distal body segments as well as forces generated from expected or unexpected perturbations.The objective of this study was to evaluate the effects of an intervention based on core stability in patients with Parkinson's Disease.

Core muscle coordination is important because lack of sufficient core muscle coordination can lead to decreased efficiency of postural control and functional activity. Clinical manifestations of patients with Parkinson's Disease include postural instability. Core system could be relevant to be included in an intervention. Thus, the objective of this study was to evaluate the effects of an intervention based on core stability in patients with Parkinson's Disease.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's Disease diagnosis.
* Stable medication usage
* Able to maintain standing independent

Exclusion Criteria:

* Cognitive impairment
* Comprehension deficits that prevented them from following verbal commands
Efficacy of Intralesional Platelet Rich Plasma in Patients of De Quervain's Tenosynovitis

De Quervain's tenosynovitis (DQT) was originally identified by Swiss surgeon Fritz de Quervain in 1895. It is a condition involving the entrapment of tendons within the first dorsal compartment of the wrist. In DQT, the sheaths surrounding the abductor pollicis longus (APL) and extensor pollicis brevis tendons thicken as they pass through a fibro-osseous tunnel near the radial styloid of the distal wrist. This thickening leads to pain, which worsens with thumb movements and radial or ulnar deviation of the wrist. Traditional treatment methods, such as corticosteroid injections and physical therapy, often provide only temporary relief and may not address the underlying inflammation effectively. Intralesional platelet rich plasma (PRP) therapy has emerged as a promising alternative, utilizing the patient's own growth factors and cytokines to promote healing and reduce inflammation. By investigating the efficacy of intralesional PRP in patients with DQT, this research aims to provide evidence for a minimally invasive treatment option that could enhance recovery times, reduce pain, and improve functional outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Either gender,
* Aged between 18 and 60 years
* Presenting with de quervain's tenosynovitis

Exclusion Criteria:

* Previous surgery or intervention forde quervain's tenosynovitis
* Local skin infection or osteomyelitis
* Pregnant or lactating mothers
HPV Self-sampling for Underscreened Latinas

The goal of this study is to learn if women of Hispanic/Latina ethnicity are willing to self-collect a cervico-vaginal sample for HPV testing. The main question the study will answer is:

• Does a brief educational intervention increase the feasibility and acceptability of HPV self-sampling among Hispanic/Latina women?

The study team will compare whether including a brief educational intervention with a mailed HPV self-sampling kit is more acceptable than receiving a mailed HPV self-sampling kit alone.

Participants will be asked to complete surveys at study entry (baseline) and then randomized to receive only the HPV self-sampling kit, or the kit plus a small group education that meets with a bilingual health educator.

Participants will then be contacted about one-month later to complete a follow-up survey. The study team will also measure the number of participants in each group who self-collect a sample and mail it in for HPV testing.

The study team will recruit a sample of underscreened Latinas (n=100) who will be randomly assigned to either the educational intervention (n=50) or a control condition (n=50). Feasibility will be measured through study enrollment and intervention completion (defined as the proportion of women who self-collect a sample). Acceptability of intervention materials and self-sampling procedures will be measured using self-report surveys at follow-up assessments.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported Hispanic/Latina ethnicity
* Assigned female sex at birth
* Age 30-65, consistent with guidelines for HPV DNA testing for cervical cancer screening
* Speak and read English or Spanish
* Computer or other device with internet connection
* Overdue for cervical cancer screening (e.g., no cytology-based screening within the past 3 years; no hrHPV testing either alone or in combination with cytology in the past 5 years).

Exclusion Criteria:

* Prior diagnosis of cervical cancer or abnormality (e.g., dysplasia)
* Had a hysterectomy/removal of the cervix
* Compromised immune system (e.g., known HIV)
* Women who self-report that they are pregnant or are within three months after a pregnancy
Observatory of the Prescription of Erythropoietin as Treatment of Anemia Induced by Chemotherapy or Allograft Conditioning Among the Patients With a Haematological Malignancy

Anemia concerns a lot of patients with cancer and affects their quality of life (QOL). Numerous studies in oncology have demonstrated the benefit of erythropoiesis-stimulating agents (ESA) in the treatment of anemia. ESAs allow the improvement of QOL,of the hemoglobin level (Hb) and is a validated alternative to transfusion.

However, in hematology, if there are some specific recommendations for the use of ESAs in lymphoid pathology, there are none for myeloid disorders and in the context of autografts and allogeneic hematopoietic stem-cell transplantation (HSCT). Thus, the investigators are in particular interested in both indications: treatment of anemia in acute myeloid leukemia (AML) patients treated with chemotherapy, and the in patients receiving a myeloablative or a non-myeloablative conditioning before allogeneic HSCT, whatever type of donor and cell source.

In this context, a prospective observatory was conducted from 2006 to 2009 in the hematology department of Prof. Michallet to assess the impact of prescribing ESAs (epoetin beta and darbepoetin) for these two distinct patient populations. A significant improvement in QOL during the six-month follow- up was observed in both groups. The effectiveness of the ESA on the red cell recovery and the reduction of red blood cell transfusions was established by comparing the evolution of Hb and transfusion needs of the population under ESA to a matched population. Moreover, no significant difference in the occurrence of thromboembolic events in survival and progression-free survival was observed between the ESA group and the control group.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Patient with AML de novo or secondary myelodysplasia in Complete Remission (CR) after induction and / or salvage therapy and candidate to receive a consolidation therapy.
* OR Patient with hematologic malignancies (ALL, AML, chronic lymphocytic leukemia, CLL, non-Hodgkin lymphoma, MDS, myeloma, myeloproliferative syndrome) and candidate for blood marrow or stem cell or placental blood transplantation.

Depending on the hematologic malignancy, pre-transplant status of patients included will be the CR, very good partial or partial response.

* Patient with anemia (Hb blood level ≤ 110g / l) induced by consolidation chemotherapy or allograft conditioning (myeloablative or non-myeloablative).
* Patient eligible according to the investigator, to treatment with ESA (evaluation by the investigator of the benefice- risk ratio).
* Written informed consent.

Exclusion Criteria:

* Contraindication to epoetin alfa or epoetin zeta.
* Patient not able to receive adequate antithrombotic prophylaxis.
* Patients who received ESA therapy within 3 weeks prior to inclusion.
* non French-speaking patient
* Patient participating or having participated to a clinical trial evaluating a novel molecule in the 30 days before inclusion.
* pregnant or nursing, woman or woman of childbearing potential without effective contraception
Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening, Surveillance and Diagnosis

The present study aims to compare effectiveness and cost-effectiveness of the miRFec test with respect to fecal immunochemical test (FIT) for the detection of advanced colorectal neoplasm among individuals participating in colorectal cancer (CRC) screening, surveillance and diagnosis.

The miRFec test -a Gradient Boosting Machine-generated algorithm that includes two fecal miRNAs (miR-421 and miR-27a-3p) and fecal hemoglobin concentration, along with age and gender- is more effective and cost-effective than FIT for the identification of patients with advanced colorectal neoplasm (i.e. colorectal cancer, advanced adenomas or advanced serrated lesions) among individuals participating in colorectal cancer screening and surveillance programs, and diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 50 to 75 (average-risk) referred to colonoscopy-based CRC screening.
* Male or female aged 30 to 80 with family history of CRC (moderate-risk) referred to colonoscopy-based CRC screening.
* Male and female aged 18 or older with personal history of colorectal polyps referred to colonoscopy surveillance.
* Male and female aged 18 or older with personal history of CRC referred to colonoscopy surveillance.
* Male and female aged 18 or older with colorectal symptoms referred to diagnostic colonoscopy.

Exclusion Criteria:

* Lack of informed consent to participate
* Personal history of Lynch syndrome
* Personal history of adenomatous or hamartomatous polyposis
* Personal history of serrated polyposis syndrome
* Personal history of inflammatory bowel disease
* Personal history of total colectomy for any reason
* Family history of Lynch syndrome
* Family history of adenomatous or hamartomatous polyposis
* Family history of serrated polyposis syndrome
Bioequivalence Study of Torrent Pharmaceutical Limited's ISMN 120 mg ER Tablets Under Fasting Condition

Objective:

to compare the single dose bioavailability of Torrent's Isosorbide Mononitrate 120 mg ER Tablets (Test) and Isosorbide Mononitrate 120 mg ER Tablets (Reference) of Kremers Urban, USA. Dosing periods were separated by a washout period of 8 days.

Study Design:

randomized, two-way crossover, single-dose, open-label study in healthy human adult subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy males within the age range of 18 to 55 years.
* A body mass index within 18-25 Kg/m2.
* Given written informed consent to participate in the study.
* Absence of diseases markers of HIV 1 \& 2, Hepatitis B \& C virus and RPR.
* Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history and physical examination during the screening.
* A normal 12-lead ECG.
* A normal chest X-Ray.
* Comprehension of the nature and purpose of the study and compliance with the requirements of the entire protocol.
* No history or no evidence of hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.
* No history of allergic rash.
* No history of significant systemic diseases.
* No history of psychiatric disorders or addiction to any recreational drug or drug dependence.
* No donation of blood within 56 days prior to study check-in.
* No participation in any clinical study within the past 56 days.
* No receipt of any prescription drugs or OTC products, with in two weeks prior to study check-in.
* No history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to study check-in.
* No family history of neurological disorders.
* Not consumed alcohol and xanthine containing food and beverages, cigarettes and tobacco products, for at-list 48 hours, prior to study check-in.
* Negative results for drugs of abuse in urine and alcohol breath analysis during check-in of each period.
* Not consumed grape fruit juice within the 48 hours prior to study check-in.

Exclusion Criteria:

* Blood pressure Systolic\> 140 mm Hg and \< 110 mm Hg Diastolic\< 70 mm Hg \> 90 mm Hg
* History of seizures
* History of alcohol consumption for more than 2 units/day.
* High caffeine or tobacco consumption
* History of difficulty with donating blood or difficulty in accessibility of veins.
* Any unusual or abnormal diet, for whatever reason e.g. fasting due to religious reasons.
* Used any pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study.
Automated Bilingual Computerized Alcohol Screening and Intervention in Latinos (AB-CASI)

To study the efficacy of AB-CASI against standard of care in a randomized controlled trial in the Emergency Department.

The research team will rigorously test the efficacy of AB-CASI, against a standard condition (SC) in a first-of-a-kind ED randomized controlled trial. Studying an urban adult (≥ 18 y/o) Latino ED population, the objectives are to demonstrate the superiority of AB-CASI compared to SC in: 1) reduction of alcohol consumption (Aims 1), 2) reduction of negative health behaviors and consequences (Aim 2), and 3) increasing 30-day treatment engagement (Aim 3). The investigators will also explore variation of the AB-CASI intervention on alcohol consumption, alcohol-related negative health behaviors and consequences, and 30-day treatment engagement by Latino subpopulations (Puerto-Rican, Mexican-American, Cuban-American, South/Central American) as well as other potential modifiers (age, birthplace, gender, preferred language, reason for ED visit, and smoking status). English and Spanish speaking Latino adults presenting to the Bridgeport Hospital ED will be screened using the study inclusion and exclusion criteria.

In March 2020, the primary and secondary outcomes were corrected to reflect the protocol as it was written initially. The citations section of this study registration also includes the citation for the published protocol manuscript.

Eligibility Criteria:
Inclusion Criteria:

* English and Spanish speaking adult
* ≥ 18 y/o
* Latino patients who present to the Bridgeport Hospital's ED
* Drink over the NIAAA low-risk limits.

Exclusion Criteria:

* Primary language other than English or Spanish
* Current enrollment in an alcohol or substance abuse treatment program
* Current ED visit for acute psychosis
* Condition that precludes interview or AB-CASI use i.e., life threatening injury/illness
* In police custody
* Inability to provide two contact numbers for follow-up
Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients

The study was designed to investigate the correlation between perioperative adverse cardiovascular events and the degeneration of sensory nerves in patient diagnosed with type 2 diabetes mellitus, undergoing elective non-cardiac surgery.

The study was designed to investigate the correlation between perioperative adverse cardiovascular events and the degeneration of sensory nerves in patient diagnosed with type 2 diabetes mellitus, undergoing elective non-cardiac surgery. Diabetes mellitus and peripheral sensory nerve degeneration will be diagnosed via clinical evaluation. Serum levels of constituent neuropeptides, including neuropeptide Y (NPY), calcitonin and substance P (SP) and calcitonin gene related peptide (CGRP), and transient receptor potential vanilloid 1 (TRPV1), a molecular nociceptor in peripheral sensory nerves will be quantitatively evaluated. The clinical and the biochemical consequence will be compared between the cohorts of diabetic and non-diabetic patients. The differences and the correlations will be analyzed. The results of the study may reveal whether or not the perioperative adverse cardiovascular events in diabetic patients are correlated with degeneration of peripheral sensory nerves and the alterations in the neuropeptides and TRPV1 are potentially applicable for evaluation of the risk of cardiovascular events in perioperative period in diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* The main discharge diagnosis is T2DM；
* Age \> 18 years old;
* No acute complications of diabetes

Exclusion Criteria:

* T1DM patients;
* EGFR \< 60 ml/min/1.73 m or proteinuria (or both);
* Patients with history of acute cardiovascular events;
* Familial hypercholesterolemia or other hereditary lipid metabolism diseases;
* anti-HIV patients;
* Patients with serious mental health problems;
* Patients receiving drugs that can lead to dyslipidemia, such as antipsychotics, corticosteroids, or immunosuppressants;
* Patients with systemic inflammatory diseases, such as systemic lupus erythematosus;
* Patient are quitting smoking and severe obesity (BMI\>40)
Safety of Trypan Blue on Endothelium of Diabetic Retinopathy Patients

This study examines the use of Trypan Blue staining of the corneal endothelium in patients undergoing phacoemulsification. It is a single-center prospective, randomized individual cohort study. One eye in each patient with diabetic retinopathy will undergo phacoemulsification without Trypan Blue capsule staining (control eye) while the other eye will undergo phacoemulsification with Trypan Blue capsule staining (study eye). Both eyes will undergo intraocular lens implantation. Preoperative and four-week postoperative quantitative and qualitative morphometric endothelial cell analyses of the cornea will be performed using noncontact specular microscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with bilateral cataract and diabetic retinopathy

Exclusion Criteria:

* History of ocular surgery Active
* ocular inflammation Corneal opacities
* Pseudoexfoliation syndrome
* Anterior chamber flare and (or) other signs of possibly altered blood - queous barrier
* Iris neovascularization (rubeosis)
* Uncontrolled glaucoma
* Congenital or traumatic cataracts
* History or present chronic use of topical or systemic steroids
* Poor papillary dilatation (\<6 mm)
* Specular microscopy cell density \< 2000 cell/mm2
* Patients who experienced complications fromphacoemulsification
Split-mouth Study of a New Flowable Composite in Non-carious Cervical Lesions

The overall objective of this clinical investigation is to evaluate the clinical safety and performance of the new flowable composite TM Flow for treatment of non-carious cervical lesions. Each participant receives two different fillings (test- and control material) in two different teeth. The fillings are assessed according to selected FDI criteria at baseline (7-10 days after filling placement) and after 1, 6, 12, 24, 36 and 60 months.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent signed by the subject
* Age: 18-65 years
* 2 NCCL needing treatment, comparable in extend and size, preferably located in different quadrants
* Vital teeth, regular sensitivity
* Sufficient language skills
* No active periodontitis
* Preoperative VAS values \< 3 regarding tooth sensitivity on biting. Tooth sensitivity on temperature or touching (tooth brushing, probing) originating in the area of the NCCL is accepted.
* Subject wishes to have a restoration as part of the study (written declaration of consent after detailed explanation)

Exclusion Criteria:

* Not completed hygiene phase or poor oral hygiene
* Sufficient isolation of the cavity not possible
* Patients with a proven allergy to one of the ingredients (methacrylates)
* Patients with severe systemic diseases
* Periodontally insufficient dentition
* Pregnancy
* Part of the development project team of TM Flow
* Staff of the study management team
* Staff of the internal clinic
The Success of Labor Induction Based on a Modified BISHOP Score.

Pregnant women at term will be divided randomly into 3 groups:

1. Gynecological evaluation based on classic BISHOP score.
2. Gynecological evaluation based on a modified BISHOP score.
3. Gynecological evaluation based on cervical length as measured by transvaginal sonography.

After gynecological evaluation, women will undergo induction of labor based on obstetric evaluation according to the group they were part of.

Women presenting to the obstetric emergency room for follow-up for various obstetric/other medical conditions over 37 weeks' gestation that are candidates for labor induction will receive an explanation regarding the study and sign informed consent.

The women will be divided randomly into 3 groups:

1. Gynecological evaluation based on classic BISHOP score.
2. Gynecological evaluation based on a modified BISHOP score.
3. Gynecological evaluation based on cervical length as measured by transvaginal sonography.

After gynecological evaluation, women will undergo induction of labor based on obstetric evaluation according to the group they were part of.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies.
* Candidates for vaginal delivery.

Exclusion Criteria:

* Multiple pregnancies.
* Candidates for cesarean section.