cyrilzakka/clinical-trials huggingface dataset:
Ethyl Chloride Versus 5% Lidocaine for Topical Anesthesia of Oral Mucosa

Local anesthesia in the oral cavity is a pain full experience for the patient. All means should be made to reduce the pain and anxiety of the patient for needle stick procedures. My study aims in elevating the pain experienced by the patient during this procedure by using either cold application with ethyl chloride or 5% lidocaine gel.

Local anesthetic procedure is always a dreadful experience for the patient specially for the patients who are already in pain . It is a job of the dentist to provide a painless dental treatment from the very beginning. Most dental procedures require administration of local anesthesia for a painless procedure with local anesthesia procedure being painful itself with the administration of needle in the oral cavity. Dentist everyday in their practice utilise various techniques and procedures in alleviating this painful experience with either application of lidocaine gel or spray . Numbing the oral mucosa with cold application is well documented and tested therefore my study aims in application of ethyl chloride spray on cotton pallet for a duration of 30 seconds in producing the desired numbing effect of the oral mucosa before infiltration of local anesthesia in alleviating the needle prick sensation perceived by the patient.

Pain level is assigned to one of four categorical scores using visual analogue scale

1. :None(0)
2. : Mild (1-3)
3. : Moderate (4-6)
4. : Severe (7-10)

Eligibility Criteria:
Inclusion Criteria:

* No medical history
* No age restrictions
* Patients suffering from Symptomatic Irreversible Pulpitis requiring buccal infiltration

Exclusion Criteria:

* Patients having any medical conditions considered to affect patient safety or the quality of the study
* if they had any known hypersensitivity to local anaesthetics of amide type or any of the other contents in the substance used
A Clinical Trial to Evaluate the Efficacy and Safety of MXP22 on Liver Health

A randomized, double blind, placebo controlled clinical trial to evaluate the efficacy and safety of MXP22 on liver health


Eligibility Criteria:
Inclusion Criteria:

1. Adult men and women aged more than equal to 30 and less than or equal to 60 years, diagnosed with NAFLD within last 2 years.
2. CAP scores more than equal to 248 and less than or equal to 270 dB/m indicating steatosis grade I/ II.
3. Non-alcoholics (little or no consumption of alcohol).
4. Willing to participate in the study with a signed and dated written consent.
5. Overweight and obese participant with BMI more than or equal to 25 kg/m2.
6. Having at least 3 of the following five metabolic risk factors:

i Waist circumference: Men: more than or equal to102 cm (40.15 inches); Women more than or equal to 88 cm (34.65 inches).

ii Triglycerides \>150 mg/dL. iii Blood pressure more than or equal to 130 mm Hg (systolic, SBP) and/or more than or equal to 85 mm Hg (diastolic, DBP).

iv Fasting blood glucose more than or equal to 100 mg/ dl. v Low HDL level: Men: \< 40 mg/dL; Women: \< 50 mg/dL.

Exclusion Criteria:

1. Treatment of NAFLD for at least 3 months prior to the screening.
2. History of decompensated liver disease (ascites, encephalopathy, variceal bleeding).
3. Participants with liver cirrhosis, any concomitant liver disease.
4. Participants with systemic inflammatory disease or autoimmune disorders.
5. Participants with blood pressure Less than or equal to 160 mm Hg (systolic, SBP) and/or less than or equal to 95 mm Hg (diastolic, DBP).
6. Participants with Fasting blood glucose Less than or equal to 140 mg/ dl.
7. Participants with cardiopulmonary disease.
8. Heavy alcohol drinkers defined as follows:

   i For men, consuming more than 4 drinks on any day or more than 14 drinks/week ii For women, consuming more than 3 drinks on any day or more than 7 drinks/week
9. Participants with liver cancer - primary hepatocellular carcinoma or liver metastasis.
10. Participants with other systemic disorders of the heart, lungs, blood, and endocrine system, including thyroid dysfunction and Type I diabetes mellitus.
11. Histologic evidence of NASH with fibrosis stage (METAVIR score) F1 or F4.
12. Individuals with Inflammatory bowel diseases.
13. Use of medications containing systemic steroids, methotrexate corticosteroids, amiodarone, tamoxifen, valproate, vitamin E, omega-3, Anti-retroviral agents; 1 month prior to screening.
14. Intake of probiotics (lactic acid bacteria, etc.), prebiotics (dietary fiber, fructooligo saccharide, etc.), new biotics, fermented milk and proton pump inhibitor within one month before screening or during the study period.
15. Participants who have hypersensitivity to the test drug/ placebo or components contained in the test drug/placebo or have severe allergic reactions.
16. Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
17. Regular use of a probiotic or prebiotic supplement within 3 months prior to screening.
18. Antibiotic use within 3 weeks prior to screening.
Validity and Reliability of a New Mobile Application

In this study, we aimed to study the validity and reliability of the Angle Meter, a Smartphone application for elbow joint position sense.

The validity and reliability of the elbow joint position sense with the mobile application will be evaluated with the angle meter. This application works on phones with the IOS operating system. The validity and reliability of the Angle Meter will be evaluated by comparing it with a small universal goniometer for measuring elbow range of motion. The elbows of healthy subjects will be photographed at 3 different angles in the open and kinetic chain position. The elbow photo of healthy individuals measured with the Angle meter will be evaluated simultaneously but independently with the Angle meter by 2 different evaluators. The measurements will be repeated after 3 days. It will be noted that each picture is sufficient, i.e. there is no obvious perspective error.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-25
* Being healthy
* Agreeing to participate in the study

Exclusion Criteria:

* Those who have had upper extremity surgery within the last year
* Those with neurological, orthopedic, rheumatic or cardiovascular problems affecting the neck, shoulder, elbow, hand and wrist
* Those with central and peripheral nervous system involvement Having pain anywhere in the body
Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine

Primary Objective:

To demonstrate significant reduction in postprandial plasma glucose (ΔAUC0:30-4:30h) after a standardized breakfast from baseline to Day 29.

Secondary Objectives:

To demonstrate:

* Changes from baseline to Day 29 in maximum postprandial plasma glucose excursion, C-peptide and glucagon levels after a standardized breakfast
* Delaying gastric emptying (13C-acetic acid breath test)
* Safety and tolerability

The duration per patient could be minimum of 38 to 47 days depending on screening visit and post-treatment observation allowances.

13C-acetic acid breath test will be conducted only in investigational site which can be implemented (about 40 patients).

Eligibility Criteria:
Inclusion criteria:

* Type 2 diabetes mellitus, treated with Lantus±SU; ≥5-year after diagnosis
* Aged 20-75 years
* Hemoglobin A1C ≥7.0%-≤10.0%
* Fasting plasma glucose ≤180 mg/dL at screening
* Stable treatment (±20%) with Lantus for 3 months or more prior to screening.
* Sulfonylurea dose stable for 3 months or more prior to screening

Exclusion criteria:

* Type 1 diabetes mellitus
* Pregnancy or lactation
* Hypersensitivity to Lixisenatide
* Severely uncontrolled glycemic situation
* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery or inflammatory bowel disease
* History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening
* History within the previous 6 months of myocardial infarction, stroke or heart failure requiring hospitalization or drug or alcohol abuse
* Uncontrolled/inadequately controlled hypertension at the time of screening, with a resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>95 mmHg
* Amylase and/or lipase \>3 times or aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (ALP) \>2 times the upper limit of the normal laboratory range
* End-stage renal disease and/or dialysis and clinically relevant history of gastrointestinal disease

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Intervention to Prevent Mental Health Disorders of Women and Their Partners Who Experienced Pregnancy Loss

The goal of this clinical trial is to test impact of a multiprofessional intervention in mothers and partners who suffer a pregnancy loss. The main questions it aims to answer are:

* impact on mothers and partners mental heatlht status
* reasons why mothers do not consent to the intervention

Participants will:

* mothers and partners will complete 4 scales
* mothers and partners will participate in a interview

Researchers will compare with mothers with standard care to see if the multiprofessional intervention has an impact.

Objective 1: Evaluate the effectiveness of the multi professional intervention to reduce the intensity of grief, depression, anxiety and PTSD symptoms in women and their partners after pregnancy loss.

Objective 2: Assess the extent to which the multiprofessional intervention was implemented as intended (fidelity) and understand how the intervention becomes integrated into routine healthcare practice (implementation).

Eligibility Criteria:
Inclusion Criteria:

* Women and their partners who suffer a pregnancy loss
* Health professionals who have worked for at least 1 year in the hospital studied

Exclusion Criteria:

* Participants who do not understand spanish/catalan
The Effect of Levonorgestrel Intrauterine System in Preventing Endometrial Polyps Recurrence

The goal of this clinical trial is to determine whether the LNG-IUS is more effective to that of expectant in preventing endometrial polyp recurrence after hysteroscopic polypectomy.

Researchers will compare LNG-IUS to expectant management to see if LNG-IUS works to reduce the recurrence rate of endometrial polyps.

Participants will:

Receive Mirena placement or not after hysteroscopic polypectomy； Be scheduled for a follow-up with TVCD to screen for endometrial polyps recurrence every 6 months.


Eligibility Criteria:
Inclusion Criteria:

1. （1）Women age 20 to 48 years old;
2. （2）Previous history of endometrial polypectomy;
3. （3）Postoperative pathology confirmed endometrial polyps；
4. （4）Women without fertility desire within 2 years；
5. （5）Signed informed consent.

Exclusion Criteria:

1. （1）Contraindications for a hysteroscopic polypectomy or LNG-IUS or not willing to receive this type surgery；
2. （2）Women who have a positive pregnancy test；
3. （3）A I and II type submucosal uterine leiomyoma, congenital uterine malformation, atypical endometrial polyps, a (suspected) malignancy, atypical endometrial cells, reproductive tract infections；
4. （4）Postoperative pathology confirmed non-endometrial polyps；
5. （5）Postoperative pathology confirmed endometrial proliferative diseases which need hormone drug therapy after surgery；
6. （6）Treatment with hormonal three months before surgery；
7. （7）The uterine cavity is more than 10 cm deep；
8. （8）Women with severe diseases；
9. （9）Women who were enrolled in another clinical study that could potentially impact the objectives of this study prior to their initial visit were excluded.
10. （10）Unable to cooperate with the study procedures for various reasons, such as language comprehension difficulties, mental illness, inability to travel to the study center, or poor compliance.
Effects of a Whole Grain Cereal Product on Blood Glucose Response After 3 Consecutive Meals

In this pilot study it will be investigated if a whole grain product will improve the glucose response not only when it is eaten at breakfast, but also at the two following meals; lunch and dinner (2nd and 3rd meal effect) in a healthy population.


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female, 35 to 65 years of age
2. BMI 22-29 (±0.5) kg/m2
3. Agree to maintain consistent dietary habits and physical activity levels for the duration of the study.
4. Healthy as determined by medical history and information provided by the volunteer.
5. Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits.
6. Has given voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

1. Elevated fasting blood glucose (above 6.1 mmol/L at fasting on visit 1 or 2)
2. Women who are pregnant or breast feeding
3. Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI
4. Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the QI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless other is recommended by their physician.
5. Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
6. Use of antibiotics within 2 weeks of enrollment
7. Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
8. Allergy to ingredients included in investigational product, placebo, or standardized meal
9. Participants restricted to a vegetarian or vegan diet
10. Intolerance to gluten
11. Individuals who are averse to capillary blood sampling
12. Currently active smokers (or using other tobacco products, and e-cigarettes)
13. Unstable medical conditions as determined by QI
14. Participation in other clinical research trials
15. Individuals who are cognitively impaired and/or who are unable to give informed consent
16. Acute infection
17. Any other condition which in the QI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual
The Effect of Cherry Seed Pillow on Fibromyalgia

In this study, the effects of 4-week Cherry seed pillow application on pain and quality of life in individuals diagnosed with fibromyalgia will be examined.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Diagnosis of Fibromyalgia according to ACR classification criteria
* Neuromuscular system examination is normal
* Pain (vas-visual anologous scale) level of at least 5 points
* No communication problems
* Willingness to participate in the practice of using cherry seed cushion
* To be capable of answering the data collection tools to be used in the research
* Not having made hot, cold etc. applications at home

Exclusion Criteria:

* -No diagnosis of Fibromyalgia according to ACR classification criteria
* Normal examination of the neuromuscular system
* Pain (vas-visual anologous scale) level between 0-5
* Communication problems
* Failure to accept the practice of using cherry seed cushion and failure to finish the implementation process
* Having a musculoskeletal disorder other than fibromyalgia
* Pregnant or lactating
* To be capable of answering the data collection tools to be used in the research
* Having made hot, cold etc. applications at home
Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration

The goal of this clinical trial is to evaluate the effectiveness of transpalpebral microcurrent stimulation as a therapy for dry age-related macular degeneration.

Participants are assessed at baseline for visual acuity and treated for 4 consecutive days for a total of 8 sessions (2 per day) with microcurrent stimulation. A follow-up visit is conducted to evaluate the participant and collect follow-up visual acuity.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged at least 50 years with dry AMD in at least one eye

Exclusion Criteria:

* Eye diseases other than dry AMD
* Implanted electrical devices
* Seizure disorders
Yoga for Adolescent Knee Pain

Adolescent atraumatic anterior knee pain is a common yet cumbersome diagnosis that is currently managed with home exercises and physical therapy. The goal of this project is to present patients with an alternative treatment in the form of yoga available in an online video format. This new treatment, in the form of online yoga videos, may be more preferred for some patients and allow for higher compliance with home exercises aimed at treating anterior knee pain.

Adolescent atraumatic anterior knee pain is a common yet cumbersome diagnosis that is currently managed with home exercises and physical therapy. The goal of this project is to test the compliance and efficacy of an alternative treatment in the form of yoga available in an online video format. This study will help further the treatment understanding of one of the most common patient clinical presentations, atraumatic anterior knee pain in adolescents. This is a cumbersome patient presentation that is frustrating for both the patient and treating team in that there is no concrete treatment algorithm that works for everyone. Online yoga videos may be more preferred for some patients and allow for higher compliance with home exercises aimed at treating anterior knee pain. With this study, the investigators hope to ensure that the yoga videos provide equal, or more, pain relief and flexibility at the completion of the program.

It is hypothesized that patients completing the yoga program will have equivalent or greater flexibility, compliance, and pain relief when compared with current treatment recommendations for anterior knee pain.

This study aims to assess the success of a video-based eight-week home yoga program at improving compliance, increasing flexibility and functionality of knee movements. Compliance will be tracked through recorded access to the specific YouTube videos hosted through the CTPO YouTube Channel. Anterior knee pain patients will be given a link to two yoga videos and will be asked to do them at home, or wherever convenient for 8 weeks, 3-4 times a week.

Eligibility Criteria:
Inclusion Criteria:

* Children with non-structural anterior knee pain

Exclusion Criteria:

* Any intra-articular injuries
* No access to internet
* Non-english speaking
Role of Inflammation in Carpal Tunnel Syndrome

This study aims to investigate the role of inflammation in carpal tunnel syndrome (CTS) using a prospective cohort study design. The study will involve a sample of at least 50 individuals with CTS who will undergo a comprehensive clinical and biochemical evaluation to assess the role of inflammation in CTS. The primary outcome measures include inflammatory markers, such as C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α), as well as clinical measures of CTS severity. Data will be analyzed using regression analysis to determine the relationship between inflammation and CTS. The study is expected to provide information on the role of inflammation in CTS and inform the choice of drug and concentration for transdermal drug administration.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 years or older
* Diagnosis of carpal tunnel syndrome based on clinical symptoms and nerve conduction studies
* Willingness and ability to provide informed consent to participate in the study
* Willingness and ability to comply with study procedures and follow-up visits

Exclusion Criteria:

* Presence of other neurological conditions that may affect nerve function in the upper extremities
* Use of medications that may affect inflammation or carpal tunnel syndrome severity
* History of previous carpal tunnel release surgery on the affected wrist
* Inability to comply with study procedures or follow-up visits
* Pregnancy or breastfeeding
Lenvatinib Plus DEB-TACE and HAIC Vs. Lenvatinib Plus DEB-TACE for Large HCC with PVTT

This study is conducted to evaluate the efficacy and safety of lenvatinib plus transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (Len+DEB-TACE+HAIC) versus lenvatinib plus DEB-TACE (Len+DEB-TACE) for large hepatocellular carcinoma (\> 7cm) with portal vein tumor thrombosis (PVTT).

This is a multicenter, prospective and randomized study to evaluate the efficacy and safety of Len+DEB-TACE+HAIC compared with Len+DEB-TACE for unresectable large HCC (\>7cm) with PVTT.

178 patients with large HCC (\> 7cm) and PVTT will be enrolled in this study. The patients will receive either Len+DEB-TACE+HAIC or Len+DEB-TACE using an 1:1 randomization scheme. In the Len+DEB-TACE+HAIC arm, the microcatheter will be reserved at the main hepatic tumor-feeding artery after DEB-TACE and chemotherapy drugs (oxaliplatin, fluorouracil and leucovorin; FOLFOX-based regimen) will be intra-arterially administered though the microcatheter. DEB-TACE+HAIC treatments can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In the Len+DEB-TACE arm, patients will be treated with DEB-TACE alone. TACE treatment can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In both arms, lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd will be started within 7 days after the first DEB-TACE+HAIC/DEB-TACE.

The primary end point of this study is time to progression (TTP). The secondary endpoints are tumor response (objective response rate and disease control rate), overall survival (OS), and adverse events (AEs).

Eligibility Criteria:
Inclusion Criteria:

* a confirmed diagnosis of HCC
* the largest intrahepatic lesion \>7 cm
* presence of PVTT on imaging
* tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
* Eastern Cooperative Oncology Group performance status ≤1
* Child-Pugh class A/B
* adequate hematologic and organ function, with leukocyte count\>3.0×10\^9/L, neutrophil count\>1.5×10\^9/L, platelet count≥75×10\^9/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal
* life expectancy of at least 3 months

Exclusion Criteria:

* Diffuse HCC
* accompanied with vena cava tumor thrombus
* central nervous system involvement
* previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy
* organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment
* history of other malignancies
* uncontrollable infection
* history of HIV
* history of organ or cells transplantation
* prothrombin time prolongation \>4 s