cyrilzakka/clinical-trials huggingface dataset:
The Effect of Diclofenac Potassium Insitu Gel Vs Calcium Hydroxide as Intra-canal Medications on Post-operative Pain and Anti-bacterial Effect

The aim of this study is to clinically compare the post-operative pain level and antibacterial effect when using the Diclofenac Potassium Insitu gel versus calcium hydroxide as an intra- canal medication in patients with apical periodontitis.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-45 years old.
* Males/Females.
* Lower permanent premolars with: Non-Vital pulps. Sensitive to percussion. Negative response to cold pulp tester (ethyl chloride spray1). Apical periodontitis
* Systemically healthy patients (ASA I or II).

Exclusion Criteria:

* Medically compromised patients having significant systemic disorders. (ASA III or IV).

  * History of intolerance to NSAIDS.
  * Patients with two or more adjacent teeth requiring endodontic treatment.
  * Teeth with :
* Association with swelling or fistulous tract.
* Acute or chronic peri-apical abscess. Mobility Grade II or III.
* Pocket depth more than 5mm.
* Previous root canal therapy.
* Non-restorability
* Patients with a contraindication for the use of DFK or those known to be allergic to any of the study medications.eg. Patient with kidney problems.
18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder

The goal of this project is to understand what causes bipolar disorder and how medications treat bipolar depression. Particularly, the project focuses on the importance of dopamine signaling in the process. Participants will have two different brain scans (MRI and PET scan). They will also have treatment for your depression with an FDA approved medication, lurasidone (Latuda). The study is funded by the Columbia University Irving Institute to improve the treatment of bipolar disorder.


Eligibility Criteria:
Inclusion Criteria:

* Bipolar I disorder, bipolar II disorder or other specified bipolar disorder
* Currently in a major depressive episode and moderately depressed
* Age 18-50 years old
* Patients on psychiatric medications will not be benefitting from those medications
* Females of childbearing potential must be willing to use an acceptable form of birth control throughout the study

Exclusion Criteria:

* Diagnosis of schizophrenia or other psychotic disorders, recent alcohol or substance use disorder, recent anorexia or bulimia nervosa
* Previous failed trial of lurasidone, or had intolerable side effects of lurasidone
* Significant active physical illness
* Actively suicidal
* ECT within the past 6 months
* Recent pregnancy, abortion or miscarriage or plans to conceive during the study; currently lactating
* Metal in the body that is not MRI compatible
* Current, past or anticipated exposure to radiation
* Currently taking an anticoagulant medication
Intraoperative Celiac Plexus Neurolysis for Patients With Operable Pancreatic and Periampullary Cancer

Determine if the addition of an intraoperative ethanol celiac plexus neurolysis (alcohol block) in patients undergoing surgical intervention for pancreatic cancer will result in a decrease in cancer associated pain

Pancreatic adenocarcinoma is the fourth leading cause of cancer related death in the United States and is usually fatal. Surgery provides the only chance for long-term survival. Pain is a significant, often difficult to control component of survivorship for many who succumb to this disease. The purpose of this trial is to evaluate the effect of ethanol celiac plexus neurolysis (alcohol nerve block) in patients undergoing surgical intervention for pancreatic cancer. Patients undergoing surgery for pancreatic cancer will be enrolled in a prospective randomized double blind placebo controlled clinical trial.

This protocol is designed to definitively determine the role of ethanol celiac plexus neurolysis as a simple addition to the surgical management of pancreatic adenocarcinoma and help define the standard of care for cancer associated pain management in this disease.

Eligibility Criteria:
Inclusion Criteria:

* Preoperative imaging indicates possibility of resectable pancreatic cancer
* Intraoperative biopsy histologically confirming pancreatic adenocarcinoma

Exclusion Criteria:

-
Glucose Regulation During Risperidone and Olanzapine Treatment

The overall purpose of this research is to look at how two of the most commonly prescribed newer antipsychotic medications, risperidone and olanzapine, affect substances in the body such as glucose and insulin. Undesirable changes in blood sugar control, or glucose regulation, and type 2 diabetes can occur more commonly in individuals with schizophrenia compared to healthy subjects and subjects with other psychiatric conditions. While abnormalities in glucose regulation were first reported in schizophrenia before the introduction of antipsychotic medications, antipsychotic treatment may contribute significantly to abnormalities in glucose regulation. Attention to the way that antipsychotic medications may affect glucose regulation has increased as doctors have become more concerned in general about disease- and drug-related medical complications, including weight gain during antipsychotic treatment.

This study will include 70 patients diagnosed with schizophrenia, taking either risperidone, olanzapine or haloperidol, and 20 healthy control subjects. Each subject will undergo a 4 hour glucose tolerance test. In addition, there will be a small project within the overall study to measure the effects of risperidone and olanzapine on glucose regulation as the individuals switch from their prior treatment with a conventional antipsychotic medication to either risperidone or olanzapine. Ten subjects will be studied on a typical neuroleptic at baseline then switched over a one week period to risperidone or olanzapine. The participants will be evaluated at 1 week, 4 weeks, and 12 weeks, prospectively. Each evaluation will consist of a 4 hour glucose tolerance test.

Eligibility Criteria:
Inclusion Criteria:

* meet DSM-IV criteria for schizophrenia, any type, or schizoaffective disorder;
* able to give informed consent;
* no medication changes for 2 weeks prior to and during the period of study;
* currently taking olanzapine, risperidone, haloperidol or another typical antipsychotic
Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fasting Conditions

The purpose of this study is to assess the bioequivalence of Naproxen sodium 220 mg + Pseudoephedrine Hydrochloride 120 mg Extended Release tablets of with Aleve Cold and Sinus in healthy adult human subjects, under fasting conditions.

Open randomized, two treatment, two period, two sequence, single dose, crossover study of 26 healthy human adult subjects under fasting conditions with a washout period of 14 days.

Eligibility Criteria:
Inclusion Criteria:

Subjects must fulfill all of the following criteria to be considered for inclusion into this study:

* Subjects will provide written informed consent.
* Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg.
* Subjects must be within ±15% of ideal body weight in relation to height according to Life Insurance Corporation of India height-weight chart for non- medical cases.
* Subjects must be of normal health as determined by medical history and physical examination performed within 21 days prior to the commencement of the study.
* Have normal ECG, X-ray and vital signs.
* Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.

If subject is a female volunteer and

* Is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies. diaphragm,intrauterine device (IUD), or abstinence.
* Is postmenopausal for at least 1 year.
* Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject.

Exclusion Criteria:

The subjects will be excluded under following conditions:

History or presence of significant:

* Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine,immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
* Alcohol dependence, alcohol abuse or drug abuse within past one year.
* Moderate to heavy smoking (\>10 cigarettes/day) or consumption of tobacco products.
* Asthma, urticaria or other allergic type reactions after taking any medication.

Subjects who through completion of the study, would have donated in excess of

* 500 ml of blood in 14 days, or
* 500 - 800ml of blood in 14 days (unless approved by the Principal Investigator)
* 1000 ml of blood in 90 days
* 1250 ml of blood in 120 days
* 1500 ml of blood in 180 days
* 2000 ml of blood in 270 days
* 2500 ml of blood in 1 year Subjects who have participated in another clinical trial within 3 months of study start.

Subjects who have:

* Systolic blood pressure less than 90 mm of Hg and higher than 150 mm of Hg
* Diastolic blood pressure less than 60 mm of Hg and more than 95 mm of Hg. Minor deviations (1-3 mm Hg) at check-in may be acceptable at the discretion of the physician/investigator.
* Pulse rate below 50/min. and above 105/min. Female volunteers demonstrating a positive pregnancy screen or currently breast-feeding.
The Relationship Between The Stomatognathic System, Spine Posture And Pelvic Symmetry

This study was planned to examine the relationship between the stomatognathic system, spine posture and pelvis symmetry. 91 healthy adolescence were included in the study. For stomatognathic system, temporomandibular range of motion with millimeter ruler, cervical joint range of motion and craniovertebral angle measurement with goniometer, tragus-wall distance measurement with tape measure, kyphosis and lordosis angle measurement with Baseline Bubble Inclinometer®, trunk rotation angle scoliometer for scoliosis, lower extremity length measurements for pelvis symmetry were made using a tape measure.


Eligibility Criteria:
Inclusion Criteria:

* No known neurological, rheumatological, musculoskeletal problems
* Has no visual or hearing impairment
* Ability to adapt to the parameters to be applied in the study
* Ability to perform tests to be applied
* Consists of voluntary adolescent individuals whose families gave permission to participate in the study.

Exclusion Criteria:

* Receiving joint sounds in the form of clicks or crepitations from the TMJ during mouth opening and closing or chewing
* Passion and tenderness in the TMJ on palpation
* Having a tumor Having received orthodontic treatment in the last 3 years
* Having a history of head, neck and maxillofacial surgery
The PROMISE Survey

The PROMISE Survey was developed to systematically assess the real-world experiences, treatment preferences, side effects, and outcomes from both patients and physicians dealing with prolactinomas. The aim is to generate insights that can guide future clinical research and improve individualized care strategies.

Background

Prolactinomas are the most common hormone-producing pituitary tumors, causing symptoms like menstrual irregularities, infertility, galactorrhea, and reduced libido due to elevated prolactin levels. The standard treatment involves dopamine agonists (DAs) such as cabergoline or bromocriptine, which are usually effective. However, many patients report side effects (e.g., nausea, dizziness, psychiatric symptoms), leading to challenges in long-term adherence and uncertainty about outcomes after discontinuing therapy. Surgical treatment has emerged as a potentially safe and effective alternative, especially for selected patients, but perspectives from both patients and physicians on treatment preferences and outcomes are not well studied.

The survey is designed to be completed in 5-10 minutes, fostering high participation across diverse patient and physician populations. Data are collected anonymous covers the following areas:

1. Patient Characteristics
2. DA Therapy
3. Surgical Treatment
4. Diagnostic Pathway
5. Treatment Side Effects \& Recurrence
6. Quality of Life and Psychosocial Impact
7. Physician Perspectives
8. Knowledge Gaps
9. Hypothesis Generation

Outcome

The collected data will inform:

* Better understanding of real-world management and challenges in prolactinoma care.
* Insights for improving clinical guidelines, patient education, and treatment decision-making.
* Hypotheses for future studies comparing outcomes of DA therapy vs. surgery and optimizing long-term management strategies.

Eligibility Criteria:
Inclusion Criteria:

* Prolactinoma patients
* Prolactinoma treating physicians including endocrinologists and neurosurgeons
Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity

This is a phase 3 open-label, clinical study to evaluate the efficacy, safety and tolerability of setmelanotide over 1 year of treatment, in pediatric participants aged 2 to \<6 years with obesity due to either biallelic variants of the pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) genes or Bardet-Biedl Syndrome (BBS).

Pediatric participants aged 2 to \<6 years with obesity due to either biallelic variants of the POMC, PCSK1 or LEPR genes or BBS will be enrolled into this phase 3 open-label clinical trial at one of approximately 8 clinical centers in North America, Europe, or Australia. All participants will be assigned to receive setmelanotide via daily subcutaneous (SC) injection for 1 year.

Eligibility Criteria:
Key Inclusion Criteria:

1. Participants must have obesity due to either:

   1. POMC, PCSK1, or LEPR deficiency, confirmed by genetic testing demonstrating biallelic variants that are interpreted as pathogenic, likely pathogenic, or of undetermined significance (VUS) by the American College of Medical Genetics and Genomics criteria (ACMG), or
   2. BBS confirmed clinical and genetic diagnosis
2. Age between 2 to \<6 years at the time of informed consent
3. Obesity, defined as body mass index (BMI) ≥97th percentile for age and gender and body weight of at least 15 kilograms (kg) at the time of enrollment.
4. Symptoms or behaviors of hyperphagia
5. Parent or guardian of study participant is able to understand and comply with the requirements of the study (including QD injection regimen and all other study procedures) and is able to understand and sign the written consent/assent.

Key Exclusion Criteria

1. Glycated hemoglobin (HbA1c) \>9.0% at screening
2. History of significant liver disease
3. Glomerular filtration rate (GFR) \<60 milliliter per minute per 1.73 meter square (mL/min/1.73 m\^2)
4. History or close family history of melanoma, or participant history of oculocutaneous albinism.
5. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)
6. Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing.
7. Previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide.
8. Significant hypersensitivity to any excipient in the study drug.
9. Inadequate hepatic function
10. Any other uncontrolled endocrine, metabolic or medical condition(s) known to impact body weight

Other protocol defined Inclusion/Exclusion criteria may apply.
Pulsed Electromagnetic Therapy Versus Whole Body Vibration on Quadriceps Strength Post Burn

The purpose of the study is to evaluate which is more effective pulsed electromagnetic field therapy or whole-body vibration on quadriceps strength after chronic burn

Severe burn is associated with excessive muscle wasting and atrophy. Muscle wasting is defined as unintentional weight loss of 5%- 10% of muscle mass, and severely burned patients are reported to lose up to 25% of total body mass acutely. (Dirks et al., 2016). These are worsened by deconditioning (eg, prolonged bed rest, immobilization, and inactivity). (Baker et al., 2007).

Furthermore, the need of this study is developed from the lack in the quantitative knowledge and information in the published studies about the effect of pulsed electromagnetic field therapy and whole-body vibration on quadriceps strength after chronic burn.

This study will be designed to provide a guideline about the effect of pulsed electromagnetic field therapy and whole-body vibration on quadriceps strength after chronic burn

Eligibility Criteria:
Inclusion Criteria:

1. Both sex.
2. Their ages will be ranged from 25 to 40 years.
3. Have second degree burn of 10 % to 25 %.
4. Their body mass index (BMI) will not exceed 34.9 Kg/m2.
5. All patients will be clinically and medically stable when attending the study.

Exclusion Criteria:

1. Unstable cardiovascular problems like arrhythmia and heart failure.
2. Diabetes mellitus.
3. Chronic chest disease.
4. Patients on medications affecting muscle power as steroids.
5. Auditory and visual problems.
6. Pregnancy \& lactation.
7. Patients with history of epilepsy.
8. Clinically significant peripheral vascular disease.
9. Musculoskeletal or neurological limitation to physical exercise.
10. Any cognitive impairment that interferes with prescribed exercise procedures.
11. Amputation of lower limb.
Children With Fever and Respiratory Symptoms at Out-of-hours Services in Norway

Viral self-limiting infections in respiratory organs among children are common in primary care. Serious infections have low prevalence and are challenging to distinguish from self-limiting infections.

Prescription of antibiotics in primary care is still high but stable since 2009 in Norway, and 90% of all antibiotics are prescribed in primary care.

C-reactive protein (CRP) has been especially popular in Norway for point-of-care testing in primary care, but its role in ruling-out serious infections and the cut-off value for prescribing antibiotics has been discussed a lot.

The aim of this study is to identify if pretesting with CRP of all children 0-6 year with fever or respiratory symptoms at Out-of-Hours Services will affect the prescription of antibiotics and the referral to hospital for children.

Design: A randomized controlled observational study including children 0-6 year with fever and/or respiratory symptoms at 4 different Out-of-hour Services and at 1 Emergency Children Department Clinic at a hospital (open clinic). The data consist of clinical data and anamnestic information from a nurse at OOH-service collected before the consultation, the doctor's journal and a questionnaire to parents before the consultation and 1 week after the consultation.

Eligibility Criteria:
Inclusion Criteria:

* Children 0-6 years with fever and/or respiratory symptoms

Exclusion Criteria:

* Children older than 6 years with other conditions
MItral Regurgitation Risk Assessment and CLinical ModElling

Mitral regurgitation (MR) is a common valvular heart disease worldwide, and untreated severe MR is associated with an elevated risk of heart failure and mortality. According to causes, MR could be divided into primary or secondary MR. The risk factors of mortality or heart failure hospitalization in different types of MR patients are under intensive investigation.

MItral Regurgitation risk Assessment and CLinical modElling (MIRACLE) study is a prospective cohort study including adult patients diagnosed with ≥ moderate MR during hospitalization. We aim to evaluate the prognostic risk factors of patients with MR and construct a prognostic clinical model to guide clinical decision-making.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with ≥ moderate mitral regurgitation during hospitalization.
* Aged over 18 yrs.

Exclusion Criteria:

* Patients unable to provide written consent.
A Study of LY3079514 in Healthy Participants

The main purpose of this study is to evaluate the safety and how well the body will handle a single dose of study drug, LY3079514. This study will last about 12 weeks for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy participants as determined by medical history and physical examination
* To qualify as Japanese for the purpose of this study, the Japanese participant must be first-generation Japanese
* Have a body mass index (BMI) between 18.5 and 32.0 kilograms per square meter (kg/m\^2) and have a minimum body weight of 50 kilograms (kg), inclusive at screening
* Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

Exclusion Criteria:

* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have an abnormal blood pressure that is considered to be clinically significant, as determined by the investigator
* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
* Have known or ongoing psychiatric disorders
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Show evidence of hepatitis C and/or positive hepatitis C antibody
* Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Evaluation of the Global Auditory Nerve Activity for Exploration of Hearing in Humans

To date, all the electrophysiological methods for auditory testing rely on the measure on synchronous evoked auditory nerve activity. This measure only takes into account the response of the first action potential in every auditory fibber, but provides no information about the neural response during a sustained activity. This can explain why in experimental models, a loss of more of 80% of auditory nerve fibbers cannot be detected by usual electrophysiological measurements. In this study we aim at investigating the global spontaneous and sound evoked auditory nerve activity by recording directly the electrical field by an electrode placed directly on the auditory nerve of subjects during a skull base surgical procedure. We expected to demonstrated differences in the electrical activity between subjects with or without hearing loss.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 80 years ( inclusive borders)
* patient having to undergo surgery at the level of the ponto-cerebellar angle (microvascular decompression, vestibular neurotomy, tumor resection of the meningioma type or schwannoma) and
* Unaffected by neuro-sensory hearing loss, defined by mean auditory thresholds of less than 20 dB in tone audiometry in bone conduction on the side of the ear to be operated (N = 15, Group 1) or
* Showing mild to moderate hearing loss defined by average hearing loss (average of 500, 1000, 2000 and 4000 Hz thresholds) greater than 20 dB and less than 55 dB in air conduction threshold tone audiometry (N = 15 Group 2).
* Voluntary subjects to participate in the study,
* Subjects having signed written consent to participate in the study,
* Easily accessible topics.

Exclusion Criteria:

* Subjects unable to understand the nature and goals of the study and / or having difficulty communicating with the investigator,
* Subjects refusing to participate, subjects whose free and informed consent has not been sought, subjects for which a consent form has not been signed,
* Subjects for whom there is a contraindication to general anesthesia,
* Subjects with a central neurological pathology that can disrupt electrophysiological recordings
* Not affiliated to a French social security scheme or not benefiting from such a scheme,
* Majors protected by law,
* Pregnant women,
* deprived of liberty by judicial or administrative decision,
* Infectious or inflammatory pathology of the middle ear.