cyrilzakka/clinical-trials huggingface dataset:
Antibacterial Effect of New Herbal Paste Used as an Intracanal Medication

studying the antibacterial effect of Cosuts paste as an intracanal medication against Enterococcus faecalis that present in necrotic primary teeth

The children were randomly divided into two groups (I, II) Group I (N=12): using Costus-based paste as an intracanal medicament. Group II (N= 12): Calcium hydroxide iodoform paste (Metapex) as an intracanal medicament.

Procedure:

Access opening was started. then a swab was taken from the distal root canal with a dry paper point and transferred to a sterile test tube. The canals were filled with an intracanal medication according to the patient group. In group I, the canals was filled with a previously prepared Costus-based paste for one week, and In Group II, the canals were filled with Meta paste for one week. After 1 week, the paste was washed away from the canals then another swab was taken from the distal canal by a dry paper point as done before preoperatively.

The 2 swabs were transferred within 2 hours to the lab for bacterial culture and detection of enterococcus faecalis count.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically and radiologically diagnosed infected primary teeth in their mandibular arch.
* Teeth should be deeply carious, with a history of spontaneous pain and carious exposures with necrotic pulp was also be selected
* radiographic evidence of adequate alveolar bone support, and absence of internal or external resorption.
* tooth must be restorable.

Exclusion Criteria:

* vital tooth
* Non restorable teeth
Pilot Study of Effect of Intravenous Lidocaine on Propofol Requirement in Facial Plastic Surgery

The purpose of this randomized pilot study is to evaluate the effect of intravenous lidocaine on propofol requirement during BIS (Bispectral index) guided MAC (monitored anesthesia care) in facial plastic surgery.

Several studies reported the usefulness of intravenous lidocaine as a coadjuvant agent during general anesthesia. We thought that there would be an interaction between intravenous lidocaine and hypnotic agent requirement. However, there is no data regarding the effect of systemic lidocaine during MAC. We, thus, would like to perform a randomized, double-blinded pilot study to evaluate the effect of intravenous lidocaine on propofol requirement during BIS guided MAC in facial plastic surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status classification 1 or 2 patients
* aged 20-65 years who were undergoing elective facial plastic surgery under monitored anesthesia care

Exclusion Criteria:

* unwillingness to participate in the study
* adverse reaction to the drugs used in the study
* use of medications that interfere in local anesthetic metabolism
* history of liver disease or kidney failure
* neurological or psychiatric disease
* history of drug or alcohol abuse
* chronic use of benzodiazepine
A Study to Evaluate the Effect of Food on LOXO-783 in Healthy Participants

The main purpose of this study is to measure how much of LOXO-783 is in the bloodstream and how the body handles and eliminates LOXO-783 when administered in fasting and fed states in healthy participants. The study will also evaluate the safety and tolerability of LOXO-783. Participation could last up to 63 days including screening period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
* Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Exclusion Criteria:

* Females who are lactating or of childbearing potential
* Clinically significant history of any drug sensitivity, drug allergy, or food allergy
MRI in BPD Subjects

The investigators are wanting to learn more about early development of the lungs and to help them better understand prematurity and the development of a breathing disorder call BPD (Bronchopulmonary Dysplasia)

This is an observational case study involving up to three MRI visits. The first MRI will be complete after the infant's clinical initial evaluation. The second image will be obtained approximately 1 month later and the third MRI will be complete prior to discharge. Infants will be imaged at various ages, based up their initial evaluation. The investigators will collect urine and obtain clinically collected remnant blood around time of MRI, tracheal/endotracheal aspirate at time of the MRI when available and BAL samples as clinically available. MRI findings will be correlated with laboratory findings and outcomes from the medical record, and a research database will be built for the data. The investigators will also obtain a one-time MRI visit in non-BPD NICU patients to acquire data related to normal vasculature and pulmonary alveolar development.

Sub-study 1: Inpatient polysomnography Patients with the same inclusion/exclusion criteria as reported below will be approached for a brief inpatient polysomnogram. The population will include patients with and without BPD. The polysomnography (PSG) will be performed in the NICU within 1 week from the MRI that is obtained prior to discharge.

Eligibility Criteria:
Inclusion Criteria:

* any term age NICU patient

Exclusion Criteria:

* - ECMO,
* Evidence of congenital diseases that may affect lung development, such as congenital diaphragmatic hernia,
* Suspected muscular dystrophy or neurologic disorder that may affect lung development.
* Significant genetic or chromosomal abnormalities that may affect lung development
* Evidence of any respiratory infection at the time of imaging (imaging may be rescheduled for a common viral infection such as a cold).
* Standard MRI exclusion criteria as set forth by the CCHMC Department of Radiology. This includes any contraindications from tracheostomy tubes that are not MR compatible.
Comparison of the Effects of Whole Body Vibration Training and Aerobic Exercise on Premanstrual Syndrome

Aim: The aim of the study was to compare the effects of whole body vibration training (WBVT) and aerobic exercise on premenstrual syndrome in young women with routine dietary intake.

Methods: A prospective, randomised, pre-post-test, single-blind, controlled study was conducted in 34 women diagnosed with PMS. Participants were randomly assigned into three groups: the Aerobic Exercise Group (AEG, n=11), the Whole-Body Vibration Training Group (WBVT, n=11), and the Control Group (CG, n=12). Participants in the AEG performed 45-minute exercise sessions (10 minutes warm-up, 30 minutes walk, 5 minutes cool down) three times a week for eight weeks. The WBV program was conducted using a 25 Hz frequency and a 2 mm low amplitude on the Power Plate® (pro5TM) machine, which provides three-plane oscillatory motion. The program lasted eight weeks, with sessions held three days a week, ensuring at least one rest day between sessions. The control group was asked to continue their daily life routines. Dietary intake of all participants was monitored, and those with different diets were excluded from the study. Premenstrual Syndrome Questionnaire (PMSS) was used to evaluate PMS symptoms and Visual Analogue Scale (VAS) was used to evaluate pain.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5-25
* Score over 110 points on the PMS questionnaire
* To be between the ages of 18-35
* Sedentary women
* Having a regular menstrual cycle (24-35 days)

Exclusion Criteria:

* Diagnosed with eating disorder
* Taking nutritional supplements before the last three cycles
* DM, thyroid and liver kidney disorders
* Endocrine drug use
* Has undergone orthopedic surgery within the last 6 months
* With a neurological diagnosis
* With limited range of motion
* Diagnosed with cardiovascular and cardiopulmonary system disorders
* Diagnosed with women's health and diseases such as polycystic ovary syndrome, endometriosis
* Oral contraceptive users
* Psychiatric diagnosis
* Smoking
* Diagnosed with Amenorrhea
* Following a regular diet
* During pregnancy and lactation
Role of Tzanck Smear in Determining Pemphigus Vulgaris Disease Activity

Aim: Pemphigus vulgaris (PV) is a rare, life-threatening autoimmune bullous disease that can involve the skin and mucous membranes, characterized by intraepidermal bullae and eroded lesions caused by rupture of the bullae. The aim of this study is to research the relationship of the findings obtained with Tzanck smear, which is an inexpensive and easy method, with disease activity and its prognostic importance in the clinical course in PV patients.

Material and Methods: Pemphigus patients who visited to Goztepe Prof. Dr. Suleyman Yalcın City Hospital, Dermatology Clinic will be included in our study. Pemphigus disease area index (PDAI), Tzanck smear findings from the lesions and desmoglein levels during routine follow-up of patients with pemphigus vesicle/bulla/erosion will be evaluated. In the evaluation of Tzanck smear preparations, the entire slide will be scanned, acantholytic cell count performed and scored 1 to 4 accordingly (1 point: 1-3 cells, 2 points: 4-10 cells, 3 points:11-20, 4 points: \>21 cells or cell clusters). Anti-desmoglein antibody levels will be analyzed by using enzyme-linked immunosorbent assay (ELISA) method.


Eligibility Criteria:
Inclusion Criteria:

* Clinical, histopathological and immunological diagnosis of pemphigus vulgaris
* Must be active bullae or erosion at any stage of the disease

Exclusion Criteria:

* Patients with uncertain diagnosis of pemphigus vulgaris
* Eroded lesions due to causes other than pemphigus vulgaris (such as herpes in the oral mucosa, candida infection)
Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control

It is unknown whether surgical treatment of chronic sinusitis improves asthma control in patients with poorly controlled asthma. This is a randomized trial of surgical plus medical sinus therapy versus medical therapy alone.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria: General

  1. 18 years of age or older
  2. Women need one of the following: negative pregnancy test or suitable birth control or post-menopausal status
  3. Informed consent and ability to comply with study procedures
  4. Patients must meet inclusion criteria for both asthma and sinus disease.

Inclusion criteria: Asthma

In order to qualify for the 6 week run-in, patients must have poorly controlled asthma as defined by the following criteria:

1. Diagnosis of asthma confirmed either by demonstrating a positive methacholine challenge test (defined as a decrease in FEV1 by at least 20%, following administration of 8mg or less of inhaled methacholine) or a positive bronchodilator response (defined as a change from base line of \>12% and at least 200ml in either FEV1 or FVC, following administration of a short-acting, inhaled bronchodilator).
2. Either:

   * Asthma Control Questionnaire score \> 1.5 or
   * Use of inhaled rescue ß-agonist \>/= 16 puffs per week (excluding use as a pre-medication for exercise; 1 nebulizer treatment = 2 puffs of inhaler) at any time during the past month or
   * \>1 hospitalization or unscheduled MD visit in the past 6 months for asthma symptoms or
   * \>1 course of oral steroid use in past 6 months or
   * \> 2 weeks of systemic steroids in last 6 months.

Exclusion Criteria:

1. Current smokers or those with at least a 10 pack-year smoking history
2. Presence of any concurrent diseases that, in the investigator's opinion, would interfere with participation in the study or that might put the participant at risk
Adaptive Optics (AO) Analysis of Retinal Arteries in Patients With Recent Stroke (STROKAO)

The eye has long been recognized as a window to pathological processes occurring in the brain. By imaging the vascular system of the retina scientific understanding and clinical practice have been improved for a wide range of pathologies from diabetes to stroke and dementia.

Adaptive optics (AO) reveals retinal details that remain invisible with other current imaging techniques. Indeed, vessels can be perfectly visualized, making it possible to detect wall irregularities, accurately measure their different structures and monitor their evolution under treatment if necessary.

In AO, studies on retinal vessels involve the calculation of wall thickness (WT), outer diameter (OD), inner diameter (ID), wall cross-sectional area (WCSA) and wall to lumen ratio (WLR). An increase in WLR \> 0.31 is characteristic of hypertensive microangiopathy and predictive of cardiovascular and brain damage. This accurate assessment of microvascular structure may even be required in the near future in all patients with arterial hypertension. For vessels \> 300 microns in diameter, the increase in vessel wall thickness occurs without changing the ID, a process known as external hypertrophic remodeling. For small arteries \< 300 microns, remodeling occurs differently. The total volume of the vessel wall remains constant, but the OD and ID each decrease, a process known as inward eutrophic remodeling.

The objective of this study is to describe the parameters measured in AO in patients in the acute phase of a stroke and then at 3 months.


Eligibility Criteria:
Inclusion Criteria:

* For the patients with stroke: Inpatients with confirmed stroke (clinical and imaging) for less than 10 days
* For the controls: Individuals presenting at the Rothschild Foundation Hospital with no history of stroke who are matched to cases already included in the matching criteria: Age ± 5 years, Gender, high blood pressure (no history, untreated, treated) Diabetes (Yes, No), Body Mass Index (BMI \< 25, 25 ≥ BMI \< 30, BMI ≥ 30)

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Insufficient state of consciousness or physical condition to perform the adaptive optics examination
* For the patients with stroke: Hemorrhagic post-traumatic hematoma stroke type, or symptomatic stroke of a brain tumour or an arteriovenous malformation.
Selective Dentine Removal in Primary Teeth

Background There is little information regarding the longevity of the restored tooth, considering the health of the pulp-dentine complex, in children who do not sufficiently cooperate with dental treatment.

Aim To evaluate the longevity of primary molar teeth with an occluso-proximal cavity that was treated with the selective removal of carious tissue.

Design A total of 150 children were allocated to two parallel groups: group 1 (G1, n = 70, control, Ketac Molar Easymix®, 3M/ESPE, Seefeld, GE) and group 2 (G2, n = 80, test, Maxxion®, FGM, Joinville, BR). The study was double-blinded, and an operator specialized in paediatric dentistry performed the selective removal of soft dentine and the restoration of the cavity with GIC. During the follow-up periods, the teeth were evaluated via periapical radiography by two trained examiners specialized in radiology. Statistical analysis was performed using Stata 11.2 software (StataCorp, Texas, USA) and a survival curve (Kaplan-Meier).


Eligibility Criteria:
Inclusion Criteria:

* An active denture caries lesion
* The molars in primary, without anterior restoration, with the exclusive involvement of occlusal and mesial or distal surfaces present (International Caries Detection and Evaluation System, ICDAS score 5)

Exclusion Criteria:

* Those who did not accept care after 3 adaptation sessions
* Teeth with the following characteristics were excluded from the study: spontaneous pain, pressure sensitivity, suspected cellulose involvement, necrosis pulp, fistula, or tooth mobility
* Teeth in which extension of the lesion could lead to pulpal exposure were excluded
* Children whose parents or guardians do not sign an Informed Consent Term
Effect and Mechanism of Jiajian Guishen Formulation on Premature Ovarian Insufficiency Based on Metabolomics

1. Identify differential metabolites in POI patients.
2. Analysis of differential metabolites and their involved mechanism pathways.


Eligibility Criteria:
Inclusion Criteria:

POI Inclusion Criteria:

1. Patients diagnosed by Western medicine with premature ovarian insufficiency;
2. Patients with Chinese medicine differentiation of kidney deficiency and liver depression;
3. 18 ≤ patients' age ≤ 39 years;
4. Patients who do not use other drugs during treatment;
5. Patients who voluntarily participate in this study, sign an informed consent form, and agree to take the corresponding treatment plan.

The above five items must be met to be included in the POI patient group in this study.

Healthy subjects inclusion criteria:

1. 18 ≤ Age≤ 39 years old;
2. menstrual regularity;
3. There is no abnormality in sex hormone and AMH examination;
4. Voluntarily participate in this research and sign the informed consent form;
5. Those who match the general information such as age, height, and weight of the patients included in POI.

Exclusion Criteria:

POI exclusion criteria:

1. Patients with congenital gonadal dysplasia or a family history similar to "early menopause";
2. POI patients with acquired organic lesions or ovarian surgery;
3. Patients who have taken Western medicine artificial cycle therapy or other endocrine therapy in the past three months;
4. Patients with serious primary diseases and mental disorders such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system;
5. Patients who are breastfeeding or pregnant;
6. Patients who are allergic to the drugs used in this study or have a history of previous allergy to traditional Chinese medicines.

Those who met any of the above 5 criteria were excluded from this study. Healthy subjects were excluded as (1), (3), (4), (5).
Phase I Study on Rivaroxaban Granules for Oral Suspension Formulation in Children

To characterize the pharmacokinetic profile of rivaroxaban administered as granules for suspension formulation and to document safety and tolerability


Eligibility Criteria:
Inclusion Criteria:

* Children with an age ≥2 months and weight between 3 and \<12 kg, who have completed anticoagulant treatment at least 10 days prior to the planned study drug administration.

  * Gestational age at birth of at least 37 weeks
  * Oral feeding/ nasogastric/ gastric feeding for at least 10 days
* Normal PT and aPTT within 10 days prior to planned study drug administration
* Written informed consent provided and, if applicable, child assent provided

Exclusion Criteria:

* Active bleeding or high risk for bleeding, contraindicating anticoagulant therapy
* Planned invasive procedures, including removal of central lines, within 24 hours before and after single dose intake
* An estimate glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2
* Hepatic disease which is associated either with:

  * coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase (ALT) \> 5x upper level of normal (ULN), or
  * total bilirubin \> 2x ULN with direct bilirubin \> 20% of the total.
* Platelet count \< 50 x 10\^9/L
* Hypertension (defined as systolic and/or diastolic blood pressure \>95th percentile for age)
* Concomitant use of strong inhibitors of both CYP3A4 and P-glycoprotein, e.g., all human immunodeficiency virus protease inhibitors and the following azoleantimycotic agents: ketoconazole, itraconazole, voriconazole, and posaconazole, if used systemically (fluconazole is allowed)
* Concomitant use of strong inducers of CYP3A4, e.g., rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
* Inability to cooperate with the study procedures
* Hypersensitivity to rivaroxaban
* Participation in a study with an investigational drug other than rivaroxaban or a medical device within 30 days prior to treatment
* History of gastrointestinal disease or surgery associated with impaired absorption
Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol

The purpose of this study is to determine if once-daily treatment with colchicine, compared to placebo, is effective in preventing gout flares in patients who are initiating therapy with allopurinol.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria include, but are not limited to the following:

1. Men and postmenopausal women between the ages of 18 and 70
2. Meets the ARA criteria for classification of acute gout
3. Tophi present and/or a history of gout attacks in 2 or 3 joints
4. Self-reported history of at least 2 gout flares in the prior 12 months
5. Serum uric acid greater than or equal to 7.5 mg/dL at the first visit

Exclusion Criteria:

Exclusion criteria include, but are not limited to the following:

1. Patients with an acute gout flare within 2 weeks prior to the first visit
2. Patients with chronic, active gout with at least 1 continuously inflamed joint for at least 4 weeks
3. Patients with more than three joints affected by gout
4. History of intolerance or allergy to colchicine or allopurinol
5. Use of allopurinol, benzbromarone, febuxostat, probenecid, or sulfinpyrazone less than 3 months prior to entering the study
6. Use of colchicine less than 14 days prior to entering the study
Effects of PS128 on Parkinsonian Symptoms

The purpose of this study is to examine the short term effects (12 Weeks) of Lactobacillus plantarum PS128 (PS128) on Parkinson's disease (PD) symptoms.

This study is designed to examine the extent to which L. plantarum PS128 can improve symptoms in PD patients. L. plantarum PS128 is a psychobiotic that regulates the level of dopamine in specific brain regions. Patients with PD will receive PS128 treatment for 12 weeks. Symptoms of PD will be clinically evaluated before and after the treatment, and the results will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Between ages of 40-80 years old
* Diagnosed as a patient with Parkinson's disease of modified Hoehn and Yahr Stage between 1 and 2.5 as rated during an "on" period

Exclusion Criteria:

* Patients on antibiotics within the preceding one month
* Patients using of other probiotic products (sachet, capsule or tablet) within the preceding two weeks
* Have current or history of inflammatory bowel disease
* Have history of cancer
* Have undergone surgery of liver, bladder, or gastrointestinal tract
* Known allergy to probiotics
* Patients with comorbid dementia (Mini-Mental State Examination score ≤ 26) or major depression (The Beck Depression Inventory-II score ≥ 29)
* Have received deep brain stimulation
* Patients receiving artificial enteral or intravenous nutrition
The Effectiveness of Advanced Decision Support Tool (OPT-IVF) for IVF Treatment

This prospective study is subject to approval of institutional medical research ethics committee. Patient undergoing second cycle IVF will be enrolled into the intervention group. Intervention involved using a clinical decision support tool, Opt-IVF to guide gonadotrophins dosing and trigger dates for a personalized controlled ovarian stimulation cycle based on the distribution of follicle sizes on day 1 and day 5, and hormone dosages given on day 1 to 4.

Patients will undergo transvaginal ultrasound exam on day 1 and day 5 of the cycle to determine the number and size of follicles present. The data is used in the Opt-IVF decision support tool to suggest Gonadotropin dosage for D5 and beyond and to recommend the antagonist start day and trigger day.

Clinical investigators will not override the Opt-IVF recommended dosage in any patients.

The total dosage of gonadotrophin, number of good quality oocytes and blastocyst will be analyzed from each arm.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing 2nd cycle of IVF

Exclusion Criteria:

* Polycystic ovarian syndrome patient