cyrilzakka/clinical-trials huggingface dataset:
Toluidine Blue Versus Frozen Sections for Assessment of Tumor Margins in Oral Squamous Cell Carcinoma

The purpose of this study is to test the accuracy of toluidine blue in the assessment of intraoperative tumor margin after excision of oral squamous cell carcinoma(OSCC)in comparison to H\&E stain on frozen section.

The incidence of oral cancer remains high, it is ranked to be the sixth most common cancer worldwide, oral squamous cell carcinoma represent more than 90% of all oral malignances.

Standard treatment for oral squamous cell carcinoma is surgical resection with free margin. Negative margin status is an important for control local recurrence and improve outcome in squamous cell carcinoma of the head and neck. Hematoxylin and Eosin (H\&E) Frozen section biopsy is useful tool for intraoperative assessment of resected margins and control of local recurrence, allowing for additional resection intraoperatively in case of positive margins. However in the least developed countries with limited resource, the frozen section is not available in a majority of centers, in addition to that if present in developed countries, it somewhat considered time and cost consumer.

Toluidine blue(TB) is metachromatic stain, easily available, economical, with high affinity for DNA and RNA. It is rapidly uptaken by malignant epithelium which contain quantitatively more nucleic acid than normal tissue. It has been widely used as screening tool for malignant and premalignant lesion.

The purpose of this study is to test the accuracy of toluidine blue in the assessment of intraoperative tumor margin after excision of oral squamous cell carcinoma(OSCC)in comparison to H\&E stain on frozen section.

Eligibility Criteria:
Inclusion Criteria:

* Patient with biopsy-proven primary oral squamous cell carcinoma undergoing primary excision.

Exclusion Criteria:

* Patients with prior history of head and neck malignancy
* Patients with non-squamous cell carcinoma.
* Patients with previously undergone treatment (surgery and/or radio-/ chemotherapy) for the current oral squamous cell carcinoma.
AMBU Bag Manual Ventilation Vs. Transport Ventilator Mechanical Ventilation for Transport

This is a clinical trial to compare the oxygenation and ventilation performance between manual ventilation and mechanical ventilation when transporting cardiac patients to the ICU.

Following cardiac surgery, patients often require ventilation during transport to the intensive care unit (ICU). Most of the time, manual ventilation using an AMBU bag (AMBU INC. MD, USA) is utilized, but some patients need mechanical ventilation due to concern for oxygenation, ventilation, and hemodynamics. The indication to choose mechanical ventilation over manual ventilation is determined on a case-by-case basis, mostly based on providers' experiences or surgical request, because currently there is no clear clinical evidence behind that. With this clinical study, the investigators intend to build up clinical evidence by comparing oxygenation, ventilation, hemodynamics, and cardiac functions between two arms: manual ventilation using AMBU bag arm and mechanical ventilation using a transport ventilator.

Objective: In this study, the investigators plan to compare the effects of transport ventilators (Hamilton C1: Bodaduz, Schweiz) and AMBU bag manual ventilation on oxygenation, ventilation, biventricular function, and hemodynamics. This is a two-arm study.

1. To assess pre and post transport PaO2/FiO2 (P/F ratio), PaCO2, biventricular function, and hemodynamics (including blood pressure, heart rate, pulmonary artery pressure and central venous pressure) in the AMBU bag and Hamilton transport ventilator groups. The investigators hypothesize that using the Hamilton transport ventilator will show a smaller change in P/F ratio, hemodynamics, and biventricular function compared to the AMBU bag group. If true, these findings would support using the Hamilton ventilator for transport in appropriate surgical patients.
2. To perform "in-vitro" flow analysis using a flow analyzer analyzer (CITREX H5:

Buchs, Schweiz) and lung simulator (SmartLung 2000: Buchs, Schweiz) to measure the accuracy of the ventilations of Hamilton C1 ventilator and AMBU bag manual ventilation on different resistance and compliance settings of the lung simulator

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old (any gender or race)
* Cardiac surgery
* Require postoperative mechanical ventilation and care in the ICU.

Exclusion Criteria:

* Patients' refusal
* Extubation in OR
* On mechanical circulatory support
* Requirement for postoperative therapy with inhaled pulmonary vasodilators (epoprostenol (FLOLAN), inhaled nitric oxide, etc.)
* Severe RV dysfunction with preoperative echocardiography
* Contraindication to TEE and pulmonary artery catheter.
Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan

The purpose of this study is to evaluate the efficacy and safety of ONO-2506PO in patients with Parkinson's Disease


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Parkinson's disease
2. Stage 2 - Stage 4 of revised Hoehn \& Yahr severity score
3. Taking L-dopa/DCI without changing dose and regimen
4. Having motor complication
5. Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

1. Previous participation in ONO-2506PO or ONO-2506 protocol
2. Previous brain surgery for Parkinson's disease
3. Presence or history of serious cardiac disease
4. Other exclusion criteria as specified in the study protocol
Dental and Periodontal Changes Following the Acceleration of Alignment of Crowded Lower Anterior Teeth Using a Surgical Technique

Patients at the Orthodontic Department of the University of Damascus Dental School will be examined and subjects who meet the inclusion criteria will be included. Then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, and radiographic images) will be studied to ensure that the selection criteria are accurately matched.

This study aims to compare two groups of patients with moderate crowding of the lower anterior teeth. Experimental group: the patients in this group will be treated with periodontally accelerated osteogenic orthodontics Control group: the patients in this group will be treated using fixed appliances without any acceleration method.

Correction of irregular teeth can take a long time, and this depends on various factors such as the good compliance of the patient, the amount of dental crowding, and the need for extraction in the course of orthodontic treatment.

Many methods have been used to accelerate tooth movement, and recently the PAOO technique has emerged as an effective therapeutic intervention.

PAOO is a promising procedure but only a few cases were reported in the literature. Controlled clinical and histological studies are needed to understand the biology of tooth movement with this procedure, the effect on teeth and bone, post-retention stability, measuring the volume of mature bone formation, and determining the status of the periodontium and roots after treatment.

Eligibility Criteria:
Inclusion Criteria:

* skeletal class I malocclusion (ANB=2-4)
* normal vertical growth pattern.
* moderate crowding of lower anterior teeth (i.e., 4-6 millimeters of a tooth size-arch length discrepancy)
* 1 to 3 mm of overjet and 1 to 4 mm of the overbite
* good oral health

Exclusion Criteria:

* medical, social, and psycho contraindications to oral surgery
* presence of periodontal diseases
* poor oral hygiene
* previous orthodontic treatment
Evaluation of the Analgesia Nociception Index With Varying Remifentanil Concentrations Under Sevoflurane

Analgesia Nociception Index（ANI）which is derived from heart rate variability can be used to detect noxious stimulation during propofol while changing remifentanil concentrations. The aim of this study is to verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination during sevoflurane while changing remifentanil concentrations.

General anesthesia with sevoflurane and remifentanil is widely used in minor surgeries. Monitoring noxious stimulation during general anesthesia is still worth further studies and reaching clinical consensus. Analgesia Nociception Index can be used to detect noxious stimulation during propofol while changing remifentanil concentrations. Previous studies suggest that an ANI≥50 can be useful in detecting sufficient analgesia for patients who cannot self-report pain. The aim of this study is to verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination during sevoflurane while changing remifentanil concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18- 65 years
* ASA physical status I or II
* Elective surgery in general anesthesia planned
* Written informed consent

Exclusion Criteria:

* Use of CNS-active medication or abuse of alcohol
* Presents of any neuromuscular or neurologic disease
* History of cardiac arrhythmia
* Pregnancy or using a pacemaker
Skin-to-Skin Contact With a Sling in Primipar Mothers Who Delivered by Cesarean Section

The first hours after birth are critical for the physiological and psychological adaptation process of the newborn from intrauterine to extrauterine life. The World Health Organization (WHO) recommends skin-to-skin contact as a routine part of care to stabilize the newborn's vital signs and strengthen the mother-infant bond. However, the rate of skin-to-skin contact in women who give birth by cesarean section is lower compared to vaginal deliveries. Considering the global increase in cesarean birth rates, it is necessary to develop appropriate and practical care methods for mothers and newborns who deliver by cesarean section.

The literature has examined the effects of the duration of skin-to-skin contact on breastfeeding initiation, neonatal hypothermia, and cardiopulmonary stability. However, studies aimed at increasing the duration of skin-to-skin contact are limited. This study compares the effects of standard skin-to-skin contact and skin-to-skin contact using a sling on the duration of skin-to-skin contact, postpartum breastfeeding success, and physiological weight loss of the newborn in primiparous mothers who delivered by cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Healthy mothers who gave birth by cesarean section
* Primiparous mothers
* Healthy newborns

Exclusion Criteria:

* Mothers who gave birth vaginally
* Newborns using formula milk
* Mothers with breastfeeding difficulties
* Preterm newborns
* Multiple births
* Mothers and newborns with unstable health conditions
Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)

This is a global multicenter study designed to evaluate the safety and clinical effects of 4 oral doses of TCH346 (1.0, 2.5, 7.5, and 15 mg) compared to placebo in patients with mild or mild to moderate stages of ALS. The study consists of 3 phases: screening (up to 2 weeks), run-in (16 weeks), and a double-blind treatment phase of variable duration (at least 24 weeks).


Eligibility Criteria:
Inclusion criteria:

* clinical diagnosis of laboratory-supported probable, probable, or definite ALS;
* sporadic or familial ALS;
* ALS symptom onset for no more than 3 yrs at study entry;
* FVC equal to or more than 70%;
* patients who are either riluzole naive or patients who are receiving concomitant treatment with riluzole at a stable dose of riluzole (50 mg bid) at study start.

Exclusion criteria:

* Known or suspected chronic infectious disease including HIV, hepatitis B, or hepatitis C.
* Clinically significant ECG abnormalities.
* Known hypersensitivity to study drug or related drugs (e.g. selegiline, MAO-A and B inhibitors, or tricyclic antidepressants).
* Patients treated with potent inhibitors of CYP1A2 or CYP3A4 (a list of such inhibitors will be provided to the investigator).
* Treatment with MAO-A and B inhibitors (including selegiline) within the past 30 days.
Entecavir for Chronic Hepatitis B in Hepatocellular Carcinoma Patients Underwent Radiofrequency Ablation Therapy

Persistent replication of HBV (47-55%) is frequently found in patients with HCC, which in turn leads to deterioration of liver reserve. Moreover, a large proportion of HCC patients who underwent curative therapy died from progressive liver decompensation rather than recurrence of cancer. It had been proved that anti-viral therapy for hepatitis C virus (HCV)-related HCC patients could reduce the rate of tumor recurrence after surgical resection.

This is a prospective study to evaluate the efficacy of ETV therapy in chronic hepatitis B patients after receiving RFA therapy for HCC.


Eligibility Criteria:
Inclusion Criteria:

* HCC diagnosed by pathology verification or in accordance with the guidelines of American Association for the Study of Liver Diseases published in 2010 (typical vascular pattern in computed tomography scan or magnetic resonance imaging study) ,
* Solitary tumor less than 5 cm in diameter or 2-3 tumors with the largest one no more than 3 cm in diameter,
* No extrahepatic metastasis,
* No radiological evidence of invasion into major portal vein or hepatic vein branches,
* Good liver reserve with Child-Pugh Class A or B,
* A platelet count of more than 50,000/mm3,
* Serum creatinine level ≤ 2 mg/dL,
* No previous treatment for HCC,
* Positive for serum hepatitis B surface antigen (HBsAg) for more than 6 months
* Positive serum HBV DNA using a Cobas Amplicor HBV monitor (Roche Diagnostic System, Basel, Switzerland).

Exclusion Criteria:

* Dual or multiple infections with hepatitis C virus, hepatitis D virus, or the human immunodeficiency virus,
* Other forms of liver disease such as alcoholic hepatitis, autoimmune hepatitis, Wilson's disease, hemochromatosis,
* Use of interferon alpha, thymosin or antiviral agents within 6 months preceding entry into the study,
* Women who are pregnant or nursing.
The Effect of an Online Exercise Course on the Increase of Elders' Regular Exercise Intention

The effect of an online exercise course on the increase of elders' regular exercise intention.

This project expects that after the four-week exercise course intervention, the elderly can increase their knowledge about exercise and experience the benefits of exercise, enhance the intention of the elderly to exercise regularly, and reduce the chance of the elderly falling due to muscle loss and causing related diseases.

Eligibility Criteria:
Inclusion Criteria:

* The patients from outpatient clinic for elderly health examination.

Exclusion Criteria:

* The elderly who has severe hearing impairments.
* The elderly who has severe visual impairments.
* The elderly who has severe health problems.
* The elderly who need to be quarantined.
* The elderly who is living alone.
Treatment of Metastatic Cancer in Terminally Diagnosed Patients

The objective is to provide terminally diagnosed patients with a last line of treatment while improving overall quality of life. Tempol can be added to any chemotherapy regimen to potentially reduce side effects and overcome chemoresistance.

The objective is to provide terminally diagnosed patients assigned to palliative care and palliative chemotherapy a last line treatment with Tempol. In vivo studies have shown Tempol to work synergistically with a number of chemotherapy agents increasing treatment response and reducing chemoresistance. Additionally, Tempol has been shown to provide protection to non-cancerous cells allowing for increased chemotherapy dosing by reducing side effects. Tempol inhibits HIF-1/VEGF among others in cancerous cells while upregulating GSH/NrF2 among others in non-cancerous cells.

Eligibility Criteria:
Inclusion Criteria:

* metastatic terminally diagnosed cancer

Exclusion Criteria:

-
Sublay Versus Intraperitoneal Onlay Mesh Repair in Large Ventral Hernias

The aims of this study is to compare the efficacy of modified sublay hernioplasty versus intraperitoneal onlay mesh repair for large ventral hernias.

Specifically, this study will assess the primary outcome of recurrence rate one year post surgery and evaluate secondary outcomes, including intraoperative complications, infection rates, pain levels, and post operative hospital stay durations.

In general surgery, the management of ventral abdominal hernias characterized by the protrusion of tissue through weaknesses in the abdominal wall presents significant challenges, particularly when dealing with large ventral hernias, defined as those ≥10 cm or those under tension if closed primarily.

Incisional hernias, a specific subset of ventral hernias, add to the complexity of repair.

While the Intraperitoneal Onlay Mesh (IPOM) technique is noted for its reduced surgical and postoperative complications and lower reoperation rates, it also suffers from high costs, limited availability of specialized meshes like dynamesh, and increased intraoperative complications.

Alternatively, the modified open sublay technique, which employs a primary retro-muscular fascial repair and uses an affordable polypropylene mesh, offers a promising and cost effective solution with potential for a tension free repair.

This thesis aims to evaluate and compare these techniques to identify the most effective approach for large ventral hernia repair, balancing surgical outcomes, and complication rates.

Eligibility Criteria:
Inclusion Criteria:

* Age (18-70) years, both sexes.
* Fitness for surgery.
* Patients with uncomplicated ventral hernia.
* Large anterior abdominal wall defect.

Exclusion Criteria:

* Patients don't fit for general anesthesia due to sever co-morbidity.
* Patients with complicated ventral hernia.
* Patient refusal of surgical intervention.
* History of bleeding disorders.
* Pregnancy in female patients
Botswana Combination Prevention Project

The BCPP study is designed to test the hypothesis that implementing an enhanced combination prevention package which includes provision of ART to all participants, regardless of CD4 count or HIV disease severity, will impact the HIV/AIDS epidemic by significantly reducing population-level, cumulative HIV incidence in a defined geographic area over a period of 3 years and will be cost-effective.


Eligibility Criteria:
Inclusion Criteria:

* Protocol #1 - Baseline Household Survey (BHS): Permanent or part-time study community resident in any of the 30 study communities; Botswana citizen or spouse of a Botswana citizen; able to provide informed consent if ≥18 years old, or able to provide assent to complement a guardian's permission, if a minor (aged 16 or 17).
* Protocol #3 - Expanded treatment cohort: HIV-infected persons in Combination Prevention communities who are not yet on ART and are able to provide informed consent if ≥18 years old, or able to provide assent to complement a guardian's permission, if a minor (aged 16 or 17).

Exclusion Criteria:

* Persons who do not meet inclusion criteria.
NRM on Vascular Perfusion in Healthy Adults

The purpose of this study is to better understand the effects of nicotinamide riboside supplement in overall cardiovascular health in healthy adults.

This study is a randomized, double-blind, placebo-controlled, parallel-dose clinical trial. Participants will be randomly assigned to one of three groups. Study measurements will be completed at three timepoints and intervention taken daily throughout the subject's 12 weeks of participation.

Eligibility Criteria:
Inclusion Criteria:

* \>= 40 and \<=60
* Provides consent to participate in the study
* Not pregnant at time of consent
* Understands and agrees to follow all study procedures and limitations
* Have no contraindicating comorbid health condition as determined by the clinical investigators

Exclusion Criteria:

* Pregnant, nursing, or trying to conceive
* BMI Restrictions: \<30
* Allergy or sensitivity to study agent ingredients
* Hypertension treated with medication
* Use of natural health products containing nicotinamide riboside, quercetin, trans-resveratrol, or betaine anhydrous within 7 days prior to randomization and during the course of the study.
* Surgery planned during the course of the trial
* History or past diagnosis of chronic diseases, unstable medical conditions, blood/bleeding disorders or stroke
* History or current diagnosis of cancer (except for successfully treated basal cell carcinoma diagnosed less than 5 years prior to screening or cancer in full remission more than 5 years after diagnosis.
* Abnormal blood chemistries for renal or liver function (defined as 1 standard deviation outside of the normal range), alcohol dependence, uncontrolled thyroid disease, severe obesity (body mass index \>40 kg m-2), or weight stable for at least 3 months prior to enrolling in the study (defined as \>2 kg change in body mass).
* An unstable medical or mental health condition as determined by the physician investigator.
The Effect of Emotional Freedom Technique on Premenstrual Syndrome and Pain in University Students

PMS is one of the common menstrual disorders affecting many young women, and according to epidemiological data, approximately 75% of women have PMS symptoms and 3-8% have severe PMS symptoms. The prevalence of PMS was different in different countries, with 34% in China , 72% in Turkey , 80% in Pakistan and Jordan. It was detected in the range of 92% in India and 14.3%-74.4% in India. Common premenstrual symptoms include anxiety, lack of concentration, depression, bloating, abdominal cramps, breast tenderness, anger, general body pain, nausea, vomiting, fatigue, decreased concentration, mood swings, headache, anxiety, sleep disturbance, appetite changes. In addition to physical symptoms, studies indicate that individuals reporting PMS experience more stress and anxiety, and their sensitivity to depressive symptoms increases due to hormonal fluctuations. Studies have shown that mindfulness-based cognitive methods are effective in the treatment of mood disorders such as depression. It is thought that modulating many PMS symptoms such as stress and experienced emotional problems through mindfulness-based cognitive methods may be an effective approach for future PMS interventions.


Eligibility Criteria:
Inclusion Criteria:

* Persons with amenorrhea,
* pregnancy,
* menstrual irregularity,
* chronic disease,
* mental disorders,
* psychiatric disorders,
* polycystic ovarian syndrome,
* those who have received training on EFT before and those who have communication problems will not be included in the study.

Exclusion Criteria:

* Female students between the ages of 18-25,
* who scored 111 or higher on the Premenstrual Syndrome Scale (PMSS)
* participated in the study voluntarily will be included in the study.