cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Bleeding on Brushing Using Neem Extract Mouthwash Versus Chlorhexidine Mouthwash

i will compare the effect of neem extract mouthwash versus the chlorhexidine mouthwash on bleeding on brushing among a group of Egyptian children.

1. First , we will select the patients according to the inclusion criteria.
2. We will take sulcus bleeding index which is defined as an index of gingival inflammation in which bleeding is measured from four gingival units using a periodontal probe. The scoring is ranging around eight anterior teeth from 0 to 5.In this study, we will take only score 2 which is bleeding on probing, change in colour and no edema in order to reduce variability.
3. 2%neem extract will be used to prepare mouthwash while, chlorhexidine will be used as positive control.
4. Chlorhexidine will be coded with the letter "A" and the mouthwash of 2%neem extract with the letter "B".
5. The participants included will be allocated into 2 groups by drawing of sealed and opaque envelopes containing the codes "A" and "B"
6. The intra and extraoral examinations will be made using masks, gloves, cap, goggles, gauze, medical tray, dental mirror and WHO probe. All materials will be packaged in sterilization wraps and autoclaved, following the required biosafety standards.
7. The rinses will be performed twice daily, which will be supervised by the parents legal guardians previously instructed. Kits containing toothpaste an brush will be provided, so that the patients will use the same toothpaste, avoiding any interference with the results.
8. After 3 weeks, we will ask the patient if there is any gingival bleeding in addition we will measure the sulcus bleeding index.

Eligibility Criteria:
Inclusion Criteria:

* 1. Children aged 8-10 years old with gingivitis

  2. cooperative children

  3.both genders

  4.medically free

  5. sulcus bleeding index score is 2

Exclusion Criteria:

* 1. Children undergoing orthodontic treatment

  2.Children undergoing any other oral hygiene aid other than routine teeth brushing

  3.Children with known history of allergy to any mouthwash or drug

  4.Parents unable to give informed consent

  5.Children taking antibiotic or antiseptic in previous two months
Application of Surgical Navigation System in Sentinel Lymph Node of Breast Cancer Research

The purpose of this study is to compare the sentinel lymph node (SLN) detection rate of early breast cancer patients between using Indocyanine green (ICG) and Methylene blue with a novel surgical navigation system.

Assessment of the sentinel lymph node (SLN) in patients with early stage breast cancer is vital in selecting the appropriate surgical approach. However, the existing methods, including methylene blue and nuclides, possess low efficiency and effectiveness in mapping SLNs, and to a certain extent exert side effects during application. Indocyanine green (ICG), as a fluorescent dye, has been proved reliable usage in SLN detection by several other groups. In this paper, the investigators introduce a novel surgical navigation system to detect SLN with ICG. This system contains two charge-coupled devices (CCD) to simultaneously capture real-time color and fluorescent video images through two different bands. During surgery, surgeons only need to follow the fluorescence display. In addition, the system saves data automatically during surgery enabling surgeons to find the registration point easily according to image recognition algorithms. The investigators aim to show that the usage of our surgical navigation system with ICG to detect SLNs in breast cancer patients is technically feasible.

Eligibility Criteria:
Inclusion criteria: (Before the test, all the subjects required for meeting the entry requirements before they join the group)

* female patients;
* The preoperative core needle biopsy or open surgical excision biopsy diagnosis as breast cancer;
* tumor diameter ≤ 3cm;
* No clinical examination of suspicious axillary lymph node-positive;
* diagnosed clinical conditions can be directly surgery as I, II breast cancer patients;
* preoperative clinical or radiologic evidence without distant metastases (M0);
* signed informed consent.

Exclusion criteria: (Before the test, the subjects under any one of items to meet the requirements can not be enrolled)

* Sentinel lymph node biopsy history had received surgery or axillary area;
* multi-center breast cancer or multiple lesions;
* clinical axillary lymph node metastasis have been found;
* mammary area had received neoadjuvant chemotherapy or radiotherapy;
* inflammatory breast cancer;
* pregnancy;
* no personal freedom and independent civil capacity.

Exclusion criteria: (trials, subjects necessary to meet the requirements of any one item, exit the clinical trial research.)

* severe allergic reaction occurs;
* persistent allergic reaction;
* subjects were required to withdraw from a clinical trial;
* researchers consider it not appropriate to continue to participate in the clinical trial investigator.
Proton Magnetic Spectroscopy in Children and Adolescents With ADHD Before and After Treatment With OROS Methylphenidate

This will be an open label study using daily does of up to 126mg/day of Concerta in the treatment of children and adolescents, ages 12-17, who meet DSM-IV criteria for ADHD. Specific hypotheses are as follows:

Hypothesis 1: Children and adolescents with ADHD will have significantly higher ACC and DLPFC Glutamate/myo-Inositol containing compounds (Glu/Ino) and Glutamate/creatine + phosphocreatine (Glu/Cr) than matched HCS.

Hypothesis 2: After six weeks of treatment, OROS methylphenidate will lower ACC and DLPFC Glu/Ino and Glu/Cr levels in children with ADHD who are methylphenidate responders.

The primary objective of this study is to use 1H MRS to assess Glutamate (Glu), myo-Inositol (Ino), and creatine + phosphocreatine (Cr) levels in brain regions of interest in 20 children with ADHD between the ages of 12-17 years old, before and after a six-week open treatment trial with OROS methylphenidate. For comparison, 1H MRS will also be obtained from 20 controls matched by age and gender. We also will scan 20 children with ADHD between the ages of 12-17 years old that are currently enrolled in the protocol entitled "Prevention of Cigarette Smoking in ADHD Youth with Concerta" (2003-P-001313) and on a stable dose of Concerta. These 20 children will be scanned once while on medication and once while off medication

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, 12-17 years of age.
2. ADHD subjects must meet study criteria for the "Prevention of Cigarette Smoking in ADHD Youth with CONCERTA Protocol"; #2003-P-001313.
3. Control subjects must not meet full DSM-IV criteria for Attention Deficit Hyperactivity Disorder, or any other current major psychiatric disorder.
4. Each subject and his/her authorized legal representative must understand the nature of this proposed study, and must sign informed consent and informed assent documents.
5. Subject and parent must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with study procedures.

Exclusion Criteria:

1. Clinically significant chronic medical condition including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
2. Organic brain disorders or mental retardation (I.Q. \<75).
3. Contraindication to MRI including presence of metal or surgical devices (plates, implants, braces or other items).
4. Pregnancy; women of child bearing potential must be using a medically approved method of birth control. Women of child bearing potential will receive a urinary pregnancy test prior to each MR scanning session.
5. Severe phobia of being in small, enclosed spaces.
6. Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild will not be eligible to participate in the treatment arm of the study.
Direct Peritoneal Resuscitation Plus Conventional Resuscitation

The purpose of this study is to find out if direct peritoneal resuscitation (DPR) (putting a sugar solution into the abdominal cavity) helps blood flow through vital organs in the body that may suffer from low blood flow due to surgery. We will also try to find out if the DPR will help patients recover faster from liver surgery. Lastly, this study will also try to find if direct peritoneal resuscitation decreases levels of signaling chemicals in the blood called 'cytokines' and a protein called high-mobility group protein 1, which is known to cause tissue damage.

Our study will focus on 108 patients requiring hepatic resection for colorectal cancer metastasis or primary hepatocellular carcinoma. These patients will then be randomized into two 54 patient arms: the control arm of conventional resuscitation only and the experimental arm of conventional resuscitation with DPR immediately post operatively. Patient exclusion criteria will be: 1) unable to obtain proper consent for enrollment, 2) age less than 18 years or greater than 75 years, 3) chronic renal failure, cirrhosis, or congestive heart failure, 4) patients requiring portal venous embolization prior to resection, or 5) women who are pregnant or lactating/breast feeding. A pregnancy test (urine or blood) will be done for female subjects of child bearing potential the day prior or the morning of surgery per the usual standard of care pre-op labs.

Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer
* Scheduled for liver resection
* 18 to 75

Exclusion Criteria:

* Chronic renal failure
* Cirrhosis
* Congestive heart failure
* Requiring portal venous embolization prior to resection
* Pregnant or nursing
Testing the Effectiveness of Telephone-based Early Childhood Developmental Screening

The purpose of this research study is to test the effectiveness of telephone-based early childhood developmental screening and care coordination, compared to usual care in a primary care pediatrics clinic. Investigators randomized 152 participants to one of two study arms, with the intervention families receiving developmental screening over the phone, and control families receiving usual care with their pediatricians.

Although the American Academy of Pediatrics (AAP) recommends universal early childhood developmental screening as part of routine well-child care, there have been many studies documenting that many pediatricians do not follow the AAP guidelines. One intervention that has the potential to improve care, especially for low-income families, is centralized, telephone-based developmental screening, and care coordination for families whose children have developmental or behavioral concerns. 2-1-1 Los Angeles developed such an intervention and this study aims to test its effectiveness, in partnership with a local community clinic, using a randomized, controlled study design. Investigators partnered with the Clinica Oscar A Romero, a federally-qualified health center in Los Angeles, serving predominantly low-income Latino families. Investigators hope to enroll up to 300 families in the study. Eligible families will have children ages 12 to 42 months of age who receive well-child care at the clinic. As investigators obtain informed consent and enroll families, they will randomize study participants into intervention and control groups. Intervention group families will be transferred to 211 Los Angeles to complete developmental screening over the phone, while control group families will go to their pediatricians for well-child care as usual.

Eligibility Criteria:
Inclusion Criteria:

* child receives well-child care at the clinic
* child is not already receiving intervention services for a developmental disability
* parent speaks Spanish or English well enough to be interviewed

Exclusion Criteria:

* child is younger than 12 months or older than 42 months at time of enrollment
* child is already receiving intervention services for a developmental disability
* parent is unable to speak Spanish or English well enough to be interviewed
Comparison of Accuracy and Functional Outcome Between Robotic and Gyroscopic Assisted Surgery in Primary TKA

A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis (Kellgren and Lawrence grade 2-3). The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group. Baseline characteristics, including age, body mass index, length of stay, and estimated blood loss, were recorded. The primary outcome measure was the accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months. Secondary outcomes included functional outcomes (KOOS, Oxford knee score, EQ-5D-5L, range of motion) assessed preoperatively and postoperatively at 3 months, as well as at 6 months postoperatively.

Introduction: Primary total knee arthroplasty is considered the gold standard treatment for end-stage osteoarthritis of the knee. The primary objective of this surgical procedure is to restore mechanical alignment. At Siriraj Hospital, we employ technology to enhance the accuracy of our surgical procedures. The purpose of this study is to compare the accuracy of robotic-assisted surgery (ROSA) and gyroscope-based surgery in primary total knee arthroplasty.

Methods: A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis (Kellgren and Lawrence grade 2-3). The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group. Baseline characteristics, including age, body mass index, length of stay, and estimated blood loss, were recorded. The primary outcome measure was the accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months. Secondary outcomes included functional outcomes (KOOS, Oxford knee score, EQ-5D-5L, range of motion) assessed preoperatively and postoperatively at 3 months, as well as at 6 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* primary osteoarthritis knee with indicated for total knee replacement
* age equal or more than 55 years old

Exclusion Criteria:

* revision surgery
* deformity greater than 15º
* Intra/Post operative complication
Prevention of Adverse Drug Events (ADEs) in Hospitalised Older Patients

The next four decades will see a marked expansion of the elderly population in Ireland, in particular people aged over 80 yrs. Persons aged over 80 are the highest consumers of prescription medicines in Ireland and have the highest prevalence rates of major polypharmacy. Polypharmacy is intimately linked with serious adverse drug events (ADEs) and consequent major morbidity and mortality. Epidemiological data from the United States indicate that ADEs is the fifth most common cause of death nationally. Experts suggest that effective evidence based interventions can be applied to this major public health problem.

Recent research data indicate a cause-and-effect relationship between inappropriate prescription medicines and serious ADEs in older people in hospital. To date, Beers' criteria have been the dominant set of criteria for defining potentially inappropriate medicines (PIMs) in late life. Research data collected by this group show that the recently validated STOPP/START criteria (Screening Tool of Older Persons' Prescriptions and Screening Tool to Alert doctors to Right Treatment) identify ADEs that are causal or contributory to acute hospital admission in older people 2.7 times more frequently than Beers' criteria. Based on these findings, our hypothesis is that STOPP/START criteria have the potential to be used as a regular intervention for the purpose of ADE prevention in older people. A recent single centre randomised control trial (RCT) undertaken at Cork University Hospital showed that prospective application of STOPP/START criteria led to a highly significant improvement in medication appropriateness in older hospitalised patients compared with standard inpatient pharmaceutical care. Significantly, the improvement in medication appropriateness was maintained to the end of the study follow-up i.e. 6 months post-discharge. However, the ability of STOPP/START criteria to significantly reduce ADEs in a prospective RCT has yet to be demonstrated.


Eligibility Criteria:
Inclusion Criteria:

All patients aged 65 years and over presenting to CUH Accident and Emergency Departments with acute illness for admission under a medical or surgical team.

Exclusion Criteria:

1. Age less than 65 years.
2. Patient to be admitted under the care of a Geriatrician Psychiatrist of Old Age or Clinical Pharmacologist, or having been admitted under these services or attended their outpatient clinics in the previous 12 months. (These doctor groups are likely to minimise inappropriate medications in this population).
3. Terminally ill patient attended by palliative care team.
4. Critically ill patient e.g. admitted to Intensive Care Unit.
5. Patients who do not wish to participate in the study.
6. Patients whose hospital physician does not wish to participate in the study.
Evaluationn of Tolerability and Safety of CBT101, an Autologous Natural Killer Cell, in Patients With Solid Cancer

The objective of the study is to evaluate tolerability and safety of CBT101 in patients who underwent curative surgery and adjuvant therapy for solid cancer


Eligibility Criteria:
Inclusion Criteria:

1. Male and female adults aged 19 years and older
2. Patients with solid tumors as below (1) histologically or cytologically confirmed solid tumors (2) 4 - 12 weeks of last adjuvant therapy after radical operations and adjuvant therapy
3. Life expectancy 6 months
4. Eastern Cooperative Oncology Group perfornace status (ECOG PS) 0-1

Exclusion Criteria:

1. History of leptomeningeal carcinomatosis or spinal cord compression
2. History of peritoneal carninomatosis
3. Hemoglobine less than 9.0g/dL
4. Absolute Neutrophil Count (ANC) less than 1.5x10\^3/mm\^3
5. Platelet count less than 75x10\^9/L
6. Total bilitbinn grater than 1.5 times te upper limit of normal
7. Alanine amino transferase (ALT) greater than 3 times the upper limit of normal
8. Alanine phospatase (ALP) greater than 2.5 times the upper limit of normal
9. Uncontrolled hypertension
10. Intensive insuline therapy
11. Active infectious disease
12. Patients with hypersensitivity history or allergy to investigational product
13. Pregmant of lactating woman
14. Patients who have participated in another clinical trials witin 30 days before the start of this clinical trial
15. Patients judged to be inappropriate for this study by the investigator with other reasons
Hematopoiesis in MBL and CLL Versus Healthy Age-Matched Control Subjects

This study evaluates hematopoiesis to determine how MBL/CLL affected bone marrow responds to fight off infections in the body.

PRIMARY OBJECTIVES:

I. Determine the cellular and mechanistic basis of bone marrow (BM) hematopoietic dysfunction in untreated MBL and CLL patients.

II. Determine if MBL and CLL B cell derived cellular products directly alter the differentiation and functional capacities of Hematopoietic Stem and Progenitor Cells (HSPCs).

III. Utilize the Emu-Tcl1 transgenic mouse model to determine how MBL and CLL patient-derived cellular products alter BM hematopoiesis.

OUTLINE: This is an observational study.

Patients undergo blood sample collection and bone marrow aspiration and biopsy and have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects in the CLL cohort who are eligible for these studies will have a clinically established diagnosis of CLL as assessed by flow cytometry and will include subjects who

  * Remain untreated
  * Are currently being treated
  * Who have already been treated
* Subjects in the MBL cohort will have a clinically established diagnosis of MBL
* Healthy age-matched control subjects
* Healthy younger control subjects aged \> 40 years

Exclusion Criteria:

* Anyone under 40
* Healthy control subjects must not have a diagnosis of CLL or MBL
NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain

This is a multiple-dose, double-blind, double-dummy, active-control, parallel-group, multi-center, safety and efficacy study.


Eligibility Criteria:
Inclusion Criteria:

* Males or females age are ≥20 ,≤80 years.
* Clinical diagnosis of musculoskeletal pain for 4 weeks or longer with non-malignant pain etiology at Visit 1.
* Subject is a current user of NSAIDS or paracetamol and reports a history of insufficient therapeutic benefit in musculoskeletal pain.
* Subjects must record an 'average pain over the last week at study institution' score at primary pain site of ≥ 4 on an 11-point numerical pain rating scale.
* Subjects must be able to understands the study procedures and assessment, and agree to participate in the study by giving written informed consent.

Exclusion Criteria:

* Subjects who have been taking long-acting or short-acting opioid analgesic formulations within the last 4 weeks.
* Subjects who have a current chronic disease(s) or who have a past history and high possibilities to relapse, in addition to their musculoskeletal pain, requiring frequent analgesic therapy.
* Subjects with clinically unstable respiratory disease, dysfunction of the biliary tract, thyroid disease, adrenal cortical insufficiency, prostatic hypertrophy requiring intervention or renal artery stenosis.
* Subject who have a past history of malignant neoplasm including leukemia and lymphoma.
* Subjects with clinically unstable, active or symptomatic heart disease.
* Subjects who have psychiatric disorder, uncontrolled seizures or convulsive disorder and so on.
* Subjects who have a current or past (within 5 years) history of substance or alcohol abuse, or subjects who give a positive result in drug abuse test during the Screening Period.
* Subjects scheduled for therapies within the study period which might effect study assessment.
* Females who are pregnant, lactating or have a possibility of being pregnant.
* Subjects with values \> 2 times the upper limit of normal for AST or ALT or total bilirubin at visit 1 or who have severe impaired liver function.
* Subjects with serum creatinine \> 2 mg/dL at Visit 1 or who have severe impaired renal function.
* Subjects with serum potassium \< 3.5 mEq/L at Visit 1.
* Subjects receiving hypnotics or other central nervous system (CNS) depressants.
* Subjects receiving monoamine oxidase inhibitor (MAOI) within 2 weeks before screening.
* Subjects who have a history of supersensitivity to study drug.
* Known intolerance to and/or lack of effect of tramadol.
* Subjects who participated in a clinical research study within 1 month of study entry.
* Subjects who participated previously in a BTDS study.