cyrilzakka/clinical-trials huggingface dataset:
The Role Of Laserpuncture For Prevention Of Nausea And Vomiting Post Strabismus Surgery With General Anesthesia In Adult Patients

This study to determine the effectiveness of a combination of pre-surgical laserpuncture with standard anti-emetic therapy for PONV symptoms in adult patients after strabismus surgery under general anesthesia compared to a combination of pre-surgical placebo laserpuncture with standard anti-emetic therapy. Research design using a double blinded randomized controlled trial (RCT) where research subjects and data takers who will be disguised. The research will be carried out in the Operation and Inpatient Room, Kirana Building, RSUPN Dr. Cipto Mangunkusumo (RSCM) with research subjects as adult patients undergoing strabismus surgery under general anesthesia. Assessment of nausea and vomiting using AVS ( Analog Visual Scale) consists of scoring using a score from 1-5 which indicates the severity of nausea and vomiting.

This clinical trial is to evaluate the role of laserpuncture as a prevention of nausea and vomiting in adult patients after strabismus surgery under general anesthesia. Participants are 32 males/females aged 18-59 years. They will be divided into 2 groups: (1) Group laserpuncture and (2) Sham laserpuncture. The study intervention was performed 30 minutes before surgery. The primary outcome in this study was the incidence of postoperative nausea and vomiting.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients aged 18-59 years.
2. Patients undergoing simple strabismus surgery involving no more than two muscles without transposition under general anesthesia.
3. Meets the ASA (American Society of Anesthesiologists) score of 1-2.
4. Complete the surgical preparations according to the presedation sheet.
5. Sign the informed consent sheet.
6. Patients who can communicate with the research team.
7. Patients undergoing surgery \<3 hours.

Exclusion Criteria:

1. The patient is pregnant.
2. Patients who have a history of drug or drug abuse.
3. Patients with hypersensitivity to laser light.
4. There are wounds or skin disorders at the radiation site (skin TB, SLE(Systemic Lupus Erythematosus) skin
5. Patients who have gastrointestinal diseases (intestinal obstruction, peristaltic disorders gastrointestinal tract, gastroenteritis, irritable bowel syndrome, dyspepsia,gastroesophageal reflux disease/GERD, appendicitis, hepatitis, cholecystitis, inflammatory bowel synchrome, pancreatitis, peptic ulcer, peritonitis, food poisoning).
6. Patients with metabolic diseases (acid-base imbalance, metabolic diseases calcium, glucose metabolism disease, hyperlactemia, mitochondrial disease, phenylketonuria)
7. Patients with conditions of high intracranial pressure, head trauma, migraines, disease with symptoms of seizures, vestibular diseases, malignancies, mental and psychogenic diseases, diseases arising from consumption of drugs, nephrolithiasis, other kidney diseases, myocardial infarction, as well as the occurrence of nausea and vomiting before surgery.
8. Infection accompanied by high fever (temperature \>38°C)
Effects of Environmental Opportunities and Barriers on Physical Activity, Fitness, and Health in Hispanic Children in Wisconsin

This is a pilot community-based research study to examine the effects of specific environmental and social factors on physical activity, fitness, and health of middle school Hispanic children living in an inner-city community.

Our primary hypothesis is that the disparity between a community's potential for physical activity and nutrition, and the realized fitness and health of its children, can be attributed to specific environmental and social factors. "Built environment" studies to date have measured potential for physical activity but have not looked at how social factors mediate an individual's activity within a particular environment. The unique aspect of this proposal is the development of a model that explains how physical, social, cultural, and nutritional SEM layers interact to create gaps between potential and realized physical activity. This project will utilize novel technologies to:

1. identify and analyze characteristics of the social and built environment that inhibit or enhance physical activity and healthy nutrition;
2. determine the direction and extent of influence of these variables on children's activity, nutrition, and health;
3. gather ideas from students, parents, and school staff to inform a potential health campaign to reduce and prevent obesity in the community.

To address these goals and demonstrate a causal relationship between physical activity and the social-nutritional factors within a built environment, the following specific objectives/aims are being addressed:

Specific Aim 1: Assess the built environment for energy requirements of movement, nutrition options, suitability for outdoor physical activity, and for children's actual physical activity and energy expenditure within those environments.

Specific Aim 2: Assess the impact of children's social environment on movement and nutrition choices within the built environment.

Specific Aim 3: Conduct a quantitative assessment of children's fitness, obesity, and indicators of metabolic health.

Specific Aim 4: Develop a quantitative model from Specific Aims 1-3 that describes the causal relationships among children's physical health, community "healthfulness," and other mediating factors such as attitudes, perceptions, and behavior.

Eligibility Criteria:
Inclusion Criteria:

1. The child is in academic attendance at the BGCS in Grades 5-8 and Cherokee Middle School in Grades 6-8.
2. The child and parent or legal guardian is able to provide assent and/or consent.
3. The child is able to understand instructions for study-related activities and comply

Exclusion Criteria:

1. The child is not in academic attendance at the BGCS in Grades 5-8 or at Cherokeed Middle School grades 6-8
2. The child and parent or legal guardian is not able to provide assent and/or consent.
3. The child is able to not able to understand instructions for study-related activities and comply

   -
Analysis of Genes Present in Cutaneous T-cell Lymphoma Cells

RATIONALE: Analyzing genes that are present in cancer cells may be useful in developing better methods to detect, predict, and treat cutaneous T-cell lymphoma.

PURPOSE: Clinical trial to study genes that are present in cutaneous T-cell lymphoma cells.

OBJECTIVES:

* Identify gene expression patterns in malignant T cells that can be used to diagnose cutaneous T-cell lymphoma.
* Determine the patterns of gene expression that distinguish normal skin-homing T cells from malignant T cells.

OUTLINE: Patients are stratified by disease (Sezary syndrome vs mycosis fungoides) and prior treatment (yes vs no).

All patients receive a physical examination, and a medical history is taken. Patients with Sezary syndrome undergo leukapheresis. Patients with plaque/tumor stage mycosis fungoides undergo skin biopsy of involved skin. Malignant T cells from blood or skin are then isolated and patterns of gene expression in the malignant T cells are compared to those in normal skin-homing T cells from healthy donors using a "gene chip" (Lymphochip).

Patients are followed annually for 5 years.

PROJECTED ACCRUAL: A total of 40 patients (20 per disease stratum) will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven mycosis fungoides with 2 or more plaques or tumors greater than 1 cm in size OR
* Immunologically proven Sezary syndrome with all of the following:

  * Erythroderma
  * Lymphadenopathy
  * T-cell receptor variable beta chain clonality greater than 10% of total lymphocytes by flow cytometry OR
  * CD4+CD7- T-cell fraction that represents greater than 10% of CD4+ T cells

PATIENT CHARACTERISTICS:

Age:

* 18 to 85

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* See Disease Characteristics

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Not pregnant or nursing
* HIV-1 and HTLV-1 negative
* No prior intravenous drug use

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 2 months since prior systemic chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 2 months since prior electron beam radiotherapy

Surgery:

* Not specified

Other:

* At least 2 weeks since prior topical therapy
* At least 2 months since prior photopheresis
* At least 2 months since prior psoralen ultraviolet light (PUVA) or ultraviolet B (UVB) therapy
Propofol-related Euphoria in Pain-free Gastrointestinal Endoscopy Patients

To define the prevalence, duration and severity of propofol-associated euphoria in patients undergoing painless gastrointestinal endoscopy and to explore the independent influencing factors by means of a single-center, cross-sectional clinical research study


Eligibility Criteria:
Inclusion Criteria:

* Proposed to perform painless GI endoscopy, and simple endoscopic maneuvers such as single small polyp clamping, performing HP examination, etc;
* Gender is not limited;
* 18 years old ≤ 80 years old;
* ASA classification: I-II;
* 18 kg/m2 \&amp;lt;BMI \&amp;lt;30 kg/m2;
* Informed consent, voluntary participation in the trial, and informed consent signed by the subjects themselves.

Exclusion Criteria:

* adjudicated respiratory management difficulties;
* History of substance abuse as well as drug use;
* Participation in a clinical trial of another drug or device within 3 months prior to the screening period
* Use of therapeutic drugs (e.g., benzodiazepines, opioid analgesics) by the subject within 3 months prior to the Screening Period for a variety of reasons (e.g., insomnia, pain, etc.) that may have an impact on the outcome of the trial, etc;
* Allergy or contraindication to the study drug or components thereof;
* Previous psychiatric or neurological disorders (e.g., schizophrenia, mania, bipolar disorder, psychosis, epilepsy, neuralgia, etc.) and a history of taking medications corresponding to the treatment of the corresponding psychiatric or neurological disorders (e.g., antidepressants, anxiolytics, convulsants, antiepileptic drugs, etc.);
* Pregnant women;
* Subjects with severe communication disorders due to severe hearing deterioration;
* Refusal to participate in this study;
* Those deemed unsuitable by the investigator.
Phase II of Lenvatinib Plus Toripalimab for Advanced HCC

The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with toripalimab in patients with advanced hepatocellular carcinoma (HCC)

Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. No study has evaluated the efficacy and safety of lenvatinib plus toripalimab. Thus, the investigators carried out this single-arm, prospective, phase II study to find out it.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
* Barcelona clinic liver cancer-stage C
* Eastern Cooperative Oncology Group performance status of 0 to 2
* with no previous systemic treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* The following laboratory parameters:

Platelet count ≥ 75,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3 Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease
Evaluation of Quality of Life and Self-assurance and Social Support Earned for Non-cellular Head Cancer

Research objectives:

* To evaluate the quality of life of patients before and after surgery for benign head tumors ( meningiomas) and malignant tumors at stage I, II and III, to assess whether it depends on the size of the tumor, type of tumor, malignancy and its location
* evaluation of the independence of patients before and after surgery for head tumors at different stages of the disease - benign tumors (meningiomas) and malignant tumors in stage I, II and III, evaluation of what factors affected the different independence of patients
* Multidimensional evaluation of perceived social support of patients before and after surgery for head cancers - benign ( meningiomas) and malignant tumors in stage I, II and III, taking into account three sources of support: significant person, family and friends

Scientific (research) problems:

- What is the quality of life of patients before and after surgery for benign ( meningiomas) and malignant head cancers at stages I, II and III ? Is quality of life in patients with head cancer dependent on tumor size, malignancy, location or type of cancer ?


Eligibility Criteria:
Inclusion criteria for the study:

-clinical diagnosis of head cancer

Study exclusion criteria:

- cranio-brain injuries and inflammatory brain diseases.
Multiple Grain in Type 2 Diabetes

We aim to investigate the beneficial effect of adding grain fiber to daily rice meal in type 2 diabetic patients. We anticipate this intervention will improve glycemia and lipid profile in these patients.

Resistance of insulin-mediated glucose transport is a fundamental early defect in the pathogenesis of type 2 diabetes mellitus (DM). It has been found that high fiber concentration in meal is frequently associated with low GI. In many single-blind cross-over study, short term consumption of high fiber meal has been shown to enhance postprandial insulin sensitivity in healthy subjects. We presume that increasing daily consumption of fiber would improve the insulin resistance and therefor glycemic parameters patients with DM. Patients with type 2 diabetes with stable dose of hypoglycemic medication control will be recruited, two types of meals will be given, type A is a general Asian rice-meal and type B consists of the same rice with multiple-grain-fiber added. Both type of meals will be consumed for 3 months by each patients.

Eligibility Criteria:
Inclusion Criteria:

* Mentally competent adults of either sex with age 30-75 years old
* Patients have type 2 diabetes mellitus diagnosed after 25 years of age
* Patients have been in inadequate but stable glycemic control by diet. Inadequate glycemic control isdefined as: HbA1c 7.1-11.0%
* Patients have signed the written informed consent.

Exclusion Criteria:

* Patients with type 1 diabetes mellitus
* Patients with alcohol, drugs or medications abuse considered by the investigator
* Patients with impaired liver function (AST, ALT\>2.5× upper limit of normal)
* Patients with impaired kidney function (serum creatinine\>3.0 mg/dl)
* Patients with emphysema or chronic bronchitis
* Patients with hepatic cirrhosis
* Patients with chronic intestinal diseases related to marked disorders of digestion or absorption
* Patients participated investigational drug trial within 1 month before entering this study
* Patients with any other serious diseases considered by the investigator not in the condition to enter the trial
Evaluation of Subcutaneous Desferrioxamine as Treatment for Transfusional Hemochromatosis

To determine whether deferoxamine prevented the complications of transfusional iron overload.

BACKGROUND:

The prognosis of congenital or long-term anemia was formerly limited by the complications of blood transfusion, splenectomy, or infection, problems now largely overcome by sophisticated clinical care. Lifespan is now determined by the rate of myocardial iron deposition, with death occurring from cardiac failure or arrhythmia, usually between the ages of 15 and 25. Endocrine complications and hepatic enlargement are also evident by this age. Deferoxamine increases urinary iron excretion and is the only chelator currently available for chronic administration. Daily administration of deferoxamine results in negative iron balance in most patients by the age of 10; this study was designed to determine whether the onset of cardiac complications was delayed and life prolonged by iron removal.

This trial began in 1978. Its forerunner was a study involving both deferoxamine and ascorbic acid. Although ascorbic acid promotes iron removal, its administration was followed by cardiac deterioration in several patients. In this study, patients receiving subcutaneous deferoxamine were randomized to receive either ascorbic acid or placebo, thereby providing a controlled test of this agent in treatment of iron overload. Sixty-five patients with homozygous beta-thalassemia participated in the long-term chelation trial. Of these, 49 were randomized to the ascorbic acid trial.

Several noninvasive techniques have been developed to evaluate organ function in iron-overloaded patients, thereby facilitating the assessment of chelation therapy. These techniques included chest x-rays, electrocardiograms, echocardiograms, and 24-hour Holter monitoring to assess cardiac function. Liver function was evaluated by standard liver function tests, CAT scan, and live biopsy. During the last six years of the study, hepatic iron stores were measured magnetically with a dual channel superconducting quantum-interference susceptomer. Endocrine function was also assessed by standard tests.

DESIGN NARRATIVE:

All patients received subcutaneous deferoxamine and iron removal was determined by measurement of serum ferritin and periodic non-invasive measurements of liver iron concentration. Clinical status was evaluated by non-invasive testing of cardiac and endocrine function.

The study completion date listed in this record was inferred from the last publication listed in the Citations section of this study record.

Eligibility Criteria:
Males and females, 5 years or older, with transfusional hemochromatosis.
PMCF Study for COSEAL® in Gynecologic Surgery

The study is a single-arm, retrospective, chart review with a patient questionnaire intended to supplement the patient chart, when necessary. The population will consist of patients who underwent an index gynecologic surgery (performed at least 2 years prior to the start of the study) during which COSEAL was used as an adjunct to good surgical technique to reduce the incidence, severity, and extent of post-surgical adhesion formation. The purpose of the study is to detect the incidence of adhesion-related morbidities as measured by the proportion of adhesion-related readmissions, including reoperations in these patients.

Patient charts will be reviewed to collect the data on readmissions related to adhesions, If the patient chart has no record of adhesion related readmission within approximately 2 years of the index surgery, then a patient questionnaire will be sent. A questionnaire may still be sent if a patient chart has a record of adhesion related readmission within approximately 2 years of the index surgery and further clarification is needed. The questionnaire will collect information regarding readmission or reoperation directly or possibly related to adhesions following the index gynecologic surgical procedure at a hospital or outpatient clinic other than that of the index surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Adult female patients who, at the time of surgery, were ≥18 years of age and who have undergone an index gynecologic surgery at least 2 years prior to the start of the study.
2. Patients in whom COSEAL was used for the reduction of post-surgical adhesion formation

Exclusion Criteria:

1. Patients who had frank infection in the abdominopelvic cavity at the time of the surgery
Dasatinib Down-regulates the Expression of PD-1 and Enhances Killing pH + Leukemia Stem Cells

Research on the mechanism of dasatinib down-regulates the expression of PD-1 in CMV-activated NKG2C+NK cells and enhances killing pH + leukemia stem cells.

Some patients with CML can withdraw from TKIs after treatment, and the mechanism might be related to the effect of memory NK cells on anti-Ph+ leukemic stem cells (LSCs). Dasatinib affects immune through several pathways including the expression of PD1 in immune cells. Our previous work showed increased NKG2C+ NK cells were found in cases with CMV-DNA+ who suffered Ph+ leukemia and received Dasatinib, and these memory NK cells have anti-LSCs activity. We hypothesize that: CMV infection activates NKG2C+ memory NK cells proliferation; Dasatinib down-regulates the expression of PD1 in PD1+NKG2C+ NK cell subsets and then enhances anti-LSCs activity of these cells. In this study, the effect of Dasatinib on CMV-activated NKG2C+ cell subsets and its mechanism will be studies. Besides, the different NKG2C+ cell subsets on LSCs will be compared. This study might be helpful to clarify the mechanism of TKI withdrawal and to offer foundation for CMV and Ph+ ALL treatment strategies

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years old, gender is not limited
2. CML-CP patients treated with TKIs
3. No pregnancy was planned during the treatment

Exclusion Criteria:

1.The researcher judged that it was not suitable to participate in this study
Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Giza Governorate

- One single operator will assess the prevalence of molar incisor hypomineralization and its Severity among a group of Egyptian children .

the study is about the prevalance of molar incisor hypomineralization and its severity among a group of Egyptian children aged 8-12 years old in Giza Governorate schools.

* Participants will be randomly selected from primary and preparatory schools in Giza governorate, seated in the school lap or an empty classroom.
* Clinical examination will be made in the daylight using disposable diagnostic sets (mirror, and explorer). No diagnostic radiographs will be taken.
* Prior to performing dental examination, index teeth including incisors and 1st permanent molars will be cleaned using a cotton roll.
* A dental explorer will be further used for cleaning molar fissures.
* The examiner carefully inspect the coronal part of the 1st permanent molars and permanent incisors for demarcated opacities.
* A specially made examination chart will be taken for the child including his name, age, address, gender, school, date, medical health and any previous dental treatment.

prevalance of molar incisor hypomineralization is measured by presence or absence.

severity is measured by Modified index based on European Academy of Paediatric Dentistry (EAPD) criteria

Eligibility Criteria:
Inclusion Criteria:

* schools in Giza Governorate.
* Positive patient acceptance for participation in the study.
* Patients who are apparently medically free from any systemic disease.

Exclusion Criteria:

* Uncooperative child.
* Children with appliances.