cyrilzakka/clinical-trials huggingface dataset:
Effect Of Smart Phone Addiction On Pulmonary Function, And Functional Capacity In Children

Statement of the problem:

Are there relations between smartphone addiction, neck posture, pulmonary functions and functional capacity in children? Null hypothesis

It will be assumed that:

* There will be no effect of smart phone addiction on head posture, pulmonary function and functional capacity in children.
* There will be no relation between smartphone addiction, head posture, pulmonary function and functional capacity in children.

Subjects:

Sample size estimation will be carried out to determine the recruited number of children selected randomly from both governmental and private primary and preparatory schools at El Mansoura educational administration, Dakahlia Governorate and Damietta governorate to participate in this study. The survey targets the normal students from both sexes.

They will be selected based on the following:

Inclusion criteria:

* All children will be age ranges from 10 to 12 years
* The BMI \<95th percentile (WHO, 2007)
* Smartphone addiction scale short version will be used to categorize the children to addicted group (score \> 32) (Kwon et al., 2013) .
* They will be cooperative and followed the instructions.

Exclusive criteria:

Children will be excluded from the study if they have:

* Neurological diseases.
* Respiratory disorders.
* Congenital deformities.
* Vision disorders not corrected by glasses.
* Children who participate in competitive sports.
* Obesity.

Eligibility Criteria:
Inclusion Criteria:

* All children will be age ranges from 10 to 12 years
* The BMI \<95th percentile (WHO, 2007)
* Smartphone addiction scale short version will be used to categorize the children to addicted group (score \> 32) (Kwon et al., 2013) .
* They will be cooperative and followed the instructions.

Exclusion Criteria:

* • Neurological diseases.

  * Respiratory disorders.
  * Congenital deformities.
  * Vision disorders not corrected by glasses.
  * Children who participate in competitive sports.
  * Obesity.
Placebo Controlled Study of 3 Doses of Rifaximin-EIR Tablet to Treat Moderate, Active Crohn's Disease

This study aims to determine which of 3 doses of a non-absorbable antibiotic Rifaximin is most effective in treating active moderate Crohn's disease. Rifaximin tablets are already marketed in some European countries and the USA to treat traveller's diarrhoea. A new gastro-resistant form of Rifaximin called Rifaximin-Extended Intestinal Release (EIR) will be used in this study. These tablets dissolve in the stomach,releasing gastro-resistant granules which pass into the intestines and deliver Rifaximin directly to the site of the disease. Rifaximin is not absorbed, making it more effective and greatly reducing the frequency of side effects.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Crohn's disease localised in the ileum and/or colon, documented either radiologically or endoscopically at least 3 months previously;
* patients with a CDAI of ≥ 220 to ≤ 400;
* patients capable of and willing to conform to the study protocol;
* patients who have provided signed and dated written informed consent.

Exclusion Criteria:

* patients potentially needing immediate surgery for Crohn's disease, including patients with occlusive symptoms and/or stenotic tract with dilation above;
* patients with active perianal Crohn's disease;
* patients with other infectious, ischemic, or immunological diseases with gastrointestinal involvement;
* patients with symptoms attributed to Short Bowel Syndrome or previous surgery;
* patients with stoma;
* patients affected by upper gastro-intestinal disease (gastro-duodenum-jejunum Crohn's disease) alone or in combination with colitis or ileitis;
* patients treated with: oral steroids and budesonide less than 30 days prior to screening; i.v. steroids less than 30 days prior to screening; antibiotics (such as metronidazole, tinidazole, ciprofloxacin, clarithromycin) less than 15 days prior to screening;
* rectal steroids less than 30 days prior to the screening visit;
* anti-tumour necrosis factor (anti-TNF) and other biological therapies less than 6 months prior to the screening visit;
* pregnant women or nursing mothers;
* females of childbearing age (unless surgically sterile) without a negative urine pregnancy test at screening and at enrolment;
* patients with severe hepatic insufficiency (Child C);
* patients with severe cardiac insufficiency (NYHA - New York Heart Association classes 3 - 4);
* patients with known hypersensitivity to Rifaximin;
* any condition or circumstance that would prevent completion of the study or interfere with analysis of study results, including a history of drug or alcohol abuse, mental illness or non-compliance with treatments or visits, with immunological (including HIV infection), haematological or neoplastic disease;
* withdrawal of informed consent;
* patients who have used any investigational drug (except biological therapies) within 3 months prior to screening;
* patients who have donated 250 ml or more of blood in the last 3 months.
Regional Prophylactic Vancomycin in Revision Total Knee Replacement

The purpose of this study is to determine whether or not giving a lower dose of antibiotics (Vancomycin) in the area where it is needed (the knee joint) is more effective at preventing infection than the current standard dose which is given intravenously (IV) through a wrist vein.

Patients were assigned to one of two groups by chance (like a coin toss):

* GROUP 1 - Received 500mg of vancomycin into the tibia (shin) bone of the leg being operated on.
* GROUP 2 - Received 1g of vancomycin, which is the amount normally given to patients.

For both groups, the revision knee replacement will then be carried out as normal.

OTHER ANTIBIOTICS All patients received cefazolin IV (an antibiotic used to prevent infection) prior to the beginning of surgery to ensure effective preventive antibiotics. The patient will also received 3 postoperative doses of cefazolin over a 24-hour period (4 doses in total). This is standard of care for all total knee replacement surgeries.

TISSUE SAMPLES

* Ten (10) tissue samples were taken during the surgery, consisting of both bone and fat beneath the skin. Each sample were very small, around the size of a pinhead.
* In addition, a drain sample was taken from the knee joint drain fluid to measure vancomycin concentration the morning following surgery.
* These samples were frozen and sent to a lab for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Revision total knee arthroplasty
* Informed consent given

Exclusion Criteria:

* Current treatment with IV Vancomycin within the preceding 7 days
* Previous hypersensitivity to vancomycin
* Significant cardiac or respiratory abnormality
* Contraindications to using the intraosseous vascular access system (EZ-IO)
* Sepsis
Intraocular Pressure (IOP) Assessed by Dynamic Contour Tonometer (DCT) and Goldman Applanation Tonometry (GAT)

The purpose of this study is to evaluate an assessment of the intraocular pressure with the dynamic contour tonometry and the Goldmann applanation tonometry in patients with active anterior uveitis.

Keratoprecipitates are often found in anterior uveitis. Also elevation of the IOP can be seen in these patients. Goldmann applanation tonometry is the standard technique to assess the IOP but depends on the corneal thickness. Therefore IOP is measured by Goldmann and dynamic contour tonometry and corneal thickness is quantified by Orbscan at active uveitis and after the keratoprecipitates have disappeared.

Eligibility Criteria:
Inclusion Criteria:

* active anterior or panuveitis with keratoprecipitates

Exclusion Criteria:

* corneal endothelial dystrophy
Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma

Cholangiocarcinoma (CCA) is a heterogeneous group of cancers arising from the epithelial cells of bile ducts. Because of highly aggressive malignancy, most of the patients are diagnosed at an advanced stage and lose the chance to undergo surgery. As more effective and novel chemotherapy, targeted therapies, and immunotherapy become available, multiple treatments can be chosen for the patients with advanced CCA. Cytotoxic cell death during tumor chemotherapy triggers antigen release and induces strong anti-tumor effects of T cells. Tyrosine kinase inhibitors (TKI) can reduce the expression of PD-L1 and inhibit Treg cell infiltration, and together with immune checkpoint inhibitors, they can relieve tumor immunosuppressive microenvironment. Therefore,we aim to investigate the safety and efficacy of lenvatinib, tislelizumab combined with gemcitabine plus cisplatin (GPLET) in the treatment of advanced cholangiocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients.
* the world health organization (WHO)/ECOG physical state (PS) to 0 or 1.
* at least 1 RECIST 1.1 standard target lesions.
* not previously received immunotherapy, including but not limited to CTLA 4, PD-L1 or/and PD-1 inhibitors.
* adequate organ and bone marrow function, defined as follows: 9.0 g/dL or higher hemoglobin; neutrophil count 1.5 x 109 / L; platelet count 100 x 109 / L.

Exclusion Criteria:

* Active or previously documented autoimmune disease or inflammatory disease.
* Uncontrolled complications.
* History of other primary malignancies.
* Active infection.
* Women who are pregnant or breastfeeding.
Psychometric Validation of an Oral Health-related Scale for Quality of Life and Coping in People With Schizophrenia

Schizophrenia is a severe and persistent psychological disorder affecting 0.7 to 1% of the world's population and 600,000 people in France. Schizophrenic patients are exposed to excess mortality and a life expectancy that is 10 to 15 years lower than the general population (excluding causes of suicide) and to numerous co-morbidities, including oral diseases.

To improve this public health problem, concrete action must be undertaken and evaluated in both quantitative and qualitative terms. While there are many quantitative indicators, there are no reliable and valid tools for the perceived oral health of these individuals in the context of their real and/or imagined world.

The results of a qualitative study previously carried out by our team (QUALITY Study: NCT02730832) made it possible to develop two hypothetical questionnaires for evaluating quality of life related to oral health, the Schizophrenia Oral Health Profile (SOHP), and a questionnaire for evaluating coping strategies with regard to oral health, the Schizophrenia Coping Oral Health Profile (SCOOHP).

However, before these questionnaires can be used in clinical practice, their psychometric properties must be validated.


Eligibility Criteria:
Inclusion Criteria:

* Adult person,
* Patients for whom a diagnosis of schizophrenia is defined according to ICD 10
* Person who has given his or her oral agreement to participate in the study, with the agreement of the tutor in the context of a tutorship,
* Managed in a Specialised Institution (University Hospital, Psychiatric hospital or Hospital), either in full hospitalisation or on an outpatient basis,
* Fluent use of the French language.

Exclusion Criteria:

* Psychiatrically unstable and delusional patients.
* Patients with cognitive abilities too impaired to participate in the study
* Individuals with no natural teeth
* Pregnant or breastfeeding women
* Patients not affiliated to the national health insurance system.
Effect of Oligosaccharides and Optimizing Multiple Nutrients to Infant Formula on Growth and Development of Infants

The research objective is to compare the effects of infant formula supplemented with milk oligosaccharides and optimized with multiple nutrients on the immune function of infants under 1 year old with conventional infant formula, and to compare the effects of different infant formulas on infant intestinal health, immune function, growth and development, cognitive development, and tolerance with those of breastfed infants.

In this clinical trial, the effects of adding oligosaccharides to breast milk and optimizing multiple nutrients in infant formula, conventional infant formula, and breast milk on the growth and development of infants under 1 year old were evaluated by comparing the intestinal indicators (16s rRNA, SCFAs), inflammatory indicators, nutritional indicators, immune indicators, growth and development indicators, bone development indicators, tolerance indicators, cognitive development, adverse events, and serious adverse events of 80 experimental groups, 80 control groups, and 80 breastfeeding groups

Eligibility Criteria:
Inclusion Criteria:

* 0-28 days after birth;
* Single birth;
* The gestational age is between 37 and 42 weeks;
* Birth weight ranges from 2500 to 4000 grams;
* Parents or guardians agree not to allow infants to participate in other interventional clinical studies during the study period

Exclusion Criteria:

* Artificial assisted reproduction;
* The mother suffers from a disease that may endanger intrauterine growth;
* The mother suffers from pregnancy diabetes or serious metabolic disease or chronic disease during pregnancy
* Suffering from congenital malformations and genetic diseases, chronic diseases, and congenital diseases that may interfere with the investigation;
* Suffering from IgE mediated milk protein allergy, or having factors that increase the risk of milk protein allergy;
* Suffering from acute infection or gastroenteritis;
* Suffering from functional gastrointestinal diseases, such as gastroparesis;
* Currently participating in other clinical trials;
* Researchers cannot determine whether parents have the willingness or ability to comply with the requirements of the protocol.
Peking University Birth Cohort in Weifang (PKUBC-WF)

The PKUBC-WF is a prospective cohort study carried out in Weifang city of Shandong, China. The primary aim of this study is to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers and their children from birth to before 18 years old. Biological samples including peripheral blood, urine, placenta, umbilical cord, cord blood, and faeces are also collected.

Maternal and child health is of great concern globally. Early life phase of a fetus and infant is a critical period for the development of health and disease in the whole life. Exposure of negative environmental, nutritional and lifestyle factors in pregnant women during this period can have adverse effects on fetal and infant. In addition, for mothers, complications during pregnancy could also have a negative effect on long-term health of mothers, such as diabetes, hypertension. Thus, the Peking University Birth Cohort in Weifang is primarily aimed to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers, husbands and their children from birth to before 18 years old. Biological samples including peripheral blood, urine, placenta, umbilical cord, cord blood, and faeces samples are also collected.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman

  1. Pregnant women, 6-13\^+6 gestational weeks
  2. Resided in Weifang in the past half years and have no plan to move out after delivery
  3. Pregnant women who plan to have antenatal care and delivery in Weifang maternal\&Child Hospital.
  4. Pregnant women who is willing to participate in this study with informed consent
* Pregnant woman's husband

  1. His wife was eligible for enrollment
  2. He is the biological father of the child (his wife's current pregnancy)
  3. Pregnant women's husband who is willing to participate in this study with informed consent
* Offspring 4. Children born to pregnant women who met the inclusion criteria after enrolling in this study.

  5. Before the age of 8 years, his/her mother provided written informed consent. 6. After 8 years old, he/she agreed to continue this study and signed the informed consent.

Exclusion Criteria:

* Participants who cannot communicate normally.
Healing Assessment of Osseous Defects After Surgical Removal of Periapical Lesions

recruited patients with periapical lesions will be divided into three groups and surgically treated with three types of bone graft (hydroxyappatite, nanohydroxyappatite and PRF WITH NANOHYDROXTAPPATITE) and then evaluated for month, three months and six months for the healing of periapical bone


Eligibility Criteria:
Inclusion Criteria:

* The patient will be in range of 20-45 years of age at the time of treatment, having periapical lesions starting from 5mm or more in diameter related to failed endodontically treated single canaled teeth.

Exclusion Criteria:

* Any systemic debilitating disease such as:

Diabetes mellitus, renal disease, Liver disease or liver failure, Rheumatoid arthritis, Neoplastic disease or its treatment, chronic corticosteroid therapy, chronic hepatitis B or C , History of hepatitis A, pregnant females.
Clinical Evaluation of the Long-Term Effects of Contact Lens Care Systems

The purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old.
* Signed Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
* Require a visual correction in both eyes (monovision allowed but not monofit).
* Have a contact lens spherical distance requirement between +6.00D and -9.00D in both eyes.
* Astigmatism of 1.00D or less in the better eye and 1.50D or less in the other eye.
* Be correctable to a visual acuity of 20/30 (6/9) or better in each eye.
* Have normal eyes with no evidence of abnormality or disease.

Exclusion Criteria:

* Requires concurrent ocular medication.
* Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Clinically significant corneal edema, corneal vascularisation, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
* Worn lenses on an extended wear basis in the last 3 months.
* Diabetic.
* Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
* Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.
* Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
* Abnormal lacrimal secretions.
The Efficacy of Acupressure on Sleep Quality in Menopausal Women

Sleep disorder is a common problem in menopausal women and the decrease in the sleep leads to poor daily activity. Traditional Chinese acupressure is a noninvasive, effective and safe technique that can be easily taught to menopausal women so that they apply it as a self-care method and a manager of sleep disruption. The purpose of the present study was to evaluate the effectiveness of acupressure on sleep quality of postmenopausal women.This double blind randomized clinical trial was performed on 120 qualified menopausal women at the age of 41-65 years; and sleep quality was measured with Pittsburgh Sleep Quality Index (PSQI ).Participants were randomly assigned to an acupressure group, a sham acupressure group and a control group by two time randomized method (systematic and simple randomized). These interventions were carried out for 4 consecutive weeks. Participants in acupressure group and sham acupressure group learned to carry out acupressure technique as a self care at home with the simultaneous massage techniques that were to be performed 2 hours before sleep, whereas only conversation was used in the control group. The statistical software package for social science (SPSS) Version 17 was used for data analysis.


Eligibility Criteria:
Inclusion Criteria:

* spending at least 12 months after amenorrhea or follicle stimulating hormone
* (FSH) Serum level ≥ 40,
* healthy of the pressure points,
* having a full consciousness
* having an acceptable ability of listening
* speaking to receive training
* doing the self- care techniques at home,
* no mental and physical disorders,
* getting a score higher than 5 from the Pittsburgh Sleep Quality Index (PSQI)
* able to sit for about 30 minutes.

Exclusion Criteria:

* having specific eating diets,
* addicted to narcotic drugs,
* using the drugs causing sleep disorders,
* suffering from special disease,
* taking hormonal drugs during 3 last months,
* using herbal medicine to improve the menopausal symptoms,
* BMI higher than 30,
* having the moderate and severe depression based on Beck Depression Inventory,
* feeling of severe tiredness/ fatigue and anxiety,
* having circular job specially night job
* lack of cooperation with researchers.
Dissemination of a Weight Management Program Among US Veterans

This study is being conducted with the Veterans Affairs National Center for Health Promotion and Disease Prevention (VANCP), which is overseeing the current dissemination of MOVE! (Managing Overweight/Obesity for Veterans Everywhere), a national weight management program for veterans. It will be based at 10 local sites in the national network of VA medical settings and community-based outpatient clinics and will compare two different models for disseminating and implementing MOVE! using a randomized experimental design. One study arm will implement the MOVE\* VETS! (Volunteer Education and Tailored Self-management and support) model that includes tailored newsletters and peer counseling MI calls and activities, and the other will receive the standard MOVE! program.

The purpose of this research is to study the dissemination and implementation of MOVE!. MOVE! is a national weight management program for veterans that has moved form pilot to full dissemination. Overweight and obesity are rapidly rising in the United States and interventions to combat this epidemic are desperately needed. Within the VA population, approximately 70% of veterans are overweight and or obese. Participants will be male and female Veterans, aged 21 and over receiving health services at one of the 10 study sites, who qualify for the MOVE! program. We are recruiting a minimum of 800 -1000 Veterans to complete a baseline survey at the 10 VA sites participating in the study. Participants at the 10 VA sites are recruited during a primary care visit by primary care provider, they will not be chosen based on the presence or absence of any disease, thus health status will vary. The primary outcome measures will be participation after enrollment into MOVE! and participant weight loss.

Eligibility Criteria:
Inclusion Criteria:

* Receiving primary care at the one of the 10 selected VA centers
* BMI 25 or over
* 21 years old, no upper age limit
* Pregnant women may participate in the study with the approval of the VA medical staff

Exclusion Criteria:

* Not a patient at one of the 10 VA sites
* BMI less than 25
* Under 21 years of age
* Pregnant without medical approval to participate
Evaluating Expectancy Effects in Weight Loss Measurement

The purpose of this project is to examine potential bias or expectancies in individuals' measurement and recording of weight in a clinical-research setting.


Eligibility Criteria:
Inclusion Criteria:

* 19+ years-old
* available to attend clinic sessions on dates provided for data collection

Exclusion Criteria:

* younger than 19 years
* not available on specified dates of data collection