cyrilzakka/clinical-trials huggingface dataset:
Comprehensive Analysis of the Program:Salud Escolar

The purpose of this study is to comprehensively evaluate Salud Escolar (School Health), a program led by the Mexican Ministries of Health and Education. This comprehensive evaluation considers a design, implementation, results, and impact evaluation of Salud Escolar.

This study aims is to comprehensively analyze the design, implementation, results, and impact of Salud Escolar, a program led by the Mexican Ministries of Health and Education, during the first phase of implementation, from August 2020 to July 2021. Salud Escolar considers the World Health Organization (WHO) health promoting framework to foster a healthy environment and enhance children's physical activity, healthy eating and hydration. Salud Escolar consists on several activities aligned in the following components: healthy eating, healthy hydration, physical activity and additional cross sectional strategies.

The first phase of implementation will be conducted in a total of 58 schools located in Mexico City purposively selected by the Ministry of Education.

The design evaluation will use available policy documents and program implementation guidelines, scientific literature, to investigate wether the design of Salud Escolar is adequate to achieve the proposed objectives.

The implementation evaluation will be conducted in a sub-sample of 6 intervention schools using qualitative methodologies among key informants.

The results evaluation will be conducted in the 58 intervention schools and pre-post changes in self-reported knowledge, attitudes and practices related to healthy eating, hydration and being physically active will be measured.

The impact evaluation aims to evaluate the effect of Salud Escolar on the consumption of fruits, vegetables and plain water and daily moderate to vigorous physical activity. A sample of 1200 children (6-12 years old) in 15 intervention schools- randomly selected from the sample of 58 intervention schools-, and 15 comparison schools - randomly selected from the waiting list of available schools in the city will be recruited.

Based on the results derived from this analysis, a set of recommendations will be provided to improve the feasibility of scaling up the program at the national level during the second and third phases of Salud Escolar.

Eligibility Criteria:
School

Inclusion criteria:

* Public school
* Minimum of 200 children

Exclusion criteria:

+ None

Children

Inclusion Criteria:

* Aged 6 to 12 years
* Grades 1-6
* Attending school on the day of recruitment at the included schools in Mexico City, Mexico during the school-year 2020/2021

Exclusion Criteria:

+ Schoolchildren with a physical or mental disability not able to participate in daily physical activity or other intervention components or measures.
Vaginal Progesterone Versus Progesterone in Oil in Donor Egg Recipient In Vitro Fertilization Cycles Utilizing Vitrified Donor Eggs

The aim of this study is to evaluate both pharmaceutical therapy and advanced treatment techniques for infertile patients requiring in-vitro fertilization utilizing donor eggs.

The primary objective of this study is to evaluate the clinical pregnancy rate of micronized progesterone (Endometrin, Ferring Pharmaceuticals) compared to progesterone in oil injections in in-vitro fertilization (IVF) donor egg recipients. The secondary objective is to evaluate the effectiveness of freezing/vitrification of donor eggs. Effectiveness of vitrification will be evaluated by egg thaw/survival, fertilization, and implantation rates.

Eligibility Criteria:
Inclusion Criteria:

Oocyte Donors:

* Age 21-34 years of age
* BMI 18-34
* Normal ovarian reserve, defined as FSH \<10 and AFC \>10
* Medical evaluation consistent with FDA criteria for donor inclusion

Donor Oocyte Recipients

* Documented history of infertility requiring donor oocyte for optimal fertility potential
* Documentation of a normal uterine cavity by hysteroscopy, hysterosonogram, or HSG within 1 year of study screening
* Fresh or Frozen Sperm

Exclusion Criteria:

Oocyte Donors:

* Abnormal ovarian reserve, defined as FSH \<10, AFC\>10, prior poor response to controlled ovarian hyper-stimulation(COHS)
* Failure to meet FDA criteria for donor approval (risk factor and medical evaluation)
* Previous history of poor response to COHS

Donor Oocyte Recipients:

* Uncontrolled hypothyroidism, hyperprolactinemia, or systemic disease that may interfere with study treatment
* Active thrombophlebitis or thromboembolic disorders, or a history of hormone associated thrombophlebitis or thromboembolic disorders
* Surgically aspirated sperm (TESE)
* 2 or more clinical pregnancy losses (excluding aneuploidy for previous autologous cycles)
* Clinically significant gynecologic pathology or uterine abnormality, such as submucosal fibroids \> 5 cm, communicating hydrosalpinx, uncorrected uterine septum, undiagnosed vaginal bleeding, endometrial atypia, or any other condition that could adversely affect pregnancy outcomes
* History of 2 or more failed IVF donor cycles
Minimally Invasive Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases

To examine survival of patients who underwent minimally invasive versus open liver resection for colorectal cancer with liver metastases.

the minimally invasive procedure contain laparoscopic or robotic surgery

Eligibility Criteria:
Inclusion Criteria:

* patients were diagnosed with colorectal cancer liver metastases
* without extra-hepatic liver metastases
* age were within 18-75 yeas
* the numbers of metastases more than 3
* the maximal tumor size of liver metastases more than 10 cm

Exclusion Criteria:

* liver metastases were unresectable.
The Correlation Between Renal Injury and Biomarkers in Pediatric Ureteropelvic Junction Obstruction Patients

Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be related with the degree of hydronephrosis in pediatric ureteropelvic junction obstruction (UPJO) patients. We are trying to analyze whether it is related with the grade of renal injury in UPJO patients.


Eligibility Criteria:
Inclusion Criteria:

\<Group 1\>

1. 0-3 year old patients with SFU grade 2 or more hydronephrosis without ureteral dilatation
2. needs pyeloplasty due to differential renal function (DRF)\<40%, decreased DRF by more than 5%, development of urinary tract infection, development of urinary stone, and development of pain related with UPJO \<Group 2\>

1. 0-3 year old patients with SFU grade 3 or 4 hydronephrosis without ureteral dilatation 2. doesn't meet the above criteria for the indication of pyeloplasty \<Group 3\>

1. 0-3 year old children without any abnormality of urinary tract

Exclusion Criteria:

\<Group 1\>

1. patients with contralateral disease affecting DRF
2. history of previous urinary tract surgery
3. follow up loss before diuretic renogram performed at 6-12 months from operation \<Group 2, 3\>

1. patients with contralateral disease affecting DRF 2. history of previous urinary tract surgery
Effects of Preoperative 3D Printing of Distal Intra-articular Radius Fractures on Quality of Fracture Reduction

The investigators aim to evaluate the effect of a preoperative 3D printed Model (3PAS) of distal intraarticular radius fractures on quality of fracture reduction. Surgical procedure is equal in the 3PAS and in the conventional group. To evaluate the quality of fracture reduction each patient receives a postoperative CAT-scan.


Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years
* Surgery criteria fulfilled
* Informed consent
* Intra-articular Fracture of the distal radius (AO 23-B and 23-C) (also including Avulsion of the processus styloideus ulnae AO/OTA 2U3A1.1) in preoperative CAT-Scan

Exclusion Criteria:

* Patient does not want a surgical treatment
* Patient does not want to participate
* Positive history for surgery due to injury of the hurt wrist beforehand
* Positive history for surgery due to injury of the opposite wrist beforehand
* Additional injuries to the hand and forearm (except distal ulna fracture AO 2U3A1.1)
* Pregnancy
* Vulnerable people
* Distal ulna fracture (except AO 2U3A1.1)
* Extraarticular radius fracture (AO 23-A)
* Concomitant injuries which interfere with the planned aftercare (intubated for a long time, additional elbow or shoulder fracture)
Investigating Health Related Quality of Life in Patients With Chronic Respiratory Failure

To determine the quality of life of patients living with chronic respiratory failure and the impact interventions have on it.

To determine the quality of life of patients living with chronic respiratory failure and the impact interventions have on it.

Eligibility Criteria:
Inclusion Criteria:

Diagnosed with chronic respiratory failure receiving any of:

* Non-invasive ventilation
* Prolonged mechanical ventilation
* Mechanical insufflation-exsufflation therapy

Exclusion Criteria:

* Aged \<18
* Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol
Different Volumes of Durolane in Knee OA

The purpose of the study is to assess the safety and efficacy profiles of new single-injection volumes of Durolane in patients with knee OA.

To assess the safety and efficacy profiles of different volumes of Durolane in patients with knee OA and compare with the current standard single-injection of the product. The study aims to investigate whether different volumes of Durolane compared to the standard injection volume will improve the benefit/risk profile.

Eligibility Criteria:
Inclusion Criteria:

* Subject (female or male)
* 40-85 years of age
* Unilateral knee pain fulfilling American College of Rheumatology (ACR) criteria for diagnosis of osteoarthritis(OA)
* Radiographic evidence of OA in the study knee
* WOMAC pain score of 7-17 in the study knee
* WOMAC pain score of 2-3 in the study knee (WOMAC Likert 3.1 A1)
* Subject normally active
* Subject has attempted but not responded adequately to previous non-pharmacological therapy(ies)and to simple analgetics
* Subject cooperative and able to communicate effectively with the investigators
* Body mass index ≤ 35 kg/m2;
* Signed informed consent obtained

Exclusion Criteria:

* Knee effusion
* Contralateral knee OA
* Clinically significant joint pain from joints other than the knee
* Previous intra-articular steroid injection into the study knee within the last 6 months
* Previous intra-articular Hyaluronic Acid (HA) injection into the study knee within the last 9 months
* Previous allergic type reaction to a HA product
* Treatment with analgesics other than paracetamol (acetaminophen) (including topical agents for the knee) within 5 half lives of the drug prior to the baseline visit
* Use of analgesics 48 hours preceding the baseline visit
* Use of systemic glucocorticosteroids (excluding inhaled steroids) within the last 3 months
* Treatment with glucosamine/chondroitin sulfate initiated within the past 3 months
* Change in physical therapy for the knee within the last three months
* Arthroscopy or other surgical procedure in the study knee within the past 12 months
* Serious injuries to the study knee in the past
* Any planned arthroscopy or other surgical procedure during the study period
* Previous history or presence of active septic arthritis
* Active skin disease or infection in the area of the injection site
* Systemic active inflammatory condition or infection
* Bleeding diathesis or use of anticoagulants
* History of drug or alcohol abuse within 6 months
* Any medical condition that in the opinion of the investigator makes the subject unsuitable for inclusion
* Pregnant or breastfeeding woman or woman of childbearing potential not practicing adequate contraception
* Involvement in other clinical trials
Bone Health in Hyperemesis Gravidarum

The purpose of the study is to determine whether maternal bone resorption would be seen in Hyperemesis Gravidarum and could be detected in early period using serum vitamin D levels, serum calcium (Ca) levels, serum parathormone (PTH) levels and urine N- telopeptide levels in the patients with Hyperemesis Gravidarum.


Eligibility Criteria:
Inclusion Criteria:

* Between 7. and 20. weeks of gestation pregnant women in both groups
* İn hyperemesis group; 5% weight loss with regard to pre-gestation vomiting more than 3 times 3-5 % weight loss with ketonuria.

Exclusion Criteria:

* Other pathologies that cause nausea and vomiting in pregnancy gastroenteritis gastroparesis gall duct diseases hepatitis peptic ulcers appendicitis pyelonephritis ovarian torsion urinary tract stones diabetic ketoacidosis hyperthyroidism hyperparathyroidism migraine pseudo tumor cerebra vestibular diseases
* Additionally some situations causing to rise of Ntx levels osteoporosis paget disease bone tumors
* Furthermore some of conditions resulted in pre-menopausal osteoporosis or decreasing in Bone Mineral Density Malignancy Smoking Celiac Disease Depression Inflammatory Bowel Disease Pre-gestational Diabetes Chronic Kidney or Liver Disease Drug Use such as steroids, anticonvulsants, antiepileptic, heparin or low molecular weight heparin
Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus

To explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with high level of HBV DNA.

Telbivudine and Lamivudine,a preganancy category B medication,reduces HBV DNA and normalizes serum ALT in chronic hepatitis B patients with few adverse effects.Two aspects on the drug use in pregnancy will be evaluated prospectively in this study.

Eligibility Criteria:
Inclusion Criteria:

HBeAg+CHB pregnant woman gestational age 28 weeks HBV-DNA\>log10 copies/ml

Exclusion Criteria:

co-infection with hepatitis A,C,D,E or HIV evidence of hepatocellular carcinoma decompensated liver disease or significant co-morbidity concurrent treatment with immune-modulators,cytotoxic drugs,or steroids clinical signs of threatened miscarriage in early prenancy evidence of fetal deformity by ultrasound examination the biological father of the child had CHB
Hypertension in Patients Hospitalized With COVID-19

Some studies have shown that the main pathogenesis of patients with covid19 is related to ACE2 receptor. Lung is one of the main organs, and there are many ACE2 receptors in cardiovascular system. ACEI / ARB is the main target of antihypertensive drugs. Previous reports suggested that there were large number of patients with covid19 also suffered from hypertension, suggesting that patients with hypertension may be the susceptible to covid19. Therefore, we try to follow up the patients admitted to Hankou hospital to explore the impact of hypertension and hypertension treatment on the severity and prognosis of patients with covid19, so as to provide new methods for the treatment of patients with covid19 in the future.

In December, 2019, a cluster of severe pneumonia cases of unknown cause emerged in Wuhan, China, with clinical presentations greatly resembling viral pneumonia1. Deep sequencing analysis from lower respiratory tract samples indicated a novel coronavirus, which was named 2019 novel coronavirus (2019-nCoV, then named COVID-19). Up to Mar 16, 2020, the total number of patients had risen sharply to 153,546 confirmed cases worldwide (http://2019ncov.chinacdc.cn/2019-nCoV/global.html). The data extracted from 1099 patients with laboratory-confirmed COVID-19 in China from January 29, 2020 showed that hypertension is the most common coexisting illness of COVID-19 patients, ranging from 13.4% in nonsevere patient vs. 23.4% in severe patients, and the total incidence is as high as 15%2. Interestingly, ACE2 is involved in the pathogenesis of both hypertension and SARS-COV-2 pneumonia. The above reasons prompted us to speculate that the organs attacked by SARS-COV-2 might not only be lungs, but also include other ACE2 expression organs, especially cardiovascular system. In addition, patients with comorbid hypertension, especially those with long-term oral ACEI/ARB medication for hypertension, might have different susceptibility and severity levels of pneumonia upon SARS-COV-2 attack. Therefore, we investigated and compared the demographic characteristics, coexisting disease, severity of pneumonia, and the effect of antihypertensive drugs (ACEI/ARB versus non-ACEI/ARB) in patients with COVID-19 coexisting hypertension, thereby, hopefully, to reduce the mortality and morbidity associated with hypertension in patients with COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 pneumonia patients diagnosed by WHO criteria

Exclusion Criteria:

* Patients who were younger than 18 years.
* Patients whose entire stay lasted for less than 48 hours.
Effect of Dill Seed on Uterus Contractions Pattern

Dill is herbaceous and aromatic herb used in order to convenient and shorter labor in Iran. The objective of this study was to evaluate the effect of Dill seed on uterus contractions in active phase of labor.


Eligibility Criteria:
Inclusion Criteria:

* 18-35 yrs, primiparous, having single fetus with cephalic presentation, gestational age 37-42 weeks, having no medical diseases, having no history of hospitalization due to psychological diseases, having no addiction to cigarette, having no complications during pregnancy such as hypertension, and BMI\< 26.
Clinical Observation on Kuntai Capsule in Treating Early-onset Ovarian Hypofunction

To evaluate the efficacy and safety of Kuntai capsule alone or combined with hormone therapy in improving ovarian function in POI patients (including subclinical stage).

The study is expected to be conducted between 2021.08 and 2023.12.120 subjects with early-onset ovarian insufficiency will be randomly assigned to trial, control, or combination groups using a computer-generated randomization table.By comparing the data of primary efficacy indexes, secondary efficacy indexes and safety indexes before and after medication, The principal investigator will write and publish the paper.

Eligibility Criteria:
Inclusion Criteria:

1. The women aged \<40 years old.
2. Serum basal follicle stimulating hormone (FSH) level ≥15 IU/L at least twice inspection (two occasions \>4 weeks apart). Rare menstruation or menopause for at least 4 months.
3. Individuals meeting the above criteria who voluntarily consented to study participation.

Exclusion Criteria:

1. Pregnant and lactating patients;
2. Patients with endometriosis, adenomyosis, endometrial lesions (submucous fibroids, endometrial polyps, etc.), hysteromyoma \> 4cm or hysterectomy;
3. Patients with known or suspected breast cancer history and estrogen-dependent malignant tumor;
4. Patients with personal history of venous thromboembolism (VTE) or high risk of VTE (including body mass index \> 30 kg/m2, smoking and family history of thrombosis);
5. Patients with porphyria;
6. Patients with serious primary diseases or mental illness such as cardiovascular, liver, kidney and hematopoietic system;
7. Patients who are participating in other clinical trials or have participated in other clinical trials in the past three months;
8. Patients who suspect or have a history of alcohol and drug abuse;
9. Patients who are known to be allergic to the test drugs or their components;
10. The researchers determined that patients are not suitable for this trial.
Safety Procedure Pulmonary Artery Denervation in Addition to Pulmonary Vein Isolation Combined With Ganglionated Plexi Ablation in Patients With Persistent Atrial Fibrillation and Pulmonary Hypertension

Some patients with a long history of AF develops PH "reactive" type with an increase in pulmonary vascular resistance due to vasoconstriction or structural changes of the vascular wall. RFA PVI + RFA GP is the "gold standard" in the treatment of patients with persistent AF, do not respond to optimal therapy. The rear area of the pulmonary artery bifurcation is adjacent to the roof and part of the front of the left atrium. In the projection of this area are ganglionic plexus of the left atrium, the sympathetic nerve fibers of the pulmonary artery and baroreceptors main pulmonary artery.Recent studies have shown that radiofrequency denervation of the pulmonary artery improves the quality of life in patients with PH.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic, drug - refractory AF ( inefficiency 1C or III Class antiarrhythmic drugs), history of AF 6 months or more without the restoration of sinus rhythm.
* MPAP ≥25 mmHg
* PCWP≥15 mmHg
* Pulmonary vascular resistance (PVR). The PVR =(mPAP-PCWP)/ carbon monoxide\] \> 2.5 woods unit

Exclusion Criteria:

* Left ventricular ejection fraction \<35%
* Diameter LA\> 60 mm on transthoracic echocardiography in the "M" -Mode or volume of LA more than 140 ml
* Significant regurgitation at the mitral valve
* Uncorrected congenital heart disease
* RFA PVI, RFA GP, PADN in history
* Foregoing heart surgery
* Life expectancy less than 12 months
* WHO group I, III, IV, V pulmonary artery hypertension
* Tricuspid valve stenosis, pulmonary supravalve stenosis.
* Cancer
* Pregnancy
* Thromboembolism LA history
* Hyperthyroidism.
Optical Biopsy for Peripheral Pulmonary Lesions

The purpose of the study is to describe confocal laser endomicroscopy (CLE) interpretation criteria for different types of peripheral pulmonary lesions (PPLs), with histopathological correlation, and to perform the validation of these criteria.

CLE is a modern imaging technique that uses an excitation laser light to create real-time microscopic images of tissues. During transbronchial lung biopsy, CLE has the potential to provide real-time non-invasive diagnosis of PPLs ("optical biopsy"). In this study, we will obtain CLE images within the target lesion before taking a biopsy during transbronchial lung biopsy of PPLs. We will compare the results of the "optical biopsy" with the corresponding histopathological results and develop CLE interpretation criteria for different types of PPLs. In addition, we will perform the validation of these criteria to evaluate the ability of CLE to discriminate between benign and malignant PPLs.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 years.
2. Chest CT shows peripheral pulmonary lesions (peripheral pulmonary lesions are lesions beyond the segmental bronchi that are invisible during bronchoscopy), and transbronchial biopsy is considered necessary and feasible.
3. Patients who have good compliance and sign informed consent.

Exclusion Criteria:

1. Patients with known allergy for fluorescein.
2. Pregnant or lactating women.
3. Patients with contraindications of bronchoscopy.
4. The investigators believe that patient has other conditions that are not suitable for the study.
Investigational Study of Oral Fish Oil in Treating Parenteral Nutrition Associated Liver Disease

The purpose of this study is to investigate the usefulness of oral fish oil(Lovaza)in normalizing liver function in patients who have parenteral nutrition associated liver disease. The investigators believe that patients who take oral fish oil will normalize liver function faster than those who do not

This is designed as a randomized placebo controlled trial of oral fish oil (Lovaza) in normalizing parenteral nutrition associated liver disease.

Eligibility Criteria:
Inclusion Criteria:

* History of parenteral nutrition(PN)administration \>4weeks
* PN associated liver disease from intestinal failure
* ability to take full enteral feed
* body weight equal or greater than 3kg
* elevated ALT level twice of that normal(ALT\>84)at the time PN is weaned off

Exclusion Criteria:

* Hemodynamic instability
* renal failure
* suspected congenital obstruction of the hepatobiliary system
* diagnosis hepatitis A, B, or C
* diagnosis of alpha 1-antitrypsin deficiency
* diagnosis of cytomegalovirus infection
* diagnosis of HIV
* children in care