cyrilzakka/clinical-trials huggingface dataset:
Non-interventional Cross-over Study to Reduce Items of PROactive Tools Measuring Physical Activity in Chronic Obstructive Pulmonary Disease (COPD)

The purpose of the protocol is to develop final draft PRO instruments of physical activity in daily life to be used and evaluated in the further validation studies measuring physical activity in chronic obstructive pulmonary disease (COPD) patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria: post bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)\<70%) confirmed with spirometry in stable clinical conditions. For patients recruited during an exacerbation, the diagnosis of COPD should be confirmed in stable conditions.
* Current or ex-smokers with a smoking history equivalent to at least 10 pack years.
* Able to read and write and to use electronic devices and physical activity monitor.

Exclusion Criteria:

* Orthopaedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator.
* Respiratory diseases other than COPD (e.g. asthma).
* Cognitive impairment, as judged by the investigator
Local Proof of Concept of Evira in Abu Dhabi Study

Evira is a digital treatment tool developed for treatment of childhood obesity. Through daily weighings at home using a special scale together with a message function in the Evira application, parents and the clinicians can easily follow the child's weight development. The primary aim of this study is to evaluate its efficacy for childhood obesity treatment in Abu Dhabi, with a secondary objective to establish non-inferiority compared to outcomes in a cohort in Stockholm, Sweden.

Obesity remains a critical global health concern. Traditional treatment often yields limited results, necessitating innovative solutions.

In this study, participants aged 6-15.9 years with obesity at the Sheikh Shakabout Medical City in Abu Dhabi, will be asked for participation. If agreed to participate, they will use a digital treatment tool as a complement to behavioral treatment.The treatment is based on outcome goals set by the treatment staff together with the family. Briefly, the families follow the child's weight outcome via daily weight measurements and the outcome is shown graphically in the mobile application as BMI SDS with the BMI SDS weight goals as background. The staff will provide support to the families via the app. The staff is encouraged to react and contact the families if the weight goals are not reached or if they fail to perform the daily weighings. Regular physical visits at baseline, 3 months, and 6 months, alongside questionnaire assessments, will facilitate data collection via electronic case report forms.

The purpose of this study is to evaluate the treatment tools efficacy for childhood obesity treatment in Abu Dhabi. Furthermore, the study aims to establish non-inferiority compared to outcomes in Stockholm, Sweden (referred to as the "Stockholm cohort"), on 107 children and adolescents who were treated with the same treatment method between October 2018 and August 2019 (Clinicaltrials.gov ID: NCT04323215).

Eligibility Criteria:
Inclusion Criteria:

* Age \>6.0 and \<16.0 years of age at inclusion
* Obesity according to International Obesity Task Force (IOTF)
* Willingness to participate in an obesity treatment proof of concept trial
* Family ability to communicate e.g. write and read messages in the mobile application
* Parents having a smart phone and an email address

Exclusion Criteria:

* Morbid obesity defined as iso-BMI\>40 kg/m2 independently of age
* Endocrine disorders other than well controlled hypothyroidism
* Metabolic disorders of importance for weight control
* Treatment for depression and other psychiatric disorders during the last 6 months before inclusion
* Pharmacological treatment of importance for weight control
* Hypothalamic or monogenic obesity, e.g. syndromes and Mb Down
* Severe neuropsychiatric disorders that could affect study compliance
* Eating disorders requiring therapy during the last six months before inclusion or observed at the inclusion screening.
Effectiveness Study of a Behavioral Teacher Program Targeting ADHD Symptoms

The goal of this study was to investigate the effectiveness of a behavioral teacher program addressing symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) in the classroom.

Background:

Most behavioral teacher programs involve intensive and expensive teacher trainings by health care specialists, which may limit successful large-scale implementation. This behavioral program, on the contrary, involves a self-containing manual that does not require expert training in order to increase the likelihood of successful implementation (if proven effective). The aim was to investigate the program's effects on behavioral, socio-emotional and school functioning in primary school children.

Methods:

Children with ADHD symptoms were randomly assigned at school level to the intervention condition (receiving the program during 18 weeks) or control group (not receiving the program but who were allowed to receive care as usual).

Measures to assess program's effectiveness:

* Strengths and Weaknesses of ADHD-symptoms and Normal Behavior,
* Strengths and Difficulties Questionnaire
* Social Skills Rating Scale
* Spence Children's Anxiety Scale
* Classroom Observation Code
* Actigraphy
* Sociometric measures (peer nomination and peer rating)
* Dutch arithmetic test (Tempo-Test-Rekenen)
* reading test (Drie-Minuten-Toets) and writing test (PI-dictee).

Additional measures:

* Wechsler Intelligence Scale for Children (Block Design and Vocabulary; used to estimate IQ);
* Sensitivity to Punishment and Sensitivity to Reward Questionnaire and several neuropsychological computer tasks

Eligibility Criteria:
Inclusion Criteria:

* sub-threshold or clinical level of ADHD symptoms as observed by participant's teacher through the Dutch version of the Disruptive Behavior Disorders Rating Scale (Pelham, Gnagy, Greenslade, \& Milich, 1992)
* at least one clinical and three sub-threshold ADHD symptoms as measured by the Teacher Telephone Interview (Holmes et al., 2004), a semi-structured interview which is based on the Diagnostic and Statistical Manual of Mental Disorders (American Psychiatric Association, 2000)

Exclusion Criteria:

* (medication) treatment for ADHD at study entry or in preceding 6 months;
* neurological or severe physical condition
* IQ \< 80 based on a short version of the Wechsler Intelligence Scale for Children (Block Design and Vocabulary; Legerstee, van der Reijden-Lakeman, Lechner-van der Noort, \& Ferdinand, 2004; Hrabok, Brooks, Fay-McClymont, \& Sherman, 2014)
* participant enrolled in a daily contingency management program or other teacher program targeting behavior or social problems at study entry or in the preceding month
* Maximum of 2 children per classroom and 5 classrooms per school (in order to limit teachers' burden and increase heterogeneity of teacher and classroom settings)
Preventing Caries with Silver Diamine Fluoride

Background: Early childhood caries (tooth decay, ECC) affected 55% 5-year-old Hong Kong children, and 70% of these children had gross destruction of the upper anterior teeth with negative long-term impacts on health and quality of life. The existing standard of care for prevention of ECC, topical application of 5% sodium fluoride (NaF) varnish, is inadequate. In Hong Kong and other parts of the world, 38% silver diamine fluoride (SDF) solution, applied topically to cavities, is used to arrest ECC. Work published by our research group suggests it likely also has a preventive effect of ECC. Moreover, SDF has been shown to be preventive in tooth decay in permanent teeth. Nevertheless, no pivotal clinical trial has been performed to support a change in usual practice.

Aim: This is a Phase II single-centre randomized, double-blind, active-controlled, parallel-group pragmatic trial with two arms to assess the effectiveness of 38% SDF and 5% NaF in preventing new caries lesions in primary anterior teeth. Methods: 688 three-year-old kindergarten children who are healthy will be recruited, stratified by school, and block randomized to receive either 38% SDF (treatment group) or 5% NaF (standard treatment group) therapy on primary upper anterior teeth. This sample size is sufficient for a superiority trial with power at 90%, allowing for a 15% dropout rate. The primary outcome is the number of sound tooth surfaces that become cavitated caries per child at 12-month follow-up. The secondary outcome is the number of carious tooth surfaces developed after baseline that become arrested at 12-month for each child. Dental examinations for the status of caries (active or arrested) will be conducted by the same calibrated examiner. The examiner, children and children's parents will be blind to treatment allocation. Parents will be surveyed to study the children's oral health-related behaviours and socioeconomic backgrounds, which will allow the adjustment for effect modification. Possible results and implications: If the results are as anticipated, it will help change the standard of care for caries prevention. If adopted in Hong Kong, SDF therapy will prevent 20,800 (13% of the 160,000) kindergarten children from having caries developed in their anterior teeth, thus reduce significantly the burden of ECC of the children and related stress of their family. Moreover, the results will be widely available and increase adoption of SDF in other countries to reduce the global burden of ECC among children.


Eligibility Criteria:
Inclusion Criteria:

* generally healthy, with parental consents

Exclusion Criteria:

* uncooperative and difficult to manage, have major systemic diseases such as porphyria, or are on long-term medication such as anti-epileptic drugs.
Study on ICU Patients With Nosocomial Lower Respiratory Tract Infections

This is a multicentre, multinational, prospective observational investigation on ICU critically ill patients affected by nosocomial pneumonia, defined as: Out of ICU Hospital-acquired Pneumonia (HAP), Non-ventilator ICU-acquired Pneumonia (NV ICUAP), Ventilator associated pneumonia (VAP) Ventilator associated tracheobronchitis (VAT).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of nosocomial pneumonia
* ICU and HDU admission (patient may be admitted to the ICU with NP or may develop pneumonia during ICU stay)
* Informed consent (if required)

Exclusion Criteria:

* Community Acquired Infection
* Absence of Microbiological Findings
Visual Quality and Contrast Sensitivity Function for Limbal Dermoid Children After Corneal Transplantation

This study is to inquiry the contrast sensitivity function in the 50 eyes of limbal dermoid children with keratoplasty with quick contrast sensitivity function (quick CSF) test, as well asa to analyze its relationship between visual quality.

Limbal dermoid(LD) is a congenital benign tumor that consist of overgrowths of epidermal appendages that influence vision and cause visual abnormalities due to the induced corneal astigmatism. A large proportion of patients, all of whom had epibular dermoids, has amblyopia. In a previous study, keratoplasty, such as LKP (Lamellar Keratoplasty) or PKP (Penetrating Keratoplasty), was shown to facilitate the reconstruction of appearance, and improve visual acuity significantly postoperatively. However, the reestablishment of visual acuity and visual function are always ignored by parents after visual appearance recovery. Several studies have evaluated the visual acuity and objective and subjective visual function of patients after keratoplasty. These outcomes include contrast sensitivity (CS), refractive error, graft clarity, anterior and posterior corneal higher order aberration, and vision-related quality of life. Although a subjective visual function assessment has been deemed critical, postkeratoplasty patients with vision complaints are not uncommon despite clear grafts and relatively good visual acuity, and the visual function evaluation for LD were relatively less.

50 eyes of 50 limbal dermoid children with corneal transplantation more than 1 year were included in this study. All participants underwent an ophthalmic examination that included slit-lamp biomicroscopy, visual acuity, quick CSF under full optical correction, 9-SF life quality questionnaire and fundus examination. Then the normal group would be covered by the positive spherical lens of 1.0D to 6.0D to repress the BCVA to 0.1 to 0.9 respectively to compare the visual functions with the keratoplasty patients on the same visual acuity.

Eligibility Criteria:
Inclusion Criteria:

* Accept the corneal transplantation based on the clinical diagnosis of ocular surface disease;
* more than 7 and less than 60 years old;
* absence of other ocular disorders and no history of eye surgery and other systemic diseases.

Exclusion Criteria:

* less than 7 or more than 60 years old;
* with the history of eye surgery and other systemic diseases.
Clinical Study of Umbilical Cord Mesenchymal Stem Cells Combined With Collagen Scaffold in the Treatment of Thin Endometrium

This is a non-blind self-control trial. We mainly compare the changes of endometrial thickness，changes in menstrual flow, and improvement in pregnancy before and after stem cell treatment in patients with thin endometrium.

According to the medical history and the results of the examination, the selected cases were screened and the informed consent was signed. After hysteroscopy, the collagen/umbilical cord mesenchymal stem cell was spread on a foley catheter, and placed in the uterine cavity, and 5 ml of saline was filled into the balloon. B-ultrasound confirmed that the stent was attached to the uterine wall. The balloon was removed in situ after 1 week. We mainly compare the endometrial thickness before and 6 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. According to the GCP regulations, obtain the informed consent of the subject, volunteer for the test, and have signed the informed consent form.
2. Women aged 20-40 years with fertility requirements
3. Infertility patients who are treated in this hospital
4. After more than 2 times of hysteroscopic adhesion separation surgery, the uterine cavity morphology has basically returned to normal. The patient has a normal menstrual cycle or an estrogenic dose of 6 mg per day, and the highest thickness of the endometrium is 5.5 mm in 6 cycles by ultrasound.
5. or receive adjuvant reproductive treatment, the endometrial thickness is less than 5.5mm for unknown reasons, the treatment of estrogen, colony stimulating factor, aspirin, sildenafil and other drugs up to 8mg / day is invalid.
6. HBVAg negative, HCV negative, HIV negative, syphilis negative
7. Normal bone marrow morphology, normal blood routine
8. Previously failed to receive relevant stem cell therapy

Exclusion Criteria:

1. Those who cannot accept the treatment observation process required by the test
2. There are contraindications for hysteroscopic surgery;
3. congenital uterine malformation; severe adenomyosis; uterine fibroids that may affect embryo implantation; the investigators judged that there are other uterine factors that are not suitable for embryo implantation
4. Patients with chromosomal abnormalities
5. contraindications to estrogen therapy; systemic diseases such as thrombosis, cardiopulmonary disease, hematopoietic diseases, malignant tumors, etc.
6. Patients without fertility requirements
New Method of IUD Insertion During Cesarian Section

In women undergoing elective CS, half of them will have Intra-caesarian copper T 380 IUD insertion using the standard method and the remaining half will undergo copper T 380 IUD insertion during CS using a new technique in order to detect which technique is more effective in having more accurate IUD position with visible threads.

Intrauterine device (IUD) is considered one of the most acceptable and effective contraceptive methods used. It is widely accepted and used in Egypt at a large scale than any other type of contraception with many advantages over the other types of contraceptive methods including long acting hormonal methods . Despite IUD complications, it remains the most accepted method, as it has many advantages like being non-coital related, had no systemic complications, of long duration and reversible with rapid return of fertility after its removal . The complications of IUD include heavy menstrual bleedings, menstrual irregularities and infection complications which could be minimized by using strict aseptic techniques during insertion . The most distressing complication is the displacement of IUD, especially if this displacement was extra-uterine, as the patient needs a surgical maneuver (endoscopic usually) for extraction of this IUD. Displacement of IUDs puts a financial and psychological burden to the patient also increases the risk of unwanted pregnancies and its related risks . Displacement of IUD occurs mainly during its insertion, and occurs mainly due to rough or wrong technique; also IUD insertion at a wrong timing may increase risk of IUD displacement. So it is very important to insert IUDs at the proper time with the proper technique . Timing of insertion of IUD after cesarean section is a matter of debate, some gynecologists insert IUDs during cesarean section after placental removal, while other gynecologists prefer insertion of IUDs after an interval either immediately after puerprium (42 days), or after 6 months post-cesarean section, but the majority inserts IUDs after 3 months from cesarean section . The idea of waiting a three-month interval after cesarean section is to assure that the scar had completely healed and the uterus involutes completely to its pre-pregnancy size. The drawbacks of waiting this long interval are poor accessibility of the cervix which may be pulled upward in some cases of repeated cesarean section and loss of self-enthusiasm for rapid contraception after delivery .

Eligibility Criteria:
Inclusion Criteria:

* pregnant , full term patients , scheduled for elective CS.

Exclusion Criteria:

* contraindications for IUD insertion ( chorioamnionitis , congenital uterine malformations ) - Patient refusing IUD contraception.
* Patients with intra-operative bleeding or vital instability.
* Active genital infection at time of insertion.
* Medical disorders e.g. : cardiac , bleeding disorders , T.B. .. etc.
A Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects

The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child-Pugh classification) on the pharmacokinetics (PK) of ABL001 after a single oral dose.


Eligibility Criteria:
Key Inclusion criteria:

* Body mass index of 18-36 kg/m2, with body weight 50 kg and no more than 120 kg
* Vital signs (after at least 3 minutes rest in the supine position) within the following ranges (inclusive):

  * Oral body temperature between 35.0 °C - 37.5 °C (95.0-99.5°F)
  * Systolic BP ≥90 mmHg and ≤140 mmHg
  * Diastolic BP ≥60 mmHg and ≤90 mmHg for healthy subjects and 50-100 mmHg for subjects with impaired hepatic function (groups 2-4)
  * Pulse Rate: ≥50 and ≤90 bpm for healthy subjects (group 1) and ≥50 and ≤100 bpm for subjects with impaired hepatic function (groups 2-4)
* Healthy subjects with no clinically significant abnormalities as determined by past medical history, physical examination, vital signs, ECG, and clinical laboratory test
* Subjects with Child-Pugh Clinical Assessment Score as calculated per the Child-Pugh classification

Key Exclusion Criteria:

* Presence of clinically significant ECG abnormalities or a family history or presence of prolonged QT-interval syndrome
* History of cardiac disease
* Sexually active males must use a condom during intercourse while taking the drug and for 7 days after stopping
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs
* Administration of strong or moderate CYP3A4 inhibitors or inducers (including St John's wort) within 14 days prior to dosing

Other protocol-defined inclusion/exclusion criteria may apply.
Tap to "Tap", Pathobiome Associates Health Care

The bacteria live in community and in some cases it is the combination of several microorganisms that facilitates transmission and pathogenicity. The concept of pathobiome follows from this finding. Investigators hypothesize that the microbial community water point is a pathobiome influencing installation and transmission of pathogens associated with care

Goals :

Key: To study the impact of bacterial communities on the risk of transmission of waterborne pathogenic bacterium Pseudomonas aeruginosa in patients hospitalized from a contaminated water source by this bacterium.

secondary:

1. Assess the role of communities on installing the water points in P. aeruginosa by comparing contaminated and uncontaminated water sources.
2. To evaluate the effect of the quality of water and the conditions of use of water points network on the composition of bacterial communities associated or not with P. aeruginosa.

Experimental Study conducted from 6 points of water, contaminated deliberately experimental backs onto the project to assess conventional and alternative measures decontamination network and water points

Eligibility Criteria:
Inclusion Criteria:

* Patients in the Otorhinolaryngology department

Exclusion Criteria:

* Immunocompromised patients
* Patient Opposition to enter the research protocol
Evaluation of a New Radiotracer (68Ga-NOTA-AE105) for Diagnosing Aggressive Cancer With Positron Emission Tomography

The primary objective of the study is to test a new radiotracer called 68Ga-NOTA-AE105 for PET imaging of uPAR (urokinase plasminogen activator receptor). The tracer has the potential of identifying the invasive cancer phenotype, thereby distinguishing between aggressive and less aggressive tumors. This is a first in human study to test the radiotracer in cancer patients. The biodistribution and tumor uptake will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).

The primary objective of the study is to test a new radiotracer called 68Ga-NOTA-AE105 for PET imaging of uPAR (urokinase plasminogen activator receptor). The tracer has the potential of identifying the invasive cancer phenotype, thereby distinguishing between aggressive and less aggressive tumors. This is a first in human study to test the radiotracer in cancer patients. The biodistribution and tumor uptake will be evaluated by repeated PET scans (10 minutes, 1 and 2 hours post injection). The primary end points are safety, biodistribution and dosimetry of 68Ga-NOTA-AE105. In addition, the quantitative uptake of 68Ga-NOTA-AE105 will be compared to the expression of uPAR measured directly in tumor tissue obtained by surgery or biopsies. The project will be monitored and evaluated in accordance with the principles of Good Clinical Practice (GCP).

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with cancer of prostate, breast or urinary bladder
2. capable of understanding and giving full informed consent

Exclusion Criteria:

1. pregnancy
2. lactation
3. contraindication for the use of intravenous CT contrast-agencies
4. claustrophobia