cyrilzakka/clinical-trials huggingface dataset:
Computerized Attention Functions Training Vs. Executive Functions Training for Children with ADHD

The goal of this clinical trial was to compare the effectiveness of two computerized neurocognitive training programs for children with Attention Deficit/Hyperactivity Disorder (ADHD) and to examine their impact on attention functions, executive functions, academic performance, and behavior. The main questions this study sought to answer were:

How does Attention Functions Training (AFT) compare to Executive Functions Training (EFT) in improving cognitive abilities related to attention and executive functions in children with ADHD? What are the effects of these programs on academic performance and behavior? Researchers compared the outcomes of the AFT group, the EFT group, and a passive control group, in order to determine which program was more effective across these domains.

Participants completed computerized training sessions focused on attention or executive functions twice a week for nine weeks. They also underwent cognitive, academic, and behavioral assessments at baseline, after the training, and at follow-up.

This randomized controlled trial aimed to investigate and compare the effects of two distinct computerized neurocognitive training programs on children diagnosed with Attention Deficit/Hyperactivity Disorder (ADHD). The two interventions, Attention Functions Training (AFT) and Executive Functions Training (EFT), were designed to target different cognitive domains. The AFT program focused on improving sustained, selective-spatial, orienting, and executive attention, while the EFT program aimed at enhancing working memory, cognitive flexibility, and problem-solving abilities.

A total of 80 children with ADHD, aged 8-13 years, were randomly assigned to one of three groups: AFT, EFT, or a passive control group. Each training program included twice-weekly sessions over nine weeks. Participants underwent comprehensive assessments at three time points: baseline (pre-intervention), immediately after the intervention, and at a three-month follow-up. The assessments covered cognitive functions, academic skills, and behavioral symptoms as reported by parents.

The study employed repeated measures ANOVA to analyze the effects of the interventions. Primary outcome measures included improvements in attention and executive functions, with secondary measures focused on academic performance and parent-rated behavioral symptoms. Both short-term and long-term effects were assessed to evaluate the persistence of any observed improvements.

Eligibility Criteria:
Inclusion Criteria:

* ADHD

Exclusion Criteria:

* Coexisting diagnosis of other mental illness or neurological disorder (with the exception of ADHD and Learning Disabilities); previous serious head injury; uncorrected vision; additional developmental, sensory or motor issues; and if they are participating in other non-pharmacological treatment interventions specifically for ADHD (e.g., neurofeedback, cognitive-behavioral therapy, etc.).
The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus

This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone.

The trial has been extended by 52 weeks. The extension will consist of two 26-week periods:

1. Week 27-52 after randomisation

   - All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen.
2. Week 53-78 after randomisation

   * Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals.
   * Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Treatment with metformin alone for at least three months
* HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive)
* Body Mass Index (BMI) less than or equal to 45.0

Exclusion Criteria:

* Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors
* Treatment with anti-diabetic drugs other than metformin within the last three months
* Any serious medical condition
* Females who are pregnant, have the intention of becoming pregnant or are breastfeeding
Impact of Feeding Interval of Preterms on the Time of Transition From Tube Feeding to Oral Feeding

Preterms are usually fed with intervals of either two or three hours during their stay in neonatal intensive care unit. Recommendations of World Health Organization about feeding regimens, 3-hourly for infants 1500 - 2000 gr, and 2-hourly for infants 1000 - 1500 gr, are not proposed with regards to results of randomized controlled trials. Investigators aimed to investigate the impact of 2-hourly feeding on time of transition from orogastric to oral feeding.

Preterms are usually fed with intervals of either two or three hours during their stay in neonatal intensive care unit. Recommendations of World Health Organization about feeding regimens, 3-hourly for infants 1500 - 2000 gr, and 2-hourly for infants 1000 - 1500 gr, are not proposed with regards to results of randomized controlled trials.

Stomach volume of preterms varies a wide range of upto 20 ml. This should be taken into consideration during the process of feeding of preterms in neonatal intensive care unit. Trials were focused on early neonatal outcomes and it was found that duration of phototherapy and nasal noninvasive ventilation, and time to achieve full enteral feeds were shorter during 2-hourly feeding when compared to 3-hourly feeding, on the other hand 3-hourly feeding was shown to accelerate the stomach emptying. Besides, duration of catheterization, and ratio of feeding intolerance, apnea, and hypoglycemia were found to be similar infants who fed either 2 or 3-hourly.

Investigators aimed to investigate the impact of two feeding regimens, 2-hourly or 3-hourly, on time of transition from orogastric to oral feeding in preterms.

Patients and Methods: Preterms of birth weight less that 1500 gr and gestational age smaller than 32 weeks are going to be eligible for study if no congenital anomalies exist. Regarding current clinical protocol infants are fed every 2 hours until they weigh 1500 gr, and every 3 hours afterwards. At the day that the infants reach 1500 gr of body weight, a randomization will be performed in to two groups, Intervention group: Q2 interval (2-hourly feeding) or Control group: Q3 interval (3-hourly feeding), due to study protocol. Infants with inherited metabolic disorders, congenital anomalies, neonatal sepsis, and surgical diseases and the ones who fed with exclusively formula will be excluded.

After randomization infants will be followed until discharge. The type of feeding, volume of each feed, weight gain per week, feeding intolerance (abdominal distention, vomiting, apnea, newly onset or increase of oxygen treatment demand), day of first oral feeding, time of transition from orogastric tube to oral feeding, duration of hospitalization will be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. birth weight \<= 1500 gr gr
2. gestational age \<= 32 weeks
3. postnatal age at randomization: between 7 - 90 days

Exclusion Criteria:

* congenital anomaly
* multi organ failure
* sepsis
* surgical pathology
* inherited metabolic diseases
* exclusively formula feeding
After Cesarean Time Interval for Exercise (ACTIVE) Trial

The purpose of this study is to test whether or not activity restrictions after a cesarean section are warranted and if exercise can improve postpartum wellness. This research study is being done because there is no science-based evidence to support postpartum activity restrictions after cesarean sections.

Participants will be randomly placed into one of the following study groups:

* Standard postpartum and post-operative instructions group: activity restrictions, including no strenuous exercise, sexual intercourse, or lifting objects greater than 25 pounds for 6 weeks or until evaluation at the 6 week postpartum visit
* Study group: Structured 10 week exercise protocol consisting of core strengthening exercises (concentrating on the abdominal, gluteal, and pelvic areas), breathing exercises, and diaphragm exercises.


Eligibility Criteria:
Inclusion Criteria:

* pregnant woman at least 18 years of age
* carrying only one baby at time of delivery
* delivery planned by scheduled cesarean section
* baby of gestational age of \> 37 weeks
* no known restrictions to exercise.

Exclusion Criteria:

* woman with pre-existing post operative complications
* medical history with exercise limitations/disabilities
* carrying more than one baby at time of delivery
* delivery (planned by scheduled or emergent) cesarean section with fetal concerns (anomaly, growth restriction, NICU admission, etc)
Incorporating Patient Capacity Into the Clinical Landscape

This study is designed to answer why "patient capacity" (i.e. patient available abilities and resources to enact self-care and access healthcare) is not regularly documented in the Electronic Medical Record (EMR) in a way that is useful for clinicians.

Through the implementation of communication tools designed for patient capacity assessment and engagement of stakeholders in a process of user-centered design, the study team hypothesizes that the study can help clinicians elicit this information in conversation and regularly document it in the medical record for future healthcare discussions.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have one or more chronic condition and do not have any barriers to consent (such as major cognitive disabilities) will be eligible for enrollment.
RCT of Evening Primrose Oil for the Treatment of Breastfeeding Pain

Breastfeeding related mastalgia is a common post-partum complaint. We propose a double-blind, randomized, placebo-controlled trial that investigates the use of Evening Primrose Oil in the treatment of breastfeeding related mastalgia.


Eligibility Criteria:
Inclusion Criteria:

* currently breastfeeding
* recent delivery within the trailing 60 days

Exclusion Criteria:

* history of seizure disorder
Post Marketing Surveillance Study on Linezolid

The purpose of this study is to determine if Linezolid is safe for adult Filipino patients diagnosed with gram positive infections.

The subjects were identified after the physician decided to prescribed the drug to the subject.

Eligibility Criteria:
Inclusion Criteria:

* Has clinical diagnosis of of the following, including cases with concurrent bacteremia, when suspected or known to be caused by susceptible strains of anaerobic or aerobic gram positive microorganisms - nosocomial pneumonia, community acquired pneumonia, complicated skin and skin structure infections, uncomplicated skin and skin structure infection, and vancomycin-resistant E. faecium
* Male or female, 18 years old and above

Exclusion Criteria:

* Known hypersensitivity
* Subjects diagnosed with pure gram-negative infection
Preoperative Evaluation of 3D Reconstruction Tool for Nipple-sparing Mastectomy

The goal of this clinical study is to explore whether preoperative application of 3D reconstruction tool can reduce the occurrence of ischemic complications in the flap and nipple areola complex after surgery.

The 3D reconstruction tool was applied preoperatively to assess the blood supply and volume of participants' breasts and to recommend personalized prosthesis volume. Compared with electrosurgical knife separation，the flap was separated intraoperatively using a combination of cold knife and electrosurgical knife to observe whether there was a difference in the incidence of ischemic complications of participants' nipple areola complex and flap, and whether the use of the 3D tool in the preoperative assessment was effective in reducing the occurrence of postoperative ischemic complications.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of breast cancer
* Age: 18 to 70 years old
* No infiltration of the nipple-areola complex and negative histopathology of the nipple basal margins;
* Participants who meet the indications for breast conserving surgery require total mastectomy and reconstruction;

Exclusion Criteria:

* Inability to tolerate surgery or subjective desire not to undergo nipple-sparing mastectomy;
* Participants with clinical or imaging evidence of preoperative involvement of the nipple/areolar region, including Paget's disease, nipple spillage, inflammatory breast cancer, and/or imaging findings suggesting malignant involvement of the nipple or subareolar tissues, according to the 2023 NCCN guideline recommendations, where retaining the NAC fails to yield negative margins;
A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies

To determine the rate of response and duration of reponse following therapy with Aroplatin in subjects with advanced colorectal cancer resistant to standard therapies. Secondary objectives are to determine safety and tolerability of the Aroplatin therapy.

Primary Objective:

* To determine response rate (RR; complete and partial response\[CR,PR\] and duration after therapy with Aroplatin (Liposomal NDDP, L-NDDP) in subjects with locally recurrent, unresectable or metastatic colorectal cancer refractory to 5-FU/leucovorin or capecitabine, and irinotecan.

Secondary Objective:

* To determine safety and tolerability of the Aroplatin therapy.

This is a single-arm, open-label phase II study. Subjects refractory to 5-FU/leucovorin or capecitabine, and irinotecan therapies will be enrolled. Dosing will be every four weeks with individual dose escalations and adjustments for toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer, locally recurrent, unresectable or metastatic disease (AJCC);
* Measurable disease (RECIST criteria);
* Cancer refractory to 5-FU/leucovorin or capecitabine, and irinotecan;
* ECOG performance score of 0-2;
* Adequate hematopoietic, liver and renal function;
* Adequate cardiac function (maximum of class II, NYHA);
* Women of child-bearing potential must have a negative urine or serum pregnancy test;
* Signed written informed consent;
* Subjects must be willing to to be followed during the course of treatment/observation and follow-up.

Exclusion Criteria:

* Other malignancies treated within the last five years, except in situ cervix carcinoma or non-melanoma skin cancer;
* Pregnant or breast feeding subjects, or male or female subjects of child producing potential who will not agree to use adequate contraception during the treatment phase of the study;
* Prior therapy with oxaliplatin;
* Known brain metastases;
* Active, uncontrolled infection or other serious medical illnesses;
* Subjects may not be using or have used any investigational therapy during four weeks before start of the protocol treatment.
Carbapenem-resistant Organisms (CRO) Screening From Rectal Swabs in Patients With Hematological Diseases in China

Carbapenem-resistant Organisms (CRO) include Carbapenem-resistant Enterobacteriaceae (CRE), Carbapenem-resistant Pseudomonas aeruginosa (CRPA) and Carbapenem-resistant Acinetobacter baumannii (CRAB). Due to the high fatality rate of CRO infection, and its potential for wide spread, it is currently one of the issues that seriously affect the global public health safety. In 2019, CDC of the United States listed CRE and CRAB as the highest level of "antibiotic-resistant bacteria with urgent threat", while CRPA was listed as "antibiotic-resistant bacteria with serious threat".

Previous studies show that in China, patients with hematological disease are at high-risk of CRE colonization and infection, but there still lack the data of colonization rate of CRPA and CRAB in patients with hematological disease. Intestinal flora is not only an important micro-ecological environment for the human body, but also an important place for the habitation of multidrug-resistant bacteria. The colonization of these bacteria can not only lead to the spread of bacteria in hospital, but also may lead to the translocation infection of carriers. Patients with hematological diseases are often in a state of neutropenia after chemotherapy. At the same time, chemotherapy drugs and various factors can cause intestinal mucosa damage, which is prone to induce intestinal microflora translocation, causing serious infections such as sepsis, and posing a serious threat to the prognosis of patients. Early detection of CRO carriers is not only beneficial to the control of nosocomial infection, but also beneficial to early precise anti-infection treatments, reducing the probability of infection and improving the prognosis of infected patients.

Our study is designed to clarify the intestinal carriage rate of carbapenem-resistant Organisms (CRO) in patients with hematological diseases, and the risk factors of intestinal CRO colonization in patients with hematological diseases and its correlation with subsequent infections. 5000 patients diagnosed with hematological diseases will be enrolled, and rectal swabs or feces will be collected to detect the CRE intestinal colonization. Subsequently, the last 6 months clinical data of CRO-colonized patients and matched non CRO-colonized patients (1:1) will be collected. Then, the randomly selected 200 CRO-colonized patients and matched 200 non CRO-colonized patients (1:1) are followed up for 12 months, a total of 400 patients will be enrolled. Every month, rectal swabs and relevant clinical data will be collected.


Eligibility Criteria:
Inclusion Criteria:

* On a certain day in each chosed hospital, all the inpatients diagnosed with hematological malignancies diseases will be enrolled

Exclusion Criteria:

* Patients or their legal representatives refused to enter the study
* Patients died because of hematological malignancies diseases.
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination

This study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a 2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23 months at the time of first vaccination. Considering that febrile reactions are frequently observed following pneumococcal vaccination, usually co-administered with other routine paediatric vaccines, the primary study objective will focus on evaluating the increase in grade 3 fever (i.e. rectal temperature \>40.0°C).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
* Male or female between, and including, 12 and 23 months of age at the time of the first vaccination.
* Written informed consent obtained from the parents/LAR(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s).
* Previous vaccination against S. pneumoniae since birth.
* History of any hypersensitivity reaction following any previous vaccination.
* Eczema and any history of allergy
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus infection.
* A family history of congenital or hereditary immunodeficiency.
* Major congenital defects or any chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease and/or fever at the time of enrolment.
* Fever is defined as temperature \>= 37.5°C on oral or axillary setting, or \>= 38.0°C on rectal setting.
* Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
* Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned use during the study period.
* Child in care.
Priming Attachment Security Within an IAPT Setting

There is growing evidence that priming attachment security is associated with improved attitudes towards therapy, increased engagement and decreased levels of depression and anxiety. Within the Improving Access to Psychological Therapies (IAPT) programme a consistent problem has been identified of high dropout rates at step 2 services (i.e. where mild to moderate anxious and depressed patients receive guided self-help interventions). The current study incorporates a feasibility and pilot design. The feasibility element will explore issues related to study design to determine suitability for conducting a future randomised control trial (RCT). The pilot study will look at the processes outlined in the protocol to determine whether the study components all work together. Moreover, it will preliminarily aim to explore the effectiveness of the attachment security priming intervention on symptoms of depression and anxiety, as well as impaired functioning. Both elements of the study will determine whether any changes are needed to the study design or protocol, and whether a future RCT is suitable and necessary.

The study is being conducted in an IAPT primary care service in North Yorkshire. The study will be recruiting 50 participants experiencing mild to moderate depression who are deemed suitable for 'behavioural activation' low intensity guided self-help intervention. Following telephone screening for intervention, clinicians will ask clients if they wish to hear more about participating in a research study. If participants say yes, their contact details will be passed on to the researcher who will send them the study information sheet and consent form in the post. If the participant consents to taking part in the research, they will be randomised to receive either treatment as usual (low-intensity guided self-help utilising behavioural activation for depression) or treatment with security priming intervention (treatment as usual with an additional security priming task). They will have between 6-8 sessions as routinely delivered within the service and will be asked to complete measures of depression, anxiety and impaired functioning on a sessional basis. The principal investigator at the study site will collect information regarding attendance to therapy, dropout rates, and 'stepping' clients up to higher-intensity therapies as primary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Accepted for Behavioural Activation guided self-help intervention for depression with study NHS IAPT site.
* Over age 18.
* Adequate English ability.

Exclusion Criteria:

* Not suitable for Behavioural Activation guided self-help intervention for depression with study NHS IAPT site.
* Inadequate English ability.