cyrilzakka/clinical-trials huggingface dataset:
Physical Therapy Treatment on Children and Adolescents With Neurological Pathologies

To evaluate the positive effects of a home-based physical therapy intervention added to the usual physical therapy programs performed in children with neurological pathologies that induce sensorimotor impairments that affect their quality of life and the importance of the implications of their families in their treatment.


Eligibility Criteria:
Inclusion Criteria:

* Parents agree to include their children on the study
* Affiliated to the Duchenne Parents Project Association (Spain)
* Between 3-18 years old

Exclusion Criteria:

* Other pathological conditions
* Parents refuse the participation on the study
Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta

The aim of this prospective, explorative study of noninvasive neuromonitoring was to search potential and practical methods associated with neurological outcome in the perioperative and immediate postoperative setting of surgery of the thoracic aorta. These methods include abbreviated EEG monitoring, near-infrared spectroscopy, transcranial Doppler ultrasound and biochemical markers associated with neuronal damage.

For the purpose of this study, 30 patients undergoing aortic surgery via a median sternotomy (n=29; 97%) or left thoracotomy (n=1; 3%) and cardiopulmonary bypass with deep hypothermic cardiac arrest were recruited. All patients were operated under deep hypothermia and circulatory arrest, with optional selective cerebral perfusion during circulatory arrest. Active patient recruitment started from September 2007 and ended in May 2011. All patients were monitored with a bilateral fronto-temporal four channel abbreviated EEG, a bilateral frontal two-channel near-infrared spectroscopy, postoperative transcranial Doppler ultrasound evaluation of median artery circulation and postoperative biochemical neuromarkers. The study montage was set up by a dedicated research nurse, who also performed the transcranial Doppler measurements. The neuromonitoring data were not used at the time to guide therapeutic decisions, with the exception of near-infrared spectroscopy monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective or emergency surgery on the thoracic aorta (study group) or coronary heart disease (control groups)
* Informed consent from patient or next of kin

Exclusion Criteria:

* Age under 18 years
Electronic and Lab Pre-screening of New Rheumatology Patients With Rheumatoid Arthritis

By forming the foundation of a delivery system that integrates primary care (PC) and rheumatology, this initiative strives to strengthen the roles of both primary care and rheumatology practices as they co-manage patients in a quality care delivery system. Importantly, it strives to fill an unmet need, the rapid evaluation by Primary Care providers; the appropriate and timely referral of inflammatory disease patients to a rheumatologist; and the implementation of early aggressive therapy in the management of patients with rheumatoid arthritis (RA) with tight control. Given the call for improved quality, value, and demonstration of results\[1\], this initiative uses the tenets of National Center for Quality Assurance's Patient Centered Specialty Program\[1\] (PCSP) and it successfully masters and streamlines coordination of care.


Eligibility Criteria:
Inclusion Criteria:

* First ever referral to a rheumatologist.

Exclusion Criteria:

-
Platelet Transfusion in HBV-related acute-on Chronic Liver Failure

Acute-on-chronic liver failure (ACLF) is a syndrome that has recently been recognized as encompassing acute deterioration of liver function in patients with pre-existing chronic liver disease. It is associated with multi-organ failure and a high risk of short-term mortality. Thrombocytopenia is common in ACLF. In addition, the function of platelet is also compromised according to our previous data. The aim of this study is to explore whether platelet transfusion could reduce the short-term mortality rate of HBV-related ACLF. This is a single center, open labeled randomized controlled study. There are two arms. Subjects who is assigned to platelet transfusion group will receive both platelet transfusion (9 times/4 weeks, 1 unit each time) and standard medical treatment. While those in standard medical treatment group will receive standard medical treatment only. The major endpoint is 28-day transplant-free mortality rate.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years old
* Diagnosed with acute-on-chronic liver failure (grade-2) according to EASL-CLIF criteria and grading system.
* Chronic hepatitis B infection.
* ADP inhibition rate ≥70%.

Exclusion Criteria:

* Combined with chronic liver disease other than chronic HBV infection.
* Previous decompensation.
* Intracranial hemorrhage proved by radiological methods, symptoms and physical signs.
* Under anti-platelet or anticoagulants therapy within 4 weeks.
* Esophageal variceal bleeding within 1 week.
* Platelets transfusion within 1 week.
* Hepatocellular carcinoma or other types of malignancies.
* Pregnancy or breastfeeding.
* Severe chronic extra-hepatic disease.
* Comined with situations that researchers considered not suitable for inclusion
* Refusal to sign the informed consent form.
Urdu Translation of Duke Activity Status

To translate, culturally adapt, and validate the Duke Activity Status Index (DASI) to the Pakistani Urdu language. The study will measure the reliability \& validity of DASI in the Urdu version.No study has been conducted in the Pakistan region to translate DASI which follows the proper cross-culture adaptation.

Literature suggested that Duke Activity Index (DASI) is a questionnaire originally developed in English To evaluate the functionality. DASI was used primarily to assess patients with cardiovascular diseases such as coronary artery disease, heart failure, myocardial ischemia, and infarction. In clinical practice, DASI can be used to know the effects of medical treatments and cardiac rehabilitation and to assist clinical decisions In controlled clinical trials, DASI can also be used to assess interventions and as a component for assessing the costs/benefits of treatment.

Studies demonstrated that DASI is characterized as a questionnaire with good functional ability, evidence of validity, usefulness, and great clinical and scientific applicability, it seems to be a useful tool for evaluating cardiac patients. So, to be used with Brazilian CVD patients it is necessary to validate DASI and verify its psychometric properties in this population.

Eligibility Criteria:
Inclusion Criteria:

* Individuals have enough education level to understand Urdu and English as well with a body mass index between 18.6 and 39.9 kg/m with the diagnosis of cardiovascular diseases such as coronary artery disease, valvular heart disease, arrhythmia with at least one symptom11 such as chest pain, palpitations, fatigue, or dyspnea, and physician referral to exercise testing.

Exclusion Criteria:

* Individual is unable to read the questionnaire, who have cognitive deficits screened by Mini-Mental State Examination according to the cut-off points and Hospitalization two months before as well as acute illness, fever, or severe physical limitation that would prevent from doing the exercise test.
A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD

This is a double-blind study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) versus placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

* Age \>=7 and \<18 years of age
* Primary diagnosis of major depressive disorder (MDD)
* CDRS-R score \>40

Exclusion Criteria:

* History of suicidal behavior or requires precaution against suicide
* Not in generally healthy medical condition
* History of psychosis or bipolar disorder
* Seizure disorder
Cancer-associated Cachexia in Patients With Incurable Gastroesophageal Cancer

Patients with incurable gastroesophageal cancer are at high risk of cancer cachexia with an estimated prevalence of 60-80%. Cancer cachexia is defined as ongoing loss of skeletal muscle mass with or without loss of fat mass and is associated with impaired quality of life, loss of physical function, treatment intolerability, and increased mortality.

Cancer cachexia is a multifactorial syndrome, and in patients with gastroesophageal cancer, the wasting is compounded by a high prevalence of dysphagia. To date, no drug therapy has been approved for the treatment for cancer cachexia. Sufficient nutritional support is imperative in cachexia treatment, but to effectively treat cancer cachexia there is a need to fully understand the biological mechanisms underpinning the wasting syndrome.

The primary objective of the present cohort study is to determine the incidence and extend of skeletal muscle wasting in patients with incurable gastroesophageal cancer. The investigators will also investigate the prevalence of low skeletal muscle at time of diagnosis. The secondary objective is to investigate, if loss of skeletal muscle is associated with treatment intolerance and increased mortality.

Furthermore, the investigators aim to explore factors differentially expressed in the circulation, in skeletal muscle, and in adipose tissue of patients experiencing wasting compared with patients not experiencing wasting.

The study is a prospective cohort study including patients with incurable gastroesophageal cancer referred to first line chemotherapy. Blood and plasma samples as well as clinical and simple functional assessments will be obtained from all patients. The participants will also be offered to take part in a sub-study in which, we will collect skeletal muscle and subcutaneous adipose tissue.

The main questions the investigators aim to answer are:

* What is the prevalence and extent of skeletal muscle mass wasting in patients with incurable gastroesophageal cancer?
* Are the loss of skeletal muscle mass and low skeletal muscle mass associated with treatment intolerability and overall survival in patients with incurable gastroesophageal cancer?
* Can there be identified potential biological processes and factors in skeletal muscle, adipose tissue, and plasma that contribute to the loss of skeletal muscle mass in patients with incurable gastroesophageal cancer?


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for participation are any patient diagnosed with histologically verified, incurable cancer of the esophagus, stomach, or gastroesophageal junction, referred to first line chemotherapy.

Exclusion Criteria:

* Age \< 18 years
LTAP Block in Endometriosis Surgery - a Randomised Controlled Double-blind Trial

The purpose of this study is to compare the efficacy and safety of laparoscopically inserted transversus abdominis plane block (LTAP) in comparison to local wound analgesia in laparoscopic surgery due to suspected or diagnosed peritoneal endometriosis.

The LTAP-trial is a prospective randomized controlled double-blinded study comparing the efficacy and safety of LTAP with local wound analgesia in laparoscopic endometriosis surgery. Patients are randomized to receive LTAP with levobupivacain and wound infiltration with placebo or wound infiltration with levobupivacain and LTAP with placebo. The primary outcome is postoperative opioid consumption measured by Patient Controlled Analgesia -pump (PCA). Secondly, subjective postoperative pain up to 24 h postoperatively will be measured by Numeric Rating Scale (NRS). Additional outcome measures are factors related to recovery and length of stay in the hospital as well as a 6 month follow-up survey regarding pain and general wellbeing after surgery. A total of 46 patients will be randomized in a proportion of 1:1.

Eligibility Criteria:
Inclusion Criteria:

* Surgery indicated because of pain caused by diagnosed or suspected peritoneal endometriosis
* ASA class 1-3
* Patient is capable of giving informed consent

Exclusion Criteria:

* Obstructive sleep apnea
* ASA class \>4
* Other significant risks associated with opioid use
* Contraindications for local anesthetics or NSAIDs
* Regular opioid consumption before operation
Exploring the Effectiveness of AI Generative Models for Diabetic Patients

We plan to explore the usability of Generative AI-Chatbot for Diabetic Patient

Diabetes is rapidly spreading, affecting a significant number of adults, with a staggering total of 537 million diabetic individuals. This condition gives rise to various complications that can lead to diabetic retinopathy, foot ulcers, cardiac problems, and kidney damage. However, many of these complications can be mitigated by providing patients with accurate information concerning their diet, stress management, and weight control.

The recent advancements in Generative Artificial Intelligence-based chatbots have demonstrated their efficacy as intelligent assistants across various aspects of human life. In this study, we aim to assess the effectiveness of these Language Models in assisting patients. Our research plan entails the interaction between patients and chatbots like ChatGPT, both with and without human support, followed by evaluations of these interactions by specialists. Additionally, we will gather feedback from patients regarding their experiences and perceptions of the chatbot interactions.

Eligibility Criteria:
Inclusion Criteria:

* Present physically in Pakistan
* Adults (18 years or older)
* Diabetic Patient

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners
Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans

Tomatoes contain several compounds which may be beneficial for human health and prevention of disease, although this relationship is poorly understood and very controversial. This study uses a new technology to study the absorption and metabolism of three different compounds found in tomatoes. These compounds are called: phytoene, phytofluene, and lycopene. We hypothesize that by studying the absorption and metabolism of these compounds, we may be able to understand how the compounds may influence health and disease processes.


Eligibility Criteria:
Inclusion Criteria:

* Between ages of 21-70 years old.
* Body mass index of between 18 and 27 kg/m2 (inclusive).
* Eastern Cooperative Oncology Group (ECOG)performance status of O.
* Not currently be taking carotenoid supplements
* Have Blood Urea Nitrogen (BUN)/Creatinine (CR), liver enzymes, Complete Blood Count (CBC), and Prothrombin time (PT/PTT/INR) within normal limits.
* Have a hemoglobin level of at least 11 g /dL at the time of randomization.
* Voluntarily agree to participate and sign an informed consent document.

Exclusion Criteria:

* Have a known allergy or intolerance to tomatoes.
* Have a history of a nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring special diet recommendations.
* Have uncontrolled hyperlipidemia (total cholesterol \> 200 mg/dL, LDL \> 160 mg/dL and serum triglycerides \> 200 mg/dL) or lipidemia that may influence carotenoid pharmacokinetics or transport.
* Smoke tobacco products
* Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, ACTH, growth hormone) or other endocrine disorders requiring hormone administration with the exception of diabetes and osteoporosis.
* Are taking certain medications (prescription or over-the-counter) such as Orlistat, which interfere with dietary fat absorption.
* Are taking complementary and alternative medications that at the discretion of the study physician Steven K. Clinton(SKC) may interfere with carotenoid absorption or metabolism.
Movement Disorders Caused by Antipsychotic Drugs in Older Patients

This study will assess the risk of experiencing tardive dyskinesia and other movement disturbances associated with three atypical antipsychotic drugs among middle-aged and elderly psychiatric patients.

Use of antipsychotic drugs can result in tardive dyskinesia and extrapyramidal symptoms. Tardive dyskinesia (TD) is a syndrome that causes repetitive, involuntary, purposeless movements in the tongue, lips, or jaw. It can also cause facial grimacing, random movements of arms, legs, fingers, and toes, as well as swaying movements of the trunk or hips. Extrapyramidal symptoms (EPS) include a variety of symptoms, such as involuntary movements, tremors, rigidity, body restlessness, and changes in breathing and heart rate. TD and EPS are side effects of older antipsychotic drugs. Newer antipsychotic drugs, such as quetiapine, olanzapine, and risperidone, do not present as large a risk of developing these side effects. This study will assess the incidence of and risk factors for tardive dyskinesia and extrapyramidal symptoms associated with quetiapine, olanzapine, and risperidone among middle-aged and elderly individuals with psychotic disorders. Additionally, the study will examine the effect of these drugs on symptoms of pre-existing, drug-induced TD. It will also explore the impact of movement disorder symptoms on everyday functioning and quality of life.

Some participants in this open-label study will be randomly assigned to receive quetiapine, olanzapine, or risperidone. Participants who are not randomly assigned to a medication will still receive one of the three medications, based on the decision of their physician. Initial evaluations will be conducted to collect demographic information, as well as medical, psychiatric, and pharmacologic histories. Dosing will be determined by each participant's psychiatrist. All participants will be followed for approximately 5 years. They will report to the study site for outcome assessments at baseline, Months 1 and 3, and every 3 months for the remainder of the study.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of any psychiatric disorder for which an antipsychotic medication is needed

Exclusion Criteria:

* N/A
The Colorado LEAP Study: A Socioecological Approach to Obesity Prevention in Early Childhood

The Colorado Longitudinal Eating And Physical activity (LEAP) Study utilizes a social ecological approach to explore individual, family and environmental factors and their relationship to child weight status over a 3 year timeframe. Our primary research questions are as follows:

1. Are behavior changes (increased willingness to try new foods and gross motor skills) from a preschool nutrition and activity program, The Food Friends®, sustained through early elementary school?
2. Do The Food Friends® programs have an impact on reducing the percentage of children considered overweight and/or obese over a 3 year timeframe?
3. Do food preference and gross motor performance directly affect child weight status or are they mediators to dietary intake and physical activity?

The preschool years are a critical time to begin obesity prevention efforts as they represent a time when young children establish healthy eating habits and physical activity patterns. These habits can place children at risk for obesity and are shaped by many characteristics, including individual characteristics as well as school, family and societal environmental characteristics. Predictive behaviors, or behavioral antecedents, within these environments can influence child behaviors. While many predictive behaviors have been shown to influence dietary intake, physical activity, and weight status, two potential behavioral antecedents - food preference and motor performance - need further exploration. Understanding the context in which child behavioral patterns are developed is critical to developing a model to address childhood obesity.

The Colorado LEAP project is a longitudinal cohort study utilizing a controlled quasi-experimental design in 5 rural Colorado communities. Two communities serve as intervention communities with the other 3 as matched controls. Intervention sites receive The Food Friends® nutrition and physical activity programs in preschool and 'booster' programming in kindergarten and 1st grade. Assessments are administered 4 times - twice in preschool (Fall and Spring) and once in both kindergarten and 1st grade (Spring). Observational measures with children are conducted at the school; parent/home measures are sent home and returned to school via the child; and school personnel complete school environment and policy assessments.

Eligibility Criteria:
Inclusion Criteria:

* Children enrolled in participating schools; entering kindergarten the year after recruitment

Exclusion Criteria:

* Children not entering kindergarten within one year of recruitment.
Body Composition Sub-study of the D2EFT Trial

This is a non-randomised, controlled, parallel group, sub-study of D2EFT (NCT03017872), a randomised, open-label study in approximately 1,000 HIV-infected adults failing first-line antiretroviral therapy (ART) in low-middle income countries. The sub-study will be offered to all D2EFT sites with access to DXA technology for whole-body composition analysis. Sites will offer the sub-study to consecutive clinic patients. Patients must be approached for participation and provide informed written consent prior to randomisation into D2EFT. This study will recruit approximately 300 patients. Allocation to one of three ART treatment regimens will follow the result of D2EFT randomisation. The study will investigate the role of contemporary ART on body composition and metabolic parameters by comparing over 96 weeks the effects of the D2EFT ART regimens. The primary endpoint will be assessed at week 48.

Consenting participants will be randomised within the main D2EFT protocol to receive either ritonavir-boosted darunavir plus two nucleosides or dolutegravir plus two predetermined nucleosides (lamivudine or emtricitabine) or ritonavir-boosted darunavir plus dolutegravir. Enrolment into the sub-study is voluntary and not a requirement for enrolment into D2EFT. Parameters relevant to this study including demographics, arm of randomised ART, smoking status, body habitus and fasting lipid parameters and resting blood pressure at required time points will be collected as part of the main D2EFT study. Sub-study specific assessments performed at baseline and at weeks 48 and 96 include clinical and laboratory assessments, sample collection and dual-energy X-ray absorptiometry (DXA)-assessed whole-body composition. Consenting participants will have blood for storage collected at weeks 0, 48 and 96. The specimens will be used for future studies into treatment of HIV infection and immunity.

Eligibility Criteria:
Inclusion Criteria:

* Fulfil the criteria for D2EFT randomisation
* Able to undergo DXA whole-body scanning
* Provide informed written consent for the D2EFT Body Composition Sub-study

Exclusion Criteria:

* Unwilling to comply with the study requirements