cyrilzakka/clinical-trials huggingface dataset:
Understanding Physical Activity and Quality of Life in Children and Young People with Chronic Kidney Disease

Children and young people (CYP) with chronic kidney disease (CKD) say that physical activity, school, social activities and tiredness are the main issues they want to improve. As CKD in CYP is a rare disease, there is not much research into understanding these aspects, making it difficult to know how to support patients better. This project aims to investigate how physically active CYP with CKD are, and what psychosocial factors are affected by their illness. CYP aged 6-18 will take part in a battery of physical activity tests, par-take in an online survey looking at physical activity, quality of life, mental health, fatigue and strengths and difficulties, and take part in an interview to better understand what it is like to live with CKD.

The aim of this research is to document and evaluate the relationship between physical activity patterns and behaviours and psychosocial outcomes in children and young people with CKD. A second aim is to explore through qualitative methods contextual factors that may explain the type, direction and nature of relationships identified in the quantitative phase.

This research will be conducted in multiple phases to maximise recruitment.

1. Phase 1 consists of a battery of in-person physical functioning tests.
2. Phase 2 consists of an online survey of validated questionnaires.
3. Phase 3 consists of online or in-person interviews with CYP

Participants recruited through NHS Scotland will take part in all 3 phases. Only Phase 2 (online survey) will additionally be disseminated through patient organisations across the UK to maximise recruitment.

In phase 1, participants will take part in a battery of physical activity functioning assessments including multistage bleep tests, sit-up tests, and handgrip tests. Participants will also be given an accelerometer measure to track movements over 7 days. Participants taking part in this phase will also complete the phase 2 online survey which includes a physical activity, Quality of life, Fatigue, Strength and Difficulties, and Mental health questionnaire.

In phase 3, participants from phase 1 will return and take part in an interview to gain deeper insights into psychosocial influences and limitations in engaging in physical activity as well as gaining a better understanding of the impact of CKD on psychosocial wellbeing.

Eligibility Criteria:
Inclusion Criteria:

* CYP of school age between 6 and 18 years
* Living and receiving care in Scotland for CKD
* no clinical contradictions to physical function assessments

Exclusion Criteria:

* Enrolment in other clinical trials in which treatment is masked/blinded
* Deemed to be clinically unstable by treating physician for participating in physical activity and exercise
* Severe cognitive impairment (as will be unable to give consent)
* Aged \<6 or \>18 years.
Setting up a Website in Paediatric Surgery at the Rouen University Hospital for Parents and Children to Better Understand the Postoperative Prescription of Painkillers.

Although outpatient surgery is increasing in France, particularly in paediatrics, compliance with analgesics prescriptions and pain management on return home remain poorly controlled parameters, although they are essential for optimal care. This is due, among other things, to parents' lack of knowledge and fears about the medicines prescribed to them. The paediatric anaesthesia unit of the Rouen University Hospital has set up a website for families to improve understanding of and compliance with the prescription of painkillers and thus improve the management of postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a Physical status score equal or II
* Ages 2-12
* Receiving outpatient surgery according to the eligibility criteria established in the latest expert recommendations in 2009 and in accordance with the service's practices

Exclusion Criteria:

* Lack of access to internet
* Cognitive dysfunction in children that interfere with understanding instructions
* Patient already receiving a analgesic treatment
Preoperative Noninvasive Hemoglobin Monitoring in Pediatric Patients

The preoperative evaluation including sampling blood in pediatric patients is hard to perform. However, the knowledge of the baseline cell blood count is important to prepare unexpected surgical bleeding etc.. The invasive procedure for blood sampling in small children is often failed and sometimes induces iatrogenic blood loss and parent's complaints. The Pulse Co-oximetry (Masimo) is recently developed device which can provide noninvasive hemoglobin value. However, the accuracy is controversial. There are studies in pediatric patients during surgery and in ICU. However, the comparison for preoperative evaluation is not analysed. Therefore, the investigators want to evaluate the accuracy for preoperative preparation in pediatric patients.

There are not enough data comparing the noninvasive hemoglobin and venous hemoglobin in pediatric patients during preoperative period. The investigators will collect the venous sample and the noninvasive hemoglobin data from masimo within 1 hour. Without any additional medication, the patients will visit preanesthetic room and attach the probe of masimo on index finger. The R 20L or R25L will be used based on their weight. The parameter will be stabilized within 2 minutes and the SpHb and perfusion index will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASA class 1,2

Exclusion Criteria:

* Poor peripheral circulation
* Infection or trauma on the sensor contact region
Risk Factors for Achieving TO After LDPPHR-t

This is a single, retrospective, observational study to investigate the risk factors for achieving textbook outcome after laparoscopic duodenum-preserving total pancreatic head resection.

Increasing numbers of benign or low-grade malignant neoplasms at the head of pancreas are being diagnosed due to computed tomography (CT), magnetic resonance imaging (MRI) and endoscopic ultrasonography (EUS). Laparoscopic duodenum-preserving total pancreatic head resection (LDPPHR-t) has been accepted as a valid alternative treatment for benign and low-grade malignant neoplasms at the head of the pancreas. The evaluation of quality of LDPPHR-t is important for surgeons to improve surgical quality. Currently, the evaluation of surgical quality mainly depends on some single outcome indicators, such as morbidity, mortality, readmission rate, or hospital stay. These single outcome indicators are difficult to accurately reflect the overall surgical quality and the composite outcome measures may be better than single outcome indicators. Textbook outcome (TO) is such a composite concept and is realized when all the requirements after operation are achieved according to the "all or none" principle. TO reflects the ideal surgical outcome and is a multidimensional measure for surgical quality assurance. However, the risk factors for achieving TO after LDPPHR-t is unknown and no relevant articles have been reported so far. The objective of study was to identify the risk factors for achieving TO after LDPPHR-t.

Eligibility Criteria:
Inclusion Criteria:

1. Patients underwent laparoscopic duodenum-preserving total pancreatic head resection.
2. Aged 18 to 75 years old.

Exclusion Criteria:

1. Peritoneal seeding or metastasis to distant sites.
2. Incomplete clinical data.
Study to Assess Adverse Events and How Oral ABBV-990 Moves Through the Body of Adult Healthy Participants

This study will assess how safe ABBV-990 is and how ABBV-990 moves through the body of adult healthy participants. Adverse Events will be assessed.

ABBV-990 is an investigational drug being developed for the treatment of SARS-CoV-2 infections. Participants are randomly assigned to one of the 5 treatment groups. Each group receives different treatment. There is 1 in 4 chance that participants are assigned to placebo. Approximately 40 adult healthy volunteers will be enrolled in a single site in the United States.

Participants will receive oral tablet of ABBV-990 or matching placebo on Day 1 and followed for approximately 30 days.

Participants will be confined for 5 days. Adverse Events and blood tests will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) is \>= 18.0 to \<= 32.0 kg/m2.
* Laboratory values meet the protocol-specified criteria.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
* In the opinion of the investigator, participant is a suitable candidate for enrollment in the study.

Exclusion Criteria:

* Have any clinically significant ECG abnormalities.
* History of any clinically significant sensitivity or allergy to any medication or food.
* Known active SARS-CoV-2 infection at screening and upon initial confinement.
* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
* Currently enrolled in another interventional clinical study.
To Determine if Chromium Nicotinate Supplementation Will Improve Insulin Resistance in HIV Patients With Metabolic Abnormalities

In HIV patients, fasting insulin levels decrease with chromium supplementation. This study is to determine if chromium nicotinate supplementation at 400ug/day for 16 weeks will improve insulin resistance in HIV patients with metabolic abnormalities.

This study is a randomized, double-blind, placebo-controlled, crossover study where patients will be supplemented for 16 weeks with either chromium nicotinate 400 ug/day or placebo and then crossover to the opposite treatment for another 16 weeks. Each soft gel capsule of chromium contains 200ug of chromium and patients will take 1 capsule twice a day or its placebo. Placebo contains di-calcium phosphate in a soft gel capsule and its appearance is similar to the chromium capsules.

Eligibility Criteria:
Inclusion Criteria:

* HIV documented patients will be considered for the study if they have at least one abnormality with respect to fasting blood glucose, TG, total or HDL cholesterol. Normal fasting glucose is defined as \< 6.1 mmol/L. Hypertriglyceridemia is defined as concentrations above 2.0 mmol/L on the basis of reports of increased risk of cardiac disease. Hypercholesterolemia is defined as concentrations above 5.5 mmol/L and a low HDL-cholesterol concentration as less than 0.9 mmol/L.
* Patients will need to be on a stable drug regimen for at least 8 weeks and not taking any chromium supplement or chromium-containing multivitamins 4 weeks prior to and during the study period. Patients can stay on their hypoglycemic or lipid-lowering medications and the required dosage will be monitored.

Exclusion Criteria:

* Patients will be excluded if there is concomitant acute infection or malignancy.
Apixaban as Treatment of Venous Thrombosis in Patients With Cancer: The CAP Study

This study is a single-arm, phase IV trial, of apixaban as treatment of venous thrombosis in patients with cancer. The current standard treatment of venous thrombosis in cancer patients is subcutaneous injections with low molecular weight heparin. During the last 5 years several new direct acting oral anticoagulants have been tested out as treatment of venous thrombosis. But very few cancer patients were included in the phase III clinical trials of the direct acting oral anticoagulants. Thus, there is a lack of information on how cancer patients with venous thrombosis will respond to treatment with direct acting oral anticoagulants. The current study will investigate the direct acting oral anticoagulant apixaban in cancer patients with venous thrombosis.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of cancer, other than basal-cell or squamous-cell carcinoma of the skin, within six months before enrollment. Any treatment for cancer within the previous six months, or recurrent or metastatic cancer.
* Objectively verified venous thrombosis
* Informed consent

Exclusion Criteria:

* Anticoagulant therapy prior to trial entry for \> 96 hours
* Severe thrombocytopenia (platelets \<50·109/L)
* Severe renal failure - creatinine clearance \<30 ml/min
* The patients will be treated with catheter based thrombolysis for deep venous thrombosis or systemic thrombolysis for severe pulmonary embolism
* Pregnancy or breastfeeding.
* Childbearing potential without proper contraceptive measures
* Drug abuse or mental disease that may interfere with treatment and follow-up.
* Severe malabsorption so that oral treatment are expected to have reduced effect
* Mechanical heart valves
* Known allergy to apixaban
* Active bleeding or severe risk of bleeding so that the risk of bleeding is considered a greater danger than the risk of not treating the venous thrombosis
* Clinically significant liver disease (e.g., acute hepatitis, chronic active hepatitis, or cirrhosis)
* Concomitant use of strong cytochrome P-450 3A4 inhibitors (e.g., human immunodeficiency virus protease inhibitors or systemic ketoconazole, voriconazole or posaconazole) or inducers (e.g., rifampicin, carbamazepine, or phenytoin). Fluconazol is allowed.
Striatal and Extra-striatal Mechanisms of Falling in Parkinson's Disease

This research study will evaluate functions of memory, thinking, eye movements and walking and how these relate to the measurement of certain chemicals (acetylcholine and dopamine) in the brain using an imaging procedure called positron emission tomography (PET). You may know that the brain chemical dopamine, a "neurotransmitter" substance (a chemical messenger that nerve cells need to communicate with each other), is important for the brain to control movements and that the brain chemical acetylcholine may have functions related to mental concentration and attention. At the present time, the investigators have no clear information how these two chemicals in the brain of patients with Parkinson's disease are related to the risk of falling.

Although most research in PD has a focus on presynaptic dopaminergic denervation, new lessons may be learned by exploring to what extent alterations in non-motor and non-dopaminergic systems may play a role in the balance impairment in this disorder. This project is designed to evaluate striatal pre-synaptic dopaminergic, cortical, thalamic, and brainstem cholinergic, cognitive, and oculomotor mechanisms underlying the risk of falling and imbalance in PD. The proposed study will exploit advances in our center in the development of dynamic biomathematical modeling of electronic platform data, application of specialized cognitive and oculomotor assessments, and positron emission tomography (PET). This novel multi-system approach holds promise for understanding mechanisms of falling in PD beyond pre-synaptic dopaminergic nigrostriatal denervation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects considered for inclusion will be female or male subjects either currently enrolled or eligible for care at the VA aged 50-85 years, or community volunteers.
* The racial, gender and ethnic characteristics of the proposed subjects population reflect the demographics of the patient population of the VA. However, extra efforts will be made to recruit women and minorities (see table 5).
* Children will be excluded from the study.
* No exclusion criteria shall be based on race, ethnicity, gender, or asymptomatic HIV status.

Exclusion Criteria:

* Inability to stand or walk independently (i.e., patients in Hoehn and Yahr stage IV and V).
* Vertiginous disorder.
* Orthostatic hypotension or unstable cardiovascular disease at risk of syncope (drop in systolic blood pressure of \> 20 mm Hg upon standing).
* History of stroke with focal cortical lesions.
* Cerebellar, myelopathic or significant radiculopathy syndrome.
* Diminished light perception in both eyes (\< 20/40 corrected OU).
* Intracranial surgery.
* Subjects who have participated in other research protocols such that their cumulative radiation absorbed dose to whole body, gonads, bone marrow or lens of the eye would exceed 5 Rem, or dose to other body organs is more than 15 Rem in preceding 12 months.
* Pregnancy (beta-HCG test within 48 hours of PET study) or breastfeeding.
* Contra-indications to MRI.
Exercise in Adults with Post-Acute Sequelae of SARS-CoV-2 (COVID-19) Infection Study

To examine the efficacy of an 8-week exercise training program on functional, cognitive, and emotional health outcomes compared to a no treatment control condition in adults with PASC.

Conduct a randomized control trial with a wait-list control to examine the efficacy of an 8-week exercise training program on functional, cognitive, and emotional health outcomes compared to a no treatment control condition in adults with PASC.

Examine participant compliance (in-person attendance, online engagement) with the 8-week exercise training program including in-person exercise sessions, cognitive performance training, and virtual exercise sessions delivered via a mobile application.

To determine if compliance with the 8-week exercise training program is associated with improvement in functional, cognitive, and emotional health outcomes.

Determine if there is a maintenance effect for individuals randomized into the 8-week exercise training program by comparing their outcomes at the end of the 8-week training exercise program to their outcomes at the end of their trial participation (16 weeks).

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Self-reported history of COVID-19 diagnosis
* Self-reported ongoing symptoms of PASC \>4 weeks after initial infection

Exclusion Criteria:

* Neuromotor, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise or conditions preventing cooperation
* COVID-19 infection occurring \> 6 months prior to screening date
* Contraindications to Symptom-limited Maximal Exercise Testing
* Individuals without access to a device with iOS (apple devices such as iPhone, iPad, MacBook, etc.)
* Patient-reported diagnosis of severe arterial hypertension
* Patient reported metabolic disease
* Patient reported uncontrolled asthma
* Inmates
* Pregnancy
* Patient reported supplemental O2 use
* Presence of beards
* Patient reported diagnosis of claustrophobia
* Non-English speaking
Association Between Preoperative HALP and Immediate Postoperative Outcomes

Multiple inflammation-based prognostic scores have been developed for the prediction of perioperative morbidity and mortality following pancreaticoduodenectomy (PD). Preoperative "Hemoglobin, Albumin, Lymphocytes and Platelets index (HALP)" is one of the promising inflammatory markers that has emerged as a predictor of postoperative survival. To date, no study has been done with preoperative HALP to predict 30days morbidity and mortality.

Is there any association between Preoperative HALP (hemoglobin, albumin, lymphocyte, and platelet) and 30 days post operative morbidity and mortality in patients undergoing Pancreaticoduodenectomy?

General Objective:

To assess the association between preoperative HALP and immediate postoperative outcome among patients undergoing PD.

Specific Objectives:

1. To identify the magnitude of immediate post-operative morbidity and mortality in patients undergoing PD.
2. To evaluate the descriptive measurement of preoperative Hemoglobin, Albumin, Lymphocytes, Platelets and HALP among patients undergoing PD.
3. To compare the preoperative HALP with morbidity and mortality among patients undergoing PD.

Operational Definition:

1. Immediate postoperative time - was taken as 30days following surgery.
2. Morbidity- was defined by Clavién-Dindo20 grading for the surgical complication and DGE,21 POPF,22 and PPH23 -according to International Study Group of Pancreatic Surgery (ISGPS) grading.
3. Mortality- survival within 30days.
4. Level of preoperative HALP- normality test was done via SPSS and data of HALP followed normal Gaussian distribution. So, mean was used for the calculation of cut off value as 35.83. And, patients were divided into low HALP (≤35.83) group and high HALP (\>35.83) group respectively

Eligibility Criteria:
Inclusion Criteria:

1. All the cases of elective pancreaticoduodenectomies for malignant pancreatic head disease

Exclusion Criteria:

1. Incomplete clinicopathological and follow-up data,
2. Age \<15 years and age \>80 years
3. History of antitumor treatments, and
4. Record of other malignant tumors, (unresectable?)
Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes

A suitable concentration of omega-3 fatty acids in relation to omega 6 is considered necessary for a good cell function and prevention of various inflammatory processes. Diet and supplementation are the fundamental procedures to achieve the reference values for several years. Athletes are individuals under physical stress and higher tissue restoration, while maintaining adequate diets they show, as the rest of humans, lower than desired levels. In the present study the investigators aims to determine the modification of those levels by the administration of two different doses of a given product, keeping the same model of diet and physical and competition.

The study aims to assess concentrations of the different fatty acids in the erythrocyte membrane before and after administration of a compound with high quality omega3 (EPA and DHA) in two different doses, compared with control group . The period of evaluation and management is four months, one month for the proposed renewal of red blood cells. The composition of the diet, the sports calendar, caloric expenditure and level of training is determined. During the study process it is excluded subjects with injuries or disease processes and ensure that no one take any supplement or modify workouts or diet.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, young men and women athletes from the Olympic Training Center (OTC) of Sant Cugat del Valles in Barcelona (Spain) (20 to 45 years of age) belonging to different summer sport activities were asked to participate.

Exclusion Criteria:

* Any type of inflammatory process, or the use of anti-inflammatory medications, consumption of n-3 Fatty Acids (FA) supplements and n-3 FA-supplemented foods in the past 3 months; planning to change dietary habits, or training schedule.
* During the study, any subject that falls under injury or need nonsteroidal antiinflammatory drug or get sick by inflammatory or infectious disease.