cyrilzakka/clinical-trials huggingface dataset:
Diaphragm Structure and Function in Childhood Cancer Survivors

The purpose of this research is to study the feasibility of a specific training program for the breathing muscles (inspiratory muscle training) and the effects on how breathing is regulated during exercise in childhood cancer survivors.

During the first study visit, participants will undergo a series of pulmonary function and muscle performance tests followed by treadmill walking trials at different speeds with concurrent expired gas analysis via a face mask. The participants will then perform a training program for the breathing muscles at home for 6 weeks. The research team will follow up each week via telehealth visits to support training. After the 6-week training program, participants will return in-person for a follow-up visit and will undergo the same series of assessments as the first visit.

Eligibility Criteria:
Inclusion Criteria:

* Completed medical treatment (chemotherapy, chemotherapy/surgery, chemotherapy/radiation or any combination of cancer treatment) for any type of cancer, except for cancer of the central nervous system, at least 1 year ago

Exclusion Criteria:

* History of neuromuscular, cardiac, or pulmonary disease prior to the diagnosis of cancer
* Recent injury or condition (less than 6 months ago) that precludes strength testing or walking
* Dyspnea with minimal activity (4 on the modified Medical Research Council Dyspnea Scale)
Evaluation of Enteral Nutrition in Critically Ill Children

The aim of this study was to evaluate the effect of calorie and enteral feeding timing on survival in critically ill children receiving inotropic, vasopressor and inodilatory supplements.

The aim of this study was to evaluate the effect of calorie and enteral feeding timing on survival in critically ill children receiving inotropic, vasopressor and inodilatory supplements. Early enteral nutrition will be initiated within the first 24 hours of hospitalization in critically ill children who have inotropic vasopressor and inodilator support without any problems and contraindications in gastrointestinal system functions. The energy requirement of the intubated patients will be measured by indirect calorie meter method. Schofield method will be used to calculate the daily energy needs of extubated patients. 30% of the targeted energy in the first 48 hours of hospitalization and 80% of the targeted energy in the first week will be achieved by enteral nutrition.Nutritional solutions with a concentrated formula of 1 / 1.5 will be given to patients with cardiac pulmonary or renal disease requiring fluid restriction.Patients will be followed up for vomiting, diarrhea, abdominal distention, feeding intolerance, gastric residues and gastrointestinal bleeding. If these findings develop, the patient's nutrition will be interrupted according to the clinician's assessment and enteral nutrition will be re-fed as soon as possible.

Eligibility Criteria:
Inclusion Criteria:

* Children with normal gastrointestinal system function
* Children receiving inotropic, vasopressor or inodilatory support

Exclusion Criteria:

* Children with gastrointestinal system dysfunction
* Children with enteral nutrition contraindicated
* Children with metabolic disease with special nutrition
The Association of Protein-Energy Adequacy With Mortality in Critically Ill Patients With Acute Kidney Injury.

This is a prospective observational single-center study in which the association of Protein-Energy Adequacy and 28-Days of Mortality among critically ill patients with Acute Kidney Injury, AKI will be investigated. The association of Protein-Energy adequacy with a length of ICU and hospital stay, total ventilator, and inotropic drug days among critically ill patients with AKI also will be investigated.

Patients with Acute Kidney Injury, AKI are probably more exposed to the risk of malnutrition especially if they undergo Renal Replacement Therapy, RRT. Optimization of nutrients especially energy and protein can ensure a better health outcome for critically ill patients with AKI. Moreover, there is no research on the association of Protein- Energy adequacy with mortality among critically ill patients with AKI in Malaysia. So, the main purpose of this study is to investigate the relationship of Protein-Energy adequacy with mortality among critically ill patients with AKI

Subjects will be recruited upon admission in ICU after fulfilling the inclusion and exclusion criteria. They will be follow up from day 1 until day 14 or until ICU Discharge. Data including Demographic, Clinical, Laboratory, and Nutritional Status will be recorded. On Day 28, the outcome data including Mortality, length of ICU Stay, and Length of Ventilator day will be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are 18 years old and older
2. Patients who are admitted to the participating ICU.
3. Patients who are mechanically ventilated.

Exclusion Criteria:

1. Patients who are less than 18 years old
2. End-stage renal disease patients
3. Patients undergo kidney transplantation within 3 months before ICU admission
4. Pregnant patients
5. The patient is moribund with expected death within 24 hour or whom survival to 28 days is unlikely due to uncontrollable comorbidity (cardiac, pulmonary or hepatic end-stage disease; hepatorenal syndrome; poorly controlled cancer; severe post-anoxic encephalopathy and others)
6. Prior treatment with RRT within 30 days
7. Anticipated alive ICU discharge within 24 hours
8. Readmission to the ICU during the same hospitalization episode.
Serum Vitamin D Levels in Critically Ill Patients Undergoing Regional Citrate Anticoagulation CRRT

Several studies point at a potential relationship between vitamin D deficiency and worse outcome in critically ill patients admitted to the intensive care unit. It is linked with the lack of vitamin D pleiotropic effects in the state of hypovitaminosis D. The pleiotropism of vitamin D is dependent on a specific feature of vitamin D receptor (VDR) namely polymorphism and its universal existence in the human body. Vitamin D pleiotropism is linked with cancer cells inhibition, a modulation of the immune system, an influence on cardiovascular system and neuroprotection.

In 35-65% critically ill patients hospitalized in the intensive care unit the acute kidney injury (AKI) is diagnosed. Acute kidney injury increases significantly the probability of death. The standard therapy of a severe AKI in many intensive care units is the regional citrate anticoagulation continuous renal replacement therapy by means of continuous veno-venous hemodiafiltration (CVVHDF). The specificity of the regional citrate anticoagulation by means of precise ionized calcium and citrate dosing evokes questions regarding its influence on vitamin D and entire calcium-phosphate metabolism in the state of a severe AKI treated with regional citrate anticoagulation continuous renal replacement therapy.

The intention of that trial is to measure vitamin D plasma levels and other parameters (parathormone, ionized and total calcium, magnesium, phosphate, albumin, globulin) linked with calcium-phosphate metabolism in the human body. We would like to assess potential relationships between the regional citrate anticoagulation continuous renal replacement therapy and these parameters.


Eligibility Criteria:
Inclusion Criteria:

* Respiratory, circulatory failure and acute kidney injury mechanically ventilated critically ill patients admitted to the critical care unit undergoing regional citrate anticoagulation continuous renal replacement therapy by means of continuous veno-venous hemodiafiltration (CVVHDF)

Exclusion Criteria:

* age less than 18 years
* acute liver failure
* hypercalcemia at admission (total calcium plasma level \> 10.6 mg/dL; total ionized calcium plasma level \> 1.35 mmol/L)
* parathyroid glands disease at admission
* serum vitamin D level \< 10 ng/ml at admission
* end stage renal disease at admission
* lack of relatives consent
The Epidemic Status and Development Trend of Hepatitis C Virus Infection in Pregnant Women in Xi'an

The objectives of this study are to improve HCV linkage-to-care in Chinese women and provide theoretical basis for the scientific formulation of HCV prevention and control strategies for pregnant women.

To understand the epidemiological changes and status of hepatitis C virus (HCV) infection in pregnant women in Shaanxi province in recent 10 years, and to analyze the main influencing factors of hepatitis C infection in pregnant women.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women or parturient women confirmed by blood HCG test.
2. Patients aged 18 years old and above.
3. Patients with HCV antibody seropositive or HCV RNA positive from 2014-2023.

Exclusion Criteria:

1. Patients without valid telephone numbers.
2. Duplicate records: For duplicate records of the same pregnant woman, only one record should be kept.
Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol

This non-interventional study concerns a safety data collection based on adverse event data from a third-party registry (European Haemophilia Safety Surveillance System, EUHASS) that includes information about adverse events from patients with haemophilia A treated with turoctocog alfa pegol. There is no extra burden to the patients by participating in this registry-based data collection.


Eligibility Criteria:
Inclusion Criteria:

* Participation in the European Haemophilia Safety Surveillance System (EUHASS).

Exclusion Criteria:

* N/A
Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma

The aim of this study is to assess the auditory nerve functionality with an intraoperative approach following a surgical removal of acoustic neuroma in patients with severe to profound sensorineural hearing disabilities.

Whatever the acoustic neuroma treatments, the patient risks a hearing loss. The global strategy of hearing care aims to preserve the quality of life and patient hearing. For severe to profound hearing loss and anatomical auditory nerve preservation, the cochlear implant is put forward compared to the auditory brainstem implant. Indeed, cochlear implant provides better speech outcomes. If cochlear implantation is not possible or no benefit for the patient, the brainstem implant is the most widely used. The Neuristim device is used to investigate the auditory nerve integrity following neuroma surgery or on an affected auditory nerve. The Neuristim is an intra-cochlear stimulator used in an intraoperative way. The intra-cochlear electrodes provide an electrical stimulation to auditory nerve fibers, and auditory nerve response measurements to these electrical stimulation are recorded and evaluated to determine the auditory nerve functionality. The Neuristim is a device for helping surgeons to choose the most appropriate implantable solution. 2 groups of patients will be involved in this study:

* a group of 17 patients with an acoustic neuroma or a past neuroma surgically removed or acoustic neuroma not requiring a surgery and with severe to profound hearing loss candidate for a cochlear implant or a auditory brainstem depending on the auditory nerve functionality,
* a group of 17 patients with severe to profound hearing loss candidate for a cochlear implant.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years or older
* Patient with an acoustic neuroma already surgically removed with associated hearing loss (experimental group),
* Patient with an acoustic neuroma programmed to be surgically removed and candidates for an implantable hearing rehabilitation solution (experimental group),
* Patient with an acoustic neuroma that not need to be removed and candidate for an implantable hearing rehabilitation solution (experimental group), or
* Typical patient candidate for a cochlear implant (control group)

Exclusion Criteria:

* Cochlea malformation, cochlea ossification
* Vulnerable subject
Connective Tissue Motion Measure

The goal of this project is to develop a biomarker - the Connective Tissue Motion Measure (CTMM) -quantifying the functional behavior of perimuscular connective tissues.

The differential motion between specific connective tissue strata will be measured during tissue displacement (linear oscillation) initiated by a computer-controlled needle stimulus tool (NST). The CTMM will be suitable as an outcome measure for mechanistic and clinical studies of CAM interventions. The CTMM also will potentially serve as a clinical diagnostic and treatment-monitoring tool for manual therapists, acupuncturists, and CAM clinicians interested in assessing the functional status of a patient's connective tissue.

Eligibility Criteria:
Inclusion criteria for LBP subjects:

* history of recurrent or chronic LBP for a minimum of 12 months
* ability to stand and walk without assistance
* ability to understand and read English
* ability to understand and sign a consent form

Inclusion criteria for No-LBP subjects:

* no history of low back pain or any other chronic pain that has limited activities of daily living or work
* a numerical current pain index of less than 0.5.

Exclusion Criteria for all subjects:

* previous severe back or low extremity injury or surgery
* major structural spinal deformity (scoliosis, kyphosis, stenosis)
* ankylosing spondylitis or rheumatoid arthritis
* neurological deficit (weakness and/or sensory loss, decreased deep tendon reflexes suggesting nerve root compression, but not subjective symptoms of nerve root irritation (sciatica)
* neurological or major psychiatric disorder
* bleeding disorders
* corticosteroid or anticoagulant medication
* pregnancy
* worker's compensation or disability case
* in litigation for the LBP problem
* acute systemic infection
* BMI less than 21 or greater than 35
Efficacy and Safety of ATL-962 in Obese Diabetics

The purpose of this study is to investigate whether ATL-962 induces weight loss in diabetic patients and whether its safety and tolerability profile is superior to that of orlistat in such patients

Obesity is a significant and increasing clinical problem. There is a need for effective therapeutic agents to help people reduce weight. ATL-962 is a lipase inhibitor which could reduce the amount of fat absorbed from a person's diet, leading to weight reduction.

In this study patients with Type II diabetes who are clinically obese will receive ATL-962 at one of three dose levels, or placebo, or orlistat (another lipase inhibitor). The study will investigate the amount of weight lost after 12 weeks' treatment and will compare the safety and tolerability profile of ATL-962 and orlistat.

Eligibility Criteria:
Inclusion Criteria:

* Type II diabetes
* Body mass index 28-45kg/m2
* HbA1c 6%-10%

Exclusion Criteria:

* Significant weight loss in the previous 3 months
* Weight gain during the run-in period
* Other serious systemic conditions, except controlled hypertension, mild asthma, and primary hypothyroidism
* History of GI disorders
* Previous surgery for weight loss
Home Monitoring to Predict Exacerbation in Cystic Fibrosis

The study aims to establish if it is possible for people with Cystic Fibrosis to monitor a number of parameters on a daily basis at home which might predict respiratory infections before they have symptoms and which might also predict treatment failures before this is obvious with conventional measures.

Participants will collect the following clinical information daily: pulse rate and oxygen saturations, wellness and cough scores, spirometry measurements, physical activity, temperature, weight and sleep quantity and quality. The patients will also collect daily sputum samples.

Data will be collected via Bluetooth-enabled devices and transmitted via a Smart-phone to a secure National Health Service approved web-based site to be analyzed.

The information obtained will allow the investigators to develop a software program that will identify signals that can predict the onset of a chest infection before symptoms develop.

The investigators will also measure specific substances in sputum to identify changes before, during and after chest infections. The investigators hope this additional information will enable them to more accurately predict the onset of chest infections in cystic fibrosis.

The results of this study will determine if it is possible to develop a simple sputum test for patients to use at home in combination with other home-based assessments of well-being to provide an early warning system of a chest infection before patients feel unwell.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride.
2. Age ≥ 18 years of age.
3. A history of at least 1 acute pulmonary exacerbation in the past 12 months.
4. Able to provide written informed consent.
5. Willing and able to produce daily sputum samples.
6. Willing and able to provide daily telemetric measure of several physiological parameters.

Exclusion Criteria:

1. Patients unable to provide written informed consent
2. Patients unable to produce daily sputum samples
3. Less than 1 infective pulmonary exacerbation in 12 months
4. Lung transplant recipients
Alcohol Consumption and Coronary Heart Disease Onset

The primary aim of this study is to examine if long-term patterns of alcohol consumption are associated with time-to-onset for incident coronary heart disease (fatal and non-fatal), using data from multiple cohorts.

The relationship between alcohol consumption and coronary heart disease (CHD) remains an issue of debate. By capturing drinking trajectories over time, we may be equipped to obtain new insights into this relationship. Studies have shown that such trajectories have differential associations for intermediate traits (carotid intima-media thickness, pulse wave velocity and inflammatory markers), but no studies exist that link stability of drinking to actual CHD. The current study will employ a longitudinal cohort design to evaluate the association between long-term alcohol consumption trajectories and time-to-event for CHD. Data will be drawn from six cohorts (five British, one French). The combined participant pool comprises 64,926 individuals (58% male, individual cohort sizes ranging from 1,444 to 25,636 participants); those with a baseline history of CHD will be excluded. Repeat alcohol intake measurements across a 10-year interval will be the exposure, with participants' intake trajectory defined according to their alcohol consumption volume and its consistency over time. To account for heterogeneity across cohorts, individual participant data meta-analysis methods will be employed in determining CHD diagnosis rates and hazard ratios for the different intake trajectories, with adjustment for relevant demographic and clinical characteristics. Results from the modelling work illustrating the form and magnitude of the association between the alcohol intake categories and CHD will be presented.

This work will help further understanding of the role that alcohol intake and its stability over time play in subsequent CHD risk, and will have implications for our understanding of alcohol's relationship to cardiovascular health in the general population.

Eligibility Criteria:
Inclusion Criteria:

* Participated in cohort studies being investigated
* Provided alcohol intake data at least one time point
* Was included in coronary heart disease onset tracking

Exclusion Criteria:

* Left cohort study prior to completion of 10 year exposure window
* Had history of coronary heart disease before end of 10 year exposure window
Effect of Isometric Handgrip Training on Ambulatory Blood Pressure in Patients With Hypertension

Meta-analysis studies have demonstrated that isometric training with handgrip promotes reductions in clinical blood pressure, reaching 8 mmHg for systolic blood pressure and 4 mmHg for diastolic. However, the effects of this training modality on ambulatory blood pressure, which is better discriminant of cardiovascular risk than clinical BP, remains uncertain. Thus, the ISOPRESS Network, consists of researchers from Brazilian institutions of education and research (Federal University of Santa Catarina, Federal University of Amazonas, Federal University of Sergipe, Federal Rural University of Pernambuco and Universidade Nove de Julho), will conduct a multi-center study to analyze the effects of isometric handgrip training on clinic and 24-h ambulatory blood pressure in patients with hypertension. For this, each research center will conduct a randomized controlled trial with medicated patients with hypertension, of both sex. The participants will be randomized into two groups: isometric handgrip training group (HBT: n = 25 per center) and control group (CG: n = 25 per center).Subjects assigned to the HBT will train three times per week, four sets of 2-min isometric contractions (using alternate hands) at 30% of maximal voluntary contraction, during 24 weeks. Subjects randomized to the CG will perform stretching and relaxation exercises three times per week, during 24 weeks. The evaluations will occur in three moments: baseline, post-12 and post-24 weeks. The primary outcome will be ambulatory blood pressure, while clinic blood pressure and cardiac autonomic modulation will be analyzed as secondary outcomes. For data analysis, in addition to descriptive statistics, two-way ANOVA for mixed model will be applied for within and between groups comparison. The level of significance that will be adopted is p\<0.05.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hypertension, controlled by up to three antihypertensive medications
* Blood pressure levels between 130 and 180 mmHg
* No high cardiovascular risk (no other cardiovascular, metabolic or pulmonary disease nor any signals or symptoms of these disease)
* Not engaged in a physical exercise program for at least six months
* Not present cognitive impairment (Montreal Cognitive Assessment ≥ 26 points)

Exclusion Criteria:

* Adherence to less than 85% of training sessions
* Diagnosis of other cardiovascular diseases or diabetes during the course of the study
* Adherence to another supervised physical exercise program
* Change in medication class and/ or dose during the study
* Aggravation of the disease (i.e. blood pressure above 180 or use of four or more medications).
Omega-3 Supplementation and Attention-deficit-hyperactivity Disorder (ADHD)

It is assumed that only 1/5 of children diagnosed with attention-deficit-hyperactivity disorder (ADHD) are treated. New treatment modalities are urgently needed. Omega-3 fatty acids have been used in this setting, yet results are conflicting. The parent omega-3 fatty acid alpha-linolenic acid (ALA) has only been used in one trial. 40 children diagnosed with ADHD will be randomized to consume either ALA or placebo for two months. Baseline and end assessments will include ADHD-related questionnaires and a computerized test. The investigators hypothesize that ALA supplementation will prove beneficial for children with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* ADHD diagnosis
* informed consent

Exclusion Criteria:

* refusal of any testing
* any comorbidities
* any medication or supplement use
Sleep in Cluster Headache: Sleep Parameters in- and Outside a Cluster Bout

Sleep study in episodic cluster headache patients.

This is an explorative study that aims to describe the sleep in 30 episodic cluster headache patients in- and outside of cluster using polysomnography. Data will be compared to a group of healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years of age
* Episodic cluster headache according to ICHD-III beta
* Ability to differentiate attacks of other primary headaches from cluster headache.
* 1-8 daily attacks
* Cluster bouts normally lasting more than 2 weeks

Exclusion Criteria:

* Treatment with psychiatric medication other than lithium.
* Pregnancy or breastfeeding
* Serious somatic or psychiatric disorders
* Chronic primary or secondary headache
* Alcohol intake higher than 14 units a week for males and 7 units a week for females.
* Cannot accept the conditions of the trial.
* Does not understand Danish.