cyrilzakka/clinical-trials huggingface dataset:
Compare Pharmaceutical Economics and Efficacy of Sevoflurane With Low Fresh Gas Flow Balanced Anesthesia, Propofol Target Controlled Infusion Anesthesia and Propofol Induction Sevoflurane Maintenance Anesthesia

This study is being performed to compare the cost of anesthetic techniques with sevoflurane (low fresh gas flow balanced anesthesia) versus propofol (target controlled infusion \[TCI\]) versus propofol induction and sevoflurane maintenance anesthesia in subjects undergoing elective laparoscopic surgery with predicted anesthesic use between 1 and 3 hour duration.

Three hundred thirty-six subjects were enrolled in this study. Two subjects, one treated with propofol for induction and maintenance and one treated with propofol for induction and sevoflurane for maintenance are not included in the study participation since no information was available for these two subjects.

Eligibility Criteria:
Inclusion Criteria

1. Men or women, aged from 18 to 65
2. ASA (American Society of Anesthesiologists) physical status (a requirement of the subject's physical status): I or II
3. Body mass index (weight/height\^2) from 16 to 30 kg/m\^2
4. Elective laparoscopic surgery requiring general anesthesia managed with endotracheal intubation
5. Duration of anesthesia use will be greater than or equal to 1 hour, but less than 3 hours in length.

Exclusion Criteria

1. Hypersensitivity or unusual response to any halogenated anesthetics.
2. History of significant cardiovascular, pulmonary, hepatic, renal, central nervous system or muscular disease.
3. Pre-operative cognitive dysfunction or disabling neuropsychiatric disorders.
4. Need for emergency surgery or surgery requiring additional regional anesthetic techniques.
5. Need for intracranial surgery, cardio-surgery or thoracic surgery.
6. Subjects inability to cooperate with the anesthetist before administration of the anesthetic agent.
7. Personal or familial history of malignant hyperthermia.
8. Females who are either pregnant or breast feeding.
Meals on Wheels, the Effect of a Home Food-delivery Service for Cancer Patients

The overall objective of the study is to investigate the effect of energy- and protein enriched home delivered meals vs. habitual diet in malnourished patients suffering from cancer on various endpoints.

Despite the fact that nutritional deterioration has been associated with patients' functional impairment, the effect of individualized nutritional support or counselling to outpatients, focussing on ordinary food, have not yet been thoroughly explored (Ravasco P. et al. 2007). A few studies have investigated the effect of nutritional counselling on quality of life (QoL) in cancer patients after discharge (Ovesen et al. 1993, Persson et al. 2002, Isenring et al. 2004, Ravasco et al. 2005a, Ravasco et al. 2005b). However, there is to our knowledge not conducted any studies examining the effect of home delivered meals on QoL and other endpoints in outpatients suffering from cancer.

The overall objective of the study is to measure the effect of energy- and protein enriched home delivered meals vs. habitual diet in malnourished outpatients diagnosed with lung cancer. The intervention diet will consist of optional protein- and energy-dense main and in-between-meals. There will be 22 different main meals and 13 in-between meals to choose between. The meals are prepared by The Nordic Kitchen of Copenhagen University Hospital Herlev. The offered main meals will consist of a selection of warm dishes taken from the ordinary menu. The in-between meals are a collection of the Delights of Herlev (dishes previously shown to increase dietary intake among in-patients). The food will be delivered to the participants' home 3 times per week, and participants can order one warm dish and ad libitum in-between meals for each day.

Eligibility Criteria:
Inclusion Criteria:

* Have a nutritional risk score ≥ 3 according to NRS-2002 (Kondrup J. et al. 2003)
* Be diagnosed with lung cancer
* Have a life expectancy \> 12 weeks
* Not plan to loose weight or go on a diet
* Not plan to go on vacation for \> 2 weeks during the study period
* Live at their own home
* Live ≤ 25 km from the hospital
* Be able to read, write and understand Danish

Exclusion Criteria:

* Receives food from a food-delivery service
* Have food allergies or intolerance
* Exclusively receives enteral or parenteral nutrition
* Suffers from cognitive impairment e.g. dementia
* Is terminal
Lung Cancer Diagnosis by Detecting Epigenetic Imprinting Alterations in Bronchoalveolar Lavage

The goal of this multicenter observational study is to evaluate the lung cancer diagnostic value of epigenetic imprinting detection in bronchoalveolar lavage. This study will mainly focus on varifing the previously identified epigenetic imprinting biomarkers for lung cancer and upgrading and validating a lung cancer imprinting diagnostic model specifically for bronchoalveolar lavage. The lavage sample will be collected from each eligible paticipants under bronchialscopy and undergo QCIGISH detection to analyze the allelic expression status of imprinted genes. The QCIGISH detection results will be compared with the final surgical histopathology. No interventions will be taken according to the QCIGISH detection results.

Bronchial biopsy and bursh are widely used in lung cancer diagnosis but not bronchoalveolar lavage because of its low sensitivity. As the molecular alterations usually occur before the morphological changes, genetic and epigenetic biomarkers will be helpful for early diagnosis of cancers. As an important epigenetic regulation in mammalian embryo development, genomic imprinting plays important roles in cancers. In normal post-natal somatic cells, imprinted genes are "silenced", that is mono-allelically expressed either from the maternal or paternal allele, while in cancers, some silenced imprinting genes' copies could be reactivated, leading to expressions from both alleles. The loss of monoallelic gene regulation is named loss of imprinting (LOI), and has been previously found in various human cancers. Our previous studies has identified several imprinted genes with elevated aberrant allelic expressions in lung cancer. A diagnostic model based on the epigenetic imprinting biomarkers achieved 99.1% sensitivity and 92.1% specificity. In this study, we will first verify the epigenetic imprinting biomarkers in bronchoalveolar lavage, and refine the previously developed diagnostic model specifically for lavage samples. The diagnostic model will be independently validated in a group of prospectively enrolled cases. This study will help to distinguish benign and malignant pulmonary nodules presurgically, and improve the early diagnosis of lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old, and ≤ 75 years old;
* Chest CT showed pulmonary nodule with diameter\<3cm;
* Subjects voluntarily participated and signed the informed consent form.

Exclusion Criteria:

* Active massive hemoptysis;
* Severe heart and lung dysfunction;
* Severe arrhythmia;
* Extreme exhaustion of general condition;
* Coagulation dysfunction;
* Acute attack of asthma;
* Aortic aneurysm.
Preoperative Immunonutrition in Patients Undergoing Spine Surgery

A malnutritional status is known to be associated with altered immune function, reduced function, and worsen outcomes after orthopedic surgery. Medical and surgical complications are not uncommon in Orthopedics and infection rates are potentially life-threatening complications, with the highest morbidity, mortality, and healthcare costs. Most patients undergoing orthopedic surgery are elderly, malnourished, osteosarcopenic, sedentary, anemic, and suffer from low levels of vitamin D. A mono-nutrient supplement may be not sufficient for supporting the arthrodesis techniques, which are invasive open surgeries procedures with significant blood losses and the need of transfusions. In this therapeutic area, immuno-nutrition has been used in spine surgery, with the reduction of complications, revisions, and readmissions. In addition, prosthetic surgery outcomes have been observed to ameliorate by using this nutritional support. Therefore, preoperative oral immuno-nutrition therapy may be applied in older adults undergoing spine surgery to improve patients' outcomes and reduce complications.

This is a randomized, controlled, open-label, 2-arm non-parallel-group, single-center interventional study to assess the efficacy of an immuno-nutrition therapy vs. hospital standard of care in spine surgery to improve patients' outcomes. This is a single primary endpoint study. A total of 136 patients from IRCCS Orthopedic Institute Galeazzi in Italy will be recruited and assigned in a 1:1 ratio to the treatment arm.


Eligibility Criteria:
Inclusion Criteria:

* male and female sex, of all ethnicities, aged over 60
* arthrodesis involving ≥ 6 vertebrae
* American Society of Anesthesiology (ASA) risk: 1, 2, or 3
* Absence of neurological or psychiatric disorders
* Signing of informed consent and consent to collaborate in all study procedures
* Patients who meet the clinical requirements to undergo their first spinal surgery

Exclusion Criteria:

* American Society of Anesthesiology (ASA) risk: 4
* No cervical arthrodesis
* Diagnosis of neurological or psychiatric disorders
* Revisions
* Therapy with other supplements at the time of the first visit 0
* Known allergy or adverse food reactions
* Chronic inflammatory or autoimmune diseases (e.g. rheumatoid arthritis)
* Gastrointestinal disorders
* Conditions that do not allow to undergo surgery
Soft Robotics for Infants With Cerebral Palsy

Children with spastic cerebral palsy suffer from significant weakness that contributes to abnormal posture and movement. It is thought that this arises due lack of frequency sufficient tension to encourage normal muscular growth underlying the need for early intervention to encourage walking. The failure of muscle growth to keep pace with bone growth is most evident in the bi-articular muscles and contributes to joint contractures and gait abnormalities such as toe-walking and flexed-knee gait.

Recently, our research team has developed a novel, lightweight (0.2kg at knee joint) and portable (energetically autonomous) Soft Wearable Robotic Knee System that can provide active powered knee assistance and synchronized proprioceptive feedback for the gait training of stroke patients' standing and walking.


Eligibility Criteria:
Inclusion Criteria:

* capable of understanding the proposed exercises;
* aged 2 to 15 years;
* maximum weight 75 kg;
* children with no deformations that could prevent the use of the exoskeleton;
* Gross Motor Function Classification System (GMFCS) levels I to III;
* able to signal pain or discomfort.

Exclusion Criteria:

* unhealed skin lesions in the lower limbs;
* aggressive or self-harming behaviors;
* severe cognitive impairment.
Effects of Physical Training on Vascular Function as a Therapeutic Target in Pulmonary Hypertension

The role of physical training in the treatment of pulmonary arterial hypertension (PAH) is controversial. The aim of the project is to evaluate the effect of physical training on markers of endothelial function and integrity and to identify those biomarkers associated with a better therapeutic response in patients with PAH and in an experimental model of pulmonary hypertension. Methodology: 1) Study in humans: sample size will be 50 patients with PAH. Responders and non-responders will be identified for a 12-week resistance training program. Before and after the physical training program, endothelial microparticles and circulating vascular progenitor cells, and metabolomic and mitochondrial function parameters in circulating endothelial cells will be analyzed. Patients will be identified in whom a more favorable response to the training program is obtained. Additionally, investigators will evaluate the relationship between this response and the biomarkers both at baseline and their change with the training program. 2) Study in a murine experimental model: investigators will study mice with pulmonary hypertension induced by the administration of Semaxanib (SU5416) and exposure to hypoxia for 3 weeks and control mice. Half of them will exercise on a treadmill for 3 weeks. At the end of the program the right ventricular pressure will be measured and the animals will be sacrificed. Morphometric studies in pulmonary and cardiac tissue, pulmonary endothelial function and metabolomic parameters in cardiac and skeletal muscle will be performed. Differences in these variables between the different experimental groups will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Functional class of New York Heart Association (NYHA) II-III
* Diagnosis of pulmonary hypertension (PH) by right heart catheterization, as follows:
* Mean pulmonary arterial pressure (mPAP) \>=25 mmHg
* Pulmonary vascular resistance (PVR) ≥240 din / s / cm5
* Pulmonary interlock pressure (PCWP) ≤15 mmHg
* Patients with optimized PAH treatment, including intensified treatment with diuretics and who have remained stable for at least 2 months before entering the study (changes in medical treatment are not expected during the entire 12-week study period)
* Be able to understand and be willing to sign the informed consent form

Exclusion Criteria:

* Other type of PH (groups 2, 3, 4 or 5)
* Pregnant women
* Disability to exercise on a cycle ergometer or walk
* Acute infection or fever
* Any change in the treatment of the disease in the last 2 months
* Acute ischemic heart disease, unstable angina pectoris, exercise-induced ventricular arrhythmias, decompensated heart failure
* History or suspicion of inability to cooperate adequately in the study
New Markers of Cardiac Surgery Related Acute Kidney Injury.

Cardiac surgery related acute kidney injury (CS-AKI) is a clinical problem associated with a cardiopulmonary bypass used during cardiac surgery procedures. In this study the investigators will assess the biochemical markers of acute kidney injury such as ischemia modified albumin (IMA) or urinary excreted of brush-border enzymes of the proximal renal tubules perioperatively. There has been no official recommendations toward routine use of analysed biomarkers.

Cardiac surgery related acute kidney injury (CS-AKI) is an important clinical problem. Kidney injury occurs following a cardiopulmonary bypass used during cardiac surgery procedures. The pathomechanisms of acute kidney injury (AKI) is complex and multifactorial. It may involve few injury pathways: ischemia and reperfusion, endogenous toxins, inflammation, metabolic factors and oxidative stress. Biochemical markers of acute kidney injury such as ischemia modified albumin (IMA) or urinary excreted of brush-border enzymes of the proximal renal tubules analysed perioperatively will be assessed in this study. There has been no official recommendations toward routine use of analysed biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* a planned operation of coronary artery bypass grafting with the use of cardiopulmonary bypass

Exclusion Criteria:

* emergency operations or re-operations;
* a known pathology of the urinary tract or renal failure;
* chronic use of the following medications: iron, non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppression, or steroids in the preoperative period;
* polycythemia, porphyria or pathological hemoglobin species in anamnesis;
* preoperative signs of hepatic failure;
* active autoimmune or neoplastic diseases, active infection;
* anticipated significant bleeding (anti-platelet agents), suggesting the use of blood-derived products during the operation and afterward
* acute myocardial infarction after operation
Exercise Intolerance in Heart Failure

The investigators are studying whether metabolic abnormalities in cardiac and skeletal muscle in patients with heart failure with preserved ejection fraction (HFpEF) are associated with debilitating exercise intolerance.

This research is being done to better understand why patients with heart failure have difficulty exercising and performing some activities of daily living. Heart muscle and skeletal muscle (in the legs and arms) depend on normal metabolism (the conversion of foods to chemical fuel) to function properly. Investigators will measure metabolites in the heart and leg muscles, including the levels of high energy phosphates and lipids (fats) using magnetic resonance (MR) techniques. High-energy phosphates serve as a source of energy, which is used by the heart and skeletal muscle for contraction. Magnetic resonance uses magnetic fields to measure the levels of these substances.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either gender who are greater than 21 years of age (no upper age limit),
* Permission of patient's clinical attending physician,
* Previous clinical diagnosis of HF with current New York Heart Association (NYHA) Class II-III symptoms for at least 1 month,
* Left ventricular ejection fraction (EF) \>50% by echocardiography, MRI, CT or x-ray or nuclear ventriculography within prior 12 months,
* Stable medical therapy for at least 30 days (no addition or removal or major (\>100%) dose change of Renin-Angiotensin-Aldosterone System (RAAS) antagonists, beta-blockers, or calcium channel blockers for hypertension).

Exclusion Criteria:

* Unable to understand the risks, benefits, and alternatives of participation and give meaningful consent,
* Contraindications to MRI such as implanted metallic objects (pre-existing cardiac pacemakers, cerebral clips) or indwelling metallic projectiles,
* Significant valvular abnormalities,
* Pregnant women (women of childbearing potential will undergo blood or urine pregnancy testing),
* History of clinical CAD or significant epicardial coronary disease (\>50% stenosis) in major coronary artery by x-ray or CT angiography unless (a) the patient underwent prior successful revascularization with percutaneous coronary angioplasty within the prior three years and (b) there are no residual lesions of \>50% on the most recent coronary angiographic study.
* History of infiltrative cardiomyopathy or constrictive pericarditis,
* Cor pulmonale,
* Significant pulmonary disease,
* Estimated glomerular filtration rate (eGFR) \<20ml/min,
* Any condition other than HF which could limit the ability to perform a 6MW or cardiopulmonary exercise test (CPET) test (e.g., critical peripheral vascular disease, significant orthopedic or neurological conditions),
* Any diseases other than HF which are likely to significantly alter the patient's global perception of status or quality of life over a period of 6 months.
* Significant peripheral vascular disease
Sleeping For Two: Trial for CBT for Insomnia in Pregnancy

Cognitive-behavioural therapy for insomnia (CBT-I) has been shown to be an effective treatment for insomnia in multiple populations, including women during pregnancy and postpartum. This randomized-controlled trial will compare the efficacy of CBT-I for pregnant women with insomnia to a treatment as usual group.

Sleep disturbances are common during pregnancy and typically worsen as pregnancy progresses.Treating antenatal insomnia with pharmacotherapy effectively improves sleep quality and confers a protective benefit against the onset of postpartum depression; however, data suggests that pregnant women are reluctant to take prescribed medications due to perception of risk.

A large body of research has demonstrated that CBT-I has short-term efficacy equivalent to medication, while long-term results suggest that it outperforms medication. Despite the literature showing cognitive behavioural therapy for insomnia (CBT-I) to be effective in a variety of populations including postpartum women, and the demonstrated harmful consequences of sleep disturbances in late pregnancy, there have been few pilot studies examining the effectiveness of CBT-I in pregnancy, which was conducted by our group. Results suggested that CBT-I was effective and acceptable in reducing both objective and subjective indices of sleep quality and quantity of insomnia. These results are encouraging, and warrant larger investigations into the efficacy of CBT-I in pregnancy.

Research Question and Objectives:

The current proposal is an extension of a pilot study into a randomized design of in-person CBT-I compared to a treatment as usual (TAU) control for the treatment of insomnia experienced in pregnancy.

The primary aim of the current project is to evaluate the impact of a 5-week in-person CBT-I versus a control group in reducing symptoms of insomnia (assessed subjectively by self-report and objectively with actigraphy) experienced in pregnancy. The investigators hypothesize that participants who receive a 5-week program CBT-I (versus TAU) will report fewer insomnia symptoms and have improved objectively assessed sleep as measured post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* At or over the age of 18
* Between 12 and 28 weeks pregnant
* Are able to read, write and speak in English
* Have a diagnosis of insomnia according to the DSM-V criteria.

Exclusion Criteria:

* Experiencing symptoms of sleep disorders other than insomnia (i.e. restless legs syndrome \[RLS\], sleep-disordered breathing \[SDB\]
* Having a history of untreated, serious psychiatric illness (i.e., bipolar disorder, schizophrenia)
* Active suicidal ideation
* Currently taking prescribed medications for sleep problems
* Smoking, drinking alcohol or drug abuse during pregnancy
* Being pregnant with multiples
* Diagnosis of chronic pain.
Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)

There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). One of the most common treatments for POI is hormone replacement therapy (HRT), but HRT doesn't work well, and it has been shown to increase the risk of blood clots in the veins, ovarian cancer, and breast cancer. The ability of MSCs to differentiate into oocyte-like cells has been previously documented. Herein the purpose of this work is to evaluate the therapeutic potential of cell therapy in women suffering from POI.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with primary ovarian insufficiency;
2. Women between 20 and 40 years;
3. Have fertility requirements, husband has sperm;
4. Willing to sign the Informed Consent Form.

Exclusion Criteria:

1. Primary amenorrhea;
2. Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome);
3. Thyroid dysfunction;
4. Severe endometriosis;
5. Contraindications for pregnancy;
6. Prior personal history of ovarian cancer;
7. Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period;
8. History of serious drug allergy or allergic constitution;
9. Autoimmune disease, history of severe familial genetic disease;
10. HIV+, hepatitis B, C;