cyrilzakka/clinical-trials huggingface dataset:
Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.

This study is a single-center, blind, prospective, randomized, controlled trial of pressure support ventilation (PSVpro) versus pressure control ventilation - volume guaranteed (PCV - VG) during laparoscopic and robotic abdominal surgery.

The objective of the study to evaluate the possibility and feasibility of using PSVpro during anesthesia during long-term laparoscopic and robot-assisted abdominal operations at different levels of neuromuscular block.

Intervention: We plan to include 100 patients who will undergo elective long (more 2 hours) laparoscopic or abdominal robotic surgery. All patients will be randomly assigned in two groups in ratio 1:1. 1 group- deep neuromuscular block and mandatory ventilation; 2 group- partial neuromuscular block and pressure support ventilation.

Expected Results. PSV may reduce the systemic inflammatory response compared to the mandatory ventilation during laparoscopic and abdominal robotic surgery.

Eligibility Criteria:
Inclusion criteria:

* Written consent.
* Men and women aged 18 years or more.
* The physical status from ASA classification I, II or III.
* BMI \<= 34.9 kg / m2.
* Low risk of respiratory complications.
* Laparoscopic surgery in the pelvis.

Exclusion criteria:

* The physical status from ASA IV or V.
* BMI\> = 35 kg / m2.
* Neuromuscular disease.
* Allergy to Anesthetic Agents.
* Operations on two cavities.
* Operations on the chest cavity.
Differentiating the Invasiveness of Lung Adenocarcinoma by Dual Energy CT Parameter

The core purpose of this study is to investigate whether the extracellular volume (ECV) fraction measured in delay phase by dual energy computed tomography (DECT) can distinguish precancerous lesions from early-stage lung adenocarcinomas, which could assist clinical decision making for surgery operation indication and strategy.

Although progression of lung adenocarcinoma (LUAD) depends on driver mutations, it is also affected by tumor microenvironment (TME), including vessels, immune cells and extracellular matrix (ECM). As major constituent of TME, ECM mediates interactions between cancer cells and stromal cells, promotes angiogenesis, epithelial-mesenchymal transition, causes metastasis and resistance to immune therapy. Along with the progression of LUAD histologic stages, from atypical adenomatous hyperplasia (AAH) and adenocarcinoma in situ (AIS) to minimally invasive adenocarcinoma (MIA), and finally to invasive adenocarcinoma (IA), the composition of the ECM changes a lot, which has some characterizations same as interstitial pulmonary fibrosis. Hence, identifying the pathological ECM status may help differentiating the invasiveness of lung adenocarcinomas.

Based on the theory that in delay phase, the contrast medium is evenly distributed in the intravascular and extravascular-extracellular spaces and not entering the cell, extracellular volume (ECV) fraction is considered as a potential quantitative imaging parameter for ECM. It has been confirmed that ECV fraction is highly consistent with pathological fibrosis in cardiac and hepatic diseases. In other lesions with fibrosis such as pancreatic and thymic epithelial tumors, ECV fraction also has positive effects in malignancy prediction. It has been verified that ECV fraction is capable of differentiating lung cancer with benign lung lesions and classifying lung cancers into three subtypes. However, there has yet no study testified it as an invasion predictor.

The core purpose of this study is to investigate whether ECV fraction can distinguish precancerous lesions from early-stage lung adenocarcinomas and compare it with other confirmed radiological features in prediction performance, which is clinically meaningful regarding optimal treatment selection and avoidance of unnecessary surgical procedures.

Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years old with pulmonary nodules (diameter≤3 cm).
* pathologically confirmed as lung adenocarcinoma.
* without history of other malignancies.
* accurate hematocrit within 1 week before contrast enhanced dual energy CT examination.

Exclusion Criteria:

* with a history of allergy to iodine contrast agents and other reasons who are unable to complete the examination.
* without histopathology of invasion stage, such as AAH, AIS, MIA and IAC.
* history of chemotherapy, radiotherapy, or other anti-tumor therapy before contrast enhanced dual energy CT.
* poor image quality.
* contrast enhanced dual energy CT scans ≥ 4 weeks before surgery.
Ferinject® Assessment in Patients With Iron Deficiency and Chronic Heart Failure (FAIR-HF)

This study is designed to evaluate the efficacy of Ferinject® in improving symptoms of CHF in patients with iron deficiency. Analyses will focus both on subjective and objective measures. Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF)
* Left ventricular ejection fraction (LVEF) 40% or lower for patients in NYHA II and 45% or lower in NYHA III
* Screening haemoglobin (Hb) at least 9.5 g/dL but below or equal to 13.5 g/dL (average of 2 haemoglobin concentrations)
* Screening ferritin below 100 µg/L, or below 300 µg/L when transferrin saturation (TSAT) is below 20%

Exclusion Criteria:

* History of acquired iron overload.
* Known active infection, clinically significant bleeding, active malignancy.
* Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST)
* Anaemia due to reasons other than iron deficiency
* Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months).
* History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months.
* Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias.
* Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months.
* Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.
Swallowing Function Before and After Surgery for Thyroid Goiter

To date, there have been no comprehensive studies on swallowing function in patients undergoing surgery for multinodular goiter. We hypothesize that 1. Multinodular goiter has significant effect on swallowing function in symptomatic and asymptomatic patients, which can be demonstrated by a standardized questionnaire and a formal swallowing evaluation and 2. Surgery will improve swallowing function as measured post-operatively by these same parameters. Patients with multinodular goiter will be asked to fill out a validated survey (SWAL-QOL) on swallowing function in addition to undergoing a formal swallowing evaluation before and after surgery for multinodular goiter (subtotal thyroidectomy) and compared to patients undergoing total thyroidectomy for follicular cancer and less extensive thyroid surgery for other benign processes (lobectomy or lobectomy plus isthmusectomy).

Detailed description not desired.

Eligibility Criteria:
Inclusion Criteria:

* thyroidectomy

Exclusion Criteria:

* na
Effectiveness and Safety of Respiratory Training in the Prevention and Severity of COVID-19

A randomized controlled clinical trial will be carried out using inspiratory and expiratory training devices on healthy subjects recruited in social networks and university environments. The aim will be to determine the effectiveness and safety in the prevention and severity of COVID-19 disease by a respiratory training with inspiratory and expiratory devices.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Drugs
* Surgery
* Neurology diseases
* Rheumatic diseases
* Systemic diseases
* Smokers
Recording High Frequency Oscillations in Patients With Tumors and Epilepsy

The investigators want to characterize high-frequency oscillations (HFOs) in intracranial recordings, which may occur as markers of epileptogenic tissue and also under physiological stimulation.

The investigators want to show that recording of high-frequency oscillations (HFOs) is feasible in our project population both intraoperatively and during presurgical physiological conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patients intend to be treated at the Klinik für Neurochirurgie
* Patients fall into one of the patient groups: (1) Patients with symptomatic epilepsy with focal and/or secondary generalized seizures resistant to medication where a neurosurgical resection is considered as an intervention of epilepsy surgery. (2)Patients where a tumor is planned to be resected that has caused preoperative seizures. (3) Patients where a tumor is planned to be resected that has not caused preoperative seizures.
* Male and Female subjects 18 years to 99 years of age
* Written informed consent after participants' information

Exclusion Criteria:

* contraindications on ethical grounds
* known or suspected non-compliance, drug or alcohol abuse,
* enrolment into a clinical trial within last 4 weeks
Proprioception and Sensorimotor Control in Hereditary Sensory and Autonomic Neuropathy

This project comprises three sets of physiological studies - testing eight specific hypotheses - that will contribute new knowledge on proprioception and motor control in a genetic disorder that affects specific components of the sensory nervous system.

I: To investigate the neurophysiological basis for disturbed motor control in Hereditary sensory and autonomic neuropathy (HSAN) III II: To investigate the effects of enhancing cutaneous feedback on motor control in HSAN III III: To investigate the cortical representation of proprioceptive inputs in HSAN III

HSAN III patients (n=15) and healthy control subjects (n=15) will lay supine on an MRI bed and a tungsten microelectrode inserted percutaneously into a muscle or cutaneous fascicle of the right common peroneal nerve at the fibular head, according to standard techniques employed by Prof Macefield. Neural activity will be acquired, RMS-processed (200 ms) and analysed on computer. The subject's head will be tightly enclosed in a standard clinical 32-channel SENSE head coil and headphones will be provided to minimize noise and to allow communication with the subject. The subject will be placed in the bore of a 3T whole-body scanner for 60-90 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed genetic diagnosis of HSAN III will be recruited from the Dysautonomia Center at NYU

Exclusion Criteria:

* homeless
* active drug or alcohol dependence
* evidence of neurological disorder or diabetes
* exposure to neurotoxic drugs that in the investigator's opinion may compromise results
* Pregnant women
Evaluation of Adherence to the Mediterranean Diet in Patients with Recurrent Renal Stones and Disease Osteometabolic

The aim of this research protocol is to evaluate the adherence to the Mediterranean diet in patients suffering from recurrent kidney stones and osteometabolic diseases. Results of the study will allow to assess the dietary habits of patients with the above diseases. Given the universal prevalence of nephrolithiasis and osteometabolic diseases, the knowledge of these data appears crucial for the proper management of the dietary approach to prophylaxis secondar


Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic relapsing nephrolithiasis with evidence instrumental of bilateral renal stones or emission of more than one stone in the past 5 years

Exclusion Criteria:

* Patients who had albumin-corrected plasma calcium levels \> 11.0 mg/dl at the time of the first determination of serum levels of 25 OH vitamin D;
* Patients who had glomerular filtration rate \< 60 mL/min/1.73 m2;
* Patients who had positive personal history of chronic granulomatous disease;
* pregnancy patients;
* Positive personal history for morphological abnormalities of the excretory system;
* incomplete data collection.
Assessment of Socket Shapes Made by Central Fabrication Facilities

Quality and accuracy of prosthetic sockets manufactured by central fabrication facilities may be lacking. Poor quality manufacturing can be detrimental to socket fit in amputees and may require more work by prosthetists to redesign the socket. The aim of this research is to assess the accuracy of prosthetic sockets manufactured by commercial companies. Determination of how and where manufacturing errors occur will contribute to better quality of socket fit for the amputee patient and improve the efficiency of prosthetists who fit the manufactured products to their patients.

Computer manufactured sockets are made for subjects, then their fits assessed by research practitioners.


Eligibility Criteria:
Inclusion Criteria:

* trans-tibial amputees who use a prosthesis and are ambulatory

Exclusion Criteria:

* do not have a prosthesis, cannot ambulate
Clinical Characteristics of Infantile Hemangioma

The primary purpose of this study is to identify the clinical characteristics of infantile hemangioma (IH) in our single center in China. The second objective of the study is to identify the clinical features of infantile hepatic hemangioma (IHH) and ulceration in patients with IHs.

Infantile hemangioma (IH) is the most common benign tumor of infancy with an estimated prevalence of 4%-5%. IHs may be presented in any part of body including the visceral organs, but are preferentially located on the face, head and neck area. IHs exhibit a characteristic life cycle consisting of a rapid proliferating phase within the first year of life followed by a slowly involuted phase lasting for up to five years. Although most resolve over time without major sequelae, a significant subset can result in severe complications including disfiguring and ulceration, some even could impair organ functions and threaten patients' life. Risk factors of IHs have been identified including multiple gestation, low birth weight, prematurity, white race, eclampsia and placental abnormalities. However, the exact occurrence, clinical features and risk factors of IHs is still unknown in Chinese patients because of the lack of large scale of prospective studies. In addition, characteristics of ulceration of IHs and infantile hepatic hemangiomas (IHHs) are also not well documented. Therefore, it's important to perform this prospective study to determine the clinical features of Chinese patients with IHs, and this study will also make contributions to the prevents, diagnoses and treatments of IHs.

Eligibility Criteria:
Inclusion Criteria:

* Age ≤6 years old
* Diagnose of IHs
* Consent of both parents (or the person having parental authority in families)

Exclusion Criteria:

* Congenital hemangioma, kaposiform hemangioendothelioma, or other vascular anomalies
* Age\>6 years
* Hemangioma has been previous treated with corticosteroids, laser, cryotherapy, or only other treatments
* Patients with an inability to participate or to follow the study treatment and assessment plan
The Effect Of Sitting Position On The Labor Process

This study was conducted to determine the effect of sitting position on the labor process. The randomized controlled experimental study was conducted in the delivery room of Sivas Numune Hospital.


Eligibility Criteria:
1. Inclusion Criteria:

   * Age range: 19-35
   * 38-42 weeks of pregnancy
   * No health problems that would prevent the use of sitting position
   * -Amniotic membranes not ruptured
   * Having a singleton pregnancy
   * Fetus in vertex position
   * Labor occurs with normal spontaneous vaginal delivery
   * No diagnosed chronic physical disease
   * No diagnosed psychiatric disease
   * No risky pregnancy, risky delivery and newborn/fetus
   * No communication problems
   * Voluntarily participating in the research
2. Exclusion Criteria:

   * Only women who gave birth at Sivas Sample Hospital were included in the study
   * Women who gave birth more than two times were not included in the study
Preschool Attention and Sleep Support (PASS)

This study will be investigating two telehealth interventions for preschoolers with ADHD. The study is divided into two Aims. During Aim 1, caregivers of preschoolers with attention concerns, pediatric behavioral health professionals, and pediatric primary care providers will take part in two virtual focus groups to provide their perspective on ways to improve the telehealth intervention being evaluated.

During Aim 2, caregivers of preschool children with ADHD symptoms will be randomly assigned to participate in one of two 9-week telehealth interventions. Both interventions will teach evidence-based skills and provide practice opportunities to manage their children's ADHD-related behaviors. Caregivers and their children will also attend three study visits (one before the intervention, and two following the intervention) where they will be asked to complete questionnaires and assessments related to the child's ADHD symptoms, psychiatric health, and sleep habits. Following each study visit, participating children will be asked to wear an ActiGraph device on their nondominant wrist for 24 hours/day for a 7-day period. During this time, the caregivers will be asked to complete an electronic daily diary about their child's sleep.

Eligibility Criteria:
Inclusion Criteria:

* child must be ages 3-5 years at intake
* child with score of 30 on the Child Sleep Habits Survey-Short Form and a caregiver rating of child's sleep problems as moderate/severe
* child with ≥80th percentile on the clinician-rated ADHD-RS based on age and sex norms, with at least 4 symptoms in the clinically significant range (scores of 2-3) in either the inattention or hyperactive/impulsive domains
* parent/caregiver must have ability to speak, read, and write in English
* parent/caregiver must have access to a device with internet and/or smartphone to access telehealth visits
* parent/caregiver must have ability to follow written and verbal instructions
* parent/caregiver must have ability and willingness to comply with study procedures.

Exclusion Criteria:

* child with suspected obstructive sleep apnea or restless legs syndrome (via screening questionnaires)
* child with current use of stimulant medication, other psychotropics, or medications for sleep (prescription or over-the-counter, including melatonin)
* child with caregiver report of psychiatric disorder other than ADHD requiring treatment (medication and/or therapy), Autism Spectrum Disorder, or intellectual disability
* parent/caregiver is currently participating in another parent training intervention or have previously participated in another parent training intervention in the past 6 months.
* Severe and/or uncontrolled medical condition (e.g., pulmonary and neurological conditions such as cystic fibrosis and seizure disorder) that would interfere with sleep and/or study participation according to the study team
Long-term Safety Trial with NVDX3

An study evaluating the long-term safety of all patients previously treated with NVDX3.

An study evaluating the long-term safety of all patients previously treated with NVDX3 (referred to as the "core NVDX3 trial"). All patients having signed the ICF enter the long term follow-up study.

Eligibility Criteria:
Inclusion Criteria:

1. Patient being implanted with NVDX3.
2. Previously participated to one of the NVDX3 core clinical trials.
3. Patient accepts to comply to a yearly follow-up safety visit for 10 additional years
4. Patient has understood and accepted to participate in the long-term follow-up study by signing the informed consent.

Exclusion Criteria:

No exclusion criteria are applicable.
Blood Sugar Response to Commercial Nutritional Supplements in Patients With Type 2 Diabetes

The purpose of the study is to determine which of the commonly used meal supplements is the best product for patients with DM. This is important because meal supplements are becoming more popular as meal replacements in the United States. Peak blood sugar occurs about 2 hours later after a meal. Therefore, the best product would be the one that produces a smallest rise in blood sugar.

The purpose of the study is to determine which of the commonly used commercial nutritional supplements are preferential for patients with Diabetes Mellitus (DM). We will compare the post-prandial blood glucose (BG) responses in response to 3 different nutritional supplements each containing 50 grams of carbohydrate in adult patients with type 2 diabetes mellitus and relate these responses to one of the two well-recognized indices of insulin sensitivity - HOMA-R and QUICKI.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-75 years
* Type-2 diabetes mellitus for over 3 months
* A1c of 7.0 - 10.0% within the past 3 months
* Controlled with diet /exercise and/or on oral anti-diabetic agents which are non-insulin secretatgogues, i.e. Metformin and/or Pioglitazone
* Able to give informed consent
* Expected to be in the DC metropolitan for the duration of the study
* Fasting blood glucose between 70 and 250 mg/dl

Exclusion Criteria:

* Patients with type 2 diabetes mellitus treated with insulin secretagogues (sulfonylurea and non-sulfonylurea), pramlintide (Symlin), GLP-1 analogs (Byetta), insulin, or alpha-glycosidase inhibitors
* A1c under 7.0% or over 10.0%
* Fasting blood glucose \< 70 or \> 250 mg/d
* Gastrointestinal disorders affecting digestion and absorption of nutrients such as lactose intolerance, chronic diarrhea, pancreatic insufficiency.
* Clinical history of documented gastroperesis.
* Patients on hemodialysis or peritoneal dialysis
* Pregnancy
* Inability to read and/or speak English