cyrilzakka/clinical-trials huggingface dataset:
Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for NARDS

1. A predictive model for NARDS was established based on perinatal risk factors. Multivariate Logistic regression analysis was used to screen the independent prenatal risk factors for NARDS. A Logistic regression model was constructed using the above independent risk factors and quantified in a nomogram to construct a visualization model for prenatal prediction of NARDS.
2. The role of ACS in the prevention and treatment of ARDS in near-term/full-term infants.

For neonates with a probability greater than 80% in the prediction model of ARDS, at least one ACS was given before the termination of pregnancy. The GC level of cord blood (taken at birth) and the mRNA levels of α-ENaC, Na-K-atpase and SGK1 in nasal epithelium were measured within 2 hours and 1 day after birth in the ACS intervention group and the control group. The occurrence and severity of pulmonary edema, the occurrence and severity of ARDS, and the mortality rate of NARDS were evaluated by lung ultrasound. The indexes of the two groups were compared horizontally and longitudinally.

Based on the proposed scientific hypothesis, the project team intends to achieve the following research objectives through scientific experiments:

To explore the role of ACS in promoting fetal lung maturation from the perspective of lung fluid clearance through the traditional concept that ACS promotes fetal lung maturation mainly by inducing PS, so as to further expand the object and scope of ACS application.

The prenatal prediction model of ARDS was established by using perinatal risk factors, and the predictive value was visualized.

To explore the clinical value and mechanism of ACS in pregnant women at high risk of NARDS, and to open up new ideas for the prevention and treatment of NARDS from the perspective of promoting lung fluid clearance; The early prevention and treatment strategy of NARDS was established by combining the "prenatal prediction model +ACS", and its effect was evaluated.

Eligibility Criteria:
A predictive model for neonatal acute respiratory distress syndrome was established based on perinatal risk factors.

Inclusion Criteria:

1. The pregnant women with a probability greater than 80% in the prediction model of neonatal acute respiratory distress syndrome and agreed to ACS intervention.
2. Obtaining patient consent.

Exclusion Criteria:

1. the pregnant women with a probability of less than 80% in the neonatal acute respiratory distress syndrome prediction model.
2. The patient refuses.
To Identify Urinary Biomarkers Associated With Gestational Diabetes Mellitus [GDM]

Gestational diabetes mellitus(GDM) is one of the most common complications of pregnancy. The incidence of GDM is higher in Asian than in other regions, and GDM can increase the risk of a series of perinatal complications. The investigators has been committed to the early diagnosis of GDM, and several biomarkers in the first trimester and urinary proteomic markers that were associated with GDM have been found. Based on the previous work, the aim of this study was to verify the predictive ability of urinary proteomic markers for GDM that has been found in the previous study of the researchers. This study is a multi-center, prospective, and observational study. Urine samples will be collected twice, at 12 weeks and 24-28 weeks of gestation, respectively.

The eligibility criteria are as follows:

1. singleton pregnant women over 18 years old;
2. gestational age less than 12 weeks;
3. regular follow-up until delivery;
4. able to understand and sign an informed consent.

The exclusion criteria of pregnant women are as follows:

1. with impaired glucose tolerance or diabetes mellitus before pregnancy;
2. severe chronic diseases or infectious diseases (e.g., liver disease, urinary system disease, cardiovascular disease, autoimmune disease, hematological disease, AIDS and other diseases before pregnancy);
3. medications other than vitamins used during pregnancy;
4. inability to understand and follow-up regularly;
5. other conditions judged by the investigators to be inappropriate for participation in the study.

Eligibility Criteria:
Inclusion Criteria:

* Women of childbearing age who are in early pregnancy(gestational age less than 12 weeks);
* Regular prenatal examination until delivery;
* Older than 18 years old;
* Obtained informed consent from participants and/or their family members.

Exclusion Criteria:

* Twins or multiple pregnancy;
* With impaired glucose tolerance or diabetes mellitus before pregnancy;
* With severe chronic diseases or infectious diseases (e.g., liver disease, urinary system disease, cardiovascular disease, autoimmune disease, hematological disease, AIDS and other diseases before pregnancy);
* Medications other than vitamins used during pregnancy;
* Inability to understand and follow-up regularly;
* Other conditions that were judged by the investigator to be ineligible for participation in the study.
Implementation Strategy for a Breastfeeding Guideline in Primary Care

The purpose of this study is to determine whether an implementation strategy for a breastfeeding guide is more effective than the usual practice (simple circulation of the guide) in terms of increasing the percentage of children receiving exclusive or preferential breastfeeding at 6 months age.

Protection and promotion of breastfeeding is considered a priority in Europe where only 22% of children less than 6 months old are exclusively breastfed. In Spain this percentage reaches 24.8% but in our city it falls to 18.26%. Various studies emphasise that the improvement of these results falls upon the training of health professionals. Following the recommendations of a breastfeeding guide can modify professional practice and improve results with respect to patients.

Aim:to determine whether an implementation strategy for a breastfeeding guide is more effective than the usual practice (simple circulation of the guide) in terms of increasing the percentage of children receiving exclusive or preferential breastfeeding at 6 months age.

Method/Design: The present work involves a community, clinical trial, randomised by clusters in Primary Health Care Centres in Madrid Region (Spain). The project aims at determining whether the use of implementation strategy (including training session, information distribution, an opinion leader) of Breastfeeding CPG in primary care is more effective than the usual practice of mere circulation.

Number of patients required will be 240 (n=120 in the intervention group and control group), all mothers of children born during the study period (6 months), who come to the health centre on the first visit of child attention programme and give their consent to participate.

The main outcome variable is age at which breastfeeding ceases; secondary outcome variables include sex, age, educational level.

Analysis of main effectiveness will be done, comparing the proportion of patients with breastfeeding completed at 6 months in the two study groups. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis.

Eligibility Criteria:
Inclusion Criteria:

* Mothers of children born during the study period (6 months)
* Mothers who come to the health centre on 1st visit (child attention programme)
* Mothers who give their consent to participate.

Exclusion Criteria:

* Breastfeeding Contraindications
Study to Evaluate the Efficacy and Safety of EG-009A Compared to DEX in Patients With COVID-19 Pneumonia

To study signals of efficacy and safety of a currently available dosage form (IM) of EG-009A in reducing the severity of respiratory disease in patients hospitalized with SARS-CoV-2 virus.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥18), or willing and able to provide assent (age ≥12 to \<18, where locally and nationally approved) prior to performing study procedures
2. Patient is aged at least 18 years, enrollment of patients \< 65 years old will be limited to 20% of the total with the first 50% of enrollment conducted solely among those patients ≥ 55 years old.
3. Patient has SARS-CoV-2 pneumonia from COVID-19 infection of moderate to serious severity (WHO Ordinal Scale for Clinical Improvement score of 4 or 5)
4. Patient has COVID-19 symptoms ≤ 10 days and at least 1 of the following:

   * Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.)
   * O2 saturation (SpO2) ≤ 94% on room air
   * Requiring supplemental O2 (patients on HFNO ≤ 20 L/min with FiO2 \< 0.5 are allowed), but not requiring mechanical ventilation.

Note: Patients admitted with immediate need for mechanical ventilation are of a severity too critical for inclusion into this protocol. Patients who are already in the hospital and have been removed from mechanical ventilation are not eligible.

Exclusion Criteria:

1. Patient has SARS-CoV-2 infection of severity ≥ 6 on COVID-19 WHO Ordinal Scale for Clinical Improvement or for those subjects who have a WHO Ordinal Scale for Clinical Improvement score of 5, nasal intermittent positive pressure ventilation (NIPPV) or requiring HFNO \> 20 L/min with FiO2 ≥ 0.5 will be exclusionary.
2. Patient is currently receiving extracorporeal membrane oxygenation, nitric oxide therapy, or high-frequency oscillatory ventilation
3. Patient is unlikely to survive for \> 24 hours from randomization, in the opinion of the investigator
4. Patient has a history of chronic oxygen use or any pre-existing respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization
5. Patient has a history of venous thromboembolism, DVT, or pulmonary embolus
6. Has taken other investigational drugs or participated in any clinical study within 30 days or 5 half-lives (if known) of the investigational drug's PK, PD, or biological activity (if known), whichever is longer, prior to the first dose of study drug in this study or is currently participating in another clinical study.
The Correlation Between the Pulmonary Function and Intrarenal Hemodynamics in 37 T2DM Patients in Early Period

Objective: The main target of this study was to research the early changes in pulmonary function and intrarenal hemodynamics, then research the correlation between the pulmonary function and the renal hemodynamics in type 2 diabetes (T2DM) patients without diabetic kidney disease (DKD).

Method: 37 T2DM patients (diabetes group) without DKD and 33 healthy people (control group) were choosed to research early changes in pulmonary function and intrarenal hemodynamics, then research the correlation between the pulmonary function and the renal blood flow in T2DM patients, all having normal renal function. The primary endpoints were the pulmonary function parameters (VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%); the secondary endpoints were the intrarenal hemodynamic (bilateral kidney RI) in bilateral interlobular renal arteries were evaluated using; the tertiary endpoints were the biochemical variables: blood-fat (TC, HDL-C, LDL-C, and TG), renal function parameters (BUN, Cr, and GFR); in addition, the albumin excrete rate (AER), urinary albumin/creatinine ratio (UACR) were measured.

Pulmonary function was measured by spirometer which was provided by Jaska Corporation in Japan, model number: HI-101; RI were measured by Logiq 400 MD Pro Series scanner (GE Medical Systems, Milwaukee, WI) using a 3.5-4 MHz vector array transducer

Eligibility Criteria:
Inclusion Criteria:

1) The patients were diagnosed with T2DM according to the guidelines of the American Diabetes Association ; 2) No smoking history, pulmonary disease, cold, nor pulmonary infection within a fortnight; 3) Did not have hepatopathy, nephropathy, hyperuricemia, and gastrointestinal disease; and 4) Likely to have good compliance and able to visit our hospital for periodic assessments.

Exclusion Criteria:

1) T1DM, gestation and lactation; 2) Renal inadequacy; 3) Hypohepatia; 4) Intensive care with insulin treatment; 5) The patients combinated with DKD and hypertension (antihypertensive drugs were used); 6) Patients with other renal conditions that could affect the hemodynamics, such as urolithiasis, urinary infection, and renal cyst (diameter \> 3 cm); 7) Heart failure; 8) Cholesterol-lowering drugs can not control the blood-fat ; and 9) Use of systemically injected glucocorticoids within 3 months prior to our study.
Spinal Anaesthesia vs. General Anaesthesia for THA, TKA and UKA

The goal of this randomized clinical trial is to investigate the postoperative recovery following hip and knee arthroplasty procedures depending on the use of either spinal anaesthesia (SA) or general anaesthesia (GA).

The main questions are:

* Are more patients able to be safely mobilized within 6 hours postoperatively when using GA compared to SA?
* Does postoperative pain, nausea and vomiting, dizzyness, occurence of delirium and urinary retention differ between the anaesthetic methods?

Participants, scheduled for total hip, total knee and unicomartmental knee arthroplasty, will be randomized to recieve spinal anaesthesia or general anaesthesia in relation to surgery. At 6 hours postoperatively a physiotherapist will conduct a 5-meter walking test to evaluate whether the participant can be safely mobilized.


Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological hip or knee osteoarthritis meeting the indications for primary total hip, total knee, or unicompartmental knee arthroplasty.
* ≥18 years of age.
* Able to speak and understand Danish
* Able to give informed consent and must be cognitively intact.

Exclusion Criteria:

* Lives in an institution.
* Uses walking aid such as a walker or a wheelchair.
* Terminal illness.
* Has contraindications for either general or spinal anaesthesia.
* Has objections to receiving either general or spinal anaesthesia.
* Requires anxiolytics as premedication prior to anaesthesia.
* Traumatic aetiology as a basis for surgical indication.
* Altered pain perception and / or neurologic affection due to diabetes or other disorders.
* Daily preoperative use of opioids \> 30 mg of morphine milligram equivalents (MME).
* Standard primary arthroplasty procedure is evaluated not to be suitable.
* Women considered fertile but without sufficient birth control.
Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction

The aim of the present study was to investigate if NTG, administered intravenously during gastric tube reconstruction, could preserve gastric fundus tissue blood flow and oxygenation and reduce the incidence of postoperative leakage.

Complications of oesophagectomy and gastric tube reconstruction are leakage and stenosis, which may be due to compromised microvascular blood flow (MBF) in the gastric tissue. We recently demonstrated that peri-operatively decreased MBF could be improved by topical administration of nitro-glycerine NTG). In this present study we investigate the effect of intravenous NTG on gastric microcirculation.

This single centre, prospective, double blinded study randomized thirty-two patients scheduled for esophagectomy into two groups. The intervention group received intravenous NTG during gastric tube reconstruction, as the control group received normal saline.

Baseline values of MBF, microvascular haemoglobin O2 saturation (μHbSO2), and microvascular haemoglobin concentration (μHbcon) were determined at the gastric fundus before and after gastric tube construction and after pulling up the gastric tube to the neck.

Eligibility Criteria:
Inclusion Criteria:

* Planned esophagectomy with gastric tube reconstruction
* written informed consent
* ASA I and II

Exclusion Criteria:

* younger than 18
Tissue Procurement for Gastric Cancer, Gastrointestinal Stromal Tumors (GIST), Esophageal Cancer, Pancreas Cancer, Hepatocellular Cancer, Biliary Cancer, Neuroendocrine, Peritoneal Mesothelioma, Anal Cancer and Colorectal Cancer in Patients Undergoing Surgery or Biopsy

The purpose of this study is to collect and store normal and malignant tissue from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, an estimated 50 to 100 of each tumor type. To collect and store blood samples from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer. To create a database for the collected tissue and allow access to relevant clinical information for current and future protocols. To create tissue microarrays for each gastrointestinal cancer subtype, namely, gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, to facilitate future molecular studies. To grant access to Dr Kindler, Dr. Salgia, and Dr. Catenacci to this database (as it is being acquired) of the coupled patient tissue samples (normal and malignant) and relevant clinical information for the investigation of tyrosine kinases, such as Met and Ron, receptor tyrosine kinase family members, STATs, paxillin, focal adhesion proteins, cell motility/migration proteins, tyrosine/serine/threonine kinase family members, related molecules, and downstream targets implicated in the pathogenesis of GI cancers. Examples of molecular testing include evaluation of DNA mutation, alternative splice variants, protein expression and phosphorylation, and immunohistochemistry on samples. These studies will be correlated with clinical information as stated above.


Eligibility Criteria:
Inclusion Criteria:

* any patient diagnosed with Gastric (stomach) Cancer, Esophageal (foodpipe) Cancer, Pancreas Cancer, Liver Cancer, Biliary (gallbladder) Cancer, Gastrointestinal Stromal Tumor, Peritoneal Mesothelioma (cancer in the lining of the abdomen), Neuroendocrine (of or relating to the cells that release a hormone into the blood in response to a neural stimulus) Tumor, Anal Cancer or Colorectal Cancer cancer that requires you to undergo a surgical or diagnostic procedure.
Flex Intramedullary Rod Study

The purpose of this study is to compare the effect of post-operative ROM between Flex IM rod and Rigid IM rod, to collect bone morphology of Japanese lower extremity and to research the incidence of overhung with Flex IM rod.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
2. Patient is a male or non-pregnant female age 20 years or older.
3. Patient is candidate for primary Total Knee Arthroplasty (TKA).
4. Patient whose preoperative range of motion (ROM) is over 110 degree.
5. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

1. Revision cases
2. Patients that use bone wedges or allograft due to bone loss.
3. Patient has a Body Mass Index (BMI) \>40.
4. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
5. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
6. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
7. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
8. Patient has failed unicondylar knee prosthesis.
9. Patient has a known sensitivity to device materials.
10. Patient who are inappropriate for participating in the study in the judgment of the investigator.
Anonymized Data Collection From the CS6BP for Heart Arrythmias Measurements

The purpose of this clinical study is to collect data simultaneously with the CS6BP watch sensors during EPS in order to characterize different evoked arrhythmias and record Blood Pressure during the procedures that blood pressure is collected by an automated cuff.

The proposed clinical study is a Prospective Feasibility, Single-Center Study to collect data simultaneously with the CS6BP watch sensors during EPS or during admission in order to characterize different evoked arrhythmias. Subjects will be screened by the principal investigator or PI's delegate for meeting the study inclusion/exclusion criteria.

Subjects will be fitted with the CS6BP and ECG Holter by Investigator/Study Coordinator during the preparation of the subject to the procedure; when the subject is anesthetized and fitted with an automatic cuff that is preset to measure BP on a frequency as defined in the procedure protocol.

Subjects will be measured simultaneously with CardiacSense device, ECG Holter and EPS recording system if available (- ECG and intracardiac ECG recorded form intra-cardiac catheters). During the EPS the physician will timestamp and mark any provoked arrythmia either on ECG printouts or EPS recording system traces.

The device will be removed once patient has recovered. Subjects candidates for pacemaker implantation will be measured simultaneously with CardiacSense device and ECG Holter before procedure, during patient's hospitalization at cardiology division. At the end of the test the CardiacSense device and ECG Holter will be removed and their data will be downloaded. The recorded ECG (from Holter and if available also EPS recording/ mapping system) data will be analyzed by site staff. The analyzed ECG data will be sent to the company with the CS6BP raw data for further investigation.

BP values will be collected from subjects that are fitted with an automated cuff for BP monitoring for the purpose of evaluation and if required by the physician, during the hospitalization.

All adverse events (whether device related or not) will be reported during the course of the clinical study. All serious adverse events will be reported immediately to the study sponsor and monitor (within one working day). All clinical data will be recorded on appropriate CRFs.

Eligibility Criteria:
Inclusion Criteria:

* Age of eighteen (18) year and above
* In clinical need for electrophysiology study (standalone or before ablation procedure) and/or Subjects with AVB who are candidates for pacemaker implantation
* Ability and willingness to sign an informed consent form

Exclusion Criteria:

* Patients with significant co morbidities (assessed by the clinician at screening only):

Mechanically ventilated patients Mechanical circulation (LVAD, IABP, ECMO)

* Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study
* Subjects with PPG SNR \<100 indicated by the CS6BP device
* Women who are pregnant or breastfeeding
* Subjects with had deformity banning from wearing the device