cyrilzakka/clinical-trials huggingface dataset:
Effect of Albumin Administration in Hypoalbuminemic Hospitalized Patients With Community-acquired Pneumonia.

Community-acquired pneumonia (CAP) remains a leading cause of death world-wide. Hypoalbuminemia is associated with worse outcomes. However, whether albumin administration would have a beneficial effect in outcome in patients with CAP remains uncertain.

This project proposes to test the hypothesis of whether the administration of albumin in hypoalbuminemic patients with CAP would increase the proportion of clinical stable patients at day 5.

This project will consist of a superiority, non-blinded, multicentre, randomized, phase 3, interventional controlled clinical trial. The estimated sample size is of 360 patients, who will be recruited from three Spanish hospitals. Hypoalbuminemic (≤30g/L) adult patients with CAP will be randomly assigned (1:1) to receive standard care plus albumin (20g in 100ml) every 12 hours for 4 days or standard care alone.

The primary endpoint will be the proportion of clinical stable patients at day 5, defined as stable vital signs for at least 24h, analyzed by intention to treat.

The secondary endpoints will be time to clinical stability; duration of intravenous and total antibiotic treatment; length of hospital stay; intensive care unit admission; duration of mechanical ventilation and vasopressor treatment; adverse events; readmission within 30 days and all-cause mortality.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Diagnosis of CAP (Chest radiography consistent with CAP AND the presence of ≥2 following prespecified clinical criteria: Fever or hypothermia; Cough; Purulent sputum; High white blood cell count; Dyspnea; Pleuritic chest pain; Signs consistent with pneumonia on chest auscultation)
* Serum albumin concentration ≤ 30 g/L at presentation

Exclusion Criteria:

* Pregnancy or lactation
* Immunosuppression (e.g. chemotherapy or radiotherapy within 90 days, immunosuppressive drugs, corticosteroids at a minimum dose of 15mg/day of prednisone within 2 weeks of enrolment, HIV with a CD4 count below 200, solid organ transplant recipients, hematopoietic cell transplant recipients).
* Severe clinical status with expected survival of less than 24h.
* Congestive heart failure (New York Heart Association classes 3 or 4)
* Any contraindication for albumin administration such as hypersensitivity to albumin.
* Clinical conditions in which there is another indication for albumin administration (e.g. hepatic cirrhosis with ascites, malabsorption syndrome and nephrotic syndrome).
* Absence or impossibility of obtaining informed consent from the patient/next of kin.
* Patient already included in another clinical trial testing a treatment method.
Ultrasound Guided Recruitment Manauvere Versus Individualized Positive End Expiratory Pressure in Pediatric Patients Undergoing Laparoscopic Abdominal Surgery

The aim of this prospective randomized controlled study is to compare the effect of US-guided Recruitment Manauvere (RM) versus individualized positive end-expiratory pressure (PEEP) on oxygenation and preventing respiratory complications in pediatric patients undergoing laparoscopic abdominal surgeries.

Atelectasis is among the most frequent postoperative pulmonary complications (PPCs) of general anesthesia with an incidence of between 68% and 100% in children. Atelectasis impairs gas exchange, thus causing hypoxemia and other respiratory disorders such as acute lung injury and pneumonia.

Pneumoperitoneum is another risk factor for perioperative atelectasis. It elevates the diaphragm and intra-abdominal pressure. In order to prevent atelectasis, applying positive end-expiratory pressure (PEEP) or an alveolar recruitment Maneuvere (RM) have shown beneficial effects.

Lung ultrasound (US) is a noninvasive, radiation-free, convenient, and reproducible bedside imaging modality for anesthesia-induced atelectasis in children.

Eligibility Criteria:
Inclusion Criteria:

* Age from 3 to 8 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I-II.
* Children scheduled for elective laparoscopic abdominal surgeries.

Exclusion Criteria:

* Parental refusal.
* Bronchial asthma or any preexisting chest disease.
* Congenital deformity of the thoracic cage.
* Patients with a history of thoracic surgery.
* Cardiac, hepatic, or renal failure.
* Obese children with BMI at or above 95th percentile of the same age and sex.
Endoscopic Mucosal Resection for the Diagnosis of a-Ganglionosis, a Controlled Prospective Trial (EDGE Trial)

Patients undergoing routine rectal suction biopsy will undergo as part of the study an additional Endoscopic mucosal resection. The biopsy results will also be correlated with patient's clinical data including clinical history, Bristol stool scale, anorectal manometry results, and SITZ marker studies. Cost and recovery time will be compared.

Background: Adult and pediatric patients presenting with chronic constipation and/or motility disorders may be referred for rectal biopsy to rule out aganglionosis or Hirschsprung's disease. The traditional diagnostic test, rectal suction biopsy, is a blind technique and is insensitive in confirming the diagnosis. Frequently, patients require subsequent referral for a surgical full thickness biopsy.

Hypothesis: Endoscopic mucosal resection (EMR) will improve the diagnostic yield for aganglionosis and decrease the need for subsequent surgical full thickness biopsy.

Methods: This is a prospective, single center, controlled investigation of EMR for the diagnosis of colonic aganglionosis / Hirschsprung's disease. Patients who are offered rectal suction biopsy will be offered enrollment. Enrolled patients will have one additional procedure (EMR) at the time of their rectal suction biopsy. Specimens will be analyzed pathologically for size, submucosal tissue adequacy, the presence of ganglionic tissue, and positivity by acetylcholinesterase staining. The adequacy of the tissue specimen, the proportion of diagnostic specimens, and the proportion of patients that would have required subsequent referral for full thickness biopsy, will be compared. Variable such as cost and recovery time will be compared. Biopsy results will be compared with patient's pre-endoscopy clinical data including their history of constipation, results of SITZ marker studies, Bristol stool scale, and anorectal manometry.

Results: The primary outcome variable will be the proportion of patients with a diagnostic specimen in each group. Secondary outcome variables will include the size of the specimen, the presence of ganglionic tissue, the presence of submucosal tissue, and the positivity of the acetylcholinesterase stain. The biopsy results will also be correlated with patient's clinical data including clinical history, Bristol stool scale, anorectal manometry results, and SITZ marker studies. Cost and recovery time will be compared.

Discussion: The proposed investigation may demonstrate that a simple endoscopic test, which uses direct visualization, can improve the diagnostic yield of rectal biopsies for Hirschsprung's disease, and spare patients an additional surgical full thickness rectal biopsy.

Eligibility Criteria:
Inclusion Criteria:

* 10 years of age or older
* offered Rectal Suction biopsy

Exclusion Criteria:

* any contraindication to general anesthesia or conscious sedation
* contraindication to endoscopy
* untreated or unmanageable coagulopathy
* thrombocytopenia (\<50)
* inability to provide informed consent.
Real World Study on the Efficacy and Safety of Anti-HER2 Therapy

Anti HER2 therapy can improve the survival of HER2 positive patients and reduce mortality. The aim of the open-label, real-world study is to assess efficacy and safety of Anti-HER2 treatment drugs.

About 30% of breast cancer is human epidermal growth factor receptor-2 (HER2) amplification or overexpression (i.e. HER2 positive). HER2 positive breast cancer is one of the indicators of poor prognosis because of its high risk of invasion and metastasis. Anti HER2 therapy can improve the survival of HER2 positive patients and reduce mortality. The aim of the open-label, real-world study is to assess efficacy and safety of Anti-HER2 treatment drugs including antibody drugs such as trastuzumab and pertuzumab, small-molecule tyrosine kinase inhibitors (TKIs) such as lapatinib, neratinib, and pyrotinib, and antibody-drug conjugates such as trastuzumab deruxtecan (DS-8201) and trastuzumab emtansine (T-DM1).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old, voluntary consent and signed written informed consent.
* ECOG 0\~2.
* Diagnosis of locally advanced (stage IIIB or IIIC) or metastatic (stage IV) breast cancer.
* At least one measurable disease lesion before treatment.
* Anticipated survival time is longer than three months.
* Pathological and IHC reports for ER, PR, HER2 and Ki67 are available.
* For women with fertility, the pregnancy test before administration was negative, and agreed to take appropriate measures to avoid pregnancy during the study treatment and at least half a year after the end of treatment
* There are traceable medical records during treatment.

Exclusion Criteria:

* Pregnant or lactating women. Active infection requiring systemic treatment。
* HIV positive
* Suffering from or suspected of suffering from central nervous system diseases.
* Serious heart disease.
* Pulmonary lymphatic involvement leads to pulmonary dysfunction and requires active treatment, including the use of oxygen
* The investigator considered that the patient was not suitable for in this study, with any other situation.
Continuous Glucose Monitoring System Use in Pediatric Patients with Diabetes

To verify and evaluate the efficacy and safety of i3 CGM system manufactured by Changsha Sinocare Inc. for continuous or regular monitoring of interstitial fluid glucose level in pediatric patients with diabetes.

This clinical investigation is of a multi-center and self-controlled design.

This clinical investigation is planned to be conducted in 3 study sites, with a total of 78 subjects to be enrolled, of which no fewer than 15 cases are aged 2-5 years old, and no fewer than 60 cases are aged 6-17 years old. This clinical investigation is to verify the safety and efficacy of the investigational device. Referring to the number of pediatric patients with diabetes in the 3 study sites, it is expected that about 20 subjects will be enrolled in each site every month, and it will take about 2 months to close the site. This clinical investigation is expected to be completed in about 6 months from the first participant recruited.

The real-time glucose values measured by CGM system on the left and right abdomen are compared with the venous blood glucose value (EKF value) measured by EKF analyzer, respectively, and the consistency rate is analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Aged 2 (inclusive) - 18 years (exclusive);
* Clinically diagnosed with diabetes;
* Being willing to wear the device continuously for 15 days and conduct blood collection for blood glucose testing in accordance with the requirements of this protocol;
* Body weight not less than 10.0 kg;
* Consent to participate in this clinical investigation, and sign the Informed Consent Form (ICF).

Exclusion Criteria:

* Need to undergo magnetic resonance imaging (MRI) during the clinical investigation;
* Diffuse subcutaneous nodules;
* Acute complications of diabetes;
* Abnormal coagulation function (coagulation cannot be too quick or too slow); the criteria for judging abnormalities are: The activated partial thromboplastin time (APTT) is higher than 1.5 times the upper limit of normal value or lower than the lower limit of normal value; or The prothrombin time (PT) is higher than 1.5 times the upper limit of normal value or lower than the lower limit of normal value
* Participation in other clinical investigations within the past 1 month;
* Where the investigator does not consider the patient suitable for enrollment.
Diagnostic Assessment of 18F-fluciclovine and 18F-FDG -PET/MRI of Primary Central Nervous System Lymphoma

Primary central nervous system lymphoma (PCNSL) is a rare subtype of extranodal non-Hodgkins Lymphoma (NHL) with rising incidence and variable response to treatment. MRI is considered the most useful imaging modality of PCNSL, but conventional MRI has its limitations, and contrast-enhanced MRI sometimes does not clearly differentiate PCNSL from other neoplasm or non-neoplastic diseases.

Positron emission tomography (PET) could have a number of potential advantages in refining and improving the management of patients with PCNSL. Because of the rare incidence of PCNSL, the value of PET has however not been well defined in this subtype of lymphomas. There are a few studies that have investigated the role for FDG-PET and amino acid PET in the primary staging/diagnosis and response assessment in PCNSL patients, but the results are inconclusive. Further studies are therefore needed.

Previous studies support an integration of both MRI and PET for the routine diagnostic workup and response assessment for PCNSL, and the newly available simultaneous PET/MRI scanners may have the potential to improve imaging baseline accuracy, response assessment and add prognostic value in PCNSL.

The main aim of the study is to compare the sensitivity and specificity of a combined PET/MRI examination with the clinical routine MRI examination given to these patients today. It will be investigated whether PET (18F-FDG and 18F-fluciclovine) can provide additional prognostic value at baseline and in response assessment compared to MRI and established pre-treatment prognostic scores in PCNSL, and evaluate which PET/MRI parameters that are best suited as an imaging biomarker for progression-free survival.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of PCNSL based on cytology/flow cytometry of cerebrospinal fluid (CSF) or brain biopsy
* Written informed consent from patient or guardian
* Immunocompetent

Exclusion Criteria:

* Previous chemotherapy
* Contra-indications for MRI (Pacemakers, defibrillators, aneurysm clips, any form of metal in the body, or severe claustrophobia)
* Hypersensitivity to either 18F-Fluciclovine or 18F-FDG or to any of the excipients
* Pregnancy (pregnancy test for all women in fertile age)
* Breastfeeding
* Weight \> 120 kg
* Estimated glomerular filtration rate (eGFR) \<30ml/min/1,73m2
* HIV-positive
Holographic Screens as a Replacement of Monitors During GI Endoscopies

Nowadays, the application and development of spatial technologies have shown an increased interest in different fields of medicine, especially in procedural specialties. Many studies have shown the utility of augmented and virtual reality; however, studies evaluating mixed reality are scarce.

In gastroenterology, some proposed advantages of MR are the 3D space guidance, its increased situational awareness, remote assistance, and the reduction of surgical monitors in the units. Based on this, the researchers proposed a multicenter trial to assess the added value of MR through a holographic device during gastroenterology endoscopic procedures.

In the medical field, many technologies have emerged to aid healthcare providers during training, communication, and management of patients. The area of spatial computing is becoming part of the immersive developing technology. The main components of spatial computing are augmented, virtual, and mixed reality (AR, VR, and MR, respectively).

VR is a human-computer interface that simulates a realistic environment, while AR superimpose elements of VR in a real-world environment. AR is an enhanced version of the real-world achieved through sensory information delivered via technology. Moreover, the combination of both is known as MR. Mixed reality is an interactive, real-time processed, three-dimension registered technology.

In medicine, published data has broadly demonstrated the utility and advantages of AR and VR in many fields like neurosurgery, cardiology, maxillofacial, hepatobiliary, and orthopedics. However, information about MR for health purposes is scarce.

Based on the above, it is necessary to develop studies to assess the utility of MR in other procedural medical fields like gastroenterology. Some of the proposed advantages of MR in gastroenterology, mainly during endoscopic procedures, are the 3D space guidance and gesture operation (translation and rotation) without touching the object, the increase in situational awareness by reduction of real-world and content refocusing, the remote assistance during procedures, and the replacement/reduction of the use of monitors during the procedures.

To evaluate the advantages and added value of MR in gastroenterology, the researchers proposed a multicenter trial in the endoscopic units by using a built developed application (HXtendTM, mdconsgroup, Guayaquil, Ecuador) for the HoloLens2TM (Microsoft, Redmond, WA, USA) holographic device.

Eligibility Criteria:
Inclusion Criteria:

* Expert gastrointestinal endoscopists performing diagnostic colonoscopy, cholangioscopy, ERCP or EUS evaluation/intervention
* Written informed consent provided

Exclusion Criteria:

* Refuse to participate in the study or to sign corresponding informed consent
* Internet connection less than 100 MBs per second.
Investigation of Impairments in Body Functions and Structures, Activities and Participation Restrictions in COPD

This cross-sectional study aims to investigate to the impairments in body functions and structures, activities and participation restrictions according to the International Classification of Functioning, Disability and Health (ICF) framework in Chronic Obstructive Pulmonary Diseases (COPD) patients.

To investigate the impairments in body functions and structures, activities and participation restrictions according to the International Classification of Functioning, Disability and Health (ICF) framework in patients with COPD, fifty patients with COPD will be included.

The Modified Medical Research Council Dyspnea (MMRC) scale and Six-Minute Walking Test (6MWT) will be used for evaluating the how dyspnea limits the patients' daily activities and functional capacity, respectively. Isometric muscle strength will be measured with a handheld dynamometer of quadriceps femoris. Fear of falling will be assessed with Activities-Specific Balance Confidence (ABC) scale. The level of dyspnea during daily activities will be assessed with London Chest Activity of Daily Living (LCADL) scale. The global impacts of COPD symptoms on overall health status will be evaluated by The COPD Assessment Test (CAT). Pulmonary function data will be retrieved from the last 1-month clinical records of the COPD patients. Statistical analysis will be performed using the Statistical Package for Social Sciences (SPSS) version 21.0. Descriptive statistics of continuous variables will be presented with mean, standard deviation (SD), confidence interval (CI) values, and descriptive statistics of categorical variables will be presented with frequency and percentage values. The conformity of the data to the normal distribution will be evaluated with the "Shapiro Wilk Test". According to the results of the analysis, "Pearson correlation test" or "Spearman correlation test" will be used to determine the relationship between dependent variables. The significance level will be set as p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

1. stable disease (no severe exacerbations in the prior 3 months)
2. ability to walk independently
3. ability to read and write in Turkish
4. able to follow simple instructions
5. no pathology in visual ability and hearing

Exclusion Criteria:

1. a history of specific balance problems (i.e., diagnosed vestibular or neurological disorder)
2. severe musculoskeletal, neurological or cardiovascular disorders that limit mobility
3. use of medication(s) that may increase the risk of falls
4. participate in pulmonary rehabilitation in the lasts six months
Pharmacokinetic Interaction Between SSP-004184 (SPD602) and Midazolam in Healthy Adult Subjects

A Study to Evaluate the Pharmacokinetic Interaction Between SSP-004184 and Midazolam in Healthy Adult Subjects


Eligibility Criteria:
Inclusion Criteria:

* Normal healthy male and female volunteers between the ages of 18 and 65, inclusive
* Serum ferritin, hemoglobin and erythrocyte indices within normal range

Exclusion Criteria:

* Evidence of any active or chronic disease
Artificial Intelligence in Kinematics Analysis

1. Establish data sets. The private data set includes relevant parameters including video of the subject's gait and standard methods for kinematic analysis;
2. Develop new models. Based on public and private data sets, the kinematic analysis model of human key point detection is further developed.
3. Test the new model. By comparing the parameters with the standard method, the accuracy of the model was verified, and the kinematics analysis model of artificial intelligence with accuracy above 98% was obtained

Artificial intelligence human key point detection model mainly has traditional algorithm, "top-down" algorithm and "bottom-up" algorithm three methods, three methods have advantages. This project will comprehensively use the above three methods to conduct algorithm and parameter debugging in the public data set and test in the private data set, so as to obtain the most suitable human key point recognition method for gait analysis

Eligibility Criteria:
Inclusion Criteria:

* 1. Abnormal gait.
* Can walk 6m or more independently.
* Older than 18.

Exclusion Criteria:

* Fracture may be aggravated by walking in the acute stage or early postoperative stage. Have heart, lung, liver and kidney And other serious diseases, heart function grading greater than GRADE I (NYHA), respiratory failure and other symptoms and signs or Check the results.
* The mental and psychological state cannot cooperate with the completion of the experiment.
* High risk of falls (Berg score ≤20）
* Gait kinematics analysis equipment cannot be used together.
Deep Friction Massage Effects: Asymptomatic

Despite DFM being a widely-used technique and the empirical grounding regarding the importance of the pressure applied, there is no study characterizing the pressure applied during DFM, remaining it a discretion of the physiotherapist. Additionally, it is not known how the amount of pressure applied may influence pain mechanisms and, consequently how it affects the time needed promote an analgesic response.

Having this, our general objective is to establish a dose-response relationship between the pressure applied during DFM and time of onset of analgesia, in the asymptomatic patellar tendon.


Eligibility Criteria:
Inclusion Criteria:

* the participants should have an asymptomatic patellar tendon

Exclusion Criteria:

* history of previous injury of the lower limbs;
* intake of medication that could interfere with pain mechanisms;
* presence of any factors or conditions that could interfere with the tendinous tissue as well as with the awareness and sensibility to pain.