cyrilzakka/clinical-trials huggingface dataset:
Radiomics Model for the Diagnosis of Pneumocystis Jirovecii Pneumonia in Non-HIV Patients

To evaluate the performance of radiomics in differentiating Pneumocystis jirovecii pneumonia (PCP) from other types of pneumonia and to improve the diagnostic efficacy of non-invasive tests in non-HIV patients.

Retrospective study, including non-HIV patients hospitalized for suspected PCP from January 2010 to December 2022. The included patients were randomized in a 7:3 ratio into training and validation cohorts. Radiomic features were extracted from semi-automatically identified infected areas in computed tomography (CT) scans and used to construct a radiomic model, which was then compared to a clinical-imaging model built with clinical and semantic CT features in terms of diagnostic performance of PCP. The combination of the radiomic model and serum β-D-glucan levels was also evaluated for PCP diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* aged over eighteen years;
* presence of an underlying disease known to be associated with PCP
* symptoms of lower respiratory tract infection, such as fever, cough or dyspnea
* signs of lung infection on high resolution CT at the on-set of the disease
* received BAL examination within three days after CT scans
* underwent qPCR and IF staining tests on the BAL fluid sample.

Exclusion Criteria:

* with HIV infection
* taking trimethoprim-sulfamethoxazole for prophylaxis
* undiagnosed by qPCR and IF staining tests
Cognitive Process of Diagnostic Error in Emergency Physicians

Diagnostic error, Dual process model of reasoning) During the last decade, much emphasis has been placed on system solutions to patient safety problems. However, diagnostic error, despite being responsible for twice as many adverse events as medication error, has received little attention. The rate of diagnostic errors have been estimated to be between 0.6% to 12%.Some estimates are as high as 15%.The rate of negative outcome or adverse effects of diagnostic errors range from 6.9% to 17%. Most authors accept that the dual process model of reasoning explains how clinicians make diagnoses. The purpose of this study is to investigate why diagnostic errors occurred in the emergency departments (EDs).

Diagnostic error, Dual process model of reasoning) During the last decade, much emphasis has been placed on system solutions to patient safety problems. However, diagnostic error, despite being responsible for twice as many adverse events as medication error, has received little attention. The rate of diagnostic errors have been estimated to be between 0.6% to 12%.Some estimates are as high as 15%.The rate of negative outcome or adverse effects of diagnostic errors range from 6.9% to 17%. Most authors accept that the dual process model of reasoning explains how clinicians make diagnoses. The purpose of this study is to investigate why diagnostic errors occurred in the emergency departments (EDs). A qualitative study approach was used with in-depth semi-structured interviews conducted with emergency physicians to investigate the cognitive diagnosis process. The study takes place in the EDs of three hospitals in Taiwan. We chose the participants using a purposive sampling technique to yield a sample that would be most likely contribute significant information on the diagnostic process. Sampling continued until novel information was no longer being gathered. All audiotapes were transcribed verbatim. The transcripts are analyzed by two of the investigators based on the ground theory. Once all relevant codes were identified, they were grouped together into meaningful categories. These categories were then grouped under appropriate themes, which were used to generate a theory of diagnostic errors.

Eligibility Criteria:
Inclusion Criteria:

* trained emergency physicians

Exclusion Criteria:

* refused interview
MVX-ONCO-1 in Patients With Solid Tumor

The objectives are to assess the safety and tolerability of 6 vaccine doses of MVX-ONCO-1, administered sub-cutaneously (injections and capsules implantations), in patients with advanced metastatic solid tumor in progression who are not or not any longer amenable to any standard therapy of their tumour disease.

Endpoints:

Primary: To assess safety parameters including adverse and serious adverse events (incidence, causality, severity), local and systemic tolerance to the administered study treatment, changes in laboratory values and vital signs in patients with solid tumor; Secondary: to measure some tumor responses in using imaging technique, serological tumor markers, immune monitoring and metabolic monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 18 years and older with advanced metastatic cancer in progression of various sites \[Carcinoma of lung (either small cell or non-small cell), colon, breast, pancreas (exocrine or endocrine), stomach, oesophagus, head\&neck, thyroid, kidney, bladder, prostate, ovary, uterus (cervix or corpus); Sarcoma of soft tissue, bone, uterus, melanoma; primary brain tumor\] where all recognized treatment are exhausted or not feasible.
* Life expectancy: estimate of at least 4 months.

Exclusion Criteria:

* Have participated in any other investigational study or received an experimental therapeutic procedure considered to interfere with the study in the 4 preceding weeks.
* Have received any chemotherapy treatment in the 4 preceding weeks.
* Serious concomitant health condition such as organ transplant requiring immunosuppressive drugs, severe psychiatric disorders.
* History of second cancer within the last 2 years with the exception of basal cell carcinoma of skin and localized cervical carcinoma treated with curative intent.
* Patient with a systemic disease other than cancer, that is not controlled by usual medication.
* Therapeutic anticoagulation with coumarine or continues iv heparin. Low-molecular weight heparin (LMWH) is permitted as long as treatment can be withheld several hours prior to subcutaneous implantation.
* Positive HIV-1, HIV-2, HTLV-1, HTLV-2, hepatitis B surface antigen, or hepatitis C antibody.
A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Revised Hypertrophic Scars

The purpose of this study is to determine the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a pre-existing hypertrophic scar.


Eligibility Criteria:
Inclusion Criteria:

* Adults, 21-55 years of age
* General good health
* Previous surgery or injury resulting in a hypertrophic scar

Exclusion Criteria:

* Scars on the face or front of neck may not be included in the trial
* Use of tobacco or nicotine-containing products
* Pregnant or lactating
Mild Resistive Expiratory Breathing Technique On Spinal Cord Injury

Studies have been conducted on the effectiveness of inspiratory muscle training on tetraplegics, and less has been reported on expiratory muscle training on paraplegics; especially in Pakistan there was no such study done up-to my knowledge. Paraplegic individuals develop pulmonary complications due to prolonged general immobilization of body and ineffective cough due to respiratory muscle weakness. This study will identify the effects of expiratory muscle training using "Expiratory Muscle Strength Trainer- 150" in paraplegic individuals in Peshawar, Pakistan

A study on the effects of accessory expiratory muscle training and showed that there was a significant improvement in vital capacity of experimental group. The investigator recruited 40 patients and randomly allocated them to control and experimental groups. Experimental group received expiratory muscle training for half hour a day, six days a week for eight weeks, which included training using PFLEX muscle trainer. Control group received conventional breathing exercises and assistance in coughing. Experimental group showed improvement in mean vital capacity from 1.48 to 1.98 liters and in mean expiratory muscle strength from 43.76 cmH2O to 68 cmH2O. Control group yielded no changes.

A respiratory muscle training and electrical stimulation of abdominal muscles on thirteen quadriplegic individuals to assess their respiratory function. The study consisted of training the patients for three months. Each subject was given one-month inspiratory training, followed by second month of expiratory muscle training, and then last month without training. Vital capacity showed 19% increase in the experimental group while control group showed no improvement .

A randomized controlled trial to assess the effect of expiratory muscle training on pulmonary function of 29 spinal cord injury patients in an acute inpatient rehabilitation hospital. Patients were randomized into two groups. Experimental group consisting of 16 patients received expiratory muscle training using EMST for 10 repetitions twice a day, 5 days a week, for 6 weeks. Control group consisted of 13 individuals and they received sham training. There was no significant difference reported between both groups

Eligibility Criteria:
Inclusion Criteria:

* Spinal Cord Injury (level T1 and Below)
* Paraplegic

Exclusion Criteria:

* Rib fractures
* Active inflammation or infection going in body
* Diagnosed (primary Lung Diseases)
* Individuals with psychiatric disorders or malignancies
Determining Serum and Urinary Levels of miRNA 192 and miRNA 25 in Patients With and Without Type 2 Diabetes.

Diabetes kidney disease (DKD) is the leading cause of end stage renal disease (ESRD) in western countries and its incidence is worryingly increasing worldwide. Cardiovascular disease shows a continuous relationship with declining of renal function in type 2 diabetes patients. Moreover, there is a strong evidence of all-cause mortality risk excess even in patients with early stages kidney disease.

MicroRNA (miRNA) are small non-coding RNA molecules, containing 21-25 nucleotides, that modulate post-transcriptional gene expressions. In the past years many human miRNAs involved in the pathogenesis of renal disease have been discovered, such as miR-192, miR-194, miR-204 and miR-25. Among these, miR-192 and miR-25, are receiving greater attention while it seems that they play a role in glomerulosclerosis and renal fibrosis. However too few data are available in large publish trials among patients with renal impairment and the role of serum and urinary levels of miR-192 and miR-25 in people with preserved renal function remain unclear.

To evaluate the association between serum and urinary expression of miR-192 and miR-25 and renal function (according to different extent of renal impairment) in patients with or without type 2 diabetes.

The day of the study patients undergo a routine clinical evaluation. Whole blood samples are collected from an antecubital vein to assess serum/plasma aliquots of 200 μl each (frozen at -80°C until required for quantitation) for evaluation of biochemical parameters (fasting glucose, HbA1c, lipid profile, serum creatinine, uric acid, electrolytes, liver function enzymes, albumin) and determination of serum miR-192 and miR-25.

Two urine samples will be also collected to assess aliquots of 200 μl each (frozen at -80°C until required for quantitation) for determination of albumin:creatinine ratio and urine expression of miR-192 and miR-25.

Eligibility Criteria:
Inclusion Criteria (Group 1, Diabetic patients):

* age ≥ 18 years and ≤ 75 years
* male or female patients with type 2 diabetes treated with life style modification only or any OAD or insulin
* BMI ≥ 20 e ≤ 40 Kg/m2
* patients able to consent

Exclusion Criteria (Group 1, Diabetic patients):

* personal history of current or previous cancer or chemotherapy in the past 5 years
* personal history of alcohol and/or drugs abuse in the previous 3 months
* pregnancy

Inclusion Criteria (Group 2, Non-diabetic patients):

* age ≥ 18 years and ≤ 75 years
* BMI ≥ 20 e ≤ 40 Kg/m2
* patients able to consent

Exclusion Criteria (Group 2, Non-diabetic patients):

* diagnosis of type 2 or type 1 diabetes
* personal history of current or previous cancer or chemotherapy in the past 5 years
* personal history of alcohol and/or drugs abuse in the previous 3 months
* pregnancy
Estimation of Osteoporosis' Prevalence in France: Pilot Study in the Department of the Alpes-Maritimes

The purpose of this study is to estimate Osteoporosis' prevalence in France and is a pilot study in the Department of the Alpes-Maritimes.


Eligibility Criteria:
Inclusion Criteria:

* Patient member of Caisse Primaire d'Assurance Maladie

Exclusion Criteria:

* Patient incapable of understanding the questionary
The Influence of Infant Feeding Type on Preterm Infant's Intestinal Microbiome

This study aims to examine the factors associated with preterm infant's intestinal microbiota depending on feeding type (breast milk or preterm formula)

The gut microbiome has been increasingly found to affect human health. Feeding plays an important role in determining the composition and diversity of the neonatal gut microbiome. Preterm infants are at a high risk of gut microbiota disruption and dysbiosis because of physiological immaturity and environmental factors. In preterm infants, breast milk has been associated with improved growth and cognitive development and a reduced risk of necrotizing enterocolitis and late onset sepsis.

The objective of study is to determine the impact of feeding type on gut microbiome of very preterm infants admitted in a neonatal intensive care unit (NICU). Meconium and the additional 2 fecal samples will be collected from preterm infants. Fecal samples will be collected every 14 days, during 28 days, from diapers into sterile tubes. DNA will be extracted from fecal samples and different bacterial genus and species will be analyzed.

The type of infant feeding (breast milk or preterm formula) is recorded daily to classify the type of infant feeding received during the 14 days prior to each fecal sample collection.

Eligibility Criteria:
Inclusion Criteria:

- Very preterm infants (\< 32 weeks gestational age) admitted in the NICU of CHA Bundang Medical Center within the first 24 hours after birth

Exclusion Criteria:

* Parents refuse to participate/sign informed consent
* Major congenital anomalies
Diagnosis Predictive Modle for Dense Density Breast Tissue Based on Radiomics

It is a prospective, observational cohort study of patients with dense breast tissue. The study was based on the radiomics and other clinicopathological information of patients to establish the diagnostic system for breast disease by using artificial intelligence.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with dense breast density tissue
* Digital breast tomosynthesis was performed
* Breast ultrasound examination was performed
* Pathologic examination of breast lesions was performed

Exclusion Criteria:

* Incomplete clinicopathologic data
* Female patients with fatty glands of the breast
Effect of Curcumin on Systemic Lupus Erythematosus

The purpose of this investigator initiated study is to determine the efficacy of curcumin on disease activity of subjects with systemic lupus erythematous. Curcumin has been found to have anti-inflammatory effects and has been found to improve disease activity in lupus patients. In addition, subjects with rheumatoid arthritis as well as osteoarthritis have also found benefit for their disease activity.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 18 or older
* Diagnosed with Systemic Lupus Erythematous according to the 2012 Systemic Lupus International Collaborating Clinics Classification Criteria.
* SLEDAI score of 6 or higher
* Ability to take oral medication and be willing to adhere to the study drug regimen

Exclusion Criteria:

* Inability to provide written consent for study participation
* Use of curcumin supplements within 30 days of enrollment of study
* Liver function disorders (AST/ALT \> 2.5x upper limit of normal)
* Pregnancy or lactation
* Known allergic reactions to turmeric
* Subjects who are admitted for recent hospitalization within past 60 days
* Treatment with another investigational drug or other intervention within past 60 days
* Subjects with end stage renal disease on dialysis
* Subjects who lack the ability to provide consent
Phase III Randomized Study of Sodium Dichloroacetate in Children With Congenital Lactic Acidosis

OBJECTIVES:

I. Compare the safety of sodium dichloroacetate (DCA) vs placebo in children with congenital lactic acidosis.

II. Determine the quality of life of these patients.

III. Determine the pharmacokinetics and metabolic fate of DCA over the course of drug administration in these patients.

PROTOCOL OUTLINE: This is a randomized, double blind, crossover study. Patients are stratified according to age (3 months to 2 years vs over 2 to 18 years).

All patients receive at least 12 months of sodium dichloroacetate (DCA) during a 2 year period of double blind, crossover evaluation of DCA and placebo by mouth.

Quality of life is assessed before treatment and periodically during treatment.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of congenital lactic acidosis (CLA) meeting the following criteria: Three basal venous lactates at least 2.5 mM, arterial lactates at least 2.0 mM, or CSF lactates at least 2.5 mM OR any combination of these, obtained over at least 1 month and within 6 months OR Increase in blood lactate at least 1.0 mM over basal following a carbohydrate meal challenge

AND

Enzymatic or molecular genetic proof of a defect of pyruvate dehydrogenase complex, one or more respiratory chain enzymes, or a Krebs cycle enzyme OR Over production of C14-lactate from C14-glucose by cultured skin fibroblasts

AND

Ability to withstand an 8 hour (if 2 years and under) or 12 hour (if over 2 years) fast without developing hypoglycemia (blood glucose less than 50 mg/dL)

No secondary lactic acidosis due to impaired oxygenation or circulation

No hyperlactatemia associated with proven biotinidase deficiency (biotin responsive CLA) or with enzyme deficiencies of gluconeogenesis

No primary, defined organic acidurias other than lactic acidosis, for which effective therapy is available (e.g., propionic aciduria)

No primary disorders of amino acid metabolism or fatty acid oxidation

No malabsorption syndromes associated with D-lactic acidosis

--Prior/Concurrent Therapy--

No chronic dialysis

--Patient Characteristics--

Hepatic: No primary hepatic disease unrelated to CLA

Renal: Creatinine less than 1.2 mg/dL OR Creatinine clearance at least 60 mL/min

Other: No concurrent infection or fever
Comparison of Long-term Outcomes Between Upfront Surgery and Neoadjuvant Therapy Followed by Surgery in Patients with Node-Negative Gastric Cancer

Patients with lymph node-negative gastric cancer, the prognosis of patients who underwent neoadjuvant therapy was poor than that of those who had upfront surgery.

We retrospectively analyzed the clinicopathological data of patients who underwent curative surgery for gastric cancer and were pathologically confirmed to have node-negative metastases between January 2010 and June 2021 at 8 institutions in China. Data from the Surveillance, Epidemiology, and End Results (SEER) database (2004-2020) were used as the validation cohort. The patients were divided into two groups based on whether they received neoadjuvant therapy before surgery: the upfront surgery (UFS) group and the neoadjuvant therapy followed by surgery (NATS) group. A 1:1 propensity score matching analysis was employed to reduce the potential selection bias between the two groups.

Eligibility Criteria:
Inclusion Criteria:

(1) preoperative clinical staging of cT2-4NxM0; (2) primary gastric adenocarcinoma confirmed via pathology; (3) no distant metastasis to the liver, lungs, or abdominal cavity as confirmed through preoperative chest X-ray or chest CT, abdominal ultrasound, and abdominal CT; (4) underwent radical gastrectomy (R0) and D2 lymphadenectomy; (5) postoperative pathology confirmed no lymph node metastasis (i.e., lymph node-negative); and (6) follow-up for at least 3 years.

Exclusion Criteria:

(1) considered early-stage gastric cancer before surgery; (2) distant metastasis detected preoperatively or intraoperatively; (3) failure to achieve R0 resection and D2 lymphadenectomy during surgery; (4) concurrent diagnosis of other malignancies; (5) remnant gastric cancer; (6) death within 30 days postoperatively; and (7) incomplete baseline data or follow-up records.
Study to Assess Safety and Tolerability of AZD0530 in Combination With Carboplatin and Paclitaxel

The primary purpose of this study is to explore the safety and tolerability of AZD0530 in combination with carboplatin and paclitaxel in Japanese patients with non small cell lung cancer and epithelial ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Japanese patients with non small cell lung cancer or epithelial ovarian cancer
* Must be suitable for treatment with carboplatin and paclitaxel
* Relatively good overall health other than cancer

Exclusion Criteria:

* Poor bone marrow function (not producing enough blood cells).
* Poor liver or kidney function.
* Patients unable to discontinue drugs known to be potent inhibitors or inducers of CYP3A4 within 2 weeks prior to registration
Effect of Skate Skin Extract on Cognitive Function in Adults

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Skate Skin extract on cognitive function in adults with subjective memory impairment for 12 weeks.

Previous animal studies have indicated that Skate Skin extract may have the ability to improve cognitive function. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Skate Skin extract on cognitive function in adults with subjective memory impairment for 12 weeks; the safety of the compound are also evaluate. The Investigators examine chemical and metabolic parameters, and cognitive function at baseline, as well as after 6 and 12 weeks of intervention. One hundred adults were administered either 500 mg of Skate Skin extract or a placebo each day for 12 weeks;

Eligibility Criteria:
Inclusion Criteria:

* Global Deterioration Scale (GDS) 2 or 3

Exclusion Criteria:

* Abnormal liver or renal function (i.e., serum aminotransferase activity \> 3 times of upper limit of reference range and serum creatinine concentrations \> 1.2 mg/dL)
* Diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dL)
* History of viral hepatitis or cancer
* Uncontrolled hypertension
* History of serious cardiac disease such as angina or myocardial infarction
* History of gastrectomy
* History of medication for psychiatric disease
* Administration of oriental medicine including herbs within the past 4 weeks