cyrilzakka/clinical-trials huggingface dataset:
Developing a Real-Time PCR Assay for Fusobacterium and Epidemiological Analysis of Tumor Patients

This study presents an academic approach to developing a fluorescence quantitative PCR detection method capable of accurately measuring the presence of Fusobacterium (specifically F. nucleatum, F. mortiferium, F. varium, F. ulcerans, F. and F. necrogens) in human fecal samples. It aims to perform an epidemiological analysis on the presence of Fusobacterium in patients with tumors, elucidating the prevalence of Fusobacterium members in this patient population. Additionally, it seeks to investigate the potential correlation between Fusobacterium presence and various test indicators, diagnostic predictions, and prognosis outcomes.

Fusobacterium nucleatum, a gram-negative obligate anaerobic bacterium, is known to colonize the oral cavity and is implicated in various diseases affecting the oropharynx, gastrointestinal tract, cardiovascular vessels, and genital tract. Precise classification of the Fusobacterium genus is of utmost importance as it will facilitate a deeper understanding of the pathogenicity of its members in tumor development, establish an accurate etiological association with tumors, and ultimately enhance clinical practice and epidemiological investigations.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for this study encompassed fecal specimens obtained from patients with a documented history of tumor, specifically those who received their primary or initial tumor diagnosis at our hospital.
* Inclusion criteria for the control group consisted of the following: (1) Individuals who were in good health, devoid of evident diseases, and possessed normal physical examination reports; (2) Individuals who had not experienced significant chronic illnesses, such as hypertension, diabetes, chronic kidney disease, etc., in recent years, in order to exclude those who had been unwell but had normal physical examination reports; (3) Age and gender were matched with the case group.

Exclusion Criteria:

The exclusion criteria for this study include: A) Individuals who have taken an antimicrobial preparation within the past three months. B) Samples that lack complete information and cannot be traced back to their source. C) Samples with an insufficient volume for detection. D) Samples that do not meet the requirements for sample collection and preservation.

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Gastrografin in Postoperative Ileus

After abdominal surgery there is a period of unavoidable dysfunction of the gut. During this time patients are often unable to eat and drink, and do not pass any flatus or stool. Though this resolves within a few days for most, there are a significant number (around 30%) who go on to have a prolonged period of this dysfunction known clinically as postoperative ileus. It has been clearly shown that this group of patients have worse health outcomes and spend a longer time in hospital.

The aim of this study is to trial a drug - gastrografin - in the management of prolonged postoperative ileus. Gastrografin is safe, economical, readily available, and has been used with great success in the similar condition of bowel obstruction. It is predicted that gastrografin will shorten the duration of a prolonged postoperative ileus, thus affording affected patients a better outcome from surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Current inpatient following elective laparoscopic or open surgery.
* Classified as having prolonged postoperative ileus.
* Able to understand risks/benefits of the study.
* Able to give informed consent.

Exclusion Criteria:

* Pregnancy.
* ASA of 4 or greater.
* Previous allergic reaction to gastrografin or iodinated contrast agents.
* Manifest hyperthyroidism.
The Effect of a Self-Management Program on Individuals With Scleroderma

Introduction: Individuals with systemic sclerosis (SSc) have problems with perceived occupational performance and satisfaction in daily life activities due to many symptoms caused by the disease.

Purpose: This study will plan to examine the effect of a self-management program for individuals with SSc on perceived occupational performance and satisfaction.

Materials and Methods : Twenty-nine individuals with SSC, 28 females and 1 male will participate in the study. Perceived occupational performance and satisfaction levels before and after the program will evaluate with the Canadian Ocupational Performance Measure (COPM). The training programme will design according to the activities of COPM, the needs of the patients, and the literature. The programme consists of 8 sessions for 8 weeks, 1 day a week for 45 minutes.

In this study, 36 individuals, diagnosed with scleroderma by a rheumatologist at Gazi University, were included. In the study approved by the Gazi University Clinical Research Ethics Committee (21.09.2020, Decree No: 635) and planned by the Declaration of Helsinki, consent forms were sent to all participants to confirm that they were volunteers. Demographic information of the individuals was obtained. The Canadian Occupational Performance Measure (COPM) was used to identify occupational problems and to implement a person-centered program. This information was obtained by submitting online forms. The videos were prepared by a team of physiotherapists, occupational therapists, and rheumatology doctors. The program manager was an occupational therapist. 29 people completed the 8-week program, which included 40-50 minute videos and assignments (keeping a pain diary, creating an exercise routine, etc.). At the end of the program, individuals were reminded of the difficult occupations again so that the Canadian Occupational Performance Measure could be re-scored. Initially, the open-ended question "In which ways did the program contribute to you?" was asked. Individuals were evaluated in the first and last week of the program and the results were compared. These evaluations and interventions were made during the Covid-19 pandemic.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Scleroderma's Disease, being in remission period for 6 months, being between the ages of 18-65, knowing how to use technological devices.

Exclusion criteria:

Neurological disease, continuing a different study or rehabilitation programme, having COVID-19 infection, exacerbation the disease in the last 6 months.
A Prospective, Single Blinded Study for Predicting Colon Polyp Histology With Narrow Band Imaging

The investigators hypothesize that NBI will have a high accuracy in predicting polyp histology real time during a colonoscopy by visualization of the surface mucosal and vascular patterns. Aim#1: To determine the sensitivity, specificity and accuracy of NBI and standard white light colonoscopy for predicting polyp histology by evaluating the surface mucosal and vascular patterns during colonoscopy. Aim#2: To determine the inter-observer agreement between investigators for the recognition of various polyp patterns.


Eligibility Criteria:
Inclusion Criteria:

* referral for screening or surveillance colonoscopy
* the ability to provide informed consent

Exclusion Criteria:

* prior surgical resection of any portion of colon
* prior history of colon cancer
* history of inflammatory bowel disease
* use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure
* poor general condition or any other reason to avoid prolonged procedure time
* history of polyposis syndrome or Hereditary Non-polyposis colon cancer
* inability to give informed consent
Evaluating Air Leak Detection in Intubated Patients

This trial is designed to assess the effectiveness of the AnapnoGaurd 100 system relative to standard of care (SOC) Control, in the course of mechanical ventilation and intubation. The main effectiveness aspect of this trial is the AnapnoGaurd 100's ability to reduce leaks between the endotracheal tube and the trachea walls as a result of the cuff pressure management. Since the primary outcome can't be measured by any method other than the investigational device, the study groups will be treated as follows:

* The Treatment group in this study will be treated with the fully functional AnapnoGaurd 100 device (per its intended use),
* The Control group will be treated with the AnapnoGuard device, where the cuff control will be disabled (off) and the cuff management will be done according to SOC.

Effectiveness will be measured by the duration and level of carbon dioxide (CO2) leakage around the endotracheal tube (ETT) cuff, from the lungs to the subglottic space and safety will be measured by adverse events (AEs).


Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 (men and women);
2. Subject is expected to receive mechanical ventilation for more than 12 hours;
3. Connection of the ETT to the AnapnoGuard system within 12 hours from intubation initiation;
4. Subject or subject's legally acceptable representative signed the Informed Consent Form

Exclusion Criteria:

1. Subjects with facial, oropharyngeal or neck trauma 2. BMI\>40 3. Pregnant women 4. Patient ventilated in prone position 5. Difficult intubation (defined as more than 3 intubation attempts)

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Evaluation of the Frequency, Risk Factors, and Outcomes of ROP in Infants with a BW >1500 Grs or GA ≥33 Wks in Turkey.

The study includes preterm infants who are being screened for ROP between August 1,2023 and August 1, 2024 in 94 neonatal intensive care units (NICUs) in Turkey. Infants with birth weight (BW) of \>1500 g or ≥ 33 weeks' gestation who are screened for retinopathy of prematurity are included. The incidence of any ROP, severe ROP and treatment modalities will be determined. The risk factors for ROP development will also be evaluated.

This study, promoted by the "Turkish Neonatology Society", involved preterm infants who are being screened for ROP between August 1,2023 and August 1, 2024 in level III/IV Turkish NICUs.

An electronic questionnaire is being filled by certified neonatologists in Turkey via a special network. Neonatologists working in 94 centers who agreed to participate in this study provide their data regarding the ROP in their NICU. The medical records of retinal examinations of preterm infants who met the screening criteria will be evaluated.

A case report form for each patient will be filled including risk factors for the development of ROP such as gestational age, birth weight, small for gestational age (SGA), gender, multiple gestation, antenatal steroid therapy, invitro fertilization, preeclampsia/eclampsia, infants of diabetic mother, chorioamnionitis, resuscitation in delivery room, respiratory distress syndrome (RDS), duration of mechanical ventilation and oxygen therapy, intracranial hemorrhage, hemodynamically significant patent ductus arteriosus (PDA), early/late sepsis, necrotising enterocolitis (NEC), number of blood transfusions, bronchopulmonary dysplasia (BPD), time to full enteral feeding, percentage of own mothers milk.

Risk factors for developing ROP will be evaluated. Multivariate analysis will be performed among significant variables. In addition, the incidence of any ROP, severe ROP in relation to GA and BW and treatment modalities will be determined.

Severe ROP is defined as ROP requiring treatment. Since Turkey is receiving many refugees in recent years, the investigators also planned to evaluate the incidence and risk factors for developing ROP in preterm babies of refugees.

Ophthalmologic examination is continued until full vascularisation. So, the maximum stage of ROP detected for every infant will be reported. Data from 94 NICUs will be pooled together and analyzed.

The "International Classification of ROP" guidelines (ICROP-3) are used to record the stage of disease, location by zone, signs of plus disease and signs of regression/reactivation/persistent avascular retina.

Criteria for treatment of ROP are based on the Early Treatment for Retinopathy of Prematurity (ETROP) recommendation.

Confirmed forms are also assigned by the parents before the initial screening and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Infants with BW \>1500 g or ≥33 weeks' gestation who were determined to be at risk for ROP by the attending clinician and were screened for ROP.

Exclusion Criteria:

* Neonates who died before the first ROP examination are excluded from the study.
General Surgery Training Outcomes Project

The purpose of the General Surgery Training Outcomes Project: Evaluating the Impact of the Curriculum on General Surgery Resident Training and Evaluation is to analyze data collected as a normal course of the general surgery curriculum. The information collected is data readily available and routinely collected on all participants in the general surgery curriculum at NewYork Presbyterian Hospital/Columbia Campus. This information may lead to improvement in the general surgery curriculum.


Eligibility Criteria:
Inclusion Criteria:

* All general surgery interns and PGY2-5's at NewYork Hospital/Columbia
Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO

Prospective, multi-center, randomized (1:1), controlled trial of Impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation vs. veno-arterial extracorporeal membrane oxygenation alone for the treatment of cardiogenic shock.

In the past years extensive efforts in developing treatment strategies for patients with cardiogenic shock have been performed. One promising such strategy is active unloading of the left ventricle while simultaneously supporting the circulatory system with veno-arterial extracorporeal membrane oxygenation. Recently, in a multinational, multicenter, retrospective registry, it has been shown that this approach might be associated with lower mortality .

The investigators now seek to extend the evidence on this topic and to test this approach in a prospective, randomized, controlled, multicenter trial. A power calculation has been conducted based on the data from the registry. N=198 patients with cardiogenic shock will be randomized 1:1 to be either treated with an Impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation or with veno-arterial extracorporeal membrane oxygenation alone. A blinded interim analysis will be performed, which might lead to an adjustment of the enrollment target. The primary endpoint of this study will be death from any cause 30 days after randomization.

Eligibility Criteria:
Inclusion Criteria:

Severe cardiogenic shock due to severe left ventricular dysfunction:

* Systolic blood pressure \<90 mmHg or need for catecholamines to maintain such blood pressure
* Signs of impaired organ perfusion with at least one of the following: altered mental status OR cold, clammy skin OR oliguria with urine output \<30 ml/h
* Arterial lactate \>5 mmol/l

Exclusion Criteria:

* Post-cardiotomy cardiogenic shock.
* Cardiogenic shock due to acute rejection in heart transplant recipients.
* Obstructive cardiogenic shock (e.g. cardiogenic shock due to fulminant pulmonary embolism)
* Cardiogenic shock due to other causes (e.g. bleeding, hypothermia)
* Pre-existing Impella treatment.
* Onset of shock \>12 hours.
* Mechanical complication of acute myocardial infarction.
* Prolonged resuscitation (\>60 minutes).
* Severe peripheral artery disease with infeasibility for Impella or veno-arterial extracorporeal membrane oxygenation implantation.
* Age \<18 or \>80 years.
* Other severe concomitant disease with life expectancy \<6 months.
* Participation in another trial with an intervention or pregnancy.
Improving Pain Management in Nursing Homes: a Pilot Study

This study aims to improve pain management in Swiss nursing homes by addressing behavior change of the care workers with a multilevel intervention

Pain management in nursing homes often is inadequate despite the availability of evidence- based pain management guidelines. Barriers to pain management in nursing homes occur on several levels including lack of knowledge and negative beliefs towards pain of care workers.

For this embedded mixed-methods pilot study a convenience sample of maximum six nursing homes will be recruited. The planned intervention comprises the implementation of pain management policies, training of all care workers in pain assessment and management as well as training and introduction of a facility pain champion. Quantitative outcomes assessed at baseline, after three and six months include self-efficacy and attitudes to pain of care workers, functional interference from pain and pain intensity in residents. Feasibility and acceptability of the intervention and potential barriers to its implementation will be explored in focus groups and interviews.

Eligibility Criteria:
Inclusion Criteria:

Care workers:

* Registered nurses, licensed practical nurses/certified caregivers, nursing assistants, nurse aides and other care workers from the participating nursing home
* Working in direct resident care
* Participating care workers have to be employed for at least one month at the data collection
* Students, apprentices and interns have to be employed at least six months in total
* Speak and understand German
* Older than 16 years

Residents:

* All residents living in a participating nursing home, older than 64 years
* Written informed consent to participate in data collection signed by the resident or in case of severe cognitive impairment by his/her legally acceptable representative

Exclusion Criteria:

Care workers:

* Temporary employment for less than six months

Residents:

* Critical current health status or terminal life situation
* Known life expectancy less than 3 months
* Short term residents (length of stay \<6 months)
Prescription and Utilization of Low Molecular Weight Heparin in Usual Medical Practice for the Curative Treatment of Venous Thromboembolism in Patients With Cancer

The study purpose is to document the prescription and the use of Low Molecular Weight Heparin in usual medical practice in patients with cancer and established Venous Thromboembolism. This study also aims at gathering epidemiological data on the Low Molecular Weight Heparin therapy of Venous Thromboembolism in patients with cancer.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must provide informed consent
* Men or women aged 18 years or more
* Ongoing cancer disease recent diagnosis of veinous thromboembolism treatment with Low Molecular Weight Heparin before entry into the study

Exclusion Criteria:

- Contraindication to the use of Low Molecular Weight Heparin
Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis

The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoarthritis of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Medical history and symptoms of knee osteoarthritis

Exclusion Criteria:

* Any other disease or medication affecting the bone or cartilage.
* Any clinical signs or laboratory evidence diseases, which in the Investigator's opinion would preclude the participant from adhering to the Protocol or completing the trial.

Other protocol defined inclusion/exclusion criteria may apply
Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

This is an interventional study on Duchenne muscular dystrophy patients who will be receiving sedation for a muscle biopsy as part of another study.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a muscle biopsy for IRB11-00203.
To Assess the Safety, Efficacy and Tolerability of CKD-519, Administered With HMG-CoA Reductase Inhibitors

A multicenter, double-blind, parallel-group, active-controlled, dose-ranging study to assess the safety and efficacy of the novel cholesteryl ester transfer protein (CETP) inhibitor CKD-519 in combination with atorvastatin or rosuvastatin in subjects with dyslipidemia.

The purpose of this study is to assess the safety, efficacy, and tolerability of CKD-519, administered with HMG-CoA reductase inhibitors in subjects with dyslipidemia

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 80 years.
2. Dyslipidemia with LDL-C

   * At screening if untreated: 100 to 190 mg/dL
   * At screening if treated with statins or other lipid-lowering drugs: 100 to 170 mg/dL
   * At start of double-blind treatment: 100 to 190 mg/dL.
3. HDL-C \<45 mg/dL (males) or \<50 mg/dL (females).
4. Fasting TG \<400 mg/dL.
5. Presence of the following conditions is permitted but not mandatory, at the discretion of the investigator:

   * Treated and stable coronary heart disease without acute events in the past 3 months and stable, state-of-the-art medication.
   * Treated and stable carotid artery disease or peripheral arterial disease on stable, standard medication for the past 3 months
   * Treated and stable Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤9.5%.
6. Willing and able to sign the informed consent form (ICF).

Exclusion Criteria:

1. Chronic heart failure as defined by New York Heart Association classes III and IV.
2. Uncontrolled cardiac arrhythmias.
3. Myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, or unstable angina in past 3 months before Visit 1.
4. Stroke or transient ischemic attack within 3 months before Visit 1.
5. Uncontrolled hypertension.
6. Clinically significant laboratory abnormalities

   * Aspartate aminotransferase or alanine aminotransferase \>2 times upper limit of normal range
   * Bilirubin \>1.5 times upper limit of normal range
   * Creatine kinase \>2 times upper limit of normal range.
7. Any active nephropathy or estimated glomerular filtration rate \<60 mL/min/1.73m2 or on kidney dialysis.
8. Poorly controlled (thyroid-stimulating hormone \[TSH\] \>2 times upper limit of normal) hyperthyroidism.
9. Homozygous familial hypercholesterolemia.
10. Intolerance or hypersensitivity to atorvastatin or rosuvastatin.
11. Prior treatment with any CETP inhibitor.
12. Positive for human immunodeficiency virus (HIV) positive, hepatitis B or hepatitis C.