cyrilzakka/clinical-trials huggingface dataset:
Predictive Value of the mNutric Score and Survival Analysis in Critically Ill Patients Hospitalised in the Intensive Care Unit

Our study is an observational study and the follow-up hematological tests of patients in the intensive care unit will be recorded during their first admission. In this study, routinely checked blood parameters in patients will be interpreted and mnutric scores created together with their clinical features will be recorded. Routine blood tests will be performed during these records and no intervention will be made. Only an observational study will be conducted.

Written informed consent was obtained from all participants or participants whose signature could not be obtained and included in the study. Between 1 December 2024 and 1 April 2025, 85 critically ill patients admitted to the anaesthesia intensive care unit of our hospital were included in the study. Patients aged 18 years and older who were admitted to the ICU and followed for more than 24 hours were included in the study. Patients younger than 18 years, pregnant women and patients with gastrointestinal motility disorders were excluded from the study. Patients' demographic characteristics, including age, sex, and comorbidities, were recorded at the time of initial admission. Haemoglobin (Hb), white blood cell (WBC), lymphocyte, platelet, aspartate aminotransferase (AST), alanine aminotransferase (ALT), C-reactive protein (CRP) and albumin levels were recorded during the first hospitalisation. Sequential Organ Failure Assessment Score 2 (SOFA 2) and Apache 2 score values were recorded. The 28-day follow-up of these patients was recorded. Patients who died within 28 days and patients who survived were grouped as survivors. The use of vasoactive drugs, renal replacement therapy, the need for mechanical ventilation and the length of stay in the intensive care unit of the groups were recorded during the follow-up period. The nutrition team placed a nasogastric catheter in all patients and started enteral nutrition at 25-30 kcal/kg in patients without contraindications.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old , Patients who have been hospitalized for more than 24 hours

Exclusion Criteria:

* under 18 years old, pregnancy patients, Patients hospitalized for less than 24 hours
Comparison of Two Different Resuscitation Devices

There is a complex physiological process involved in establishing regular breaths at birth. After initiation of the first breath, fluid is removed from the alveoli and enough pressure must be generated to inflate the lungs . Most newborns will establish spontaneous regular breathing sufficient to maintain the heart rate above 100 beats/min and to improve perfusion within 3 minutes of birth. According to the neonatal resuscitation programme (NRP), if heart rate is below 100 or there is persistence of apnoea or gasping after the initial steps of drying/stimulation and oropharyngeal suction, intervention is required .

The main focus of neonatal resuscitation is effective ventilation to improve gas exchange and prevent respiratory failure. After birth, approximately 4% to 10% of term and late preterm newborns will receive help breathing with positive-pressure ventilation (PPV). Adequate mask ventilation is essential when providing breaths during neonatal resuscitation. However, this can be difficult, especially for less experienced staff and may be affected by inadequate seal of the mask, gas leaks and airway obstruction. In addition, trauma may be caused by the volumes being given during pressure controlled ventilation.

Comparison of two different neonatal resuscitation devices (Neopuff and rPAP) in the Neonatal Unit in Cork University Maternity Hospital. Participants will use the devices on a mannequin. Performance of the two devices is judged by comparing the tidal volumes produced.

Participants will be recruited from the medical staff (Non-consultant Hospital Doctors and Consultants) of the neonatal unit.

Eligibility Criteria:
Inclusion Criteria:

1. Neonatology consultants and NCHD's from CUMH
2. Participants must have completed Neonatal Resuscitation Programme (NRP)
3. Participants must be working as doctors in the area of neonatology

Exclusion Criteria:

1. Any history of cardiac or respiratory disorder
2. Physicians who are post-call
3D Ultrasound Microvessel Imaging for Breast Masses

This early phase I trial studies how well 3D ultrasound microvessel imaging works for the diagnosis of breast mass. The 3D ultrasound microvessel imaging technology demonstrates significantly increased vessel detection sensitivity over conventional doppler methods without the need of using contrast agents. This study may improve cancer diagnosis and reduce unnecessary biopsy on benign tumors.

PRIMARY OBJECTIVES:

I. Optimization of imaging protocol for this new ultrasound technology. II. Investigate the diagnostic performance of the new ultrasound technology using clinically indicated biopsy as the reference standard.

OUTLINE:

Patients undergo 3 dimensional (D) ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Women with solid breast lesion who are scheduled for a clinically indicated ultrasound-guided biopsy.
* Lesion size of 3 mm or larger.
* Age 18 or greater.

Exclusion Criteria:

* Women with previous breast surgery or breast implant.
* Lacking the capacity to consent.
* Women who are pregnant or lactating.
* Women who are receiving cancer therapy such as chemotherapy or radiation therapy.
Pilot Trial Of Urinary Nerve Growth Factor (NGF) As Biomarker for Male Lower Urinary Tract Symptoms

A single center, pilot trial using tamsulosin and solifenacin in 10 men with symptomatic lower urinary tract symptoms (LUTS). Subjects will be evaluated at baseline, 1, 2, and 3 months for urinary NGF, urine creatinine, NGF/CR ratio and patient reported outcomes through questionnaires.

Single center, pilot trial, single arm study using once daily dosing of tamsulosin and solifenacin in 10 men with symptomatic lower urinary tract symptoms (LUTS). Assessments occur at Baseline, 1 Month, 2 Month and 3 Month to evaluate: urinary NGF (pg/mL), urine creatinine (mg/dL), NGF/Cr ratio and patient reported questionnaire outcomes (AUA Symptom Score/IPSS, Patient Perception of Bladder Condition, Patient Perception of Urge Intensity 'PPIUS', LUTS Urinary Symptoms and Quality of Life). Each participant is assessed from baseline to Month 3 measurements. Protection of human subjects will be provided through the Houston Methodist Research Institute Institutional Review Board (see appendix 2). All men will receive morning dosing with Tamsulosin 0.4 mg (1 tab) and Solifenacin 5 mg (1 tab) orally at the same time.

Eligibility Criteria:
Inclusion Criteria:

* Men \> 45 years old with symptomatic LUTS (clinical benign prostatic hypertrophy/BPH)
* International Prostate Symptom Score (IPSS) \> 8
* PSA \< 10 ng/ml (negative biopsies within 6 months for any age-specific PSA elevation suspicious for prostate carcinoma)
* Post void residual urine \< 150 mls
* Urinary Flow rate \> 15 mL/sec

Exclusion Criteria:

* Neurogenic bladder
* Urinary tract infection, Urinary stone(s), Urinary tract tumor
* Radiation therapy for urologic malignancy or prostate surgery; radiation to pelvic, colon, rectum, prostate, bladder, uterus or ovaries
* Alpha blocker therapy or anticholinergic therapy within 3 months of entry or 5 alpha reductase therapy within 18 months.
* History of cataracts with planned surgery
rTMS on Appetite and Cognitive Function in Schizophrenia

The weight gain and metabolic dysfunction has been vital conditions for individuals with schizophrenia. rTMS is a promising novel intervention, which have strong potentials on moderating increased appetite and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.

Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of rTMS, using iTBS pattern, on prevention and treatment for elevated appetite and cognitive deficiency in individual with schizophrenia.

The weight gain and metabolic dysfunction has been vital conditions for individuals with schizophrenia. The cognitive function deficit has also been a major symptom for schizophrenia. However, metabolic dysfunction could further impair the cognition. rTMS is a promising novel intervention, which have strong potentials on moderating increased appetite and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.

Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of rTMS, using iTBS pattern, on prevention of the elevated appetite and cognitive deficiency in individual with schizophrenia. The intervention will last for 5 continuous days and the follow-ups are scheduled at baseline, 6days and 36days. The primary outcomes include the change of MCCB score, TFEQ score and EEG data. Secondary outcomes include the change of serum metabolic indexes and anthropometry indexes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with schizophrenia in accordance with DSM-5
* Commorbid with significant weight gain after antipsychotics
* Informed Consent

Exclusion Criteria:

* Diagnosed with other mental disease in accordance with DSM-5
* Comorbid with other severe physiological disease
* Used antipsychotic, antidepressants, mood stabilizer, or other psychoactive substances before
* Drug or alcohol abuse
* Pregnant or lactating
* Contraindication to rTMS
Study on Blood Pressure Variability and Frailty in the Older People

Observational prospective single-center, non-profit study. Primary objective of the study: To determine if the hypotensive phenotype, defined as one episode of daytime systolic blood pressure (SBP) \<90 mmHg (or two episodes of daytime SBP \<90 mmHg, if mean 24 h SBP is \<125 mmHg) detected at Ambulatory Blood Pressure Monitoring (ABPM) is associated with adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events)

Observational prospective single-center, non-profit study. Primary objective of the study: To determine if the hypotensive phenotype, defined as one episode of daytime systolic blood pressure (SBP) \<90 mmHg (or two episodes of daytime SBP \<90 mmHg, if mean 24 h SBP is \<125 mmHg) detected at Ambulatory Blood Pressure Monitoring (ABPM) is associated with adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events)

Secondary objectives of the study:

* To examine the association between home Blood Pressure Variability (BPV) and frailty, assessed using various tools for assessing frailty
* To examine the association between short term BPV and adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events)
* To determine the prevalence of hypotensive phenotype according to frailty status in hypertensive individuals.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 75 years
* Diagnosis of hypertension according to the criteria of the European Society of Cardiology guidelines \[Williams 2018\]
* Consent of the patient (or legal representative) to participate in the study

Exclusion Criteria:

* Refusal of the patient or his/her legal representative
* Life expectancy of less than 6 months
French National Database of Rare Dermatological Cancers

Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, and cutaneous adnexal carcinomas are 3 types of rare skin cancers for which much remains unknown in terms of natural behavior, prognosis, treatment and outcomes.

CARADERM is a French prospective national cohort enrolling patients with either one of these 3 tumor types, whose objectives are :

* to provide epidemiological, clinical and socio-economic characteristics of patients
* to identify new clinical or epidemiological prognostic factors for these rare cancers
* to evaluate the impact of various treatments on outcomes

CARADERM is a French national multidisciplinary project which will prospectively enroll from 37 French centers any patient presenting with Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment or cutaneous adnexal carcinoma.

A structured and centralized database of clinical monitoring of patients will be established. Information captured will include clinical constitutional factors, factors linked to primary carcinoma, factors linked to lymph node involvement, "American Joint Committee on Cancer" (AJCC) stage at inclusion, recurrence patterns, therapeutic interventions (medical, surgical, radiotherapy and palliative strategies) with evaluation of response, date of death, date of latest news.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, or cutaneous adnexal carcinoma

Exclusion Criteria:

* Subjects without Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, or cutaneous adnexal carcinoma
* Patients refusal
Sleep Apnea Treatment After Stroke (SATS)

The purpose of this study is to determine if treating stroke patients who have obstructive sleep apnea with continuous positive airway pressure will improve symptoms caused by the stroke.

Stroke is the leading cause of adult disability in the United States, yet there are very few treatments that improve stroke outcome. Obstructive sleep apnea (OSA)--frequent upper airway blockage that occurs during sleep--is common after stroke, affecting more than half of stroke patients. The most common treatment for obstructive sleep apnea in the general population is nasal continuous positive airway pressure (CPAP) applied through a nasal mask during the hours of sleep. Positive air pressure holds the naso-oro-pharyngeal airway open during sleep.

The objective of this single-center, prospective, randomized study is to evaluate CPAP treatment in post-stroke patients. Participants will go through a medical interview, a brief neurological examination, and a sleep study to screen them for OSA. Those with OSA will be eligible for the second phase of the study during which participants will be randomly selected to receive either treatment with CPAP or with sham CPAP (placebo).

This project promises to establish feasibility, develop design and identify suitable outcome measures (e.g. hours of CPAP treatment per week, functional outcome, depression, fatigue, and impaired alertness) for a large-scale clinical trial of CPAP in stroke patients with OSA. If the larger trial shows benefits of CPAP, a new treatment for more than half of all stroke patients will become available.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke within 7 days of planned polysomnography/sleep screening study
* Modified Rankin Scale score \>1
* If of child-bearing potential, has a negative urine or serum pregnancy test

Exclusion Criteria:

* Decompensated heart failure
* Cardiac or respiratory arrest within the past 3 months
* Myocardial infarction within the past 3 months
* Severe pneumonia
* Hypertension refractory to treatment
* Any other unstable medical condition which is thought to interfere with participation
* Known preexisting OSA already on CPAP or previously failed CPAP or used CPAP
* Previous pneumothorax
* Bullous emphysema
* Chronic obstructive pulmonary disease (COPD), obesity-hypoventilation, or another condition warranting the use of nasal bilevel positive airway pressure instead of CPAP
* Acute sinus or ear infection
Melanoma Image Analysis Algorithm (MIAA) Validation Study

Prospective, single-arm, cross-sectional, study to establish the effectiveness of MIAA to detect melanoma in pigmented lesions, compared to gold standard histological determination.

Skin Analytics Limited have developed an algorithm (MIAA) which reviews photographs of pigmented lesions to determine whether melanoma is likely to be present. This study aims to establish how well MIAA determines the presence or absence of melanoma, compared to a biopsy.

Pigmented lesions that a dermatologist has decided to biopsy, and are suitable for photographing, will be photographed up to five times in a single visit. Three different camera will be used, and two different dermoscopic lens attachments will be used on smartphone cameras. Images will be analysed by MIAA and the results compared to the biopsy result. Clinicians, patients and the statistical analysis team will be blinded to the result of MIAA.

At least 65 pigmented lesions positive for melanoma (as determined by biopsy) are required, which is predicted to mean 1250 patients will be recruited.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study,
* Male or Female, aged 18 years or above,
* Have at least 1 lesion suitable for photographing that is scheduled for biopsy to determine the presence of melanoma,
* In the Investigators opinion, able and willing to comply with all study requirements.

Exclusion Criteria:

• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
A Trial Of Azithromycin SR For The Treatment Of Acute Bronchitis And Secondary Infection Of Chronic Respiratory Diseases

To evaluate the clinical efficacy and safety in patients with Acute Bronchitis or Secondary Infection of Chronic Respiratory Diseases receiving a dose of 2 g of azithromycin in the SR formulation.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed as mild or moderate in severity by the classification of infection of the Japanese Society of Chemotherapy guidelines for the evaluation methods of new antibacterial drug (established in 1997).

Exclusion Criteria:

* Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
The Incidence, Risk Factors, and Effects of Constipation in Critical Patients

This study aimed to investigate the early, late, and total constipation frequency, related factors, and their effects on the hospitalization day, gastric residual volume, vomiting, distension, and diarrhea, the feeding type, white blood cells, and C-Reactive Protein levels, and body temperature.

Constipation is one of the most encountered nursing problems in intensive care unit patients.

Constipation is an important issue, especially in intensive care patients, requiring careful discussion since it has negative effects as well as high incidence and excessive risk factors. Furthermore, untreated constipation in these patients delays enteral feeding prolonging the time of weaning from the mechanical ventilator, which consequently increases the duration of stay in the intensive care unit. Additionally, it involves complications such as distention, nausea-vomiting, an increase in bacterial infection rate, high morbidity, and mortality. Therefore, the definitions, risks, and effects of constipation, especially early and late constipation, in critically ill patients should be determined for evidence-based interventions. However, studies on the subject are limited.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Not abdominal surgery
* Not stoma
* Not constipation during admission
* Not intraperitoneal infection
* Not had a recent colonoscopy -\> 5 hospitalization days

Exclusion Criteria:

* Having prolonged constipation and complications (such as decreased bowel sounds, and excessive distension)
* Order for regular laxatives or enemas
* Not meet inclusion criteria during follow-up
A Long Term Follow-up Study up to 4 Years After Study Vaccination to Assess Immunogenicity and Safety of the Investigational Vaccine in Adults

The purpose of this long-term follow-up of a Phase I study is to evaluate the kinetics of the antibody response to NTHi-Mcat antigens and long-term safety, in subjects aged between 50-71 years at the time of enrolment in the NTHi-Mcat-001 study. These subjects were previously exposed to two adjuvanted formulations of the NTHi-Mcat vaccine administered according to a 0, 2 months schedule in the NTHi-Mcat-001 (201281) study. The subjects that had received saline placebo controls will also be included in this follow-up study to make comparisons with the investigational vaccines. No vaccinations will be administered in this trial.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who previously participated in STEP 2 of study NTHi-Mcat-001 (201281), and performed the last study visit (Month 14) and received the 2 study vaccinations.
* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. return for follow-up visits). And subjects' Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
* Written informed consent obtained from the subject/ LAR(s) of the subject prior to performance of any study specific procedure.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) during the period starting 30 days before the first follow-up study visit (Month 19 to Month 20), or planned use during the study period.
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since the end of the NTHi-Mcat-001 study. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
* Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
* Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first follow-up visit or planned administration during the study period.
* Current alcoholism and/or drug abuse.
* Has significant disease (including significant neurological or psychological disorders), in the opinion of the investigator, likely to interfere with the study and/or likely to cause death within the study duration.
* Any other condition that the investigator judges may interfere with study findings.