cyrilzakka/clinical-trials huggingface dataset:
Vital Signs Patch Early Feasibility and Usability Study v1.0

To assess the feasibility and usability of the Vital Signs Patch (VSP) System in the in-patient hospital setting to monitor vital signs using a patch, brain, gateway, and console. The VSP System will be incorporated into the study site's Information Technology infrastructure.

The primary objective of this clinical feasibility study is to evaluate the feasibility of the Vital Signs Patch System (VSP). The VSP will be incorporated into the study site's Information Technology infrastructure and worn by in-patients for a minimum of 3 days and for the duration of their hospital stay up to 7 days.

The VSP will take and monitor vital signs in addition to the normal equipment the facility uses to monitor and take vital signs. This study will not be assessing safety and no comparator groups will be used. As this study will not be treating any particular disease or condition, no randomization or blinding is required. Subjects will be chosen as they are admitted in accordance with the general population characteristics, inclusion and exclusion criteria and willingness to sign the Informed Consent.

This clinical study involves a device with no additional drugs administered.

During this study, a single VSP System patch will be worn for up to 48 hours. The first patch will be placed using the NEHB configuration. After the first 48 hours, the NEHB-configured patch will be replaced with a new patch in the PAL configuration. The second patch can remain on the subject for the duration of the subject's hospital stay, or up to seven (7) consecutive days. Individual patient use will determine the duration of time that the second patch can be worn.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female in-patients with vital signs considered 'stable' by clinical caregivers.

Exclusion Criteria:

* Pediatric patients
* Female patients who are pregnant
* Patients with internal or external defibrillators
* Patients who have undergone surgery and still have a fresh incision on the chest.
* Patients with skin damage on the chest such as burns, irritation, infections, wounds, etc.
* Patients in the Critical Care Unit (CCU)
* Patients who otherwise satisfy any of the contraindications associated with the VSP system.
Quality of Life and Sjögren Syndrome

The aims of this study are: To compare salivary pH changes and stimulation efficacy of two different Gustatory Stimulants of Salivation (GSSS) in patients with Primary Sjögren Syndrome (PSS); To evaluate Primary Sjögren syndrome (PSS) impact and gustatory stimulants of salivary secretion (GSSS) on oral health related quality of life measured by a Portuguese version of Oral Health Impact Profile-14 (OHIP-14) and specific Xerostomia assessment questionnaires.

The Products to be used are the Xeros® Dentaid system and a citric based mouthwash.


Eligibility Criteria:
Inclusion Criteria:

* unstimulated whole saliva secretion rate \< 0.1 ml/min
* stimulated whole saliva secretion rate \> 0.2 ml/min
* above 18 years of age
* Primary Sjogren Syndrome diagnostic according to the European-American Consensus Group

Exclusion Criteria:

* wearer of complete dental prosthesis
* those who were pregnant or lactating
* non-speakers of Portuguese.
Registry for Degenerative Spinal Disease (RDSD)

The outcome after spinal surgery is important and the evidence is critical to develop treatment. The purpose of this study is to make a prospective registry of database for further research.

The outcome after spinal surgery is important and the evidence is critical to develop treatment. The purpose of this study is to make a prospective registry of database for further research.

Included patients Degenerative cervical spinal disease. Degenerative lumbar spinal disease.

Eligibility Criteria:
Inclusion Criteria:

* Degenerative lumbar spinal disease.
* Degenerative Cervical spinal disease

Exclusion Criteria:

* combined progressive cancer disease
Multiple Dose Study in Healthy Volunteers to Assess Safety, Pharmacokinetics and Pharmacodynamics of PF 03882845

To demonstrate the safety, pharmacokinetics and pharmacodynamics of drug candidate.

The study was terminated on June 19, 2009. Decision to terminate was based on Cohort 1 related safety concerns. An alternative clinical design was envisaged to better assess the benefit to risk.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.
* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant disease, allergy or clinical findings at screening.
* A positive urine drug screen, history of significant regular alcohol consumption within 6 months of screening or use of tobacco or nicotine containing products within the three months preceding study date or a positive urine cotinine at screening or Day -3.
* Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
* Pregnant or nursing females; females of childbearing potential.
Refractive Error and Biometry in Retinopathy of Prematurity

The investigators compared long-term refractive and biometric outcomes in children with retinopathy of prematurity who received two different anti-vascular endothelial growth factor agents.

Purpose:

To compare refractive and biometric outcomes in patients with type 1 retinopathy of prematurity (ROP) treated with intravitreal injection of Ranibizumab (IVR), versus bevacizumab (IVB), at a corrected age of 3 years.

Methods:

A retrospective case series compared cycloplegic refractive statuses and biometric statuses in patients who received either IVR or IVB for Type 1 ROP, from April 2011 to April 2014.

Comparison of refractive errors and biometric findings between the two groups was performmed and multivariate analysis of possible factors contributive to visual acuity was also performmed

Eligibility Criteria:
Inclusion Criteria:

* children with type 1 retinopathy of prematurity
* children received anti-vascular endothelial growth factors (bevacizumab or ranibizumab)

Exclusion Criteria:

* children withour retinopathy of prematurity
* children with retinopathy of prematurity received laser therapy
Newborns Supplemented With Gentle-UHT Donor Milk

This study evaluates the effects of providing breastfeeding mothers with Gentle-UHT donor human milk (GHM) after discharge to bridge the gap during delayed onset lactation, to support an exclusive human milk diet and continued breastfeeding through the infant's first week of life. The investigators aim to determine the safety of GHM, and if GHM provided to breastfeeding mothers of outpatient babies with early weight loss will ensure babies adequately gain weight according to age-matched controls.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age \>36 weeks
* Exclusively fed human milk
* Age \<96 hours (4 days)

Exclusion Criteria:

* Previous admittance to the neonatal intensive care unit
* Supplementation of any formula
Validation of a Model for Predicting Duodenal Stump Leakage After Gastrectomy

This study aims to validate a machine learning model for predicting duodenal stump leakage after laparoscopic radical gastrectomy for gastric cancer.

Gastrectomy is an essential procedure in radical surgery for gastric cancer. Duodenal stump leakage (DSL) is one of the critical short-term complications after distal and total gastrectomy in gastric cancer patients. Identifying patients with high-risk of DSL will assist the surgeons' decision making to give efficient previous intervention, such as a more rigorous operation, placing dual-lumen flushable drainage catheter and decompression tube in afferent loop. Investigators have developed a high-performance machine learning model based on 4070 gastric cancer patients, which showed good discrimination of DSL. Hence, this multi-center prospective study will validate the reliability of this model for predicting DSL in gastric cancer patients who receive laparoscopic distal or total gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Aged older than 18 years and younger than 85 years
2. Primary gastric carcinoma confirmed by preoperative pathology result
3. Expected curative resection via laparoscopic distal or total gastrectomy and reconstruction via Billroth-II or Roux-en-Y anastomosis
4. American Society of Anesthesiologists (ASA) class I, II, or III
5. With full documents of preoperative examinations such as blood test and abdominal CT scanning
6. Written informed consent

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Severe mental disorder or language communication disorder.
3. Other surgical procedures of gastrectomy is performed.
4. Interrupted of surgery for more than 30 minutes due to any cause.
5. Malignant tumors with other organs
6. Performed gastrectomy in the past
Pulmonary Hypertension in Trisomy 21 Patients

Evidence has shown poor outcome for adult patients with pre-operative pulmonary hypertension following closure of an atrial septal defect. Life-threatening pulmonary hypertensive crises may occur in these patients when they no longer have an atrial communication to decompress high right heart pressures. This concern has led some to advocate fenestrated patch closure of ASDs in patients with pulmonary hypertension with the prospect of a repeated procedure in order to close the fenestrations at a later date.

Pre-operative resolution of pulmonary hypertension would clearly provide the best long-term outcome for these patients, allowing a definitive surgical procedure. There are no reported cases of resolution of pulmonary hypertension with the use of pulmonary vasodilators allowing successful ASD closure.

We report the case of a patient with trisomy 21 and a primum atrial septum defect with associated cleft mitral valve who was diagnosed with pulmonary hypertension at 8 days of life. Elevated pulmonary pressures were documented by cardiac catheterization during which the patient was found to have minimally responsive pulmonary vasculature to the administration of oxygen. He was started on pulmonary vasodilators which were continued for the following 5 months which resulted in gradual reduction in estimated PA pressure allowing successful closure of the primum ASD and repair of the cleft mitral valve. Following surgery, he was not restarted on pulmonary vasodilators and has continued to do well. The ability to reverse his pulmonary hypertension through the use of pulmonary vasodilators made him a candidate for his successful, definitive surgical repair. He currently has no residual cardiac problems and requires no cardiac medications. There will be no patient follow-up.

Eligibility Criteria:
Inclusion Criteria:

* case report of a patient with trisomy 21 and primum atrial septum defect with associated cleft mitral valve who was diagnosed with pulmonary hypertension at 8 days of life

Exclusion Criteria:

* those who do not fit into inclusion criteria
Percutaneous Peristyloid Glossopharyngeal Block After Tonsillectomy

Adenotonsillectomy surgery in paediatrics is commonly managed as an ambulatory surgery. This may be attributed to the use of the electro-dissection surgical technique that decreases the incidence of immediate postoperative haemorrhage. However, the use of the electro-cautery technique increases postoperative inflammation.

This study aimed to compare the glossopharyngeal nerve block using the blind technique with the use of the ultrasound guidance Primary: FLACC score in the two groups 0,2,4,6 h after surgery at rest and with swallowing Secondary: need to analgesics, the difficulty of the technique, time consumption, recovery time, surgeon satisfaction, parents satisfaction, staff nurse satisfaction, anaesthetist self-confidence

INTRODUCTION Adenotonsillectomy surgery in paediatrics is commonly managed as an ambulatory surgery. This may be attributed to the use of the electro-dissection surgical technique that decreases the incidence of immediate postoperative haemorrhage. However, the use of the electro-cautery technique increases postoperative inflammation.

Sensory fibres of the glossopharyngeal nerve supply the tonsillar and peri-tonsillar areas. Thus, a bilateral glossopharyngeal nerve block may alleviate post-tonsillectomy pain and improve postoperative analgesia.

This is a Prospective randomized controlled clinical study, to compare two different technique used to block the glossopharyngeal nerve.

AIM OF WORK To improve post tonsillectomy pain control in children Anaesthesia, postoperative analgesia Paediatrics 3-7 years Tonsillectomy NOT adenotonsillectomy Postoperative control of pain OBJECTIVES This study aimed to compare the glossopharyngeal nerve block using the blind technique with the use of the ultrasound guidance Primary: FLACC score in the two groups 0,2,4,6 h after surgery at rest and with swallowing Secondary: need to analgesics, the difficulty of the technique, time consumption, recovery time, surgeon satisfaction, parents satisfaction, staff nurse satisfaction, anaesthetist self-confidence METHODOLOGY 54 ASA I children allocated randomly into two groups: Group BL: Blind percutaneous peristyloid injection Group US: ultrasound-guided percutaneous peristyloid glossopharyngeal nerve block 54 children aged 3 to 7 years undergoing adenotonsillectomy without adenoidectomy were randomized to receive either local blind percutaneous peistyloid glossopharyngeal nerve block (n=27) or the use of ultrasound guidance for the same block (n=27). The pain was assessed by the FLACC scale or Face, Legs, Activity, Cry, Consolability scale, need for analgesics, and acceptance of diet during the postoperative period.

Eligibility Criteria:
Inclusion Criteria:

* children aged 3-7 years
* scheduled for tonsillectomy

Exclusion Criteria:

* younger or elder children
* associated adenoidectomy
* history of allergy to local anaesthetics
Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase

The aim of the study was to evaluate the feasibility of TS determination in a multicenter trial setting using a central facility for measurement and confirm its role as predictive factor for 5-FU treatment in MCRC.

Eligible were patients with non-resectable metastasized or recurrent histologically proven CRC with the presence of a reference lesion two-dimensional measurable and accessible for a biopsy.The biopsy was taken from the reference lesion either by surgery during primary tumor resection, by trans-cutaneous true-cut needle biopsy or by trans-anal approach. Intratumoral relative TS mRNA expression levels were determined using samples shipped in RNA-preserving solution or as glass slides after microdissection of tumor cells. An independent company stratified the patients according to ther relative TS mRNA expression level in TS low and TS high followed by randomization to receive either FUFA of Folfiri. Response to chemotherapy was evaluated and documented according to the RECIST criteria after every therapy cycle.

Eligibility Criteria:
Inclusion Criteria:

* patients (\>= 18 years) with non-resectable metastasized or recurrent histologically proven CRC with the presence of a reference lesion two-dimensional measurable and accessible for a biopsy
* a performance status WHO 0-2 (Karnofsky \>= 60%)
* an estimated life expectancy of at least 3 months
* written informed consent

Exclusion Criteria:

* patients older than 75 years not fulfilling these criteria
* brain metastases or a secondary cane
* a history of a systemic palliative chemotherapy
* and an adjuvant chemotherapy (within 6 months)
* pregnant or nursing women
* a known allergy toward irinotecanhydroclorid or of any ingredients of Campto or other severe medical
* laboratory and social conditions not allowing chemotherapy and follow-up
Programming Implantable Cardioverter Defibrillators in Patients With Primary Prevention Indication

Although shock therapy is effective in terminating ventricular tachycardia (VT), it can be painful to the patient and repetitive shocks can decrease a patient's quality of life. Previous studies have suggested that one or more sets of aggressive device parameter settings may reduce the total number of shocks in primary prevention patients. In addition to shock therapies, antitachycardia pacing (ATP) is also available in ICDs to treat VT. The PROVIDE trial aims to prospectively study the effect of high detection rates, prolonged detection intervals, aggressive SVT discriminators, and extensive ATP therapy in prolonging the time to first shock in primary prevention patients.


Eligibility Criteria:
Inclusion Criteria:

* Primary Prevention indication for ICD/ CRT-D

Exclusion Criteria:

* No prior documented history of spontaneous VT/VF
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes

The purpose of this study is to determine the efficacy of tirzepatide in participants with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing Type 2 Diabetes Mellitus (American Diabetes Association 2017).
* Have HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory.
* If on metformin, have been treated with stable doses of metformin for at least 3 months.
* Have a body mass index (BMI) between 23 and 45 (Inclusive) kilograms per square meter.

Exclusion Criteria:

* Have type 1 diabetes (T1D).
* Have used any glucose-lowering medication other than metformin within 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past 12 months.
* Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke).
* Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial.
* Have had chronic or acute pancreatitis any time prior to study entry.
* Have an estimated glomerular filtration rate (eGFR) \<45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation.
* Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry.
* Have any condition that is a contraindication for use of the GLP-1 RA class (per country-specific labels) at study entry or develop such condition between study entry and randomization.
Community Health Worker Training to Reduce Depression and Substance Use Stigma in TB/HIV Care in South Africa

Poor engagement in care contributes to HIV- and TB-related morbidity and mortality in South Africa (SA). Community health workers (CHWs) are frontline lay health workers who work to re-engage patients who are lost to follow-up (LTFU) in HIV/TB care. Patients with depression and substance use (SU) have a greater likelihood of being LTFU in HIV/TB care, and there is evidence that CHWs may exhibit stigma towards these patients. When CHWs have negative attitudes towards these patients, on average they spend less time with these patients, are less likely to implement evidence-based practices, and deliver less patient-centered care. Therefore, this purpose of this study is to examine the implementation and preliminary effectiveness of a brief training ("Siyakhana"). The purpose of this training is to provide CHWs with psychoeducation, skills, and support around working with HIV/TB patients with depression/SU. The investigators will assess the training's implementation and changes in CHWs' stigma towards HIV/TB patients with depression/SU.

South Africa (SA) has the highest number of people living with HIV in the world and a high tuberculosis (TB) burden. Poor engagement in care contributes to HIV- and TB-related morbidity and mortality. In this context, community health workers (CHWs) are frontline lay health workers who play a central role in re-engaging patients who are lost to follow-up (LTFU) in HIV/TB care. Even with existing CHW programs focused on re-engaging patients who are LTFU, people with depression, hazardous alcohol use, or other substance use (SU) are particularly susceptible to poor engagement in HIV/TB care and have a greater likelihood of being LTFU. At the moment, CHWs receive minimal, if any, training on depression and SU, and there is some evidence that CHWs may exhibit stigma towards these patients. When CHWs have negative attitudes towards these patients, on average they spend less time with these patients, are less likely to implement evidence-based practices, and deliver less patient-centered care. Therefore, the purpose of this study is to examine the implementation and preliminary effectiveness of a brief training ("Siyakhana") focused on providing CHWs with psychoeducation, skills, and support around working with patients with depression/SU. In a Type 2, hybrid effectiveness-implementation trial, and using a stepped wedge design, the investigators will primarily assess the training's implementation (feasibility, acceptability, and fidelity) and changes in CHWs' stigma towards HIV/TB patients with depression/SU.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Employed as a CHW through a partner non-governmental organization (NGO) that provides HIV/TB CHW services
* Works with patients who have HIV and TB, some of whom may be struggling with depression or substance use

Exclusion Criteria:

* Unable to complete informed consent or study procedures in English or Xhosa