cyrilzakka/clinical-trials huggingface dataset:
Validation and Reliability Testing of Dysphagia Trained Nurse Assessment

Nurses at Royal Derby Hospital, UK have been trained to use a comprehensive protocol based dysphagia assessment (Dysphagia Trained Nurse Assessment (DTNAx)) to assess all acute stroke patients on admission. This study aims to validate the tool by comparing it to the gold standard assessment - Videofluoroscopy and usual assessment by a Speech and Language Therapist. Inter-rater and intra-rater reliability will also be tested by comparing the assessment results of two different nurses or the same nurse.

Speech and Language Therapists (SLTs) at Royal Derby Hospital (RDH) have developed a tool that trained nurses can use to carry out swallowing assessments with patients following a stroke. It consists of checks to ensure the patient is alert/well enough, checks any abnormalities in the muscles of the mouth or throat and trials different types of foods/drinks. If they 'pass' the assessment patients are started with regular diet and fluids. If they have dysphagia the nurses can recommend modified foods/drinks if they have found to be safe during the assessment. If the patients 'fail' with all trials - they remain nil by mouth. Around 50% of patients who have a stroke have difficulties swallowing (dysphagia). If dysphagia is identified early it reduces secondary complications such as pneumonia. There are no similar tools in the UK that have been tested to check they are doing what they say they are doing (validity) or the results are the same no matter which trained nurse uses the tool (reliability). This study aims to test the validity and reliability of the Dysphagia Trained Nurse Assessment DTNAx that is currently used in the acute stroke pathway at RDH.

Over an 18 month period we aim to recruit 50 patients admitted to RDH with a new stroke and who have had an initial DTNAx. The results of the DTNAx will be compared to the gold standard dysphagia assessment - videofluoroscopy - a video xray of swallowing and also compared to the usual SLT assessment. We can calculate whether the tool identifies dysphagia and whether the recommendations made by using the tool are accurate and safe. To test reliability - the DTNAx will be repeated by the same nurse or by a different nurse. The patients will be involved in the study for approximately 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18
* Clinical diagnosis of stroke (ischaemic or haemorrhagic)

Exclusion Criteria:

* Dysphagia of another cause
* Unable to tolerate VFS due to agitation or severe cognitive difficulties (patients need to be able to sit in a suitable chair - REA assist, 9L, Mangar Porter, Tilt and Space etc. for VFS)
* Not medically well enough to undertake assessments (as determined by the clinical care team)
* Pregnant women
Effects of Mucoprotective Product on Xerostomia

In the present study with a randomized, cross-over, blind, placebo controlled design, the effects of a salivary substitute product and a new mucoprotective product with similar mechanisms of action but with different composition and characteristics will be evaluated in cancer patients suffering from xerostomia.


Eligibility Criteria:
Inclusion Criteria:

1. The patient must be at least 18 years of age.
2. The patient must have clinical symptoms of xerostomia (dry mouth) due to treatment of head and neck cancer
3. The patient must understand and consent in writing to the procedure.

Exclusion Criteria:

1. Do not meet the criterion for "dry mouth" regarding saliva secretion threshold values.
2. Known allergy to ingredients in the products to be used in the trial and/or allergy to soy, peanuts, citrus fruit,Yerba Santa or methyl parabene
3. Patients who are unable or unwilling to cooperate with study procedures.
Exploring Sarcopenia in Parkinson's Disease Patients by Combining Serum Biomarker Levels

Parkinson\&#39;s Disease (PD) and sarcopenia are prevalent age-related syndromes, often occurring simultaneously within individuals. Sarcopenia is notably common among PD patients, with severe cases affecting approximately one in every five individuals with PD. Moreover, sarcopenia is closely linked to the accelerated progression of PD, diminished quality of life, heightened mortality risk, and increased susceptibility to falls and fractures. Therefore, early detection of sarcopenia assumes particular significance as it offers an opportunity for interventions aimed at mitigating or delaying muscle degeneration, potentially influencing PD outcomes. This review will delve into the relationship between sarcopenia and PD, methods for screening and testing sarcopenia, and potential avenues for further research and the development of strategies for risk reduction and treatment

The onset of sarcopenia in PD may be intricately linked to both motor and non-motor symptoms. In terms of motor symptoms, sarcopenia exacerbates muscle weakness, impairs balance and gait, and may worsen symptoms like rigidity and bradykinesia in PD. Numerous studies have shown that sarcopenia is strongly associated with disease duration, Hoehn-Yahr staging, and Unified PD Rating Scale-III(UPDRSIII) scores. Regarding non-motor symptoms, sarcopenia contributes to increased fatigue due to muscle weakness, disrupts sleep patterns, exacerbates psychological distress including depression and anxiety, and may impact cognitive function. In addition, some studies supported that the incidence of falls, disability and death in PD with Sarcopenia were higher than those in PD without sarcopenia.

Nevertheless, other studies have reported controversial results. Some researchers believed that sarcopenia had no correlations with disease duration, HY, UPDRS-I/III, cognition and depression. However, most of the current studies are small cross-sectional studies that are not very convincing about the relationship between diseases. Thus, further studies with long-term follow up and large sample sizes are required to determine the causal direction of these relationships.

Eligibility Criteria:
Inclusion Criteria:

Diagnosed as either ''definite'' or ''probable'' PD based on Chinese diagnostic criteria of Parkinson\&#39;s disease (2016 version)

Exclusion Criteria:

Parkinson\&#39;s syndrome or Parkinsonian superimposed syndrome due to encephalitis, cerebrovascular disease, poisoning, trauma, drugs or other factors
Stromal Vascular Fraction (SVF) for Treatment of Enterocutaneous Fistula (HULPUTC)

The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the treatment of enterocutaneous fistula.

SF-12 Test

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Enterocutaneous fistula
* Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination

Exclusion Criteria:

* Presence of severe proctitis or dominant active luminal disease requiring immediately therapy
* Patients with an abscess unless a complete toilet of the area with drainage of the collections and the absence of abscess and other collections is confirmed prior to treatment start
* Patients with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion
* Patients with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or patients with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years
* Patients with cardiopulmonary disease which, in opinion of the investigator, in unstable or sufficiently serious to exclude the patient from the study.
* Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study
* Patients with congenital or acquired immunodeficiencies. HIV, HBV, HCV or treponema infection, whether active or latent
* Patients who have suffering major surgery or severe trauma in the prior 6 months
* Pregnant or breastfeeding women
* Patients currently receiving, or having received within 1 month prior to enrollment into this clinical trial, any investigational drug.
Targeting Taboo Thoughts In Obsessive-Compulsive Disorder

The purpose of this pilot study is to investigate if a cognitive treatment targeting obsessive beliefs in patients with aggressive obsessions is feasible and effective as an online treatment.

Patients with obsessive-compulsive disorder who presents with aggressive obsessions (also known as taboo thoughts e.g. fear of being a pedophile) and mental rituals have shown to respond less well to treatment. Thus, there is room for further innovation. The primary objective of this pilot study is to investigate if an internet-based cognitive therapy (I-CT) is feasible and effective in reducing the frequency and distress of aggressive obsessions. The study will also investigate if I-CT is associated with any significant side effects. Another objective of this study is to get a power estimate of the treatment effects for a subsequent randomized controlled study (RCT). This will be done by using an open pilot study with repeated measurements.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of OCD taboo thoughts as specified in the DSM-5
* ≥ 18 years
* Situated in Sweden
* Informed consent

Exclusion Criteria:

* No signed consent
* Not fluent speaking in Swedish or cognitive abilities to read written material in the study
* Adjusted pharmacological treatment the last month symptoms that may affect OCD symptoms
* Substance dependence during the last six months
* Psychosis
* Ongoing mania or hypomania
* Suicidal risk that may affect study participation
* Personality disorder that may significantly affect the treatment participation
* Other ongoing psychological treatments that may affect OCD-symptoms
* Other primary psychiatric diagnosis
MultiPAP Plus: Improving Prescription in Primary Care Patients With Multimorbidity and Polypharmacy

This study assesses the effectiveness of a complex intervention in young-old patients with multimorbidity and polypharmacy aimed at improving physician drug prescription in primary care, measured by hospitalization-mortality at six 6 (T1), 12 (T2) and 18 (T3) months from baseline compared to usual care.

Design: Pragmatic cluster randomized clinical trial with 18 months follow-up.

Unit of randomization: general practitioner.

Unit of analysis: patient.

Setting: Primary Health Care Centres in three different Spanish Autonomous Communities (Aragón, Madrid and Andalucía).

Population: Patients 65-74 years of age with multimorbidity (3 or more chronic diseases) and polypharmacy (5 or more drugs taken for at least three months). N=1234 patients (617 in each arm, 8 patients per physician) will be recruited by general practitioners before randomization.

Intervention: Complex intervention incorporating previous MultiPAP intervention (based on the ARIADNE principles with two main components: 1) Training of general practitioners and 2) Patient-centered clinical interview) And it adds a clinical-decision support system to help structured treatment-plan review.

Control group: usual care.

Variables: First level (Patient): a) Main: hospitalizations and/or mortality; b) Secondary: health services use, quality of life (Euroqol 5D-5L), disability (WHODAS), fractures, pharmacotherapy and adherence to treatment (Morisky-Green), clinical and socio-demographic. Second level (Physician): a) Socio-demographic. b) CDSS use: acceptance and satisfaction of health care provider use c) Professional background: time in the position, center characteristics and medical education involvement.

Analysis: All analyses will be carried out adhering to the intention-to-treat principle. Description of baseline characteristics. Basal comparison between groups. Analysis of primary outcome: difference in percentages in the final combined variable from 0 (T0) to 18 months (T3), with its corresponding 95% CI. Adjustement by main confounding and prognostic factors will be performed through a multilevel analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients 65-74 years of age with multimorbidity (3 or more chronic diseases) and polypharmacy (5 or more drugs taken for at least three months).
* Informed consent.

Exclusion Criteria:

* Institutionalized patient at nursing homes or similar
* Life expectancy \< 12 months
Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer

Objectives:

To evaluate the safety and effectiveness of cell therapy using precision cells to treat Advanced Lung Cancer.

Eligibility:

Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Lung Cancer.

A total of 40 patients may be enrolled over a period of 1-2 years.

Eligibility Criteria:
Inclusion Criteria:

* Age 18\~65 years old, male or female;
* Life expectancy≥6 months;
* ECOG score: 0-3;
* Advanced Malignancies (lung cancer) were diagnosed by pathological or clinical physicians;
* Enough venous channel, no other contraindications to the separation and collection of white blood cells;
* Laboratory examination: white blood cell≥3 x 10\*9/L, blood platelet count≥60 x 10\*/L,hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level;
* Signed informed consent;
* Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.

Exclusion Criteria:

* Expected Overall survival \< 6 months;
* Patients with uncontrolled hypertension (\>160/95mmHg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> Class II, NYHA), or myocardial infarction within 6 months;
* Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
* Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month;
* Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
Motivation Effects During Cued Visual Search

In this line of research, we are examining whether motivation increases the utilization of target (positive) or distractor (negative) color cues to improve visual attention performance.

When finding a search target, receiving a target cue or distractor cue can increase search efficiency. We are examining whether we can improve people's use of the cues to aid visual search performance if we increase their motivation through reward or time pressure.

Eligibility Criteria:
Inclusion Criteria:

* normal or corrected to normal visual acuity, normal color vision

Exclusion Criteria:

-
Differences in Rate of Recovery Between Young and Middle-aged Men After Downhill Running

The aim of this study is to evaluate differences in rate of recovery between young and middle-aged men after prolonged (downhill) running. Thirty healthy young (n=15, 18-30 y) and middle-aged (n=15, 35-50y) men will be recruited for this study. Participants will perform 60 minutes of downhill run at 65% of their maximal oxygen consumption (VO2max). Recovery parameters will be evaluated during 48 hours following the downhill protocol, and will include changes in performance tests, inflammatory markers, muscle integrity and heart-rate variability. Questioners will be used to evaluate muscle soreness and fatigue. We hypothesized that middle-aged males will have longer rate of recovery following the downhill running protocol, as compared to younger age males.


Eligibility Criteria:
Inclusion Criteria:

* Active man which perform a minimum of 150 minutes/week of exercise
* Able to complete 60 min run.

Exclusion Criteria:

* Injuries in lower body
* cardio-respiratory disease
* supplementing with performance enhancing supplements
Digital Foot Check by Using the D-Foot, a New Software

Patients with diabetes should be thoroughly examined before they are provided with insoles and shoes. In the study the feet are examined with the help of a new software, the D-Foot. D-Foot includes questions and surveys.

The aim of the of the study is evaluate how the patients experience the visit at the department of Prosthetics \& Orthotics based on the digital foot check.

Patients with diabetes should be thoroughly examined before they are provided with insoles and shoes. The purpose of the foot examination is to determine whether the patient is at risk of developing diabetic foot ulcers (DFU). Risk factors are: neuropathy, peripheral angiopathy, foot deformities, skin pathologies, earlier history of DFU/amputation. With effective control and examination of the feet, foot complications, such as DFU, can be prevented. In the study the feet are examined with the help of a new software, the D-Foot. D-Foot includes questions and surveys.

The aim of the of the study is evaluate how the patients experience the visit at the department of Prosthetics \& Orthotics based on the digital foot check.

Eligibility Criteria:
Inclusion Criteria for patients:

* To be diagnosed diabetes
* Age ≥ 18 years
* To understand the Swedish language.

Inclusion Criteria for certified prosthetist \& orthotists

* To work at the department
* To be assigned to work with patients with diabetes at risk of developing foot ulcers.
* Have completed the introduction course D-foot
Effectiveness of Osteopathic Manipulative Therapy in Paediatric Patients, With High Frequency Headache.

The aim of this study is to evaluate the effectiveness of osteopathic manipulative therapy, in supporting prophylactic medications in paediatric patients, with high frequency headache.

Headache is one of the most common medical complaints in childhood, with migraine and tension-type headaches (TTHs) being the most frequent diseases. The prevalence of tension-type headache (TTH) varies from 10% to 25% in school children and adolescents. Therefore a range varying from 0,1% to 5,9% of this population presents chronic tension-type headache, occuring at least 15 days on a monthly basis.

The tension-type headache is most likely multifactorial. In children, a connection seems possible between tension-type headache and psychosocial stress, psychiatric disorders, muscular stress, or oromandibular dysfunction.

The treatment of tension-type headache covers a systemic approach that includes both pharmacologic and nonpharmacologic therapies, such as biobehavioural management, and patient and family education regarding lifestyle modifications to develop and/or maintain healthy habits. Efficacy of these therapies is still unclear. Complementary therapies could be a good support to pharmacologic treatment. Osteopathic treatment results effective in some paediatric conditions, but in primary headache the possible efficacy is still unknown.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary high-frequency headache attacks.
* No reduction or inconsistent reduction of attacks after two months of prophylactic treatment.

Exclusion Criteria:

Secondary headache.
Effectiveness of High Intensity Interval Training (HIIT) on Improving Cardiometabolic Health After SCI

Testing the efficacy of high intensity interval training (HIIT), as compared to current research supporting moderate intensity continuous training (MICT), as a means to improve cardiometabolic health after spinal cord injury.

This study aims to challenge the effectiveness of the current aerobic exercise recommendations for individuals with spinal cord injuries (SCI). Currently, moderate intensity continuous training (MICT) is suggested however this study intends to explore the effectiveness of high intensity interval training (HIIT). To do so, approximately 8 individuals with SCI will be undergo a 6 week HIIT intervention consisting of 3 sessions per week. With a focus on cardiometabolic health markers (listed in outcome measure section), we aim to provide support for HIIT as a viable method of mitigating cardiovascular risk in a SCI population.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a spinal cord injury (paraplegia or tetraplegia, complete or incomplete) who are at least one-year post injury.
* Declared medically stable, and able to communicate clearly in English.
Optimized Radiological Diagnosis of Hepatic Candidiasis During the Treatment of Acute Leukemias

Hepatic candidiasis is a frequent complication in patients receiving intensive chemotherapy for acute leukemia. Hepatic lesions may be detected by computerized tomographic (CT) scans, but there is no standardized CT protocol for the diagnosis and follow-up of hepatic candidiasis.

The investigators compared the size of the fungal lesions in the chest and abdomen CT. The current analysis aimed to increase the value of CT for the diagnosis and the follow-up of hepatic candidiasis in daily routine.


Eligibility Criteria:
Inclusion criteria:

* Chest and Abdomen CT with fungal lesion in patients with leukemia

Exclusion criteria:

* Other liver pathologies
Dose-dense Biweekly Docetaxel Combined With 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer

This is an open-label, phase II study to evaluate the efficacy and safety of biweekly docetaxel and DeGramont regimen on unresectable gastric adenocarcinoma in the first-line therapy.

Primary endpoint: Overall Response Rate

Secondary endpoint: Time to progression, overall survival, safety data

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Patients with histologically or cytologically confirmed unresectable gastric adenocarcinoma whose ECOG performance status are 0-2
* Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination
* At least 3 weeks since last major surgery
* At least 12 months since last adjuvant chemotherapy
* At least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is NOT expected
* Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields
* Patients with reproductive potential must use effective BC;
* Required Screening Laboratory Criteria:

Hemoglobin 90g/L WBC 3.5 x 109/L Neutrophils 1.5 x 109/L Platelets 100 x 109/L Creatinine 133 umol/L and creatinine clearance 60 mL/min

* A probable life expectancy of at least 6 months;

Exclusion Criteria:

* Brain metastases
* Female of childbearing potential, pregnancy test is positive
* Concomitant malignancies or previous malignancies other than gastric cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer
* Active infection
* Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk
* Sexually active patients refusing to practice adequate contraception; Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) unless discussed and agreed with principal investigator
* History of grade 3 or 4 toxicity to fluoropyrimidines