cyrilzakka/clinical-trials huggingface dataset:
Mobility Assessment in Multi-morbidity

Multimorbidity (the presence of two or more coexisting long-term conditions) is a significant challenge facing the NHS, especially given UK's ageing population and the association with high levels of illness burden and healthcare costs. Over 50% of adults \>65 years have multiple long-term conditions (MLTCs).

Our group has validated a broad range of algorithms applied to single wearable sensors that have the potential to capture walking-related mobility outcomes (such as walking cadence and walking speed) accurately and reliably during activities of daily living across five single long-term conditions. These algorithms, however, cannot be readily applied to people with MLTCs because the effect of multimorbidity on mobility is amplified compared to single long-term conditions secondary to a greater number of complications and sequelae. Accordingly, the aim of this study is to validate algorithms that would allow robust estimation of walking-related mobility outcomes during daily life activities in MLTCs.

To meet our objectives, the investigators will perform: i) laboratory-based technical validation of existing and newly developed algorithms for walking-related mobility outcome detection; ii) unsupervised real-life validation of selected algorithms; and iii) examination of how well the validated walking-related mobility outcomes reflect global and disease specific characteristics in older adults with multimorbidity. The investigators will adopt an integrated patient-centric approach where patients with MLTCs will be engaged early in the project to provide input of their perception and concerns regarding mobility limitation in daily life activities.

The investigators aim to recruit 55 older adults (\>65 years), men and women, with multiple long-term conditions with the following inclusion criteria: having two or more of the following conditions including osteoarthritis, rheumatoid arthritis, osteoporosis, type 2 diabetes, depression and/or anxiety, hypertension, coronary heart disease, heart failure, atrial fibrillation, chronic obstructive pulmonary disease, asthma, bronchiectasis, chronic kidney disease, cancer, or stroke within the last 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥65 years old
* Able and willing to provide informed consent
* Able to read and write in English
* To be mobile (including the use of walking aids)
* Two or more of the following long terms conditions: Arthritis, Asthma, Atrial fibrillation, Bronchiectasis, Cancer, Chronic kidney disease, Chronic obstructive pulmonary disease, Coronary heart disease, Anxiety, Depression, Diabetes mellitus, Heart failure, Hypertension, Osteoporosis, Parkinson's disease, Peripheral vascular disease, Stroke or transient ischaemic attack

Exclusion Criteria:

* Unable to give consent for the study
* Severe mental health problems
* Active malignancy (on chemotherapy/radiotherapy/planned urgent surgery)
Evaluation of Regional Ventilation Distribution in Patients Affected by Abdominal Sepsis After Emergent Laparotomy

The goal of this clinical trial is to evaluate regional ventilation distribution in patients admitted to the intensive care unit after emergent laparotomy due to abdominal sepsis. The main question it aims to answer is:

• evaluate if patients admitted after an open abdomen strategy have a different regional ventilation distribution compared to patients in which abdomen is closed at the end of the procedure

Participants will undergo non-invasive monitoring (esophageal pressure and electrical impedance tomography) and an blood gas analysis samples.

Researchers will compare open abdomen group and closed abdomen group to see if the ventilation distribution pattern is different.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 and \< 90 years
* Admitted to the ICU after emergent laparotomy for abdominal sepsis
* Acute respiratory failure

Exclusion Criteria:

* Controindications to electrical impedance tomography monitoring
* body mass index \> 40 kg/m2
* Haemodinamic instability
* Pneumothorax - Pneumomediastinum
* refusal to participate
Groin Complications Post Percutaneous Coronary Intervention Using Either Manual Compression or PERCLOSE Device

The objective of this study is to compare groin complication rates in low and high risk patients post percutaneous coronary intervention (PCI) closed by either a 6 French Perclose vascular closure device (VCD) or manual compression.

It is commonly accepted that that there exists a learning curve in performing successful groin closure with Vascular Closure Devices (VCD). Manual compression continues to be 'standard of care' at most institutions for closure of 5 - 8 French femoral arteriotomies, as previous studies evaluating the safety and efficacy of vascular closure devices have failed to show a statistically significant decrease in groin complication rates when compared to manual compression. Importantly, no studies to date have been performed to specifically assess the potential decrease in vascular complication rates by highly experienced VCD operators, when their safety results are compared to manual compression. This retrospective, multi-center study will demonstrate a lower vascular complication rate in PCI patients post deployment of a 6 Fr Perclose VCD by a single, experienced operator, when compared to manual compression in two comparable, high volume, hospital cardiac catheterization laboratories.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received vascular closure with the Perclose device post PCI at Baptist Miami Hospital
* Patients who received vascular closure by manual compression at Tampa General Hospital

Exclusion Criteria:

* Patients less than 18 years old
Reversal of the Antithrombotic Action of New Oral Anticoagulants

The main goal of this study is to improve safety and efficiency of clinical practice with the new generation of oral anticoagulants.

1. To determine the effect of new oral anticoagulants (dabigatran and rivaroxaban) on platelets and coagulation mechanisms under flow conditions.
2. To evaluate the ability of the concentrates containing coagulation factors (PCCs and FVIIa) to reverse the effects induced by the new anticoagulants.

These studies will be carried out ex vivo in blood samples obtained from healthy volunteers undergoing oral anticoagulant therapy at doses of proven efficacy and safety used in previous clinical trials.

There is a lack of information on antidotes that could reverse the effects of new oral anticoagulants in patients that require a rapid restoration of their impaired hemostatic mechanisms. The present study seeks to improve the security and efficacy of the clinical practice with the new generation of oral anticoagulants.

OBJECTIVES:

1. To assess the action of new oral anticoagulants (dabigatran y rivaroxaban) on hemostasis with specific interest on possible interference with platelet interactions and coagulation mechanisms under flow conditions;
2. To evaluate comparatively the effects of coagulation factor concentrates of established efficacy (prothrombin complexes and rFVIIa) to reverse the alterations of hemostasis parameters induced by the new anticoagulants.

METHODOLOGY:

Studies will be performed ex vivo using blood samples from healthy individuals subjected to treatments with the new anticoagulants at doses of proven efficacy and safety (150mg/12 h for dabigatran and 20 mg/day for rivaroxaban). Blood samples from the participants will be spiked "in vitro" with know concentrations of the coagulation factors. Modifications in:

* morphometric parameters (platelet deposition and fibrin formation) in perfusion studies under flow conditions; and
* analytical tests evaluating changes in coagulation mechanisms (thrombin generation, ecarine and prothrombin times) will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers ages from 21 to 60 years
* Approval informed consent

Exclusion Criteria:

* History of hepatic or kidney disease
* Previous history of hemorrhagic or thrombotic disease
* Pregnancy or breast feeding
* Concomitant use of drugs affecting hemostasis
* Use of medications of herbal treatments that could interfere with the pharmacokinetics or pharmacodynamics of the study drug (according to manufacturers label)
* Practice of risky sports (during the study period)
* Blood donation in the previous 3 months
Long-term Effects of Arabinoxylans on Intestinal Barrier Function

The higher prevalence of overweight and obesity among the population contributes to increased incidences of chronic metabolic diseases. Obesity is considered a low-grade systemic inflammatory condition through 1) production of pro-inflammatory cytokines by adipose tissue and 2) alterations in intestinal microbiota composition and associated increase in intestinal permeability. Healthcare costs related to these diseases are rising; prevention or delay of onset of disorders associated with overweight is needed. Administration of wheat arabinoxylans (NAXUS), a non-digestible carbohydrate, may change the intestinal microbiota composition and have beneficial effects on gut epithelial barrier, especially on permeability and innate immune function.

Objective: To assess the effects of NAXUS on intestinal barrier function, immune system performance and metabolic control. Prebiotic properties of NAXUS will be studied. Tolerance of the product in different doses will also be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Overweight men/women (BMI 28-35 kg/m2)
* Besides overweight, healthy human beings
* Fasting glucose \<7.0 mmol/L
* Normal HbA1c (4.4 to 6.2%)
* Consistently stable body weight for at least 6 months (± 2 kg)

Exclusion Criteria:

* Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L);
* Gastroenterological diseases or abdominal surgery;
* Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
* Abuse of products; alcohol (\>20 alcoholic consumptions per week) and drugs
* Smoking
* Plans to lose weight or following a hypocaloric diet;
* Use of any medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing;
* Regular use of laxation products;
* Use of antibiotics in the 90 days prior to the start of study.
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
* Known pregnancy, lactation (checked by a pregnancy test before start of study)
* Blood donation within 3 months before study period
* Prohibited use of pro-, pre- or synbiotics during study period and three months prior to start of study. A list with forbidden products will be provided (E4 PreProbiotics).
* Self-admitted HIV-positive state
* History of any side effects towards intake of pro- or prebiotic supplements of any kind
Radiation Therapy Using Helical Tomotherapy IMRT for Head and Neck Cancer

Historically, patients with stage III and IV head and neck cancer have been treated with surgery and/or radiation therapy. Based on the results of recent clinical trials, in patients not able to undergo surgery, chemotherapy with radiation therapy has been adopted as the current standard of care. The chemo-radiation approach, however, entails a significant increase in treatment-related toxicity, limiting the extent to which this treatment can be offered to patients. In this trial, the ability of a new form of radiation therapy delivery called IMRT will be evaluated for its ability to reduce the amount of radiation-induced toxicity.

The mechanisms of action to explain the radiation-induced toxic effects resulting from the more aggressive radiation therapy treatments of head and neck cancer include the additive and synergistic increase in mucositis from the combination of chemotherapy and radiotherapy. The severe toxicity associated with more aggressive radiation therapy treatments for locoregional head and neck cancer limits the extent to which these treatments can be offered since many patients present with nutritional deficiencies and consequent general debility. Intensity Modulated Radiotherapy (IMRT) is a technology has the potential for exquisite dose painting and structuring in such a manner that it can permit exclusion of normal tissues and sensitive structures from the high dose radiation volume without compromising primary tumor or nodal target coverage. In this phase I/II feasibility trial, radical radiotherapy will be delivered using Helical Tomotherapy Intensity Modulated Radiotherapy (HT-IMRT) to a dose of 66-70 Gy to involved areas and to at least 50 Gy to un-involved sites, treated prophylactically. It is hypothesized that the pattern of failure and toxicity profiles of patients treated with helical tomotherapy will demonstrate the greater efficacy of helical tomotherapy, as compared with conventional radiotherapy, in the treatment of cancers of the head and neck.

Eligibility Criteria:
Inclusion Criteria:

1. Stage II, III or IV non-metastatic histologically confirmed carcinoma of the head and neck region (Oral cavity, pharynx or larynx).
2. Treatment with radical radiotherapy with or without chemotherapy
3. Patients in whom definitive radiotherapy with or without planned neck dissection is the selected curative treatment
4. ECOG performance status of 0, 1 or 2

Exclusion Criteria:

1. Previous radiotherapy to head and neck mucosa
2. Patients with disabling co-morbid conditions, which do not permit effective immobilization
3. Patients with severe trismus, which disallow effective assessment
4. Patients in whom it is deemed necessary to commence enteric nutrition prior to the start of treatment.
Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population

In this study, the investigators aim to form a Brazilian national prospective active surveillance cohort of patients with low-risk prostate cancer in the public health system. The investigators aim to demonstrate data on the pathological reclassification rate, treatment-free survival, among others. This cohort aim to evaluate and validate the active surveillance strategy in Brazil.

Prostate cancer is the most common malignancy in men in Brazil. It is estimated that about 80% of patients diagnosed with prostate cancer have localized disease, and many of these cases have low-risk cancer.

Active surveillance(AS) is a treatment strategy mainly for low risk prostate cancer to avoid radical treatment through periodic assessments (PSA, digital rectal exam and Prostatic Biopsies). During this follow-up, the patient will be treated only when necessary and with curative intent. Several series of institutional cohorts with long-term follow-up have demonstrated that the AS strategy in selected patients is a safe alternative to immediate treatment, with comparable survival.

The active surveillance strategy has never been evaluated in the Brazilian population. The main outcomes from AS derive from international cohorts. The Brazilian population is extremely diverse, so validation in this cohort is relevant. The current study aim to form a national multicentric prospective cohort of patients with low-risk prostate cancer following an AS protocol in the the public health system to evaluate and validate this strategy in Brazil.

Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of prostate adenocarcinoma;
* Prostate biopsy with at least 12 cores;
* PSA less than or equal to 10 ng/ml and clinical stage cT1/cT2a;
* Gleason score below or equal to 6 (3+3);
* Prostate multi parametric MRI performed or planned
* Availability of pathological samples

Exclusion Criteria:

* Clinical contraindication to prostatectomy and/or radiotherapy procedures;
* Life expectancy below 10 years, according to the Charlson Comorbidity Index (ICC);
* Previous treatment with hormone blockade or radical therapies.
* Intraductal or cribriform histology on biopsy
Implementation of a Depression Screening Intervention at a Transgender Health Clinic in Thailand

The study aims to develop and implement a depression screening intervention into routine HIV and sexual health service provision at a transgender health clinic in Thailand, and to explore the facilitators, barriers, feasibility and acceptability of the screening implementation.

The study will follow a mixed-methods approach that will incorporate quantitative and qualitative components. Aim 1 will involve the development and implementation of depression screening intervention at Tangerine Clinic. Aim 2 will involve semi-structured interviews with a purposive subset of participants who received the intervention and healthcare providers to explore the multilevel facilitators, barriers, feasibility and acceptability of the screening implementation. Aim 3 will evaluate the proportion of participants who are offered, accept, and receive the peer-led depression screening intervention, and the proportion who screen positive.

Eligibility Criteria:
Inclusion Criteria:

1. Thai nationality
2. Transgender women ≥18 years
3. Attending the Tangerine Clinic for routine care visits during the intervention period.
4. Can be a new or returning clients.

Exclusion Criteria:

1. Transgender women currently receiving care for a mental health diagnosis will be excluded from participating in this study.

Inclusion Criteria for healthcare providers:

1. Currently working at the Tangerine Clinic
2. Can be medical doctors, nurses, peer counselors and other members of the clinic management team involved in the routine delivery of HIV and health services to Transgender women.

Exclusion criteria for healthcare providers

1. Not willing to participate in this study
Analgesic Protocol With Gabapentin Dexmedetomidine For Postoperative Pain Managment

Assessment of quality of post mastectomy analgesic protocol of Gabapentin and Dexmedetomedine in a placebo-controlled study

Assessment of quality of post mastectomy analgesic protocol of Gabapentin and Dexmedetomedine in a placebo-controlled study.

Dexmedetomidine is a highly selective X2 adrenergic receptor aganist; it has anxiolytic, sedative, analgesic and sympathdytic properties without significant respiratory depressant effects. Research evidence has shown that this drug protects the body (including heart, nerves, etc.) against ischemia and hypoxic injury. Therefore, dexmedetomidine can be one of the best options for reducing pain after surgery.

Gabapentin, a structural analog of gamma aminobutyric acid, is used as an anticonvulsant drug since 1993. In addition it has been effective in neuropathic pain, diabetic neuropathy and reflex sympathetic dystrophy. It acts through binding to the X-2-5 subvnits of voltagegated calcium ion channels and preventing the central sentization and hyperalgesia. Gabapentin has demonstrated to inhibit the development and establishment of hyperalgesia and secondry allodynia in human volunteers.

Gabapentin may also decrease postoperative obioid requirement through preventing the tolerance development. Furthermore, it has minimal or no effect on gastric mucosa, renal function, and platelets count or activity in the perioperative period to be prefer over nonsteroidal anti-inflammatory drugs.

The Combination of both drugs will be tested for potentiation of post-operative analgesia and decrease of opioid consumptions

Eligibility Criteria:
Inclusion Criteria:

* adult female patients below 65 years of age scheduled for modified radical mastectomy surgery, American society of Anesthesiologists(ASA) physical status I-II

Exclusion Criteria:

* known allergy to study drugs; patients already taking oral gabapentin, knal or hepatic defunction, current treatment with narcotics, antihypertensives, benzodiazepines, X2 agonists, antiepileptics and antipsychotics
Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy

The purpose of this study is to collect blood samples, as well as tumor tissue for genetic analysis. The collection of samples will allow the creation of a plasma bank. Targeted individuals are cancer patients of all types, treated with immunotherapy or targeted therapy.

Immunotherapy or targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.

With the aim to identify predictive markers of response to treatment or possible resistance mechanism, the plasma samples and the tumor samples will be used for genetic analysis, for example but not limited to, whole exome sequencing. This may lead to the discovery of some germinal mutations implicated in other diseases than cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cancer treated with one of the following regimens: Molecular targeted agents or Immunotherapy
* Paraffin-embedded tumor tissue available for immunohistochemistry and/or DNA extraction.
* Patient able to give written informed consent.

Exclusion Criteria:

* Patients with cancer treated with other regimen
Novel Sepsis Sub-phenotypes Based on Trajectories of Vital Signs

Sepsis is a dysregulated host response to infection resulting in organ dysfunction. Over the past three decades, more than 30 pharmacological therapies have been tested in \>100 clinical trials and have failed to show consistent benefit in the overall population of patients with sepsis. The one-size-fits-all approach has not worked. This has resulted in a shift in research towards identifying sepsis subphenotypes through unsupervised learning. The ultimate objective is to identify sepsis subphenotypes with different responses to therapies, which could provide a path towards the precision medicine approach to sepsis.

The investigators have previously discovered sepsis subphenotypes in retrospective data using trajectories of vital signs in the first 8 hours of hospitalization. The team aims to prospectively classify adult hospitalized patients into these subphenotypes in a prospective, observational study. This will be done through the implementation of an electronic health record integrated application that will use vital signs from hospitalized patients to classify the patients into one of four subphenotypes. This study will continue until 1,200 patients with infection are classified into the sepsis subphenotypes. The classification of the patients is only performed to validate the association of the subphenotypes with clinical outcomes as was shown in retrospective studies. Physicians and providers treating the patients will not see the classification, and the algorithm classifying the patients will in no way affect the care of the patients. Further, all the data needed for the algorithm (vital signs from the first 8 hours) are standard of care, and enrollment in the prospective study does not require any additional data.

The primary goal of this study is to investigate the feasibility of implementing a prospective sepsis subphenotyping tool in the electronic health record and evaluating the characteristics and outcomes of the sepsis subphenotypes. During this study, clinicians will not see the results of the algorithm or have access to its predictions. Instead, the algorithm will run silently in the background and continuously compute the subphenotypes of patients who are presenting to the emergency department (ED). For each patient, the probability of subphenotype membership over the first 8 hours of presentation to the ED will be calculated using an algorithm previously validated on retrospective data. Differences in clinical characteristics and outcomes between the subphenotypes will be compared. Investigators will seek to classify 1,200 patients with suspected infections. Since it will not be apparent on ED presentation who has suspected infection, all patients will be classified into subphenotypes using the algorithm, but the primary subgroup who will be analyzed will be patients with suspected infection.

Eligibility Criteria:
Inclusion Criteria:

* All adults who present to the emergency department

Exclusion Criteria:

* None