cyrilzakka/clinical-trials huggingface dataset:
Feasibility and Acceptability of Implementing DIALOG+ in a Psychiatric Rehabilitation Unit

This study aims to understand if implementing DIALOG+ in an inpatient psychiatric rehabilitation setting is feasible (can the intervention be implemented) and acceptable (how the intervention is perceived by staff and patient participants). If the intervention is proven to be feasible and acceptable a larger-scale study may take place. This study has been developed in response to the trust-wide implementation of DIALOG outcome measures. DIALOG+ offers additional solution-focused and person-centred follow-up questions to the DIALOG questions and links to multidisciplinary team (MDT) discussions. It is hoped that the conversations had during DIALOG+ meetings will support positive outcomes, and the learning gathered from this study will drive change and improvement for other people requiring psychiatric rehabilitation inpatient admissions in the future. DIALOG+ has been successfully implemented in community settings in the national health service (NHS) but has not been implemented in psychiatric rehabilitation inpatient settings. This study will aim to recruit patient and staff participants from NHS psychiatric rehabilitation inpatient wards. Patient participants who will be eligible to take part are those who can consent, are between the ages of 18-65, and can complete DIALOG and DIALOG+. To understand the feasibility of the intervention, descriptive statistics will be collected and to understand acceptability focus groups will take place and surveys will be collected. Quantitative data collection will take place over 5 months and will be split into 2 groups. Group one will be a comparison group where participants will act as an extended baseline group and biweekly DIALOG outcomes will be collected. Group 2 will be a Treatment group and participants will receive the DIALOG+ intervention intervention, DIALOG outcomes will be collected biweekly as part of the intervention. Finally, there will be a period to gather qualitative feedback from patient participants using surveys, and from staff participants using focus groups or semi-structured interviews.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-65
* Capacity to give informed consent as determined by the MDT and through following informed consent processes.
* Admitted into the inpatient ward
* Can complete DIALOG and DIALOG+

Exclusion Criteria:

* No capacity to consent
* Insufficient command of the English language
Discrepancies Between Patients and Physicians in Their Perceptions of Rheumatoid Arthritis Disease Activity

Patients and physicians often differ in their perceptions of rheumatoid arthritis (RA) disease activity, as quantified by the patient's global assessment (PGA) and by the evaluator's global assessment (EGA).

The objectives of this study were:

1. to explore the extent and reasons for the discordance between patients and physicians in their perception of RA disease activity
2. to determine if this discordance at baseline is associated with RA outcomes at 1 year (remission, function and structure) in early arthritis (EA) in daily clinical practice.

   * Patients: from the French cohort of early arthritis (EA) ESPOIR³ (at least 2 swollen joints for less than 6 months, DMARD naïve), fulfilling the ACR-EULAR criteria for RA at baseline

Analysis: At baseline, agreement between PGA and EGA (Bland-Altman plot) was assessed. Multivariate linear regression was used to determine the patient and EA features independently associated with discordance (calculated as PGA - EGA). Logistic regression was used to analyze discordance as│PGA - EGA│≥20.

Multivariate logistic models were used to determine if discordance at baseline is associated with remissions (Boolean, SDAI and DAS28), functional stability (HAQ≤0.5 and deltaHAQ≤0.25) and absence of radiographic progression (delta Sharp score\<1) after 1 year of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* fulfilling the ACR-EULAR criteria for RA

Exclusion Criteria:

* no RA
Multicenter Study on the Pathogenic Germline Gene Variants of Colorectal Polyposis in China

Patients suspected of adenomatous polyposis were included. The criteria used were more than 10 polyps observed under colonoscopy, and pathological confirmation of adenoma. Clinical data and pedigree information were collected. The variants of 139 genes associated with different hereditary cancers and polyposis were screened by NGS, which was performed by Genetron Health on the HiSeqX-ten sequencing platform.


Eligibility Criteria:
Inclusion Criteria:

1. clinical diagnosis of adenomatous polyposis;
2. enough samples (provide at least 5ml of peripheral whole blood) for germline variant detection

Exclusion Criteria:

genetic diagnosis of polyposis syndrome
PSG Validation Study of Zensorium Biosensing Wearable Device

The objective of this study is to collect data comparing the Zensorium Biosensing Wearable Device (zBWD) to polysomnography (PSG) in individuals with Sleep-Wake Disorders. zBWD is similar to other wearable devices (e.g., fitbit and apple watch) that use an optical light sensor and Tri-axis Accelerometer to record steps, activity, sleep/awake states, sleep staging, and statistical variation of pulse pressure to track stress. Specifically, it is designed to report sleep duration, non-rapid eye movement (NREM) and REM sleep duration. However, zBWD has not been validated against PSG for sleep tracking in healthy controls or in individuals with sleep-wake disorders.

Subjects known to have or not have sleep-wake disorder, as well as healthy subjects, will be enrolled if they otherwise meet all the inclusion criteria, and none of the exclusion criteria. Subject will be asked to complete several questionnaires and wear the zBWD for 7-days, in an off-site (Home) study, followed by a single overnight PSG study to compare the zBWD data to the current gold standard of PSG. Subjects who have completed the study will also be sent a letter thanking them for their participation and offering a summary of the results of their sleep study.

Eligibility Criteria:
Inclusion Criteria:

* 1. Health status: Healthy, or those with sleep-wake disorders

Exclusion Criteria:

1. Pregnancy
2. Currently smoking
3. Any respiratory disorder other than associated with Sleep/Wake Disorder or well-controlled asthma
4. Habitual use of medications known to affect respiratory function (e.g. opioids, benzodiazepines, etc).
5. Use of medication known to affect pulse pressure (Beta Blockers)
6. Atrial Fibrillation
7. Tattoos located on wrist
Clinical Outcome of Endotracheal Intubation in Non-trauma Patients

The study will involve all adult patients visiting the Alexandria University main hospitals' Emergency department for reasons other than trauma that will require assisted ventilation via endotracheal intubation. Those pre-intubated or intubated post CPR will not be included. The main aim is to evaluate the clinical outcome (complications) of emergency endotracheal intubation and to correlate the incidence and nature of complications associated with tracheal intubations to demographic data and patient characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of both sex with a life threatening impairment of the cardiovascular, respiratory or neurological system requiring emergency endotracheal intubation in the emergency department of Alexandria Main University Hospital.

Exclusion Criteria:

* • Patients who are less than 18 years of age.

  * Patients intubated out of the hospital.
  * Trauma patients.
  * Patients intubated for cardiac arrest.
  * Failed intubation in the field
Examining Different Modes of Exercise for Acute Reduction in Blood Pressure

The purpose of the study is to compared different modes of exercise for eliciting post-exercise hypotension. The study will randomize 10 healthy participants to 30 minutes of either aerobic exercise, isometric exercise, stretching, or rest (control). Blood pressure and heart rate will be assessed before and for one hour post-exercise.

The purpose is to compare different modes of exercise (aerobic vs. isometric vs. static stretching) for reducing blood pressure post-exercise. : Using a randomized crossover design, 5 male and 5 female (n=10) normotensive university students will participate in four different exercise sessions for 30 minutes: aerobic (cycle ergometer at 70% of VO2max), isometric (alternating wall-sit for 70% of max, and handgrip dynamometer at 30% of max for 2 minutes), stretching (targeting the larger muscle groups of the body), and control (rest). Participants' blood pressure and heart rate will be measured before each exercise session and monitored for 60 minutes afterwards to analyze the post-exercise hypotensive response.

Eligibility Criteria:
Inclusion Criteria:

* Able to safely perform exercise according to the Get Active Questionnaire

Exclusion Criteria:

* Taking blood pressure medications
Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological Disorders

The purpose of this study is to study the efficacy of Traditional Chinese Medicine (TCM) on anaemic and cytopenic haematological disorders including myelodysplastic syndrome (MDS), aplastic anaemia (AA), myelofibrosis (MF) and thalassemia intermedia who do not have or did not respond to available treatment options.


Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of MDS, AA, MF or thal based on currently recognized diagnostic criteria.
2. Explored or undergone established therapies eg haemopoietic stem cell transplant, immunosuppressive therapy, chemotherapy, growth factors, thalidomide, hypomethylating agent or androgens, and (a) are deemed not suitable, or (b) refuse or (c) have failed therapy
3. A preceding follow up period (without or with treatment) of 2-4 months as baseline (depending on the severity of cytopenia) before being enrolled into this study
4. Understand the trial nature of this treatment, agree to be compliant to medication, do not self medicate and have signed informed consent
5. Agreeable to regular blood tests and follow up marrow study as listed in schedule

Exclusion Criteria:

1. Life expectancy of shorter than one year
2. Significant organ failure including the following
3. Renal impairment with Cr above 200umol/L
4. Liver impairment with serum bilirubin \> 2x upper limits or transaminase \>3x upper limits
5. Escalation of treatment of introduction of new agents including growth factors, thalidomide, hypomethylating agents, immunosuppressive therapy or androgens once started on treatment with TCM is not allowed. Continuation of current therapy at same or lower doses is allowed
6. Women during pregnancy or lactation.
Adult Stem Cell Therapy in Liver Insufficiency

In order to determine the clinical application potential of adult stem cells we propose to investigate the safety and toxicity of infusing adult stem cells in the hepatic artery or portal vein of five patients with chronic liver insufficiency and to identify any clinical benefit if such occurs.

Objectives:

1. To assess safety and treatment related toxicities
2. To determine clinical benefit or deterioration by monitoring changes in liver function

The liver in an adult healthy body maintains a balance between cell gain and cell loss. Though normally proliferatively quiescent, hepatocyte loss such as that caused by partial hepatectomy, uncomplicated by virus infection or inflammation, invokes a rapid regenerative response to restore liver mass. This restoration of moderate cell loss and 'wear and tear' renewal is largely achieved by hepatocyte self-replication. More severe liver injury can activate a potential stem cell compartment located within the intrahepatic biliary tree, giving rise to cords of bipotential, so-called, oval cells within the lobules that can differentiate into hepatocytes and biliary epithelial cells. A third population of stem cells with hepatic potential reside in the bone marrow; these haematopoietic stem cells can contribute to the albeit low renewal rate of hepatocytes, make a more significant contribution to regeneration and even completely restore normal function in a murine model of hereditary tyrosinaemia.

A recent abstract has suggested that an astonishingly high number of bone marrow cells (\~25% of liver parenchyma occupied by bone marrow-derived cells) will engraft and differentiate into hepatocytes in a model of cirrhosis in the mouse when injected intravenously. More importantly, this bone marrow infusion resulted in significant improvements in liver function (serum albumin) within the cirrhotic animals.

This is a safety and toxicity study in five patients with chronic liver disease. Each will receive autologous stem cells 10 to the sixth cells via the hepatic artery or portal vein under image guided scanning. Patients will be followed for a total of 60 days.

Eligibility Criteria:
Inclusion Criteria:

- Male or female aged from 20 years to 65 years Evidence of chronic liver failure Abnormal serum albumin and/or bilirubin and/or prothrombin time Unsuitable for liver transplantation WHO performance status \<2 Women of childbearing potential may be included but must use a reliable and appropriate contraceptive method Life expectancy of at least three months Ability to give informed consent

Exclusion Criteria:

- Patients aged below 20 years or above 65 years Pregnant or lactating women Patients with recent recurrent gastrointestinal bleeding Spontaneous bacterial peritonitis Evidence of active infection HIV infection Patients unable to give informed consent
To Evaluate the Efficacy and Safety of HL151 Versus Placebo in Perennial Allergic Rhinitis Patients

4week, a Multicenter, Randomized, Double-blinded, Parallel, Therapeutic confirmatory Clinical Trial

4week, a Multicenter, Randomized, Double-blinded, Parallel, Therapeutic confirmatory Clinical Trial to Evaluate the Efficacy and Safety of HL151 versus Placebo in perennial allergic rhinitis patients

Eligibility Criteria:
Inclusion Criteria:

1. Both gender, 19 years ≤ age
2. At least two years history of allergic rhinitis prior to participate in clinical trial
3. Patients with positive reaction for perennial allergen in tests(prick test or Intradermal test or MAST(Multiple Allergen Simultaneous Test) or Immuno CAP test) within 12 months
4. In visit 2, patients with over mean 5 points of the total reflective TNSS score per day (during the run-in period) (highest value 12 points)
5. Patients who can ability to record subject diary
6. Patients who agreed to maintain the same environment throughout the entire clinical trial period.
7. Written consent voluntarily to participate in this clinical trial after understanding and detailed explanation about this clinical trial

Exclusion Criteria:

1. Patients with non-allergic rhinitis
2. Patients with asthma due to the following diseases(but patients with mild and intermittent asthma are available to participate in clinical trials)

   * Within four weeks from the date of screening, patients who visit the emergency room or have been hospitalized within 12 weeks or
   * patients with asthma who need other treatment except short-acting Beta-efficient respiratory relaxants Inhalation
3. Patients with obstructive nasal polyp or severe deviated nasal septum
4. Patients who Within 12 weeks from the date of screening, had damage or surgery around nasal cavity
5. Patients with anamnesis in acute /chronic sinusitis
Short and Long-term Effects of Surgical Repair of Pectus Deformities

A large number of institutions have reported their early results with minimally invasive repair of pectus excavatum and open repair of pectus carinatum, but only few have addressed the outcomes relevant to the concerns of the patients and even fewer have reported long-term results following bar removal. Even fewer studies have investigated the prevalence and characteristics of long term persistent post-surgical pain following surgical repair of pectus deformities. The reasons as to why acute postoperative pain in some patients persists and becomes chronic whereas in others the pain dies down shortly after wound healing are largely unknown, and why some patients complain of loss of sensibility in wide regions of their chest following surgery also remains unclear.


Eligibility Criteria:
Inclusion Criteria:

* Minimally invasive repair of pectus excavatum from 2001 throughout 2010.
* Open surgical repair of pectus carinatum from 2001 throughout 2010.

Exclusion Criteria:

* Not being able to fill in detailed questionnaires in Danish
Master Study of the Acticor/Rivacor ICDs/CRT-Ds and the Plexa ProMRI S DX Lead

Post-Market Clinical Follow-up of the new Cor Family ICDs/CRT-Ds (Acticor, Rivacor) and the new Plexa ProMRI S DX right ventricular lead to provide post-market data and supporting evidence for the clinical safety and performance of the devices.


Eligibility Criteria:
Inclusion Criteria:

* Standard indication for ICD or CRT-D therapy according to clinical guidelines
* Planned for de novo implantation of an ICD/CRT-D, or upgrade/exchange from existing ICD/CRT-D or pacemaker implant
* Able to understand the nature of study and to provide written informed consent
* Willing and able to perform all follow-up visits at the study site
* Willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept

Exclusion Criteria:

* Contraindication to ICD and CRT-D therapy
* Planned for implantation of a CRT-DX system
* For VR-T DX devices: permanent atrial tachyarrhythmia
* For VR-T DX devices: patients requiring atrial pacing
* Less than 18 years old
* Pregnant or breast feeding
* Participating in another interventional clinical investigation
* Life-expectancy is less than 12 months
* Cardiac surgical procedure planned within 12 months after implantation (including interventional procedures like ablation, valve replacement, heart transplant etc.). Procedures to occur during or prior to implantation are not exclusionary
Characteristics of Empagliflozin Initiators

Empagliflozin, a sodium glucose cotransporter 2 (SGLT-2) inhibitor, was launched in the United Kingdom (UK) in August 2014. It can be expected that patients initiating empagliflozin may differ in their characteristics from patients initiating other glucose lowering drugs (GLDs) that have been on the market longer (e.g. patients may have poorer glucose control). Therefore, the proposed study aims to characterize patients with T2DM in the UK initiating empagliflozin in terms of baseline characteristics, concomitant medications, and comorbidities compared to patients with type 2 diabetes mellitus (T2DM) initiating other SGLT-2 inhibitors or other non-insulin GLDs. Due to the mode of action, some patients taking empagliflozin have experienced weight loss in clinical trials. A theoretical possibility exists that empagliflozin may be used by patients without T2DM. Therefore, this study also aims to assess the potential off-label use of empagliflozin compared to other non-insulin GLDs.

Study Design:

cross sectional

Eligibility Criteria:
Inclusion criteria:

All patients will be required to meet all of the following criteria:

* At least 12 months of continuous registration prior to the index date in a practice contributing up to standard (UTS) data to the Clinical Practice Research Datalink (CPRD). Infants younger than 1 year will not be required to have 12 months of continuous UTS registration in the CPRD.
* A new user of one of the index prescriptions (empagliflozin, other SGLT2 inhibitor, or non-insulin GLDs) or a fixed dose combination (FDC) with metformin.

Exclusion criteria:

There is no exclusion criterion in this study.
Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters

In this trial, the investigators intend to examine whether the concentration of local anesthetics during epidural analgesia could be modulating factor for change of hemodynamics in patients undergoing major upper abdominal surgery.

One hundred and twenty patients scheduled for major abdominal surgery under TEA combined general anesthesia were randomized in a double-blinded method to receive one of three different concentration study solutions in 8 ml of volume after the induction of anesthesia: 0.75% ropivacaine (60 mg), 0.375% ropivacaine (30 mg), or 0.2% ropivacane (16 mg).

In each group, the patients were divided into two subgroups at the age of 60 to perform age based analysis. The acquired hemodynamic data after administration of epidural loading dose were compared and analyzed between young and elderly groups in each group.

Eligibility Criteria:
Inclusion Criteria: all of the followings needed.

* ASA I or II patients
* 18 to 65 years old
* undergoing major upper abdominal surgery
* planned combined thoracic epidural analgesia and general anesthesia

Exclusion Criteria:

* any contraindication to epidural analgesia
* allergy to local anesthetics of the amide type
* communication difficulties that would prevent reliable assessment
* known significant cardiac or respiratory disease
* pregnant
* patients who were not in cardiac sinus rhythm
Study of Pomegranate Juice in the Modulation of Oxidative Stress Markers in Endurance-based Athletes

The purpose of this study is to evaluate modifications of plasma protein carbonyls and malondialdehyde levels in endurance-based athletes after three weeks of pomegranate juice consumption.


Eligibility Criteria:
Inclusion Criteria:

* Perform specific endurance training sessions
* More than 1 hour per session and more than 3 sessions per week
* Have participated recently in a half marathon or similar event

Exclusion Criteria:

* Intake of antioxidant or anti-inflammatory supplementation
* Present a chronic disorder
* Non-smoker
* No-alcoholic beverage consumption
TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women

The primary goal of this proposed physical activity (PA) intervention is to develop a realistic and an economical intervention to promote regular PA among older, overweight or obese Black women. Physical inactivity is prevalent among older Black women and this lifestyle behavior is both a destructive and expensive public health issue. Because many in this population do not engage in sufficient amounts of regular PA, this group miss the cardio-protective effects that may reduce many chronic conditions that disproportionately affect Blacks such as hypertension, diabetes, and obesity. The proposed obesity-reduction intervention is aligned with Stage 1 of the National Institute on Aging Stage Model for Behaviors Interventions Development. For the proposed hypothesis, the investigators propose a 2-group randomized controlled pilot, feasibility study in which 30 women will be randomized to receive either the TOSS PA Text messages Plus Fitbit community or the Control group and followed for 12 weeks to detect intervention effect.


Eligibility Criteria:
Inclusion Criteria:

* Black women
* 60 years and older
* Have a BMI ≥ 25 kg/m2
* Do not meet the weekly 150 minutes of physical activity (PA)
* No health conditions that would prevent or limit PA or walking
* Able to read text messages
* Access to a mobile phone with text receiving capability
* Mobile phone with ability to download a Fitbit app.

Exclusion Criteria:

* Currently participating in another PA promotion program
* Non-English speaking
* A contraindication to exercise as indicated by the PA Readiness Questionnaire (PAR-Q) unless written permission was provided from the participant's primary care provider.