cyrilzakka/clinical-trials huggingface dataset:
Computerised Interventions for Thinking and Anxiety in Delusions (CITADEL) Trial

People with a schizophrenia spectrum diagnosis often experience distressing worries or beliefs about others intending to cause them harm (also known as paranoia). Paranoid beliefs are associated with significant distress and disruption to the person's life. This results in high use of services and costs to mental health providers.

The National Institute of Clinical Excellence recommends that cognitive behavioural therapy for psychosis (CBTp) is offered to everybody with a schizophrenia spectrum psychosis. The latest meta analyses report improved outcomes, and reduced inpatient stays following CBTp, making it a cost effective intervention.

Although improved outcomes have been obtained by therapies, CBTp has only small to moderate effects on paranoid beliefs. Further, training therapists to competently deliver CBTp is intensive, expensive and takes up to a year. CBTp is therefore not widely available to service users, resulting in inequalities in access to care.

The investigators are seeking to improve outcomes and accessibility of CBTp for people with distressing, paranoid beliefs. The proposed research programme aims to conduct a feasibility study of a brief therapeutic intervention, aimed at targeting and improving anxiety processes that are causally implicated in paranoia (Freeman et al, 2015).

The investigators have preliminary evidence indicating that the pilot intervention, with interactive multimedia content, reduced distressing beliefs and improved coping (Freeman et al, 2015). Participants also reported they found the therapy acceptable, enjoyable and useful. Based on these results, the investigators have further modified the intervention. The feasibility and efficacy of the therapy will be investigated in a randomised controlled design (n = 34).

Please note the protocol has been been amended to exclude a pilot trial of a second brief intervention targeting reasoning styles in paranoia, as since the initial protocol was developed we have obtained data from two randomised pilot studies demonstrating its feasibility and acceptability (Garety et al, 2015; Waller et al, 2015). A further pilot trial of the reasoning styles intervention is therefore not indicated.


Eligibility Criteria:
Inclusion Criteria:

* Self reported worries about being harmed or at risk from others
* Non-affective psychosis(ICD10,F20-F29)
* Age 18-65
* Symptoms stable no major relapse or crisis in last 3 months prior to consent
* Sufficient command of English to provide informed consent, complete the measures and participate in the brief interventions
* Score above the cutoff for clinically significant levels of paranoia on the Green Paranoid Thoughts Scale (Green et al, 2008)
* Paranoia is triggered by being outside

Exclusion Criteria:

* Lack of capacity to provide informed consent
* Primary diagnosis of drug or alcohol use with secondary psychosis
* Primary diagnosis of mood disorder or bipolar affective disorder
* Primary diagnosis of learning difficulty
* Unstable residential arrangements (making a move away during the course of participation in the research likely)
Dielectric Property Test Compared With Frozen Pathological Section in the Rapid Diagnosis of Lung Nodules/Mass

Patients with lung nodules/mass found by CT (computed tomography) or PET (positron emission tomography) who agree to receive lung resection are arranged to test the dielectric property before receiving the frozen pathological examination. And the final pathological results are recognized as the standard diagnosis. Then the sensitivity and specificity of the dielectric property test will be evaluated comparing with the frozen pathological examination.


Eligibility Criteria:
Inclusion Criteria:

* Patients with lung nodules/mass found by CT or PET who agree to receive lung resection;
* Diameter of the lung nodule/mass is longer than 8 millimeters;
* More than 50% of the lung nodule/mass is solid component by image examination;
* Diameter of the solid component is longer than 5 millimeters by intraoperative exploration.

Exclusion Criteria:

* Cutting open the resected nodule/mass will interfered with the pathological examination;
* Diameter of the solid component is shorter than 5 millimeters by intraoperative cutting open;
* Cutting open the lung nodule/mass will cause great damage to the patient, such as inducing allergic shock.
Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients

The DETECT randomized controlled trial addresses the question of whether surveillance ultrasound in critically ill patients by facilitating DVT detection reduces the incidence of PE and lowers all-cause 90-day mortality. The primary outcome is 90-day all-cause mortality.

This is an open-label multicenter multinational randomized-controlled trial. All patients admitted to ICU will be screened within the first 48 hours of ICU admission for eligibility. Subjects who meet all criteria for enrollment will be randomized via a password-protected, secure website using a variable-size block concealed computer-generated randomization procedure. Patients will be allocated to twice weekly bilateral lower limb ultrasound or standard care (control) in a 1:1 ratio.

Eligibility Criteria:
Inclusion criteria

1. Medical, surgical or trauma ICU patients ≥18 years old.
2. Patients who are expected to stay in the ICU more than 2 calendar days (unlikely to be discharged out of ICU on the day of admission or on the next day).

Exclusion Criteria

1. Patients with DVT or PE diagnosed within the last year.
2. Patients receiving chronic systemic anticoagulation.
3. Patients who have received up to the time of ICU admission or are receiving therapeutic doses of anticoagulation with UFH, LMWH, or other anticoagulants.
4. Inability or contraindication to obtain adequate ultrasound on the lower extremities (Burns in the lower extremities, lacerations, active skin infection, \& ischemic limb in the legs, large dressings in the thighs that prevent adequate ultrasounds OR amputated foot or leg on one or two sides)
5. Patients with Inferior Vena Cava (IVC) Filter.
6. Known or suspected pregnancy.
7. Limitation of life support, life expectancy \<7 days or palliative care.
8. Previously enrolled in DETECT trial within the last 180 days.
9. Enrolled in another trial for which co-enrolment is not approved.
Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)

The objectives of this study were to evaluate long-term safety and efficacy of caplacizumab, to evaluate safety and efficacy of repeated use of caplacizumab and to characterize long-term impact of acquired thrombotic thrombocytopenic purpura (aTTP).


Eligibility Criteria:
Inclusion Criteria:

1. Completed the Final (28 day) follow-up visit in Study ALX0681-C301.
2. \>= 18 years of age at the time of signing the informed consent form.
3. Provided informed consent prior to initiation of any study specific activity/procedure.

Exclusion Criteria:

1. Not being able/willing to comply with the study protocol procedures.
2. Currently enrolled in a clinical study with another investigational drug or device.
the Effect of Preoperative Sodium Ibuprofen on Postoperative Endodontic Pain

The aim of this study is to clinically compare post-operative pain levels after administration of preoperative single dose of sodium ibuprofen versus placebo for patient with symptomatic irreversible pulpitis related to mandibular molar teeth.

Oral pharmacologic agents have been the primary option, and the use of drugs has increased exponentially. Many pharmacological agents have been used to manage endodontic pain, including Non-steroidal Anti-inflammatory Drugs (NSAIDs),.administration of NSAIDs before root canal treatment will reduce inflammatory process before it begins. NSAIDs are widely used to control post endodontic pain They act by blocking the activity of cyclooxygenase (COX 1 and 2) enzyme. In human dental pulps with irreversible pulpitis, a higher level of expression of COX 2.In cases of irreversible pulpitis NSAIDS can be administered preoperatively since they reduce the level of prostaglandinE2(PGE2) which is responsible for sensitization of nociceptors. Ibuprofen is one of the most commonly used NSAIDs and a potent inhibitor of prostaglandin (PG) synthesis that can manage various pain types and has anti-inflammatory activity. Enhancements in ibuprofen acid's pharmacokinetics have led to the development of ibuprofen salts with a faster dissolution rate and onset of action. These ibuprofen salts.Fast acting ibuprofen like Sodium ibuprofen delivers maximum plasma drug concentrations at about 30-40 min, compared with around 90-120 min for standard ibuprofen acid formulations

Eligibility Criteria:
Inclusion Criteria:

* Patients above 18 years old and below 66.
* Male or female
* Patients seeking root canal treatment
* Mandibular posterior molarteeth with Symptomatic irreversible pulpitis .
* Spontaneous pain
* Systematically healthy patient(ASA I,II)

Exclusion Criteria:

* Medically compromised patients having significant systemic disorders. (ASA III or IV)
* History of intolerance to NSAIDS.
* Patients with two or more adjacent teeth requiring endodontic treatment.
* External root resorption
* Internal root resorption
* Vertical root fracture
* Periapical lesion
* Pregnancy
* Use of ibuprofen in the last 12 hour
* Bleeding disorder
* Long term corticosteroid use
* Mobility Grade II or III.
* Pocket depth more than 5mm.
* Previous root canal therapy.
* Non-restorability
* Temporomandibular joint (TMJ) problems, bruxism, clenching or traumatic occlusion.
* Inability to perceive the given instructions.
Korean Diet Efficacy Clinical Trial

To determine:

1. the acceptability of a Korean diet to an Australian overweight and obese population
2. which Korean recipes are easily prepared
3. the effect of a Korean diet on weight, blood pressure, and metabolic complications of obesity in this population.

The primary endpoint (Korean diet acceptability) will be assessed by reliability tested questionnaire, dietary compliance, and quantities of food returned over the 12 weeks.

Analysis of differences in weight loss will be based on all participants with a baseline and a 12-week weight assessment. In order to investigate the impact of missing data, all subjects will be analysed using last weight observation carried forward and baseline weight carried forward.

Other secondary endpoints will determine the effect of the Korean diet on blood pressure, metabolic parameters and chronic metabolic disease control in the Australian population.

Eligibility Criteria:
Inclusion Criteria:

* Residents of metropolitan Sydney
* Aged 18-65 years
* BMI 25-45kg/m2

Exclusion Criteria:

* Diabetes treated with oral medications or insulin
* Unstable angina or recent onset of cardiovascular disease
* Serious hepatic or renal disease
* serum transaminases (ALT or AST) \> 2.5 times upper limit of normal
* serum creatinine \> 1.5 times upper limit of normal or urinary microalbumin \>40 mg/L or eGFR \< 60ml/min/1.73m²
* Alcohol or illicit drug abuse
* Pregnant, breastfeeding, or planning pregnancy during the study
* Serious gastrointestinal disease (inflammatory bowel disease, active peptic ulcer, recent helicobacter pylori treatment)
* Treatment for an eating disorder, weight loss medications and other drugs that affect body weight e.g. some anti-psychotics, anti-depressants, or corticosteroids
* Hypothyroidism defined by elevated thyroid stimulating hormone (TSH) and low free thyroxine (fT4), or current hyperthyroidism under treatment
* Participation in another weight loss clinical trial within past 3 months
* Individuals who have lost \>10% weight within past 3 months
* Vegetarian eating practices
* Inability to cook or lack of facilities for home cooking
* Inability to read and write English
* Subjects who frequently change smoking habits or who have stopped smoking within 6 months prior to screening
The Health Outcomes Management and Evaluation (HOME) Study

There is an urgent need to develop practical, sustainable approaches to improving medical care for persons treated in community mental health settings. This study will test a novel approach for improving mental health consumers based on a partnership model between a Community Mental Health Center and a Community Health Center. When this study is completed, it will provide a model for a medical home for persons with severe mental illness that is clinically robust, and organizationally and financially sustainable

Findings of excess cardiometabolic morbidity and mortality in persons with severe mental illness (SMI) have led to a growing interest by Community Mental Health Centers (CMHCs) in improving the medical care of the populations they treat. However, these organizations face a number of financial and organizational barriers to implementing and sustaining such programs. In previous and ongoing work, the study team has documented the promise of team-based models in improving health and health care in this population. This study will test a novel approach for improving mental health consumers based on a partnership model between a CMHC and a Community Health Center (CHC). This partnership will capitalize on collocation of services, the primary care expertise of the CHC, and favorable reimbursement conditions, to develop a program that is both clinically robust and financially and organizationally sustainable A total of 300 CMHC clients with a severe mental illness and one or more active cardiometabolic problem (diabetes, hypertension, hyperlipidemia) will be randomized to either onsite Integrated Community Care (ICC) (n=150) or to a referral to the partner community health center (CHC) (n=150) for their medical problems. For those in the ICC, the CHC will establish a satellite clinic at the CMHC staffed by a physician assistant and care manager. The ICC will provide care for both the index cardiometabolic conditions and common acute and chronic comorbidities.

The study will use standardized, validated instruments to assess the impact of integrated community care on quality and outcomes of cardiometabolic and general medical care. A budget impact analysis will be used to assess the program's financial and organizational sustainability. When this study is completed, it will provide a model for CMHCs to provide a medical home for the populations they serve.

Eligibility Criteria:
Inclusion Criteria:

* Patient at Cobb County CSB
* one or more of the following conditions: hyperlipidemia, high blood pressure, heart failure, diabetes
* able to give consent

Exclusion Criteria:

* unable to give consent
* does not have a cardiometabolic condition
Increasing Food Literacy in Preschoolers to Reduce Obesity Risk

The goal of this clinical trial is to examine the effects of a nutrition education program on preschool children's food literacy and food acceptance, and to examine the added influence of a healthy eating curriculum and parent education on children's food knowledge and healthful food choices. The project will be evaluated with 450 children ages 3 to 5 years in center-based childcare programs serving predominantly Supplemental Nutrition Assistance Program (SNAP)-eligible families in Pennsylvania. Outcomes for children who receive the added healthy eating curriculum will be compared to children in classrooms that only receive the nutrition education program.

Repeatedly exposing young children to new foods can increase their willingness to try those foods, and they may - with time - learn to like those foods. Being able to learn about, touch and taste new foods can be a powerful tool to foster young children's liking of new foods. This project's goals are to test whether a preschool nutrition education program can improve (1) children's ability to name and identify fruits and vegetables, (2) children's knowledge about food and nutrition, (3) children's healthful food choices during a meal, and (4) parenting around children's eating. Participants will include 450 children ages 3 to 5 years in center-based childcare programs serving a large majority of families experiencing poverty in Pennsylvania. In all classrooms, children will receive food literacy lessons designed to help them learn about different fruits and vegetables, where they grow, and why they are good for our bodies. Children in intervention classrooms will receive food literacy lessons, in addition to lessons on healthy eating designed to improve children's nutrition knowledge. Teachers in intervention classrooms will be provided with materials designed to increase children's knowledge about nutrition and healthy eating. Intervention parents will receive web-based lessons designed to improve parenting practices related to children's eating behaviors. The study will be conducted over a 14-month period, and a variety of child, teacher, classroom and parent outcomes will be measured before, during and after the intervention. The results of this study are anticipated to add new information on ways to improve children's nutrition knowledge and acceptance of fruits and vegetables.

Eligibility Criteria:
Inclusion Criteria:

* Preschool children enrolled in participating centers

Exclusion Criteria:

* Severe food allergies that prevent children from consuming project foods
* Presence of a developmental or sensory disability that affects food intake and/or learning
* Lack of English fluency (children and caregivers)
* Children not regularly present during days/times that intervention lessons are delivered
* Parents who are not involved in feeding/preparing meals for children at least 50% of the time
Platelets in Cystic Fibrosis Lung Inflammation

Cystic fibrosis (CF) is a chronic multiorgan disorder caused by mutations in the CFTR (cystic fibrosis transmembrane conductance regulator) gene. Chronic airway infection by bacterial pathogens accounts for the progressive, suppurative pulmonary disease that leads to significant morbidity and mortality in patients with CF. Neutrophil recruitment to the lungs accounts the most important contributor to pulmonary destruction. However, there is evidence that platelets may also have an important role in the pathogenesis of inflammation. To our knowledge, there is few information in platelet levels in patients with cystic fibrosis during pulmonary exacerbation, chronic airway colonization and when stable.

Airway inflammation in CF is predominantly neutrophilic in nature with increased concentrations of pro-inflammatory mediators include TNF-α, IL-1β, IL-6, IL-8, IL-17, IL-33, GM-CSF and G-CSF. In addition, other cell types including macrophages and T-lymphocytes are expressed by CFTR and contribute to the CF inflammatory response.

Researches have indicated that platelets may also have a significant contribution to the inflammation. Platelet depletion or antiplatelet therapies attenuate injury and mortality in animal models of acute lung injury. More importantly, CFTR expression has been shown on human platelets. Recent data suggests that CF patients have an increase in circulating activated platelets and platelet reactivity.

Taken together, these observations support a potentially important role of platelets in regulating lung inflammation in CF. However, there are few studies examine platelet and lung inflammation interraction in patients with CF. Therefore we aimed to investigate platelet count (PC) and mean platelet volume (MPV) levels in various conditions in our CF patients.

Eligibility Criteria:
Inclusion Criteria:

* All regularly followed cystic fibrosis patients with clinical and laboratory results could be obtained from medical charts.

Exclusion Criteria:

* None
Narrow Band Imaging Versus White Light for Colonoscopy Serrate Lesions Detection

Colorectal cancer (CRC) is a leading cause of cancer death and its' incidence is rising in most European countries. Colonoscopy has been shown to reduce CRC incidence, however its effectiveness depends on the sensitivity to detect pre-malignant lesions.

Our aim is to evaluate narrow band imaging (NBI) during colonoscopy and serum miRNAs as novel tools for the early detection of colonic sessile serrated lesions (SSL). The investigators will perform a multicenter-randomized-controlled-trial to study the role of NBI in SSL detection.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective colonoscopies

Exclusion Criteria:

* known polyposis syndromes
* primary sclerosing cholangitis
* inflammatory bowel disease
* personal colorectal cancer history
Drug-drug Interaction of Empagliflozin (BI 10773) and Microgynon

The objective of this study is to investigate the possible effect of multiple oral doses of 25 mg BI 10773 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (Microgynon®).


Eligibility Criteria:
Inclusion criteria:

1. Healthy female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)

This is a Phase 1b/2 study evaluating the anti-PD1 antibody, cemiplimab, in combination with either S095018 (anti-TIM3 antibody), S095024 (anti-CD73 antibody), or S095029 (anti-NKG2A antibody) in adult participants with previously untreated advanced/metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression. The study includes two parts: part A, the combination-therapy safety lead-in phase to determine the recommended dose for expansion (RDE) for S095018, S095024, and S095029 in combination with cemiplimab and part B, the randomized dose expansion phase to assess the efficacy of S095018, S095024, or S095029 in combination with cemiplimab. Study treatment will be administered for a maximum of 108 weeks, or until confirmed disease progression per iRECIST and/ or until meeting other treatment discontinuation criteria.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient aged ≥ 18 years
* Written informed consent
* Histologically (squamous or non-squamous) or cytologically documented locally advanced NSCLC not eligible for surgical resection and/or definitive chemoradiation, or metastatic NSCLC
* No prior systemic treatment for locally advanced or metastatic NSCLC
* High tumor cell PD-L1 expression \[Tumor Proportion Score (TPS) ≥50%\] based on documented status as determined by an approved test
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Measurable disease as determined by RECIST v1.1

Exclusion Criteria:

* Tumors harboring driver mutations/genetic aberrations for which targeted therapies are approved as frontline treatment (e.g. EGFR mutation, ALK fusion oncogene, ROS1 aberrations)
* Prior immune checkpoint inhibitor therapy
* Active brain metastases
* Participants with active and uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Uncontrolled HIV infection. Participants with HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are allowed to enroll
* Active, known or suspected autoimmune disease or immune deficiency
* History of hypersensitivity reactions to any ingredient of the investigational medicinal product (IMP) and other monoclonal antibody (mAbs) and/or their excipients
* History of interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis or active pneumonitis ≥ grade 2
* History of inflammatory bowel disease or colitis ≥ grade 2
* History of hemophagocytic lymphohistiocytosis.
* Systemic chronic steroid therapy (\>10mg/d prednisone or equivalent)
* Active infection, including infection requiring systemic antibiotic therapy
* Pregnant or breast-feeding (lactating) women
* Participants with a history of allogeneic organ transplantation (e.g., stem cell or solid organ transplant)
* Any medical condition that would in the investigator's judgement prevent the participant's participation in the clinical study