cyrilzakka/clinical-trials huggingface dataset:
Ventriculo-arterial Coupling and Myocardial Work in Sepsis and Septic Shock

Sepsis is a term which describes an excessive response of the body to an infection and, if not promptly treated, can turn into septic shock a condition in which the organs don't receive enough oxygen to satisfy their needs. The aim of the study is to assess how the treatment of sepsis and septic shock will modify myocardial work and ventriculo-arterial coupling, that can be considered as indicators of ventricular and arterial performance efficacy respectively. Each patient will be treated according to updated guidelines for sepsis and septic shock management, they will voluntarily be enrolled and they can decide to withdraw in each moment without any consequence on their treatment. The investigators, after receiving the consent, will collect patients' data, take blood samples and perform ultrasound measurements and then will start the treatment which can be based on fluids infusion, vasopressors or both. The investigators think that a modern cardiovascular assessment approach can be used to individually set the optimal blood pressure target in sepsis and septic shock with the combined evaluation of myocardial work and ventriculo-arterial coupling.


Eligibility Criteria:
Inclusion Criteria:

* 18 or more years old
* sepsis
* septic shock

Exclusion Criteria:

* lack of consent
* less than 18 years old
* pregnancy
* more than moderate aortic stenosis ( aortic valve area (AVA) \< 1.4 cm2, aortic valve area indexed (AVAi) \< 0.85, doppler velocity index (DVI) \< 0.5)
* more than mild mitral regurgitation (vena contracta (VC) width \<= 3 mm, mitral regurgitation (MR) effective regurgitant orifice area (EROA) \< 20, MR regurgitant volume (RegV) \< 30 ml)
* cardiac arrythmias (e.g. atrial fibrillation/flutter, frequent ventricular and supraventricular or nodal activity)
* renal replacement therapy
* other than continous modes of mechanical ventilation
The Sensitivity and Specificity of Sniff Dog as a Tool in Diagnosing the Suspected Tumor Patients

Previous studies have demonstrated that sniff dogs can identify cancer patients from healthy subjects through sniffing exhaled breath air or blood or serum or urine or feces. It is hypothesized that sniff dogs may be used as a tool in identifying cancer patients in the high risk population or suspected patients. Trained dogs will sniff serum from participants who are suspected to suffer from tumor by their physicians and not yet but will be diagnosed by pathological examination.The results will be compared with the outcome of the pathological examination.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers who have been examined by the currently used procedures and find to be without tumors.
* Patients in the breast surgery, thoracic surgery, gynecological and neurosurgery departments with lesions with characteristics of tumors

Exclusion Criteria:

* Patients who have had pathological results
Cost-benefit Evaluation of a Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care

The aim of this study is to compare, in cost-effectiveness and cost-utility terms, a brief transdiagnostic cognitive-behavioural therapy in two different modes, individual and group, with the treatment usually administered in primary care (TAU).

Participants between 18 and 65 years old and with, according to the pretreatment evaluation, mild to moderate emotional disorders will be randomly allocated to the three clusters. They will be assessed again immediately after treatment and 6 and 12 months later.

The study hypotheses expect to find (H1) the individual treatment generally as effective as the group one, whereas (H2) the TAU will be the least effective. (H3) The group therapy is expected to get the best results in terms of cost-effectiveness and (H4) the TAU will get the worst cost-effectiveness results. Furthermore, (H5) it is expected to find these results across the follow-up assessments too.


Eligibility Criteria:
Inclusion Criteria:

* Mild/moderate emotional disorder

Exclusion Criteria:

* Severe mental disorder (including severe depressive or anxiety disorders, not somatizations)
* High level of impairment
* Recent, severe suicide attempt
* No emotional disorder/Below the instruments cut-off points
Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Docetaxel in Patients With Advanced Solid Tumors

Primary Objective:

To determine the dose limiting toxicity (DLT), the maximum administered dose (MAD) and the maximum tolerated dose (MTD) of AVE8062 and docetaxel in combination administered sequentially on D1 \& D2 respectively every 3 weeks in patients with advanced solid tumors.

Secondary Objectives:

* To define the overall safety profile of the combination.
* To characterize the pharmacokinetic (PK) profile of AVE8062 and docetaxel when administered in combination.
* To evaluate anti-tumor activity of the combination.
* To evaluate potential predictive biomarkers.

The study includes a tumoral pharmacogenomic sub-study conducted in a subset of sites. The objective to analyse a set of biological biomarkers in order to identify a potential predictive signature of efficacy for AVE8062 in combination with docetaxel.

The duration of study for each patient will include 4-week screening phase prior to first inclusion of study drug, 21-day study treatment cycles, end of treatment visit and follow-up phase. Each patient will be treated until disease progression, unacceptable toxicity or other study discontinuation criteria.

Eligibility Criteria:
Inclusion criteria:

* Advanced neoplastic disease (i.e metastatic or locally advanced disease) for which docetaxel-based regimen therapy is indicated such as breast, non-small cell lung and prostate cancer.
* ECOG performance status of 0 to 1.

Exclusion criteria:

* Concurrent treatment with any other anticancer therapy.
* Patient with locally advanced or metastatic breast cancer who never received adjuvant chemotherapy.
* Brain metastases and carcinomatous leptomeningitis.
* Prior intensive chemotherapy with autologous stem cell rescue.
* Patients who received a high cumulative dose of anthracycline (i.e doxorubicin \> 400mg/m2 or epirubicin \>750 mg/m2).
* Impaired cardiovascular function.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Evaluation of Minimal Invasive Glaucoma Surgery

Glaucoma is a neurodegenerative disease with an accelerated and progressiv retinal ganglion cell loss and concomitant visual field defects. Glaucoma can be treated with eye drops, laser therapy or surgery. Various surgical approaches to lower intraocular pressure are available, amongst which trabeculectomy is the gold standard. Recently minimal invasive glaucoma surgery has been introduced and has become a good alternative to trabeculectomy. Randomized clinical trials investigating the postoperative outcomes of various types of glaucoma surgery are limited.

150 Patients will be randomized to one of the 3 surgeries. Trabeculectomy Preserflo® or Xen® will be done according to a standard protocol Data will be collected for 5 years after surgery, Visual Acuity, Applanation Tonometry, Slit lamp Biomicroscopy, Endothelial cell cound, visual fields, optical coherence tomography of the optic disc, retina and anterior segment, impression cytology and life quality will be done on day of enrollment and during followup. Mean Intraocular pressure and number of glaucoma medications, Endothelial cell loss, visual acuity, visual fields and assessment of life quality will be assessed during the post-operative follow-ups at one week, one month, 3 months, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patiens with glaucoma in which surgery is indicated to reach target intraocular pressure
* Subjects not anticipated to require any further surgery in the next 12 months

Exclusion Criteria:

* Patients who do not want to make follow-ups at the department
* angle closure, uveitic, neovascular, congenital glaucoma, iridocorneal endothelial syndrom, Axenfeld-Rieger syndrom.
* Prior filtering glaucoma surgery, suprachoroidal stent, retinal surgery, corneal graft surgery or cyclophotocoagulation
* Any major ocular inflammation up to 30 days prior to surgery
* Conjunctival scarring
* Allergy to any drugs required for the protocol
Dementia Care Training With Virtual Reality and Support for Home Care Staff

This study aims to evaluate a dementia care training with virtual reality and peer support program on dementia care knowledge, attitude, care competence, work stress, and empathy of home care staff.

Home care staff often have insufficient knowledge and skills of caring people with dementia at home. Many lack empathy for those with dementia. Training courses for home care staff often are not developed according to their educational background and workplace needs.

This two-group cluster randomised controlled trial aims to evaluate a dementia care training with virtual reality and peer support program on dementia care knowledge, attitude, care competence, work stress, and empathy of home care staff.

The dementia care training consists of dementia care e-books, dementia virtual reality activity and peer support program.

The interventional group will receive a dementia care training using dementia care e-books, dementia virtual reality activity and peer support program.

The control group will only receive dementia care e-books and peer support with no dementia virtual reality activity.

Both groups will be assessed for their dementia care knowledge, attitudes, care competence, work stress and empathy at baseline, month 3, and 6.

Eligibility Criteria:
Inclusion Criteria:

* age 20 to 65 years
* Taiwanese nationality
* had worked as a home care staff for at least three months
* had experience in providing home care for patients with dementia
* had a mobile phone or tablet and regular access to the internet

Exclusion Criteria:

* Home care staff who do not meet the inclusion criteria
* can not provide informed consent.
The Effect of Smartphone Addiction on Physical Activity and Depression in University Students

This study was planned considering that young people with smartphone addiction are depressed and their physical activity is significantly reduced. In this direction, our aim is to examine the relationship between smartphone use and physical activity among universities in the 18-25 age group, which uses technology extensively. Our results are to raise awareness of this prevention by uncovering the possibility that it may be the cause of smartphone use in young people.

Smartphone addiction short scale, beck depression questionnaire and international physical activity(IPA) scale short form questionnaires were used in our study.

Eligibility Criteria:
Inclusion Criteria:

1. Being a university student
2. Voluntary participation in the study
3. The adults who were diagnosed as having palliative care needs and are considered to be within the last 5 years of life as determined by their medical practitioner
4. Age between 18-25 years
5. Able to provide consent
6. Have the means to communicate
7. Able to read, understand, and provide informed consent in Turkish

Exclusion Criteria:

1. No chronic wrist deformity or disease
2. Unable to meer the iclusion criteria
3. Too unwell to participate
4. Physical impairments precluding participation in physical activity;
5. Unwilling or unable to sign the Participant Informed Consent Form; Received a diagnosis of brain cancer or thyroid cancer. Brain cancer survivors will be excluded as a function of the cognitive impairments associated with their diagnosis and treatment and thyroid cancer survivors will be excluded due to the vastly different treatment regimens. That is, both of these cancers may result in different physical, psychological/emotional, and social effects that could impact the outcomes of interest.

Eligible participants who want to participate in the other pre-specified outcome measures to assess cognitive functioning must also meet the following additional inclusion/exclusion criteria.
The Effect of Web-Assisted Peer Education for Early Diagnosis of Breast Cancer on Health Beliefs, Knowledge Levels and Breast Self-Examination in University Students

The aim of this study was to examine the effect of web-supported peer education on health beliefs, knowledge levels and breast self-examination in university students.

In line with the general purpose of the study, an experimental design will be used in the study. The population of this study consists of female students of Ankara Medipol University. Considering that there may be dropouts from the study in line with the determined sample size, 200 students (intervention; n=100, control; n=100) who were excluded from the exclusion criteria and who agreed to participate in the study were planned to constitute the study group.

Hypotheses of the Research Between the experimental group and the control group, which received peer education on breast cancer and Breast Self-Examination (BSE); H1a1: There is a difference in terms of the sensitivity subscale score average. H1b1: There is a difference in terms of the mean score of the seriousness/importance subscale.

H1c1: There is a difference in terms of the average score of the benefit perception subscale.

H1d1: There is a difference in terms of the average score of the obstacle perception subscale.

H1e1: There is a difference in terms of the mean score of the trust subscale. H1f1: There is a difference in terms of the health motivation subscale score average.

H2a1: There is a difference in terms of the average knowledge score. H3a1: There is a difference in terms of performing breast self-examination.

Eligibility Criteria:
Inclusion Criteria:

* Young women who do not have any diagnosis of cancer or breast cancer
* who have no communication barriers
* who are not pregnant or breastfeeding
* who volunteer to participate in the study

Exclusion Criteria:

* Participants with a previous cancer diagnosis
* CHCMM training and who were absent for more than two sessions in the intervention group
Hip Arthroscopy Versus Total Hip Arthroplasty RCT

The aim of the proposed study is to perform a comparative pilot, randomized controlled trial of hip arthroscopy versus definitive total hip arthroplasty (THA) for the treatment of early hip osteoarthritis (Tönnis Grade 1-2) in patients between the ages of 40-60 years.

The purpose of this study is to conduct a randomized trial to compare hip arthroscopy to THR and estimate the long-term cost-effectiveness. Specifically, we aim to:

1. Estimate the magnitude of the between-groups difference in the primary outcome (Hip Dysfunction and Osteoarthritis Outcome Score - HOOS);
2. Evaluate the clinical and cost-effectiveness of early definitive THA compared to arthroscopy for early-stage hip OA at 1-year postoperative;
3. Estimate the lifetime cost-effectiveness of arthroscopy vs THA using a Markov model; and
4. Identify imaging and biomechanical predictors of outcomes following hip arthroscopy

Eligibility Criteria:
Inclusion criteria:

1. Between the ages of 40-60 years at the time of surgery.
2. Radiographic evidence of mild to moderate hip OA (Tönnis Gr 0 with MRI chondral wear, Tönnis Gr 1 and 2).
3. Patients must have completed ≥3 months of non-operative management with ongoing symptoms.

Exclusion criteria:

1. Advanced OA, defined as \<2 mm joint space (Tönnis Gr 3) or those with acetabular or femoral head cysts.
2. Patients who are pregnant or may become pregnant around the time of surgery.
3. Prior arthroplasty of the contralateral hip.
4. Current or prior hip dysplasia (defined by a lateral centre edge angle of \<20 degrees).
5. Acetabular protrusio or coxa profunda, making arthroscopic access unsafe/unfeasible.
AMNIODERM+ Medical Device Clinical Study

This is retrospectively-prospective clinical trial with medical device AMNIODERM+ intended for the non-healing wounds. Retrospective data will contain information about the subject's history and wound treatment by SoC. Prospective data will contain information about wound treatment by AMNIODERM+®.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females over 18 years of age
2. Type 1 or Type 2 diabetes mellitus
3. Presence of a diabetic neuropathic or neuroischemic wound, anywhere on the leg, that has not healed at least 20% after the 6 weeks of the standard of care (SoC)
4. History of an evaluable defect ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion
5. Size of a wound to be evaluated 2 to 16 cm2
6. Wound treatment can be provided either on an inpatient or outpatient basis, based on the doctor's decision
7. The subject agrees to periodic visits to the clinical trial site during their participation in the clinical trial
8. The subject is able to understand the clinical trial information
9. Signed informed consent form
10. Data on previous wound care are available in the subject medical documentation

Exclusion Criteria:

1. Necrotic wound requiring surgical treatment
2. Pregnancy or breastfeeding
3. Venous etiology of ulceration
4. Burns or chemical burns
5. Clinical manifestations of systemic infection
6. Undermined wound edges
7. The wound involves deeper structures (bone, tendons, joints)
8. Inadequately controlled diabetes mellitus with HbA1c \> 12 % (DCCT) diabetes mellitus
9. Renal insufficiency with eGF \< 30ml/min/1.73m2
10. Infected ulceration either Stage ≥2 according to EWMA Position Document (2006) (Appendix II) or with CRP \>10
11. Topical treatment with any growth factor-based products
Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer

The purpose of this study is to determine \[for patients with previously treated well-differentiated thyroid cancer and evidence of residual disease based on serum thyroglobulin (Tg) level\] whether positron emission tomography-computed tomography (PET-CT) fusion scanning performed after recombinant thyroid-stimulating hormone (TSH) (rTSH, thyrotropin alfa for injection) will be more sensitive for the detection of disease sites than PET-CT scanning without rTSH. The study will also determine if this information will significantly alter the therapeutic approach in some patients.

PET/CT was performed before (basal PET) and 24 - 48 h after rhTSH administration (rhTSH-PET) in 63 patients (52 papillary and 11 follicular thyroid cancers). Images were blindly analyzed by two readers. The proposed treatment plan was prospectively assessed before basal PET, after basal PET, and again after rhTSH-PET.

Eligibility Criteria:
Inclusion Criteria:

* Adults (aged ≥ 18 years) with history of treated well-differentiated epithelial thyroid carcinoma (papillary, follicular or Hurthle cell), for which total or near total thyroidectomy plus postoperative radioiodine remnant ablation with 131-I has either been performed or found to be unnecessary by radioiodine imaging after TSH stimulation.
* Serum thyroglobulin (Tg) concentration ≥ 10 ng/mL (in the absence of interfering Tg autoantibodies).
* No findings of a "qualifying" radioiodine whole body scan that are sufficient to localize the disease suspected on the basis of the serum Tg.
* Inconclusive disease localization despite clinical assessment, cervical sonography, CT or magnetic resonance (MR) of the chest, and when appropriate other imaging and biopsy procedures. Patients must have no more than three foci of known or suspected extra-cervical metastasis.
* Must be in stable medical condition.
* Must be able to fully understand the protocol and be compliant with instructions.

Exclusion Criteria:

* Diabetes mellitus, due to interference with fluorodeoxyglucose (FDG) PET scanning.
* Claustrophobia, inability to lay supine, or other factors preventing cooperation with scanning procedures.
* Withdrawal of thyroid hormone or rTSH administration within the preceding month.
* Presence of circulating Tg autoantibodies interfering with serum Tg measurement.
* Women who are pregnant or breastfeeding
Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder

Study ITI-007-037 is a Phase 1b, open-label study to evaluate the safety, tolerability, and PK of lumateperone long-acting injectable (LAI) formulations after a single intramuscular injection in patients with stale schizophrenia or schizoaffective disorder.


Eligibility Criteria:
Main Inclusion Criteria:

* Male or female patients between 18 and 55 years of age, inclusive;
* Clinical diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
* Clinically stable and free from acute exacerbation of psychosis for at least 3 months prior to Screening;
* Clinical Global Impression - Severity (CGI-S) score ≤ 3 at Screening and prior to dosing on Day 1;
* Body mass index (BMI) between 18.0 and 38.0 kg/m2, inclusive at Screening, and a minimum body weight of 50 kg at Screening.

Main Exclusion Criteria:

* History of psychiatric condition other than schizophrenia that, in the Investigator's opinion, may be detrimental to participation in the study;
* Any suicidal ideation or wish to be dead within the past 6 months of Screening, any suicide attempt within the past 2 years prior to Screening, or any current concern for the patient's safety based on the Columbia-Suicide Severity Rating Scale (C-SSRS) (excluding self-injurious, non-suicidal behavior), and/or Investigator assessment that the patient is a safety risk to him/herself or others;
* Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables;
* Has a QT interval corrected for heart rate using Fridericia formula \> 450 msec in males or \> 470 msec in females, or evidence of clinically significant bundle branch blocks on ECG at Screening.