cyrilzakka/clinical-trials huggingface dataset:
Hierarchy of Effects of Laboratory Markers and Their Interaction With Comorbidity Concerning Outcome and Personalized Treatment of Trauma Patients in Emergency Care and Rehabilitation

At least ten percent of trauma patients suffer from any sort of complication. The study aims to identify a risk factor profile to early identify trauma patients at risk.

Trauma patients suffer from a high risk of complications that ranges from soft tissue complications, surgical site infection till bone non-union. Comorbidities are often know to be associated with complications. Also certain blood markers could be identified to be an indicator.

However, certain risk factors have only been investigated in small trauma cohorts so far. This study is a prospective multi center cohort trail that aims to collect all clinical data, comorbidities, medication, blood markers in trauma patients after long bone fractures. In a 6 months and one year follow up patients with complications will be identified. Methods of machine learning will help to identify a risk factor profile for certain groups of patients with complications.

The aim of the study is to early identify patients at risk for a complication after trauma according to their blood marker, clinical, comorbidity and medication profile.

Eligibility Criteria:
Inclusion Criteria:

* acute long bone fracture (humerus, ulna, radius, femur, tibia) with surgical treatment

Exclusion Criteria:

* associated severe injury (ISS \> 16)
* associated traumatic brain injury
* associated traumatic spine injury
* dementia
Validity of Different Prognostic Models Assessing 1 Year Survival After Liver Transplantation

Validity of MELD vs MELD XI in assessing 1 year survival after living donor liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* liver transplantation recipients

Exclusion Criteria:

* Patient refusal
Validity of Profile Fitness Mapping Low Back Questionnaire

As patients improve on one parametric result, the results on the other parametric may worsen, but the total score may not be affected. For this reason, it would be useful to make measurements that evaluate all the parameters of the patients. Thus, it would be more advantageous to score both pain and symptoms separately, as well as activity limitations. Therefore, neck specific surveys are needed to meet this need.

For this reason, this study was planned to determine the validity of the questionnaire named "Profile Fitness Mapping Low Back Questionnaire" in patients with low back pain.

The translation of the original version of "Profile Fitness Mapping Low Back Questionnaire" to Turkish will be translated by two independent professional translators. Afterwards, a person without a medical history and a native English speaker will be translated into English again. Once the translation stages are complete, the translators will be brought together to discuss the two versions of the questionnaire. Then the final state will be translated into the main language of the questionnaire and the compliance will be checked.

First of all, people who have been suffering from low back pain for at least six months will complete the "Profile Fitness Mapping Low Back Questionnaire", "Oswestry Disability Index" and "SF-36 health related quality of life questionnaire".

Seven days after the questionnaire, the "Profile Fitness Mapping Low Back Questionnaire" will be completed again.

Eligibility Criteria:
Inclusion Criteria:

* low back pain for more than six months during activity or rest
* Having a problem with low back based on clinical examination and story

Exclusion Criteria:

* Having neurological problems
* Having vestibular or cerebellar problems
The Evaluations of Cardiovascular Changes in Long-term Treated HIV-infected Individuals

The present study aims to evaluate the cardiovascular changes in long-term virologically controlled HIV patients. All the participants have been treated and have been undetected for at least five years. Vascular ultrasound and echo will be carried out at 0, 24, 48 and 96 weeks of follow-up.

Previous studies have indicated that chronic HIV infection has resulted the diastolic cardiac dysfunction. In this study, 500 long-term virologically controlled HIV-infected individuals will be followed for two years, and evaluated at 0, 24, 48 and 96 weeks of follow-up. At each visiting point, ultrasound evaluation of carotid and vertebral arteries and the heart function will be carried out and compared.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Willingness and availability to engage in study activities for the duration of the study
* Age between 18-65
* Documented HIV-1 infection (confirmed by Western blot)
* regular ART treated for over 240 weeks
* HIV-RNA \< 200 cp/ml

Exclusion Criteria:

* Pregnancy or breastfeeding or anticipated pregnancy in two years
* History of AIDS-defining illness
* Virological failure during the ART ( Definition of virolgocial failure: plasma HIV-RNA \> 200 cp/ml upon continuous HARRT)
* Hemoglobin \< 9g/dl；or peripheral white blood cell counts \< 2000/μl；or neutrophil counts \< 1000 /μl；or platelet count \< 75,000/μl；
* Liver disease (transaminase and alkaline phosphatase levels more than three times the upper limit of the normal range (ULN), bilirubin level more than 2.5 times the ULN)
* Chronic kidney disease (serum creatinine level more than 1.5 times the ULN)
* Patients with a history of injection drug usage
* Patients with a history of mental disorders
Kogito: App to Reduce Perinatal Psychosocial Stress

The purpose of this research study is to test the efectivness of the remote solution for psychosocial stress in pregnant women and postpartum women. Based on the connection of know-how in the field of social sciences and humanities (psychology, volunteer community and peer work with target group) and technological know-how (software design and development), investigators developed an interactive intervention software (Kogito app) to reduce psychosocial stress in the target group.

This study examine the potential of Kogito app in the delivery of mental and social support care to pregnant and postpartum women using psychometric methods.

A) Clinical efficacy of Kogito app in a clinical cohort. Sample: pregnant or postpartum women with who are being treated in the psychiatric perinatal outpatient clinic of the National Institute of Mental Health, Czech Republic. The app will be tested as a add-on method of care.

Intervention group: Kogito app is added to the usual care Control group: usual care Randomization: 1:1

Participants in the intervention group will be asked to do following things:

1. complete survey questions at entrance into the study
2. use the kogito app
3. complete survey questions one month after study entrance

Participants in the control group will be asked to do following things:

1. complete survey questions at entrance into the study
2. complete survey questions one month after study entrance

B) Clinical efficacy of the Kogito app in a general cohort. The app will be offered free of charge to users from the population of pregnant and postpartum women for the duration of the study.

Recruitment method: advertisements on social networks of National Institute of Mental Health and other public media in Czechia Sample: pregnant or postpartum women from general population in Czechia. The app will be tested using the waiting list as a control condition.

Intervention group: Kogito app Control group: one month waiting list Randomization: 1:1

Participants in the intervention group will be asked to do following things:

1. complete survey questions at entrance into the study
2. use the kogito app
3. complete survey questions one month after study entrance

Participants in the control group will be asked to do following things:

1. complete survey questions at entrance into the study
2. complete survey questions one month after study entrance

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* pregnant women to 1 year after childbirth
* speak, read, and understand Czech
* signing of informed consent to the study and the GDPR form
* participant owns a smart phone and has access to the internet access plus for the clinical group:
* participant is undergoing the usual psychiatric care of the perinatal outpatient clinic of the National Institute of Mental Health, Czechia.

Exclusion Criteria:

* none
EPIC-P Intervention

This non-randomized, open-label study will address the following research aims in People who inject drugs (PWID):

* To assess the feasibility and acceptability of the Expanding PrEP Implementation in Communities of PWID (EPIC-P) intervention among high-risk PWID.
* To determine the preliminary efficacy of the EPIC-P intervention in terms of increasing adherence to PrEP and primary HIV prevention among high-risk PWID.

A non-randomized, open-label design will be utilized to test the feasibility, acceptability, and preliminary efficacy of the Expanding PrEP Implementation in Communities of PWID (EPIC-P) intervention among high-risk people who inject drugs (PWID) with opioid dependence (N=100). Since the aim of this pilot study is to establish whether the EPIC-P intervention is feasible/acceptable among at-risk PWID in a community-based setting, proposed is a non-comparative design. With the hopes to target PWID who are not linked with existing harm reduction services, proposed is to recruit participants using respondent driven sampling (RDS), a chain referral method with demonstrated success in recruiting hard-to-reach populations. Initial RDS participants, called "seeds," will be carefully recruited from the community where the study team leadership have built a well-established relationship. Participants enrolled in the study will be assessed at baseline and will be followed for 9 months (with follow-up assessments at 3- and 6-months) by trained research assistants. Importantly, structured interviews will be conducted at follow-up visits to examine the barriers and facilitators and feedback about optimal implementation of the EPIC-P intervention.

Eligibility Criteria:
Inclusion Criteria:

* Residing in the Greater New Haven area;
* Confirmed HIV-negative;
* Reporting injection drug use (past 3 months) with substantial ongoing risk for HIV acquisition;
* Started on PrEP (within the last week).

Exclusion Criteria:

* Not on PrEP;
* Not available during the full duration of the study;
* Cannot speak English;
* Unable to provide consent;
* Anyone actively suicidal, homicidal, or psychotic as assessed by trained research staff under the supervision of a consultant that is a licensed clinical psychologist.
TR(ACE) Assay Clinical Specimen Study

The TR(ACE) Assay is a quantitative in vitro diagnostic test run on the TR(ACE) Instrument intended for the measurement of high molecular weight human DNA from plasma as an aid to monitoring disease progression or response to therapy or recurrent or residual disease.

This study is to establish the clinical performance of the TR(ACE) Assay. Deltas of serial TR(ACE) Assay measurements will be compared to the standard of care physician clinical assessment and RECIST 1.1 criteria evaluation relative to the previous visit. Significant changes in serial TR(ACE) Assay measurements are hypothesized to correlate with disease progression or response.

Eligibility Criteria:
Inclusion Criteria:

* Non-small cell lung: Male or Female Adult patient \>= 21 years old
* Breast only: Female Adult patient \>= 21 years old
* Previously diagnosed with one of the following cancers:

Breast or Non-small Cell Lung

* Cancer has progressed to at least Stage III or higher for lung cancer or,
* Cancer has progressed to stage IV (metastatic) breast cancer
* Participating in standard of care cancer therapy requiring frequent treatments, typically intravenous chemotherapy visits (or as determined by the standard of care for the particular cancer assessed), of a minimum of three (3) treatment visits planned in 9 months from date of enrollment where a clinical assessment will be conducted

Exclusion Criteria:

* Physician assessment that obtaining two extra whole blood specimens with minimum volume of 5 mL per treatment visit is contraindicated
* Stage I and II Non-small Cell Lung Cancer
* Stage I through III breast cancer
* Pregnant or planning to become pregnant during the course of the study
* Unable to obtain informed consent from subject or their legal representative
* Life expectancy is less than 9 months
* Presence of one or more of the following other chronic diseases
* Another type of cancer except for non-melanomatous skin tumors
* Autoimmune disease requiring DMARDS or Biologics
* Infectious disease requiring prolonged intravenous antibiotics or hospitalization
* Renal disease specifically those in End Stage Renal Failure
* Recent (\< 3 weeks) major trauma or major surgical procedure(s) or radiation therapy prior to enrollment in the study
* Recent (\< 2 months) major occlusive arterial event such as MI or CVA prior to enrollment in the study
Non Verbal Communication and Dementia

Cognitive impairements in Alzheimer's and apparented disorders may lead to the decreased engagement in activities, spetially in moderate and advanced stages of evolution. The lack of stimulation for people with dementia is associated with the risk of challenging behaviors, depressives symptoms, sleeping disorders or faster cognitive deterioration. Those challenges may lead to the increased administration of pharmacological treatments, though the risks of neurleptics use in this population are currently known. In this context, non-pharacological interventions hold a significant place in dementia care.

This research focuses on cognitve stimulation activities. More precisly, our study compares two aproaches using the reading groups. The first type (" usual " reading group) is based on the principle of stimulating those cognitive functions which dicreases with the evolution of dementia. The second (Montessori reading group) approach relies on the idea to use preserved capacities in order to compensate the cognitive impariments.

The aim of our study is to compare the impact of these two non-pharmalogical interventions on non-verbal communication. The collected datas will help analyzing and understanding the internal and behavioral states of people living with dementia. Our study will also extend relfexions about cognitive stimulation groups in care institutions.


Eligibility Criteria:
Inclusion Criteria:

* 65 years and more
* Diagnosed with Alzheimer's disease and/or related disease (frontotemporal dementia, vascular dementia, multiple etiologies dementia, Lewy's Body dementia) according to DSM-IV-TR criteria (2005)
* MMSE ≤ 15
* Good reading ability assessed using Montessori Reading Test (ability to read text written in Arial 40)
* The written agreement of the patient, primary caregiver or curator or or guardian to participate in the study and to make a film about the participant.
* Patient receiving social security benefits

Exclusion Criteria:

* Previously known associated psychotic disorder
* Deafness not compensated by hearing aid
* Extrapyramidal syndrome diagnosed by a practitioner
* Tendency to daytime sleepiness (Score 6 on the Karolinska somnolence scale)
* Patient with disruptive behaviour disorders such as screaming and/or motor agitation likely to affect the smooth running of the workshop
* Subject deprived of liberty by judicial or administrative decision.
* Subject under exclusion for another research protocol.
* Presence of motor stereotypes
* Patient receiving State Medical Assistance (AME)
* Patient under Justice Safeguard
* If the patient or guardian cannot be given informed information
Functional Outcome Anterior Cruciate Ligament Reconstruction

The purpose of this study is to compare hop performance and jump landing strategy in soccer players with higher level sports activities after ACLR using either BPTB or STG and controls.

The choice of graft for anterior cruciate ligament reconstruction (ACLR) remains controversial. Despite the need for outcome studies comparing bone-patellar tendon-bone (BPTB) with semitendinosus and gracilis tendon (STG), few studies have evaluated functional outcomes. The objective of the current study was to compare hop performance and jump landing strategy in soccer players with higher level sports activities after ACLR using either BPTB or STG and controls.

Eligibility Criteria:
Inclusion Criteria:

* ACLR and controls.

Exclusion Criteria:

* Musculoskeletal injuries
Gait Analysis by Induced Disorientation in a VR Environment

The aim of the study is to investigate whether the effect of disorientation on physical motion and gait among dementia patients, can be reliably measured in a laboratory environment, by means of a virtual reality (VR) experimental setup.

Challenges in wayfinding and orientation are early symptoms of MCI and dementia. These deficits decrease mobility which again leads to further cognitive decline. In a field study, we developed a pattern recognition model of disorientated behaviour based on accelerometric data. However, it is questionable if phases of disorientation also affect gait parameters. Furthermore, there is growing evidence that impaired cognitive functioning is associated with changes in gait performance, e.g. gait variability, measured in dual-task walking conditions. Increases in heart rate and skin conductance have also been reported during instances of disorientation.

Hence, We implemented a 3D environment of a familiar city centre in the GRAIL, which combines a fully instrumented treadmill with a synchronized VR environment. We record gait parameters through the motion capture system, and accelerometric and physiological data using wearable sensors (movisens), for comparability with the SiNDeM field study. Young and old healthy adults will participate in the first phase of the study, while Mild dementia or MCI patients will participate in the later phases. Phases of disorientation will be induced by changing the virtual environment.We aim to assess gait, accelerometric and physiological parameters during instances of disorientation, using the GRAIL (Gait Real-Time Analysis Interactive Lab, Motekforce Link).

The results will further enable the automatic detection of disorientation based on gait parameters, physiological and accelerometric data. This is necessary for the development of a situation-aware assistive system which supports persons with dementia in autonomous outdoor mobility.

Eligibility Criteria:
Inclusion Criteria:

* Within the required age bracket
* Mobile
* Dementia

Exclusion Criteria:

* Other neurological conditions besides dementia
* Inability to understand task instructions, deaf-mute, blindness
Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.


Eligibility Criteria:
Inclusion Criteria:

* Must have a new diagnosis of multiple myeloma according to IMWG criteria and have received induction +/- consolidation.
* Must have received only one line of therapy and achieved at least a partial response (≥PR) as per IMWG 2016 response criteria (Kumar 2016) without evidence of progression at the time of first treatment dose.
* Must not be intolerant to the starting dose of lenalidomide.
* Must not have received any maintenance therapy.
* Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
* Have clinical laboratory values within prespecified range.

Exclusion Criteria:

* Received any prior BCMA-directed therapy.
* Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells).
* Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.
* Progressed on multiple myeloma therapy at any time prior to screening.
* Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14 days prior to first treatment dose.
* Received a live, attenuated vaccine within 4 weeks before first treatment dose. Non-live vaccines or non-replicating authorized for emergency use (eg. COVID-19) are allowed.
Erythroferrone and Its Impact on Maternal and Neonatal Iron Homeostasis

Erythroferrone (ERFE) is a recently identified iron-regulatory hormone that couples iron homeostasis to erythropoiesis but at this time there are no human data on this hormone in pregnant women and their neonates. The investigators hypothesize that ERFE is a sensitive biomarker of iron deficiency and anemia in pregnancy and neonates, and that it mediates the feedback mechanism to correct iron deficiency and anemia. To address this research gap, the investigators will measure ERFE in maternal serum, umbilical cord serum and placental tissue using an existing biospecimen archive.


Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant volunteers

Exclusion Criteria:

* Hemoglobinopathies
* Pre-existing diabetes
* Malabsorption diseases
* Pregnancy induced hypertension
* Elevated diastolic blood pressure (\>110)
* Previous treatment for lead exposure or elevated childhood lead concentrations.
* Preexisting medical conditions known to impact iron homeostasis
A Study Comparing the Efficacy and Safety of Intracoronary Stenting With or Without Abciximab, an Anti-Platelet Therapy, and Conventional Coronary Angioplasty With Abciximab

The purpose of this study is to compare the effectiveness and safety of intracoronary stenting with or without abciximab, an anti-platelet therapy, and conventional coronary angioplasty with abciximab in patients undergoing percutaneous coronary intervention.

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and effectiveness of intracoronary stenting with or without abciximab, an anti-platelet therapy, and conventional coronary angioplasty with abciximab in patients undergoing percutaneous coronary intervention. Patients will be randomly assigned to one of three treatment groups: coronary angioplasty plus abciximab, intracoronary stent plus abciximab, or intracoronary stent plus placebo. The primary measures of effectiveness will be a 30-day composite, clinical outcome as determined by the number of deaths, myocardial infarctions, or urgent repeat revascularizations. Please see attached results.

Patients will receive one of three different treatments: Coronary angioplasty plus abciximab; Intracoronary stent plus abciximab; or Intracoronary stent plus placebo.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for elective or urgent percutaneous coronary intervention
* Who are suitable candidates for either conventional angioplasty or primary intracoronary stent implantation
* Having a target artery (native or graft) stenosis of \>= 60% (visual estimation)

Exclusion Criteria:

* Patients with acute ST-segment elevation myocardial infarction within the previous 12 hours
* With a planned staged procedure or having an unprotected left main coronary artery stenosis \> 50%
* With active internal bleeding, having a condition that may increase the risk of bleeding, or receiving ongoing treatment with an oral anticoagulant at the time of study entry
* Having had a percutaneous coronary intervention within the previous 3 months or prior intracoronary stent placement in a target vessel
* Having hypertension with systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 100 mm Hg at the time of study entry, or a platelet count \< 100,000/μL at baseline