cyrilzakka/clinical-trials huggingface dataset:
Work-related MusculoSkeletal Disorders Questionnaire

Development and validation of a multi-factor and self-perceived risk assessment questionnaire, specifically referred to WMSDs-related pain and risk factors

The World Health Organization (WHO) has defined a WMSD as one musculoskeletal disorder (MSD) that results from a number of factors, and where the work environment and the performance of the work contribute significantly, but in varying magnitude, to the causation of the disease. The term MSD denotes health problems of the musculoskeletal system, i.e. muscles, tendons, the skeleton, cartilage, the vascular system, ligaments and nerves; ranging from light and transitory disorders to disabling injuries and permanent disability, with the loss of employment. WMSDs are in general not caused by one specific, but by multiple risk factors. These include physical (e.g. manual handling of loads, working in awkward postures, repetitive work and working at high speed, exposure to vibrations) as well as psychosocial (work stress, pain believes, sleep disturbances) factors. Consequently, a holistic preventive approach is currently needed. In order to tackle WMSDs, three different levels of prevention can be used to categorise these strategies: i) primary prevention includes the risk assessment process and technical/ergonomic, organisational and person-oriented interventions; ii) secondary prevention involves the identification and health monitoring of workers at risk; and iii) tertiary prevention comprises return-to-work actions.

The answer to the WMSDs problems in companies is holistic prevention, taking into account multifactorial risks for every individual, in order to propose a tailored educational program to every worker need

The study aims to develop and validate a multi-factor and self-perceived risk assessment questionnaire, specifically referred to WMSDs-related pain and risk factors

Gathering information and collecting data on the target population and WMSDs related risk factors:

* Basic characteristics of the target populations (e.g. age, sex, work conditions etc.)
* Potential work-related risk factors (e.g. repetitive motion, static posture, etc.)
* Which of WMSDs affect more the target populations (e.g. back pain, neck pain, upper limb pain, etc.)
* Potential effects of these and related domains (quality of life, pain, number of days of absence from work etc.)

Eligibility Criteria:
Inclusion Criteria:

* Understanding of the Italian language
* Worker of the IRCCS Istituto Ortopedico Galeazzi

Exclusion Criteria:

- Previous surgery for musculoskeletal disorders
Project Harmony 2.0: Relationship Education for Couples

Project Harmony directly addresses prioritized areas identified by Administration of Children and Families, emphasizing healthy marriage promotion activities and career advancement opportunities for adults. Included in service provisions are elements of: \[a\] marriage and relationship education/skills, \[b\] marriage enhancement, \[c\] divorce reduction and \[d\] job and career advancement. The targeted service population for Project Harmony includes married/committed couples in the greater Orlando metro area.

The primary program consists of 12 hours of relationship education. The investigators seek to conduct an impact evaluation utilizing a randomized control trial (RCT) to compare outcomes of couples enrolled in either face to face relationship education or web-based relationship education to assess the impact of program structure on outcomes. By offering both face to face and online versions of evidenced based curricula, the investigators are directly addressing requests from ongoing needs assessments of our targeted population. The project is designed for couples 18 years and older; all participants in the face-to-face group will receive the Prevention and Relationship Education Program (PREP) 8.0 + Career Pathways Program (CPP) curricula whereas couples in the online group will receive the OurRelationship Intervention + CPP curricula.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years older and be in a committed relationship, must attend with partners

Exclusion Criteria:

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Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings.

The transobturator tension-free vaginal tape (TOT) procedure has demonstrated high cure rates comparable to those obtained by retropubic suburethral tape, becoming the first line treatment for stress urinary incontinence (SUI) in many cases. The TOT procedure is not exempt from complications such as bleeding, bladder injuries and pain in the thigh/groin. In addition it is commonly performed under general or regional anesthesia1-3. The single-incision mini-slings (SIMS) were developed to reduce the risk of complications by avoiding the blind passage of the trocars through the obturator space. In addition, the use of SIMS could enable surgeons to perform the procedure truly under local anesthesia.

Different devices for SIMS procedure are available. However, the evidence about their efficacy is controversial4-7. The main limitation of these devices could be the predetermined length of the mesh and the weakness on its fixation. The design of the SIMS Ajust® allows adjusting the length of the sling to each individual woman and provides a robust fixation into the obturator membrane. Recent prospective studies on the efficacy and safety of the sling Ajust® have obtained promising results8,9. Even so, the NICE guidelines advise to use SIMS in the context of research studies10.

The objective of this study is to establish if the effectiveness of the SIMS Ajust® is non-inferior to that of a standard TOT, as well as to compare the comorbidity of both procedures. Owing to the new appearance and fast evolution of these procedures, randomized comparative studies with SIMS are required in order to determine its place in the treatment of SUI.


Eligibility Criteria:
Inclusion Criteria:

* Stress urinary incontinence with urethral hypermobility.

Exclusion Criteria:

* Incapacity to understand the information or give their consent.
* Previous anti-incontinence surgery with slings.
* Urethral hypomobility (Q-tip test \<30º).
* Low pressure urethra (MUCP \< 20cmH2O).
* Detrusor overactivity.
Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia

This study will evaluate the overall remission rate of treatment with vosaroxin (formerly voreloxin) Injection in patients at least 60 years of age with previously untreated AML

Other objectives of this study include:

1. Assess the safety of treatment with vosaroxin, including the 30 and 60 day all-cause mortality
2. Assess leukemia free survival (LFS), event-free survival (EFS), overall survival (OS), and duration of remission (DR).
3. Characterize the pharmacokinetic (PK) profile of vosaroxin in this patient population.
4. Evaluate potential stratification biomarkers by evaluating DNA-damage and apoptotic pathways in bone marrow samples before and after treatment with vosaroxin

Eligibility Criteria:
Key Inclusion Criteria:

1. At least 60 years of age and diagnosis of previously untreated AML (either de novo or from an antecedent hematologic disorder or therapy related AML)
2. At least 20% blasts by BM biopsy or aspirate
3. ECOG performance status of 0,1,or 2
4. Adequate cardiac, renal and liver function

Key Exclusion Criteria:

1. Uncontrolled DIC
2. Active central nervous system involvement by AML
3. Requiring hemodialysis or peritoneal dialysis
4. Some prior history of heart attack or stroke (depending on how long ago the event occurred)
Links Between Perception of Temporal Order Judgment and Causality in Schizophrenia

People with schizophrenia show disturbances in the perception of time. Among these alterations are the perturbations of the temporal order judgment. They are characterized by the fact that, as opposed to the general population, people with schizophrenia require a longer time interval between two successive stimuli to estimate which of the two events appeared first. If these alterations are now well documented, their consequences remain little explored. Among these consequences could however appear distortions of the judgment of causality (likely to underlie certain delusional interpretations) as well as a distressing experience of loss of the continuity of the lived experience (that could contribute to the alterations basic of self-awareness).

The objective of our work lies in the study of the links between temporal sequencing, subjective perception of time and causality.

To carry out this work, the investigators will rely on an experimental paradigm (derived from Michotte's paradigm) which makes it possible to explore the links between temporal sequencing and perception of causality, validated in the normal subject. subjective consequences of these alterations will be explored using a phenomenological-inspired clinical scale (EAWE time-scale items)

Eligibility Criteria:
Inclusion Criteria:

Subjects with schizophrenia:

* Age from 18 to 45 years
* Diagnosis of schizophrenia according to DSM V criteria
* French mother tongue
* Psychotropic treatment unchanged during the month preceding the inclusion
* Stable symptomatology
* Normal or corrected visual acuity (\> 0.8 at Snellen scale) and normal color vision
* Patients who gave informed consent to participate in the study

Control subjects (healthy volunteers):

* Age from 18 to 45 years
* Absence of neurological and psychiatric disorders
* French mother tongue

Exclusion Criteria:

* Recent addiction and abuse of cannabis or any other substance (according to DSM V criteria)
* Neurological disorders of vascular, infectious or neurodegenerative origin
* Taking somatic drugs with a cerebral or mental impact (eg corticosteroids)
* Disabling sensory disturbances, and in particular visual acuity
* Participation in a Neuro Cognitive Remediation Program
* Schizophrenia resistant to neuroleptic treatments
* Persons protected by law (pregnant women, minors, major under guardianship ...)
Prevention of Intrusive Memories and Posttraumatic Stress Symptoms After Emergency Cesarean Section

This pilot study aims to investigate the effects of a brief computerized intervention (the computer game "Tetris") on intrusive memories and other posttraumatic stress symptoms following an emergency cesarean section. Patients who have undergone an emergency cesarian section will be randomly allocated to either the brief computerized intervention or usual care within the first 6 hours following the operation. Participants will be followed up at one week and one month. It is predicted that participants given the brief computerized intervention will develop fewer intrusive memories and less severe clinical symptoms than those who are not. This will inform the potential future development of a simple computerized intervention to prevent distressing psychological symptoms after a traumatic event such as an emergency cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Female, aged 18+ years
* Had emergency caesarean section within the past 6 hours
* Have given birth to a live baby at ≥ 37 weeks gestation

Exclusion Criteria:

* Do not speak French sufficiently well to participate in assessments
* Have established intellectual disability or psychotic illness
* Baby was transferred to intensive care unit after the birth
T Regulatory Cells IN LUPUS NEPHRITIS

* To study the role FoxP3-positive T regulatory cells in the pathogenesis of Lupus Nephritis, and determine the factors associated with levels of T regs .
* To compare the functional capacity of T regs in LN and in normal individuals.

Lupus Nephritis (LN) encompasses a group of glomerulonephrites, that occur in association with systemic lupus erythematosus (SLE). The mainstream theory that it is an immune disease resulting from loss of immune tolerance against body cells. The regulatory T cells (T regs ) are a subpopulation of immune cells that maintain tolerance to self-antigens and suppress autoimmune diseases. The main marker of Tregs is FoxP3 (forkhead box protein 3) positivity. Moreover, It has been suggested that functional capacity of Tregs is also compromised in autoimmune diseases. Studying the role of T regs in LN is a promising field that can help tailor current immune therapy and develop new treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

adults both genders clinical diagnosis of lupus nephritis

Exclusion Criteria:

patients diagnosed with other renal pathologies, e.g. diabetic kidney disease
Chidamide Prevents Recurrence of High-risk AML After Allo-HSCT

The goal of this phase I/II clinical trial is to test in high-risk acute myeloid leukemia (AML) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:

• The efficacy and safety of chidamide maintenance therapy in reducing the recurrence rate and GVHD incidence in high-risk AML patients after allo-HSCT.

Participants will take oral chidamide (Epidaza) until 180 days after allo-HSCT.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old and ≤ 65 years old when signing the Informed Consent Form (ICF);
2. KPS score \> 60 or ECOG score 0-2;
3. The expected survival period \> 3 months;
4. Received allo-HSCT and achieved complete remission (CR);
5. Reach the standard of hematopoietic reconstitution (neutrophil count ≥ 0.5×10\^9/L for 3 consecutive days without G-CSF application, platelet count ≥ 20×10\^9/L for 7 consecutive days without platelet transfusion, Hb ≥ 80 g /L without red blood cell transfusion); and neutrophil count ≥ 1.5×10\^9/L, platelet count ≥ 50×10\^9/L within 45 days after transplantation;
6. No central nervous system involvement or clinical symptoms after transplantation;
7. Those who have no serious functional damage to important organs of the body;
8. Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;
9. Females of childbearing age must afford a serum pregnancy test within 7 days before the first dose, and the result should be negative; female participants and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose.

Exclusion Criteria:

1. Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;
2. Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;
3. Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study;
4. Poor graft function (PGF) occurred after allo-HSCT;
5. Combined with other malignant tumors and require treatment;
6. Active GVHD;
7. Have a history of allergy to Chidamide;
8. Pregnant or lactating females;
9. Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome;
10. Patients with active chronic hepatitis B or active hepatitis C;
11. History of prolonged QT syndrome;
12. Patients considered by other researchers to be unsuitable for this study.
Coarctation Of the Aorta Stent Trial

The purpose of this study is to determine whether Cheatham Platinum bare metal stents are safe and effective in the treatment of native and recurrent aortic coarctation in selected children, adolescents and adults.

The goals of this study are to provide information that will support labeling of both the CP bare metal and covered stents to treat native and recurrent aortic coarctation in selected children, adolescents and adults. The investigation will have two phases: Phase One will examine the safety and efficacy of the bare metal stent, and will collect information about the covered stent when used as rescue therapy for aortic injuries occurring during bare metal stent procedures.

The aims of the Phase One study are to assess the use of the CP bare metal stent to:

1. provide a reduction equivalent to surgery in arm-leg systolic cuff blood pressure gradient 12 months after dilation and stent implantation, in comparison to the pre-dilation gradient;
2. accomplish gradient relief with a shorter number of days in hospital than surgery;
3. accomplish gradient relief with a rate of occurrence of serious procedure-related adverse events occurring within 30 days of dilation that is equivalent to surgery; and
4. accomplish gradient relief with a rate of occurrence of post-procedural paradoxical hypertension that is lower than surgery.

Eligibility Criteria:
Inclusion Criteria:

* Native or recurrent aortic coarctation
* Weight greater than or equal to 35 kg
* Noninvasive, arm-leg cuff systolic blood pressure difference or catheter measured systolic coarctation gradient greater than or equal to 20 mmHg

Exclusion Criteria:

* Age \> 60 years
* Connective tissue disorders, including Marfan syndrome and other genetic syndromes such as Turner syndrome and Noonan syndrome
* Inflammatory aortitis
* Bloodstream infection, including endocarditis
* Pregnancy
* Aortic aneurysm
* Prior stent placement
* Adults lacking capacity to consent
* Foster children and/or wards of the court
A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation

The purpose of this study is to evaluate the safety and tolerability of INCB099280 in combination with adagrasib and to establish the MTD or identify RDE(s) for the combination of INCB099280 and adagrasib.


Eligibility Criteria:
Inclusion Criteria:

* KRASG12C-mutated solid malignancy determined by a sponsor-approved assay using either tumor tissue or ctDNA.
* Histologically confirmed malignant solid tumor with locally advanced and/or metastatic disease.

  * Only participants with NSCLC will be enrolled into Part 2 Cohort A.
  * Only participants with CRC will be enrolled into Part 2 Cohort B.
* Part 1: Disease progression on or after at least 1 prior systemic treatment.
* Part 2 (Cohort A - NSCLC): Received an anti-PD-(L)1-containing regimen and platinum based chemotherapy regimen either concurrently or sequentially
* Part 2 (Cohort B - CRC): Received at least 1 line of systemic therapy that includes the combination of fluoropyrimidine-based chemotherapy (in combination with oxaliplatin and/or irinotecan) and either a vascular endothelial growth factor-targeting monoclonal antibody or an anti-epidermal growth factor receptor monoclonal antibody (if RAS wild type). Participants with MSI-H/dMMR CRC must also have received a prior immune checkpoint inhibitor approved for this indication.
* Measurable disease according to RECIST v1.1.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Estimated life expectancy \> 3 months.
* Willingness to avoid pregnancy.

Exclusion Criteria:

* Known additional malignancy that is progressing or requires active treatment.
* Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease.
* Part 2 only: Prior treatment with an approved or investigational agent targeting KRASG12C.
* Toxicity from prior therapy that has not recovered to protocol-defined limits.
* Received thoracic radiation of \> 30 Gy within 6 months of the first dose of study treatment.
* Participation in another interventional clinical study.
* History or evidence of interstitial lung disease, including noninfectious pneumonitis.
* Presence of gastrointestinal condition that may affect drug absorption.
* Active autoimmune disease requiring systemic treatment, including corticosteroids exceeding a daily dose of 10 mg of prednisone or equivalent.
* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy exceeding a daily dose of 10 mg of prednisone or equivalent.
* Active infection requiring systemic therapy.
* History of organ transplantation, including allogeneic stem cell transplantation.
* Receipt of systemic antibiotics within 28 days of the first dose of study treatment.
* Probiotic usage is prohibited during screening and throughout the study treatment period.
* Received a live vaccine within 28 days of the planned start of study drug.
* Laboratory values outside the Protocol-defined ranges.

Other protocol-defined Inclusion/Exclusion Criteria may apply.
Investigating the Effects of Probiotic Yoghurt on Reducing the Levels of Aflatoxin B1 Toxin Among the School Children in Eastern Kenya

We hypothesis that intake of probiotic yogurt reduces absorption of AFB1 in the gut and subsequently reduce AFM1 and aflatoxins adduct, the biomarker in human urine and blood respectively. We have demonstrated that yogurt made using weisella cibiria NN20 isolated from fermented dough made from pearl millet in eastern part of Kenya sequestered upto 42% of aflatoxin available in our invitro texts.

In both the developed and developing world, humans are continuously exposed to a plethora of environmental toxins, both in nature and as the result of anthropomorphic activity. Aflatoxin B1, one such example, is one of the most toxic substances known to man, but it is all around us and can be found in our food, and especially cereals which form over 70% of Kenya staple food.

Limiting cereal intake is not always easy, as it is one of the most plentiful and nutritious food sources in Kenya and is the primary source of dietary energy for many societies in Kenya.

We have recently discovered a novel property of lactic acid bacteria in which aflatoxin B1, is sequestered and/or detoxified by the microbes causing reduction of toxin levels in their environment. We hypothesize that sequestration of toxins in the gastrointestinal tract by ingested probiotic bacteria will cause a reduction in host toxin uptake by carrying them out of the body in the feces preventing their passage from the gastrointestinal tract into the host. Our primary objective is to test our hypothesis that consumption of a probiotic yogurt will result in decreased levels of Aflatoxin B1 in a group of school-aged children. The secondary objective is to determine the baseline levels of aflatoxin B1 in a group of school-aged children in eastern Kenya. The tertiary objective is to establish the baseline gastrointestinal microbiota of these children and how consumption of a probiotic yogurt affects the microbiota.

A class of 60 pupils from Identified primary school, approximately 7 years old, will be randomized to two groups matching ages, sex and weight. They will receive a daily 100g serving of the probiotic yogurt and a portion of local milk in between the trial period. Before the first administration of the yogurt/milk, blood, urine and feces will be collected. After 30 days; biological specimens will again be collected to observe potential reductions in toxin levels.

Eligibility Criteria:
Inclusion Criteria:Participants will be recruited from an identified primary school and parental/ legal guardian consent will be required as well as assent from the child. The primary school has been identified with the help of Ministry of agriculture home economics extension officer. The criterion of selecting the primary school is accessibility from Embu ATC where yogurt will be produced and the area which is prone to aflatoxin B1. Children between the ages of 6 and 10 will be enrolled in the study.

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Exclusion Criteria:Children would be excluded if they are already consuming fermented milk products or are lactose intolerant.

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