cyrilzakka/clinical-trials huggingface dataset:
Incidence and Relationship of Positive Preoperative Methicillin Resistant Staphylococcus Aureus (MRSA) Screens and Post-operative Infections

The purpose of this study is to evaluate the prevalence of pre-surgical patients who are MRSA carriers. From an evidence-based practice perspective, findings from this study can be considered in the evaluation of the hospital SOP mandating pre-surgical MRSA screening requirements for patients with scheduled surgeries.

The central hypothesis to be addressed in this study is whether the MRSA colonization and subsequent post-operative infection are the equivalent in these populations.

Design and Methods: Subjects in this study of 975 pre-operative, scheduled surgical patients are in one of the three following groups:

* Group 1 (N=325): Allocation sample of surgical patients required to be MRSA screened per hospital SOP (including patients having a positive MRSA history, orthopedic surgery, undergoing dialysis, or transfer from another hospital, nursing home, skilled nursing facility, or jail).
* Group 2 (N=650): Randomized sample (1:1 ratio) of surgical patients not required to be MRSA screened per hospital SOP, to one of the following two groups:

  * 2a (N=325): MRSA screening; or
  * 2b (N=325): No MRSA screening. All subjects were followed for 30 days post-operatively to determine the incidence of post-operative infection. Treatment, diagnostic, and hospitalization data were collected for patients diagnosed with post-operative infection.

Eligibility Criteria:
Inclusion Criteria:

1. Pre-surgical out patient at ILH
2. Surgical procedure scheduled at least 2 days before surgery
3. Surgery being done at ILH operating room
4. Provision of signed ICF

Exclusion Criteria:

1. Patient 18 years of age or older who is deemed by the hospital incapable of providing Informed Consent
2. Inability to communicate in the English language
Assessment of Three Formulations of the Candidate Vaccine AMA 1 in Healthy Dutch Adult Volunteers

The objective of this study was to evaluate the safety of a candidate malaria vaccine (PfAMA-1) at 3 doses given at monthly intervals of 2 different dosages of AMA-1 (10 μg or 50 μg ) adjuvanted either with alum hydroxide or AS02A or Montanide ISA 720 in healthy adults not previously exposed to the parasite Plasmodium falciparum.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 and \< 45 years healthy volunteers.
* General good health based on history and clinical examination.
* All volunteers have to sign the informed consent form.
* Negative pregnancy test.
* Use of adequate contraception for females up to three months after the third injection (D140).
* Reachable by phone during the whole study period (18 months).

Exclusion Criteria:

* History of malaria or residence in malaria endemic areas within the past six months.
* Positive serology for malaria antigen PfAMA-1
* Previously participated in any malaria vaccine study
* Symptoms, physical signs and laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the study results or compromise the health of the volunteers.
* Any laboratory abnormalities on screened blood samples beyond the normal range, as defined at UMC St Radboud. Positive HIV, HBV or HCV tests.
* Volunteers should not be enrolled in any other clinical trial during the whole trial period.
* Volunteers should not receive chronic medication, especially immunosuppressive agents (steroids, immunomodulating or immunosuppressive drugs) during the three months preceding the screening visit or during the study period.
* Pregnant or lactating women.
* Volunteers unable to give written informed consent.
* Volunteers unable to be closely followed for social, geographic or psychological reasons.
* Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrollment in the study.
* Volunteers should not perform exercise four hours before blood draw and should not donate blood for non study-related purposes during the entire duration of the study.
* Known hypersensitivity to any of the vaccine components (adjuvant or peptide).
* Volunteers are not allowed to receive any vaccination or gammaglobulin during a period three months prior to the first immunization and up to six months after the 3rd immunization. If a vaccination is necessary during this period, the volunteer will be withdrawn from the study.
* Volunteers are not allowed to travel to malaria endemic countries during the study period.
Analysis of Exploring Optimized Sequential Treatment Strategies of Antibody-Drug Conjugates (ADCs) in HER2-Low-Expressing Breast Cancer

This study retrospectively analyzes the clinical data of HER2-low breast cancer (IHC 1+/2+ and FISH-negative) patients treated with sequential antibody-drug conjugates (ADCs). Key variables include patient demographics, tumor characteristics, ADC regimens (e.g., trastuzumab deruxtecan, sacituzumab govitecan), treatment sequencing, survival outcomes, and safety profiles. Genomic data (e.g., HER2 expression dynamics, TROP2 levels) are integrated to explore resistance mechanisms and prognostic biomarkers.mechanisms.

This study aims to investigate the efficacy of different ADC sequential regimens in HER2-low breast cancer patients.

Breast cancer is one of the most common malignancies in women, posing a significant threat to female health. According to current molecular subtypes, breast cancer is classified into hormone receptor-positive, HER2-positive, and triple-negative breast cancer. However, with the development of novel therapeutic strategies such as antibody-drug conjugates (ADCs), increasing attention has been directed toward HER2-low breast cancer (defined as HER2 immunohistochemistry \[IHC\] 1+ or 2+/FISH-negative), which accounts for approximately 60%-70% of breast cancer cases. ADCs can exert potential therapeutic effects in HER2-low breast cancer through the "bystander effect" and have been widely adopted in clinical practice. Nevertheless, the optimal sequential treatment strategy for HER2-low patients remains unclear, with a lack of definitive clinical guidelines and limited understanding of resistance mechanisms.

This study aims to investigate the efficacy of different ADC sequential regimens in HER2-low breast cancer patients and explore potential resistance mechanisms. By conducting a retrospective analysis of clinical data from HER2-low patients treated with sequential ADCs, the investigators will evaluate the therapeutic outcomes and safety profiles of various ADC sequencing approaches. Additionally, integrating genomic profiling with routine clinical data, the investigators seek to identify prognostic biomarkers and elucidate resistance pathways. The findings are expected to guide personalized treatment strategies for HER2-low breast cancer patients, ultimately improving clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with HER2-low breast cancer, defined as immunohistochemistry (IHC) score of 1+ or IHC score of 2+ with negative in situ hybridization (FISH-negative)
* Received sequential administration of two or more ADCs
* Complete data for patient's character, laboratory and imaging test, treatment and follow-up are available.

Exclusion Criteria:

* Concomitant with other tumor components at the time of diagnosis;
* Have a history of any other malignant tumors;
* Lack of complete data
REMINISCENCES and EMOTIONS : Reminiscence Triggered by Virtual Reality for Older Adults With Mood Disorders

Presentation \& Pre-screening of the control group / reminiscence group Patient/resident pre-screening team meeting for the study Explanation and proposal of the study to patients and their families Signature of resident/patient and family consents Audit of inclusion and non-inclusion criteria Inclusion Medical advice for VR Clinical interview with the family or legal guardian for an accurate life history + an anamnesis interview (psychologist or doctor) with the patient or resident.

Creation of video contents Creation of personalized video contents Clinical scales review Evaluation of the number of psychotropic molecules prescribed (coordinating doctor, general practitioner, geriatrician)

* Pre-test phase with the patient for the use of the VR headset
* Randomisation
* Session procedure As previously mentioned, the virtual reality sessions will take place in a quiet setting twice a week in the living or hosting residence. The sessions will be hold over a period of time of 6 weeks.

Each subject of the reminiscence group will have two personalised virtual surroundings (after data being collected from team and/or families).

The virtual environment will change every 3 weeks in order to avoid the phenomenon of habituation.

The subjects of the control group will be exposed to two generic virtual settings (beach, mountain etc.) with a different virtual environment every 3 weeks.

During the session, note will be taken on the subject's speech. The session will also be filmed and/or recorded with a prior signed agreement by the patient or his representative.

- Last session (S6) Review of clinical scales (re-testing) Re-evaluation of drug prescriptions


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 65 or older
* Accompanied in day care or in the geriatric structure of the CHU of Nice (EHPAD-USLD)
* Mild to moderate cognitive impairment
* Diagnostic criteria for Alzheimer's disease, NINCDS-ADRDA probably,
* Positive score on at least one of the following rating scales :
* NPI-ES depression/dysphoria and anxiety items + GDS 15 Patients
* IA caregiver = 2 on one of 2 dimensions + IA patient = 2 on one of 2 dimensions

Exclusion Criteria:

* Diagnosed psychiatric pathology
* Disabling sensory disorders such as DMLA
* Significant hearing loss
* Subjects with risk of photosensitive epilepsy or dizziness. Subjects with Lewy body dementia
Testing Two Interventions to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV

Engagement in HIV medical care and adherence to HIV medications are both essential in improving health outcomes among people living with HIV (PLH), but PLH living in rural areas-who suffer higher mortality rates than their urban counterparts-can confront multiple barriers to care engagement and adherence, especially as they face the logistical, medical, and social challenges associated with aging. This project will test the efficacy of two interventions to determine their impact on HIV health outcomes and quality of life among rural, older PLH living in the Southern U.S. The two interventions, adapted from evidence-based interventions and delivered remotely, are: (1) supportive-expressive peer social support groups and (2) strengths-based case management. We hypothesize that both interventions will increase viral suppression, antiretroviral therapy adherence, and health-related quality of life and decrease depressive symptoms. Results from this study will provide us with tools to improve health outcomes for rural older people living with HIV.


Eligibility Criteria:
Inclusion Criteria:

* Aged 50 years or greater
* Living in a county with a score of .4 or higher on the index of relative rurality (IRR)
* Living in Alabama, Arkansas, Delaware, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, Missouri, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, or West Virginia
* Living with HIV
* Has a telephone at home
* Able to provide informed consent

Exclusion Criteria:

* Not meeting eligibility criteria described above
Lamellar Transplant With Lyophilized Corneas

- The goals of this study are to develop a lyophilization method for anterior lamellar transplants in Brasil and to make a comparative analysis among patients transplanted with lyophilized and optisol corneas

* After the development of a techinique to lyophilize corneas, we randomly assingned 20 patients with keratoconus and visual acuity of \< 20/60, who signed the consent term and divided them into 2 groups. One group was transplanted with lyophilized corneas and the other group with optisol corneas.
* Patients are being followed for 6 months with visual acuity, refraction, topography, orbscan, pachmetry, ultrasound biomicroscopy and confocal microscopy.
* Results are going to be statistically analysed by SPSS program.

Eligibility Criteria:
Inclusion Criteria:

* Keratoconus patient
* BCVA \< 20/60
* No systemic diseases
* Who signed the inform consent

Exclusion Criteria:

* BCVA \> 20/60
* Presence of deep opacities
* Systemic diseases
Physiological Changes Throughout the Competitive Rugby Season.

Rugby union is a high intensity, intermittent team sport which is played over 80 minutes. Players are divided into two main positional groups, forwards and backs, with backs covering a larger distance and completing more sprints and forwards partaking in more static exertions. With the game of rugby union getting progressively faster, body composition and power to weight ratio are key determinants. Due to the demands placed on these players it is essential that they are in optimal health continually, however, whilst the required physical attributes are well documented, this research will provide an insight into physiological and anthropometric changes that occur across two seasons.

During this study subjects will be asked to attend the lab on 8 occasions over the course of two seasons (June 2018, September 2018, January 2019, April 2019, June 2019, September 2019, January 2020 and April 2020). During these visits the following tests will be completed; a peripheral Quantitative Computed Tomography (pQCT) scan of the bone mineral composition of the tibia and radius, total body composition via Dual Energy X-ray Absorptiometry (DXA), anterior-posterior spine bone mineral density to assess fracture risk via DXA, vertebral fracture risk via DXA. \~24ml of whole blood will be taken to determine serum 25(OH)D, albumin, calcium, zinc, total red blood cell count, lymphocytes, monocytes, carboxy-terminal collagen crosslinks (CTX) and amino-terminal propeptide (P1NP) concentrations. In June all players will complete a 6 minute run to determine fitness. Players will be expected to measure body weight and complete wellness questionnaires daily at the club and have skinfold measurements taken monthly. global positioning system (GPS) data will be collected during each training session and performance analysis will be utilised to determine the amount of contacts completed. Illness and injury occurrences will be recorded throughout the season.


Eligibility Criteria:
Inclusion Criteria:

* Male
* 18-35 years old
* Contracted player of Harlequins Rugby Club

Exclusion Criteria:

* Any participant who has been exposed to radiation exceeding 5millisieverts within the past 12 months will be excluded from dual-energy X-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) scans for the relevant time points, however all other (non-ionizing) measures will be collected.
Comparison of Electronic Calipers to Conventional Calipers and X-ray Measurement of Spinal Tilt

The objective is to compare the accuracy and reproducibility of measurements taken with electronic calipers and conventional calipers. Using both calipers, reproducibility will be determined by comparing results from a number of practitioners and accuracy will be determined by comparing results with those obtained from X-rays.

Participants will have 2 spinal measurements, one at the shoulder and one at the hip, taken by electronic calipers and conventional calipers with different individual research staff. Up to 5 individual research staff will take the 2 spinal measurements on each participant. This will be done to compare variation of measurements between individual operators.

The accuracy of the spinal measurements, obtained with electronic and conventional calipers will be compared to the results obtained from x-rays taken of shoulder and hip areas. Only one x-ray of the shoulder and one x-ray of the hip will be taken of each participant. X-rays represent the clinically accepted standard of obtaining spinal measurements.

The data will analyzed statistically to determine sources of variation among the methods of spinal measurement described above.

Eligibility Criteria:
Inclusion Criteria

Must be able to have shoulder and hip measurements for spinal tilt

Exclusion Criteria:

Not able to have shoulder and and hip measurements for spinal tilt.
rTMS for Relieving Chronic OA Pain

In this study the investigators aim to examine the effects of Transcranial Magnetic Stimulation (TMS) on hippocampal network connectivity and pain levels in individuals with pain due to knee osteoarthritis.

Osteoarthritis (OA) pain is one of the most prevalent causes of chronic pain worldwide. Symptoms can last from months to a lifetime, severely impacting patients' quality of life. New strategies - including non-invasive brain stimulation techniques - have shown promise for sustained pain relief, yet evidence on their reliability and efficacy is limited. Apkarian et. al have previously shown that the dorsal hippocampus plays a central role in pain analgesia; thus, the study aim is to test whether non-invasively enhancing dorsal hippocampus activity is a useful new strategy for pain relief in knee OA patients. This study will recruit 35 patients with chronic OA pain for \> 6 months. Each participant will receive 3 rounds of different treatment modalities in a cross-over manner. Each treatment modality will consist of 5 daily consecutive rTMS sessions followed by a 2-weeks wash-out period. Questionnaires will be completed prior to and following each intervention, and after each treatment round. Participants will be trained to use a pain electronic application (smartphone-based tool to rate pain intensity and mood on NRS scales, as well as indicate rescue medication use, developed in our lab). They will be asked to use this application for 7-10 days prior to the first round of intervention and during the study duration.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 6 months of knee pain on a daily basis;
* male or female with no racial or ethnic restrictions;
* 18 to 75 years old;
* average knee pain intensity \> 4/10 at study entry;
* must be able to read, understand, and sign consent form;
* generally healthy.
* able to use the PainApp

Exclusion Criteria:

* rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures,
* Chronic neurologic conditions, e.g., Parkinson's
* other severe medical diseases;
* pregnancy;
* positive urinary screen for any recreational drugs,
* opioids use;
* use of anticoagulants (low dose ASA allowed);
* history of gastric ulcer; renal insufficiency or congestive heart failure,
* contraindication to MRI,
* contraindication to TMS; including history of seizure/epilepsy\*
* Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk;
* In the judgment of the investigator, unable or unwilling to follow protocol and instructions.
* Diagnosis of major depression.
Work Related MSDs Between Egyptian Dentists

The aim of this study is to assess the musculoskeletal pain and discomfort among specialized pediatric dentists and general dentists.

Musculoskeletal disorders are caused by the accumulation of mechanical and various stresses on the body, such as repetitive work of specific body parts, uncomfortable and unnatural work postures, high work intensity, excessive force, insufficient rest, cold working environment, and frequency. It is defined as musculoskeletal complaints, musculoskeletal pain that reflect a number of conditions, such as neck pain, back pain, shoulder pain, pain of limbs, carpal tunnel syndrome, myofacial dysfunction syndrome, atypical facial pain Although these musculoskeletal disorders can appear in all occupational groups, it is known that the incidence of musculoskeletal pain symptoms is higher in the dentist occupational group than in other occupational groups This is because dentists have to sit or stand for a long time and keep their head, neck, and shoulders in a fixed position for a long time.Bending motions, twisting motions, forward bent sitting postures, and relatively static working postures, which dentists mainly take during their treatment, are considered risk factors. According to a study on musculoskeletal disorders in Sharkia - low-back pain was the most prevalent musculoskeletal complaint that reported by (56.9%) of the subjects, followed by 50.4%, 47.2% and 42.3% complained of pain in the order of wrist, neck and shoulders Valachi and Valachi (2003) reported that approximately 81% of US dentists suffered from neck, shoulder and back pain Moreover, with the onset of the Covid-19 pandemic, the use of additional protective devices increases the mental stress, the risks of imbalanced postures and further reduces the freedom of movement.

Although there are many studies on musculoskeletal disorders in the dental profession, studies on pediatric dentistry are rare. In the case of pediatric dentists, the cooperation of young patients is insufficient, the treatment time is short, and they are exposed to various environments such as general anaesthesia . In addition, pediatric dental chairs do not fit children of all ages, which affects the attitude of dentists

Eligibility Criteria:
Inclusion Criteria:

* Graduated Egyptian dentists since 2015 , practicing in egypt since 2016
* Dentists Working hours more than 4 hours and at least 4 days per week
* Pediatric dentists treating one child at least per working day

Exclusion Criteria:

* Participants with history of serious trauma or fracture
* The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc.
* Participants will not sign the consent or complete the questionnaire.
Elderly NSCLC/D vs DP (JCOG0207)

To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.

The Elderly Lung Cancer Vinorelbine Italian Study demonstrated the first evidence of the utility of chemotherapy in elderly patients with advanced non-small-cell lung cancer (NSCLC). In a large randomized trial, gemcitabine and vinorelbine failed to show any advantage over either agent alone. With the current evidence, single agent chemotherapy with a third-generation drug can be considered a recommended option for elderly patients with advanced NSCLC. A Japanese phase I/II study showed the activity (overall response rate 52%, median survival 12.4 months) and tolerability of weekly docetaxel/ cisplatin combination in patients older than age 75 years. There have been no randomized prospective trials dedicated to elderly NSCLC patients to evaluate tolerability and efficacy of platinum-based combination.

Comparison: Single-agent weekly docetaxel versus weekly regimen of docetaxel-cisplatin combination for elderly advanced NSCLC.

Eligibility Criteria:
Inclusion Criteria:

1. histologically or cytologically proven non-small-cell lung cancer
2. stage IV, or stage III disease ineligible for definitive radiotherapy
3. 70 years or older
4. ECOG PS 0-1
5. Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy
6. No prior chemotherapy(containing gefitinib) for non-small cell lung cancer or other neoplasms
7. No prior surgery within 4 weeks before enrollment
8. No prior radiotherapy for primary tumor
9. No prior radiotherapy for metastatic lesions within 2 weeks before enrollment
10. Adequate organ function
11. Signed informed consent

Exclusion Criteria:

1. Symptomatic brain metastasis
2. Active another neoplasms
3. Severe SVC syndrome
4. Massive pericardial, pleural effusion, or ascites
5. Bone metastasis emergent for palliative radiotherapy or surgery
6. Uncontrollable systemic hypertension
7. Heart failure, Unstable angina, Myocardial infarction within 6 months
8. Uncontrollable diabetes
9. Active infection
10. Interstitial pneumonia/ Pulmonary fibrosis
11. Hypersensitivity for polysorbate 80
12. Systemic administration of corticosteroids