cyrilzakka/clinical-trials huggingface dataset:
Intrathecal Enzyme Replacement for Hurler Syndrome

This protocol will examine whether the enzyme alpha-L-iduronidase (Laronidase), delivered into the spinal fluid of patients with Hurler syndrome at intervals before and after bone marrow transplant, is a safe and effective approach to slow the neurologic degeneration seen in Hurler patients undergoing transplantation.

Subjects will receive an infusion of Laronidase into his/her spinal fluid approximately 12 weeks before, 2 weeks before, 100 days after and 6 months after transplant. This procedure is done by lumbar puncture (also called a "spinal tap").

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of MPS IH (Hurler syndrome) are candidates for this protocol if they are being considered for hematopoietic stem cell transplantation according the University of Minnesota guidelines.

Exclusion Criteria:

* Patients are less than 6 months old, or older than 3 years of age.
* There is a history of clinically-severe hypersensitivity to Laronidase.
* There is a contraindication for repeated lumbar puncture.
* The family is not willing to undergo the necessary procedures and evaluations inherent in the study.
* Consent has not been signed for participation in the 2004-09 study of intravenous Laronidase administration.
Midline Catheter and Its Impact on Central Lines Removal in ICU

The study will evaluate 2 strategies to remove central venous catheter (CVC): in one part, the insertion of a midline catheter and in the other part, the conventional insertion of peripheral venous catheter (PVC)

Patients will be randomised when the last indication for CVC has disappeared, which means parenteral nutrition or vasopressors administration.

They will be randomised either in the midline group or in the PVC group.

* In the midline group, a midline catheter will try to be inserted before the 48th hour after last indication for CVC disappeared.
* In the PVC group: a PVC will try to be inserted before the 48th hour after last indication for CVC disappeared.

If successful, CVC will then be removed. If not, a PVC will try to be inserted daily till success or worthlessness of a venous line or death.

The presence of a CVC will be assessed at the 96th hour after disappearance of last CVC indication.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* admitted to ICU since at least 48h
* with a perfusion CVC inserted
* requiring or having required invasive mechanical ventilation
* lack of formal indication to CVC maintenance (weaning of vasopressors and/or parenteral nutrition) since at least 24 hours
* indication to maintain a venous access

Exclusion Criteria:

* Lack of patient or next of kin consent
* Personnel for insertion of midline catheter not available
* Admission in ICU before study start
* Admission following a transfer from another ICU
* Patient with an implantable port or a peripherally inserted central catheter (PICC Line)
* Known intolerance to components of study Midline device
* Past history of irradiation of insert area of midline catheter
* Past history of bilateral axillary lymph node dissection
* Pre-existing skin infection on upper limb
* Patient with a treatment-limitation decision
* Patient admitted after cardiac arrest with non-shockable rhythm
* Moribund
* Pregnancy, breastfeeding woman
* Patient under legal guardianship
* Patient hospitalized without consent and/or deprived of liberty by court's decision
VEGA System® Study in the Total Knee Arthroplasty

This post-market clinical follow-up study intends to investigate long-term functionality of the VEGA System®. The design of the VEGA System® is meant to provide the patient with more knee mobility compared to their pre-operative state.The endpoint is the revision of at least one of the prosthesis components


Eligibility Criteria:
Inclusion Criteria

1. Patient from 18 to 75 years old
2. Patient is able to comply with follow-up requirements including postoperative self-evaluations.
3. Patient requires a primary knee replacement.
4. Patient has a diagnosis of osteoarthritis
5. Patient has intact collateral ligaments.

Exclusion Criteria

1. Vulnerable patient under legal protection
2. Patients with inflammatory arthritis.
3. Patients that have had a high tibial osteotomy or femoral osteotomy.
4. Pregnancy
GWAS Research of Lung Cancer in Tianjin

To study the association of Genetic Polymorphisms with Lung Cancer Risk in Tianjin Population.

Eligibility criteria:

* nonsmoker
* female
* age between 35 and 80
* no other types of tumors history
* frequency-matched cases and controls on gender and age

Outcome measures:

* OR(odds ratio)
* RR(risk ratio)
* CI(confidence interval)
* SAS software

Eligibility Criteria:
Inclusion Criteria:

* Non-small cell lung cancer
* Age from 35 to 80 years old
* Female
* Non-smokers
* Frequency-matched on age and gender

Exclusion Criteria:

* Previous medical history of cancer
* Previous radiotherapy
* Previous chemotherapy
ICBT for Depression in Older Adults

The study was a randomized controlled trial investigating treatment effects against an active control condition. 101 self-recruited participants, aged 65 to 88 years, were included. The intervention was a 10-week internet-based tailored CBT protocol consisting of 6-10 pre-defined modules tailored to patient profile and preferences. Participants in the treatment group benefitted more than participants in the control condition on almost all measures with moderate between-group effect-sizes.

Depression in older adults is associated with poorer functioning, worsened cognitive impairment and disability, as well as medical illnesses. It can also increase the risk of suicide and is associated with a high usage of medical services. It is common that depressive symptoms co-occur with other psychiatric symptoms (i.e. anxiety). In the case of co-morbidity, patients present with greater difficulties and the problems tend to be more persistent. Together this stresses the importance of developing effective treatments. Psychological treatments can be effective but are rarely offered and thus alternative modes of treatment delivery should be considered such as internet interventions. Design: The study was a randomized controlled trial investigating treatment effects against an active control condition. Participants: 101 self-recruited participants, aged 65 to 88 years, were included. Intervention: The intervention was a 10-week internet-based tailored CBT protocol consisting of 6-10 pre-defined modules tailored to patient profile and preferences. Measurements: Depression, anxiety, life quality and cognitive decline were assessed through self-reported measures together with an online test of cognitive flexibility. Results: Participants in the treatment group benefitted more than participants in the control condition on almost all measures with moderate between-group effect-sizes. Cognitive decline improved during treatment and neither cognitive decline, nor cognitive flexibility predicted treatment outcome. Conclusion: The study adds to the evidence of internet-delivered psychological treatment for depression, with or without psychiatric comorbidities, in older adults. It also highlights the possibility of perceived cognitive decline as being part of the clinical picture and reversible, rather than reason for exclusion from for psychological treatment.

Eligibility Criteria:
Inclusion Criteria:

* age 65 years or older
* presence of depressive symptoms
* living in Sweden
* access to the internet and a computer on a regular basis.

Exclusion Criteria:

* heightened suicidal ideation
* drug or alcohol abuse or dependency
* other ongoing psychological treatment
* severe psychiatric or cognitive problems
* unstable psychopharmacological medication
Diagnostic Reasoning With Customized GPT-4 Model

This study will assess the impact of immediate access to a customized version of GPT-4, a large language model, on performance in case-based diagnostic reasoning tasks. Specifically, it will compare this approach to a two-step process where participants first use traditional diagnostic decision support tools to support their diagnostic reasoning before gaining access to the customized GPT-4 model.

Artificial intelligence (AI) technologies, particularly advanced large language models like OpenAI's ChatGPT, have the potential to enhance medical decision-making. While ChatGPT-4 was not specifically designed for medical applications, it has demonstrated promise in various healthcare contexts, including medical note-writing, addressing patient inquiries, and facilitating medical consultations. However, its impact on clinicians' diagnostic reasoning remains largely unknown.

Clinical reasoning is a complex process that involves pattern recognition, knowledge application, and probabilistic reasoning. Integrating AI tools like ChatGPT-4 into physician workflows could help reduce clinician workload and decrease the likelihood of missed diagnoses. However, ChatGPT-4 was neither developed nor validated for diagnostic reasoning, and it may produce misleading information, including plausible but incorrect conclusions that could misguide clinicians. If not used appropriately, it may fail to improve-and could even hinder-clinical decision-making. Therefore, it is essential to study how clinicians use large language models to support clinical reasoning before integrating them into routine patient care.

This study will examine how immediate access to a customized version of ChatGPT-4 impacts performance on case-based diagnostic reasoning tasks, compared to a stepwise approach. In the stepwise approach, participants will first use traditional diagnostic decision support tools to support their case reasoning before interacting with a customized ChatGPT-4 model, at which point they will have the opportunity to revise their initial answers.

Participants will be randomized into different study arms and will respond to diagnostic cases by providing three differential diagnoses, along with supporting and opposing findings for each. They will also identify their top diagnosis and propose next diagnostic steps. Independent reviewers, blinded to treatment assignment, will evaluate their responses.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be licensed physicians and have completed at least post-graduate year 1 (PGY1) of medical training.
* Training in Internal medicine, family medicine, or emergency medicine.

Exclusion Criteria:

* Not currently practicing clinically.
* Participated in one of our previous studies that used the same six diagnostic cases.
Development of an Application-Based Digital Navigator for Perioperative Breast Surgery Patients

The goal of this research study is to learn how accessible JEEVA is for patients during the perioperative period (the time after the pre-operative surgical appointment, and up to 30 days after surgery

Objectives:

Demonstrate feasibility of use for a mobile device-based application to provide perioperative resources and support in a multimedia format to breast surgery patients

Measure ease of use, interface and satisfaction with the electronic delivery of materials through the mobile health (mHealth) App Usability Questionnaire (MAUQ)

Eligibility Criteria:
Inclusion Criteria:

Subjects eligible for this study include breast surgical patients 18 years of age and older evaluated at the Texas Medical Center campus in the Nellie B Connally breast center or in the Houston Area Locations (HALs).

This includes patients undergoing excisional biopsy, segmental mastectomy, total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, sentinel lymphadenectomy, targeted axillary lymphadenectomy, axillary lymphadenectomy, and axillary reverse mapping.

Exclusion Criteria:

Patients who do not have a smartphone), which utilizes iOS or Android operating systems,

Patients who have visual impairment or blindness, which precludes effective utilization of an app, will be excluded.

Patients whose surgical planning is discussed by telephone outside of an in-person pre-operative visit, will be excluded from the study.

Patients who have cognitive impairment will be exclude
Life After Cancer: Behavioral Treatment Study to Improve Quality of Life

The purpose of the study is to find new ways to improve the quality of life of people who have been treated for colon or rectal cancer.

Individuals who take part in the study can expect:

Two Interviews:

* To be interviewed by our research staff over the phone. The interviews will include questions about your current quality of life and health.

Brief Writing in a Journal:

* To write for 15 minutes twice a week for two weeks about aspects of your life.

Eligibility Criteria:
Inclusion Criteria:

* Treated for stage I, II or III colon or rectal cancer in the past 5 years
* Completed surgical treatment
* Must be able to read and write in English

Exclusion Criteria:

* History of other cancers, with the exception of non-melanoma skin cancer
Aquatic Sequential Preparatory Approach and Severe Traumatic Brain Injury

Traumatic brain injury (TBI) is an acquired insult to the brain from an external mechanical force. It is considered a major cause of mortality and of long-term disabilities in young adults, especially considering high-income countries.

The TBI can cause a wide range of temporary and/or permanent brain's dysfunctions that can involve physical, cognitive, behavioural and emotional functioning limiting everyday life and social activities and leading to a lowers quality of life.

a sequential preparatory approach (SPA), performed in aquatic environment, based on increasing difficulty and following a specific sequence of preparatory exercises (from the simplest to the most complex) could be an effective complementary training during post-acute intensive rehabilitation in patients with severe traumatic brain injury (sTBI).


Eligibility Criteria:
Inclusion Criteria:

* age between 15 and 65 years;
* Glasgow coma scale (GCS) score ≤ 8 (used to objectively describe the severity of impaired consciousness at the time of injury)
* level of cognitive functioning (LCF) ≥7;
* ability to understand verbal commands.
* acclimatization to water.

Exclusion Criteria:

* Cognitive deficits affecting the ability to understand task instructions (Mini-Mental State Examination \> 24);
* Severe unilateral spatial neglect (diagnosed with a test battery that included the Letter Cancellation test, Barrage test, Sentence Reading test and the Wundt-Jastrow Area Illusion Test);
* Severe aphasia (diagnosed by means of neuropsychological assessment);
* Presence of other neurological diseases;
* Presence of cutaneous and mycosis infections;
* Presence of open wounds, eczema, skin ulcers, decubitus lesions, severe burns;
* Presence of PEG (Percutaneous endoscopic gastrostomy);
* Presence of tracheostomy;
* Urinary incontinence;
* Presence of otitis
* Presence of orthopedic or cardiac comorbidities that would limit participation in the experimental and conventional training (all of which were clinically evaluated).
Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers

This study assesses safety, tolerability and immunogenicity of NBP607QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease.

Subjects are randomly assigned in a 1:1 ratio to NBP607QIV versus Agrippal S1. To assess the safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination are assessed and reported. To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 21 days post-vaccination.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults aged 19 to 59 years
2. Those who are able and willing to give written informed consent to study participation and compliance with study instructions after being informed of and understand details of the study
3. If female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening

Exclusion Criteria:

1. Those with hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
2. Those with Immunodeficiency disease
3. Those with history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
4. Those who are contraindicated for intramuscular injection due to thrombocytopenia or coagulopathy
5. Those who experienced fever (\>38°C) within the past 24 hours or any acute respiratory infection
6. Those with history of treatment with any of Immunosuppressants or Immunomodulators within the past 3 months
7. Those with history of receiving blood products or immunoglobulin within the past 3 months
8. Those with history of influenza vaccination within the past 6 months
9. Those who received another vaccine within the past 1 month or have plan to receive another vaccine within 1 months following the study vaccination
10. Those with history of participation on another clinical trial within 1 month prior to the study vaccination
11. Those with history of blood donation within 1 week prior to the study vaccination or plan of blood donation within 7 days following the study vaccination
12. Those with any chronic diseases that interfere with the clinical trial or malignant tumors
13. Pregnant or breastfeeding
14. Those with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might interfere with the safety of the study subject.
Comparative Study Between Micro Plate Fixation and Blocking k.Wire in Management of Acute Bony Mallet Finger : Randomized Controlled Clinical Trial Study

Mallet finger is an avulsion fracture of the distal phalanx or rupture of the extensor terminal band caused by distal interphalangeal (DIP) joint hyperflexion or axial loading. In the treatment of mallet finger fractures, surgical repair is recommended in cases where the fracture involves more than one-third of the distal phalanx joint surface or the distal phalanx becomes volar subluxated

The blocking k.wire and micro plate technique are some of the methods used in the treatment of mallet finger fractures In recent years, the blocking k.wire technique has gained popularity owing to its minimally invasive nature and its ability to achieve satisfactory postoperative results

The main advantages of Micro Plate technique include provision of anatomical reduction and stable fixation, avoiding the risk of fragmentation of the small dorsal fragment, allowing early movement and increasing patient comfort and compliance


Eligibility Criteria:
Inclusion Criteria:

- Acute bony mallet finger involves more than one third of the distal phalanx joint surface or the distal phalanx becomes volar sublaxed

Exclusion Criteria:

1- . crushed distal phalanx 2. soft tissue mallet 3. multiple phalangeal fractures 4. old neglected cases
Investigation of Dysregulated Signaling in MPD Via Multiparameter Phospho-specific Flow Cytometry

The objective of this study is to better understand the underlying pathogenetic mechanisms of myeloproliferative disorders (MPDs). We will collect peripheral blood samples from MPD patients and utilize multiparameter phospho-specific flow cytometry to investigate dysregulated signaling in blood cells from these patients. This will provide deeper insights into the pathogenesis of MPDs and may lead to the identification of novel targets for therapeutic intervention.


Eligibility Criteria:
Inclusion Criteria:Any patient who carries a diagnosis of a myeloproliferative disorder (MPD). Exclusion Criteria:Any patient who is not willing to give consent.
A Study of Vatiquinone for the Treatment of Participants With Friedreich Ataxia

The primary objective of the study is to assess the pharmacokinetics (PK) and safety of vatiquinone administered in participants with Friedreich ataxia (FA) younger than 7 years.


Eligibility Criteria:
Inclusion Criteria:

* Friedreich ataxia diagnosis (homozygous for GAA repeat expansion in intron-1 of FXN gene), confirmed by clinical genetic testing.
* Must be able to abstain from anticoagulants and any aspirin (including 81 mg) for 30 days before the Baseline Visit and for the duration of the study; any possible discontinuation of anticoagulants should be monitored and indicated by a specialist (for example, cardiologist, neurologist, or hematologist), and discontinuation will be noted by the prescribing physician.
* Must be able to abstain from strong cytochrome P450 (CYP) 3A4 inducers/inhibitors (for example, ketoconazole, rifampin, St. John's wort, grapefruit juice, or any grapefruit product) for at least 30 days prior to enrollment and for the duration of the study.
* Must be able to take vatiquinone oral solution with food.

Exclusion Criteria:

* Previous treatment with vatiquinone.
* Allergy to vatiquinone or sesame oil.
* Ejection fraction \<50%.
* Participation in any other interventional clinical trial or receipt of any study drug in any other clinical trial within 60 days prior to the Baseline Visit. Participants may be rescreened after the exclusionary period of 60 days has passed.
* Concomitant use of interventional CoQ10, vitamin E, or any approved or non-approved medication for FA within 30 days prior to the Baseline Visit. These prohibited medications can be discontinued at the Screening Visit.

Note: Other inclusion and exclusion criteria may apply.
Canola Oil Multi-center Intervention Trial II

Building on the findings from the investigators previous study, COMIT I, the purpose of the COMIT II study is to supplement the DEXA measurement of body composition with a supplementary DEXA measurement of visceral adipose tissue and to specifically target the impact of oleic acid consumption on body composition as the primary objective. COMIT II also will include analysis of fatty acid ethanolamines (FAEs) and their precursors to elucidate the mechanisms by which canola oil may be modifying body composition, measurement of endothelial function, inflammatory, adiposity and insulin sensitivity biomarkers, and genetic analyses.


Eligibility Criteria:
Inclusion Criteria:

* waist circumference ≥94 cm for men and ≥80 cm for women
* Elevated triglycerides - ≥150 mg/dL and ≤ 400 mg/dL
* Reduced HDL - \< 40 mg/dL for men and \< 50 mg/dL for women
* Fasting glucose - ≥ 100 mg/dl and ≤ 126 mg/dL
* Elevated blood pressure - systolic ≥130 and/or diastolic ≥85 mm HG \[Unmedicated participants - upper limit of Stage 1 Hypertension: systolic \< 160 and/or diastolic \<100 mm HG and participants must be free of end stage/target organ disease symptoms\] \[BP medicated participants: acceptable as long as individuals meet the specified blood pressure range of \<140/90 mmHg, and have been stable for at least 6 months\]

Exclusion Criteria:

* Individuals with thyroid\*\*, kidney, or liver disease \[Individuals with thyroid disease whose blood values are within normal limits and that have been stable (on medication) for the past 6 months are considered eligible\]
* Individuals with diabetes mellitus
* Smokers
* Individuals consuming \>14 alcoholic beverages per week
* Individuals taking lipid lowering medication (ex: cholestyramine, colestipol, niacin, cloribrate, gemfibrozil, probucol, HMG CoA reductase inhibitors) for at least the last 3 months
* Pregnancy or lactation