cyrilzakka/clinical-trials huggingface dataset:
Preventing Medication Dispensing Errors in Pharmacy Practice with Interpretable Machine Intelligence

Pharmacists currently perform an independent double-check to identify drug-selection errors before they can reach the patient. However, the use of machine intelligence (MI) to support this cognitive decision-making work by pharmacists does not exist in practice. This research is being conducted to examine the effectiveness of the timing of machine intelligence (MI) advice on to determine if it results in lower task time, increased accuracy, and increased trust in the MI.

Pharmacists currently perform an independent double-check currently to identify drug-selection errors before they can reach the patient. However, the use of machine intelligence (MI) to support this cognitive decision-making work by pharmacists does not exist in practice. Instead, pharmacists rely solely on reference images of the medication which they can compare to the prescription vial contents. Previous research has shown that decision support systems can effectively improve healthcare delivery efficiency and accuracy, while preventing adverse drug events. However, little is known about how MI technologies impact pharmacists' work performance and cognitive demand.

To facilitate the long-term symbiotic relationship between the pharmacists and the MI system, proper trust needs to be established. While trust has been identified as the central factor for effective human-machine teaming, issues arise when humans place unjustified trust in automated technologies do not place enough trust in them. Over trust in automation can lead to complacency and automation bias. For instance, the pharmacists may rely on the MI system to the extent that they blindly accept any recommendation by the system. Under trust can result in pharmacist disuse and potential abandonment of the MI system.

Furthermore, little is known about the timing of the MI advice on pharmacists' work performance. For example, showing the MI's advice while the pharmacist is performing the medication verification task may yield different results than showing the MI's advice after the pharmacist made their decision.

The study investigators have developed a MI system for medication images classification. The objective of this study is to examine the effectiveness of the timing of MI advice to determine if it results in lower task time, increased accuracy, and increased trust in the MI.

Eligibility Criteria:
Inclusion Criteria:

* Licensed pharmacist in the United States
* Age 18 years and older at screening
* PC/Laptop with Microsoft Windows 10 or Mac (Macbook, iMac) with MacOS with Google Chrome, Edge, Opera, Safari, or Firefox web browser installed on the device
* Screen resolution of 1024x968 pixels or more
* A laptop integrated webcam or USB webcam is also required for the eye tracking purpose.

Exclusion Criteria:

* Participated in Wave 1 or Wave 2
* Eyeglasses
* Uncorrected cataracts, intraocular implants, glaucoma, or permanently dilated pupil
* Require a screen reader/magnifier or other assistive technology to use the computer
* Eye movement or alignment abnormalities (lazy eye, strabismus, nystagmus)
The Effect of Distant Reiki on Pain and Holistic Well-being

Phantom limb pain is a condition characterized by painful sensations in the missing part of the amputated limb, which reduces the quality of life of the individual. It has been reported that approximately 85% of patients undergoing amputation experience phantom limb pain, and chronic pain is the most common symptom in individuals who have undergone limb amputation. These problems negatively affect individuals physically, mentally and socially and lead to deterioration of holistic well-being. This study will be examined the effect of distant reiki on pain and holistic well-being of ındividuals with phantom pain after amputation.

Phantom limb pain is a condition characterized by painful sensations in the missing part of the amputated limb, which reduces the quality of life of the individual. It has been reported that approximately 85% of patients undergoing amputation experience phantom limb pain, and chronic pain is the most common symptom in individuals who have undergone limb amputation. These problems negatively affect individuals physically, mentally and socially and lead to deterioration of holistic well-being.

Reiki is one of the holistic health practices that is effective in maintaining the balance between body, mind and spirit, which forms the basis of holistic well-being. Reiki, known as an energy-based therapy, helps to rebalance the natural energy flow circulating in the body and to increase the body's self-healing ability, and it prevents or repairs physical, emotional and mental imbalances by regaining the energy we lost in daily life. The purpose of Reiki practice is to promote health and well-being by helping to relax and reduce stress.There is no study in the literature examining the effect of reiki application on phantom pain and holistic well-being.This study was planned to examine the effect of remote reiki applied to individuals with post-amputation phantom pain on pain and holistic well-being.It is thought that it will contribute to the literature in terms of being the first research to be done on this subject.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old,
* İndividuals with limb loss and phantom pain
* No communication problem,
* Have the physical and cognitive ability to answer the data collection forms,
* Individuals who have not received body-mind therapy (yoga, reiki, meditation, etc.)

Exclusion Criteria:

* individuals who have done reiki therapy before
A First in Human Study of RT001 in Patients With Friedreich's Ataxia

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of RT001 in patients with Friedreich's ataxia.

Study RT001-002 is a randomized, double-blind, controlled, ascending dose study to evaluate the safety, tolerability, pharmacokinetic, disease state, and exploratory endpoints in patients with Friedreich's ataxia after oral administration. The study includes 2 dose levels of RT001.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female 18 to 50 years of age
2. Medical history consistent with the symptoms of FRDA at ≤ 25 years of age
3. Homozygous for GAA repeat expansions in the Frataxin gene in the affected range for FRDA
4. FARS-Neurological score of 20-90 points
5. Ambulatory (with or without assistive device) and capable of performing assessments/evaluations
6. Body Mass Index ≤ 29.9 kg/m2
7. Agrees to dietary restrictions and agrees to receive calls from a dietary coach
8. Signed the informed consent form prior to entry into the study
9. Agrees to spend the required number of overnight clinic days
10. Able to provide the necessary repeated blood samples

Exclusion Criteria:

1. Received treatment with other experimental therapies within the last 30 days prior to the first dose
2. Known point mutation in the FXN gene
3. History of malignancies (other than basal cell carcinomas)
4. Impaired renal function at screening
5. Alanine transaminase (ALT) or aspartate transaminase (AST) laboratory values \> 2 x upper limit of normal (ULN) at screening
6. Known hepatitis B surface antigen (HBsAg)-positive, or known or suspected active hepatitis C infection, or is known to be human immunodeficiency virus (HIV) positive
7. Female who is breastfeeding or has a positive pregnancy test
8. Male participant or female participant of child bearing potential, who is sexually active and unwilling/unable to use a medically acceptable and effective double barrier birth control method throughout the study
9. Unwilling or unable to comply with the requirements of the protocol
10. Clinically significant cardiac abnormalities at screening that, in the opinion of the Investigator, would make the patient unsuitable for enrollment
11. Diabetes mellitus (Type 1 or 2)
12. Suicidal ideation as determined by the Columbia-Suicide Severity Rating Scale
13. History, within the last 2 years, of alcohol abuse, significant mental illness, or physical opioid dependence
14. Cannot adhere to the dietary guidance required to be followed by the protocol
15. Cannot take the medication due to impairment in swallowing capsules
Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer

This study is a single-arm, multi-center, open-label prospective phase II clinical study designed to evaluate the efficacy and safety of nab-paclitaxel and S-1 in patients with locally advanced pancreatic cancer. A total of 60 subjects who meet the criteria will be treated with nab-paclitaxel and S-1. The primary endpoint is 6 months progression free survival rate, and secondary endpoints include objective response rate, overall survival, progression free survival and toxicities.


Eligibility Criteria:
Inclusion Criteria:

1. Patients have good compliance, can understand the research process of this study, and sign a written informed consent
2. Patients with pathologically confirmed pancreatic adenocarcinoma.
3. Patients who have not received prior chemotherapy, radiotherapy or other systematic treatment for pancreatic cancer;
4. Patients with locally advanced pancreatic cancer ( NCCN Version 1，2019 criteria).
5. ECOG PS 0-1;
6. Tumor size is measurable according to RECIST1.1 criteria
7. Expected survival over 3 months;
8. Bone marrow function: neutrophils≥1.5x109/L, platelets ≥100x109/L, hemoglobin≥ 90g/L;
9. Liver and kidney function: serum creatinine≤1.5ULT; AST and ALT≤ 2.5 ULT; total bilirubin ≤ 1.5 ULT;
10. No contraindications to the use of S-1 and nab-paclitaxel.

Exclusion Criteria:

1. ≥ Grade 2 existing peripheral neuropathy;
2. Any other malignancy within 5 years prior to enrollment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
3. Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
4. Severe, active co-morbidity, defined as follows:

   Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the 6 months of study registration Uncontrolled hypertension, diabetes or arrhythmia. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization.
5. Not able to take medicine orally.
6. Pregnancy or lactation, and women of childbearing age who refused to take appropriate contraceptive measures during the course of this study;
7. Participation in other clinical trial within 30 days before the first dose of the drug;
Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis

The objectives of this single center, prospective, non-interventional inception cohort is to understand patient characteristics, general treatment patterns, effectiveness, and safety of Tofacitinib for rheumatoid arthritis patients in the real-world setting.

1. To evaluate the baseline characteristics of Korean RA patients treated with Tofacitinib
2. To evaluate the effectiveness and safety of Tofacitinib in clinical practice in Korean RA patients.
3. To further evaluate safety, effectiveness and demographic characteristics of the patients treated with Tofacitinib matched with and compared to biologic DMARDs from the BIOPSY registry database.


Eligibility Criteria:
Inclusion Criteria:

A. Patients who provide a written informed consent form of participating in this study.

B. Patients who are more than 19 years old. C. Patients with moderately to severely active rheumatoid arthritis as defined per EULAR guidelines, who have had an inadequate response or are intolerant to methotrexate.

Exclusion Criteria:

A. Patients who do not provide a written informed consent form of participating in this study
Mindfulness Training: the Effects of a Stress Reduction Program on Older Portuguese-speaking People in Luxembourg

This project aims to investigate the MBSR feasibility and its effects in old Portuguese-speaking adults living in Luxemburg.

This study will be a two-arm randomized-double blinded-controlled study, including 90 healthy older adults. The MBSR will be conducted in groups over a total of eight weeks, incorporating weekly meetings, a retreat of 4 hours, and extra activities to be practiced at home. The active control condition will be a program with different components such as painting, nutrition information, physical activity, cognitive enhancement, risk factors for dementia, and health promotion. Neuropsychological assessments will be conducted at baseline, immediately after and one-month post-intervention. The researchers will also do pre-post salivary cortisol and resting heart rate variability analyses, as surrogate measures to assess stress level.


Eligibility Criteria:
Inclusion Criteria:

* Portuguese-speaker Migrants over 55 years old, residing in the Grand-Duchy of Luxembourg the Greater Region;
* Mastery of written and spoken Portuguese;
* Subjects without cognitive impairment (The Mini Mental State Examination - MMSE, cut-off of \< 22 will be adopted since most of participants are expected to have low education level -Kochhann et al, 2010)
* Subjects with a full capacity of consent.

Exclusion Criteria:

* Previous (up to 2 years before) or actual weekly participation in formal meditation, yoga or mindfulness-based interventions
* Concomitant participation in other kind of enhancement intervention in group, e.g., cognitive training, psychological therapy
* Severe hearing or visual impairment (not corrected)
* Severe medical condition requiring intensive medical care that makes it difficult to participate in the group sessions
* Refusal to sign the informed consent
* Diagnosis of dementia
* Clinical neurodegenerative illness, psychotic disorder, unstable psychiatric condition which makes it difficult to participate in groups, posttraumatic stress disorder or history of trauma, individuals with acute psychosis, mania, suicidality or alcohol chronic or other substance abuse within the last 6 months (cutoff: 2 points at the Adult DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure)
Effects of Finasteride on Serum Prostate-Specific Antigen (0906-111)

A clinical study to collect additional data in order to characterize the reduction in PSA with finasteride 1 mg, and its reversibility in men with androgenetic alopecia between the ages of 40 to 60 years.


Eligibility Criteria:
Inclusion Criteria :

* Men 40 to 60 years of age, and in good general physical and mental health, with androgenetic alopecia

Exclusion Criteria :

* History of previous bladder surgery, acute urinary retention, urethral strictures, repeated urethral catheterizations, repeated urinary tract infections, or active urinary tract infections
* History of treatment with finasteride (PROSCAR or PROPECIA) or hypersensitivity to any component of finasteride.
Association of Single Nucleotide Polymorphisms (SNPs) in Metalloproteinases (MMPs) Genes With the Risk of Primary Knee Osteoarthritis in Greek Population.

Does the presence of gene polymorphisms -1575G / A in the MMP-2 gene, 836A / G in the MMP-9 gene and -77A / G in the MMP-13 gene, affect the risk of developing idiopathic knee osteoarthritis in the Greek population?

This is a prospective case-control study in which the patients' genotype will be studied against the genotype of the controls. The study is prospective and not retrospective, as data will be collected from patients with primary knee osteoarthritis as well as the control group from the outset. The study intends to include 200 people. The first group consists of 100 individuals suffering from knee osteoarthritis, while the second group will include 100 healthy controls without osteoarthritis. From each one DNA will be isolated and analyzed from collected blood. The prospective study allows valid data to be collected on patient demographics and disease severity. Due to the large number of cases of the disease, it is estimated that the necessary specimens will be collected within a reasonable time from the beginning of this thesis. The choice of the patient-control study is necessary to limit the influence of confounding factors (age, gender, obesity, etc.). This type of study includes rigorous selection of patients and controls with specific entry and exclusion criteria, selection of controls based on matching patient characteristics, stratification, and subgroup analyzes. The final result will be a comparison of the incidence of specific gene polymorphisms between patients with knee osteoarthritis and the normal population.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary knee osteoarthritis are selected based on clinical symptoms and radiological imaging with a score at least 2 on the Kellgren \& Lawrence scale.
* Patients without symptomatology or radiographic image of knee osteoarthritis (score \<2 on Kellgren \& Lawrence scale) will be selected as controls.

Exclusion Criteria:

* systemic inflammatory disease
* rheumatic disease
* liver disease
* renal failure
* neoplasm or other chronic disease
Use of Non Steroidal Antiinflammatory Drugs in Patients With Community Acquired Pneumonia

To investigate exposure to nonsteroidal antiinflammatory drugs (NSAIDs) during outpatient management at the early stage of community-acquired pneumonia (CAP) requiring hospital consultation. Non-interventional observational study.

Recent data suggests that such exposure to NSAIDs is associated with delay in CAP diagnosis and antibiotic prescription that influence CAP presention and outcome. The investigators' working hypothesis is that NSAIDs use may mask initial symptoms and delay antimicrobial therapy, thus predisposing to worse outcomes. All patients presenting at one of the three following locations (emergency department, ICU or pneumology ward) with a suspicion of community-acquired pneumonia will be screened for eligibility. Exposure or not to NSAIDs will be investigated. Clinical, biological and radioloigcal features and outcome of CAP will be compared with respect to NSAIDs exposure.

Eligibility Criteria:
Inclusion Criteria: at least two among the following signs

* temperature \> 37.8 °C
* respiratory rate \> 25/min
* heat rate \> 100/min
* cough
* expectoration
* chest pain
* crackles upon lung auscultation

and new infiltrate on the chest x-ray

Exclusion Criteria:

* ongoing pregnancy
* sickle cell disease
* tracheostomy
* long term oxygen therapy
* cystic fibrosis or bronchiectasis
* neutropenia (\< 500 cells/mm3)
* ongoing solid or hematologic cancer or anticancerous chemotherapy
* HIV infection
* liver cirrhosis
* long term corticosteroid treatment (20mg per day equivalent prednisone for more than 15 days)
* preexisting treatment with NSAIDs for more than 15 days
* hospital admission for more than 48hours
* aspiration pneumonia
Familial Fecal Microbiota Transplant for the Treatment of Subjects With Autism Spectrum Disorders

This is an open-label clinical trial to evaluate the benefits of familial fecal microbiota transplant following a 6-week treatment with Vancomycin in minor and adult subjects with ASD for treatment of social deficits and language delays.

This is an open-label clinical trial to evaluate the benefits of familial fecal microbiota transplant following a 6-week treatment with Vancomycin in minor and adult subjects with ASD for treatment of social deficits and language delays. Participants are given FMT by colonoscopy

Eligibility Criteria:
Inclusion Criteria:

1. Subject at least two years of age.
2. Subject has confirmed diagnosis of ASD based on the DSM-V.
3. Subject with ASD whose parents/caregiver/guardian/LAR can complete informed consent process.
4. A reliable parent or caregiver who can report the side effects and communicate effectively with the research team.
5. Stable medications during the two months prior to enrollment.
6. Currently receiving interventions in the community or school for ASD.
7. If male, and partner is of childbearing potential, must be willing to utilize at least one highly effective method of birth control for the duration of the study.

Exclusion Criteria:

1. Female subjects who are pregnant, nursing, or intend to become pregnant during the study period.
2. Subjects whose caregivers are unable/unwilling to cooperate with the protocol requirements.
3. Subject will be excluded who are suffering with Rett syndrome and Childhood Disintegrative Disorder.
4. Other serious co-morbid medical disorders affecting brain function and behaviour, including uncontrolled seizures.
5. Subjects unable to refrain from taking non-study antibiotics for the period of the study.
6. Subjects diagnosed with cancer, except small localized basal cell carcinoma.
7. Subjects known to abuse alcohol or drugs.
8. Subjects who have undergone gastric bypass or total colectomy, or who are scheduled for these procedures.
9. Infection with HIV.
10. Infection with Hepatitis B or C.
11. Hepatic values greater than 20
12. Allergy to benzodiazepine.
13. Inability to stop loperamide, diphenoxylatye/atropine, or cholestyramine before the study
14. Unable to stop opiate treatment unless on a stable dose including PRN dosing, and no dose increase planned for the duration of the study
15. Known positive stool cultures for enteropathogens including, but not limited to Shigella, Salmonella, and Campylobacter within 30 days before enrollment.
16. Known stool studies positive for ova and/or parasites in 30 days prior to enrollment.
17. Planned travel outside United States during study period.
Study on Eating Habits and Association with "omic" Profiles in Families with a Subject Affected by a Chronic Immune-mediated Inflammatory Pathology. Observational Multicenter Study.

The proposed study is part of a PNRR 2022 project (call "Non-Communicable Chronic Diseases (NCDs) with high impact on healthcare and social assistance systems," currently awaiting funding response) and represents the continuation of an observational clinical study named TRANSMIC, approved by the pediatric ethics committee of the Tuscany region. TRANSMIC was an integral part of a European research project within the joint programming initiative (JPI), under the HDHL-INTIMIC theme: "A Healthy Diet for a Healthy Life," aimed at understanding the cause-effect relationships between diet, gut microbiome, and human health.

Understanding the role of diet in inflammatory bowel diseases (IBD) and exploring its role in autoimmune inflammatory conditions with joint manifestations, such as JIA, provides additional insights into the development, progression, and management of these conditions, opening new horizons for the use of dietary treatments in preventing these inflammatory conditions.


Eligibility Criteria:
Inclusion Criteria:

For families with at least one child/adult affected by IBD/JIA:

* Father and mother with children aged between 0-18 years, in good health.
* At least one adult or one child affected by IBD, or a child affected by JIA, regardless of ongoing therapy and without distinction of disease severity or activity.

For healthy families:

- Father and mother with children aged between 0-18 years, in good health and not affected by chronic inflammatory bowel diseases or chronic autoimmune inflammatory diseases in general.

Exclusion Criteria:

For subjects affected by IBD:

* Monogenic disease
* Children with an ileostomy or who have undergone a colectomy

For subjects affected by JIA:

- No exclusion criteria

For healthy subjects:

- Any chronic inflammatory bowel disease, autoimmune disease, or ongoing infectious diseases.