cyrilzakka/clinical-trials huggingface dataset:
Accidental Hypothermia in Drowning-related OHCA

This study aims to report mortality and neurological outcome 180 days after drowning incident in patients with accidental hypothermia vs normothermia following drowning-related OHCA in Denmark during a six-year period from 2016-2021.

The incidence of accidental hypothermia in patients with out-of-hospital cardiac arrest (OHCA) due to drowning is prevalent. Accidental hypothermia is known to decrease oxygen consumption and hypoxic brain damage in patients with OHCA, but may result from prolonged submersion times, which is shown to increase drowning mortality and morbidity. However, many case reports present extraordinary instances of hypothermic patients with drowning-related OHCA surviving with a good neurological outcome despite prolonged submersion times. A larger, retrospective study is warranted to accurately investigate the role of accidental hypothermia in patients with drowning-related OHCA.

This study is a nationwide, retrospective cohort study with 180-days follow-up from 2016-2021 comparing survival and neurological outcome 180 days after drowning incident in normothermic (≥35C) vs hypothermic (\<35C) patients with drowning-related OHCA. A total of 317 patients have been identified by the Danish Drowning Formula and manually validated (Breindahl et al, 2023, unpublished data). Prehospital data from the DCAR will be linked to in-hospital data using the patients' unique civil registration number and presented the "Utstein style". The primary outcome is composite of mortality or poor neurological outcome 180 days after drowning incident (modified Rankin Scale score \> 3). Secondary outcomes include hospital length of stay (continuous), intensive care unit admission (binary) and length of stay (continuous), need for ECLS (binary) and duration (continuous), need for mechanical ventilation (binary) and duration (continuous), survival to hospital discharge, and 30-day survival.

The investigators expect to provide evidence on the role of accidental hypothermia in drowning-related OHCA to support evidence-based guidelines and improve clinical decision-making in the future.

Eligibility Criteria:
Inclusion Criteria - Drowning persons with:

* OHCA registered in the DCAR from 2016-2021.
* An in-hospital temperature measurement (using any probe) within 6 hours after hospital admission.

Exclusion Criteria - Drowning persons will be excluded if:

* They have obvious signs of irreversible death (decapitation, decomposition, post-mortem lividity, post-mortem rigidity).
* They are declared dead on scene.
* They have a valid Do-Not-Attempt-Resuscitation order or other code status orders limiting life-sustaining therapies.
* They do not have a valid civil registration number.
* They do not have a valid in-hospital temperature measurement (any probe within 6 hours after hospital admission).
A Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

This study was conducted to provide detailed information on the efficacy of indacaterol in terms of its effect on spirometry assessed forced expiratory volume in 1 second (FEV1) over a 24 hour time period.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2006) and:

  1. Smoking history of at least 20 pack-years
  2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
  3. Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%

Exclusion Criteria:

* Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
* Patients requiring long-term oxygen therapy (\> 15 hours a day) for chronic hypoxemia
* Patients who have had a respiratory tract infection within 6 weeks prior to screening
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time
* Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged
* Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period
* Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria applied to the study.
Timing of Indomethacin Administration for the Prevention of Post-ERCP Pancreatitis (PEP)

To determine if the timing of administration of indomethacin affects the primary outcome of post-ERCP pancreatitis (PEP). Patients undergoing ERCP will be randomly assigned to receive pre or post-procedure rectal indomethacin to prevent the occurrence of PEP.


Eligibility Criteria:
Inclusion Criteria:

* All patients referred for ERCP at the University of Alberta
* Age greater than 18 years
* Ability to provide written informed consent

Exclusion Criteria:

* Acute pancreatitis
* Active peptic ulcer disease
* Rectal disease
* Aspirin-induced asthma
* Nonsteroidal anti-inflammatory drug (NSAIDs) induced hypersensitivity
* Pregnancy
* Breast feeding
* Creatinine clearance \< 30 ml/min
The Study of the Efficacy of Laser Acupuncture on Osteoarthritis Knees by Using Magnetic Resonance Imaging, Clinical Evaluation, and Movement Analysis

To study the efficacy of laser acupuncture on osteoarthritis (OA) knee patients by magnetic resonance imaging (MRI), clinical evaluation and movement analysis.

The Kellgren-Lawrence (KL) grading scheme for OA knee

Patient selecting flow Age: 20-70 year old Grade II-III knee OA Exlusion: Trauma history/ Space claustrophobia /Severe chronic disease/ Malignancy Pregnancy Study Cases 40 Randomize Pre-treatment MRI (to evaluate grade of OA knee/ the T2 signal of the cartilage), MRS (baseline glutamate), Movement analysis(sit to stand), Maximum strength ratio of Quadriceps/Hamstring WOMAC Post-treatment evaluation laser therapy Modality: LA-400 Treatment protocol of low level laser

* 40mW, 50Hz, 808nm (invisible light) , 15min
* The effect of laser acupuncture is dose dependent Effect of Laser Therapy on Chronic Osteoarthritis of the Knee in Older SubjectsJ Lasers Med Sci. 2016 Spring; 7(2): 112-119
* 830nm is an effective form of treatment for chronic knee pain caused by knee osteoarthritis. Low Level Laser Therapy for chronic knee joint pain patientsLaser Ther.

  2014 Dec 27; 23(4): 273-277
* Duration: 2 weeks Frequency: 3 times/week
* Control group: no treatment Acupuncture point: EX- LE-5, EX-EL 2, SP10

Eligibility Criteria:
Inclusion Criteria:

* Kellgren-Lawrence grade II \~ III

Exclusion Criteria:

* Trauma history/ Space claustrophobia/ Severe chronic disease/Malignancy Pregnancy
Evaluation of the Impact of a Collaboration Between Hospital and Community Pharmacists At Hospital Discharge

The aim of this study is to evaluate the impact of an enhanced collaboration between a hospital pharmacist and a community pharmacist during hospital discharge. For patients taking multiple medications, hospitalization often involves numerous changes to their treatment regimen. For community pharmacies, discharge prescriptions are often complex, and they sometimes lack the information that pharmacists need to deliver the treatment as safely as possible. As a result, there is a risk of medication errors, and a risk for patients. We aim to evaluate the benefits of this collaboration for adult patients admitted to the internal medicine ward of a regional hospital who are taking seven or more drugs and are being discharged to home.

The main question it aims to answer is : Does the enhanced collaboration reduce the number of drug-related problems encountered by community pharmacists with discharge prescriptions ? Researchers will compare patients when a hospital pharmacist is involved during the discharge process and when he or she is not involved, which corresponds to normal care.

The hospital pharmacist will not perform the intervention directly on the patient, but only with the community pharmacy. Once they agree to participate in the study, patients will only have to go to their usual community pharmacy after discharge and accept that the hospital transmits medical information to their usual pharmacy.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the internal medicine ward for more than 48 hours
* Patients prescribed seven or more drugs at the time of screening
* Patients discharged to home
* Patients able to give informed consent as documented by signature

Exclusion Criteria:

* Patient discharged to another hospital, nursing home or rehabilitation clinic
* Refusal of the community pharmacy to participate
* Inability to sign consent and follow the procedures of the study, due to language problems, psychological disorders, dementia, alterations of consciousness and lack of judgement
A New Glucose Meter With Alternative Site Testing

The purpose of the study was to evaluate the performance of the blood glucose monitoring system when used with samples taken from the palm and forearm for alternative site testing (AST).

The blood glucose monitoring system may be used for alternative site testing. The blood glucose results obtained by subjects with samples taken from the palm and forearm were compared with fingerstick capillary blood glucose results obtained from subjects by an HCP. Product labeling was evaluated for comprehension of performing alternative site testing as well as for additional meter features. User feedback about the system and its features was obtained.

Eligibility Criteria:
Inclusion Criteria:

* Have type 1 or type 2 diabetes
* Be \>18\<76 years of age at time of consent, with approximately 50% (+10%) being less than 55 years of age
* Be willing to complete all study procedures
* Be routinely testing their blood sugar at home (at least once per day)
* Be able to speak, read, and understand English and understand the Informed Consent document
* Be able to read the labeling instructions

Exclusion Criteria:

* Minors \<18 years of age and adults \>75 years of age
* Pregnancy
* Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGMS
* Disorders in the fingertip lancing areas
* Acute or chronic infections, particularly skin infections
* Infection with a blood borne pathogen
* Taking prescription anti-coagulants or having clotting problems that may prolong bleeding. Taking aspirin daily (81mg or 325 mg) is not reason for exclusion.
* Hemophilia or any other bleeding disorder
* Having a condition which, in the opinion of the Principal Investigator or designee, would put the person at risk or seriously compromise the integrity of the study
* Working for a competitive medical device company
Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis

To determine the cumulative incidence of total hip replacement, time to event after treatment with Fosamax or placebo during the study peroid

To determine the cumulative incidence of total hip replacement and collpase of femoral head, time to event after treatment with Fosamax or placebo during the study peroid

Eligibility Criteria:
Inclusion Criteria:

* osteonecrosis of femoral head
* be able to provide singed informed consent

Exclusion Criteria:

* prior bisphosphonate use
* pregnant or lactating woman
* bilateral hip replacement
Family Drama Project II

A harmonious family relationship has significant effects on the psychological well-being and development of children. Good communication between parents and children is a crucial element for family health, happiness and harmony. However, communication within Hong Kong families is vastly inadequate partly due to our busy urban lifestyle.

The 3Hs Family Drama Project (Phase 2) was an enhanced version of the 3Hs Family Drama Project to promote health, happiness, harmony (3Hs), healthy eating and physical activity in primary school students. Students watched the interactive live drama (long or short version) and are given DVD and worksheets. Students were encouraged to watch the DVD with other family members at home. The present study aimed to evaluate the effectiveness and satisfaction levels of teachers, parents and students towards the drama project.

3Hs Family Drama Project (Phase 2) was an intervention to enhance the 3Hs through increasing interaction and communication between parents and children. Healthy eating and physical activity were also promoted. The drama project conducted 100 drama performances (either in the long or short version) in primary schools during the 2015-16 school year. The main targets were Primary 3 to 5 (P3-5) students and their families. Students would take home a DVD of the drama to watch and worksheets to complete with parents and other family members.

The goals of the study were to evaluate the effectiveness of the project to enhance health, happiness, harmony (3Hs), healthy eating and physical activity and participants' satisfaction levels towards the drama project.

Quantitative assessments were used to evaluate the effectiveness of the project. Process evaluations were performed in randomly selected students, parents and teachers to evaluate the process of each component of the program. Qualitative and quantitative assessments were used. Students, parents and teachers were asked to express their views on a questionnaire. Feedback from students was also collected through small group discussions, while that of parents was collected through telephone interviews.

Eligibility Criteria:
Inclusion Criteria:

Students: (both the Intervention group and waitlist control group)

* 1. Students who can read Chinese.
* 2. Primary 3 to 5 students in participating primary schools.

Parents: (Intervention group only)

* 1. Parents who can read Chinese.
* 2. With at least one primary school child.

School teachers: (Intervention group only)

* 1. Teachers who can read Chinese.

Exclusion Criteria:

* Students, parents or teachers who cannot read Chinese.
The Effect of Punctal Plugs on Ocular Surface After Povidone-Iodine Preparation of Intravitreal Injection

The aim of this study is to evaluate the effectiveness of punctal plugs in reducing ocular surface (eye surface) irritation after intravitreal injections prepared by povidone-iodine 5% solution.

Intravitreal injection is a shot of medication into the eye. Many retinal diseases, such as diabetic retinopathy, neovascular age-related macular degeneration, and retinal vein occlusions require regular, periodic injections. Patients often reports eye surface irritation post intravitreal injection. One of the reasons for such discomfort is attributed to povidone-iodine solution used to clean the eye surface to reduce sight-threatening infections. Patients who already experience symptoms of dry eye are at increased risk of discomfort after povidone-iodine prepped intravitreal injections.

Povidone-iodine is known to be corrosive to the corneal epithelium and delay eye surface healing. Human tears contain proteins and chemicals that lubricate, heal, and protect the eye surface from infections and irritants. Adequate tear film therefore not only dilutes povidone-iodine, but also promotes corneal healing post povidone-iodine prepping.

The primary long-term objective of the present study is to investigate whether punctal plugs will reduce eye discomfort post intravitreal injections as reported by the Ocular Surface Disease Index (OSDI) and other relevant surveys. The secondary outcome is to describe any other risk and protective factors associated with eye surface discomfort after intravitreal injections.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of age-related macula degeneration
* Clinical diagnosis of diabetic retinopathy
* Clinical diagnosis of retinal vein occlusion

Exclusion Criteria:

* Currently wearing punctal plugs
* History of punctal cautery,
* Active ocular infection
* History of ocular infection
* Eyelid trauma
* Eyelid surgery
* Graft versus host disease
* Thyroid eye disease.
In-house Produced PMMA- Versus PEEK-cages

Subsidence of cervical cages is a common problem. For the study, a new polyacrylmethacrylate cage was designed and prospectively implanted in patients with a mono- or bilevel cervical pathology. As control, a commercially available PEEK-cage was used, patients were randomized using minimization randomization, controlling for age and bone mineral densitiy. The investigators hypothesize that the newly developed cage has similar clinical and radiological qualities compared to the PEEK-cage, but at a much more favourable cost-performance ratio.


Eligibility Criteria:
Inclusion Criteria:

* virgin spines
* no emergency operation
* age above 18
* sufficient knowledge of the German language
* indication for anterior cervical discectomy and fusion
* absence of concomitant spinal disease

Exclusion Criteria:

* prior cervical surgery
* indications other than ACDF
* concomitant neoplastic, metabolic, severe general or infectious disease
Oscar Health Patient Pings

Oscar spends a significant amount of money every year on high cost high need individuals. With this increase in health care spending, Oscar Health is looking to expand care post emergency room and inpatient utilization for their members. In order to reduce hospital readmissions, reduce emergency room utilization, and increase the overall health of their members, Oscar is investing in a program to bring members better care through increased engagement with their primary care physician.

Using their existing technology, Oscar is employing a randomized controlled trial among their physicians to improve their engagement and relationships with patients. The goal will be to test and refine patient pings as a provider engagement tool, with an eye toward using it within the broader approach to high-risk patients as well. The Penn team is helping to design the intervention, which includes helping with determining what the three arms will be and randomizing physicians and practice sites. They will implement a three-arm trial with the first arm being usual care (no pings), the second arm being the intervention of information, and the third arm being the intervention of information and financial incentives. In the two intervention groups, providers will be sent patient pings after a patient experiences a trigger event. This trigger event could be an emergency room visit, admission to a hospital, or a hospital discharge event. The patient ping will be sent to the patients doctors including primary care physicians and specialists. If the patient does not have a doctor, a ping will not be sent. In the third arm, physicians will be incentivized to see patients immediately via phone call or in office visit. Physicians will receive an incentive for calling the member within 48 hours of trigger event and will receive a larger financial incentive for seeing the patient for an office visit within 7 days of trigger event. This bonus payment will be paid to physicians uncoupled from usual reimbursement as a separate bonus check to increase salience. No pings will be sent to the physicians for the patients randomized to arm 1: usual care.

Eligibility Criteria:
Inclusion Criteria:

* Primary care and specialist physicians under contract with Oscar Health insurance

Exclusion Criteria:

* Any primary care and specialist physician not under contract with Oscar Health.
MOSE to Improve the Diagnostic Accuracy During EUS-guided FNA Using a 19-gauge Needle for Solid Lesions

The technique of macroscopic on-site evaluation (MOSE) has recently been advocated for estimating the adequacy of a core specimen for histological diagnosis during EUS-FNA using a 19-gauge needle. How it compares to the conventional technique of tissue acquisition during EUS-FNA is uncertain.

The objective of this study is to evaluate the quantity and quality of tissue, and the diagnostic ability of MOSE when compared with the conventional combined histologic-cytologic analysis.

To evaluate the quantity and quality of tissue, and the diagnostic ability of MOSE when compared with the conventional combined histologic-cytologic analysis in a randomized controlled study.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients (aged between 18 and 80 years) referred for EUS-guided tissue acquisition for intestinal or extra-intestinal solid lesions more than 2cm in the largest diameter would be included.

Exclusion Criteria:

* Patients with coagulopathy, altered anatomy, contraindications for conscious sedation, pregnancy and those who cannot provide informed consent would be excluded.
Screening Aid to Identify Corneas That May Have Pathologies or Other Conditions

The purpose of this study is to determine the ability of a proprietary software screening tool to discriminate normal corneas (front surface of the eye) from previously diagnosed corneal conditions (diseases/surgeries/pathologies) and to determine the repeatabiltity and reproducibility of the Atlas II corneal topographer in normal human corneas.

1. To establish reference values for SF, CIM, and TKM in subjects with normal corneas.
2. To establish reference values for SF, CIM, and TKM in subjects who underwent myopic laser vision correction.
3. To establish reference values for SF, CIM, and TKM in subjects who underwent hyperopic laser vision correction.
4. To establish reference values for SF, CIM, and TKM in subjects who were diagnosed to have keratoconus.
5. To establish reference values for SF, CIM, and TKM in subjects with history of orthokeratology.
6. To establish reference values for SF, CIM, and TKM in subjects with previously diagnosed corneal conditions (diseases/pathologies/surgeries) affecting the corneal surface that are not listed above.
7. To determine the repeatabiltity and reproducibility of the Atlas II corneal topographer in normal human corneas using true elevation data and axial curvature.
8. To determine the sensitivity, specificity, and accuracy of the Pathfinder II Corneal Analysis software in discriminating normal corneas from previously diagnosed corneal conditions (diseases/pathologies/surgeries) affecting the corneal surface (Phase II).

Eligibility Criteria:
Inclusion Criteria:

Normals

* Patients seeking initial laser vision correction that were screened to be good candidates for the procedure.
* No history of refractive or other ocular surgery.
* No corneal pathologies.
* Normal corneal topography.
* Contact lens wearers should discontinue use at least 2 weeks for hard contacts, and 3 days for soft lenses prior to imaging.

Keratoconus

* An irregular cornea determined by distorted keratometry mires, distortion of the retinoscopic, or ophthalmoscopic red reflex (or a combination of these)
* At least one of the following biomicroscopic signs: Vogt's striae, Fleischer's ring of \>2 mm arc, or corneal scarring consistent with keratoconus.
* Contact lens wearers should discontinue use preferably 1 day or at least half an hour prior to imaging.

Myopic Laser Vision Correction

Patients who have undergone myopic:

* LASIK
* PRK
* LASEK

Hyperopic Laser Vision Correction

Patients who have undergone hyperopic:

* LASIK
* PRK
* LASEK

Orthokeratology

* Patients using specially designed rigid contact lenses to reshape the cornea to temporarily reduce or eliminate refractive error.
* Subjects must be 18 years of age or older; able and willing to make the required visit; and able and willing to give consent.

Exclusion Criteria:

* Patients that underwent corneal transplantation or any ocular surgery for the following categories: normal, keratoconus, and orthokeratology)
* Any active infection or inflammation of the cornea.
* PI decides that subject is not suitable due to medical risk.