cyrilzakka/clinical-trials huggingface dataset:
Assessment of Depression Levels in Elderly Patients With an Orthopedic Fracture Compared to Patients After a Stroke.

Depression is common among elderly patients hospitalized due to acute conditions like strokes or osteoporotic fractures. It has significant impacts on quality of life, hospitalization rates, and mortality. Although studies have explored depression and its assessment, most focus on non-geriatric or ambulatory populations. This study examined depressive symptoms in elderly patients after a stroke or fracture. We assessed all patients for depression symptoms using the validated Geriatric Depression Scale - 15 item (GDS-15) and searched for contributing factors in each condition.

Depression is a common condition among elderly patients hospitalized due to acute events and has both short-term and long-term prognostic impacts, including reduced quality of life, recurrent hospitalizations, and even mortality. Numerous studies have examined the effects of depression and the ability to assess it, but most have been conducted in non-geriatric populations and in ambulatory patients. It remains unclear whether different acute conditions are associated with distinct risk factors for depressive symptoms and whether depressive symptoms may have varying impacts across different acute conditions. In this study, we examined depressive symptoms in two groups of elderly patients-those with stroke and those with osteoporotic fractures. These are two common acute conditions in the geriatric population, both with significant implications for patient function and the incidence of depression.

Patients were recruited from a large geriatric hospital; all patients were capable of signing consent forms. At the beginning of their hospitalization, all patients will undergo a standardized depression screening test (GDS-15), and additional data will be collected from computerized medical records, including baseline data and the Functional Independence Measure (FIM) at the beginning and end of rehabilitation. Statistical analyses, including univariate analyses and multivariate regression, will be conducted to identify variables associated with depressive symptoms. Linear regression models will be constructed for each group based on the variables significantly associated with depression to assess the risk of depression according to the identified risk factors. To evaluate the risk of depression according to the models and assess the predicted GDS value's ability to classify participants with or without depression ROC curves will be used and AUC will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 65 and hospitalization after stroke or fracture

Exclusion Criteria:

* Prior diagnosis of depression/current antidepressant treatment before hospitalization/ significant cognitive decline as indicated by a Mini-Mental State Examination (MMSE) score below 20/lacking the capacity to provide informed consent.
DIGITAL Biomarker: Blood Based Biomarkers in the Primary Care Setting for Alzheimer's Disease

The primary objective of this study is to evaluate the feasibility of implementing blood-based biomarker testing for amyloid positivity designed to aid the early detection of Alzheimer's Disease and Related Dementia (ADRD) in patients 65+ including the rate that patients and providers follow up abnormal blood-based biomarker testing.

This study is conducted to evaluate whether a new approach to screening patients for cognitive decline in primary care practices helps with earlier detection of Alzheimer's Disease. As part of the study, the provider subjects will receive training about the PrecivityAD blood biomarker test offered by C2N Diagnostics. They will be able to order the PrecivityAD test for possible Alzheimer's disease if their patient has an abnormal screening for cognitive impairment and consents to this study. Patient subjects will have their blood drawn (1 teaspoon) for the PrecivityAD blood test and will be asked to complete a surveys before and after the blood drawn. They will receive follow up phone calls within 1 to 4 weeks after they discuss the results of their blood test with their primary care.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be \> 65 years of age
* Any gender
* Is an established or new patient at one of the 6 participating IUHP PC sites
* Is able to provide informed consent (research portion only for the biomarker consent) or has a Legally Authorized Representative (LAR) who can provide informed consent
* Has a "red" DCA screening in the last 12 months (a score of 0 or 1 out of 5)

Exclusion Criteria:

* Patients who do not complete a DCA screening for any reason
* Existing diagnosis of dementia documented in their medical record based on ICD-10 codes
Safety and Efficacy Study of JTT-705 in Combination With Simvastatin 40 mg in Patients With Low High-Density Lipoprotein (HDL) Levels

The purpose of this study is to evaluate safety of JTT-705 and to demonstrate efficacy of JTT-705 compared with placebo when co-administered with simvastatin 40 mg in patients with low HDL


Eligibility Criteria:
Inclusion Criteria:

* Patients having lipid values as indicated below:
* HDL-C ≤ 1.0 mmol/L (40 mg/dL)
* TG ≤4.5 mmol/L (400 mg/dL)
* Patients with CHD or CHD risk equivalent
* Male and females between 18 and 70 years of age (female patients must be post-menopausal, surgically sterile or using an acceptable form of contraception)

Exclusion Criteria:

* Body Mass Index of ≥ 35 kg/m2
* Females that are pregnant or breast-feeding, and females of child bearing potential who are not using an effective method of contraception
* Concomitant use of medications identified in the protocol
Effects of Rock Climbing on Parkinson's Disease

This research study is being conducted to understand the outcomes of participation in the Up ENDing Parkinson's rock climbing program (24 sessions, or twice per week for about 12 weeks) on walking \& mobility, hand strength \& dexterity, and psychological well-being in individuals with Parkinson's Disease (PD). The rock climbing sessions are administered and supervised by Up ENDing Parkinson's, and are tailored to the skill level of the participant. Participants will answer questionnaires and complete physical performance tests twice, first prior to beginning the sessions and then again after the 24 sessions have been completed.

Parkinson's disease (PD) compromises multiple systems (neurological, musculoskeletal, cardiopulmonary, cognitive) over time, leading to functional decline. Additionally, individuals with PD may experience stressors commonly associated with chronic illness that can negatively impact psychological well-being. Exercise is commonly prescribed for individuals with PD and recently, interventions that are vigorous in nature and community- and performance-based are gaining traction (e.g., dancing, boxing, rock climbing). Despite increasing popularity, the evidence-base for these programs is still developing and far from conclusive. Recommendations are strong for: Community-based exercise, intensive aerobic and resistance training, and external cueing (Osborne et al., 2022). Rock climbing (RC) contains each of these elements and could potentially be a therapeutic intervention for people with PD. Yet little is known about the outcomes of this particular form of organized physical activity programs for this health condition. One such program is the rock climbing experiences offered by the UpENDing Parkinson's Rock Climbing (UEPRC).

The specific aims of this study are to characterize the effects of UEPRC on: 1) mobility and walking; 2) upper extremity (UE) functioning and 3) psychological and social well-being.

Participants will complete 24 rock climbing sessions tailored to their skill levels supervised by UEPRC over approximately 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* Diagnosis of Parkinson's disease
* Hoehn \& Yahr score 1-3
* able to speak and read in English;
* able to ambulate at least 10 meters with no assistive device or human assistance

Exclusion Criteria:

* neurological disease diagnosis other than PD;
* uncontrolled cardiovascular, pulmonary, neurological, or metabolic disease which may impact the ability to exercise or in which exercise is contraindicated;
* cognitive or psychiatric impairment precluding informed consent or ability to following instructions;
* pregnancy;
* inability to ambulate 10 meters without assistive device or human assistance
A Study Evaluating the Effect of Frozen-Section Directed Excision Surgery on Vulvar Dysplasia

The purpose of this study is to compare "Frozen-Section Directed Excision", which has been a proven method of surgery used in dermatology, versus the current, standard method called "Wide Local Excision" to treat high-grade vulvar dysplasia.

This is a randomized, single-blinded study. The target population is adults ≥ 18 years of age with histological or cytological confirmation of VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS with a planned excisional procedure, with high suspicion by the enrolling investigator that gross surgical margins of ≥ 3 mm can be achieved without laser or other destructive procedures. One group of subjects will be assigned to the Frozen-Section Directed Excision surgery arm and will undergo this procedure. The other group of subjects will be assigned to the Wide Local Excision (standard of care) arm and will undergo this procedure. The randomization will be 1:1, meaning for every subject who gets assigned to the Frozen-Section Directed Excision surgery arm, one will also be assigned to the Wide Local Excision arm. There is a 50% chance of getting randomized to either the Frozen-Section Directed Excision procedure or Wide Local Excision. Information regarding the surgery procedure, the amount of time the surgery procedure takes, and total amount of pain medication required during surgery and while in the surgery recovery area will be collected. The study team will also look at recurrence rates (return of the cancer) in six months, if any other therapies are required, and subject satisfaction related to the surgery, recovery, and sexual function by using questionnaires before and after the procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent and HIPAA authorization for release of personal health information.
2. Age ≥ 18 years at the time of consent
3. Histological or cytological confirmation of VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS with a planned excisional procedure, with high suspicion by the enrolling investigator that gross surgical margins of ≥ 3 mm can be achieved without laser or other destructive procedures
4. Surgery is expected to occur within 90 days from randomization
5. Ability to read and understand the English and/or Spanish language
6. As determined by the enrolling physician, ability and willingness of the subject to comply with study procedures for the entire length of the study
7. No known pregnancy

Exclusion Criteria:

1. Excision is not possible due to anatomy (proximity to urethra/clitoris)
2. Known immunodeficiency syndrome
3. Immunosuppressant medications taken within the last 30 days (HIV, organ transplant recipient, chronic steroid use/immunosuppressant)
4. History of pelvic region radiation therapy
5. Active anticancer treatment
The Molecular Mechanism and the Role of NRAMP 1gene on Tuberculosis in Taiwan Aboriginal Tribes Population

The human homologue of mice natural-resistance-associated macrophage protein 1 (Nramp 1) gene, NRAMP 1, has been reported to play a role in the susceptibility to tuberculosis in humans. The aboriginal population in Taiwan has a 5-fold higher prevalence of tuberculosis than the Han Chinese. Whether genetic factors such as NRAMP 1 polymorphisms play a role in the prevalence of tuberculosis in Taiwanese aboriginals should be clarified.


Eligibility Criteria:
Inclusion Criteria:

* The NRAMP 1 polymorphism of tuberculous patients in Taiwan.

Exclusion Criteria:

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Yoga Effect on Quality of Life Study Among Patients with Idiopathic Pulmonary Fibrosis

This study will evaluate whether regular yoga exercises designed specifically for patients with Idiopathic Pulmonary Fibrosis is associated with any change in quality of life. Half of the participants will be randomized to yoga, half to usual care. Yoga was conducted live, virtually, in the setting of the COVID Pandemic.

Idiopathic Pulmonary Fibrosis (IPF) is a chronic progressive fibrotic (scarring) disease of the lung of unknown cause. Approximately 100,000 Americans will die from IPF this year. There is no cure for IPF other than lung transplantation, which only 1% of patients will receive. Recently, 2 drugs were approved by the FDA to slow the rate of decline in lung function among patients with IPF. These drugs do not decrease symptoms or improve quality of life.

Symptoms of IPF include shortness of breath, cough, and fatigue, all of which may also adversely affect quality of life. Yoga is a practice of exercises, including breathing exercises, that has been shown to be relatively safe and to improve quality of life in some patients with other advanced lung diseases. We hypothesize that regular yoga and breathing exercises, specifically designed for patients with Idiopathic Pulmonary Fibrosis, over a period of 12 weeks will lead to improved quality of life as measured by several different quality of life questionnaires.

Eligibility Criteria:
Inclusion Criteria: Adults 18 years of age or older. We will include all consecutive consenting patients with IPF who are able to provide informed consent and are seen and followed at the Center for Interstitial Lung Disease at the University of Washington Medical Center.

Exclusion Criteria: Subjects with comorbid diseases that would prohibit them from taking part in yoga will be excluded at the discretion of the clinical-investigators. Such comorbid diseases would include paralysis, musculoskeletal discomfort that would interfere with participation or broken limbs. Since we are interested in the effect of yoga among subjects with IPF, we will exclude subjects who have previously received lung transplantation. To assess the effect "new" or "initial" participation in a yoga program with breathing exercises on quality of life, subjects who are regularly participating in yoga (outside of the study) will be excluded.
Sufentanil Infusion vs Sufentanil Bolus

Randomized single blind controlled clinical trial to test the benefit of sufentanil infusion over bolus dosing to reduce time to extubation and reduced length of ICU stay.

This study will compare Sufentanil bolus vs infusion and analyze which has a faster extubation time in participants who undergo routine cardiac surgery. The hypothesis is that routine cardiac surgery patients receiving sufentanil infusion will have a lower sufentanil concentration at the end of surgery and have a shorter time to extubation than participants receiving sufentanil bolus dosing even with similar total doses of sufentanil. The intervention will be Sufentanil infusion during surgery and evaluations will include Sufentanil blood concentrations, ICU and hospital length of stay and re-intubation rate. We will follow up with the participants through their ICU stay (primary objective) and hospital length of stay (secondary objective).

Eligibility Criteria:
Inclusion Criteria:

* Scheduled non-emergency cardiac surgical patients including those with planned procedures of CABG, AVR, and combined CABG and AVR
* 19 to 80 years old
* Planned pre-operative anesthesia screening visit and/or preoperative surgical clinic visit.
* Inpatient subject that is scheduled (greater than 24hrs in advance) for a non-emergency cardiac surgical case

Exclusion Criteria:

* Sufentanil allergy
* EF less than or equal to 30%
* Moderate or severe right ventricular dysfunction,
* Moderate pulmonary dysfunction, to include patients with at home 02 and/or daily bronchodilator therapy.
* End Stage Renal Disease on Dialysis
* Chronic Kidney Disease with GFR \<30
* Sternotomy Re-do
* Emergency surgery
* Greater than 4 units of RBCs or FFP combined
* Mechanical circulatory support post-operatively such as ECMO, IABP, Impella
* Not eligible for rapid wean extubation protocol
* Requires infusion of sedative medication required during ICU admission
* Greater than or equal to 15 minute ICU hold within PACU
Study to Assess SLN124 in Patients With Polycythemia Vera

This is a Phase 1/2, multicenter study with an open-label dose escalation followed by a randomized placebo controlled and double-blind phase of SLN124 in adult patients with Polycythemia Vera (PV) to assess the safety, tolerability, efficacy, pharmacokinetic (PK), and Pharmacodynamic (PD) response of SLN124.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18 years or older.
* A confirmed diagnosis of PV according to the revised 2016 World Health Organization criteria:
* Suitable phlebotomy history
* Must agree to adhere to appropriate contraception requirements
* Patients who are not receiving cytoreductive therapy must have been discontinued from any prior cytoreductive therapy for at least 24 weeks before dosing and have recovered from any adverse events due to cytoreductive therapy.
* Patients receiving cytoreductive therapy with hydroxyurea, interferon, busulfan or ruxolitinib must have received a stable dose of cytoreductive therapy for at least 12 weeks before dosing and with no planned change in dose.
* Patients must have had a dermatological examination within 6 months prior to screening.
* Must have an Eastern Cooperative Oncology Group score of 0, 1, or 2.

Exclusion Criteria:

* Drug intolerance:

  1. History of intolerance to oligonucleotides, or GalNAc, or any component of SLN124.
  2. History of intolerance to s.c. injections.
* Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 12 weeks of screening.
* History of major bleeding events and/or a requirement for blood transfusion therapy owing to bleeding in the last 6 months prior to screening.
* Meets the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment
* Any investigational drug less than 6 weeks prior to the first dose of study drug or not recovered from effects of prior administration of any investigational agent.
* Any investigational or marketed product using GalNAc targeting less than 48 weeks prior to administration of any investigational agent.
* Clinically significant co-morbidities
* Biochemical and hematological parameters:

  1. Biochemical evidence of significant liver disease during screening
  2. Hematological parameters at screening as follows: platelets 1,000,000/µL; or white blood cell (WBC) count \> 25,000/µL; or peripheral blasts \< 1%.
ModPG3 Neo-Infant ISO 81060

Automated blood pressure cuff measurements taken by an "oscillometric device" is the standard in numerous medical settings today.

Studies show that oscillometric devices using algorithms are more accurate and consistent than devices using other non-invasive measuring techniques, especially in critical cases.

SureBP algorithm estimates BP during cuff inflation; the second, StepBP algorithm does so during deflation.

The purpose of this study is to test the algorithms contained in the ModPG3 on Neonate and Infants subjects to determine if they meet the requirements of ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type


Eligibility Criteria:
1. Inclusion Criteria

   * Meets the neonatal or infant (less than 3 years of age) subject population.
   * The neonate and infant subjects will already have an indwelling intra-arterial line.
   * Subject's legally authorized representative must consent for the subject to participate.
   * Subject's legally authorized representative must be able to read, write, speak in English and/or Italian.
   * Subject must have an arm circumference in the range of 3.3-15.0 cm.
   * Subject must be able to have blood pressures taken on the upper extremity closest to the arterial line
   * The subject has one upper arm that is free of indwelling catheters or IV lines, shunts, oximetry sensors, dressings, etc. for attachment of a NIBP cuff.
2. Exclusion Criteria

   * Lack of Informed consent.
   * Subjects with deformities or abnormalities that may prevent proper application of the device under test.
   * Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
   * Subjects with known heart dysrhythmias or arrhythmias during the measurement period.
   * Subjects with compromised circulation or peripheral vascular disease.
   * Subjects who have had surgery or have shunts or implants in the upper extremity being tested.
   * Those who have a heart rate that is irregular for any reason other than normal fluctuations in the R-to-R interval associated with respiration.
   * Hospital System Pre-Screening NIBP: those who have a systolic and/or diastolic blood pressures difference \> 12 mmHg between the hospital intra-arterial measurement and the hospital blood pressure cuff/automated vital signs monitor are excluded. The device under test cannot be used for this reading.
Carbohydrates to Prevent Hypoglycaemia During Physical Activity in Patients With Type 1 Diabetes

Backgrounds/Aims: It was the aim to prospectively study the optimum regime of "preventive" carbohydrate administration for prevention of hypoglycaemic episodes during a standardized bout of physical activity.

Research design and methods: 24 patients with type 1 diabetes participated in one experiment without physical activity and in three experiments with a 4 km, 60 min hike starting at 2 p.m., either administering 2 x 10 g or 2 x 20 g carbohydrates (muesli bars) before starting and at 30 min (during the hike). Plasma glucose was determined with a laboratory method and additional carbohydrates needed to treat hypoglycaemia between 2 and 8 p.m. were recorded.

Eligibility Criteria:
Inclusion Criteria:

Type 1 diabetes mellitus, 18-75 years, BMI 18-35 kg/m², Diabetes duration \> 1 year

Exclusion Criteria:

General bad health status, Malignant diseases, Systemic glucocorticoid treatment, Coronary heart disease, Uncontrolled arterial hypertension, Acute infection diseases, Diseases of liver or kidney with significant organ malfunction, Abuse of alcohol or other drugs, Participation in another trial in the last 3 months

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