cyrilzakka/clinical-trials huggingface dataset:
Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology

Through this cohort study, previous clinical data can be systematically reviewed and supplemented through clinical follow-up. Prospective enrollment and follow-up observation of subsequent patients can also be carried out to build a retrospective-prospective two-way cohort study. The intraoperative, perioperative, clinical follow-up and health economics of surgical robot, computer navigation, personalized osteotomy guide and other digital technologies and traditional TKA were comprehensively and objectively compared, the results and conclusions of the center were summarized and reported, and the effectiveness and safety of digital assistive technology applied to TKA were explored, providing references for clinical diagnosis and follow-up research.

Through this cohort study, previous clinical data can be systematically reviewed and supplemented by follow-up visits. Prospective enrollment and follow-up of subsequent patients can also be carried out to build a retrospective-prospective two-way cohort study. The preoperative situation (general statistical information, educational level, preoperative clinical function score, etc.), intraoperative situation (operative time, intraoperative blood loss, intraoperative complications, etc.), perioperative situation (total postoperative blood loss, blood transfusion rate, postoperative complications, etc.) and clinical follow-up situation were comprehensively and objectively compared with surgical robot, computer navigation, personalized osteotomy guide and other digital technologies and traditional TKA We summarized and reported the results and conclusions of the center (postoperative force line, implant location, pain, mobility, clinical function score, patient satisfaction and postoperative complications, etc.) and health economics (average length of stay, hospitalization cost, etc.) to provide reference for clinical diagnosis and follow-up research.

Eligibility Criteria:
Inclusion Criteria:

* a. primary knee osteoarthritis;
* b. Unilateral primary knee replacement;
* c. Surgical methods were traditional surgery, surgical robot, computer navigation or personalized osteotomy guide

Exclusion Criteria:

* a. A history of renal insufficiency (Cr \> 2.5), liver insufficiency, severe heart disease (or coronary stenting within the last 12 months), severe respiratory disease, history of VTE or high risk of thrombosis (hereditary/acquired thrombotic disease), cotting disorder, stroke, and malignancy;
* b. Those who do not accept this test for any reason and refuse to sign the informed consent.
Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses

Bilateral dispensing clinical trial of fanfilcon A toric lens verses enfilcon A toric lens over two weeks.

Evaluation of the clinical performance of an investigational silicone-hydrogel lens called fanfilcon A (test) compared to a FDA-cleared commercially available contact lens called enfilcon A toric lens (control) when worn on a daily wear basis over 2 weeks in a randomized, bilateral, cross-over, dispensing study.

Eligibility Criteria:
Inclusion Criteria:

* Are at least 17 years of age for Canada and 18 years of age for the USA and have full legal capacity to volunteer;
* Have read and signed an information consent letter;
* Are willing and able to follow instructions and maintain the appointment schedule;
* Are an adapted soft contact lens wearer;
* Require spectacle lens powers in both eyes;

  * Sphere: between -0.50 to -6.00 diopters and
  * Astigmatism: between -1.25 to -2.00 and
  * Axis: 180 ± 20 degrees
* Are willing to wear contact lens in both eyes;
* Have manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye;
* To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit including toric orientation as acceptable;

Exclusion Criteria:

* Are participating in any concurrent clinical or research study;
* Have any known active\* ocular disease and/or infection;
* Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
* Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
* Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;
* Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
* Are aphakic;
* Have undergone refractive error surgery;
Assessment of the Efficacy of Vitamins A and D and γ-oryzanol-fortified Canola Oil in Adults With Type 2 Diabetes

The aim of this study is to evaluate the efficacy of daily intake of fortified canola oil with vitamins A and D and γ-oryzanol on anthropometric, inflammatory, immunity, appetite and metabolic indicators of adults with type 2 diabetes compared to canola and sunflower oil without γoryzanol.

Ninety confirmed type 2 diabetes patients aged 20-65 years old will be selected. Participants who change their usual medicine intake or make any changes in their diet and lifestyle that could alter the effectiveness of the intervention as well as those who do not use the fortified oil for three consecutive days or do not use the fortified oil for more than ten days throughout the intervention will be excluded. Subjects will be assigned randomly to one of the three intervention groups: 1.fortified canola oil with vitamins A and D and γ-oryzanol , 2. fortified canola oil with vitamins A and D, 3. fortified sunflower oil with vitamins A and D. Each participant will consume 30 g of oil every day for 2 months.

At the first and last visits, dietary and laboratory assessments will be performed for all subjects. The primary outcomes are the improvement of anthropometric, inflammatory, immunity, appetite, glycemic, and lipidemic markers of adults with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetic patients with fasting blood sugar above 100 mg/dL or hemoglobin A1c above 6% in the last test
2. Age between 20 to 65 years
3. No use of insulin

Exclusion Criteria:

1. Changing usual medicine intake or making any changes in diet and lifestyle that could alter the effectiveness of the intervention
2. Not using the fortified oil for three consecutive days or not using the fortified oil for more than ten days throughout the intervention period
Mechanisms of Acupuncture Analgesia on Experimental Dental Pain - A Psychophysical Study (Phase1)

The investigators will assess the effects of manual acupuncture on experimental dental pain in 36 healthy subjects by means of subjective pain intensity ratings and pain-specific autonomic nervous system (ANS) reactions.

This psychophysical and -physiological study is the first part of a two-phase project which pursues to explore how acupuncture-induced pain modulation interacts with pain-specific brain processing patterns by means of functional magnetic resonance imaging (fMRI) and by using an experimental dental pain model.

In this preceding study, the characterization of manual acupuncture effects on the experimental dental pain model will be tested under laboratory conditions and without restrictions of an fMRI-measurement in order to provide a sound foundation for the following fMRI-experiment. Pain modulating effects of the manual acupuncture intervention (4 points: needle manipulation of bilateral large-intestine 4 (LI4), stomach 6 and 7 (ST6, ST7) ipsilateral to the stimulated tooth) will be compared to sham-acupuncture (insertion and manipulation of 4 non-acupuncture points) and a control intervention (no acupuncture) which will each be performed at 3 different days in a randomized order. Intervention effects on experimental dental pain will be assessed by testing of 36 healthy volunteers by means of subjective pain intensity ratings and pain-specific ANS reactions such as electrodermal activity and heart rate/respiratory changes. Besides laying the groundwork for the following fMRI experiment, this study could provide valuable basic insights into the dynamics of the tested manual acupuncture effects and further provide important knowledge for the planning of future clinical studies encompassing dental conditions and development of acupuncture treatments.

Eligibility Criteria:
Inclusion Criteria:

* right-handed
* Written informed consent
* Fluent in German language
* Sufficient dental sensitivity for the tooth stimulation
* No acupuncture treatment in the previous 12 months
* No medical knowledge about acupuncure

Exclusion Criteria:

* Alcohol, drug, and analgesics consumption within the last 24 hours
* Complaints of diseases of the oral cavity
* Pre-existing neurological and(or psychiatric conditions
* History of severe dental pain
* Regular intake of pain medication
* History of brain injuries
* Alcohol and drug abuse
* Chronic diseases that require a permanent intake of drugs
Hand-carried Ultrasound to Assess Hydronephrosis

This study evaluates if trainees can accurately rule out dilation of the renal collecting system on ultrasound (hydronephrosis) using hand-carried ultrasound (HCU). Trainees will undergo a short ultrasound training program. Patients will be adults that are hospitalized and have acute or subacute kidney dysfunction. The investigators will assess sensitivity, specificity, positive and negative predictive value of HCU compared to radiology performed ultrasound, and calculate potential cost savings to the patient and to the healthcare system.

Hand-carried ultrasound is an increasingly popular imaging modality and is widely used by emergency physicians, intensivists, trauma doctors and cardiologists. Renal ultrasonography is commonly ordered for patients with acute kidney injury, with a main focus on identifying obstruction of the collecting system, a rare but potentially reversible cause of acute kidney injury.

This study's aim is to evaluate if nephrology and internal medicine trainees can accurately rule out dilation of the renal collecting system on ultrasound (hydronephrosis) using hand-carried ultrasound (HCU). Trainees will undergo a short, uniform and well described ultrasound training program. Patients will be adults that are hospitalized and have acute or subacute kidney dysfunction. The investigators will assess sensitivity, specificity, positive and negative predictive value of HCU compared to radiology performed ultrasound, and calculate potential cost savings to the patient and to the healthcare system.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years old
* Inpatient admission to Barnes Jewish Hospital (BJH)
* Patient has a diagnosis of Acute kidney injury (AKI) or Acute kidney Disease (AKD)
* Renal ultrasound ordered or performed within the past 4 hours

Exclusion Criteria:

* End-stage renal disease
* History of kidney transplant
* Stable chronic kidney disease
* Current diagnosis of renal cell carcinoma
* Pregnant women
* Morbid obesity (BMI \>40)
* Rash or active skin lesions overlying the scanning area (left or right flank)
A Study of Fostamatinib in Subjects With Impaired Hepatic (Liver) Function

A study to evaluate the amount of fostamatinib in the blood in subjects with impaired hepatic (liver) function compared with healthy volunteers with normal liver function. The study will also evaluate safety and tolerability in subjects with hepatic impairment.


Eligibility Criteria:
Inclusion Criteria:

* Males and females (non child-bearing potential) aged 18 years or more, with a weight of at least 50 kg and body mass index (BMI) between 18 and 40 kg/m2 inclusive
* Healthy subjects only: good health as determined by a medical history, physical examination , ECG and clinical laboratory evaluations
* Healthy subjects only: negative results for serum hepatitis B and C

Exclusion Criteria:

* Subjects who have received any medications known to alter drug absorption or elimination within 30 days of first dose.
* Subjects who smoke more than 10 cigarettes or equivalent per day
* Absolute neutrophil count \<2500/mm3
* Abnormal vital signs, additional systemic disease (eg, cardiac, or renal disease) or abnormal laboratory findings that are judged to be clinically significant by the investigator
* Healthy volunteers only: use of prescribed medications within 2 weeks of first dose or use of non-prescribed medications within 1 week of first dose
* Hepatic subjects only: fluctuating or rapidly deteriorating hepatic function
SunRISe Study - Stroke Rehabilitation In Suriname

This study aims to determine the effect of a supervised home-based physical fitness program on the aerobic capacity, quality of gait and health related quality of life in people with chronic ischemic stroke. Secondly, feasibility of the program for implementing a long term lifestyle change will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* ability to give informed consent
* ability to understand measurement procedures defined as MMSE \>24
* last stroke \>6 months ago
* mild to moderate stroke deficit defined by Fugl Meyer test score of 27 to 90 for upper and lower extremities
* FAC ≥3
* medical clearance to participate in a moderate exercise program
* living at home and having a minimum of 5 stairs at home

Exclusion Criteria:

* serious cardiac condition
* other serious end organ damage
* other neurological deficits leading to disability
* uncontrolled blood pressure (systolic pressure \>140, diastolic pressure \>90)
Evaluation of the Exercise for Wellbeing Pathway At York St John University

In autumn 2024, York St John University launched a physical activity programme for university students facing mental health challenges. The purpose of this project is to conduct a mixed-methods evaluative study of this new service over a 6-month period. It is anticipated that 20-40 students will be recruited to the study, which will assess the following: assess the following: feasibility, the extent to which the service can be delivered successfully; acceptability, the extent to which the service is considered appropriate, satisfactory, or attractive by programme recipients and intervention delivery staff; fidelity, the extent to which the key service components (e.g., assessment procedures, physical activity programme) were implemented as planned and adaptations were made; preliminary effects, with relation to physical, mental and social health outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Student enrolled at York St John University
* Age 18 years and over
* Undertaking a course which requires attendance at York St John University's Lord Mayor's Walk Campus
* Presenting to the student wellbeing team with mild-to-moderate mental health concerns (defined as experiencing symptoms of poor mental health such as feeling depressed or socially isolated, prolonged stress and anxiety, or experiencing academic decline that makes their daily life more difficult but maintain daily functioning) and expressing an interest in enhancing their mental health and daily functioning

Exclusion Criteria:

* Unwilling or unable to provide written informed consent
* Unable to attend (or to participate in) the scheduled physical activity sessions
* Unsuccessful physical activity clearance using the physical activity readiness questionnaire (PAR-Q+)
A Study of Wearable Device in Essential Tremor Patients

The purpose of this research is to observe the daily loss of benefit from DBS therapy by performing a standardized set of tasks throughout the day while wearing an Apple Watch to collect movement and other physiological data.


Eligibility Criteria:
Inclusion Criteria:

* Patients with well-classified essential tremor, who are already receiving regular DBS therapy at Mayo Clinic for their movement disorder.
* Ability to understand study procedures and to comply with them for the entire length of the study and use study devices as outlined in protocol.
* Patient agrees to perform daily tasks in BrainRISE app and consents to the study collecting video and audio recordings during those tasks.
* Proficient in the use of a smart phone.

Exclusion Criteria:

* Cognitive or psychiatric condition rendering a patient unable to cooperate with data collection, or to manage and recharge smart watch and tablet computer devices.
* Presence of open or healing wounds near monitoring sites (infection risk).
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MEMP1972A in Patients With Allergic Rhinitis

This is a Phase Ib, randomized, blinded, placebo-controlled, multiple-ascending dose study in patients with seasonal or perennial allergic rhinitis to investigate the safety, tolerability, and pharmacokinetics (PK) of MEMP1972A.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of allergic rhinitis
* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
* Males or females who are surgically sterilized, post menopausal for the past year, or are using two acceptable methods of contraception against pregnancy through at least 6 months after the dose of study drug

Exclusion Criteria:

* History or clinical manifestations of significant metabolic, hepatic, renal, hematologic, immunodeficiency, pulmonary, cardiovascular, gastrointestinal, urologic, neurologic, or psychiatric disorders
* History of anaphylaxis, hypersensitivity or drug allergies
* Use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days prior to dosing
* Use of a biologic investigational therapy or participation in an investigational study involving biologic therapy within 3 months prior to dosing
* Positive blood test for chronic viral infections by: hepatitis B surface antigen, hepatitis C virus antibody, or HIV antibody
Safety and Antiviral Activity of Entecavir in Participants With Chronic Hepatitis B Following Monotherapy in Other Entecavir Trials

The purpose of this study is to provide entecavir to participants who have completed another entecavir trial without achieving virologic response or who relapsed during postdosing follow-up.


Eligibility Criteria:
Key inclusion criteria:

* Age of 16 years and older
* Receipt of entecavir or lamivudine in a previous entecavir study.

Participants who were, based on their response to entecavir:

* Virologic nonresponders at Week 48
* Partial virologic responders who became nonresponders during the second year of treatment
* Partial virologic responders at Week 96
* Complete responders who relapsed during postdosing follow-up

  * Decompensated liver disease in AI463-048 that met 1 or more of the following criteria:
* Nonresponse to adefovir after at least 24 weeks of treatment
* Partial response to adefovir after 96 weeks of treatment
* Complete response to adefovir after relapsing during postdosing follow-up
* Demonstrated intolerance to adefovir

  * Except for those participants enrolled from AI463-048, compensated liver disease.

Key exclusion criteria:

* HIV coinfection
* Receiving nephrotoxic or hepatotoxic agents
* Ongoing opportunistic infections
* Hemoglobin level \<11.0 g/dL except for those enrolled from AI463-048
* Platelet count \<70,000 mm\^3 except for those enrolled from AI463-048
* Absolute granulocyte count \<1,500 cells/mm\^3
* Recent history of pancreatitis (within 24 weeks prior to first dose of therapy)
* Current evidence of ascites requiring paracentesis, hepatic encephalopathy, or variceal bleeding, except for those enrolled from AI463-048
* Known history of allergy to nucleoside analogues.
Cardiac Rehabilitation After Pacemaker Implantation

The investigators assessed whether short-term cardiac rehabilitation following pacemaker implantation was enough to improve both physical function and quality of life.

Exercise-based cardiac rehabilitation (CR) improves clinical outcomes in patients with cardiovascular diseases. However, few data exist regarding the role of early short-term CR in patients undergoing pacemaker (PM) implantation. The investigators assessed whether short-term CR following PM implantation was enough to improve both physical function and quality of life (QOL).

Eligibility Criteria:
Inclusion Criteria:

* patients who were scheduled to undergo new PM implantation

Exclusion Criteria:

* patients older than 75 years
* patients who are contraindicated to exercise
* patients who refuse to participate
Effects of Brain Stimulation During Nocturnal Sleep on Memory Consolidation in Patients With Mild Cognitive Impairments

The beneficial effect of nocturnal sleep on memory consolidation is well-documented in young, healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity typically occuring during SWS has been implicated in the consolidation effect. Recent evidence in young healthy subjects suggest that the sleep-associated consolidation effect can be amplified by the application of a weak transcranial oscillatory electric current within the frequency range of SWS in humans (0,7-0,8 Hz) during SWS. If patients with amnestic mild cognitive impairments (MCI)- usually characterized by initial difficulties in hippocampus dependent memory functions - benefit from transcranial slow oscillatory stimulation (tSOS) during nocturnal sleep as well has not been studied so far. The primary aim of the present study is to investigate the influence of a weak slow oscillating brain stimulation (tSOS) on declarative memory consolidation applied during periods of nocturnal SWS in MCI patients.


Eligibility Criteria:
Inclusion Criteria:

* amnestic and amnestic plus MCI-patients:

  1. Concern reflecting a change in cognition reported by patient or informant or clinician (i.e., historical or observed evidence of decline over time)
  2. Objective evidence of memory impairment; additional cognitive domains may be affected as well;
  3. Preservation of independence in functional abilities
  4. no dementia
* age: 50-90 years

Exclusion Criteria:

* untreated severe internal or psychiatric diseases
* epilepsy
* other severe neurological diseases eg., previous major stroke, brain tumour
* dementia
* contraindications to MRI
Appalachians Together Restoring the Eating Environment: Improving Healthy Diet in Rural Appalachian Kentucky

Most of the nation's serious chronic health challenges and causes of death, including diabetes, heart disease, cancer, and obesity, are directly linked to sub-optimal diet. Both poor diets and associated disease are disproportionately common in the Appalachian counties of eastern Kentucky, a region with stark health inequities, including elevated rates of obesity, overweight, and premature mortality. The purpose of this study is to evaluate a multi-component intervention developed through community-based participatory research methods for improving access to healthy foods and enhancing dietary intake in eastern Kentucky. The intervention components evaluated in this study consist of: 1) a school-based campaign to promote water consumption in middle and high schools and 2) a series of group cooking classes for adults.


Eligibility Criteria:
Inclusion Criteria:

* For school-based component: Student in selected middle or high school classroom in a participating school in intervention or comparison counties (6th to 12th grades)
* For cooking classes: adult aged 18 years or older and residing in intervention county who have at least one dependent child attending middle or high school in the participating school districts

Exclusion Criteria:

* Unable to speak or read English, as all materials will be presented in English