cyrilzakka/clinical-trials huggingface dataset:
Custom Cutting Block Instrument vs Regular Instrumentation Total Knee Replacement (TKR)

To determine if the use of patient-specific custom cutting blocks for implantation of total knee components results in improved limb alignment and component positioning compared to regular instrumentation.

This is a randomized controlled trial. Patients will be randomized to have their knee implanted using either the patient-specific custom cutting blocks or the regular instrumentation system. Functional and radiographic outcomes will be assessed in a blinded fashion. The Smith and Nephew Legion Primary® total knee system will be used in both groups; this is an implant with a good long term track record based on the Genesis II design. All surgeons have used and are familiar with the regular instrumentation. They will be instructed in the use of the patient-specific custom cutting blocks prior to study initiation.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is male or female ages 18 and over.
2. Patient is having primary total knee replacement
3. Patient is willing to sign the informed consent and to come for all study visits.

Exclusion Criteria:

1. Deformity of the femur preventing use of the intra-medullary guide utilized in the regular instrumentation set.
2. Necessity for the use of constrained implants. These types of implants have intra-medullary stems, therefore all bone cuts need to be referenced off intramedullary guides, making image guided bone cuts inappropriate.
3. Patients undergoing knee replacement revision surgery. Theses types of implants also have stems, making the use of image guided bone cuts inappropriate for the same reasons.
4. Patients scheduled for bilateral knee surgery (simultaneous or staged)
Tetranectin as a Novel Obesity-associated Adipokine for Regulating Lipid Accumulation

Adipose tissue is strongly correlated to obesity and diabetes which are two major problems in the worldwide. Adipose tissue is involved in modulating glucose and energy metabolism locally and systemically by secreting factors, called adipocytokines. Tetranectin (TN), a novel adipocytokine, is secreted by adipose tissues. TN may regulate the glucose/energy homeostasis to affect lipid accumulation.The role of TN in adipocytes with or without TN on regulation of adipose tissue growth and lipid metabolism is valuable to be studied.

Materials and methods: Secreted proteins from human adipocyte culture medium were deciphered using 2-D polyacrylamide gel electrophoresis and determined by LC/MS with MALDI-TOF analysis of proteins. Adipose tissues were obtained from the breast of 15 women undergoing mastectomy. Serum samples from 200 normal healthy people and 54 breast cancer patients were assigned to either a lean or obese group according to the body mass index. The TN protein concentration was measured in the culture medium of stromal-vascular fraction (SVF)-derived adipocytes from healthy humans, breast cancer patients, pigs and also from 3T3-L1 cells. Associations between plasma TN and other biomarkers were assessed with Pearson's correlations and multivariable linear regression.

Adipose tissues were obtained from the breast of breast cancer patients with 0 to 1 progression stage. All participants gave permission and the study was approved by the Ethics Committee of National Taiwan University Hospital as no. 9461701203.

From 2012 to 2013 in National Taiwan University Hospital, a cross-sectional sampling of 21 to 78 -year old people included women and men who were living in Taiwan. Blood samples were collected after an overnight fasting. Serum was separated by centrifugation and stored at -80 ℃ until analysis. Plasma triglyceride (TG), high density lipoprotein (HDL), low density lipoprotein (LDL), cholesterol, glucose and insulin were measured. Fasting serum samples were obtained from 193 randomly selected persons having health check-ups. To investigate the relationship among TN and breast cancer, fasting serum samples also obtained from 54 randomly selected breast cancer patients who were 25 to 59 years old with elected surgery for breast cancer stage 0 and 1.

Eligibility Criteria:
Inclusion Criteria:

1. Must be above age 20 years old.
2. Subjects must sign the written informed consent form.
3. Must have residual fat after surgery.
4. Clinical diagnosis of liposuction and tumor resection.

Exclusion Criteria:

1. Terminal cancer.
2. Subjects have no fat tissue after surgery.
3. Pregnant subjects.
An Intervention Study on Transcranial Photobiomodulation in Children with Attention Deficit Hyperactivity Disorder

This study aims to intervene in children and adolescents with ADHD using transcranial photobiomodulation, comparing its effects on executive function at the levels of electroencephalography (EEG), eye tracking, and cognitive behavior. The goal is to identify the most effective clinical treatment strategy for ADHD patients.

This study is conducted as a randomized double-blind trial to investigate the effects of photobiomodulation therapy on ADHD. Initially, standardized assessment tools (physician ratings and parent self-reports) are employed to evaluate baseline clinical symptoms in ADHD patients who meet the inclusion and exclusion criteria. The experiment utilizes a within-subject design (within-subject factors: real versus sham stimulation), with each participant randomly assigned to receive two interventions-one real and one sham stimulation-administered in a counterbalanced order, with at least a one-week interval between the two sessions. Immediately following the intervention, standardized assessment tools are used to evaluate multidimensional clinical symptoms, and data related to executive function, including cognitive behavioral data, electroencephalographic data, and eye-tracking data, are collected. The intervention is carried out by trained technicians in accordance with the randomization results, while maintaining blinding for both clinical evaluators and participants.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 6 and 18 years;
2. Clinically diagnosed with ADHD by a psychiatrist;
3. Confirmed by the researcher (child psychiatrist) to meet the diagnostic criteria for Attention-Deficit/Hyperactivity Disorder as outlined in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
4. M.I.N.I. KID interview shows only ADHD, with no other comorbidities;
5. Able to cooperate with transcranial photobiomodulation.
6. The participant and their guardian fully understand the study procedures and content and agree to participate in the study, signing the informed consent form.

Exclusion Criteria:

1. Diagnosis of other severe mental illnesses, such as schizophrenia or bipolar disorder;
2. Presence of severe physical diseases or conditions, such as significant intracranial lesions, thyroid disorders, epilepsy, congenital heart disease, severe hematologic disorders, systemic lupus erythematosus, auditory or visual impairments, etc.;
3. Presence of significant structural brain abnormalities on imaging studies;
4. Presence of severe neurological diseases with a clear family history or potential risk;
5. Presence of metal implants or a pacemaker, or holes or fractures in the skull;
6. Currently undergoing other ADHD treatments (e.g., methylphenidate or other pharmacological treatments, behavioral therapy, etc.) or has discontinued such treatments for less than 2 weeks;
7. Raven's Progressive Matrices IQ score \< 85.
Optimizing Post-operative Recovery in Bariatric Patients With Obstructive Sleep Apnea Undergoing Outpatient Surgery: A Comparison of Sugammadex and Neostigmine

This study assesses the efficacy of sugammadex against neostigmine for hastening recovery from neuromuscular blockade and optimizing pulmonary function in obese patients with obstructive sleep apnea presenting for outpatient surgery. Both drugs are used in anesthesiology to reverse neuromuscular blockade that is given in the setting of inducing and maintaining general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* obese (body mass index \[BMI\] \>30 kg/m2)
* diagnosis of obstructive sleep apnea (OSA) (with or without continuous positive airway pressure \[CPAP\] use)
* scheduled for surgery requiring general anesthesia and neuromuscular blockade

Exclusion Criteria:

* history of hepatic, renal, or cardiovascular and/or cerebrovascular dysfunction
* history of difficult tracheal intubation
* history of adverse reaction to anesthesia
* history of adverse reaction to rocuronium, sugammadex, and/or neostigmine/glycopyrrolate
Injection Optimization of Infraclavicular and Axillary Brachial Plexus Block

In upper extremity surgery, brachial plexus block (BPB) is routinely applied successfully as general anesthesia (GA). However, BPB is less invasive technique than GA. Peripheral nerve blocks have some potential benefits, such as lower risk of nausea and vomiting, early ambulation, early discharge, and better control of postoperative pain. The BPB is applied to various areas such as axillary, supraclavicular, infraclavicular and interscalene areas under the guidance of ultrasound and nerve stimulator. Among these methods, BPB administration success rates are around 95-100%. The other condition is anesthetic time which is important for the turnover of operating room. Anesthetic time is the sum of the performance time and onset time. In addition performance time and number of needle attempts also associated with patient satisfaction. The primary aim of this study is to determine the number of attempts and the performance time with the onset time and anesthetic time. If the procedure is simple, the performance time may be shorter. Therefore, the investigators aim that comparison of two different procedures which are single injection infraclavicular brachial plexus block and multiple injection axillary brachial plexus block by ultrasound guidance. In addition, the investigators will examine the duration of anesthesia and surgery, the duration of sensory and motor block endings, patient comfort and pain scales in the postoperative period.

60 participants who underwent forearm or hand surgery with the axillary or infraclavicular brachial plexus block method and who have an American Society of Anesthesiologists physical status classification (ASA) score of I-II-III between the ages of 18-75 will be followed up. Number of needle attempts, block performance time, sensorial and motor block onset time, total anesthetic time, surgical duration, duration of sensory block formation, and duration of motor block formation will be evaluated with the information obtained from participants with axillary block or infraclavicular block. After surgery, participants satisfaction, visual analogue scales (VAS), sensory block ending times, motor block ending times and first analgesic requirement time will be assessed at postoperative 2. -8. -12. -24. hours by physical examination and questions. As a result of these evaluations, both groups will be compared statistically. (After the patients are informed in detail, the volunteer certificate will be obtained from the patients who agree to participate in the study.)

Eligibility Criteria:
Inclusion Criteria:

* Axillary or infraclavicular brachial plexus block who underwent forearm or hand surgery
* ASA score I-II-III
* Body weight\> 45 kg or BMI \<40 kg / m2

Exclusion Criteria:

* Under 18 years old or over 75 years old
* Body weight \<45 kg or BMI\> 40 kg / m2
* ASA score above III
* Pregnant or lactating
* Coagulopathy or anticoagulant medication
* Allergies about using local anesthetic drugs
* Neurological deficit
* Renal insufficiency or liver failure
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical

Multicenter Post market clinical follow-up Study on the Safety and Performance of Ennovate® Cervical - Prospective, pure data collection of all Ennovate Cervical patients in Total Indications

This clinical study is one of the Post market clinical follow-up measures that enables the manufacturer to monitor the clinical safety and performance of the Ennovate® Cervical system. The study enables a quick, but detailed implant documentation, which is of great interest for the current and future users of the internal fixation system targeted in this study. It includes the relevant outcomes to evaluate safety and efficacy of the implant system for various indications in trauma and degenerative disorders.

Eligibility Criteria:
Inclusion Criteria:

* Patient is minimum 18 years old
* Informed Consent in the documentation of clinical and radiological results
* Patient has indication according to Instructions for Use (IFU)
* Patient is not pregnant

Exclusion Criteria:

* Patient's clear unability or unwillingness to participate in follow-up examinations
Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses

The purpose of the study is to test a new video device for actinic keratoses. The device takes images of your skin lesions during the treatment, to learn whether this device can predict how well the treatment is working.

This intervention is designed to help establish what the optimal conditions are for treating actinic keratoses with photodynamic therapy (PDT). The primary outcome of this study is to determine whether the rate of singlet oxygen (sO2) production and/or the initial intralesional photosensitize (PpIX) levels, can predict the clinical responsiveness of AK lesions to PDT. Participants will receive standard red light PDT treatment, except that lesions will be carefully counted beforehand. During the window of red light illumination, photos and a video of one area of skin will be taken to allow us to monitor the progress of the treatment. Any remaining lesions will be counted upon follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have at least 10 Actinic Keratoses lesions on the arms of legs, and with two AK lesions close enough to be seen together within a selected region of interest (ROI)
* Participants must be able to understand and are willing to sign a written informed consent document

Exclusion Criteria:

* Female participants cannot be or become pregnant, nor can be nursing while on this study
* Using any topical treatment on their AKs; must stop at least one month prior
* Currently undergoing treatment for other cancers with medical or radiation therapy
* Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material
* Patients with history of a photosensitivity disease, such as porphyria cutanea tarda
Study Evaluating Denosumab on Vascular and Bone Metabolism in Osteoporotic Chronic Kidney Disease (HDENOBS)

Aim of this study is to evaluate in a population of osteoporotic chronic kidney disease patients the effect of denosumab:

* on coronary artery calcification scores evolution after 24 months of followup
* on abdominal aorta calcification scores evolution after 24 months of followup
* on bone mineral density (femoral T-score) at 24 months
* on bone mineral density evolution (femoral T-score) after 24 months of follow-up
* on bone mineral density evolution (lumbar T-score) after 24 months of follow-up
* on parameters of bone remodelling after 24 months of follow-up
* on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up
* the tolerance after 24 months of follow-up

Aim of this study is to evaluate in a population of osteoporotic chronic kidney disease patients the effect of denosumab:

* on coronary calcification scores evolution (by multidetector computed tomography) after 24 months of follow-up
* on abdominal aorta calcification scores evolution (by plain abdominal Xray) after 24 months of follow-up
* on bone mineral density (femoral T-score) (by bone densitometry) at 24 months
* on bone mineral density evolution (femoral T-score) (by bone densitometry) after 24 months of follow-up
* on bone mineral density evolution (lumbar T-score) (by bone densitometry) after 24 months of follow-up
* on parameters of bone remodelling after 24 months of follow-up
* on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up
* the tolerance after 24 months of follow-up

Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease stage 5D patient, hemodialyzed with extracorporeal treatment for at least 3 months
* Osteoporosis

Exclusion Criteria:

* Pregnancy or breastfeeeding female
* Current corticoid treatment
* PTH and Calcium outside the KDIGO guidelines
* Adynamic bone disease suspicion
* Cancer or myeloma
* Serious hepatic cytolysis
* Serious dental troubles
* Positive HIV serology
* Hypersensibility to active substance or one of excipients of denosumab
Effect of a Novel Protein Ingredient Combined With Oral Nutritional Supplement on Appetite in Older Adults

Reduced appetite can occur with ageing and is linked to a higher risk of undernutrition, poorer physical function and becoming frail. Strategies to increase appetite are needed to improve healthy ageing. This study follows on from previous work which has found a novel ingredient in whey protein (derived from whole milk) that may help to increase appetite and energy intake. This study will compare the effects of the ingredient added to an oral nutritional supplement (ONS) versus the ONS alone versus the ingredient dissolved in water on appetite in older adults. By studying this nutrition supplement in older adults, this will help to provide greater information on possible nutrition strategies to improve healthy ageing.


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling,
* Age 60+ years
* Poor appetite (Simplified Nutritional Appetite Questionnaire (SNAQ) score \</=14, answer a, b or c to Q.1 on SNAQ or answer b, c, or d to CES-D question regarding poor appetite in the past week)
* BMI 20-25kg/m2

Exclusion Criteria:

* Current medical condition or medication known to impact appetite or energy intake
* Other medical condition that would impact study participation and outcomes, as judged by the study investigator.
* Heavy smoker (\>10/day)
* Inability to come to study centre
* Currently participating in another intervention study
* Lacking informed consent
* Allergic to or unwilling to consume any of the study test foods
* Loss of taste or smell associated with COVID-19
* Unable to walk across a room
Exploring Buckwheat's Glucose Lowering Potential

Bioactive components in buckwheat enhance insulin sensitivity in Type 2 diabetes by improving glucose uptake and utilization through a unique mechanism that operates independent of insulin.

This is a single site, double-blind, randomized, controlled study designed to explore buckwheat's glucose lowering effects in healthy volunteers and volunteers with type 2 diabetes. A total of 24 volunteers consisting of 12 volunteers (healthy and diabetic) per group for both the acute and chronic phases of testing will be recruited through advertisement from the local community.

In the acute testing phase, volunteers (healthy and diabetic) will be asked to attend 4 visits one week apart for the duration of 3 hours per visit. A fasting blood sample will be collected at each visit. At each visit, all volunteers will consume in random order 1 of the following 4 products: i) crackers containing buckwheat; ii) crackers without buckwheat); iii) 50 mls of oral solution containing glucose; or iv) 50 mls of oral solution containing the sugar substitute Splenda. The crackers will contain equal amounts of available carbohydrates. Blood sampling will occur at 15, 30, 45, 60 minutes, and then every 60 minutes for the remainder of the visit. Sampling (pre and post product consumption) will measure insulin, glucose, and various incretins. Open venous access will be secured after the first sample has been obtained to minimize the number of needle pricks. Total amount of blood obtained will not exceed 30 mls per visit.

In the chronic testing phase, volunteers (healthy and diabetic) will receive the crackers containing buckwheat for consumption each day for 7 days. Prior to food consumption, a fasting blood sample will be obtained each day and a urine sample will be collected on Days 1, 3, and 7 to assess bioavailability of buckwheat compounds (concentrations in blood and urine), insulin and glucose. Sampling for a lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides), liver (ALT), kidney (creatinine), adipose function (adipokines), various incretins, as well as inflammatory status (various cytokines) will be done on Day 1 and Day 7. Total amount of blood obtained will not exceed 30 mls per visit.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 to 70 years
* normal glycated hemoglobin (\<6% healthy, \<7.5% diabetic)
* absence of chronic conditions (except Type 2 diabetes)
* must be able to read and sign consent
* must be able to comply with protocol requirements

Exclusion Criteria:

* allergies to eggs, buckwheat, rice flour, or sugar substitutes (Splenda)
* acute or chronic conditions (except Type 2 diabetes)
* blood glucose \>10mmol/L at beginning of test session
* medications that affect glycemic control
DAT SPECT and Procedural Motor Skills in Parkinson's Disease

Patients with Parkinson's disease (PD) are known to be affected by subtle cognitive impairment early in the disease course, mostly in the executive field. Procedural motor skills, mainly controlled by the basal ganglia associative loop (in particular dorsal caudate nucleus) (Rodriguez-Oroz et al., 2009), have also been studied in patients with PD (Schnider et al., 1995; Muslimovic et al., 2007; Terpening et al., 2013). However, the correlation of dopaminergic 123I-FP-CIT SPECT imaging and cognitive impairment has not been assessed. One reason is the absence of reference values for striatal uptake until recently. Last year, the investigators established local uptake reference values for DAT imaging based on a large cohort of subjects with non-degenerative conditions (Nicastro et al., 2016) and can therefore use these values to precisely assess uptake loss in patients with PD.

With the present study, the investigators expect to enroll patients with early PD for whom a 123I-FP-CIT SPECT has been previously performed in the center. Subjects will perform a specific motor task based on mirror-drawing of star-shaped figures. This will be done by inverting the direction of horizontal/vertical computer mouse movements on the screen. Speed and error rates will be assessed for patients as well as healthy control subjects. Correlation with striatal SPECT uptake, especially caudate nucleus uptake, will be analyzed for PD patients. In addition, resting-state EEG will be performed for all subjects. General medication and dopaminergic drugs in particular, whenever used, will not be discontinued. For all subjects enrolled in the study, cognitive and neurological examination will be performed.


Eligibility Criteria:
Inclusion criteria for PD group:

* Age \> 18 year-old
* Diagnosis of PD with onset \<2 years from enrollment
* Available DAT SPECT performed in Geneva University Hospitals \<6 months before inclusion

Inclusion criteria for control group:

Age- and sex-matched control patients

* Age \> 18 year-old
* No known neurological condition interfering with motor and cognitive abilities
* No medication interfering with central nervous system (including antidepressants, antipsychotics, hypnotics)

Exclusion criteria for both groups:

* Major depressive state (Hospital Anxiety and Depression scale ≥11 for depression score)
* Cognitive decline (Mini-Mental Score ≤ 22/30)
* Debilitating tremor (Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III - rest, postural and action tremor ≥2/4)
* Significant akinesia (MDS-UPDRS III hand brady-akinesia score ≥2/4)