cyrilzakka/clinical-trials huggingface dataset:
Central and Peripheral Changes in Quadriceps Femoris Function After Different Types of Isometric Strength Training

The purpose of this investigation is to examine the effects of 6-week unilateral isometric training interventions over quadriceps femoris on maximal strength and RFD-SF parameters and cortical excitability. Isometric strength training involved either electromyostimulation, voluntary activation, or the combination of both. The second aim is to investigate the potential cross-over effect on a non-trained leg.

A longitudinal pre-post design with random assignment of the participants to one of three experimental groups or the control group was used. Quadriceps femoris (QF) function and cortical excitability were assessed on four occasions: prior to the intervention (pre-test), after 3 weeks of training (served for the adjustment of exercise intensity), after 6 weeks of training (post-test), and three weeks after the competition of training intervention (detraining) (Figure 1). Isometric strength training involves activation of QF applying EMS, VOLUNTARY, or the combination of both EMS and VOLUNTARY (COMBINED). The pre-test also served to familiarize participants with the training protocols and to determine the intensity of EMS needed to achieve 60%MVC. Quadriceps femoris (QF) function was assessed by MVC and RFD-SF. Cortical excitability was assessed with transcranial magnetic stimulation applied over the M1 region. Prior to the pretest, body mass and percent of body fat were assessed using a bioelectric impedance method (In Body 720; USA) and body height with a standard stadiometer. After the pretest, the participants were randomly assigned to either one of the experimental groups (EMS, VOLUNTARY, or COMBINED) and the control group (CONTROL). Experimental groups performed unilateral isometric strength training three times per week for 6 weeks. All participants were advised to refrain from all resistance training targeting the legs between pre-test and post-test.

Eligibility Criteria:
Inclusion Criteria:

* young healthy, physically active participants of both genders

Exclusion Criteria:

* no history of injuries, muscle-skeletal or neurological disease, or medications intake
Pharmacogenomics of Paclitaxel in Ovarian Cancer

This study will try to determine whether or not certain genes are responsible for the huge variation in toxicity and effect observed between patients treated with paclitaxel (chemotherapeutic drug). Specifically we will study this retrospectively in patients who participated in clinical trials that are now closed. All patients had ovarian cancer and received paclitaxel/carboplatin chemotherapy after primary surgery.

Paclitaxel is an antineoplastic drug used in the treatment of ovarian cancer. The effect and toxicity is unpredictable in the individual patient. Paclitaxel is removed (eliminated) from the organism by oxidation. CYP2C8 is the enzyme mainly responsible. P-glycoprotein (Pgp) is an efflux transport protein natural to the human organism. Pgp is responsible for excretion of drugs via the bile and the kidneys and is thought to play a role in chemotherapy resistance. Paclitaxel is substrate for Pgp. Single nucleotide polymorphisms are possible causes for variation in both CYP2C8 and Pgp expression/function. We will study a possible role of these genetic variations as predictors of paclitaxel toxicity and effect and the possible implications for individual dosing in the future.

We will use tissue from patients who participated in one of two clinical trials that are both closed for inclusion. Genotypic data from this tissue will be correlated with toxicity and survival data drawn from a research database. We expect to be able to find \>300 available cases to study.

Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled in "TC/TEC" in Denmark, Sweden or Norway
* Patients enrolled in "OVAR-9" in Denmark, Sweden or Norway
Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing Surgery

This clinical trial studies lymph node mapping in patients with newly diagnosed endometrial cancer undergoing surgery. Lymph node mapping may help in planning surgery to remove endometrial cancer and affected lymph nodes.

PRIMARY OBJECTIVES:

I. To determine the detection rate, sensitivity, and negative predictive value of sentinel lymph node (SLN) biopsy in endometrial cancer patients.

SECONDARY OBJECTIVES:

I. To compare different surgical modalities (open procedures, minimally invasive procedures, and single-site technology) and different injectants (isosulfan blue and indocyanine green) for SLN biopsy.

II. To determine total operating room time (from the time the patient enters the room to the time the patient leaves the room) as well as console time (robotic)/operating time for minimally invasive procedures.

OUTLINE:

Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.

After completion of study treatment, patients are followed up at 2-4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Women must have newly diagnosed histologically or cytologically confirmed endometrial cancer
* Women should have received no prior therapy for their disease
* Women who are planning to undergo hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy for the management of their endometrial cancer
* Women must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Women who are receiving any other investigational agents
* Women with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to isosulfan blue or indocyanine green or other agents used in this study
* Women with hypersensitivity to phenylmethane compounds, or a history of allergic reaction to iodides
* Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Women with a history of prior loop electrosurgical excision procedure (LEEP) or cone procedures performed on their cervix
* Women with a history of lymphedema, lymphoma, or lymphatic hyperplasia (Castleman disease)
* Women with a history of a prior malignancy
* Women may also be excluded at the discretion of their surgeon if he or she feels that the patient is not an appropriate candidate
Using Videos to Improve Understanding of the Delivery of End-of-life Medical Care in Non-hospital Settings

To compare the decision making of elderly subjects having a verbal advance care planning discussion compared to subjects using a video.

A.1. Aim 1: To recruit 101 subjects over the age of 64 who are newly admitted to a nursing home facility and randomly assign these subjects to one of two advance care planning (ACP) modalities: 1. a video visually depicting the Goals of Care (Life Prolonging Care, Limited Care, and Comfort Care) (intervention) or 2. a verbal narrative describing the Goals of Care (control) encountered if the subject becomes very ill.

Hypothesis 1: It is feasible to recruit and randomize newly admitted elderly subjects to each of the ACP modalities.

A.2. Aim 2: To compare the care preferences for their primary goal of care (i.e., life-prolonging care, limited care, or comfort care) among 101 subjects randomized to video vs. verbal narrative intervention for ACP.

Hypothesis 2: Subjects randomized to the video intervention will be significantly more likely to opt for comfort care (vs. life-prolonging or limited care) as the primary goal of care compared to those randomized to the verbal narrative.

A.3. Aim 3: To compare knowledge assessment of the Goals of Care of 101 subjects randomized to video vs. verbal narrative intervention for ACP.

Hypothesis 3: When compared to subjects randomized to the verbal narrative arm, subjects in the video group will have higher knowledge assessment scores when asked questions regarding their understanding of the Goals of Care.

Eligibility Criteria:
Inclusion Criteria:

* over age of 64
* have decision making capacity

Exclusion Criteria:

* do not speak English
Effectiveness of Doll Therapy in People With Dementia

This study aims to evaluate the effectiveness of doll therapy in reducing the daily dose of medications (DDM), behavioral and psychological symptoms of dementia (BPSD), and improving the activities of daily living (ADL) in people living with dementia (PLwD) in residential care facilities in China. The study employs a cluster randomized controlled trial design, involving 142 participants from six nursing homes, divided into an intervention group receiving doll therapy plus routine nursing care and a control group receiving routine nursing care alone. Additionally, the study will explore the experiences and perceptions of staff and family caregivers through qualitative research methods to provide a comprehensive understanding of the intervention's impact.

Doll therapy, recognized as a non-pharmacological intervention, involves providing lifelike baby dolls to individuals with dementia to elicit positive emotional responses and behaviors. Despite its potential benefits, evidence supporting its efficacy and acceptability remains limited and inconclusive. This mixed-method research study will conduct a cluster randomized controlled trial to systematically evaluate the effectiveness of doll therapy in reducing the daily dose of medications, mitigating behavioral and psychological symptoms, and enhancing daily living activities among Chinese dementia patients in residential care settings. The trial will involve 142 participants from six nursing homes, randomly assigned to either the intervention group (doll therapy plus routine care) or the control group (routine care only). Quantitative outcomes will be measured using standardized scales for medication use, BPSD, and ADL. In parallel, qualitative data will be collected through interviews with staff and family caregivers to gain insights into their experiences and perceptions of doll therapy. The findings are anticipated to inform best practice guidelines for implementing doll therapy in dementia care.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be at least 65 years old.
* Documented diagnosis of dementia.
* Sufficient manual dexterity to hold or caress a doll.
* Sufficient visual acuity to recognize a doll.
* Must have legal family members or next of kin to sign the consent form.

Exclusion Criteria:

* Individuals with mild dementia who do not accept the doll after two attempts.
* Participants who accept the doll but leave it within two weeks.
* Individuals without the capacity to give informed consent and without a legal representative to provide consent on their behalf.
Threads Insertion in Forehead Static Wrinkles

The main objective of this study is to analyze the efficacy and safety of PDO threads in correcting deep static wrinkles on the upper face.

The upper face is a complex and dynamic part of the face, which conveys facial expression and emotion. As one age, youthful dynamic facial lines on the forehead and glabella change to static wrinkles, which remain on the face at rest. These permanent wrinkles can lead to the appearance of fatigue and negative facial expressions such as anger, which may influence psychological wellbeing, social confidence, and self-esteem.

The two major factors involved in the formation of static wrinkles in the upper face are repetitive muscle contraction and aging (loss of dermal collagen and matrix material leading to reduced dermal support). Compared with other facial muscles, the frontalis and corrugator muscles usually retain their muscle volume and even undergo hypertrophy to compensate for age-related ptosis and loss in visual acuity, which intensify the wrinkles.

Botulinum toxin and filler injections are currently the main treatment modalities in the management of facial wrinkles, especially for those on the upper third of the face. Conceptually, botulinum toxin addresses wrinkles by relaxing the muscles responsible for their creation (ie, the"dynamic" component), while soft tissue fillers provide necessary volume for the effacement of facial rhytids (ie, the "static" component). Although popular and widely accepted by the general population, some hesitate to receive toxin or filler injections due to the potential risk of unnatural facial expression, ptosis (associated with botulinum toxin), skin necrosis, and vision loss (from filler injection).

This has created a demand for a minimally invasive technique with reduced side effects, where threads may be considered. Although more commonly known as a mean for facial lifting, polydioxanone (PDO) suture materials have been applied to static wrinkles with promising outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adult females and males between 30 and 65 years of age seeking treatment for static wrinkles on forehead.

Exclusion Criteria:

* • Patients who received filler injection within a period of 12 months before thread insertion and during the follow-up period.

  * Patients with a history of plastic surgery on the face.
  * Visible scars that may affect evaluation of a response and/or quality of photography and previous botulinum toxin treatment within the prior 12 months.
Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)

The overall objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment II (SMAART-II) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a polypill (Polycap ®) containing fixed doses of antihypertensives, a statin, and antiplatelet therapy taken as two capsules, once daily orally in reducing composite vascular risk over 24 months vs. usual care among 500 recent stroke patients encountered at 12 hospitals in Ghana. Secondly, SMAART II seeks to develop an implementation strategy for routine integration and policy adoption of this polypill for post-stroke cardiovascular risk reduction in an under-resourced system burdened by suboptimal care and outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Above the age of 18 years; male or female
* Ischemic stroke diagnosis no greater than two months before enrollment. Ischemic strokes including� lacunar, large-vessel atherosclerotic, cardio-embolic subtypes are eligible
* Subjects with stroke may present with at least one of the following additional conditions:

Documented diabetes mellitus or previous treatment with oral hypoglycemic or insulin; documented hypertension \>140/90mmHg or previous treatment with antihypertensive medications; Mild to moderate renal dysfunction (eGFR 60-30ml/min/1.73m2); Prior myocardial infarction

* Legally competent to sign informed consent.

Exclusion Criteria:

* Unable to sign informed consent
* Contraindications to any of the components of the polypill
* Hemorrhagic stroke
* Severe cognitive impairment/dementia or severe global disability limiting the capacity of self-care
* Severe congestive cardiac failure (NYHA III-IV)
* Severe renal disease, eGFR \<30ml/min/1.73m2), renal dialysis; awaiting renal transplant or transplant recipient
* Cancer diagnosis or treatment in past 2 years
* Need for oral anticoagulation at the time of randomization or planned in the future months;
* Significant arrhythmias (including unresolved ventricular arrhythmias or atrial fibrillation)
* Nursing/pregnant mothers
* Do not agree to the filing, forwarding and use of his/her pseudonymized data.
Evaluation of Capillary Refill Index

Comparison of a peripheral perfusion assessment method using a pulse oximeter to the conventional capillary refill time visually assessed by a clinician.

A new technology, capillary refill index (CRI), to assess peripheral perfusion status quantitatively using pulse oximeter waveforms is being developed. The conventional capillary refill time (CRT) is widely used in clinical settings as a gold standard to assess peripheral perfusion.

The objective of this study is to evaluate the capability of CRI to predict altered peripheral perfusion determined with the conventional CRT test. Predictive capability of CRI needs to be assessed to achieve a goal to provide clinicians with an alternative method to the conventional CRT.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals 18 years of age or older
2. Patients who present to the ED or who are admitted to the ICU of North Shore University Hospital (NSUH)

Exclusion Criteria:

1. Pregnant
2. Prisoners
3. Finger, hand or forearm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor
4. Patients' deemed clinically unstable by the clinical team
Medication Use and Quality of Life Among Older People (Pilot)

This project will provide new evidence on how to optimize medication use among older people with limited life expectancy. This will be done by testing whether a patient-centered deprescribing intervention, focused on aligning medical treatment with patients' preferences, can improve quality of life among older people with limited life expectancy. This registration concerns the initial pilot study.

In a pragmatic randomized controlled trial, this project will test whether a comprehensive and patient-centered deprescribing intervention can improve quality of life among older people with limited life expectancy. This registration concerns the initial pilot study. All patients included in the pilot study will receive the intervention (that is, the pilot study will not include randomization).

The intervention will comprise a series of consultations between the patient and general practitioner (GP) (at least three) to continuously adjust the patient's medication according to the patient's goals, needs, and preferences, thereby ensuring alignment with the patient's priorities. Thus, the purpose of this intervention is to initiate and facilitate a continued deprescribing process. The process can be summarized in seven steps: During an initial consultation (1: Consultation 0), the GP assesses patient eligibility. If the patient would like to participate, a project nurse subsequently visits the patient at home (2: Home visit) for retrieval of informed consent as well as baseline measurements. During the next consultation (3: Consultation 1), the patient and GP discuss how the patient feels about his/her medical treatment, and the GP provides the patient with written material for the patient to prepare prior to the next consultation. The patients prepares (4: Preparation) by considering and verbalizing his/her goals of care and treatment preferences. Simultaneously, a clinical pharmacist examines the patient's medication list and provides suggestions to the GP on which drugs can be continued and deprescribed, respectively. During the next consultation (5: Consultation 2), the patient and GP discuss the patient's preferences and initiate deprescribing initiatives aligned with the patient's priorities. During a new consultation (6: Consultation 3), the patient and GP follow up on the changes initiated and initiate new deprescribing initiatives if such can be identified. If needed, subsequent consultations (7: Consultation X) are planned until the patient and GP consider the patient's medical treatment optimal.

Eligibility Criteria:
Inclusion criteria:

* Aged ≥80 years
* Take ≥8 different medications
* Have a life expectancy of \<2 years, estimated via the Surprise Question ("Would you be surprised if this patient died within 1-2 years?") by the general practitioner
* Have a Mini-Mental State Exam (MMSE) score of ≥15
* Are able to provide informed consent

Exclusion Criteria:

* Not able to communicate
* Does not speak and understand Danish
Virtual Reality Glasses and Stress Ball on Distress and Pain Arteriovenous Fistula Cannulation

Effects of Virtual Reality Glasses and Stress Ball on Distress and Pain During Arteriovenous Fistula Cannulation. The research was conducted as a randomized experimental study with a pre-test - post-test control group.

Beginning 1-2 minute before the start of the procedure, the patients will be watched (5 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses.

A stress ball will be applied to the patient 1-2 minutes before the start of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Be over 18 years old,
* Be able to speak and understand Turkish,
* Have the cognitive ability to answer the data collection tools,
* Be willing to participate in the study,
* Participate in a hemodialysis program three days a week,

Exclusion Criteria:

* Having a communication problem (hearing, language, understanding, etc.),
* Having a psychiatric diagnosis (To be checked from medical records),
* Having failed AVF cannulation at the first attempt,
* Having any signs of infection such as redness, swelling, open wound in the area where the procedure will be performed,
* Having used a sedative within the last 8 hours,
* Having used any painkillers before the procedure on the same day,
Testing Performance and Usability of Q300 Device

A data collection clinical study performed on live human spermatozoa samples. Spermatozoa are imaged by QART Q300TM microscopy system. For the feasibility 1st phase of the study, up to 75 donors are expected to participate. Study group will include sperm samples donated by the clinic's patients (recruited by the investigators from the clinic's patient database) and/or by healthy volunteers (responding to advertisement).

Cells will be individually selected by the system, and will be representative of the cell population to be selected in ICSI procedures. Each selected cell will be imaged by the QART system and independently and blindly reviewed by an Embryologist(s) team. According to these, each cell will be scored as 'Normal' or 'Abnormal' per WHO guidelines. Sperm cells that were successfully imaged with Q300, will be individually stained. Each stained cell will be imaged by BFM and the non-labeled image will be digitally stored (BFM-NL). The BFM-NL Image will be independently and blindly reviewed by an Embryologist team and scored as 'Normal' or 'Abnormal' per their best discretion.

The database generated in this study will be used for (i) testing the performance accuracy of the Q300 system for sperm cell dimensional measurements, (ii) providing feedback to the study sponsor (QART Medical Ltd.) regarding the usability of the Q300 system, (iii) further improving and testing the accuracy of the QART Feature Extraction algorithms and (v) assisting in determining the inclusion/exclusion criteria for subsequent clinical stages. In final validation stages, the conventional staining results will be statistically compared with the Q300 feature extraction results for each individual sperm cell. During the study, ICSI laboratory personnel (at least 10) will evaluate the suggested use scenarios of the device; device components and user interface, the simplicity of use, duration of use, level of expertise required from the Q300 operator, clarity in the use sequences, and perceived added complexity compared with contemporary ICSI routine.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers
2. Patients recruited from the hospital's andrology/IVF departments
3. Male, Age \>18
4. Patient signed on informed consent

Exclusion Criteria:

1. Severe Oligozoospermia (less than 1 million sperm cells after preparation).
2. Documented presence of infectious disease transmitted in sperm fluids (e.g. HIV, HBV, HCV, Covid-19)