cyrilzakka/clinical-trials huggingface dataset:
XIENCE Skypoint Large Vessel Post Approval Study

SPIRIT XLV PAS is a prospective, single arm, multi-center, US and OUS post-approval observational study to evaluate the continued safety and effectiveness of the XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS) Large Vessel (LV) sizes (diameter 4.5 mm and 5.0 mm) during commercial use in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

General Inclusion Criteria

1. Subject must be at least 18 years of age.
2. Subject or a legally authorized representative must provide written informed consent per site requirements.
3. Subject must have evidence of myocardial ischemia (STEMI, NSTEMI, Unstable Angina or Stable Angina) or who have silent ischemia with evidence of ischemia, appropriate for PCI treatment with DES. Subject with stable angina or silent ischemia must have objective sign of ischemia as suggested by one of the following:

   1. Abnormal stress or imaging stress test
   2. Abnormal computed tomography-fractional flow reserve (CT-FFR)
   3. Stenosis by visual estimation ≥ 70%
   4. Abnormal pressure-derived indexes (FFR, instantaneous wave-free ratio \[iFR\], or relative flow reserve \[RFR\])
4. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.

Angiographic Inclusion Criteria

1. Patients who have lesion(s) in a vessel with reference vessel diameter \> 4.25 mm and ≤ 5.25 mm as the target lesion
2. Patients who receive at least one Skypoint LV stent

   1. Lesions with RVD ≤ 4.25 mm should be treated as the non-target lesions during the index procedure with commercially available XIENCE family of stents
   2. Up to three lesions (target and non-target) in two coronary vessels can be treated at the index procedure.

Exclusion Criteria:

General Exclusion Criteria

1. Patients who have contraindications of the Skypoint LV per the IFU
2. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months.

Angiographic Exclusion Criteria:

1. Patients who require three vessel treatment.
2. If left main coronary artery (LMCA) is the intended target vessel, patients who have unprotected left main disease with the SYNTAX Score ≥ 23

   1. Unprotected LM disease with a SYNTAX score ≤ 22 (site-assessment) can be treated as the target lesion but not to exceed 40% of the study population
   2. A heart team consensus approach per site's standard of care (SOC) to enhance patient protection and optimal clinical practice for the left main treatment is required.
Effects of Modern Board Games on Well Being in Older Adults

The aim of the study is to assess the effects of an intervention using modern board game-based learning in a sample of older individuals. The evaluation will focus on determining if there is a change in executive functions, social participation, and participants' perception of well-being.

The aim of the study is to assess the effects of an intervention using modern board game-based learning in a sample of older individuals. The intervention will last for 12 weeks, incorporating the use of the 16 board games identified in the previous study, which also established the most suitable adaptations and methodologies for this age group. The study will take place in a senior living facility. A quasi-experimental methodology will be employed, involving both a control group and an experimental group. The evaluation will focus on determining if there is a change in executive functions, social participation, and participants' perception of well-being.

Eligibility Criteria:
Inclusion criteria:

* Be residents of the Centro Doctor Villacián (Valladolid).
* Willing to commit to the study.
* Have literacy skills.

Exclusion criteria:

· Presentation of advanced dementia case.
A Prospective Observational Study of Tocilizumab (RoActemra/Actemra) in Participants With Rheumatoid Arthritis

This prospective observational study will investigate the effect of tocilizumab on fatigue in participants with moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs or anti-tumour necrosis factor (anti-TNF) drugs. Data will be collected from participants for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Participants with moderate to severe RA who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab according to his/her clinical judgment and the conditions approved in the Summary of Product Characteristics (SPC).

Exclusion Criteria:

* Participants previously or currently treated with RoActemra/Actemra in clinical trials
* Absolute neutrophil count less than or equal to (\</=) 2x10\^9 per liter (/L)
Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain

Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health. This study will evaluate how well elagolix in combination with combined oral contraceptives (COC) works within the body and/or how safe it is compared to placebo (does not contain treatment drug). This study will assess the dysmenorrhea (painful periods) response in participants with endometriosis and associated pain.

Elagolix is an approved drug for the management of moderate to severe pain associated with endometriosis. Participants are randomly put in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Adult female participants who still have periods with a diagnosis of endometriosis will be enrolled. Around 800 participants will be enrolled in the study at multiple sites in the United States, including Puerto Rico.

Participants will receive oral elagolix or placebo tablets in combination with combined oral contraceptive (COC) or placebo capsules for 3 months. All the participants will receive elagolix tablets in combination with COC tablets from Month 4 through Month 18.

There will be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Documented surgical confirmation of endometriosis and associated moderate to severe pain.
* Participants must agree to use dual non-hormonal methods of contraception consistently during washout (if applicable), screening, and 3-month double-blind placebo-controlled treatment periods of the study.
* Participant, in the investigator's opinion must be an appropriate candidate to receive combined oral contraceptives (COCs).

Exclusion Criteria:

* Pregnant or breastfeeding or planning a pregnancy until completion of the study.
* Surgical history of hysterectomy or bilateral oophorectomy.
* Participant has osteoporosis or other metabolic bone disease or clinically significant gynecological findings from Screening.
* Participant has any other active chronic pain condition that would interfere with their assessment of endometriosis-related pain.
Internet-Delivered Cognitive Behaviour Therapy for Adolescent Depression

The purpose of this study is to determine whether tailored internet-administrated cognitive behaviour therapy (CBT) is a feasible approach in the treatment of depressive symptoms and comorbid anxiety symptoms.

As above

Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 15-19 years old
* Have symptoms of depression, major depression

Exclusion Criteria:

* Suicidal ideation
* Alcohol addiction
* other major primary psychiatric disorder
* Ongoing psychological treatment
* recent (during last 4 weeks) change in psychiatric medication
Modulation of Attention in Event Related Potential (ERPs) as a Marker of Early Cognitive Decline by Ginkgo Biloba

The objective of this study is to simultaneously establish the metrological characteristics of the new executive function markers (decision making and multiple flow management) derived from repeated ERP variations and to identify their ability to test whether a short treatment using Ginkgo biloba versus placebo extracts can modify the cognitive performance and functional capacity of patients in the very early stages of age-related cognitive decline. This trial, using subjects as their own control (cross-over) in repeated measurements will establish the reproducibility characteristics of the measurements and intra-individual variations of ERP over time in this population

This study is a single-center, randomized clinical trial testing the effects of Ginkgo biloba extracts versus placebo on event related potential ERP registration measurements in Electroencephalography (EEG) during neuropsychological tasks. The Hold-Release (HR) neuropsychological test allows the study of behavioral and neurofunctional correlates using several different techniques for online recording of brain activity. This test measures the engagement of focused attention and the loading of information into working memory, as opposed to the disengagement of attention.

The study will be carried out in a randomized cross-over design, with "Ginkgo" vs. Placebo", or inversely, for 170 days each (approximately 6 months), separated by an 8-weeks wash-out period. A follow-up visit will be held 3 months after the last treatment of the study.

The cross-over design uses each patient as its own control, which allows an easy comparison between the 2 groups "Placebo" vs. "Ginkgo" by limiting inter-patient variations. In addition, by doubling the number of patients per treatment compared to a classic study design in 2 groups, cross-over reduces the number of patients to be recruited, which facilitates recruitment on a single site.

The study requires the recruitment of sixteen (16) informative participants with cognitive complaints.

Eligibility Criteria:
Inclusion Criteria

* Signed consent form
* men and women
* 60 to 80 years old
* Diagnostic of Subjective complain
* Understanding the 2 Hold-Release tasks in ERP

Exclusion Criteria:

* Montreal Cognitive Evaluation Score (MoCA) \<24
* Overall Clinical Dementia Rating (CDR) score \> 0.5
* Scores of the Hospital Anxiety and Depression Scale (HADS): HADS-A (Anxiety) \> 8 and/or HADS-D (Depression) \> 8
* Mild Cognitive Impairment (MCI) or dementia
* Contraindication to MRI
* Atrophy of any region of the brain as seen in the T1 volumetric MRI sequence
* Any uncontrolled somatic or psychiatric condition
* Bleeding disorders, and/or taking medications that increase the risk of bleeding,
* Hypersensitivity to Ginkgo biloba or any of its excipients
* Lactose intolerance
* Treatment with barbiturates and/or neuroleptics
* Ongoing treatment with Ginkgo biloba derivatives (a period of 2 months without treatment before inclusion is required
Assessing Risk Factors for Radiological Complications After Transforaminal Lumbar Interbody Fusion

This retrospective study is to determine whether age is a risk factor for postoperative complications in patients undergoing transforaminal lumbar interbody fusion; specifically whether the risk (odds) of implant failure and the need for revision surgery increases with age.

Spinal fusion is one of the most commonly performed surgical procedures for the treatment of degenerative spinal disease. Interbody fusion with cages reconstructs the anterior column through disc removal, allowing to maintain proper disc height despite weight bearing, while providing firm fixation of the spinal segments. Transforaminal lumbar interbody fusion (TLIF) has fewer complications and less intraoperative bleeding than posterior lumbar interbody fusion (PLIF). Elderly patients are at high risk for perioperative and postoperative complications after lumbar fusion. This retrospective study is to determine whether age is a risk factor for postoperative complications in patients undergoing transforaminal lumbar interbody fusion; specifically whether the risk (odds) of implant failure and the need for revision surgery increases with age.

Eligibility Criteria:
Inclusion Criteria:

* Indications for TLIF surgery (e.g., degenerative disc disease, spondylolisthesis)
* Existing preoperative upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis, sacrum and femoral head
* Existing preoperative MRI of the lumbar region with clear visibility of different fatty infiltration grade and stenosis degree
* Complete follow-up at 3 months and 1 year postoperatively, including clinical and radiographic data

Exclusion Criteria:

* Neuromuscular diseases such as Parkinson's disease or multiple sclerosis according to our records
* Preoperative infection and/or malignancy tumor with involvement of the bony or soft tissue structures of the lumbar spine
* Presence of a documented consent dissent
Comparison of Spinal Kinematics Between Asymptomatic Subjects and Patients With Low Back Pain

Low back pain (LBP) is a complex and common problem with major societal repercussions. Clinical evaluations, and especially functional assessments, are necessary for proper diagnosis and decisions on the most appropriate treatment. The assessment of lumbar kinematics has been frequently described. For instance, measures of range of motion (ROM), angular velocities and acceleration of the total lumbar spine (TLx) have demonstrated some differences between healthy subjects and LBP patients. However, recent evidence has suggested that models evaluating the TLx are insufficient. In fact, regional differences in kinematics have been described between the upper lumbar spine and the lower lumbar spine.

The aim of this study is to evaluate the differences in spinal kinematics between healthy subjects and LBP patients using a multi-segment model of the spine that allows regional analysis.

A case-controlled study will be performed to compare asymptomatics subjects and patients with low back pain. ROM, angular velocities and coordination of the spine will be collected in a laboratory with a camera-based system (VICON). Subjects will have to perform normal ROM assessment in the three anatomical planes, as well as different functional activities such as sit to stand, step and walking. The measurement session will occur on one occasion for each participant.

Eligibility Criteria:
Inclusion Criteria:

* Sufficient French level
* BMI between 18 and 27
* Non-specific low back pain for more than 3 months (pain provoked by movements, postures or activities)

Exclusion Criteria:

* Pregnancy
* Spondylolisthesis
* Infection
* Rheumatological or neurological diseases
* Spinal fractures
* Known spinal deformation (scoliosis, ...)
* Back surgery
* Tumours
* Radicular symptoms (with neurological signs). Pain irradiating in the lower limbs with decrease strength, sensitivity and reflex.
* High level of pain (severity and irritability) at the time of experiment that prevents repeated movements.
* Other concomitant pain or condition that could compromise the evaluation of lumbar kinematics.
SGS: a Structured Treatment and Teaching Programme for Elderly Patients With Diabetes Mellitus

It was the aim of the study to develop and evaluate the effectiveness of a new structured teaching and training programme for elderly patients with diabetes mellitus (SGS) and insulin therapy.

Patient education has become an integral part of any diabetes therapy in Germany. But elderly people are often not able to follow the variety of topics comprising standard treatment and training programmes for insulin-treated patients with type 2 diabetes mellitus due to geriatric syndromes and neuropsychological deficits. Therefore, treatment of elderly diabetics should focus on individual therapeutic goals, which reflect reduced life expectancy and quality of life.

It was the aim of the study to develop and evaluate the effectiveness of a new structured teaching and training programme for elderly patients with diabetes mellitus (SGS) and insulin therapy.

The high prevalence of cognitive impairment and affective disorders requires special pedagogical methods as well as adapted contents. For example the advantages of physical activity, the frequent existence of malnutrition, urinary incontinency or heart failure are taken into consideration. Contents are transmitted in a practical and daily-living oriented way.

The programme comprises 7 education lessons of 45 minutes duration implying the education units: diabetes mellitus, nutrition, treatment strategies, self-monitoring and complications focussing the diabetic foot syndrome.

The effectiveness of the new structured treatment and teaching programme SGS was evaluated in a multicenter prospective randomised controlled trial. Diabetic patients admitting one of 18 study centres in Germany with at least one geriatric syndrome, comorbidity and older than 65 years were randomised either to the new SGS programme or to the standard treatment programme for patients with type 2 diabetes mellitus. Before and 6 month after participation in the structured treatment programmes the outcome quality was evaluated using structured questionnaires. We assessed HbA1c, skills of diabetes self-management, diabetes knowledge, treatment satisfaction, acute and late complications, neuropsychological status, diabetes mediation, activities of daily living and need of social service. The main treatment goal was maintenance of autonomy and quality of life in elderly people, as well as prevention of catabolism, frailty and acute complications.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 65 years, at least more than one other diagnosis than diabetes, at least one geriatric syndrome

Exclusion Criteria:

* myocardial infarction, apoplexy within the last 2 weeks before planned enrolment
Study to Assess the Safety and Tolerability of Single Doses of REGN1500

Phase 1, first-in-human, randomized, ascending single-dose, placebo-controlled, double-blind study of the safety, tolerability, and bioeffect of REGN1500


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index 18.0 to 40.0 kg/m2, inclusive
2. Normal standard 12-lead ECG
3. Willing to refrain from the consumption of alcohol for 24 hours prior to each study visit
4. Willing to consistently maintain his/her usual diet for the duration of the study
5. Willing to refrain from strenuous exercise for the duration of the trial
6. Willing and able to comply with clinic visits and study-related procedures
7. Provide signed informed consent
8. For sexually active men and women, willingness to utilize adequate contraception and not have their partner\[s\] become pregnant during the full duration of the study.

Exclusion Criteria:

1. Any clinically significant abnormalities observed during the screening visit
2. History of drug or alcohol abuse within 1 year of screening
3. Receipt of another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit.
4. Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that may adversely affect the subjects participation in this study
5. Known history of human immunodeficiency virus (HIV) antibody; and/or positive hepatitis B surface antigen (HBsAg), and/or positive hepatitis C antibody (HCV) at the screening visit
6. Hospitalization for any reason within 60 days of screening
7. History or presence of malignancy within 5 years prior to the screening visit (other than successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, and/or localized carcinoma in situ of the cervix
8. Any medical or psychiatric condition which, in the opinion of the investigator, would place the subject at risk, interfere with participation in the study or interfere with the interpretation of the study results
9. Any subject who is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff directly involved in the conduct of the protocol, or family member of staff involved in the conduct of the protocol
10. Pregnant or breast-feeding women

(The inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a patient's potential participation in this clinical trial).
CBSM Intervention Via mHealth to Ameliorate HIV-related Fatigue

The purpose of this study is to create a smartphone, tablet and web-based application to help people deal with stress. Stress often increases fatigue in people with HIV infection, so successfully dealing with stress could help reduce HIV-related fatigue. The study is being done at one site, the Medical University of South Carolina. Approximately 30 people will take part in this portion of the study.

For this study we will develop a fatigue symptom self-management cognitive behavioral stress management (CBSM) program that will be delivered via mHealth through smartphones and tablets (optimized for each). All CBSM content will be integrated into the application, but tailoring of information delivery will be derived through algorithm-driven feedback based on user input as they respond to integrated assessment and symptom monitoring questions. As a result, users of the CBSM-Self Management Intervention (CBSM-SMI) will receive personalized, relevant intervention content, when they need it, where they need it. This novel mode of CBSM delivery has not yet been provided via an mHealth format to HIV-infected individuals, despite its obvious advantages insofar as cost and reach are concerned.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* Reads and understands English
* Scores greater than 5 on the HIV-Related Fatigue Scale
* Mentally competent to give informed consent

Exclusion Criteria:

* Co-morbid conditions marked by fatigue (e.g., renal disease, cancer, multiple sclerosis)
* Pregnant women and women who are less than 1 year postpartum
* Active psychosis or dementia
* Suicidal ideation with clear intent
* Current substance dependence