cyrilzakka/clinical-trials huggingface dataset:
A Study of the Effect of Multiple Doses of Diltiazem on the Plasma Levels of MK-6916 in Healthy Participants (MK-6916-005)

The goal of the study is to learn what happens to levels of MK-6916 in a healthy person's body over time. Researchers will compare what happens to MK-6916 in the body when it is given with or without another medicine called diltiazem.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Has a body-mass index (BMI) 18 to 32 kg/m\^2

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
* Has a history of cancer (malignancy)
* Has a history of cardiac arrhythmia or recurrent unexplained syncopal events
* Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome
* Has positive test(s) for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus
Coaching for Caregivers of Children With Spinal Cord Injury

This pilot study has two aims. The first aim is to establish the feasibility of coaching for caregivers of youth with spinal cord injury, and the second aim is to establish methodological procedures for a future multi-center study on the effectiveness of coaching as an intervention for caregivers of youth with spinal cord injury.

This study addresses the unmet needs of female primary informal caregivers of youth with spinal cord injury. A one-group pre-post treatment design will be used. Consented caregivers will receive coaching via face-to-face or via the phone. Each caregiver will participate in up to 10 coaching sessions. Each coaching session will last up to 90 minutes. Coaching sessions will be audiorecorded and transcribed verbatim. Outcomes of coaching on caregivers' self-identified goals will be assessed using the Canadian Occupational Performance Measure.

Eligibility Criteria:
Inclusion Criteria:

* female primary caregiver of youth between 6-13 years of age with traumatic spinal cord injury
* female primary caregivers have legal guardianship of their child with spinal cord injury
* speak, read and comprehend English
* be available for face-to-face coaching
* have a cell phone with text messaging capabilities, and willing to utilize cell or land line for coaching and data collection
* able to verbalize changes in their own participation or their child's participation during initial screen
* written consent

Exclusion Criteria:

* severe mental health condition of female caregiver, as documented in child's medical record or reported to research staff by child's treating MD or medical team member
* abuses illicit or prescribed substances or alcohol at time of initial screen as documented in child's medical record or reported to research staff by child's treating MD or medical team member
Virtue® European Study

This study is a prospective, single arm, non-randomized, multi-center clinical study that will be conducted in Europe. It is designed to assess efficacy and safety of the Virtue® Male Sling in post-prostatectomy urinary incontinence.

This study is a prospective, single arm, non-randomized, multi-center clinical study that will be conducted at up to thirteen centers in Europe. It is designed to assess efficacy and safety of the Virtue® Male Sling. One hundred and twenty-one subjects, satisfying criteria for selection, will be implanted with no more than 15 implanted per site. The study's primary end point will be evaluated at 12 months with continued data collection through 36 months.

Eligibility Criteria:
Inclusion Criteria:

* The subject has an estimated life expectancy of more than 5 years

  * The subject has confirmed stress urinary incontinence (SUI) through medical history, urodynamics, and/or physical exam for at least 6 months
  * The subject has intrinsic sphincter deficiency due to radical prostatectomy completed at least 1 year prior to implantation date
  * The subject has a good bladder function
  * The subject has failed non-invasive therapies, eg. Pelvic Floor/Kegel exercises, behavioral modification, or biofeedback, for at least 6 months
  * The subject is willing to have the Virtue® Male Sling implanted
  * The subject is able and willing to complete all follow-up visits and procedures indicated in this protocol

Exclusion Criteria:

* The subject is unable or unwilling to comply with all follow-up requirements according to the study protocol

  * The subject has an active urinary tract infection or active skin infection in region of surgery (temporary exclusion)
  * The subject has compromised immune systems or any other conditions that affect healing
  * The subject has serious bleeding disorders
  * The subject has an urinary incontinence that is not mainly a stress urinary incontinence
  * The subject has a stress urinary incontinence due to TransUrethral Resection or laser surgery of the Prostate (TURP)
  * The subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury, CVA, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions
  * The subject had a previous implant (male sling, Artificial Urinary Sphincter) to treat stress urinary incontinence (previous implanted bulking agents are allowed)
  * The subject has undergone radiation, cryosurgery, or brachy therapy to treat prostate or other pelvic cancer within 6 months
  * The subject is likely to undergo radiation therapy within the next 3 months
  * The subject has a postvoid residual (PVR) \> or = 150mL
  * The subject has recently required transurethral instrumentation for urethral or urethro-vesical anatomosis stricture within the previous 6 months
  * The subject is enrolled in a concurrent clinical study of any treatment (drug or device) that could affect continence function without the sponsors' approval
  * The subject is deemed unfit for male sling implantation or participation in a research protocol as determined by the attending physician
Cutaneous Heart Sounds Data Collection During Cardiac Resynchronization Therapy (CRT) Optimization Study

The Cutaneous Heart Sounds Data Collection During CRT Optimization study is an acute, prospective, non-randomized multi-center feasibility clinical trial. The purpose of this clinical trial is to collect data to assist in the testing and finalization of a hemodynamic sensor-based cardiac resynchronization therapy (CRT) optimization scheme.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have been implanted with a Medtronic market approved CRT-D device (Concerto®, Concerto® II, Maximo® II, Consulta®, Protecta™, or Protecta™ XT) within two years
* Subject must be 18 years of age or older
* Subject or his/her legally authorized representative has signed and dated the study specific informed consent form ("Consent Form")
* Subject is willing and able to comply with protocol requirements

Exclusion Criteria:

* Subject with atrial tachyarrhythmia or frequent atrial or ventricular ectopy
* Subject is post mitral or aortic valve repair or replacement
* Subject is participating in other research studies that many confound the results of this study
* Subject is pregnant or in fertile age without secure birth control
* Subject has dementia
* Subject is unwilling to comply with protocol requirements
* Subject has a device and lead system with fractured leads
* Subject cannot undergo an echocardiograph procedure, or is contraindicated to undergo such a procedure
Paresthesia in Hand and Antebrachium Following CardiacSurgery: Incidence, Risk Factors and Clinical Course

To describe the incidence and severity of Paresthesia in Hand and Antebrachium in patients that have undergone CardiacSurgery.

Some patients report tingling and/or numbness in hand and/or antebrachium after cardiac surgery, but potential risc factors and clinical course are not well described, and the incidence or severity is not known. Many factors may impact on the development of these complaints: age, BMI, pre-operative neurological deficits, diabetes, type, technique and duration of cardiac surgery, positioning of arms and hands during surgery, placement of the arterial line, time-to-extubation and post-operative positioning during this period.

The investigators aim to describe incidence and clinical course of these complaints and possibly identify modifiable risc factors in a retrospective cohort of patients that have undergone fast-track cardiac surgery, as a part of the on-going patient-centered quality improvement.

The study included 361 patients. Conclusion The incidence of hand paresthesia following cardiac surgery was 10%. This study found an increased occurrence of paresthesia after aortic valve surgery and prolonged aortic cross-clamp duration; these differences were not statistically significant. The impact of arterial line placement and patient positioning as a risk factor remains unclear. The majority of patients with paresthesia were overweight and had pre-existing comorbidity, with 11% reporting preoperative paresthesia. The clinical course of hand paresthesia following cardiac surgery was predominantly transient and not severe.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* cardiac surgery in the period from january 2022 to december 2023
* perioperative data entered into the quality database SafeBrain
Iloprost in High Risk Cardiac Surgical Patients

In this study effects of the intra operative, prophylactic inhalation of Iloprost (Ventavis) before and during extracorporal circulation on perioperative morbidity and outcome in high risk cardiac surgical patients is investigated in comparison to placebo.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* for females of childbearing potential: negative pregnancy test
* patients, male or female, 18 to 85 years old
* elective open-heart surgery using heart-lung-machine
* patients with increased risk to suffer from perioperative right heart failure, i.e.,

  * protracted surgery: multiple valvular transplant or expected bypass time exceeding 120 min and/or
  * patients with preoperative known pulmonary hypertension and/or
  * patients with severe heart insufficiency (NYHA III or NYHA IV)

Exclusion Criteria:

* patient not able to give consent
* pregnant or nursing patients
* Anamnestic known hypersensitivity to the used drug (Ventavis) and its ingredients or to drugs with a similar chemical structure
* blood clotting disorder requiring treatment
* trauma, intracerebral bleeding or apoplexy within the last 3 months prior to surgery
* primary or secondary immune deficiency (e.g., pretreatment with steroids, cytostatics)
* systemic infection
* lung disorder with impaired gas exchange
* lung transplantation
* cardiac transplantation
* implantation of LVAD (left ventricular assist device)
* fluoride ulcus disorder
* planned surgery in deep hypothermia and cardiac arrest
* subconscious and psychiatric disordered patients
* participation in another clinical trial within the last 30 days prior to study start and up to 30 days after end of study
* previous participation in this study
Physical Activity in People With Sequelae of Poliomyelitis

People with disabilities are less physically active than the general population. At present, the physical activity level of people with poliomyelitis sequelae and their barriers to physical activity are unknown.

The aim of this study is to describe the physical activity level of people with poliomyelitis sequelae and their barriers to physical activity.

This is a cross-sectional, monocentric, cohort study of subjects with poliomyelitis sequelae followed in a Physical Medicine and Rehabilitation Department.

All consecutive eligible outpatient subjects consulting to the Physical Medicine and Rehabilitation Department of our university hospital will be included.

Data will be collected from the patients' medical records, in particular data related to their clinical, radiological, biological and physiological examinations.

It is an ancillary study to the NO-AGING study.

Eligibility Criteria:
Inclusion Criteria:

* Consulting to the Physical Medicine and Rehabilitation Department of our university hospital
* Having poliomyelitis sequelae
* No opposition to be enrolled in the study from the patient
* Affiliation to a social security scheme

Exclusion Criteria:

* Disability that does not allow the completion of questionnaires
* Acute intercurrent medical situation
* Use of electric wheelchair
* Under court protection.
Telehealth Could Mitigate Disease Progression Compared to Standard of Care in COPD - a Randomized Controlled Trial

The objective of this randomised controlled trial is to test, whether telehealthcare can improve HRQOL and reduce emergency admissions and hospitalisations due to AECOPD. Different outcome parameters as described in the endpoints section will be analysed.


Eligibility Criteria:
Inclusion Criteria:

* COPD GOLD B-D and age ≥ 40 years

Exclusion Criteria:

* Inability to provide informed consent or to follow trial procedures
To Explore the Effect of Huaier Granule on the Negative Conversion Rate After the CEA Level Increases Again After Colorectal Cancer Surgery

This study is a prospective, observational and exploratory study to explore the effect of Huaier Granule on the negative conversion rate of patients with increased CEA levels after colorectal cancer surgery.

This study is a prospective, single center, observational study, expected to include patients who visited the selected research center from December 2022 to December 2024 and were pathologically diagnosed with stage I-III colorectal cancer and underwent R0 radical resection surgery. During routine clinical follow-up within one year after radical surgery, if serum CEA\>5.2ng/ml occurs, patients may choose whether to use Huaier granules to prevent recurrence and metastasis according to their wishes. Patients who agree to use Huaier granules will enter the observation group; Patients who do not agree to use it will enter the control group. After the subjects are enrolled, they will be visited every 1 month ± 7 days in the first year, and every 3 months ± 14 days starting from the second year according to clinical routine diagnosis and treatment, until imaging examination determines disease progression, the end of the study, intolerable toxicity, withdrawal from the study for any reason or death, or the researcher determines no longer benefiting, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old, gender not limited
* Diagnosed with colorectal cancer through histopathology, pTNM stage I-III
* Previously underwent radical resection for colorectal cancer, with a postoperative evaluation of R0
* Imaging did not detect recurrence or distant metastasis
* Serum CEA\>5.2ng/ml within 1 year after surgery (found during routine clinical follow-up)
* Clear consciousness, language expression or reading ability, able to communicate normally, and cooperate to complete the questionnaire evaluation
* Voluntary participation in this study, good compliance, and signing of informed consent form.

Exclusion Criteria:

* Known to be allergic to the components of Huaier Granule, or to avoid or use Huaier Granule with caution (observation group)
* Cannot take medicine orally
* Have received anti-tumor traditional Chinese patent medicines and simple preparations treatment within 1 month before enrollment (subject to the instructions)
* Combining medical history of other malignant tumors
* Diabetes with serious heart, cerebrovascular and lung diseases, severe hypertension and poor blood sugar control
* Suffering from intestinal diverticulitis, rectal polyps, colitis, pancreatitis, cirrhosis, hepatitis, etc
* Currently participating in clinical trials of other drugs
* Pregnant or lactating women or those planning to conceive
* Refusing to cooperate with follow-up visits
* Other reasons led the investigators to believe that it was not suitable to participate in this study
Disaster Nursing Course Affect Nursing Students' Disaster Literacy and Preparedness

This study aimed to examine the effect of disaster nursing course on nursing students' disaster literacy and preparedness perceptions. The study, which was a one-group quasi-experimental study design in a pretest-posttest design. Pre-test was done on September 27, 2021, and the post-test was applied on January 7, 2022. The location of the study is a public university in Izmir which is located in western part of Türkiye. The population of the study consisted of nursing students (n: 66) studying in the nursing department of the university and enrolled in the elective course "Disaster Nursing". No sample selection was made, and the study was conducted with 62 volunteer students. Individual introduction form, Disaster Literacy Scale, and Perception of Disaster Preparedness in Nurses Scale were used as tools for data collection. At the beginning of the study, data collection tools were collected online form. "Disaster nursing" course was conducted for 14 weeks as an intervention. The data were stored in the SPSS 25 program.

This study aimed to examine the effect of disaster nursing course on nursing students' disaster literacy and preparedness perceptions. The study was a one-group quasi-experimental study design in a pretest-posttest design. Pre-test was done on September 27, 2021, and the post-test was applied on January 7, 2022. The location of the study is a public university in Izmir which is located in the western part of Türkiye. The population of the study consisted of nursing students (n: 66) studying in the nursing department of the university and enrolled in the elective course "Disaster Nursing". No sample selection was made, and the study was conducted with 62 volunteer students. Individual introduction form (13 questions), Disaster Literacy Scale (61 items), and Perception of Disaster Preparedness in Nurses Scale (20 items) were used as tools for data collection. At the beginning of the study, data collection tools were collected online form. "Disaster nursing" course was conducted for 14 weeks as an intervention. The descriptive statistical methods (number, percentage, mean, standard deviation), paired sample t-test, and Pearson correlation was used data analysis.

Eligibility Criteria:
Inclusion Criteria:

* enrollment in the disaster nursing course
* regular attendance at meetings
* voluntary participation in the study

Exclusion Criteria:

* participants with any form of cognitive
* a mental, or physical disability that interfered with communication,
* as well as individuals with an employment history, a diploma, or a certificate in the subject of disaster
Occupational Therapy-Based Cognitive Rehabilitation of Cocaine Abusers: A Pilot Study

This study integrates a model of occupational-therapy based cognitive rehabilitation as part of a comprehensive treatment plan for cocaine abusers. We hypothesize that cognitive impairment and quality of life would improve and that cocaine use would decrease in those participants receiving occupational-therapy based cognitive rehabilitation.

occupational-therapy based cognitive rehabilitation as part of a comprehensive treatment plan for cocaine abusers

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65
2. Primary cocaine use disorder (based on DSM-5 criteria) and in at least 3 months of remission
3. At least mild cognitive impairment, defined as = or \> 1.5 standard deviations impairment on any 2 performance-based neurocognitive measures
4. Needing to change quality of life, defined as self-identifying at least 2 life areas as needing to change on the Drug User Quality of Life Scale
5. A Veteran at the San Francisco Veterans Affairs Medical Center
6. Currently receiving weekly drug counseling (individual or group; at least 1 hour/week) through an outpatient substance use disorder treatment program

Exclusion Criteria:

1. Inability to speak, read, write, and understand English
2. Inadequate hearing or vision
3. Concurrent substance use disorder (except tobacco or caffeine) not in at least 3 months of remission
4. A psychiatric disorder that will interfere with study participation or will make participation hazardous (e.g., psychosis, suicidal or homicidal ideations, severe anxiety)
5. A depressive disorder classified as severe, defined as a Beck Depression Inventory-II score \>29
6. Current diagnosis of a bipolar disorder needing acute inpatient psychiatric hospitalization
7. Currently symptomatic from attention-deficit/hyperactivity disorder (DSM-5 criteria)
8. Any learning disorder, any type of dementia, any type of delirium, or an amnestic disorder due to any general medical condition
9. Wechsler Test of Adult Reading standard score \<70
10. Mini-Mental State Examination score \<24
11. Current use of scheduled (i.e., prescribed) regular (i.e., daily) psychotropics or other medicines with a high likelihood of sedation \& cognitive impairment (e.g., benzodiazepines, clozapine, anticholinergics)
12. Currently prescribed stimulants (e.g., methylphenidate) or cognitive enhancers (e.g., donepezil, memantine)
13. Active medical illnesses - uncontrolled diabetes, uncontrolled hypertension, uncontrolled thyroid dysfunction, or uncontrolled B12/folate deficiency; central nervous system illness with potential cognitive aspects (Parkinson's, or Huntington's dementia); Cirrhosis with complications (e.g., ascites, encephalopathy, jaundice, gastrointestinal bleeding); Needing acute medical hospitalization from HIV sequelae, such as HIV-related opportunistic infection
14. Any history of any type of stroke or brain hemorrhage
15. Any history of traumatic brain injury, intracranial pathology (e.g., tumor), or brain surgery
16. Currently on probation or parole
17. Concurrent participation in another study that medically/administratively interferes with this study
Resveratrol in Knee Osteoarthritis

The purpose of this study is to determine whether resveratrol is effective in the treatment of painful knee osteoarthritis.

Osteoarthritis (OA) is the first cause of handicap in individuals over 40 years-old in France. OA physiopathology is driven in part by local joint inflammation responsible for pain and joint destruction. Experimental studies have shown that resveratrol, a molecule antagonist to the aryl hydrocarbon receptor, has anti-inflammatory and chondroprotective properties in vitro and in vivo. The investigators hypothesize that oral resveratrol, in a new formulation improving its bioavailability, could reduce knee pain at 3 months as compared with placebo in people with knee OA.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 40 years-old
* Knee osteoarthritis fulfilling 1986 American College of Rheumatology (ACR) criteria
* Pain on numeric rating scale ≥ 40/100
* Symptom duration ≥ 1 month
* Kellgren and Lawrence X-Ray score 1, 2 or 3
* Written consent obtained
* Health insurance cover

Exclusion Criteria:

* History of symptomatic crystal or inﬂammatory arthritis
* Knee surgery ≤ 1 year
* Knee trauma ≤ 2 months
* Knee intra-articular injections of corticosteroids and/or hyaluronic acid ≤ 2 months
* Neurologic disorders involving the lower limbs
* Patient not understanding and not speaking french
* Participation in another biomedical research
* Contraindication to resveratrol or hypersensitivity to any of its constituents
* Current use of intramuscular, intravenous or oral corticosteroids
* Uncontrolled diseases that may require intramuscular, intravenous or oral corticosteroids
* Current use of anticoagulants