cyrilzakka/clinical-trials huggingface dataset:
The Impact of Stent Deployment Techniques on Clinical Outcomes of Patient Treated With the CYPHER® Stent (S.T.L.L.R.)

1500 eligible patients will be treated with the commercially available CYPHER® sirolimus-eluting Bx Velocity™ stent. Patients will be followed to twelve months post-procedure, watching for patients that require a repeat procedure on the same diseased area of the coronary artery.

Geographical miss has been associated with treatment failures after intracoronary radiation therapy. This phenomenon, which is secondary to vascular injury outside the treated segment, was strongly correlated with the development of restenosis at the edges of the treated coronary segment. The European and Canadian SIRIUS trials (E and C-SIRIUS) randomized 350 patients with similar baseline characteristics of the US SIRIUS study. Operators used shorter post-dilatation balloons and direct stented 27% of the patients, achieving a 4.0% TLR rate and a 5.1% in-lesion binary restenosis. These somewhat superior results support the concept that refinement in deployment techniques may further improve clinical outcomes of drug-eluting stents.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of de novo stenosis in major coronary artery
* Can be treated with stents
* Candidate for bypass

Exclusion criteria:

* Recent, severe MI
* Prior brachytherapy
* Impaired left ventricle function
* Heart transplant recipient
* Impaired renal function
* Disease in vein grafts from previous bypass
* Similar treatment within the last 30 days
Melissa Officinalis L. Supplementation for Emotional Health and Sleep Disturbance

This study is aimed to investigate if Lemon Balm Extract supplementation is beneficial for the relief of stress, depression and anxiety in healthy adults.

Lemon balm (Botanical name: Melissa officinalis L.) is a herbal plant belongs to the Lamiaceae (mint) family, and currently of wide scientific interest as possible adjuvant for calming effect. Lemon balm is one of the most popular and widely used medicinal herbs in central and southern Europe, the Mediterranean region, and west Asia. The European Scientific Cooperative on Phytotherapy (ESCOP) recommends the use of lemon balm to relieve of mild symptoms of anxiety, including mental stress, restlessness, and irritability. Historically, Lemon balm has been widely used in Asian traditional medicine as a sedative to treat many psychiatric disorders, such as stress, depression, anxiety, and insomnia. Lemon balm has shown anti-depressant, anxiolytic, and anti-insomnia effects both in human clinical trials and in animal model studies.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals, aged 18 - 65 years
* Individuals suffering from moderate degree of depression, anxiety, and stress with DASS scores ≥14, ≥10, and ≥19, respectively, or individual with sleep problems with Pittsburgh Sleep Quality Index (PSQI) score ≥5.
* Willing to participate in the study

Exclusion Criteria:

* Current use of prescribed medication or supplements for neuropsychiatric and sleep disorders
* Known history of neuropsychiatric or sleep disorders
* Current use or history of illicit substances misuse
* History of any allergic reactions to ingredients of the Lemon Balm Extract
* Hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90, or other cardiovascular disease
* Hyperthyroidism or Diabetes mellitus or cancer
* Use of blood thinners like Coumadin (warfarin) or Plavix (clopidogrel), Glaucoma medications like Travatan (travoprost), Chemotherapy drugs like tamoxifen and Camptosar (irinotecan)
* Severe medical problem, which in the opinion of the investigator would pose a safety risk to the subject
Novel Support Surface to Alleviate Pressure Ulcer

A prototype support surface has been designed which aims to successfully redistributes the pressures exerted and provides sufficient support to human soft tissue

We want to prove the effectiveness of the prototype support surface by enlisting patients in a clinical trial, where we will assess the presence of pressure ulcers, and the ability of the patients to tolerate the support surface, and also measure the pressure over time and compare them to when the patients are using standard mattresses.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be immobile as assessed on the braden scale.
2. Patients must require 2 hourly turning
3. Age 21-85

Exclusion Criteria:

1. No existing pressure ulcers
2. No active infections, fever, or medical conditions that require constant medical attention.
3. They must also not have severe incontinence requiring the change of diapers more frequently than 4 hours
4. No significant cognitive impairment
5. Pregnant women will be excluded from the study
Help-seeking Intentions of ROTC Trainees

Online survey measuring pre-post stigma and intentions to seek care for musculoskeletal injuries using peer and authority-delivered health promotion videos.

The survey will be hosted via QualtricsXM and accessible via an anonymous link. When participants open the survey, they will be presented with the survey's information sheet explaining the study's purpose and procedures. The information sheet will make it clear that completing the survey is voluntary and cadets may cease the survey at any time. Data from unfinished surveys will not be included in final analyses for any reports produced from this survey. Participants will complete demographics questions. Then, participants will answer injury reporting intentions and stigma questions, presented in a randomized order to reduce respondent fatigue. Participants will then watch a health promotion video that encourages reporting musculoskeletal injuries while in ROTC. Participants have the potential to be shown one of three videos: an officer-delivered health promotion, cadet-delivered health promotion, and a video of an officer exercising. Participants will be randomly assigned to one of the three videos using the in-built randomization function within Qualtrics. After watching the video, participants will answer the stigma and intentions questions again. After, participants will be asked to provide an email address that will be used to send them a link to complete the survey a second time. The follow-up portion will ask for their unique identifier as described above and have the participants answer the stigma and intentions questions again. All data will be de-identified when exporting responses from Qualtrics. No reference will be made to any individual participant in any way when presenting or reporting these data.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-39
* Actively participating in a college or university senior ROTC program (Army, Air Force, or Naval)

Exclusion Criteria:

* Anyone who does not meet inclusion criteria
High Resolution HBA-MRI Using Deep Learning Reconstruction

This study aims to compare image qualities between conventionally reconstructed MRI sequences and deep-learning reconstructed MRI sequences from the same data in patients who undergo Gd-EOB-DTPA enhanced liver MRI. The AIRTM deep learning sequence is applicable for various MRI sequences including T2-weighted image (T2WI), T1-weighted image and diffusion-weighted image (DWI). We plan to perform intra-individual comparisons of the image qualities between two reconstructed image datasets.


Eligibility Criteria:
Inclusion Criteria:

* older than 20 years old
* scheduled for Gd-EOB-DTPA enhanced liver MRI at a 3T scanner (Premier, GE Healthcare) in our institution
* signed informed consent

Exclusion Criteria:

* younger than 20 years old
* any absolute/relative contrast indication of Gd-EOB-DTPA enhanced MRI
* history of transient dyspnea after Gd-EOB-DTPA administration
Chronic-disease Self-management Program in Patients Living With Long-COVID in Puerto Rico

This is a pilot non-randomized-controlled trial to evaluate the impact of "Tomando control de su salud", an evidenced-based intervention for chronic disease self-management in the quality of life of patients living with Long-COVID in Puerto Rico.

Patients from our cohort study entitle "The Puerto Rico COVID-19 Assessment Study" (PR-COAS) (IRB# 2290030465) will be invited to participate in this pilot study during the 12-month follow-up call. Participants with long-COVID and at least one chronic diseases that agree to participate in the pilot study will be allocated into one of the study intervention groups that will participate in the "Tomando Control de su Salud" (TCS) workshops. This group will be asked to answer a final interview approximately one month after the last workshop. Those not interested in participating in the intervention will receive general information about chronic disease management available at the CDC website in Spanish, by email or in person, in addition to their regular health care and will be asked to answer the interview approximately 3 months after the last interview of the PR COAS-cohort.

Investigators expect to enroll approximately 50 participants that will be divide between the groups of intervention and non-intervention. Participants will receive an incentive for transportation and/or parking expenses and for the time dedicated for their participation.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients 21 years or older;
2. Participant of PR COAS-cohort that completed the last interview (12-month-follow-up) and authorized to be contacted for further studies;
3. Having at least one chronic condition (excluding cancer) diagnosed by a physician or healthcare provider, and
4. Ability to attend weekly sessions.

Exclusion Criteria:

1. Any clinical or cognitive impairment that limits the participant's ability to decide to participate in the study or complete the interviews;
2. presence of a life threatening or extreme medical condition, and
3. planning to move out of the municipality within the next year.
A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury

The purpose of this study is to assess the prevalence of GHD in patients who sustain a head injury or suffer a major traumatic event and to evaluate the efficacy of growth hormone (GH) therapy in the treatment of GHD caused by trauma or head injury

The study was terminated on October 9, 2003. The reason cited for the termination was due to poor patient recruitment and therefore not enough data could be collected to provide comprehensive analysis for reporting of results. No safety or efficacy issues were reported to cause the termination of the study.

Eligibility Criteria:
Inclusion Criteria:

* Documented GHD
* Documented mild, moderate, and severe head injury (e.g.,Glasgow COMA Scale score less than or equal to 15 or equivalent measure)

Exclusion Criteria:

* Active systemic malignancy or active intracranial tumor
* Growth hormone replacement therapy in the last 12 months
* History of dementia unrelated to traumatic brain injury
Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes

This study is conducted in Europe. The aim of the study is to compare the effect of semaglutide subcutaneous (s.c., under the skin) 1.0 mg once-weekly to liraglutide s.c.1.2 mg once-daily on blood sugar levels after 30 weeks of treatment in people with type 2 diabetes. The study will last approximately 9 months (37 weeks). Each participant will have 7 visits at the clinic and 3 phone calls with the study doctor. At the visits, participants will have a number of tests, for example: general health checks, blood samples, heart and eye checks etc. Participants will also fill in some forms about their health and satisfaction with their diabetes treatment.


Eligibility Criteria:
Inclusion Criteria: - Male or female, age 18 years or older at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus - HbA1c of 7.0-11.0 % (53 - 97 mmol/mol) (both inclusive) - Stable daily dose(s) including any of the following anti-diabetic drug(s) or combination regimens 90 days prior to the day of screening: a) Biguanides (metformin above or equal to 1500 mg or maximum tolerated dose documented in the subject's medical record). b) Sulphonylureas (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record). c) SGLT-2 inhibitors (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) Exclusion Criteria: - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative - History or presence of pancreatitis (acute or chronic) - History of diabetic ketoacidosis - Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening - Subjects presently classified as being in New York Heart Association (NYHA) Class IV - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 30 ml/min/1.73 sqm as defined by KDIGO 2012 classification - Impaired liver function, defined as ALT above or equal to 2.5 times upper normal limit at screening - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation
The Role of Doppler Ultrasound in Assessment of Local Factors Affecting Maturation of Arteriovenous Fistula in Hemodialysis Patient

the long term survival of the chronic kidney disease (CKD) patients depends on the adequacy of dialysis via good vascular access. the arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis. pre-operative evaluation and periodic monitoring of the AVF after creation with well-defined applied criteria by color doppler ultrasound (CDUS) will help to reduce rate of access failure and achieve better cumulative patency rate of fistulas.

In recent years, the improvement in the diagnosis and treatment of chronic kidney disease (CKD) has led to increase the number of patients who need hemodialysis, adequacy of which depends upon the appropriately placed vascular access. Although the arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis, there is still a high rate of failure to mature in clinical practice. To increase the use of AVFs, especially in the co-morbid patients, a thorough pre-operative evaluation and periodic monitoring after AVF creation by color doppler ultrasound (CDUS) allows placement of AVF in higher proportion of patients, and early detection of access dysfunction with subsequent intervention that reduce the rate of access failure.

Doppler ultrasound is the main imaging modality for assessment of dialysis access circuits as its gives information on the morphological criteria and evaluates the inflow and outflow flows. CDUS is non-invasive modality, of low cost, not using ionizing radiation or iodinated contrast media.

Eligibility Criteria:
Inclusion Criteria:

CKD and ESRD patients on hemodialysis, in whom native arteriovenous fistula operation is needed

* both sexes are included.
* age group from 15-80years
* upper limb arteriovenous fistula only.
* native arteriovenous fistula.
* surgically succeeded AVF

Exclusion Criteria:

we will exclude:

* patients refused to be in the research.
* Patients with AVF not in the upper limbs.
* Patient of age less than 15years and above 80years.
* patients with synthetic grafts.
Cognitive Decline and Underlying Mechanisms in Symptomatic Intracranial Artery Stenosis Patients: A Cohort Study

The purpose of this study is to explore the mechanism of cognitive impairment in patients with symptomatic intracranial atherosclerotic stenosis (ICAS), and further plans to explore the impact of different treatment options on cognitive function in symptomatic ICAS patients.

All participants underwent a medical evaluation that included routine laboratory studies before and after 3-month and 1-year follow-up. Upon meeting the inclusion criteria and providing informed consent, each participant will complete a battery measure of neuropsychological tests, blood sample collection, and magnetic resonance imaging scan after enrollment and after 3-month and 1-year follow-up.

About 100 participants were included in this study. A series of neuropsychological tests were obtained by a trained investigator to assess. The tests include the evaluation of global cognitive function and multiple individual cognitive domains. The various tasks and questionnaires to measure cognition function including Montreal Cognitive Assessment (MoCA), Mini Mental State Examination (MMSE), Chinese Auditory Verbal Learning Test (CAVLT), Digital Span Test (DST), , Stroop color test (Stroop test), Color trail test (CTT), Clock Drawing Test (CDT), Verbal Fluency Test (VFT), etc., at the same time, the investigators also pay attention to the evaluation of participants' emotions by Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD). Furthermore, the memory and the occurrence of cerebrovascular events as the primary outcome measure, this study focused on the multidimensional cognitive function and cerebrovascular events of patients with symptomatic ICAS. Blood sample will be collected for biological multiomics research. The patients will receive a magnetic resonance imaging scan in multi-modalities.

After 3-month and 1-year follow-up, the participants will be interviewed to obtain the same assessments, blood sample and magnetic resonance imaging scan in multi-modalities as before.

Eligibility Criteria:
Inclusion Criteria:

1. Non-illiterates, no symptoms and signs of central nervous system dysfunction, head CT or head MRI showed normal cerebral parenchyma or old lacunar cerebral infarction, and non-thalamus, frontal lobe, temporal lobe and other cognitively related infarction;
2. TCD\\CTA\\MRA\\DSA present intracranial artery stenosis (50% or more) or occlusion;
3. History of vascular-related TIA and acute cerebral infarction (more than 2 weeks after lastest), and NIHSS score was less than or equivalent to 4 points at the time of enrollment;

Exclusion Criteria:

1. History of stroke,transient ischemic attack,seizures or unexplained loss of consciousness.
2. Organic brain defects on T1 or T2 images.
3. Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
4. Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator. History of substance abuse within the last 6 months
Study in Subjects Suspected of Having CAD Undergoing VISIPAQUE-enhanced CCTA as Part of Their Routine Medical Care

To assess prognostic value of CCTA examination in subjects who undergo CCTA as part of their medical care when compared to a standard of truth, i.e. subject outcomes during each follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* The subject is over 18 years old, exhibits chest pain syndrome and is scheduled to undergo a VISIPAQUE-enhanced CCTA examination for one of the following reasons:- Intermediate pre-test probability of CAD.
* An uninterruptible/equivocal stress test (exercise, perfusion, or stress echo).
Sirolimus, Tacrolimus and Short Course Methotrexate for Prevention of Acute GVHD in Recipients of Mismatched Unrelated Donor Allogeneic Stem Cell Transplantation

The primary objective of this trial is to study the safety and efficacy of a novel regimen of sirolimus, tacrolimus and methotrexate as prophylaxis against acute graft versus host disease (GVHD) in recipients of mismatched unrelated donor stem cell grafts. Methotrexate is administered in a low dose format of 5mg/m2 on days +1,3 and 6 only.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have an identified 8/10 or 9/10 matched unrelated donor identified following a formal search with confirmatory typing through the national marrow donor program as the best available donor. No matched sibling or fully matched unrelated donor has been identified. HLA typing of donor and recipient will be performed by high resolution molecular typing at HLA A, B, C and DRB1/DQ loci. Patients whose best available donor is matched at 8/10 loci must have at least one of the mismatches at the DQ locus. (no more than one mismatch at HLA A,B,C,DR allowed).
* Candidates for this trial will meet the following criteria:

  1. Adequate organ function for conditioning type:

     For patients receiving ablative conditioning
     * Left Ventricular ejection fraction \>45%
     * DLCO \>50%
     * Creatinine \<1.5
     * Hepatic enzymes \<3x upper limit of normal.
     * KPS \>70%

     For patients receiving non-ablative conditioning:
     * KPS \>70%
  2. Patients with the following diseases will be considered eligible:

     * AML in first remission with high risk features (poor risk cytogenetic abnormalities9, persistent elevated blast count on day +15 or recovery marrow after induction therapy).
     * AML beyond first remission
     * ALL in first remission with high risk features (ph+, t4:11)
     * ALL beyond first remission
     * High risk Myelodysplasia (RAEB-II, RAEB-I with poor-risk cytogenetics)
     * Recurrent Aggressive Non-Hodgkins or Hodgkins lymphoma (indolent histologies excluded) who have failed autologous transplant or have had inadequate response to salvage therapy.
     * CML with transformation
     * CLL with transformation or Fludarabine failure.
     * Severe aplastic anemia with recurrence or failure after immunosuppressive therapy.

Exclusion Criteria:

* Prior allogeneic transplantation
* Active CNS leukemia.
* Female patients who are pregnant or breast feeding
* Karnofsky performance status \<70%.
* Active viral, bacterial or fungal infection.
* Patients seropositive for HIV -1,2; HTLV -1,2 (due to the additional immunodeficiency induced by transplantation and immunosuppressive therapy) Requirement for antifungal prophylaxis with Voriconazole for the first 30 days is prohibited.
* Patients not providing informed consent.
D2 Versus D4 Corifollitropin Alfa in GnRH Antagonists

The purpose of the present study is to analyse if corifollitropin alfa, an agent for prolonged ovarian stimulation, administered from day 4 can be clinically used instead of day 2 onwards for a controlled ovarian hyperstimulation (COH) in an antagonist protocol.

Corifollitropin alfa is a new recombinant gonadotrophin with sustained follicle-stimulating activity. It offers novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF or in vitro fertilisation resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. Normally, this medication is started on day 2 of the cycle. In the present randomised trial, we want to evaluate whether this agent can be clinically used when started on day 4 of the cycle.

Eligibility Criteria:
Inclusion Criteria:

* \< 36 years old on day of randomisation
* FSH \< 12 (in the early follicular phase)
* Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
* Regular menstrual cycles of 21-35 days, presumed to be ovulatory.
* BMI ≤ 29
* Weight \> 60 kg
* \< 3 previous trials
* ICSI
* Randomisation at out-patient clinic

Exclusion Criteria:

* ≥ 36 years old on day of randomisation
* Endometriosis ≥ grade 3
* PCOS
* Poor responders (development of \< 4 follicles in a previous IVF/ICSI cycle)
* Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)