cyrilzakka/clinical-trials huggingface dataset:
Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia

This study will evaluate the performance of Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) in patients with Alzheimer's disease (AD).


Eligibility Criteria:
Inclusion Criteria:

* 50 - 90 years of age
* Clinical diagnosis of dementia of the Alzheimer type determined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
* A diagnosis of probable Alzheimer's Disease, or mild to moderate AD determined by NIA-AA (National Institute on Aging and the Alzheimer's Association) criteria
* K-MMSE score of 12 - 26
* Global Clinical Dementia Rating (CDR) score of 0.5 - 2
* Patient taking 10 mg of donepezil per day for a minimum of 12 weeks with a stable dose, not taking other brain pills including choline alfoscerate for at least 2 weeks from screening. Drugs that are likely to affect cognition are permissible if the dose is regular and stable for at least 2 weeks before screening and if the treatment continues for the duration of the trial.

Exclusion Criteria:

* Subject suspected of dementia due to organic causes other than Alzheimer's type dementia
* Other degenerative brain diseases or major mental illnesses such as major depression, bipolar disorder, alcohol/substance abuse or dependence, delirium
* Hypersensitive to choline alfoscerate, donepezil hydrochloride, or piperidine derivatives or the components of this drug
* Subject who has contraindications as listed in the SPC of choline alfoscerate or donepezil hydrochloride
* Other than the above who is deemed to be ineligible to participate in the trial
Behavioral Insights to Encourage Judicious Prescribing of Opioids

In collaboration with the San Diego Medical Examiner's Office and the State of California's controlled Substance Utilization Review and Evaluation System (CURES), the investigators propose to review opioid poisonings over the past 12 months and will send letters to prescribers in California when at least one of the provider's prescription(s) was filled by a patient who died of an opioid poisoning in San Diego County. The letters will be non-judgmental and factual, explaining that a patient of the provider who was being treated with prescription narcotics died of an opioid poisoning. The letter will also encourage judicious prescribing including use of the CURES system before prescribing. The investigators will evaluate physician prescribing practices over 24 months 12 months pre- and 12 months post-letter using data from the CURES database. The investigators' hypothesis is that letters will make the risk of opioids more cognitively available and that physicians will respond by prescribing opioids more carefully. This will result in fewer deaths due to misuse and more frequent use of the CURES system.


Eligibility Criteria:
The investigators will not be enrolling subjects. This is an evaluation of a public health intervention involving sending prescriber's factual and nonjudgmental letters, signed by the County Medical Examiner, that would state that a patient the provider had treated with controlled substances died of an opioid poisoning.

Inclusion Criteria:

* Prescribers in California for whom at least one of their prescription(s) was filled by a patient who died of an opioid poisoning in San Diego County

Exclusion Criteria:

* Prescriber is licensed outside the State of California and does not hold a California license, but the prescription was filled in California
* The prescriber does not have a CURES report on record
* The prescriber has issued only one opioid prescription in the last 12 months since the time of the deceased death (and the prescription was to the deceased)
* Prescribers with unknown Drug Enforcement Agency number
Video Counseling for Effective Postpartum Contraception

This is a randomized clinical trial to evaluate if the addition of long-acting reversible contraception (LARC) focused video-counseling during prenatal care increases uptake of postpartum LARC.

Eligible participants will be identified in the prenatal period and will be randomized to one of two groups. The control group will receive the standard of care contraceptive counseling during prenatal counseling. The intervention group will also receive the standard of care contraceptive counseling during prenatal care, but will also watch an evidence-based,12 minute LARC First video created by the CHOICE project which provides information on different contraceptive methods. All participants will receive information regarding access to free LARC methods in the postpartum period. All participants will be called at 12 weeks postpartum. Independent of randomization arm, they will all undergo a 5-minute survey by phone about contraceptive method choice and use.

Eligibility Criteria:
Inclusion Criteria:

* woman presenting for routine prenatal care visit at University of North Carolina (UNC) Resident Continuity Clinic
* least 18 years old
* fluent in English
* able to read to a third-grade reading level
* not planning sterilization for postpartum contraception
* at least 28 weeks gestation at time of enrollment

Exclusion Criteria:

* those who do not meet the previously outlined inclusion criteria
* those who are unable to provide informed consent.
Image Guided Adaptive Radiotherapy in the Head-and-neck Region

Aim of this study is the clinical evaluation of an image-guided adaptive radiotherapy concept. This involves the adaption of the radiotherapy treatment plan according to changes in tissues and variations in patients position and posture during a radiotherapy treatment course, based on repeat CT scans.

It is investigated, if dosimetric improvements can be achieved using this approach and if the method using the software-package "ReDeform" can be implemented in clinical Routine.

Aim of this study is the clinical evaluation of an image-guided adaptive radiotherapy (ART) concept. This involves the adaption of the radiotherapy treatment plan according to changes in tissues and variations in patients position and posture during a radiotherapy treatment course, based on repeat CT scans.

It is prospectively investigated, if dosimetric improvements can be achieved using this approach and if the method using the software-package "ReDeform" can be implemented in clinical Routine. For that purpose 2 repeat CT scans are acquired during the radiotherapy course (week 3 and week 5 of radiotherapy). The Initial CT scan is "matched" to the follow-up CT-scan by means of deformable image registration.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histo-pathologically verified malignancies in the head-and-neck without clinical signs of dissemination, who consented in radiotherapy or radio-chemotherapy.

Exclusion Criteria:

* previous radiation therapy for head-and-neck
Cross-over Study of Coronary Risk Factors With a Polypill

Open-label, randomized, cross-over study conducted in a single center, applied to patients receiving a polypill with 100 mg of acetyl salicylic acid and different doses of ramipril and atorvastatin for indication of secondary prevention according to clinical practice, with objective of analyzing the level of systolic blood pressure and LDL-cholesterol in the same patient in 2 different periods: one under treatment of 3 months with the polypill and another of 3 months with the components separately.

The European Society of Cardiology indicates that reducing the frequency of administration is the most effective measure to improve therapeutic adherence. Current guidelines recommend with class I and level of evidence A the use of polypills.

A polypill, composed of 100 mg of acetylsalicylic acid and variable doses of atorvastatin and ramipril, is approved for secondary prevention of cardiovascular disease and has also been widely used in primary prevention.

Numerous studies have been carried out focusing on different designs of polypill in cardiovascular prevention to study their efficacy, cost-effectiveness and administration schedule. Specifically, that polypill already has an extensive literature. However, although there are previous studies with a cross-over design with other types of polypill to assess the effects on the control of arterial hypertension and LDL cholesterol, to date there has never been a cross-over design study with the polypill compared to the administration of its components separately in the control of blood pressure, lipid level and level of platelet aggregation.

Patients will be randomized to polypill vs separate components. Each patient will receive a follow-up visit per month for 6 months, of which will be 3 consecutive months with treatment with the polypill in its corresponding dose and the remaining 3 months with the same drugs separately.

Primary objectives: Systolic blood pressure level and LDL cholesterol. Secondary objectives: Degree of platelet aggregation with thromboxane A2 kit, diastolic blood pressure level, total cholesterol and HDL, level of patient satisfaction, degree of adherence to treatment, adverse events.

Eligibility Criteria:
Inclusion Criteria:

Patients over 18 years of age. Patients under treatment with the Trinomia® polypill in any of its presentations for indication of secondary prevention and who can make the 6 visits necessary to complete the study. Patients who sign the Informed Consent.

Exclusion Criteria:

Patients who do not sign the informed consent. Patients with an inability to understand and comply with the protocol. Patients with contraindication to any component of the polypill. Patients who are already participating in another clinical trial. Patients with any condition that limits life expectancy to \<1 year. Patients with programmed coronary revascularization. Patients with coronary stent implantation in the last 12 months. Patients treated with any antithrombotic drug in addition to acetylsalicylic acid, that is, low molecular weight heparin, P2Y12 receptor inhibitors, or oral anticoagulants.
Impact of New CLSI Guidelines on Antibiotic Susceptability Pattern

Assessing the precise MIC for the Ceftriaxone using E-test. To determine what proportion of susceptibility reports will be reclassified based on the new CLSI guidelines.Antibiotic susceptibility reports of blood cultures, urine cultures,aseptic body fluid cultures growing Enterobacteriaceae organism generated by the Phoenix machine will be obtained on a daily basis.MIC for Ceftriaxone will be noted.If the MIC is \<=2 for Ceftriaxone,those cultures would be used to run an additional test - E- test.E-test gives us more precise MIC values compared to Phoenix machine.We will analyze the data collected over 2 months. We will determine the proportion of susceptibility reports reclassified based on the new CLSI guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Antibiotic susceptibility reports of blood cultures, urine cultures,aseptic body fluid cultures growing Enterobacteriaceae organism generated by the Phoenix machine.

Exclusion Criteria:

* none
Evaluation of a High Protein, High Calorie Pudding in Adults With/or at Risk for Malnutrition

This is a multi-center, prospective, non-randomized, non-blinded, single-arm, single treatment study to evaluate the tolerance of a nutritional pudding.


Eligibility Criteria:
Inclusion Criteria:

* Subject has voluntarily signed and dated an ICF approved by an IEC, and provided applicable privacy authorization prior to any participation
* Subject is considered by a dietitian or clinician as malnourished or at risk for malnutrition based on current use of an oral nutritional supplement (ONS), recently identified as malnourished or at risk of malnutrition based on validated malnutrition screening tool or has had weight loss within last two months as a result of a hospitalization or chronic illness
* Subject currently has normal GI function
* Subject requires ONS and is willing to comply with the study protocol

Exclusion Criteria:

* Subject has severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder affecting abilities to answer questions, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
* Subject had a history of diabetes as evidenced by taking antihyperglycemic medications or by self-reported dietary modification
* Subject is currently taking or has taken antibiotics within 1 week prior to enrollment
* Subject has undergone major GI surgery less than 3 months prior to enrollment in the study
* Subject has current active malignant disease or was treated within the last 6 months for cancer, except basal or squamous cell skin carcinoma, prior to enrollment
* Subject has an immunodeficiency disorder
* Subject has had a myocardial infarction within the last 3 months prior to enrollment
* Subject is known to be allergic or intolerant to any ingredient found in the study product
* Subject has an aversion to any of the flavours of product being tested
* Subject has an obstruction of the GI tract precluding ingestion or absorption of the study product, inflammatory bowel disease, gastric esophageal reflux disease, short bowel syndrome, or other major gastrointestinal disease-causing symptoms including (but not limited to) uncontrollable severe diarrhea, nausea, or vomiting
* Subject is currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect gastrointestinal motility
* Participation in another study that has not been approved as a concomitant study
* Subject has a clinical condition that is contraindicated with this product as determined by the clinician in accordance with standard of care
* Subject is pregnant
Comparison Between PEEK With Platelet-rich Fibrin and PEEK Alone in Maxillary Sinus Augmentation

comparison between the resulted bone during maxillary sinus elevation by PEEK with and without platelet rich fibrin

Histomorphometric and clinical analysis of the bone formed after 6 months after the maxillary sinus elevation using PEEK in the 2 groups : the study group (PEEK with platelet rich fibrin) and the control group (PEEK alone ) .

Eligibility Criteria:
Inclusion Criteria:

* • Posterior edentulous ridges with pneumatized maxillary sinus and remaining bone height less than 4 mm.

  * ASA physical status I and II.
  * Patients willing to be a part of the study and ready to give their consent in writing for the same.
  * Patient not complain from maxillary sinusitis
  * Patient with good oral hygiene.
  * Both males as well as females without any active periodontal disease.
  * The edentulous ridges are covered with optimal thickness of mucoperiosteum with no signs of inflammation, ulceration or scar tissue.
  * Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.

Exclusion Criteria:

* • General contraindications to implant surgery.

  * Untreated gingivitis, periodontitis.
  * Subjected to irradiation in the head and neck area less than 1 year before implantation.
  * Untreated periodontitis.
  * Pregnant or nursing.
  * Unable to open mouth sufficiently to accommodate the surgical tooling.
  * Patients participating in other studies, if the present protocol could not be properly followed.
  * Patient who could/would not participate in the follow-up period.
Autoantibodies in Breast Cancer Detection

Prospective, single-center study in women who have recently had an abnormal mammogram followed by a breast biopsy or women who have recently had a normal screening mammogram. We are no longer enrolling women who had normal Screening mammograms.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:

All Cohorts:

* Women age 18 and older
* Understand and provide informed consent and HIPAA Authorization prior to initiation of any study-specific procedures

Cohort A:

* Recent abnormal mammogram followed by a breast biopsy
* Initial diagnosis of Stage I, II, III or IV invasive breast cancer

Cohort B:

* Recent abnormal mammogram followed by a breast biopsy
* Diagnosed benign breast tumor with high-risk pathology. This would include, but is not limited to, atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), flat epithelia atypia and phylloides

Cohort C:

* Recent abnormal mammogram followed by a breast biopsy
* Diagnosed benign breast tumor. This would include, but is not limited to, fibroadenoma, papilloma, fibrocystic changes, and Pseudoangiomatous stromal hyperplasia (PASH)

Cohort D:

• Normal screening mammogram within the last 6 months

Exclusion Criteria:

* All Cohorts:

  * Men.
  * Unable or unwilling to give written informed consent

Cohort A:

• History of cancer other than non-melanoma basal or squamous cell skin carcinoma, ductal carcinoma in situ (DCIS) and cervical carcinoma in situ.

Cohort B:

• History of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ.

Cohort C:

• History of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ.

Cohort D:

* History of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ.
* History of or current autoimmune disease including but not limited to Sjogrens Syndrome, Systemic Sclerosis (SSc), Scleroderma (Scl) and Dermatomyositis, Systemic Lupus Erythematosus, Multiple Sclerosis, Type I Diabetes, Rheumatoid Arthritis
* History of abnormal mammogram
Delivra Joint Health Cream In The Treatment Of Pain Caused By Osteoarthritis Of The Knee

The current clinical trial is designed to test the analgesic and anti-inflammatory efficacy of a topical cream compared to a placebo cream. The study population will be those with mild to moderate osteoarthritis of the knee.

The trial will also provide information about potential side effects and verify the safety of this composition. Blood levels will be done to assess inflammation and to determine whether any systemic absorption has occurred.

Hypothesis/Purpose

* Pain scores after active treatment will be significantly reduced in comparison to placebo.
* There will be an improvement in stiffness and physical function as measured by the WOMAC using the active cream as compared to placebo.
* There will be a decrease in the level of inflammation assessed at baseline, end of week 3 and end of week 6.
* The blood concentration of the active ingredient in the topical cream will not exceed the maximum daily dose that will be consumed by participants.


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee according to American College of Rheumatology criteria: Knee pain with 3:

  * age \>50 years
  * stiffness less than 30 min
  * crepitus,
  * bony tenderness,
  * bony enlargement,
  * no palpable warmth
* Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity (NRS-PI).
* All concurrent medications taken for any reason stable for 14 days
* Ability to follow protocol with reference to cognitive and situational factors (eg. stable housing, ability to attend visits)
* Ability to read and write English
* Willing and able to give informed consent

Exclusion Criteria:

* Currently taking opioids, NSAIDs, warfarin, other anticoagulants, other topical agents for treatment of pain or inflammation
* Allergy to tea tree oil, latex, avocado, soy
* Active conditions such as exzema or psoriasis
* Presence of significant medical disorder that would compromise the participant's safety to take part in the trial (eg. cancer, immunosuppressed)
* Individuals with a history or current disease which may affect the outcome of the trial (ie. Inflammatory, infections joint disease).
* Allergy to plants of the Asteraceae/Compositae/Daisy family.
* Pregnant and breastfeeding women.
* Allergy or other contraindication for acetaminophen use.
* Exercise or transcutaneous electrical nerve stimulation should be excluded prior to and during the trial.
Study of EYP-1901 in Patients With Diabetic Macular Edema (DME)

A prospective, randomized, single-masked study evaluating the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to aflibercept

A study to evaluate Efficacy and Safety of two doses of EYP-1901 in subjects with DME

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes mellitus in the study eye, with disease onset any time prior to the Screening Visit
* Previously treated with at least 1 intravitreal anti-VEGF in the last 6 months in the study eye at least 8 weeks prior to the Screening Visit.
* BCVA letter score of 35 letters (20/200 Snellen equivalent) to 75 letters (20/32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1).

Exclusion Criteria:

* Any current or history of ocular disease other than DME
* BCVA using ETDRS charts \<30 letters (20/250 Snellen equivalent) in the fellow eye.
* Active ocular inflammation or active infection in either eye at Baseline (Day 1).
Study Evaluating ASTRA TECH Implant System, OsseoSpeed™ Implants in the Upper Jaw in Women With Osteoporosis

The overall objective of the study is to compare treatment with the ASTRA TECH Implant System, OsseoSpeed™ implant in the maxilla of postmenopausal women with and without systemic osteoporosis. The hypothesis is that there will be no difference in marginal bone level alterations between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Postmenopausal women aged 60 years and over
* In need of 2-8 implants in maxilla
* A history of edentulism in the area of implant treatment of at least 6 months.
* A Bone Mineral Density (BMD) value suitable either for group A or group B:
* Group A (Osteoporosis/osteopenia): BMD at least 2 standard deviations (SD) below mean peak bone density of young adults for the spine and total hip (T-score = -2 SD or less). Absolute values (g/cm2) will be used.
* Group B (Control): BMD not more than 1 standard deviation below mean peak bone density of young adults for the spine and total hip (T-score = -1 SD or more). Absolute values (g/cm2) will be used.

Exclusion Criteria:

* Unlikely to be able to comply with study procedures, as judged by the investigator.
* Untreated, uncontrolled caries and/or periodontal disease
* Known or suspected current malignancy
* History of chemotherapy within 5 years prior to surgery
* History of radiation in the head and neck region
* History of other metabolic bone diseases, e.g. Paget's disease, hyperparathyroidism, fibrous dysplasia or osteomalacia
* A medical history that makes implant insertion unfavourable
* Need for systemic corticosteroids
* Current or previous use of intravenous bisphosphonates (esp. zoledronic acid)
* Current or previous use of oral bisphosphonates
* History of bone grafting and/or sinus lift in the planned implant area
* Current need for bone grafting and/or sinus lift in the planned implant area
* Present alcohol and/or drug abuse
* Involvement in the planning and conduct of the study (applies to both Astra Tech AB staff or staff at the study site)
* Previous enrolment in the present study.
* Participation in a clinical study during the last 6 months.
Impact of a Curriculum About Professionalism on Stress Response During a Critical Situation

The purpose of this study is to evaluate the impact of a curriculum about professionalism on stress response during a critical situation in anesthesiology residents. Residents in anesthesiology will complete a training program on professionalism during their first postgraduate year. They will go through a standardized simulated scenario where they have to manage an intra-hospital cardiorespiratory arrest and then meet the patient's family. Stress response will be assessed and compared to a control group that did not receive the training program.


Eligibility Criteria:
Inclusion Criteria:

* Residents in anesthesiology (Postgraduate year 1)
* Voluntary

Exclusion Criteria:

* /