cyrilzakka/clinical-trials huggingface dataset:
Influence of Luteolin on Memory in Healthy Subjects

Proof of concept study on physiological processes (forgetting and memory functions, attention, working memory) in participants after multiple administration of the dietary supplement Luteolin.

In the experimental phase the investigator will administer 500 mg Luteolin (2x250 mg capsules) per day formulated for oral administration for 7.5 days (first intake: visit 1/3 in the morning; last intake: visit 2/4 in the morning). The last intake on visits 2 resp. 4 is important as the participants then have to recall the learned material from visits 1 resp. 3 during a steady-state status of Luteolin.

Subjects will be randomly allocated to treatment groups (starting with investigational product or placebo).

Identity of Investigational Product: Luteolin extracted from Chrysanthemum Ramat 98% HPLC by Scyherb® food grade certified according to Safe Quality Foods (SQF) - Level 3 Comprehensive Food Safety and Quality Management System Certification by the Safe Quality Food Institute (SQFI).

Control intervention consists of identical looking placebo capsules containing mannitol formulated for oral administration to be taken twice daily (e.g. every morning and evening) for 7.5 days (first intake: visit 1/3 in the morning; last intake: visit 2/4 in the morning) with water.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* healthy
* normotensive (BP between 90/60mmHg and 140/90mmHg)
* BMI \<30 kg/m2
* aged between 18 and 40 years
* native or fluent German-speaking
* able and willing to give written informed consent as documented by signature and comply with the requirements of the study protocol

Exclusion Criteria:

* Bodyweight \<50 kg
* acute or chronic psychiatric disorder (e.g. major depression, psychoses, somatoform disorder, suicidal tendency)
* concomitant acute or chronic disease state (e.g. renal failure, hepatic dysfunction, cardiovascular disease, acute infections etc.)
* women who are pregnant or breast feeding
* intention to become pregnant during the course of the study
* known or suspected non-compliance, drug or alcohol abuse
* inability to follow the procedures of the study, e.g. due to language problems, psychological disorders
* participation in another study with investigational drug within the 30 days preceding and during the present study
* enrolment of the investigator, his/her family members, employees and other dependent persons
* participation in one of our previous studies using the same memory tests in the past 2 years
* Psychoactive drugs and alcoholic beverages 3 days (psychoactive drugs) resp. 12 hours (alcohol) before test visits 1-4.
Central Programming in Patients With a Bionic Hand After Traumatic Brachial Plexus Injury

Traumatic brachial plexus lesions may lead to permanent impairment of hand function despite brachial plexus surgery. In selected cases the affected forearm can be amputated and replaced by a bionic hand. It is unclear how cortical activation patterns change after the injury and after acquisition of the hand prosthesis considering the complex changes in sensory and motor feedback. The aim of the study is to measure cortical activity with fMRI during actual and imagery movements with the affected and healthy arm in a group of patients after traumatic brachial plexus injury and a group in whom this was followed by replacement with a bionic hand. In this prospective study three groups of patients will participate: 1) 3 adult patients with a traumatic brachial plexus lesion eligible for a bionic arm but prior to its acquisition, 2) 3 patients with a traumatic brachial plexus lesion who have acquired the bionic arm already, and 3) 10 healthy subjects. The investigators will measure cortical activity using fMRI BOLD tasks of closing the hand and motor imagery of this movement. Cortical activity will be compared between the three groups. Additionally, regional gray matter volume, resting-state, and DTI networks will be studied. Written informed consent will be provided prior to the investigation. The complete examination has a duration of approximately 45 minutes.


Eligibility Criteria:
Inclusion Criteria:

* age above 18 years
* participants should understand German or English
* patients with a bionic hand are selected who are able to open and close the hand prosthesis.

Exclusion Criteria:

* the standard contraindications for MRI will be checked for according to hospital protocol (ferromagnetic devices such as clips, claustrophobia, etc.) and, if necessary, patients will be excluded from participation.
Transforming PCI Informed Consent Into an Evidence-based Decision-making Tool

Using individualized patient estimates of procedural risks and benefits, this project will transform the process of informed consent for coronary angioplasty into a dynamic educational tool for patients and physicians and is a direct response to the Institute of Medicine's call for a more evidence-based, efficient, patient-centered healthcare system. It is hypothesized that patients will develop a greater understanding of their individual risks and benefits from PCI, will be empowered to more actively engage in shared decision-making, as well as have improved awareness of their responsibility to adhere to dual anti-platelet therapy if treated with a drug eluting stent (risks for target vessel revascularization with bare metal and drug eluting stents are also provided in the new consent form). It is also anticipated that physicians, in turn, will use these individualized estimates to better discriminate between risks and benefits among different bleeding avoidance therapies so as to improve the safety and cost-effectiveness of PCI.

This study will test the impact of a new mechanism for eliciting informed consent from patients undergoing percutaneous coronary intervention (PCI) on 1) patients' comprehension of procedural risks/benefits and participation in shared decision-making; and 2) upon clinicians' use of effective strategies to minimize the risk of bleeding at the time of PCI. To facilitate these goals, we will prospectively provide each patients' risks for bleeding at the time that the informed consent document is generated. This will be accomplished by transforming the infrastructure of the informed consent process at participating study centers using a novel, web-based system - the Personalized Risk Information Services Manager (PRISM) - to generate individualized consent forms with estimates of risks and outcomes using validated multivariable models from the American College of Cardiology's NCDR. The goals of this study are to 1) identify barriers in implementing individualized consent forms in clinical care and to test whether this novel consent process 2) improves the quality of the informed consent process, 3) supports the more rational use of Bleeding Avoidance Therapies (BATs), 4) reduces bleeding events after PCI, and 5) supports a more cost-effective PCI procedure. This will be done using a pre-post design at 6 enrolling hospitals and comparing changes in practice with contemporaneous controls matched from the broader NCDR Cath/PCI registry.

Eligibility Criteria:
Inclusion Criteria:

* All patients receiving a PCI in a participating institution

Exclusion Criteria:

* Previously enrolled in the PRISM
* Does not speak English or Spanish
* Dementia
* Too ill to interview
* Current prisoner
Investigating Age-Related Macular Degeneration

Age-related macular degeneration (ARMD) affects older Americans and can lead to irreversible blindness. Although the cause if ARMD is unclear, it appears to be a condition that is affected by both genetic and environmental influences.

The purpose of this study is to examine an Amish community to investigate genetic factors in the development of ARMD.

Study participants will be 1,000 members, ages 50 and older, of the Old Order Amish community in Lancaster and Franklin counties in Pennsylvania. Each will undergo a 30-minute dilated eye exam during which an ophthalmologist or optometrist will take digital images of the macula and optic disc. Depending on the results of their eye exam, participants may be asked to give a blood sample as well. They will also complete a brief questionnaire about personal exposure related to occupation, sunlight and smoking.

Age-related macular degeneration (AMD) is a leading cause of visual impairment in the United States. Available evidence suggests that AMD is a complex disorder with a significant genetic component as well as potential environmental influences. In this study we propose to examine 3,000 members, ages 50 and older, of the Old Order Amish community in the Lancaster and Franklin counties area in Pennsylvania. We plan to detail the epidemiology of AMD in this population isolate in attempt to elucidate genetic factors which may confer susceptibility and predispose some Amish individuals and their families to develop AMD. All study participants agreeing to enroll and providing informed consent will undergo a complete, dilated eye examination during which digital stereo images of the macula and optic disc regions will be acquired. Study participants will also be asked to complete a brief questionnaire inquiring about personal exposures related to occupation, sunlight, and smoking. AMD will be determined by an independent reading of the digital fundus photographs by the University of Wisconsin Fundus Photography Reading Center according to the AREDS AMD classification scheme. We will employ standard statistical genetics methods of parametric and non-parametric linkage analysis, association analysis, and transmission disequilibrium tests, with allowances for environmental (i.e. non-genetic) factors to determine if we can identify any candidate regions or candidate genes that predispose Amish individuals to an increased risk of AMD. Ultimately, we hope to follow up any regions that show suggestive evidence of linkage on the genome-wide scan with fine mapping in those regions, leading to eventual cloning and sequencing of a gene or genes.

Eligibility Criteria:
* INCLUSION CRITERIA:

All Amish individuals, ages 50 and older, who either respond in the affirmative to the letter of invitation or are self-referred to the Amish clinic for participation in the AMD study, will be eligible.

EXCLUSION CRITERIA:

Individuals who decline participation, who are unwilling to sign the Consent Form, and who are not recognized by the Amish as being Amish will be excluded.

There are no clinical inclusion/exclusion criteria.
Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery

The bleeding caused by hip replacement surgery (CRT) is an important source of demand for blood in the hospital. Tranexamic acid (TXA) is a drug that has proved useful in reducing bleeding associated with other surgeries and CRT results have been positive, but the variety of dosages difficult to evaluate the results To determine the efficacy and safety of TXA in reducing bleeding caused by surgery of total hip replacement.

PATIENTS: Patients ASA(American Society of Anesthesiologists) I-III that they are to perform hip replacement surgery and cementless unilateral total that have signed the informed consent.

Group A: 1st dose 15mg/kg of TXA in 100ml saline 0.9% after the completion of regional anesthesia, and before the start of surgery.

2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration.

Group B: 1st dose: 10mg/kg of TXA in 100ml 0.9% saline after the completion of regional anesthesia, and before the start of surgery.

2nd dose: intravenous infusion over 10 minutes of 10mg/kg of TXA in 100ml saline 0.9% at three hours after the first administration.

Group C: 1st dose: intravenous infusion over 10 minutes in 100ml of 0.9% saline after the completion of regional anesthesia, and before the start of surgery.

2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration.

STATISTICAL ANALYSIS Comparison of blood loss in groups and comparison of adverse events


Eligibility Criteria:
Inclusion Criteria:

* 18 years or more
* ASA I-III
* No allergies tranexamic acid
* Informed consent signed by patient

Exclusion Criteria:

* Pregnancy or lactation.
* severe vascular ischemia (coronary or peripheral)
* previous venous thrombosis, pulmonary embolism or embolic disease (atrial fibrillation, active neoplastic disease)
* coagulopathy
* Chronic treatment with ASA(acetylsalicylic acid) or NSAIDs (nonsteroidal anti-inflammatory drugs) prior to surgery without suspension
* Hemoglobine \<10
* moderate renal impairment (creatinine\> 2)
* Cirrhosis
* contraindication to prophylaxis with enoxaparin
* Patients with a history of seizures.
High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade

The goal of this study will be to assess the safety and efficacy of high-dose interval Vitamin D3 therapy in children and young adults with Inflammatory Bowel Disease being treated with serial Remicade infusions.

Study subjects will receiving 50,000 units of Vitamin D3 if they receive Remicade infusions every 4-6 weeks. Study subjects will receiving 100,000 units of Vitamin D3 if they receive Remicade infusions every 6-8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Existing diagnosis of IBD
* Age 0-25 years
* Measured serum level of 25-OH Vitamin D of 15-29 ng/ml in the last 8 weeks and no changes in Vitamin D supplementation in the interim

Exclusion Criteria:

* Pregnant Women
* History of underlying kidney disease
* History of granulomatous disease
* Inability to take oral Vitamin D
* History of hypercalcemia or hypercalciuria
* Currently taking an anti-epileptic medication
* History of pre-existing liver disease (excluding primary sclerosing cholangitis, non-alcoholic fatty liver disease, or steatohepatitis)
Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort trial in which diabetic foot ulcers (DFU) will be treated using AutoloGel and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care (UCC) as provided in up to 30 U.S. Wound Registry Research Network (USWRRN) centers.

AutoloGel is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. Prospective observational studies of the effectiveness of AutoloGel have demonstrated promising results in regard to the healing of DFUs, including severe Wagner grade 3 and 4 ulcers. The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort trial in which diabetic foot ulcers will be treated using AutoloGel to determine the time to heal at 12 weeks. Comparison will be made with a case-matched concurrent cohort of patients receiving undefined Usual and Customary Care (UCC).

Eligibility Criteria:
Inclusion Criteria:

1. Medicare/Medicaid eligible
2. ≥18 years of age
3. Type I or II diabetes requiring medical treatment as determined by the physician
4. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) is a Wagner 1-5 DFU (see Appendix 9 for Wagner Classification) that is located on the dorsal, plantar, medial, or lateral aspect of the foot or heel (including all toe surfaces)
5. For subjects with potentially multiple eligible DFUs, the largest ulcer will be selected There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure)
6. Debrided ulcer size between 0.5 cm2 and 50 cm2
7. Demonstrated adequate offloading regimen
8. Duration ≥ 1 month at first visit
9. Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician.

Exclusion Criteria:

1. Subjects known to be sensitive to AutoloGel components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
2. Presence of another wound that is concurrently treated and might interfere with treatment of the index wound by AutoloGel (malignancy in nearby wound)
3. Ulcer not of DFU pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)
4. Any malignancy other than non-melanoma skin cancer
5. Subjects who are cognitively impaired and do not have a healthcare proxy
6. Serum albumin of less than 2.5 g/dL
7. Plasma Platelet count of less than 100 x 109/L
8. Hemoglobin of less than 10.5 g/dL
9. Subject has inadequate venous access for repeated blood draw required for AutoloGel Administration.
A Clinical Study of Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-025)

The purpose of this study is to learn what happens to the amount of enlicitide decanoate in the blood when enlicitide decanoate is given in different formulations.


Eligibility Criteria:
Inclusion Criteria:

* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing.
* Medically healthy with no clinically significant medical history.

Exclusion Criteria:

* Has a history of gastrointestinal disease or has had a gastric bypass or similar surgery.
* Has a history of cancer (malignancy).
Using Immersive Virtual Reality for Cognitive Therapy in Elderly with Mild Cognitive Impairment

The proposed study aims to investigate the potential of IVR-CST in improving cognition of people with MCI, and as well the association of eye movement during therapy and treatment outcomes of IVR-CST. Four research questions have been proposed and listed as follows:

1. Is IVR-CST a feasible treatment for elderly with MCI?
2. Is IVR-CST an efficacious treatment for improving cognition of elderly with MCI?
3. Is IVR-CST more efficacious than conventional CST (i.e., without IVR) in improving the cognition of elderly with MCI?
4. Is eye-tracking data collected during therapy associated with treatment outcomes of IVR CST?


Eligibility Criteria:
Inclusion Criteria:

1. elderly aged 60 years or above,
2. a diagnosis of MCI made by a psychiatrist, or a score of 16-21 out of 30 in the Hong Kong Brief Cognitive Test (HKBC, 31), with upper and lower cutoff scores for MCI as suggested by the test. HKBC has been validated in Hong Kong with satisfactory sensitivity (0.88) and specificity ((0.81) in differentiating subjects with MCI and healthy individuals,
3. ability to speak and comprehend Cantonese,
4. normal or corrected-to-normal binocular vision and hearing,
5. absence of physical illness/disability to prevent them from IVR-CST participation, 6, compatible with IVR exposure in the 10-minute IVR trial without major signs of cybersickness, based on the symptoms given in the Simulator Sickness Questionnaire

Exclusion Criteria:

1. concurrent participation in other clinical therapy trials,
2. incompatibility with IVR exposure such as complaints of nausea, headache, or other severe discomforts during trial use,
3. a diagnosis of dementia or other psychiatric/neurological diseases such as depression, stroke, brain trauma, Parkinson's disease
4. hearing/visual/upper limb impairments that hinder CST/IVR-CST participation,
5. prior CST treatment,
6. Use of medication for MCI/dementia, e.g., aducanumab
Anastrozole 1 mg Tablets Under Fasting Conditions

The objective of this study is to evaluate the comparative bioavailability between Anastrozole 1 mg Tablets (Teva Pharmaceuticals USA) and Arimidex® 1 mg Tablets (AstraZeneca Pharmaceuticals LP, USA), after a single-dose in healthy subjects under fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking, post-menopausal or surgically sterile female subjects 18 years or age or older.
* Body mass index (BMI) between 19 and 30, inclusive.
* Indicate non-child bearing status by one of the following criteria:

  * Indication of successful hysterectomy.
  * No spontaneous menses for at least 1 year, must have luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels within postmenopausal range.
  * Indication of successful bilateral oophorectomy.
* Negative for:

  * HIV.
  * Hepatitis B surface antigen and Hepatitis C antibody.
  * Urine drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines, and methadone).
  * Urine cotinine test.
  * Serum pregnancy test.
* No significant diseases or clinically significant findings in a physical examination.
* No clinically significant abnormal laboratory values.
* No clinically significant findings in the 12-lead electrocardiogram (ECG).
* No clinically significant findings from the vital signs measurement.
* Be informed of the nature of the study and given written consent prior to receiving any study procedure.
* Participants in this study will be unable to have children (i.e. post-menopausal, hysterectomy).

Exclusion Criteria:

* Known history or presence of any clinically significant medical condition.
* Known or suspected carcinoma.
* Known history of:

  * Hypersensitivity or idiosyncratic reaction to anastrozole and/or any other drug substances with similar activity.
  * Alcoholism within the last 12 months.
  * Drug dependence and/or substance abuse.
  * Use of tobacco or nicotine-containing products within the last 6 months.
* Taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing.
* Taken any hormone replacement therapy (HRT) for 4 weeks prior to dosing.
* On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
* Participated in another clinical trial or received an investigational product within 30 days prior to drug administration.
* Donated up to 250 mL of blood within the previous 30 days OR donated from 251 to 500 mL of blood in the previous 45 days OR donated more than 500 mL of blood in the previous 56 days.
* Requirement of any non-topical medication (prescription and/or over-the-counter) on a routine basis.
* Difficulty fasting or consuming the standard meals.
* Do not tolerate venipuncture.
* Unable to read or sign the informed consent form.