cyrilzakka/clinical-trials huggingface dataset:
Myocardial Effects in Patients with ATTRv with Polyneuropathy Treated with Patisiran or Vutrisiran

ATTRv amyloidosis is a systemic disease with two clinical forms, neurological and cardiological, which are sometimes combined (so-called mixed forms).

Patisiran and vutrisiran have shown protective effects on the progression of neurological damage.

The effects of Patisiran or vutrisiran on the heart remain incompletely understood. The aim of this study is to better understand the morphological and functional cardiac consequences in ATTRv patients with stage 1 or 2 polyneuropathy with a mixed form treated with Patisiran or vutrisiran

ATTRv amyloidosis is a systemic disease with two clinical forms, neurological and cardiological, which are sometimes combined (so-called mixed forms).

Patisiran and vutrisiran have shown protective effects on the progression of neurological damage.

The effects of Patisiran or vutrisiran on the heart remain incompletely understood.

During their therapeutic management, including the prescription of Patisiran or vutrisiran, the routine examinations carried out at the inclusion, one and two year later will allow us to observe the consequences on myocardial activity during the routine consultation after 1 and 2 years of treatment.

Examinations are : clinical and biological exams, EKC, echocardiography, cardiac MRI and scintigraphy.

Data at the start of treatment and at 1 and 2 years will be collected, especially cardiac function assesment In addition, during these two consultations, a life quality questionnaire, a dysautonomia questionnaire and a functional walking test will be carried out specifically for the study.

The aim of this study is to better understand the morphological and functional cardiac consequences in ATTRv patients with stage 1 or 2 polyneuropathy with a mixed form treated with Patisiran or vutrisiran.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Patients with hereditary transthyretin amyloidosis (ATTRv) with stage 1 or 2 polyneuropathy
* Patient not previously treated for ATTRv
* Patients for whom treatment with patisiran or vutrisiran has been initiated by a hospital neurologist in accordance with recommendations for a minimum of 24 months.
* Patients with NYHA stage 1 and 2 cardiac disease.
* Beneficiary of a social security scheme
* Person who does not object to his/her participation in the research

Exclusion Criteria:

* Patients treated with Tafamidis simultaneously with patisiran or vutrisiran
* Adults under legal protection (legal guardianship, curatorship, guardianship), persons deprived of liberty.
* Contraindications to the explorations provided for in the protocol: claustrophobia, metallic implant contraindicating MRI, woman of childbearing age
Blood Sample Collection in Geriatric Patients

This study aimed to evaluate the effect of different durations of a specific pressure applied after blood collection on the development of ecchymosis in geriatric patients using oral and subcutaneous anticoagulants.

The research sample consisted of patients hospitalized in the Geriatrics Clinic of a city hospital. This study aimed to evaluate the effect of different durations of a specific pressure applied after blood collection on the development of ecchymosis in geriatric patients using oral and subcutaneous anticoagulants. In this study, whether ecchymosis developed at the 24th, 48th and 72nd hours after the blood collection procedure was evaluated.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 65 years and over
* who voluntarily agreed to participate in the study
* who used oral (Rivaroxaban 10-15-20 mg, Dabigatran, 75-110-150 mg, Apixaban 2.5-5 mg) and subcutaneous (Enoxaparin sodium 6000-4000 anti-Xa IU/0.6-0.4 ml) anticoagulants
* who were literate in Turkish
* who were scheduled for blood collection
* who would undergo blood collection from the antecubital site with vacutainer

Exclusion Criteria:

* patients with communication problems
* patients with hematoma, ecchymosis, and scarring in the antecubital site
* patients who would be discharged before 72 hours
* patients with coagulation disorders
A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect)

This is a prospective, observational, real-world study of adult participants in Japan with physician-reported diagnosis of plaque psoriasis treated with deucravacitinib or apremilast.


Eligibility Criteria:
Inclusion Criteria:

* Japanese adult participants aged 18 years old or older
* Physician-reported diagnosis of plaque psoriasis
* Newly initiating deucravacitinib or apremilast according to the label
* Participants who have signed informed consent

Exclusion Criteria:

* Participants currently participating in or planning to participate in an interventional clinical trial
* Patients enrolled in deucravacitinib post-marketing surveillance study (ClinicalTrial.gov ID: NCT05633264)
* Previous treatment experience with the treatment of interest (e.g. patients who have history of apremilast will not be eligible to be enrolled in apremilast arm of the study and similar for deucravacitinib)
Studying the Effects of Digital Interventions on Cognition, Wellbeing, Stress, and Sleep in Older Adults

The goal of this proposed research is to collect pilot data to test the hypothesis that treatment with a novel form of closed-loop digital meditation (MediTrain) will lead to a greater magnitude of gains in cognitive abilities in patients with mild cognitive impairment (MCI), compared to OA without cognitive impairment, and will lead to improvements in quantitative measures of sleep.


Eligibility Criteria:
comfortably ambulatory healthy physical condition normal or corrected to normal visual auditory acuity fluency in spoken English Between 60-85 years old No neurological or psychiatric disorders No substance abuse Not taking anti-depressants Not taking anti-anxiety medication No history of seizures No color blindness No glaucoma No macular degeneration No amblyopia (lazy eye) No strabismus (cross eyed) Aneurysm clip(s) No Cardiac pacemaker No Implanted cardioverter defibrillator (ICD) No Electronic implant or device No Magnetically-activated implant or device No Neurostimulation system No Spinal cord stimulator No Internal electrodes or wires No Bone growth/bone fusion stimulator No Cochlear, otologic, or other ear implant No Insulin or other infusion pump No Implanted drug infusion device No type of prosthesis (eye, penile, etc.) No Heart valve prosthesis No Eyelid spring or wire No Artificial or prosthetic limb No Metallic stent, filter, or coil No Shunt (spinal or intraventricular) No Vascular access port and/or catheter No Radiation seeds or implants No Swan-Ganz or thermodilution catheter No Medication patch (Nicotine, Nitroglycerine) No metallic fragment or metallic foreign body in/on the body that can not be removed No Wire mesh implant No Tissue expander (e.g., breast) No Surgical staples, clips, or metallic sutures No Joint replacement (hip, knee, etc.) No Bone/joint pin, screw, nail, wire, plate, etc. No IUD, diaphragm, or pessary No Dentures or partial plates that can not be removed No Tattoo or permanent makeup No Body piercing jewelry No Claustrophobia
Genes and Phenotype (GAP) A National Resource for Genotype-Phenotype Studies of Immunological and Inflammatory Pathways

The purpose of this study is to enrol generally healthy adults, who are asked to provide a blood sample, to study how the immune system works.

The primary purpose of this research is to develop a better understanding of how the immune system works. By studying immune function in many people, we will be able to determine the range of normal variation.

The second purpose is to enroll people who are willing to serve as comparisons in future research studies into the Genotype and Phenotype Research Registry (GAP Registry).

Volunteers are asked to provide information on age, ethnicity and medical history. Volunteers are asked to provide a blood sample of up to 100cc and allow us to contact you about additional studies.

Eligibility Criteria:
Inclusion Criteria:

* Over age 18
* Generally healthy

Exclusion Criteria:

* History of autoimmune disease
* History of chronic immunodeficiency or chronic viral infections such as Epstein Barr virus, hepatitis or HIV
* Currently undergoing treatment for cancer
* Current treatment with immuno-suppressant drugs
* Pregnancy
Mildronate for Acute Ischemic Stroke

Mildronate an inhibitor of carnitine-dependent metabolism, is considered an anti-ischemic drug. This study aims to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke.

A randomized, double-blind, multi-center clinical study was made on mildronate injection for treating acute cerebral infarction. 113 cases in the experimental group were given with mildronate injection, while 114 cases in the active-control group were given with cinepazide maleate injection. In addition, both groups were given aspirin as basic treatments. Modified Rankin Scale (mRS) score at 2 weeks and 3 months, National Institutes of Health Stroke Scale (NIHSS) score and Barthel Index score at 2 weeks after treatment, vital signs and adverse events were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* (i) had a clinical diagnosis of acute ischaemic stroke ,on the first episode within the previous 7 days, and confirmed on CT or MRI brain imaging.(ii) were between 18 to 80 years of age (patients \>= 70 years were not combined with any other poor physical condition except ischaemic stroke )(iii)had a score of 5-22 on the National Institutes of Health Stroke Scale (NIHSS).(iv)had a report that liver and kedney function were less than 1.5 folds of normal value.

Exclusion Criteria:

* (i) had other intracranial pathologies (e.g. cerebral hemorrhage, tumour, infection), (ii) were pregnant or nursing ;(iii) had a neurological or psychiatric disease ;(iv) had significant drug or alcohol misuse, (v)had been given thrombolytic therapy or medication forbidden by study protocol; (vi)participated in a clinical trial in the past 3 months.
Personalized Swiss Sepsis Study

This multi-center study is to focus on patients with sepsis in Intensive Care Units (ICUs) in order to better understand the complex host-pathogen interaction and clinical heterogeneity associated with sepsis. Understanding this heterogeneity may allow the development of novel diagnostic approaches. Data from patients will be analyzed using state-of-the art analytical algorithms for biomarker discovery including machine learning and multidimensional mathematical modelling to explore the large datasets generated. In order to discover digital biomarkers for the study endpoints a case-control study design will be used to compare data patterns from patients with sepsis (cases) and those without sepsis (controls).


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to an ICU on a Swiss University Hospital.
* Patients expected to stay at least 24h on the ICU

Inclusion Criteria (cases)

* Present at admission to ICU or subsequent development of sepsis 3.0 criteria

Inclusion Criteria (controls)

* Patients not fulfilling sepsis definition during the ICU stay

Exclusion Criteria:

* Decline of general consent or any other negative statement against using data for research.
* Patients with a clear elective stay on the ICUs.
Feasibility Study of a Web-based Program to Help Parents of Middle School Students Effectively Communicate With Their Children About Substance Use

The goal of this study is to test the feasibility of a web-based program for parents of middle school aged students. 286 parents and their child in 6th, 7th, or 8th grade will be asked to each complete two online questionnaires over the course of about a month, parents will also complete a web-based program between questionnaires. Researchers will compare the intervention and an active control to test the intervention program efficacy for improving outcomes related to parent-child communication, media message processing, and adolescent health.

The purpose of this study is to evaluate and assess a self-administered, web-based program designed to increase parent knowledge about adolescent substance use, active media mediation skills, and practice high-quality parent-adolescent communication methods. The program will help parents of middle-school aged students, 6th-8th graders, communicate effectively about substance use and enhance media literacy skills to counter unhealthy media messages. Prevention efforts are most impacting for adolescents in middle school years as this is the time frame for growing independence, desire to fit-in and an increase risk for their own experimentation with substances.

Eligibility Criteria:
Inclusion Criteria:

* The adult must be the legal guardian of a child in 6th, 7th or 8th grade (known hereafter as "parent").
* The parent must be able and willing to receive email and text communication as part of the study.
* The parent-child pair must have access to a smartphone with internet connection as the resource review will be completed online in a format that is best viewed on a smartphone.
* The parent-child pair must be fluent in English as the study materials are conducted in English.
* The parent must indicate that they will give the child participant privacy to complete the questionnaires
* Both the adult and child must agree to participate.

Exclusion Criteria:

* In an effort to ensure diversity in parent gender and race/ethnicity, not all eligible pairs who are interested in participating will be enrolled in the study.
Study on Vulnerable Plaque of Carotid Artery With Chinese Herbal and Insects Medicine

The investigators want treat Vulnerable plaque of carotid artery with a herbal and insects Chinese medicine. Designing a RCT trial to prove the effect and safety.

Vulnerable plaque of carotid artery is the important intervention target for primary prevention and secondary prevention of cerebral arterial thrombosis, but there are no effective, safe and prevalent treatment measures against it. The development that traditional Chinese medicine has achieved in treating plaque of carotid artery shows that great accomplishment could be made within this area. Academia should engage in clinical research on regulated treatment methods in traditional Chinese medicine with long-term intervention and high patient compliance, providing strong evidence for evidence-based medicine and guidance to clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria of carotid artery atherosclerosis;
2. Ultrasound of carotid artery atherosclerosis plaque specifies it as unstable plaque (including malacoplakia and mixed plaque);

Exclusion Criteria:

1. mRS Rating higher than or equal to 3 before joining the trail group;
2. Carotid artery stenosis is higher than or equal to 50%;
3. Confirmed as or suspected to be vasculitis;
4. With infection, tumor or insufficient heart, liver and kidney functions (renal function higher than twice of upper limit in normal limit, HYHA heart function grading higher than or equal to level 2 );
5. With acute myocardial infarction and unstable angina pectoris;
6. With acute cerebral arterial thrombosis;
7. lesion: Severe stenosis or occlusion of distal intracranial vessels;
8. Pregnant women or lactating mothers;
9. With known history of allergy to the drugs of the trial.
Study of Recombinant Human Insulin-Like Growth Factor I in Patients With Severe Insulin Resistance

OBJECTIVES: I. Determine the efficacy and toxic effects of recombinant human insulin-like growth factor I (rhIGF-I) on carbohydrate tolerance, insulin action, insulin secretion, hyperandrogenism, and hyperlipidemia in patients with severe insulin resistance who have failed other therapies.

II. Determine the dose and time response of rhIGF-I on carbohydrate homeostasis and secondary abnormalities in this patient population.

III. Determine the effect of rhIGF-I on insulin clearance, the regulation of insulin-like growth factor binding protein 1, the regulation of sex hormone binding globulin, and hypothalamic pituitary gonadal axis in this patient population.

PROTOCOL OUTLINE: This is an open label study. Patients receive the first dose of subcutaneous recombinant human insulin-like growth factor I (rhIGF-I) on day 7.

Patients receive rhIGF-I twice daily 15-30 minutes before breakfast and dinner, and are hospitalized for the first week of therapy. Patients return for an outpatient exam on day 19 of rhIGF-I therapy. Approximately 30 days into the therapy, patients are readmitted to the clinical center for repeat screening tests. Patients then receive maintenance therapy of rhIGF-I for up to 6-12 months. A washout period follows the maintenance therapy phase.

Patients are followed weekly, biweekly, or monthly depending on blood glucose response of patients off rhIGF-I therapy. Weekly phone contact with study coordinator is mandatory during this time.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Hematologically proven severe insulin resistance with or without diabetes
* Fasting insulin greater than 40 U/mL
* Post glucose insulin greater than 300 U/mL (unless overt diabetes mellitus is present)

--Prior/Concurrent Therapy--

Endocrine therapy: No concurrent oral hypoglycemic agents and/or insulin

Other: No concurrent birth control pills

--Patient Characteristics--

* Not pregnant
* Negative pregnancy test
* Effective barrier contraceptive method must be used by fertile patients
* Good health
Comparison of the Performance and Effectiveness of Two Transfusion-Saving Devices: Cell-Saver and SAME

An observational study comparing two systems of perioperative blood recovery in cardiac surgery, one system allowing red blood cell reinfusion and one system allowing red blood cell and platelet reinfusion. The objective is to evaluate whether platelet recovery provides better quality of hemostasis during and after surgery, improving transfusion savings, and whether it reduces postoperative complications and the length of stay in the intensive care unit and in the hospital.

° Primary outcome of the study : The primary outcome of the study is to compare the evolution of perioperative platelet count based on the type of blood recovery used, either SAME or Cell-Saver.

The main outcome measure is the difference between the preoperative and immediate postoperative platelet counts (delta platelet) for each patient between the SAME and Cell-Saver groups.

° Secondary outcomes of the study:

The secondary outcomes are to evaluate, from the preoperative period until day 28 postoperatively:

* The post-operative platelet count between days 1 and 5
* The frequency of perioperative and postoperative transfusions, including the number and type of blood products transfused
* The use of derivative medications (fibrinogen, prothrombin complex concentrates)
* The volume of postoperative bleeding
* The frequency of postoperative events (infectious, renal, thromboembolic, hemorrhagic)
* The length of stay in the intensive care unit and in the hospital
* The frequency of treatment for postoperative anemia with iron or erythropoiesis-stimulating agents.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled cardiac surgery under cardiopulmonary bypass with a predicted duration of more than 2 hours, or surgery of the aortic arch, redo surgery, multiple aorto-coronary bypasses (\>2), or combined surgery (valvular and coronary).

Exclusion Criteria:

* Pre-existing constitutional or acquired bleeding disorder (hemophilia A or B, von Willebrand disease, myelodysplastic/myeloproliferative syndrome)
* Patients with sepsis, a malignant tumor at the surgical site, or contamination of recovered blood with biological fluids/antiseptics/distilled water/local antibiotics/hemostatic agents.
* Organ transplantation and planned circulatory support in the preoperative period
* Uni-bi-ventricular artificial heart
* Reoperation in a patient already included in the study
* Patient refusing blood transfusion
* Pregnant women
* Legally Protected adults
Un-blinded Data Collection Study of Concussion Using the BrainPulse(TM)

The primary objective of this study is to collect un-blinded BrainPulse recordings from youth and adults that have a confirmed diagnosis of concussion per protocol guidelines in order to improve a concussion detection algorithm previously developed by Jan Medical, Inc. Subjects will be followed for 21 days after the initial injury with BrainPulse recordings to study the subject's recovery process. The symptomatic evaluation, physical examination, and BrainPulse recordings will be entered in a database to assess clinical outcome and device utilization.BrainPulse(TM)

Jan Medical is conducting a data collection study with the goal of developing further insight into understanding the signal features within a BrainPulse recording that are only present when the subject has a confirmed concussion. The initial pilot blinded study with Stanford University showed that there is increased energy in the 8-15 Hz range for BrainPulse recordings from adolescent male football players with a confirmed concussion. The current un-blinded study is designed to record the BrainPulse signal from a more diverse subject population to represent patients who have been diagnosed with a concussion in clinic setting. Subjects will include males and females ages 13 and older.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 13 years old and not part of any other vulnerable population such as pregnant women.
2. Suspected or confirmed concussion by medical professional
3. Not more than 3 days since injury/trauma event
4. Willing and able to participate in all required study evaluations and allow access to medical testing and records
5. Signed informed consent/assent, and/or have a legally authorized representative willing to provide informed consent on behalf of the subject.
6. Demonstrates a minimum of 3 of the following symptoms:

   * Headache
   * Pressure in head
   * Dizziness
   * Neck pain
   * Fatigue/ low energy
   * Nausea or vomiting
   * Irritability
   * Difficulty in concentrating/performing tasks
   * Memory impairment
   * Insomnia
   * Reduced tolerance to stress
   * Sensitivity to light
   * Difficulty balancing
   * Blurred vision
   * Confusion
   * More emotional than usual
   * Sadness
   * Nervous/Anxious
   * Vacant stare
   * Delayed verbal/motor response
   * 'Feeling like in a fog'
   * 'Don't feel right'

Exclusion Criteria:

1. Wound or open laceration on the head in the area of one of the BrainPulse sensors that would impede use of the BrainPulse device
2. Any serious medical condition that in the opinion of the medical professional would impair ability to provide informed consent/assent or otherwise disqualify a patient from participation
3. Currently participating in or planning to participate in another clinical study during the course of the current clinical study.
4. Implantation of any medical device in head (e.g. ventriculoperitoneal shunt)
5. An alternative diagnosis is made other than concussion