cyrilzakka/clinical-trials huggingface dataset:
Neural Mechanisms of Clinically Designed Improvisatory Music for Alzheimer's Disease

Clinically Designed Improvisatory Music (CDIM) is a form of improvised music based on calm-inducing sound parameters which brought relief to our cohort of neurology patients. As a direct sound-based approach, CDIM does not rely on autobiographical memory and may have wider applicability and generalizability. We wish to examine if CDIM decreases anxiety in 15 cognitively healthy individuals and 15 Alzheimer Disease patients with anxiety (AD-A).

The goal of this study is to identify the neural mechanisms of induced calmness through live clinically designed improvisatory music (CDIM) in cognitively healthy individuals and persons with Alzheimer's dementia suffering from agitation. This study is novel as most music interventions for dementia use familiar music and the underlying neural mechanism of calmness induced by music is not well known. We plan to investigate changes in 3 major large-scale brain networks using functional magnetic resonance imaging (fMRI). The major questions we plan to answer are as follows: 1. How does improvisatory music change the connectivity within brain emotion related networks in neurotypical individuals? 2. Does improvisatory music induce a state of calmness in individuals with Alzheimer's dementia and how? Based on objective evidence provided by this study we can justify further usage of music for patients with Alzheimer's, in particular, in the form of improvisation.

Eligibility Criteria:
Inclusion Criteria:

1. Cognitively healthy individuals

   Cognitively healthy control participants evaluated through the Northwestern Mesulam Center. BAI \> 8.

   Exclusion Criteria: hearing loss
2. Individuals with mild to moderate Alzheimer's disease

This group will similarly be recruited through the Mesulam Center. All individuals recruited by the research Core at the center are well characterized tests standardized across all NIH funded Alzheimer Centers across the nation. Individuals with mild to moderate neurocognitive disorder due to AD will have an MMSE greater than \>15 and Clinical Dementia Rating (CDR) between 0.5 and 2.. They will also have a history of neurocognitive-related agitation/anxiety, and a Beck Anxiety Index (BAI) greater than 8, suggestive of at least a mild level of anxiety.

Exclusion criteria: MMSE\<15, CDR\>2, hearing loss
Assessing User Satisfaction and Adherence to an Abbreviated Dietary Tracking App (MySnackTracker) Versus Full-intake Dietary Monitoring

To learn if a method of abbreviated food tracking (called MySnackTracker) is a reasonable alternative to traditional full-intake food tracking and to compare the adherence to and acceptability of each method.

Primary Objectives The goal of the study is to compare the adherence and acceptability of tracking only high-energy low-nutrient value foods to standard full intake monitoring of diet. We predict that use of the high-energy, low-nutrient-density food tracking app will result in greater adherence to self-monitoring and greater satisfaction with monitoring in comparison to the full intake tracking.

Secondary Objectives Assess the efficacy of the snack tracking app versus standard self-monitoring as measured by changes in the following measures between baseline and follow up; percentage weight change, weight loss self-efficacy scores, food logging self-efficacy scores, GODIN leisure time activity questionnaire scores, Vioscreen tool responses for stages of change for fats and fruit/vegetable intake, daily fruit consumption, daily vegetable consumption, servings of sweets per day, Healthy Eating Index (HEI) Score for calories from solid fats, alcohols, added sugars, HEI empty calories, total drinks of alcohol per day, calories from alcoholic beverages per day, added sugars by available carbohydrates, added sugars by total grams of sugar, calorie intake, carbohydrate intake, fat intake, saturated fatty acid intake, and total sugar intake.

Eligibility Criteria:
Eligibility Criteria

In order to be eligible to participate in this study, an participants must meet all of the following criteria:

* Provision of signed and dated informed consent form
* Access to internet connection, email address, and smartphone able to download the intervention app
* Current or previous participation in one of the following DFI cohorts: PA17-0584 (MERIT Study), Project CHURCH, High Risk Breast Cohort, Mexican-American Cohort, and rural cancer survivors from the Mind Your BEAT study
* Demonstrated ability to read and understand English. The study app is currently only available in English.

Exclusion Criteria

An participant who meets any of the following criteria will be excluded from participation in this study:

* Prisoners
* Anyone currently under 18 years of age
* Cognitively impaired participants
* Pregnant women (assessed by self-report)
* BMI less than 28 or greater than 40
* Self-reported previous or planned bariatric surgery
* Self-reported current or planned use of a GLP-1 agonist medication
* Self-reported current or planned participation in another weight loss intervention
* Cancer participants receiving active treatment
* Anyone currently unable to participate in the research for the duration of the study
* No current motivation to lose weight
Effects of Light on Melatonin and Contractions in Pregnant Women

Specific Aim: Test the hypothesis that ocular light exposure will suppress melatonin secretion and reduce uterine contractions in women at late term pregnancies.

Secondary aim. Test the hypothesis that ocular light exposure will reduce self-reported uterine contractions in women at late term pregnancies.


Eligibility Criteria:
Inclusion Criteria:

* pregnant at 35-40 weeks
* first pregnancy

Exclusion Criteria:

* pregnancy-related complications
* twin or higher pregnancy
* using medication that affects the sympathetic nervous system
Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED)

Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines


Eligibility Criteria:
Inclusion Criteria:

* Patients who are naïve to lowering lipid agent
* Patients who are treated with lowering lipid agents and had a wash-out period for 4 weeks.

Exclusion Criteria:

* Impaired kidney function
* Increased liver enzyme levels
* Pregnant women
* Hypersensitivity to ezetimibe and other statin agents
Midkine and ACE-Ang II Induced Endothelial Injury in Sepsis

Plasma midkine has reported to be elevated in infection and a regulator of angiotensin-converting enzyme (ACE). We aimed to investigate the plasma midkine in septic patients and its association with 28-day mortality and organ function, and also with plasma ACE and angiotensin II.

This study showed that Ang II induced endothelial injury in sepsis patients. Midkine has been shown to regulate the renin-angiotensin system and acts in the upstream signaling pathway of angiotensin (ANG) II. The investigators want to access the relationship between midkine level and ACE-Ang II induced endothelial injury in sepsis

Eligibility Criteria:
The inclusive criteria were adult patients (age \> 18 years-old and \< 80 years-old) diagnosed with sepsis, according the definition of the Surviving Sepsis Campaign (2016)

Exclusive criteria included: 1. age \< 18 years-old or \> 80 years-old; 2. pregnancy or breastfeeding; 3. malignancy; 4. patients with potentially elevated plasma midkine apart from sepsis including acute myocardial infarction, stroke, limb thrombosis, chronic renal dysfunction (baseline plasma creatine ≥2 mg/dL), autoimmune diseases and Alzheimer syndrome; 5. patients deceased or discharge from ICU within 24 hours; or, 6. written consents could not be obtained.
Use of Methacetin Breath Test to Predict Liver Failure in Patients With Cirrhosis

The methacetin breath test (MBT) is a non-invasive liver function test which measures the ability of the liver to metabolize a tracer dose of a compound to carbon dioxide, which is exhaled. The study hypothesis is that measurement of the MBT will allow earlier detection of a decline in liver function in patients with cirrhosis who are awaiting liver transplantation.


Eligibility Criteria:
Inclusion criteria:

1. Being considered for placement or already on the liver transplantation waiting list
2. Cirrhosis caused by any cause of chronic liver disease.
3. Age \> 18 years

Exclusion criteria:

1. Known or suspected hepatocellular carcinoma
2. Prior TIPS placement
3. Severe congestive heart failure
4. Severe pulmonary hypertension
5. Uncontrolled diabetes mellitus (HBA1C \>9.5%)
6. Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication.
7. Previous surgical bypass surgery for morbid obesity (BMI \>45)
8. Extensive small bowel resection
9. Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs
10. Women who are pregnant
11. Patients who are allergic to acetaminophen/ paracetamol or any other related medications
12. Patients with an acute current exacerbation of chronic obstructive pulmonary disease or bronchial asthma.
13. Patients that are taking hepatotoxin drugs
14. Patient, based on the opinion of the investigator, should not be enrolled into this study
15. Patient is unable or unwilling to sign informed consent.
16. Patients that are participating in other clinical trials evaluating experimental treatments or procedures
Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cryptogenic stroke (including transient ischemic attack with positive head imaging findings)
* Diagnosed with a PFO
* Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

* N/A
Non-Invasive Screening for Fetal Aneuploidy

The purpose of this study is to detect whole chromosome abnormalities in maternal blood.

The purpose of this study is to detect whole chromosome abnormalities on all chromosomes 13, 16, 18, 21, X and Y, in the fetus through analysis of cell free and compound sample DNA (cf DNA and cs DNA, respectively) in maternal blood. In addition, major deletions and duplications in chromosomes 1, 4, 5, and 22 will be detected.

Eligibility Criteria:
Inclusion Criteria:

* • Subject is a pregnant woman 18-54 years of age at 8-22 weeks' gestation inclusive;

  * Subject has additional risk indicators for fetal chromosome aneuploidy, including one or more of the following:
  * Maternal age \> 34 years at the estimated date of delivery;
  * Positive serum screening test suggesting fetal aneuploidy;
  * Previous positive noninvasive cfDNA test is acceptable
  * Fetal ultrasound abnormality suggesting fetal chromosomal abnormality;
  * Personal or family history of Down syndrome or other chromosomal aneuploidy.
  * Willing to provide written informed consent
  * Willing to be re-contacted subsequently for additional information and/or testing if necessary.

Exclusion Criteria:

* Subjects will not be entered into this study if they meet the following criteria:

  * Fetal demise at the time of the blood draw;
  * Previous specimen donation under this protocol;
  * Unwilling or lacks the capacity to provide informed consent or to comply with study procedures;
  * Currently under treatment for cancer
  * Any history of autoimmune disease
  * Any pelvic mass
  * Previous history of radiation to pelvis
  * Any history or current evidence of a twin demise at any gestational age.
The Impact of Electroacupuncture on Clinical Effect,Brain Structural and Functional Changes on Spinal Cord Injury

Spinal cord injury (SCI) is a kind of severe disease with high morbidity and complications. At present, electroacupuncture has certain advantages in treating motor sensory dysfunction, neuropathologic pain, neurogenic bladder and intestinal dysfunction after spinal cord injury. However, previous clinical studies of acupuncture neglected the brain, which is closely related to the structure and function of spinal cord.So,the aim of this study is to observe and analyse the impact of the changes of gray and white matter volume on whole brain and brain functional re-establish,to reveal the neuroimaging mechanism of improving the motor sensory functions of patients with spinal cord injury, and to provide a theoretical basis for the clinical application of electroacupuncture.


Eligibility Criteria:
1.Aged 18-75 years no matter the gender 2.14 days to 3 months after the onset of SCI 3.Patients with cervical, thoracic or lumbar spinal cord injuries 4.SCI classified as B, C, or D grade on the ASIA impairment scale(AIS), that is incomplete SCI (iSCI) 5.Patients with grade 1-3 muscle strength of lower limbs 6.Right-handed 7.Patients who submitted written informed consent

Exclusion Criteria:

1. Contraindication to MRI scanning such as metal in the body, pacemaker
2. Severe structural asymmetry or lesions in the brain
3. Complications that may affect neurologic examination, such as severe peripheral nerve injury, limb fractures, and heterotopic ossification around the joints
4. With complex injury such as traumatic brain injury, organ injury, unstable vital signs or disturbance of consciousness
5. With severe primary diseases such as heart, liver, kidney and hematopoietic system
6. Patients with SCI due to myelitis, multiple sclerosis, vascular malformation caused spinal cord hemorrhage, intraspinal tumors, etc.
7. Pregnancy
LEO 22811 - A Phase 1, Double-Blind, Placebo-controlled, Single and Multiple Oral Dose Study in Healthy Subjects

The purpose of this first-in-man trial is to determine the safety and tolerability of ascending single and multiple doses of LEO 22811 in healthy male subjects as well as to determine the safety and tolerability of single oral doses of LEO 22811 in healthy female subjects. The trial will be performed in two parts. In Part 1, single doses of LEO 22811 will be administered to healthy male and female subjects. In Part 2, multiple doses of LEO 22811 will be administered to healthy male subjects.


Eligibility Criteria:
Inclusion Criteria: (in summary)

* Subjects will be Caucasian males or females of non-child bearing potential between 18 and 65 years of age
* Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions

Exclusion Criteria: (in summary)

* Women of childbearing potential
* Subjects with an infectious illness within 3 days prior to dosing
* Subjects with a history of tuberculosis
* Subjects who have received any prescribed systemic or topical medication (including natural/herbal medicines) within 14 days of the first dose administration
* Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration
* In Part 2, subjects who have received or been exposed to Cloroquine products, endoxan, or any immunomodulating agent (e.g. azathioprin) within one month prior to the start of dosing
* Subjects who are participating in a clinical study
* Subjects with a significant history of drug allergy or with a known or suspected hypersensitivity to any of the components of LEO 22811 as determined by the Investigator
* Subjects who have any clinically significant allergic disease (excluding non-active hayfever) as determined by the Investigator
* Subjects who have a supine blood pressure and supine pulse rate at screening higher than 150/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/40 mmHg and 50 bpm, respectively
* Subjects who have PR interval \>= 200 ms, QTc(b) interval \>450 ms (males) or \> 470 ms (females), or who exhibit U waves of atrio-ventricular blocks at screening, based on 12-lead ECGs
* Subjects who consume more than 28 units (males) or more than 21 units (females) of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse
* Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
* Subjects with a significant cardiac history (e.g. heart failure, hypokalemia, long QT syndrome)
* Subjects who have had a clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator
* Subjects who, in the opinion of their General Practitioner (GP) or the Investigator, should not participate in the study, including subjects suspected for whatever reason of not being able to comply with the requirements of the protocol
Safety Study of Bile Acid to Treat Hypercholesteremia

Preclinical data support the hypothesis that the administration of AHRO-001 reduces LDL cholesterol levels, improves HDL function, and finally, decreases atheromatous plaque burden.

4 sequential dosing cohorts, each cohort beginning with single dose (SDD), single day exposure, followed by one week of multiple daily dosing (MDD) with bid exposure, a 4 day drug honeymoon, then one week of MDD utilizing tid exposure. Each subsequent cohort utilizes the same SDD/MDD design, starting with SDD higher than prior SDD but a SDD significantly lower than prior tid MDD cohort just completed, the overall goal being to provide gradually increasing dose exposure contingent on satisfactory safety and tolerability of lower doses in the previous groups. Cohort 4 (MDD) utilizes best dose determined by Cohorts 1, 2 \& 3 for 21 days.

Estimated Duration of Subject Participation: 8-9 weeks

Under Protocol Amendment Version 5.0, an additional cohort, Cohort 5, will concomitantly enroll 48 volunteers randomized to receive either AHRO-001 or placebo. Volunteers included in the study may be either currently receiving or not receiving a statin treatment. The 48 volunteers in Cohort 5 will thus be allocated to 3 treatment groups with 16 volunteers enrolled per group:

Group A: AHRO-001 alone Group B: Statin + AHRO-001 Group C: Placebo

SUBJECT POPULATION:

Healthy volunteers, both males \& infertile females, with asymptomatic mild to moderate hypercholesterolemia

Eligibility Criteria:
Key Inclusion Criteria:

* Males OR infertile Females
* 18-70 years of age, inclusive
* Asymptomatic mild to moderate hypercholesterolemia, (LDL =110-220 mg/dL)
* Cohort 5: on no statin or on a stable statin dose not meeting LDL \>110 mg%

Key Exclusion criteria

* Fasting triglycerides \<90 or \>250 mg/dl (\<0.85 mmol/l or \>2.8 mmol/l)
* Body Mass Index (BMI) \<18 or \>34 kg/m2
* Diabetes mellitus (FBS \> 125 mg% (\>6.94 mmol/l)
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>ULN
* Serum creatinine \>ULN for gender
* Hemoglobin \<11.5 g/dL
* Female volunteers of childbearing potential
* History of cancer in past 5 years
* Any disease requiring medication
* Use of investigational medication in past 3 months
* Positive results for illegal drugs, HBsAg, HBsAb, HCV or HIV
* Cohort 5:Prescription lipid lowering medications other than a statin in past 4 wks
* Cohort 5: History of gastrointestinal tract surgical resection
PEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy

Evaluation of the efficacy and safety of Jinyouli in preventing neutropenia in multiple chemotherapy cycles in elderly patients with small cell lung cancer through a multicenter, open, one-arm study Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria, chemotherapy regimen: etoposide: 100 mg/m2, d1-3, carboplatin: AUC=5, d1, q21d, prophylactic use test 48 h after chemotherapy Drug PEG-rhG-CSF.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 70 years old, gender is not limited;
* Small cell lung cancer patients diagnosed by histopathology or cytology;
* ECOG = 0-1;
* The estimated survival period is more than 3 months;
* No obvious signs of hematological disease, defined as Hb≥90g/dL, WBC≥4.0×10\^9/L, ANC≥2×10\^9/L, PLT≥100×10\^9/L before enrollment. And no bleeding tendency;
* No obvious abnormalities were observed in the electrocardiogram examination;
* Liver function tests ALT, AST, TBIL indicators are within 2.5 times the upper limit of normal values. If due to liver metastasis, the above indicators should be within 5 times of the upper limit of normal. If LDH is elevated due to non-tumor causes, LDH should be ≤ 2.5 times the upper limit of normal; if LDH is elevated due to tumor, it can be enrolled;
* Renal function test BUN, UA within 1.5 times the upper limit of normal value, creatinine clearance rate\> 60ml / min;
* Subjects (or their legal representatives/guardians) must sign an informed consent form indicating that they understand the purpose of the study, understand the necessary procedures for the study, and are willing to participate in the study.

Exclusion Criteria:

* There are currently uncontrollable infections, body temperature ≥ 38.0 ° C;
* Patients with previous malignant tumors that have not been cured or have bone marrow metastasis;
* Patients with prophylactic antibiotics;
* Accepting other test drugs at the same time or participating in other clinical trials;
* Those who are allergic to this product or other genetically engineered E. coli-derived biological products;
* The patient has any myelodysplastic and other blood system diseases;
* Patients who have received hematopoietic stem cell transplantation or organ transplantation;
* The patient has a severe mental or neurological condition that affects informed consent and/or adverse reaction presentation or observation.
Influence of Oxidative Stress and Nutrition Biomarkers on the Cognitive Decline Evolution in Alzheimer Disease

According to several reports, the oxidative stress and the nutrition could have an impact in the Alzheimer disease.

The association of these two parameters measurements and the cognitive impairment decline could help in a predictive diagnosis of cognitive decline evolution in patients presenting cognitive disorders.

This is a monocentric prospective "routine care" clinical trial on patients showing cognitive troubles especially memory complaints.

The objective is to demonstrate a correlation between oxydative stress and nutrition biomarkers and the clinical evolution of patients complaining of cognitive impairments.

The neuropsychologic data collection (the mini mental Status Examination (MMSE), the clock test, the Grober-Buschke test (FCSR-IR), the executive function evaluated by the Trail making test, and the medical imaging (by magnetic resonance imaging (MRI) or tomography in case of MRI contraindication) will be realized during the study inclusion phase in the usual intake of patients. Whole blood samples for the oxydative and nutrition biomarkers measurements will be taken at the study inclusion day during the stay at the Day hospital dedicated to the routine intake of patients issued from the memory consultation.

In this study, the principal evaluation criteria will be the MMSE score evolution during the 60 months of the patients follow-up, measured during the routine visits scheduled approximately every 6 months, according to the french national authority for health recommendations. It will allow evaluating the correlation between the cognitive decline evolution measured by MMSE during the Alzheimer disease or related diseases method during the 2 years follow-up, and the oxydative stress blood markers.


Eligibility Criteria:
Inclusion Criteria:

* \>55 years old patient
* Patient seen during a memory consultation in geriatric Unit, Lyon Sud University Hospital
* Patient or legal representative and/or person of confidence who didn't express his opposition to the clinical assay participation.
* Patient registered to the general social insurance
* Complementary health check scheduled at day hospital, conventional hospitalization or regular consultation.

Exclusion Criteria:

* Patient unable to express his participation refusal and under curatorship or unforced by the court of justice