cyrilzakka/clinical-trials huggingface dataset:
Program for the Introduction Into Clinical Practice of the Principles of Personalized and Preventive Medicine Based on the Isolation of Gene Polymorphism in Schizophrenia in People of the Kazakh Ethnic Group

This is a GWAS study that aims to identify possible candidate genes associate to schizophrenia by exploring single nucleotide polymorphism (SNP) in a group of schizophrenia, in the Kazakh population. The investigators hypothesize that the careful phenotyping of the subject sand matching with increase the power to find SNP significantly associated with schizophrenia

A genome-wide association study (GWAS) is an approach used in genetics research to associate specific genetic variations with particular diseases. The method involves scanning the genomes from many different people and looking for genetic markers that can be used to predict the presence of a disease. Once such genetic markers are identified, they can be used to understand how genes contribute to the disease and develop better prevention and treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* persons of Kazakh nationality having this ethnicity in the 3rd generation
* age from 18 to 65 years old;
* the dispensary in a psychiatric institution at the place of residence with a diagnosis of "Paranoid schizophrenia";
* the duration of the disease is at least 1 year (from the moment of taking under dispensary supervision):
* absence of severe and chronic somatic diseases;
* absence of severe and chronic neurological diseases;
* absence of comorbid drug addiction pathology;
* signed informed consent to conduct this study

Exclusion Criteria:

* persons of non-Kazakh nationality and Kazakh nationality, not confirmed until the 3rd generation
* age less than 18 years old and over 65 years old;
* those who are on dispensary registration in a psychiatric institution at the place of residence with a diagnosis not related to ICD-10 under the heading F20.0 "Paranoid schizophrenia";
* having a disease duration of less than 1 year (from the moment of taking under dispensary supervision):
* having severe and chronic somatic diseases;
* having severe and chronic neurological diseases;
* having comorbid narcological pathology;
* not signed informed consent to conduct this study
Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis

This is an open-label, single arm study of 52 weeks duration. The study will assess the safety and efficacy of lebrikizumab in adolescent participants (≥12 to \<18 years weighing ≥40 kilograms) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female adolescent (≥12 years to \<18 years, and weighing ≥40 kg).
2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit.
3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.
4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
5. ≥10% body surface area (BSA) of AD involvement at the baseline visit.
6. History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.

Exclusion Criteria:

1. Participation in a prior lebrikizumab clinical study.
2. Treatment with the following prior to the baseline visit:

   1. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
   2. Dupilumab within 8 weeks.
   3. B-cell-depleting biologics, including to rituximab, within 6 months.
   4. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
3. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
4. Uncontrolled chronic disease that might require bursts of oral corticosteroids.
5. Evidence of active acute or chronic hepatitis
6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
7. History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
Impact of Pharmaceutical Interviews on the Medication Adherence of Epileptic Patients

Many studies have reported a disparity in medication adherence among epileptic patients. In this population, Medication Possession Ratio (MPR) is an index of medication adherence. MPR is defined as the ratio of the number of days of treatment delivered to the number of days in the period of interest.

No-adherents patients are defined by a MPR of less than 80% , in whom an increase in seizures and the rate of hospitalization can be observed. A pharmacist-led intervention and medication information to epileptic patients could improve patient medication adherence to antiepileptic drugs, and possibly decrease the frequency of seizures, hospitalizations and the health costs generated by these hospitalizations. This intervention could also improve patient knowledge about their medications.

The aim of this study is to evaluate the effectiveness of a pharmacist-led intervention on medication adherence of epileptic patients with the MPR. Secondary objectives include the comparison of medication adherence with health insurance score, the evaluation of patients knowledges about their medications, community pharmacists' satisfaction about community hospital network, the comparison of the seizure free patient rate and the comparison of the rate of patient in whom seizure have decreased by 50%


Eligibility Criteria:
Inclusion Criteria:

* Epileptic patients seeing a neurologist in the neurophysiology clinic with a regular follow-up by the Lille University Hospital reference center
* Adult over 18 years old
* Living at home
* Socially insured patient
* In the case of cognitive problems, the presence of a reliable caregiver managing the medications

Exclusion Criteria:

* Inpatients
* Patient under curatorship, guardianship and/or institutionalized
* Dementia
* Patient who has participated in a therapeutic education program (TEP) about his epilepsy within the previous two years
* Administrative reasons: impossibility to receive informed information, impossibility to participate in the entire study, lack of coverage by the social security system, refusal to sign the consent form.
* Switching to home care by a registered nurse for treatment management
Pergolide for Cognitive Symptoms in Schizotypal Personality Disorder

Hypothesis: Schizotypal personality disorder patients will show cognitive improvements in 1) working memory 2) learning and memory 3) sustained attention 4) enhanced performance on the AX-CPT, N-back and Eriksen during pergolide treatment. There will be a significant diagnosis by drug administration of 0.3 mg of oral pergolide interaction for performance on the cognitive tasks, with the schizotypal personality disorder group demonstrating significantly improved peformance compared to the other personality disorder group after pergolide compared with placebo.

Design: Randomized, double-blind, crossover study of pergolide vs. placebo. Half of subjects receive pergolide for eight weeks; half of subjects receive placebo for four weeks followed by pergolide for four weeks.


Eligibility Criteria:
Inclusion Criteria: DSM-IV criteria for Schizotypal Personality Disorder (or meets full criteria bar one) or another personality disorder and shows impairment on markers of cognitive functioning. Medically healthy, not abusing drugs or alcohol, is at least two weeks medication-free and does not have significant neurological disease.

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Exclusion Criteria: DSM-IV or RDC criteria for Schizophrenia or any Schizophrenia-related psychotic disorder or for Bipolar Disorder. Any other Axis I disorders must be transient and preceded by the personality disorder diagnosis, which should be primarily responsible for subject's functional impairment.

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Study of Freefol-MCT PKPD in Healthy Volunteers

The purpose of this study is to analysis PKPD of Freefol-MCT and to investigate relationship between the concentration of Freefol-MCT and the index which signaly analyzes those: EEG, EEG approximate entropy, systolic BP, saturation wave form and invasive BP wave form.


Eligibility Criteria:
Inclusion Criteria:

* Adults males/Females aged over 20years
* Health screening examination within 60 days of the start (Interview, vital signs , 12-lead ECG, blood tests, urinalysis) .
* The applicant who agreed in writing by told an explanation enough about the characteristics of the study drug, the purpose of the test and the details.

Exclusion Criteria:

* Subjects with clinically significant disease or history such as Liver, kidney, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous psychiatric, blood tumor system and cardiovascular. (In particular, bronchial asthma, severe hepatic, renal failure, severe blood disorders, severe myasthenia gravis, cardiac dysfunction, peptic ulcer, etc.)
* Who had acute disease or organ dysfunction within four weeks of the start of the test.
* Who had significant hematologic disorders or donate whole blood within two months of the start of the test.
* Significant neuropsychiatric or more.
* Continued drug abuse.
* Who has a history of drug and other hypersensitivity reactions.
* Positive at Type B / C hepatitis , syphilis tests (VDRL), if in AIDS antibody test
* Who took other clinical medicine within two months of the start of the test.
* Who smokes or drinks within two weeks after dosing.
* Who takes drugs regularly other than the mineral claim or vitamin. However, it depends on judgment of the researchers.
The Effect of Peer-Guided Pilates Exercise on Premenstrual Syndrome Symptoms and Healthy Lifestyle Behaviors: A Randomized Controlled Study

This project is to examine the effect of pilates exercise, which is applied by university students under the guidance of peers, on premenstrual syndrome symptoms and healthy lifestyle behaviors.

Methods: The research to be carried out within the scope of the project is randomized controlled and has an experimental research design. The population of the research consists of 385 female students studying at the Department of Midwifery at Istanbul University-Cerrahpaşa Faculty of Health Sciences. In the study, it is aimed to reach all students without making a sample calculation in order to identify the students with PMS symptoms among all students. Students who score 110 and above on the Premenstrual Syndrome Scale (PMSS) will be considered to have PMS symptoms. The sample size of the students showing PMS symptoms was determined by using the G\*Power (3.1.9.2) program and considering the 0.05 margin of error and data loss, according to 95% power and medium effect size; 27 people should be included in the experimental group and 27 people in the control group. In determining the groups, the participants will be assigned to the experimental and control groups using the "Randomizer.org" program. Students included in the research will be given information about the study and will be presented with an "Informed Consent Form" and a "Volunteer Consent Form". While the experimental group will be given pilates exercises, under the guidance of a peer, for half an hour twice a week for six months, the control group will maintain their routine habits. At the beginning of the study, data will be collected with the "Personal Information Form", "Premenstrual Syndrome Scale (PMSÖ)" and "Healthy Lifestyle Behaviors Scale-II (SYBDS-II)". In the third and sixth months of the study, the hypotheses will be tested by applying PMSS and HLBS-II. The data obtained in the research will be entered into the database in the IBM SPSS 25.0 (Statistical Package for the Social Sciences) program and all necessary statistical analyzes will be performed in the same program.


Eligibility Criteria:
Inclusion Criteria:

* Being an undergraduate student studying in the midwifery department of Istanbul University-Cerrahpaşa Faculty of Health Sciences,
* Having a score of 110 and above in PMSS,
* Having an internet connection,
* The Zoom program is installed and ready to use on its electronic device (phone or computer),
* Having the environment to do Pilates.

Exclusion Criteria:

* Being under the age of 18,
* Changes in menstruation characteristics after the diagnosis of PMS,
* Having a chronic or physical illness that prevents Pilates exercise.
V501 Efficacy Study in Women Aged 18 to 26 (V501-027)

A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women


Eligibility Criteria:
Inclusion Criteria:

* Female Subject Aged 18 To 26 Years
* With 1-4 Lifetime Sexual Partners

Exclusion Criteria:

* Male Subject
Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients

The purpose of this study is to obtain a preliminary assessment of the antiviral activity and tolerability of simplified Kaletra dual agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm.


Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* \>18 years of age
* HIV RNA\> 400 copies/mL
* Any CD 4 cell count
* Antiretroviral naïve
* No acute illness

Exclusion Criteria:

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Mindful Self-compassion and Perfectionism

The study is a randomized controlled study. A total of 200 students will be invited to participate in a 5-session mindful self-compassion course aimed at increasing self-compassion and reducing maladaptive perfectionism, anxiety, depression, and unhealthy body image. Self-compassion is the ability to show oneself kindness in instances of perceived inadequacy, failure, and suffering by attending to distressing experiences with kindness, mindfulness, and the ability to recognize these as a part of a shared humanity. Twelve participants will be randomly selected for pre- and post interviews to qualitatively evaluate outcome. Ten participants with high perfectionistic tendencies will be selected to participate in a narrative life story interview.

The investigators will test four hypotheses:

1. At baseline, low levels of maladaptive perfectionism, and lower levels of depression, anxiety and body appreciation - reversed, will be related to greater self-compassion. The investigators expect high level of maladaptive perfectionism to be related to lower baseline self-compassion, higher levels of depression and anxiety and lower levels of body appreciation.
2. The intervention, a five session self-compassion intervention, will be sufficient to induce positive changes in perfectionism and psychological symptoms of anxiety, depression and body-appreciation- reversed.
3. Changes in self-compassion will co-vary with changes in maladaptive perfectionism and body appreciation.
4. Higher baseline levels of maladaptive perfectionism will predict greater gains from the intervention, because perfectionistic students will have greater need for a self-compassion intervention.

Eligibility Criteria:
Inclusion Criteria:

* College/university students

Exclusion Criteria:

* N/A
A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers

The primary objective of the study is to evaluate the effects of omeprazole (a proton-pump inhibitor) and an acidic beverage (Coca-Cola) on sotorasib pharmacokinetics (PK) when administered orally in healthy volunteers.


Eligibility Criteria:
Inclusion:

* Healthy male participants or female participants, between 18 and 60 years of age (inclusive), at the time of Screening.
* Body mass index, between 18 and 30 kg/m\^2 (inclusive), at the time of Screening.
* Females of nonchildbearing potential.

Exclusion:

* Inability to swallow oral medication or history of malabsorption syndrome.
* History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
* Poor peripheral venous access.
* History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease, including history of myolysis, not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
An Observational Study of the Correlation Between miRNA in Peripheral Blood and Prognosis in Patients With ARDS

To evaluate the correlation between the value of miRNA related to ARDS and vascular endothelial cell and ARDS severity, vascular endothelial cell damaging degree，mortality in patients with ARDS.

After consulting literature, we obtain 14 miRNAs related to ARDS and vascular endothelial cell(ARDS-VEC-miRNAs) and 2 biomarkers of scathing vascular endothelial.The ARDS-VEC-miRNAs include miR-15a-5p,miR-16-5p,miR-21-5p,miR-24-3p,miR-26a-5p,miR-27a-3p,miR-27b-3p,miR-126-3p,miR-150-5p,miR-146a-5p,miR-155-5p,miR-221-3p,miR-223-3p,miR-320a.The biomarkers of scathing vascular endothelial include vascular cell adhesion molecule-1(VCAM-1),von Willebrand factor(vWF).20 healthy controls and 60 patients diagnose as ARDS in ICU were included in this study.we blood every participants within 24 hours after enrollment and obtain the plasma.Then, we detecte ARDS-VEC-miRNAs,VCAM-1,vWF levels in plasma by real-time quantitative PCR,record the severity of the illness and survival status within 28 days of every patients.Finally,we evaluate the correlation between the value of miRNA related to ARDS and vascular endothelial cell and ARDS severity, vascular endothelial cell damaging degree，mortality in patients with ARDS.

Eligibility Criteria:
Inclusion Criteria:(1)Admitted to ICU, ARDS patients(Berlin criteria), (2)Patients diagnosed ARDS within 24 hours, (3)Patients age between 18 years old and 85 years.

Exclusion Criteria:1)Pregnant women, 2)Patients with malignant tumor, 3)Immunosuppression or immunocompromised patients.
Tailored Activity Goals - an Exercise Prescription Study

The primary goal of this study is to determine experimentally the relationship between affective response to exercise and future exercise behavior. A secondary goal is to examine potential mediators and moderators of this relationship, specifically four variables considered to contribute to the volitional control of exercise behavior - planning, attention, resource commitment, and affect regulation. An additional goal is to examine how symptoms of depression might influence the affective response to exercise, and the relationship between affective response to exercise and exercise behavior.

The specific aims are as follows:

Aim 1. The first aim is to determine the effectiveness of an experimental manipulation of individuals' affective response to a laboratory-supervised bout of exercise corresponding to a vigorous intensity (just below the ventilatory threshold), compared to a control condition that simply measures individuals' natural affective response to exercise. The investigators will specifically determine the effect of this manipulation on anticipated, experienced and remembered affective response to exercise.

Aim 2. The second aim is to examine individuals' adherence to an exercise prescription over the course of one week that asks them to exercise daily on their own for twenty minutes at the same intensity (as indicated by a heart rate monitor) as the laboratory-supervised exercise session, and to determine whether adherence to this prescription is greater for those who expect exercise to lead to positive affect than those who expect exercise to lead to negative affect, as compared to a control condition.

Aim 3. The third aim is to examine potential mediators and moderators of the relationship between anticipated affect and subsequent exercise behavior, including volitional control of exercise, affect regulation ability, and symptoms of depression.

Eligibility Criteria:
Inclusion Criteria:

* eligible participants will be between the ages of 18 and 39 (for men) and 18 and 45 (for women)
* free of overt disease (as cleared by clinical translational research center medical staff)
* free of mental health conditions other than depression and anxiety (by self-report)
* physically capable of engaging in moderate exercise activity (i.e., no injuries or physical impairments)
* willing to receive a "prescription" for exercise intensity, frequency, and duration, and have access to a computer with Internet connectivity in order to complete the online follow-up survey.

Exclusion Criteria:

* elite (i.e., paid) athletes or required to participate in aerobic exercise in conjunction with their occupation (e.g., aerobics instructors)
* women must not be pregnant or planning to become pregnant during the study period
* on any medications for which exercise is contraindicated (as cleared by clinical translational research center medical staff)
* smoker
Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance

TEG is an established technique to assess the quality of clot formation' used mainly in surgery and obstetrics to determine possible bleeding diathesis. Recently it became to be used in cardiology, where it can be a valuable tool to assess a response to antiplatelet therapy and its association with the outcome. However, there is a few data about use of TEG in STEMI patients undergoing PCI. Our study is designed to assess by TEG the platelet's response to clopidogrel treatment during acute STEMI in patients undergoing primary PCI and the correlation of this response with the long term outcome, and ability to dose adjustment according to a specific measurement by TEG in order to prevent future MACE.

TEG system may provide the capabilities needed to deliver personalized therapy, first, because it can identify patients at risk of ischemic event based on hemostatic influences, particularly platelet aggregation and platelet reactivity. Secondly, because treating those patients who exhibit high platelet reactivity -- an indication that they are not reaching a therapeutic level -- with appropriate drugs and doses is expected to improve outcomes.

In this study that would be increased clopidogrel maintenance dosing (150 mg) or aspirin maintenance dosing to 200mg in an attempt to lower platelet reactivity below the 50th%ile, which we expect to also reduce their ischemic risk during the follow up period.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or more
* Patients admitted with acute STEMI as a first Coronary event
* Duration of symptoms less than 12 hours
* PCI elected as a treatment of acute STEMI
* Informed consent signed

Exclusion Criteria:

* Thrombolytic therapy
* PCI not performed after diagnostic angiography (conservative treatment, CABG)
* DES used in PPCI
* Staged PCI procedures
* Previous clopidogrel treatment at any time for any reason
* Previous myocardial infarction
* Known bleeding diathesis of any kind
* Significant renal insufficiency (GFR\<40 ml/min)
* LFT disturbances (Transaminase elevation more than x3 ULN)
* Significant anemia (Hb\<10) or a need for blood transfusion
* Significant Thrombocytopenia (PLT Count \< 150000)
* Known Clopidogrel allergy
* Known Active peptic disease