cyrilzakka/clinical-trials huggingface dataset:
Exploring Pathology Related to Slowly Expanding Lesions Using Advanced Imaging

This is an open, follow-up study to compare the performance of three critical imaging methods to detect chronic active lesions in Multiple Sclerosis (MS) in vivo.

Smoldering inflammation is recognized as a critical contributor to MS progression-related central nervous system (CNS) damage. Activated microglia and macrophages particularly at chronic lesion edge are believed to promote lesion growth. Reversing their harmful activity may prove to be an efficient way to halt progression independent of relapses in MS.

These smoldering, or chronic active lesions can be detected in vivo using advanced imaging techniques. 1) Specific algorithms can be used to identify lesion growth, with a hypothesis that the slowly evolving lesions (SEL) are the ones harboring a rim of activated microglial cells, which contribute to damage in the surrounding tissue, and lesion growth. 2) Lesions partially or entirely surrounded by rims of increased tissue intensity on QSM-MRI (quantitative susceptibility mapping) sequences are considered as iron rim lesions, with iron-containing proinflammatory microglia/macrophages at the lesion edge. 3) In addition, 18 kDa translocator protein-positron emission tomography (TSPO-PET) imaging can be used to identify chronic active lesions based on TSPO-expression by activated innate immune cells, and their gathering at the edges of chronic active lesions. The TSPO-PET analysis of chronic active lesions can be semi-automated, and the specific radioligand binding at the chronic active lesion edge can be quantitated, which enhances the sensitivity of this method.

Despite existing preliminary data demonstrating increased QSM signal TSPO-positive lesions, it is yet to be demonstrated how these three imaging methods perform in identifying chronic active lesions when compared to each other at larger scale.

Eligibility Criteria:
Inclusion Criteria:

* Signing the informed consent form
* MS diagnosis in accordance with McDonald 2017 criteria
* Available longitudinal brain MR images (minimum 1 year)
* Simultaneous QSM MRI sequence and TSPO-PET
* Lesions with iron rim/s

Exclusion Criteria:

* Patients with other neurodegenerative disease than MS
* Patients with other autoimmune disease than MS
* Patients with other significant or malignant underlying disease of any other organ system
* Patients that are pregnant or breast-feeding
* Corticosteroid treatment within 4 weeks of imaging
* Patients with significant abnormal findings other than MS in the screening MRI
* Patients with claustrophobia, or a history of moderate to severe anxiety disorder or panic attacks (which could potentially lead to preterm termination of the imaging)
* Contraindication to PET scan investigations
* Exposure to experimental radiation in the past 12 months such that radiodosimetry limits would be exceeded by participating in this study
* Intolerance to previous PET scans; i.e. previous hypersensitivity reactions to any PET ligand or imaging agent or failure to participate in and comply with previous PET scans
Brain Training in Preterm Children at Risk for Inattention, Hyperactivity, and Executive Function Impairment

The purpose of this study is to determine if different forms of child-friendly, computer-based puzzles and games ("brain training") targeting executive function (EF) skills (i.e., thinking, problem-solving) result in improvements in EF in preschool children at risk for EF problems due to premature birth. The investigators hypothesize that children receiving active "brain training" will show greater improvements in EF and related skills immediately after treatment than children receiving passive "brain training." The investigators are also interested in whether any improvements in EF and related skills occur or are maintained at 3 and 6 months after completion of brain training.

Detailed description:

* Investigators will talk to you by telephone to determine if your child might be eligible for the study.
* Children complete two baseline testing sessions to evaluate executive function (EF) and related skills
* Parents complete a packet of information, including questionnaires about the child's behavior, EF, and functional skills.
* After completion of the baseline testing, we will inform you of eligibility for the "Brain Training" phase.
* During "Brain Training" children play online computer games for 25-30 minutes/day (can range from 15-45 minutes/day depending on your child's attention, training version received, number and length of breaks needed), 5 days a week, for 5-7 weeks to complete a total of 25 sessions.
* Children return for 3 more time points, immediately after the completion of "Brain Training" (1 session), and also at 3 months (1 session) and 6 months (2 sessions) after completion of "Brain Training."

Eligibility Criteria:
Inclusion Criteria:

* Age 4 or 5 years
* Born prematurely at \<33 weeks gestation
* Able to comprehend task instructions
* EF impairment on standardized questionnaire (t-score of 60 or greater) or EF battery (lower quartile)

Exclusion Criteria:

* Major neurosensory impairment (i.e., blind, deaf) or technology dependence (i.e., ventilator dependent) that interferes with testing
* Genetic syndrome
* Inability to comprehend task instructions
An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent

This observational, prospective, multicenter study will evaluate the efficacy and safety of MabThera/Rituxan in participants with active rheumatoid arthritis and an inadequate response or intolerance to one anti-TNF therapy. Participants who receive MabThera/Rituxan according to the current standard and in line with the summary of product characteristics at a dose of 1000 milligram (mg) intravenously on Days 1 and 15 will be followed for 20 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Participants with rheumatoid arthritis, eligible for treatment with MabThera/Rituxan in accordance with summary of product characteristics (SPC)
* Inadequate response to a single TNF inhibitor defined as change in disease activity score-28 erythrocyte sedimentation rate (DAS28-ESR) \<1.2 or DAS28-ESR \>3.5 at 5 months after first course of anti-TNF therapy
* Participants with a clinical and biological evaluation performed within 12 weeks prior to enrollment may be included

Exclusion Criteria:

* More than one previous anti-TNF therapies
* Any other biological therapy apart from the one anti-TNF therapy
* Hypersensitivity to rituximab or any of the excipients or to murine proteins
* Active severe infections
* Participants in a severely immunocompromised state
* Severe heart failure \[New York Heart Association (NYHA) Class IV\] or severe, uncontrolled cardiac disease
* Women of childbearing potential not willing to use contraception
* Pregnant or breastfeeding women
* Participation in another trial
Study of Efficacy and Safety, Tolerability and Pharmacokinetics of Telbivudine in Children and Adolescents With Compensated Chronic Hepatitis B Virus Infection

The purpose of the study was to assess the efficacy and safety of telbivudine at a dose of 20 mg/kg up to a maximum of 600 mg q.d. in compensated pediatric HBeAg-positive and negative CHB patients aged 2 to \<18 years with the indication of antiviral CHB treatment. This study was part of the commitments of the pediatric development plan for telbivudine in Europe and US.


Eligibility Criteria:
Key Inclusion Criteria:

* Clinical history compatible with compensated chronic hepatitis B
* Documented compensated chronic hepatitis B defined by the following:

  1. Positive serum HBsAg at screening and at least one other documentation of HBsAg positive at least 6 months prior to screening
  2. For HBeAg positive patients at screening, significant biologic and/or histologic signs of disease activity following EASL guidelines recommendations for CHB pediatric patients (serum HBV DNA level ≥ 5 log10 copies/mL (or 20 000 IU/mL) (COBAS Taqman®) at screening ; serum ALT ≥ 1.5×ULN and \< 10×ULN (pediatric ULN) for two times during the screening period or within 6 months prior to screening
  3. For HBeAg negative patients at screening, significant biologic and/or histologic signs of disease activity following EASL guidelines recommendations for CHB pediatric patients (serum HBV DNA level ≥ 4 log10 copies/mL (or 2 000 IU/mL) (COBAS Taqman®) at screening) ; serum ALT ≥ 1.0 ×ULN and \< 10×ULN (pediatric ULN) for two times during the screening period or within 12 months prior to screening)

Key Exclusion Criteria:

* Patients with acute or chronic infection of HCV, HDV, HIV, or with acute infection of HAV, HEV, CMV, EBV, or HSV.
* Patient has received treatment of interferon or any other immunomodulatory agents within the last 12 months prior to screening or any nucleoside or nucleotide drugs or other anti-CHB treatment (approved or investigational) at any time before screening
* Patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir, systemic corticosteroids, potentially hepatotoxic drugs or nephrotoxic drugs or chemotherapy
* Patient has one or more additional known primary or secondary causes of liver disease, other than CHB; has a decompensated liver disease ; is a Liver transplant recipient or organ or bone marrow transplant recipient.
* History of any other acute or chronic medical condition (that in the opinion of the investigator would make the patient unsuitable for inclusion into the study.
* Patient has a history of myopathy, myositis, persistent muscle weakness or persistent high serum CK levels (≥7×ULN), any muscular disease
* Patient receiving any drugs potentially associated with myopathy within 3 months prior to screening
* Any other clinical significant disease, condition or abnormality, unrelated to their HBV infection at screening, as assessed by the investigator
The Identification of Optimal Ultrasonografic Tecniques for Determining the Location , Size and the Surgical Methods of Intestinal Endometriotric Nodules

The identification of optimal ultrasonografic tecniques for determining the location , size and the surgical methods of intestinal endometriotric nodules

Nulliparous patients who had diagnosed with endometriosis ( endometrioma and/or deep endometriosis) without additional gynecological patology applying for routine gynecological check-up to Zeynep Kamil Training and Research Hospital, Gnecology and Obstetrics Clinic between March 2020 and March 2021 will be included in the study.Inclusion criteria in the study. Inclusion criterias are the presence of endometrioma and/or endometriosis diagnosed with ultrasonographic evaluation, nulliparity,no additional gynecological patology such as myoma uteri, polype, a history of pelvic inflammatuar disease, a history of cervical or uterine surgery, uterine anomalies as well as patients in the control group will be nulliparous and have no gynecological patology including endometrioma and/or endometriosis.All patients will be evaluated in the follicular phase.With the ultrasonographic examination, the uterine version ( anteversion or retroversion) will be evaluated, the length of the uterus (from fundus to cervix on the saggital axis), the anterior-posterior widest uterin length ( at the level of corpus uteri), the cervical length (the distance between the internal os and external os), the cervical anteroposterior length ath the internal os level and the servical canal length at the internal os level, uterocervical angle (the angle between the longitudinal axis of the cervix and the longitudinal axis of the uterine body will be measured three times consecutively , the avarage of the three measurements will be recoreded).with the 90 degree rotation of the probe at the transverse axis the width of the widest corpus level of uterus and the width of the cervix will be measured.Measurements will be made by the same clinician with the same ultrasound device. These measurements and the patients' age, BMI(body mass index), menarche cycle duration, dysmenorrhea, dyspareunia, family history in terms of endometriosis, endometrisosis stage will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with deep infiltrative endometriosis and intestinal involvement
* Treatment will be done surgically
* Patients should be nonvirgin

Exclusion Criteria:

* Patient has one or more extra -intestinal findings of deep infiltrative endometiosis
Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass

The purpose of this study is to compare two different dosing strategies of a drug named protamine.


Eligibility Criteria:
Inclusion Criteria:

* Patients greater than or equal to 18 years of age undergoing elective cardiac surgery with cardiopulmonary bypass.
* Patients must that have a calculated protamine dose greater than 250 mg based on standard 1:1 initial heparin to protamine dosing calculation.

Exclusion Criteria:

* Patients who are under 18 years of age or pregnant.
* Patients undergoing emergency surgery (ASA class E).
* Patients with known coagulation disorders.
* Patients requiring circulatory arrest or deep hypothermia.
* Patients who have not had the appropriate interruption in coumadin, direct oral anticoagulants or non-aspirin antiplatelet agents.
* Patients on pre-operative intravenous unfractionated heparin infusions.
* Patients ineligible for heparin administration due to known adverse reactions including allergy or heparin induced thrombocytopenia or known heparin resistance.
* Patients who are unable to provide informed consent in the form of a signature.
* History of adverse reaction to protamine.
* Have any condition that, in the opinion of the investigator, will compromise the well-being of the patient or the study, or prevent the patient from meeting or performing study requirements.
Effect of Concurrent Hookah and Alcohol Consumption on Smoking Topography and Toxicant Exposure

The purpose of the current study is to investigate in a prospective randomized cross-over trial, the impact of alcohol versus a placebo drink on smoking behavior and topography (duration and frequency of puffing), abuse liability, and toxicity. It is hypothesized that drinking alcohol before smoking will be associated with longer puffs and shorter duration between puffs and greater abuse liability and toxicity.


Eligibility Criteria:
Inclusion Criteria:

1. Report using hookah at least 1 time per month over the past 6 months
2. Are at least 21 years old
3. Speak and understand English
4. Do not currently suffer from lung disease including asthma, CF, or COPD
5. Do not currently suffer from heart disease
6. Are not currently pregnant or breast-feeding or have plans to become pregnant or begin breast-feeding at any point during the study
7. No current, regular use of \>5 cigarettes or other tobacco products (e.g., e-cig, cigar, etc.) per month.
8. No current marijuana use \> 5 times per month
9. No use of illicit drugs during the past 30 days
10. willing to provide informed consent and abstain from all tobacco, nicotine, and marijuana use for at least 12 hours and abstain from alcohol for at least 24 hours prior to each of the two sessions
11. Live within 25 miles of the study location.
12. Have a friend who is eligible and willing to participate.
13. Consume 2 or more or one or more drinks per episode for men and women, respectively
14. Drink alcohol at least one time per week
15. Not currently be seeking treatment for alcohol use
16. Able to answer at least two hookah-specific screening questions from the screener.

    -

Exclusion Criteria:

1. Hookah use less than one time per month over the past 6 months
2. Under the age of 21
3. Unwilling to abstain from alcohol for 24 hours and tobacco and nicotine products 12 hours prior to each study visit
4. Live more than 25 miles from the study location
5. Pregnant or breast feeding or plan to become pregnant or begin breast feeding at any point in the study -
Immediate Versus Delayed Intrauterine Device (IUD) Insertion Following First Trimester Suction Aspiration Procedures

The purpose of this multi-center clinical trial is to evaluate the safety and effectiveness of inserting an intrauterine device (IUD) immediately after a suction aspiration procedure compared to inserting the IUD 2-6 weeks after the procedure. This study will also evaluate how satisfied women are with the timing of their IUD placement. Subjects will be able to choose between the Paraguard IUD or the Mirena IUD.

The researchers hypothesize that:

1. the expulsion rates measured at 1, 3 and 6 months will be clinically equivalent with immediate insertion compared with delayed insertion,
2. satisfaction and tolerance of side effects will be higher with immediate IUD insertion compared with delayed insertion, and
3. overall IUD use/continuation rates measured at 1, 3 and 6 months will be higher with immediate IUD insertion compared with delayed insertion.


Eligibility Criteria:
Inclusion Criteria:

* Female
* 18 years or older
* Requesting suction aspiration for spontaneous or elective abortion
* Intrauterine pregnancy documented with ultrasound. For women with a gestational sac, the gestational age (EGA) must be ≥ 5 weeks 0 days but ≤ 12 weeks 0 days based on the following criteria:

  * If no embryonic pole present: EGA (days) = mean sac diameter (mm) + 30 (Mean sac diameter =\[length+width+depth\]/3)
  * If embryonic pole is present: EGA (days) determined by Hadlock scale for measured crown-rump length
* Desiring intrauterine contraception
* In general good health
* Willing and able to undergo informed consent
* Willing to comply with randomization and study follow-up schedule

Exclusion Criteria:

* Pelvic exam with evidence of active cervicitis or PID (eg. purulent discharge, adnexal mass, significant cervical or uterine tenderness)
* PID or sexually transmitted infection within the previous three months
* History of pelvic Actinomyces
* Unexplained vaginal bleeding
* Uterine anomaly (eg. bicornuate uterus)
* Leiomyomata that distort the uterine cavity
* Known or suspected complete molar pregnancy
* Current confirmed or possible ectopic pregnancy
* AIDS without treatment (individuals with HIV/AIDS who are clinically well are not excluded)
* Any prior surgical aspiration during this current pregnancy
* Use of osmotic dilators (eg. laminaria) or misoprostol for cervical preparation during the aspiration procedure
* Allergy to polyethylene
* Allergy to levonorgestrel (for levonorgestrel-containing IUS only)
* Allergy to copper (for copper T380A IUD only)
* Wilson's disease (for copper T380A IUD only)
* Current participation in another research study which would interfere with the conduct of this study
The Association Between Loneliness and Substance Use

The proposed study will determine if cognitive behavioral therapy will help improve loneliness in people who use opioids.

The proposed study will be the first to assess the cognitive, affective, and behavioral pathways by which loneliness impacts opioid use. Individuals with an opioid use disorder (OUD) reporting loneliness will be randomized to either a 6-session Cognitive- Behavioral Therapy for loneliness (CBT-L) or a 6-session education control condition, both delivered via telehealth. Telehealth delivery can be easily implemented and can increase reach and access to individuals not engaged in treatment. We will use an established brief CBT manual to address loneliness. We will assess loneliness, negative affect (i.e., depression and anxiety), and the quality and quantity of social interactions prior to, during, and after the intervention to evaluate the subsequent impact on opioid use trajectories. Participant will complete questionnaires pre-treatment, post-treatment, and at 1- and 2-months posttreatment.

Eligibility Criteria:
Inclusion Criteria:

* Must be ages 18+
* Understand English
* Have internet access
* Screen positive for an active OUD on the OUD Module of the Structured Clinical Interview for DSM-5 (Diagnostic \& Statistical Manual of Mental Disorder, 5th edition) Research Version (SCID-5-RV)
* Screen positive for loneliness by scoring at least a T-score \> 60 on the NIH Toolbox Loneliness Scale

Exclusion Criteria:

* Consistent with previously used telehealth-delivered assessments, we will exclude any participant with cognitive impairment as measured by the Blessed Orientation-Memory-Concentration Test (BOMC)
* Potential participants who are in the process of detoxifying as measured by the Subjective Opiate Withdrawal Scale will also be excluded
The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)

Observational cohort randomized controlled study to study the influence of correction of ID by intravenous injection of ferric carboxymaltose (Ferinject®) on quality of life indicators, functional status in a cohort of patients with HFpEF.

The prevalence of HFpEF among patients admitted to cardiology hospitals will be studied. The study will include patients with NYHA II-III who have signed an informed consent that meets the inclusion/exclusion criteria. The effectiveness of intravenous administration of iron carboxymaltose (Ferinject ® ) to correct iron deficiency and improve the clinical course of HFpEF will be evaluated. A group without iron deficiency will be recruited as a control group (n=30).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent to participate in the study;
* In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF);
* Left ventricular ejection fraction (LVEF) ≥50%; objective signs of structural and/or functional disorders of the heart consistent with the presence of LV diastolic dysfunction/increased LV filling pressure, including elevated levels of natriuretic peptide;
* Screening ferritin below 100 µg/L, or below 300 µg/L when transferrin saturation (TSAT) is below 20%;
* Screening haemoglobin (Hb) at the time of switching on ( 90-150 g/l).

Exclusion Criteria:

* Uncontrolled arterial hypertension;
* Аnemia not related to iron deficiency;
* Аnemia with a hemoglobin level of less than 90 g/l;
* Less than 1 year after acute myocardial infarction;
* Less than 1 year after acute cerebral circulation disorder;
* Less than 1 year after surgical interventions, including non-cardiac operations and myocardial revascularization (coronary bypass surgery, coronary artery stenting), operations for valvular pathology;
* Chronic alcoholism (including alcoholic heart disease), mental disorders;
* Severe hepatic (increased transaminase levels above the upper three limits of normal) and renal insufficiency (glomerular filtration rate less than 15 ml/min/1.73 m2);
* Known active infection, clinically significant bleeding, active malignancy;
* Severe autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc.);
* Severe bronchial asthma, COPD in the acute stage;
* Allergic reactions to medications in the anamnesis, eczema, atopic allergic reaction;
* Blood transfusions and taking erythropoiesis-stimulating drugs during the previous three months.