cyrilzakka/clinical-trials huggingface dataset:
Examining the Effectiveness of My Scrivener on Handwriting Legibility

The purpose of this study was to examine the changes in handwriting performance in elementary aged children who received handwriting training which included use of the My Scrivener stylus. Training on the My Scrivener stylus provided additional feedback to the children which is hypothesized to produce significant improvement.

Once parental consent was given, students met individually with the PI or a trained occupational therapy graduate student in a private space at the Boys and Girls Club of the Northern Shenandoah Valley for a pre-test evaluation session. The evaluation consisted of the following:

1. Evaluation Tool of Children's Handwriting (ETCH; Amundson, 1995). This is a criterion-referenced tool measuring a child's legibility and speed in grades one through six. This measure is able to evaluate both manuscript and cursive handwriting; however, only the manuscript portion will be used as that will be the focus of the club's training. The ETCH asks the child to write letters and words in lower-case and upper-case, write numerals, perform near point and far point copying, write to dictation, and compose original sentences. Total time for the evaluation is 15-20 minutes.
2. Brief Assessment of Motor Function (BAMF: Parks, Cintas, Chaffin, \& Gerber, 2007). This is a criterion referenced tool that can identify gross, fine, and oral motor performance in as little as 10 minutes. For this particular study, only the Fine Motor Scale of the BAMF will be used. Data from this tool will be used to categorize subjects for between group comparisons.
3. The Developmental Test of Visual Motor Integration (VMI: Beery, 1998). This gold-standard tool measures a child's visual motor performance by asking them to copy geometric shapes ranging from the very simple to the very complex. Data from this tool will be used to categorize subjects for between group comparisons.

Once all children were evaluated, twice weekly Handwriting Camp sessions were held. During these small group sessions lasting approximately 30 minutes each, 4 children at a time received instruction from the Handwriting Without Tears Curriculum from either the PI or trained OT graduate students and 20 minutes of supervised practice time on the My Scrivener equipment to reinforce the letter writing instruction for that day.

The Handwriting Camp sessions lasted for approximately 8 weeks.

At the conclusion of the camp, the pre-tests were re-administered as well as an open-ended question interview was conducted on how well the child enjoyed using the device.

Eligibility Criteria:
Inclusion Criteria:

* The subjects were any child enrolled in the summer program at the Boys and Girls Club of the Northern Shenandoah Valley entering grades 1 to 6 in Fall 2008 whose parents give consent.

Exclusion Criteria:

* None
Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B

To compare the efficacy and renal safety of tenofovir alafenamide (TAF) versus entecavir (ETV) in the chronic hepatitis B patients.

With high antiviral potency and low drug resistance rate, both ETV and tenofovir disoproxil fumarate (TDF) have been recommended as the first-line antiviral therapy for chronic hepatitis B (CHB). However, risk of renal dysfunction remains an issue in TDF long-term therapy. Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir and is formulated to deliver the active metabolite to target cells more efficiently than TDF at lower doses, thereby reducing systemic exposure to tenofovir. Importantly, TAF had improved renal safety as compared to TDF. TAF has been approved for treating CHB since 2017; however, it is still unknown whether the efficacy and renal safety of TAF is compatible to those of ETV. The investigators aim to conduct an open label, randomized controlled trial comparing TAF with ETV for assessing their efficacy and renal safety in CHB patients. The eligible CHB patients are randomly assigned (1:1) to receive TAF or ETV. After allocation to TAF group or ETV group, study subjects will receive therapy for 3 years (144 weeks).

Eligibility Criteria:
Inclusion Criteria:

1. Patients more than 20 years old
2. Chronic hepatitis B patients
3. Patients who were indicated for hepatitis B virus antiviral therapy

Exclusion Criteria:

1. Decompensated liver disease (Child-Pugh B \&C)
2. End stage renal disease (eGRF \< 15 ml/min/1.73m2)
3. Prior use of nucleot(s)ide analogues for chronic hepatitis B
4. Prior use of interferon for chronic hepatitis B within six months
5. Known history of human immunodeficiency virus or hepatitis C virus co-infection
6. Concurrent other uncontrolled malignancy
7. Women in pregnancy or lactation
8. Cannot conform to the study protocol of this study
Shared Decision Making in a General Hospital

A pilot cross-sectional study will investigate the differential effect of the type of disorder (surgical versus non-surgical) on the scores of the 9-item shared decision making questionnaire.

During a pilot cross-sectional study, the 9- Item Shared Decision Making Questionnaire (9SDMQ) will be administered in two groups of participants, one (N=60) suffering from surgical diseases and one (N=60) from non-surgical medical diseases. Patients hospitalized in four acute wards (2 surgical and 2 non-surgical wards) or visiting the relevant outpatient departments of the Triassion General Hospital of Elefsina, Greece will be recruited. The primary outcome will be the difference on the 9SDMQ scores (transformed in a 1-100% scale) in patients suffering from surgical versus non-surgical disorders. Secondary outcome measures will include the effect of patients' demographic and clinical variables, of physicians' demographic variables and of the score on the Montreal Cognitive Assessment on the 9SDMQ scores. Additionally the relationship of patients' satisfaction on the 9SDMQ scores will also be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalization in the Thriassion General Hospital of Elefsina
* Ability to give informed consent

Exclusion Criteria:

* Inability to complete the neuropsychological assessment
* Mental retardation
Investigation of Clot in Ischemic Stroke and Hematoma Evacuation

The aim of the study is to collect and analyze specimen from ischemic stroke patients undergoing thrombectomy procedures and from patients undergoing minimally invasive surgery for intracranial hematoma evacuation.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 Years of Age
* Frontline treatment with: Penumbra System for ischemic stroke patients eligible for mechanical thrombectomy or Artemis Neuro Evacuation device for intracranial hematoma evacuation in patients eligible for minimally invasive surgery (MIS)
* Extracted thrombus/embolus
* Informed consent is obtained from either the patient or legally authorized representative (LAR)

Exclusion Criteria:

* Pregnancy or positive pregnancy test according to site routine practice (only required for women of child bearing potential; serum or urine acceptable)
* Currently participating in an investigational drug or device clinical trial that may confound the ability to capture clot and/or influence clot composition. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible
A Gene Hunting Study for Familial Papillary Thyroid Cancer

The aim of this project is to identify genetic risk factors associated with familial papillary thyroid carcinoma (PTC). Papillary thyroid cancer is a type of cancer that shows high heritability. However, the specific genetic factors that cause an increased risk have been elusive.

The aim of this project is to identify genetic risk factors associated with familial papillary thyroid carcinoma (PTC). This can be accomplished in several ways, including loss of heterozygosity studies as well as comparative gene expression analysis. When possible, linkage analysis on families with multiple individuals affected with PTC may also help identify the putative gene(s).

Study participants will be asked to:

1. Complete family history and medical history questionnaires
2. Sign a medical record release so that thyroid cancer pathology reports can be obtained
3. Supply a blood or saliva sample for genetic studies
4. Provide study related information to family members who are needed for family studies

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of PTC and a family history of PTC in 3 or more living relatives
* Affected and unaffected family members of the proband\*

  * For familial cases (families with 4 or more cases of PTC), participation will be offered to all living family members with PTC or benign thyroid disease as well as selected unaffected first and second degree relatives. Participation may also be offered to spouses when needed for analyzing parent/offspring samples.

Exclusion Criteria:

* Known germline predisposition (ex: pathogenic PTEN variant)
* Non-English speaking
Effect of Adjunctive Intracoronary Streptokinase on Late Term Left Ventricular Infarct Size and Volumes in Patients With Acute Myocardial Infarction

The investigators hypothesized that complementary intracoronary streptokinase administration to primary percutaneous intervention in patients with acute myocardial infarction may provide limitation infarct size and improvement in left ventricular volumes and function in acute and late phases (6 months).


Eligibility Criteria:
Inclusion Criteria:

* Continuous chest pain that lasted \> 30 minutes within the preceding 12 hours
* ST-segment elevation of at least 1 mm in 2 contiguous leads on the ECG
* Infarct related artery (IRA) occlusion (TIMI grade 0) at the angiography

Exclusion Criteria:

* Contraindications to streptokinase, tirofiban, aspirin, clopidogrel, or heparin
* Culprit lesion in saphenous vein graft
* TIMI grade II-III flow in IRA
* Additional epicardial stenosis in the IRA distal to stented segment (significant or insignificant)
* Presence of left bundle branch block
* History of prior MI
Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma: Txagorapid Study

The objective of this pilot study is therefore to assess the safety of Truxima ultrafast infusion within 30 minutes in patients with non-Hodgkin's lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have tolerated the maximum rate of intravenous administration of rituximab (400 mg/h) in the first or second infusion.
* The last rituximab infusion must have occurred within the last 3 months.
* All patients receiving rituximab can be included, regardless of whether they receive rituximab as monotherapy or in combination with chemotherapy and regardless of the line in which they are receiving it.
* Patients will be included in both induction and maintenance treatment.
* All patients must sign the informed consent form.

Exclusion Criteria:

* Patients with initial absolute lymphocyte count \>10x10\^3 cells/µL.
* Patients who have presented hypersensitivity and severe adverse effects (grade II or higher) in the first or second infusion.
* Severe heart failure (NYHA class III-IV) or uncontrolled severe cardiac disease.
* Respiratory failure, severe uncontrolled COPD/asthma.
* Patients allergic to premedication: acetaminophen or polaramine.
* Severe active infection.
* Pregnant patients.
* Refusal to participate.
Impact of P-gp, MRP2, ENT-1 and CNT3 on the Blood Concentration / Intra-PBMC Concentration of Tacrolimus

Prospective and monocentric pharmacokinetic study

Membrane transporters supporting tacrolimus at the lymphocyte level may play a role in the variability of the relationship between tacrolimus blood concentration and intracellular concentration, or may be the main explanatory factors. Nevertheless, most of the studies carried out on the subject, have been by genetic approach, neglecting in fact the membrane expression of these transporters, which could testify more to the real effect on the transport of tacrolimus. A better understanding of the cellular transport mechanisms of tacrolimus in the T lymphocyte could thus make it possible to identify sub-populations of patients under-exposed at the intra-lymphocyte level, despite satisfactory systemic exposure.

Eligibility Criteria:
Inclusion Criteria:

* Adult of 18 or over;
* fully and honestly informed, and not having reported his non-opposition to the use of his samples for research;
* Affiliated to a social security scheme;
* Hepatic and / or renal transplant stable between two and twenty-four months after transplantation, treated with tacrolimus;
* Without modification of immunosuppressive treatment or treatment likely to modify their pharmacokinetics (imidazoles, macrolides ...) during the last two weeks;
* Each patient can only be included once.

Exclusion Criteria:

* Participation in another protocol whose procedures are incompatible with the realization of the study;
* Pregnant woman ;
* Major person subject to legal protection (safeguard of justice, guardianship, tutorship);
* Person deprived of liberty;
* Opposition to the use of clinical data and remnants of samples taken from care for research purposes.
Continuous Spinal Anesthesia With Hypobaric Bupivacaine to Preserve Hemodynamics in Elderly

The study evaluates the potential beneficial effects on hemodynamics when hypobaric bupivacaine is used instead of isobaric bupivacaine in continuous spinal anesthesia for surgical repair of hip fracture in elderly patients. Half of the patients will receive hypobaric bupivacaine and the over half will reveive isobaric bupivacaine and hemodynamic data will be compared.

Anesthesia for surgical repair of hip fracture is still controversial. Large retrospective studies and systematic reviews failed to demonstrate the superiority of either general or regional anesthesia. However, continuous spinal anesthesia has been shown to preserve hemodynamics better than general and single shoot spinal anesthesia. However, hypotension still occurs with continuous spinal anesthesia.

Unilateral spinal anesthesia may be achieved by hypobaric bupivacaine when patients are in the lateral position. Unilateral spinal anesthesia is more effective in preserving hemodynamics by limiting the spread of the sympathetic blockade to the operated side.

Our goal is to show that the use of hypobaric rather than isobaric bupivacaine in continuous spinal anesthesia for surgical repair of hip fracture reduces incidence of hypotension.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than 65 years and scheduled for a surgical repair of a hip fracture.

Exclusion Criteria:

* contraindication to spinal anesthesia or peripheral nerve blocks including hemostasis anomalies, local infection, allergic reaction to local anesthetics.
* dementia.
* consent refusal.
Mediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease a Randomized, Controlled, Clinical Trial

This is a 10-week randomized, controlled study to investigate the effect of a Mediterranean diet intervention on gastrointestinal function in Parkinson's disease. After a 2-week run-in period, participants will be instructed to receive standard of care for constipation or receive standard of care + follow a Mediterranean diet for 8 weeks and answer daily and weekly questionnaires. Nutritional and neurological evaluations and stool samples will be collected at 0, 4 and 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed Parkinson's disease aged 40-85 years
* Drug naïve or on stable dosage of Parkinson's medications with no plans to change for the duration of the study protocol
* Hoehn \& Yahr stage =\<2.5 in the clinical "ON" state
* Constipation syndrome scores \>=2.0 based on the GSRS
* Consume \<20 grams of fiber daily based on the Block Fruit/Vegetable/Fiber screener
* Able to complete informed consent in English
* Willing to maintain habitual diet through the pre-baseline period.
* Willing to make dietary changes to follow a Mediterranean diet and/or receive standard of care for constipation during the intervention period.
* Willing to complete daily and weekly questionnaires and 12 dietary recalls over approximately 10 weeks.
* Able to provide stool samples during the study collection periods.
* Willing to avoid strenuous exercise and alcohol such as beer, wine, and cocktails 24 hours prior to each of the 3 study visits.
* Able to fast (no food or drink, except water, or decaf tea) at least 12 hours before each study visit
* Willing to discontinue taking prebiotic, herbal, or high-dose vitamin or mineral supplements that may impact inflammation during the pre-baseline period and throughout the study protocol.

Exclusion Criteria:

* Atypical or secondary Parkinsonism
* Underweight (BMI \<18.5)
* History of deep brain stimulation (DBS) surgery
* Regular use of enemas or suppositories to alleviate constipation (e.g., \>1 time per week)
* Use of another investigational product within 3 months of the screening visit
* Antibiotic or probiotic supplement use within 2 months from the day of stool collection
* Currently being treated for a physician-diagnosed GI disease or condition other than constipation, irritable bowel disease, gastroparesis, reflux or diverticular disease
Trigeminal Brainstem Mapping 2: Higher Cortical Strucureas As Well As Subnuclei of the Spinal Trigeminal Nucleus

In previous studies clustering of the three branches of the trigeminal nerve in brainstem were shown, cerebellum and periaqueductal gray. To further evaluate higher cortical structures, which were not covered by our previous field of view (FOV) and to further investigate the identified 'subnuclei' of the spinal trigeminal nucleus, here the aim is to scan the whole brain as well as the brainstem and the upper spinal cord during trigeminal nociceptive as well as non-nociceptive electrical stimulation of all three branches of the trigeminal nerve (and the arm as a somatic control site) during acquisition of BOLD-fMRI in humans.

Preprocessing and processing of the MR data will follow our previous publications (Mehnert et al 2023, Mehnert et al 2024)

Eligibility Criteria:
Inclusion Criteria:

* healthy
* suitable fo MRI

Exclusion Criteria:

* headache disease
* psychological disorder
* pregnancy
* all exclusion criteria necessary for imaging in a 3 T MRI scanner
Erector Spinae Plane Block for Cervical Spine Surgery

The study aims to assess the interfacial plane blocks' effect on pain level, course of postoperative rehabilitation, and anti-inflammatory analgesic effect.

This study evaluates the analgesic efficacy in adults of bilevel, bilateral erector spinae plane (ESP) blocks after posterior cervical spinal fusion surgery by assessing postoperative pain scores and opiate requirements as the primary outcome measures. We aim to investigate how ESP blocks, performed under ultrasound guidance at the two vertebral levels, contribute to postoperative pain control. This will be determined by measuring numerical rating pain scores repeatedly following surgery and opiate consumption until the patient is discharged from the hospital. These primary outcome measures will be compared between a treatment group of participants receiving ESP blocks and a control group receiving a sham block. Our primary hypothesis is that ESP blocks significantly reduce postoperative pain and opiate requirements.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing primary posterior cervical decompression and stabilization with instrumentation involving multi-levels in the cervical region,
* aged \>18 years and \<100 years
* ASA physical status 1, 2 or 3.

Exclusion Criteria:

* refuse to participate,
* history of opioid abuse,
* infection of the puncture site,
* aged \<18 years and \>100 years
* ASA 4 and 5
HoFH, the International Clinical Collaborators Registry

Homozygous familial hypercholesterolemia (HoFH), a rare inherited disorder caused by bi-allelic mutations in the LDL Receptor pathway, is characterized by extremely elevated levels of low-density lipoprotein cholesterol (LDL-C) from birth and premature atherosclerotic cardiovascular disease (ASCVD). Our current knowledge about HoFH is disjointed and largely stems from relatively small case series and expert opinion. HICC (Homozygous FH International Clinical Collaborators) is a global consortium of clinicians who are contributing de-identified data of patients diagnosed with HoFH with the goal to advance our understanding of this rare disease.

The HICC registry is an observational, multicenter, international registry collecting de-identified clinical and genetic information from patients with homozygous Familial Hypercholesterolemia (HoFH) worldwide.

Patients are eligible to be enrolled in the registry based on the diagnosis of HoFH by the treating clinician, irrespective of how the diagnosis was made. To generate up-to-date data reflecting current rather than historic practice, patients who died or were lost to follow-up prior to 2010 are excluded.

Anonymized data on demographics, type of HoFH diagnosis (clinical and/or based on the results of a genetic test), genetic results, (cardiovascular) medical history, relevant family history, physical examination, laboratory measurements, lipid lowering treatment and cardiovascular imaging are collected for 3 different time points: at diagnosis, at enrolment and at time of best lipid profile (if this is different from time at enrolment). Data are collected using pre-definite electronic case report forms to ensure uniformity of data collected. Primary analysis will be cross-sectional (e.g. based on country of residence, age, etc)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of homozygous familial hypercholesterolemia (HoFH) clinically of genetically determined

Exclusion Criteria:

* No diagnosis of HoFH
Detecting Infections Rapidly and Easily for Candidemia Trial - Part 2 (direcT2 Study)

The purpose of this study is to validate clinical performance (i.e. estimated sensitivity and specificity) of the T2 Candida test on the T2 DX Instrument compared to blood culture results and/or known Candida positive status of prospectively collected and contrived (i.e. Candida-spiked) clinical specimens.

This study will prospectively collect and analyze whole blood T2 clinical research specimens and concomitant blood culture specimens from patients who have been referred for a blood culture per routine standard of care. Additional analysis of blinded, contrived (i.e. Candida spiked and un-spiked whole blood) specimens will be completed by study sites to augment the analysis of Candida positive blood specimens prospectively obtained from the study population.

The clinical performance of the T2 Candida test on the T2 Dx Instrument will be evaluated by calculating the:

* Estimated clinical specificity of the T2Candida test results compared to Candida negative blood culture results in prospectively collected specimens, and the
* Estimated sensitivity of the T2 Candida test results compared to the known Candida positive status or Candida positive blood culture status of contrived specimens that have been spiked at clinically relevant concentrations of the target organisms and, where detected, to Candida positive blood culture results in prospectively collected clinical specimens.

Eligibility Criteria:
Inclusion Criteria:

1. Subject or subject's authorized representative must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them.
2. Subject has had a blood culture ordered, per routine standard of care.
3. Subject is between 18-95 years of age

Exclusion Criteria:

1. Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study.
2. Subject has had previous specimens tested by the T2Candida assay with valid results.
3. Subject has had an anti-fungal drug administered through the same port or central line as is used to collect the clinical research specimens.
4. Treatment of subject with any novel drug compound within 30 days prior to the collection of T2 blood specimens.
5. T2 clinical specimen, Tube A contains \<3ml of blood.