cyrilzakka/clinical-trials huggingface dataset:
The Effects of Methylphenidate and Non-invasive Brain Stimulation on Inhibitory Control in Children With ADHD

The aim of this study is comparing the effects of non-pharmacological intervention (transcranial Direct Current Stimulation, tDCS) with those of drug (methylphenidate, MPH) administration in children and adolescents with ADHD.

The investigators hypothesized that tDCS would improve inhibitory control and visuo-spatial working memory as well as MPH.

A sham controlled within-subjects study design will be conducted. Clinical eligibility screening will be completed at baseline. All participants will undergo an extensive neuropsychiatric evaluation in which developmental neuropsychiatrists and psychologists will evaluate the cognitive and the adaptive level, the severity of ADHD symptoms, and the presence of comorbid psychiatric disorders. After completing baseline assessment (T0), participants will be exposure to 3 conditions with an intersession-interval of 24h (T1, T2, T3): A) a single administration of 1 milliampere (mA) anodal tDCS session over the dorsolateral prefrontal cortex (DLPFC); B) a single administration of 1 mA sham tDCS session over the DLPFC; C) a single administration of immediate release MPH (Ritalin®), in accordance with the National Institute for Clinical Excellence (NICE) guidelines for ADHD (NICE, 2000). The order of the conditions will be counterbalanced across participants. After recruitment, the participants will be assigned to one of the 6 possible combinations of conditions (ABC, ACB, BAC, BCA, CBA, or CAB). The assignment will be according to a randomization order generated by a computer. The randomization information will be maintained by an independent researcher until data collection is completed. Participants will be tested on inhibitory control, by the Stop Signal Task (SST) and on working memory, by the N-Back Task, at baseline (T0), during tDCS administration (after 10 minutes of anodal and sham conditions) and after 1 hour of MPH administration. To verify that carry-over effects will not occur, the SST and the N-Back Task will be performed before each session (T1, T2, T3) and results will be compared with those obtained at baseline (T0). If the participant will not return to baseline level, another evaluation will be administered at least after two hours and, again, until participant's performance will return to baseline. Participants and parents will be blinded to tDCS conditions allocation. The tDCS will be carried out with a BrainStim stimulator.

Eligibility Criteria:
Criteria: Inclusion Criteria:

* Patients must receive a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) oriented diagnosis of ADHD and need drug treatment for the severity of symptoms;
* Intelligent Quotient (IQ) \> 85;

Exclusion Criteria:

* Presence of Autism Spectrum Disorders;
* Presence of Mood Disorders;
* Previous/current diagnosis of neurological conditions (i.e. epilepsy, neurodegenerative diseases);
* Presence of Genetic Syndromes;
* Presence of basal medical conditions (i.e. heart, kidney or liver diseases) which may exclude the possibility to administer MPH.
Kinesiological Taping and Aerobic Exercise in Women With Primary Dysmenorrhea:

Dysmenorrhea is defined as the pain and discomfort of women during the menstrual period. Kinesiological taping (KT) and aerobic exercise (AE) are effective methods for dysmenorrhea. The purpose of this study is to investigate the effects of KT and AE on pain, attitude, depression, and quality of life in women with dysmenorrhoea. Forty-five women with dysmenorrhea wıll randomly be divided into three groups as KT group (n=15), AE group (n=15) and control group (n=15). In KT Group, 6 sessions of KT will be applied, starting on the 14th day of the menstrual cycle and 2 times per week for 3 weeks until the end of the cycle. In the AE group, walking and climbing stairs will be given during the menstrual cycle, 3 days a week, 45 minutes. No application will be applied to the control group. All groups will be evaluated with Beck Depression Scale (BDS), Mcgill Pain Questionnaire (MPQ), Menstrual Attitude Scale (MAS), and Short Form- 36 (SF-36) before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Being in the age range of 15-30
* Not being married
* Women with abdominal pain during menstruation 5 and above according to the Visual Analogue Scale.
* Women whose menstrual cycle has started and those whose cycle continues.

Exclusion Criteria:

* Endometriosis and adenomyosis
* Myoma
* Endometrial polyp
* Previous pelvic infections
* Intrauterine device use
* Venous congestion in the internal genital organs
Safety and Efficacy of HMI-203 in ERT-Treated Adults With MPS II

Phase 1, open-label, sequential ascending dose-escalation study. Designed to evaluate the safety and efficacy of a single IV infusion of investigational gene therapy HMI-203. Males, ages 18 to 45 years inclusive, with MPS II (Hunter syndrome) currently receiving idursulfase ERT (or the equivalent) are eligible to participate. Participants will be followed for safety and efficacy for 5 years.

This Phase 1 study will evaluate the safety and efficacy of HMI-203 gene therapy in adult male participants with MPS II currently being treated with standard-of-care idursulfase ERT or equivalent. Participants will receive a single dose of HMI-203 administered intravenously. There are 3 planned dose cohorts which will consist of 3 participants each.

Entry into the first dose cohort will be separated by a 60-day dosing interval between each participant to allow the Homology Medicines medical monitor to review safety and efficacy data prior to the second and third participants being enrolled. Enrollment of subsequent participants, in cohorts 2 and 3, will be separated by a 21-day dosing interval between each participant for review of safety and efficacy data.

Escalation to the next dose cohort will occur after 21 days of safety, efficacy, and biomarker data have been reviewed by the Homology Medicines independent DMC.

This entire study is comprised of 5 years, with the most frequent follow up visits occurring in the first year.

Eligibility Criteria:
Key Inclusion Criteria:

* Adult males 18-45 years of age at the time of informed consent
* Has capacity and is able to understand the purpose and risks of the study and is willing, able and committed to comply with all study procedures for the duration of the trial (a total of 5 years after gene therapy administration)
* Diagnosis of MPS II based on historically decreased I2S enzyme activity and elevated urine GAGs and/or presence of hemizygous IDS pathogenic variant
* Kaufman Brief Intelligence Test-Second Edition (KBIT2) score ≥ 80
* Compliance with regular treatments of ERT for MPS II for at least 12 months prior to enrollment
* Clinically stable relative to urinary GAG levels, ambulation, and cardiopulmonary status for 12 months preceding enrollment

Key Exclusion Criteria:

* Multiple sulfatase disorder as determined by abnormal activity of another lysosomal sulfatase
* Unresponsive and/or intolerant to idursulfase treatment
* History of BMT, stem cell transplant, or gene therapy
* Presence of anti-capsid neutralizing antibodies
* ALT or AST \> ULN; Total or Direct bilirubin \> ULN
* International normalized ratio (INR) \>1.2 ULN
* Hematology values below the normal range
* Hemoglobin A1c ≥ 6.5% or fasting glucose ≥126 mg/dL
* Contraindication to corticosteroid or tacrolimus use
* Any condition that would not allow the potential participant to complete follow-up examinations during the course of the study or, in the opinion of the investigator, makes the potential participant unsuitable for the study
Tenotomy or Tenodesis of Long Head Biceps in Arthroscopic Rotator Cuff Repair

During arthroscopic rotator cuff (infraspinatus/supraspinatus) repair, biceps tendon lesions are frequently encountered. However, the most optimal treatment of the diseased long head of the biceps (LHB) tendon during rotator cuff repair remains a topic of debate: tenotomy or tenodesis. The hypothesis is that there is no difference in functional outcome between LHB tenotomy and LHB tenodesis when performed in adjunct to arthroscopic rotator cuff repair.

Patients older than 50 years with a supraspinatus and/or infraspinatus tendon rupture sized smaller than 3cm, who are encountered with LHB pathology, will be randomized to either LHB tenotomy or LHB tenodesis. Clinical and self-reported data will be collected pre-operatively, and 6 weeks, 3 months, and 1 year after surgery.

Primary outcome is overall shoulder function evaluated with the Constant score. As additional measures of shoulder function, the Dutch Oxford Shoulder Test and the Disabilities of the Arm Shoulder and Hand questionnaire will be assessed. Other evaluations include cosmetic appearance evaluated by the ''Popeye'' deformity, arm cramping pain, elbow flexion strength, MRI evaluation, quality of life, and cost of surgery. To detect non-inferiority with a one-sided, two-sample t-test with a 80% power and a significance level (alpha) of 0.025, the required sample size is 98 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 50 years
* Degenerative rotator cuff lesion of supraspinatus/infraspinatus tendon, smaller than three centimeter.
* Patients need to be able to read and write in Dutch or English language in order to complete the questionnaires, and sign informed consent.

Exclusion Criteria:

* Acute, traumatic or partial thickness rotator cuff rupture, or in case a full thickness tear is larger than 3 cm measured using an arthroscopic ruler.
* Accompanying subscapularis tendon lesion
* Hour-glass deformation bicepstendon origin or in case of accompanying subscapularis tendon rupture.
* Osteoarthritis of the glenohumeral joint
* Acromion to humeral head distance measuring 6mm or smaller.
* Prior surgery to the involved shoulder
* Dementia or inability to complete questionnaires and assessments
Compined SONOPULMONARY Infection Score and APACHE Score in RICU Patients With VAP

Aim of the study :

1. Efficacy of Sono pulmonary infection score in combination with APACHE score in early diagnosis of VAP
2. Assessment of prediction role of combined SIPS SCORE and APACHE SCORE of outcome of VAP patient in RICU
3. Assessments of role of ultrasonography in early diagnosis and follow up of VAP

Pneumonia is a bacterial, viral or fungal infection of the lungs, which causes the alveoli of the lungs to fill up with microorganisms, fluid and inflammatory cells, preventing the lungs from functioning effectively\[1\]. Ventilator associated pneumonia (VAP) is the most common and a leading cause of death in intensive care unit patient. Ventilator associated pneumonia is caused by prolonged duration of mechanical ventilation ,and prolonged hospital stay, which increase hospital costs, possibly increase mortality rate, and increase antibiotic use in ICU patients , early identification of VAP is an important clinical goal to improve patient outcomes \[2\]. In recent year several scoring systems have been developed to evaluate the severity of illness and to predict the outcome, especially the mortality rate of intensive care unit patient, such as the Clinical pulmonary infection score (CPIS) or modified (CPIS)The Clinical Pulmonary Infection Score (CPIS) was developed to serves a tool to facilitate the diagnosis of ventilator-associated pneumonia (VAP),The CPIS is calculated on the basis of points assigned for various signs and symptoms of pneumonia (eg, fever and extent of oxygenation mpairment) ,a CPIS has an average between 0-12\>6 some studies suggest that CPIS \>6 may correlate with VAP Sonar is easy bedside test to diagnose pleural effusion, pneumonia pneumothorax , so recently lung ultrasonography (LUS) incorporated in evaluation and diagnosis of VAP in a new score called sono pulmonary infection score (SPIS) . The (SPIS), where is incorporated LUS finding instead of CXR finding of CPIS is assigned two points for ≥ one area of dynamic air bronchogram. One point was given for ≥ two sub-pleural consolidation or lobar consolidation areas or ≥ one sub-pleural, and ≥one lobar consolidationRecently (combination of SPIS with APACHE score in assessment of VAP is under research ).

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 yrs
2. Mechanically ventilated patients after first 48 hours of admission in RICU

Exclusion Criteria:

1. Age \<18 yrs
2. Patients already diagnosed pneumonia
3. Malignancy
4. patient refused participation in the study.
Natural History of Patients With PH3 and a History of Stone Events

This is a natural history study of adults, adolescents, and children (starting at birth) with genetically confirmed primary hyperoxaluria type 3 (PH3) who have a history of stone events during the last 3 years and/or the presence of pre existing stones detected by renal ultrasound at screening.

The relationship between the level of Uox and the incidence of kidney stones and/or nephrocalcinosis in patients with PH3 has not been established. The goal of this study is to record 24-hour Uox levels and the incidence of new stone formation and/or the degree of nephrocalcinosis in patients with PH3 over time.

Potential participants are screened over an up-to-7 week period according to the eligibility criteria and will then be followed every 6 months over an up-to-2-year period to determine the annualized new stone formation rate (number of new stones being formed per year) and the change in the degree of nephrocalcinosis (if applicable).

New stone formation is defined as occurrence of any of the following:

* Spontaneous stone passage in the absence of pre-existing stones
* Stone passage occurring without change in the number of pre-existing stones detected by renal ultrasound
* Appearance of new stones on renal ultrasound or 100% or more growth of a pre-existing stone (estimated area)
* Surgical removal of newly formed stones Note: Spontaneous passage or surgical removal of pre-existing stones does not meet the criteria for new stone formation.

This is a non-interventional study that will last up to 2 years.

Eligibility Criteria:
Key inclusion criteria

* Genetically confirmed PH3
* For participants at least 2 years of age, history of stone events (defined as presence of calcifications in the urinary tract and/or kidney, their relative location, and the number and size of stones) during the last 3 years and/or presence of pre-existing stones detected by renal ultrasound at Screening
* Uox ≥ 0.7 mmol/24 hours (adjusted per 1.73 m2 BSA in participants \< 18 years of age) OR if not able to collect 24-hour urine, average spot Uox to creatinine ratio at Screening above the 95th percentile for age:

  * \> 220 mmol/mol in participants \< 6 months
  * \> 170 mmol/mol in participants from 6 months to \< 12 months
  * \> 130 mmol/mol in participants 12 months to \< 2 years
  * \> 100 mmol/mol in participants from 2 to \< 3 years and
  * \> 80 mmol/mol in participants from 3 to 5 years
* eGFR at Screening ≥ 30 mL/min or for infants aged less than 12 months, serum creatinine below the 97th percentile of a healthy population

Key Exclusion Criteria:

* Prior or planned liver transplant within study period
* Currently receiving dialysis or anticipating dialysis during study period
* Unwillingness to comply with study procedures
Clinical Study of Divozilimab in Patients With Systemic Scleroderma

The study is a randomized, double-blind, placebo-controlled clinical study of the efficacy and safety of divozilimab in patients with systemic scleroderma.The study will enroll adult patients of both sexes diagnosed with active systemic scleroderma according to the ACR/EULAR 2013 criteria with a modified Rodnan skin score (mRSS) of 10 to 20. In patients having signs of ILD, the Forced Vital Capacity (FVC) should be at least 40 % of the due value. Subjects will be randomized to divozilimab or placebo group.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of "systemic scleroderma" in accordance with the ACR/EULAR 2013 classification.
* Modified Rodnan skin score (mRSS) from 10 to 20.
* FVC ≥ 40 % of the due value.

Exclusion Criteria:

* Induced scleroderma.
* Silicone implants/protheses.
* Digital ulcers with signs of infection or indications for any amputation.
* Blood biochemistry or hematological abnormalities at screening.
* FEV1/FVC \< 0.7 and FEV1\< 50 % at screening.
* History of threatment with anti-CD20 monoclonal antibodies.
Immune Response to COVID-19 Vaccine in Recipients of Living Donor Liver Transplantation

A prospective cohort study to evaluate the response to COVID-19 vaccine in liver transplantation patients.

fifty living donor liver transplantation recipients during maintenance immunosuppression phase will be vaccinated against COVID-19 followed by assessment of immune response to the vaccine and further investigation of correlation of immune response to genetic polymorphisms of HLA DRB1(rs2647087) gene and IL-18 (rs187238 and rs917997) gene.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18
* At least 3 month post transplantation

Exclusion Criteria:

* pediatric recipients
* Active covid infection at the time of the study
* Pregnancy
* Allergy to any ingredients included in the vaccine
* Lactation in first six month of delivery
* Active Acute cellular rejection proven by liver biopsy
* Acute Febrile state with either leucopenia or leucocytosis
* High dose of corticosteroid at study timing (pulse methyl prednisolone)
Comparing Acute Aerobic and Resistance Exercise

The purpose of this study is to determine the effect of age and fitness level on the physiological response to an acute bout of resistance or aerobic exercise.

Young and middle-aged to older adults who are physically active or not physically active will participate in two moderate to vigorous intensity exercise bouts: aerobic exercise and resistance training exercise. Blood will be collected to assess immune function and metabolism.

Eligibility Criteria:
Inclusion Criteria:

* "Young" Adults: ages 18-30
* "Older" Adults: ages 55-75 and if a female postmenopausal
* Participants classified as "trained" must participate in at least 30 minutes of moderate to vigorous intensity cardiovascular activity at least 3 days per week and engage in resistance training for all of the major muscle groups approximately 2 days / week. They must have upheld this activity for the past 3 months
* Participants classified as "untrained" must be participating in less than 30 minutes of moderate to vigorous intensity cardiovascular activity and less than 2 days of resistance training per week for at least the last 3 months.

Exclusion Criteria:

* Have any contraindications to moderate to vigorous exercise
* Range of motion restrictions that would prevent them from participating in aerobic or resistance training with proper form (they must be ambulatory)
* aking medications (prescription or over the counter) known to influence immune function, including daily NSAID's, beta blockers, statins, bisphosphonates, or steroids.
* Have known cardiovascular, respiratory, metabolic, or renal disease, with the exception of controlled hypertension (as defined by resting BP below 140/90) and/or controlled asthma (self-reported).
* Be pregnant
* Be unable to complete all visits (i.e. must not be planning to leave the Houston area long-term before concluding their participation in the study which will span several weeks)
* Fall outside of a BMI range of (18.5 - 30)
* Consume alcohol or recreational drugs for 24h prior to visits
* Older women cannot be pre-menopausal (must have not had a menses for at least 12 months)
* Unable to speak or read English
* Participants must not have scheduling conflicts that would prevent them from reporting to the laboratory of integrated physiology 4 times over the course of the study
1-Year Follow up to the 1473-IMIQ Study

This is a 1-year follow-up study to evaluate the long-term effects in subjects who completely cleared their actinic keratosis (AK) lesions in the 1473-IMIQ study. The 1473-IMIQ study evaluated the safety and effectiveness of imiquimod 5% cream compared to a placebo cream for the treatment of AK.


Eligibility Criteria:
Inclusion Criteria:

* Subject had to participate in the 1473-IMIQ Study AND have had 100% clearance of AK lesions

Exclusion Criteria:

* Did not use any topical preparations in the previous treatment area within 24-hours of the scheduled visit.
A Controlled Trial on Recreational Runners With Patellofemoral Pain

From a rehabilitation point of view, while several approaches exist to retrain runners with PFPS, it is not clear which one is most effective, or why. The goals of this randomised-controlled trial are: 1) to compare the effectiveness of three rehabilitation programs on pain and functional limitations of runners with PFPS and 2) to explain why the programs are effective or not based on laboratory analyses. After baseline evaluation, runners will be randomly assigned to one of three treatment groups, each with a specific 8-week rehabilitation program aimed at addressing the efficiency of a specific type of retraining. These groups are: 1) Control; 2) muscle recruitment; 3) reducing knee loading during running.

The investigators hypothesis is that the intervention targeting a reduction in knee loading will be significantly more effective in reducing symptoms and improving function of runners with patellofemoral pain syndrome.

Hypothesis will be tested using symptoms and functional status questionnaires. In addition, mechanistic analyses will be conducted using a running assessment using an instrumented treadmill and kinematics analyses.

Eligibility Criteria:
Inclusion Criteria:

* Running mileage at least 15km
* Symptoms since at least 3 months
* Pain level at least 3/10 during running and 3 activities among: kneeling, squatting, stairs and resisted knee extension
* Score lower than 85/100 on the KOS-ADLS

Exclusion Criteria:

* History of knee surgery or patellar dislocation
* Pain believed to originate either from meniscus or from patellar tendon
* Pain following an acute trauma
* Concurrent lower limb injuries
* History of neurological, inflammatory, rheumatoid disease
Development and Validation of a Tumour Oxygenation Monitoring Probe

Laboratory based study in which novel tissue oxygenation probe with the potential provide novel means for assessing response to cancer treatment will be developed and validated.

Tumour hypoxia is feature common to most solid tumours, with significant implications in tumour aggressiveness, metastatic potential and response to therapy. Tumour oxygenation monitoring is likely, therefore, to provide a valuable adjunct in risk stratification and treatment response monitoring.

Diffuse reflectance spectroscopy (DRS) utilises the differing absorption of oxygenated as compared to deoxygenated haemoglobin to provide an accurate measure of tissue oxygenation.

This project aims to develop and validate a tissue oxygenation probe for cancer monitoring. Using the clinical paradigms of rectal and breast cancer, anonymised MRIs of cancer sufferers will guide simulations of tissue optical properties to develop a DRS probe. The 3D reconstructed sans will then be used to 3D print tissue phantom models on which the DRS probe will be validated against reference bench top analysers.

Eligibility Criteria:
Inclusion Criteria:

* MRIs from Breast or Rectal Cancer patients (10 of each)
* Locally advanced Cancers (Stage 2 or 3)
* Patients who went on to receive neoadjuvant chemoradiotherapy.
* Anonymised scans

Exclusion Criteria:

* MRIs from patients under the age of 18, or older than 99 years old will be excluded.
* MRIs from patients who did not receive neoadjuvant therapy for cancer will be excluded.