cyrilzakka/clinical-trials huggingface dataset:
L-methylfolate Supplementation to OROS-Methylphenidate Pharmacotherapy in ADHD Adults

This pilot study seeks to evaluate initial evidence for the effect of L-methylfolate supplementation to OROS-Methylphenidate pharmacotherapy on ADHD symptoms and associated features in adults with ADHD, as well as tolerability of this supplementation. The investigators will conduct a 12-week double-blind randomized placebo-controlled trial with L-methylfolate supplementing open-label OROS-Methylphenidate (OROS-MPH). The investigators propose to examine 40 adult (ages 18-55) subjects satisfying the DSM-IV diagnostic criteria for ADHD.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female adults ages 18-55 years of age.
2. A diagnosis of childhood onset ADHD, meeting all but the age of onset criteria according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), based on clinical assessment. Childhood onset will be defined according to established research criteria, requiring onset of two symptoms of inattentive or of impulsive/hyperactive traits by the age of 12.
3. A score of 24 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS).

Exclusion Criteria:

1. A history of non-response or intolerance to methylphenidate at adequate doses as determined by the clinician.
2. A history of intolerance to L-methylfolate supplementation.
3. Pregnant or nursing females.
4. Serious, unstable medical illness including hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic (thyroid), neurologic (seizure), immunologic, or hematologic disease.
5. Glaucoma.
6. Clinically unstable psychiatric conditions including suicidality, homicidality, bipolar disorder, psychosis, history of or current marked anxiety, tension or agitation potentially exacerbated by a stimulant, or lifetime history of any other clinically serious condition potentially exacerbated by a stimulant, such as mania or psychosis.
7. Significant impairment due to tics, based on clinician judgment.
8. A family history or diagnosis of Tourette's syndrome
9. Current (within 3 months) DSM-IV criteria for abuse or dependence with any psychoactive substance other than nicotine.
10. Multiple adverse drug reactions.
11. Any other concomitant medication considered to be effective for management of ADHD; individuals on stable treatment with agents with central nervous system activity will be allowed to participate, as detailed in the Concomitant Medication portion of the protocol.
12. Current use of MAO Inhibitor or use within the past two weeks.
13. Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
14. Use of supplemental folic acid greater than 400 mcg per day, L-methylfolate, or Omega-3 Fatty Acids greater than 800 mg per day within two weeks prior to the baseline study visit.
Cortical Cerebellar Infarctions Associated With Patent Foramen Ovale in Young Stroke Patients

The investigator retrospectively analyzed consecutive young (\<60 years) cryptogenic stroke patients with Patient Foramen Ovale (PFO) recruited between January 2016 and May 2019 in our center, and compared these patients with sex- and age-matched controls with cryptogenic stroke without PFO. Analyzed baseline characteristics: sex, age, cardiovascular risk factors, history of stroke, and cortical/subcortical localization, arterial territory, number of lesions, and lesion size of the acute symptomatic infarction, together with the ROPE score. The presence and the number of acute and chronic SCCI lesions were assessed.


Eligibility Criteria:
Inclusion Criteria:

* patients : young (\<60 years) adult patients,
* Patient recruited and registered in our stroke database between January 2016 and May 2016 of our center (Nîmes University Hospital, France),
* Patients presenting with an acute symptomatic infarction (confirmed by diffusion-weighted MRI) of unknown origin
* Controls : age-matched controls with cryptogenic stroke without PFO
Comparison of Stent-Related Symptoms Between Anti-Reflux Stents and Standard DJ Stents in Children With Urolithiasis

The aim of this study is to investigate the effectiveness and related complications of anti-reflux stents used in pediatric urolithiasis surgery at the Children's Hospital affiliated with Zhejiang University School of Medicine, by comparing them with conventional stents.

Ureteral stents are crucial adjunctive devices following urolithiasis surgery, serving to support the ureter and facilitate urine drainage. However, the application of these stents can lead to complications such as urinary tract infections, lumbar pain, and bladder irritative symptoms, which significantly impact the quality of life in pediatric patients. Novel designs, such as anti-reflux stents equipped with valves, have been optimized to enhance unidirectional urine flow while effectively preventing retrograde urine flow. It is anticipated that these designs could alleviate symptoms of lumbar pain and urinary tract infections, thereby improving the postoperative recovery quality in children. Current adult studies suggest that anti-reflux stents might reduce urine reflux but may also be associated with significantly stronger urinary symptoms. To date, there have been no pediatric studies reported on the efficacy of anti-reflux stents. The aim of this study is to investigate the effectiveness and related complications of anti-reflux stents used in pediatric urolithiasis surgery at the Children's Hospital affiliated with Zhejiang University School of Medicine, by comparing them with conventional stents.

Eligibility Criteria:
Inclusion Criteria:

1. A definitive diagnosis of urinary tract stones by CT scan, with indications for ureteroscopic lithotripsy (URL), percutaneous nephrolithotomy (PCNL), laparoscopic/open stone extraction with or without robotic assistance, or combined endoscopic lithotripsy, and no contraindications;
2. Age is less than 18 years old;
3. For preschool children, the informed consent form is signed by the parents; for school-age children, the informed consent form is signed by both the parents and the child themselves.

Exclusion Criteria:

1. A history of recurrent bladder irritative symptoms or urinary tract infections;
2. Severe renal insufficiency, anatomical or functional solitary kidney, and other significant comorbidities that render the child unsuitable for participation in the study;
3. Stent placement surgery within the past 3 months;
4. Recent use of medications that may interfere with the study results, such as solifenacin;
5. Stent removal surgery performed at an external medical facility.
Role of Indoor Pollutants on House Dust Mite Allergic Asthma

It seems that the aldehydes and NO2, at the levels found indoor, could be the aggravating factors for an allergic response. However this effect has not been demonstrated. The investigators plan to study the effect of exposure to standard doses of these pollutants on the bronchial reactivity as measured by bronchial challenge tests with dust mite extract in volunteers asthmatic, allergic to house dust mite.


Eligibility Criteria:
Inclusion criteria:

* M/F 18-50 years of age
* History of intermittent HDM allergic asthma-FEV1 \> 80%
* Non smokers or smokers with smoking \< 10 PY

Exclusion criteria:

* Persistent asthma and FEV1\<80%
* Allergic to pets and pets at home
Quality Study of Anesthetic Technique on Breast Cancer Surgery

Previous studies have shown that paravertebral block (PVB) has the potential to reduce pain and side effects after breast surgery when used in addition to general anesthesia or sedation.The investigators would like to further discern the impact of GA or PVB on the postoperative QoR, pain and satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a physical status between ASA I and III
* Female
* 18 - 70 years of age
* Patients able to read a newspaper in Chinese.
* Elective unilateral wide excision/simple mastectomy and SLNB/ALND
* Patient has signed an informed consent
* Without contraindication of GA or PVB
* Body mass index (BMI) less than 24 kg/m2

Exclusion Criteria:

* ASA \> III
* inability to provide informed consent
* Bleeding disorders
* Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)
* Allergy to amide-type local anesthetics or NSAIDs
* Infection at the thoracic paravertebral injection site
* Pregnancy or breast-feeding
* Severe spine or chest wall deformity
* body mass index equal to or more than 24 kg/m2
* patients with major psychosis or drug and alcohol abuse
* patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease
* Patients with significant visual impairment or other physical disability that precludes complete cooperation
Patient-reported Outcome Questionnaire for Women With Metastatic Breast Cancer

The goal of the study is to understand the meaning of progression-free survival for women with metastatic breast cancer and to use this understanding to create and distribute a new questionnaire to assess the effect progression has on a woman's functioning and well-being.

This study is being conducted in three stages. Stages I and II are complete. Participation in Stage III requires the completion of an online survey. The survey may be accessed at the following link:

https://www.surveymonkey.com/s/mbc3survey

Compensation options for eligible participants are listed at the end of the survey.

Eligibility will be confirmed in follow-up call/email by study staff.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18 and older
* Clinical diagnosis of metastatic breast cancer
* U.S. resident
* Able to speak and read English
* Willing to sign and informed consent
* Willing to self-administer one online questionnaire that will take approximately 15 minutes to complete
The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in the Correction of Complex Congenital Heart Disease

This study is a multicenter, stepwise design, cluster randomized controlled trial. Random sequence is generated by computer, and each center enters the intervention expectation (Phase I) in random order to implement ERAS strategy. If it does not enter the intervention expectation (Phase C) center, clinical diagnosis and treatment will be completed according to the traditional scheme.

Among children, patients aged 28 to 6 who underwent cardiac surgery were included in the ERAS strategy intervention plan, which mainly includes preoperative education, preoperative comfort for the patient, preoperative oral sugary beverage, continuous infusion of dexmedetomidine, multimodal analgesia, blood protection strategies, prevention of postoperative nausea and vomiting, intraoperative insulation, early tracheal extubation and intubation, and targeted liquid therapy. The traditional plan group follows the current clinical diagnosis and treatment routine. By comparing the differences in the incidence of major postoperative outcomes (MACE events, major pulmonary complications, and acute kidney injury) between the intervention group and the non intervention group, as well as comparing other adverse events (including but not limited to pneumonia, massive bleeding, postoperative arrhythmia, incision infection, postoperative nausea, vomiting, and delirium), all cause secondary intubation, and all cause secondary surgery between the two groups, and recording hospitalization time, ICU stay time The removal time of tracheal intubation and drainage tube, the pain score during hospitalization, the total amount of opioid drug use (converted to the same dose of morphine), hospitalization expenses, and family satisfaction scores were recorded to explore whether the ERAS regimen can reduce the incidence of major postoperative adverse events, improve patient prognosis, and accelerate postoperative recovery compared to traditional regimens.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 28 days to 6 years
* Patients awaiting elective cardiac surgery with cardiopulmonary bypass (CPB).

Exclusion Criteria:

* The risk adjustment for congenital heart surgery (RACHS) is above class 5
* Patients with cardiac assist device, mechanical ventilation or the history of asphyxia
* Patients with pulmonary disease, including respiratory tract infections and asthma
* Patients with severe liver or renal dysfunction, including severe acute or chronic renal dysfunction need renal replacement therapy, and acute or chronic liver failure need artificial liver therapy
* Fetal malformation includes polysplenia syndrome, Asplenia Syndrome, Down syndrome, DiGeoge syndrome, Marfan syndrome, trachea-bronchus stricture, diabetes, nervous functioning disorders, genital system malformations, imperforate anus, and Williams syndrome
* Current enrollment in another clinical trial
* Guardian's refusal or low adherence
Pharmacology of Aminophylline for Acute Kidney Injury in Neonates

Acute kidney injury (AKI) in critically ill neonates is common and associated with significant morbidity and mortality. No targeted therapeutic treatment strategies have been established for AKI in neonates. Within a clinical pharmacokinetic and pharmacodynamic conceptual framework, this project will examine the medication aminophylline as a potential treatment approach for AKI.


Eligibility Criteria:
Inclusion Criteria:

* Neonate \< 3 months post natal age
* Diagnosed with acute kidney injury (AKI)
* Receiving aminophylline for AKI treatment as per local standard of care.

Exclusion Criteria:

* Presence of anatomical renal anomaly based on postnatal evaluation of the patient (hydronephrosis, multicystic kidney, renal agenesis, renal dysplasia, polycystic kidney, or obstructive uropathy)
* Patient on renal replacement therapy
* Major genetic abnormalities (trisomy 13, 18 or 21).
Comparative Study Between Shear and Strain Elastography in Monitoring the Response to NAC in Breast Cancer Patients

The aim is to evaluate tumor stiffness changes through a comparative study between shear and strain elastography in monitoring the response of breast cancer to neoadjuvant chemotherapy

Breast cancer (BC) is one of the most common malignant tumors in global population, with the highest morbidity and mortality rates among female.(1) Neoadjuvant chemotherapy (NAC) has become an important supplement of comprehensive and precise treatment of BC. Neoadjuvant chemotherapy (NAC) is increasingly used to induce tumor shrinkage, thereby allowing smaller surgical resection, eliminating clinically silent micro metastases, and providing prognostic information based on the extent of pathologic response(.2-4) Pathological complete response (pCR) is increasingly seen after neoadjuvant chemotherapy (NACT) for invasive breast cancer. Confident identification of pCR may lead to less radical breast surgery and to sentinel node biopsy rather than axillary clearance in women with pre-treatment positive nodes.(5)Response to NACT is routinely assessed using magnetic resonance imaging (MRI), greyscale ultrasound (US), and mammography.(6) In some studies, MRI has been shown to be superior to US.(7-8) however, MRI has the disadvantages of being time-consuming, expensive, requiring intravenous contrast agent . Ultrasonic elastography (UE) has been widely used to qualitatively and quantitatively evaluate differences in lesion stiffness or elasticity. Currently, the two most frequently used UE techniques for examination of breast diseases are strain elastography (SE) and shear-wave elastography (SWE). In practice, UE is a complementary technique for differentiating benign from malignant breast masses (9,10). Breast cancers with more aggressive pathological properties tend to have higher stiffness values .Strain elastography (SE) may be predictive of response in the early stage of treatment with high sensitivity (SEN) and specificity (SPE).(11,12) Pretreatment tumor stiffness measured by shear wave elastography (SWE) has a significant relationship with the subsequent reduction in tumor cellularity.(13) In case of NACT, early evaluation of relative changes in tumor stiffness could effectively predict the response and might indicate better therapeutic strategies.(14)

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed invasive ductal carcinoma .
2. Age equal or above 18

Exclusion Criteria:

1. Previous radiation therapy or chemotherapy
2. Mass not detected by US
3. Non Mass lesion by MRI
4. Ductal carcinoma in situ
Radiographic and Clinical Comparison of Post-reduction Splinting Constructs in the Treatment of Acute Displaced Distal Radius Fractures

Subjects with acute, displaced distal radius fractures will be randomized at the time of emergency room evaluation to one of two commonly accepted splinting methods for displaced distal radius fractures: sugar tong splints or volar/dorsal clam shell splints. Reduction will be performed in the usual, standard fashion and the selected splint applied. Standard radiographic measurements of alignment, including radial height, volar tilt and inclination will be measured on pre- and post- reduction radiographs by a single reviewer- who will be blinded to splint application type. At the first fracture follow-up visit, typically occurring between 5-10 days, as in standard practice, repeat radiographs of the wrist will be taken, and the same reviewer will measure alignment. As a secondary outcome, patients will also complete the disabilities of the arm, shoulder and hand (DASH) questionnaire at this visit, to compare patients' ability to perform activities of daily living with their respective splints.


Eligibility Criteria:
Inclusion Criteria:

* acute, displaced distal radius fracture
* isolated injury

Exclusion Criteria:

* polytrauma
* non-displaced fracture
* prior wrist fracture
LEO 27847 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Secondary Hyperparathyroidism Patients

The purpose of this trial is to determine the safety and tolerability of ascending single and multiple oral doses of LEO 27847 in secondary hyperparathyroidism patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 75 years (inclusive) at screening.
* Patients with body mass index within 18 to 34 kg/m2 (inclusive).
* Haemoglobin is stable (≥9 g/dL or 5.6 mmol/L)
* Parathyroid hormone (PTH) is ≥200 pg/mL and \<800 pg/mL.
* Screening serum albumin is ≥30 g/L.
* C-reactive protein \<25 mg/L.

Exclusion Criteria:

* Adjustment of vitamin D sterols within 14 days before the screening visit and patients for whom adjustment of vitamin D sterols is planned from screening until end of study.
* Adjustment of calcium supplements within 14 days before the screening visit and patients for whom adjustment of calcium supplements is planned from screening until end of study.
* Adjustment of phosphate binder within 14 days before the screening visit and patients or whom adjustment of phosphate binder is planned from screening until end of study.
Immediate Dentoalveolar Restoration Compared to Bio-oss

This randomised controlled trial compares the immediate dentoalveolar restoration and bovine demineralised bone in immediate implants placed in fresh sockets with buccal resorption. A total of 34 patients will be included and followed clinically and radiographically for 18 months. Patient centred outcomes will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Tooth extraction indicated for teeth in anterior area between second premolars

Exclusion Criteria:

* Diabetes and other systemic conditions that may affect osseointegration
Japanese Single and Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic (PK) & Pharmacodynamic (PD) Study of AZD7687

This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound AZD7687. It will also assess how the body handles the drug and how it responds to the drug following single dose followed by multiple dosing over 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Suitable veins for cannulation or repeated venipuncture
* Have a body mass index (BMI) between 19 and 35 kg/m2 and weigh at least 50 kg and no more than 90 kg
* Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
Large Macular Hole Closure Rate With Amniotic Membrane Graft With and Without Limitorrhexis

Patients with idiopathic macular holes (MHs) postoperative closure rates for large MHs (diameter \> 550 μm) are disappointing and often require a second intervention, different techniques have been described with very variable success rates in different published studies, an efficient technique with good functional outcome has not been found.

Interventional study in large macular holes (diameter \> 550 μm) using an amniotic membrane with and without internal limiting membrane peeling.

Eligibility Criteria:
Inclusion Criteria:

* Not myopic patients (\<6 Dioptre or \<26 mm)
* Large macular hole \>550 μm
* \> 6 months symptoms
* Signing informed consent

Exclusion Criteria:

* Patients with other ocular disease (diabetic retinopathy, glaucoma, uveitis, ocular tumors, etc)
* Using systemic drugs that are toxic for the optic nerve or retina (chloroquine, hydroxychloroquine, tamoxifen, ethambutol, etc)
* Patients with ocular surgery
Endovascular Abdominal Aortic Aneurysm Repair by Interventional Cardiologists

Registry for Endovascular repair of abdominal aortic aneurysm performed primarily by Interventional Cardiologists


Eligibility Criteria:
Inclusion Criteria:

* Patients with abdominal aortic aneurysm amenable for endovascular repair

Exclusion Criteria:

* Pregnant patients
* Patients less than 18 years old.
Misoprostol in the Treatment of Postpartum Hemorrhage

Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment with conventional methods. Uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment, and there is a serious danger that this method will be used widely without research to document the effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose to test whether 600 μg of sublingually administered misoprostol in women requiring additional uterotonics after delivery, and after routine syntocinon to all women during or after delivery, has additional effects above the additional conventional uterotonics in reducing PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals who give consent will be given locally routine treatment for PPH. In addition, they will be enrolled by drawing the next of a series of randomised treatment packs containing misoprostol or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls after enrolment.


Eligibility Criteria:
Inclusion Criteria:

* All women delivering vaginally with clinically diagnosed PPH requiring uterotonics

Exclusion Criteria:

* Refusal to give consent for participation or if the woman is too distressed to give consent
* Woman is not entitled to give informed consent (e.g. minors without a guardian)
* Woman who had a caesarean section
* Delivery is regarded as abortion (gestational age \< 28 weeks)