cyrilzakka/clinical-trials huggingface dataset:
Effect of Telerehabilitation on Handwriting Performance in Children With ADHD: RCT

This is a randomized controlled study examining the effect of telerehabilitation on fine motor performance and handwriting difficulties experienced by children with attention deficit hyperactivity disorder.

It is planned that 40 children between the ages of 6-8 diagnosed with attention deficit and hyperactivity disorder and their families will participate voluntarily. An informed consent form, BOT-2 and Minnesota Handwriting Test will be sent to volunteer participants via e-mail. An evaluation session on Zoom application will be held for each participant with the participation of the occupational therapist, child and family. After the evaluation, the participants will be randomized and allocated to study and control groups.

Fine motor skills training will be given to the study group 3 sessions a week. The training will be given on the Zoom application and the duration is 8 weeks. At the end of 8 weeks, the evaluation will be done again with BOT-2 and Minnesota Handwriting Test.

The control group will be evaluated with BOT-2 and Minnesota Handwriting Test for the second time after waiting 8 weeks and will receive fine motor skills training.

Eligibility Criteria:
Inclusion Criteria:

* To be in the age range of 6-8,
* Diagnosed with Attention Deficit Hyperactivity Disorder-Predominantly Inattentive subtype according to DSM-5 and ADHD Rating Scale-5,
* Continuing individual education,
* After being informed about the study have agreed to participate in the study.

Exclusion Criteria:

* Children with an additional physical and neurological problem to accompany
Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies

RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This clinical trial studies stereotactic radiosurgery using CyberKnife works in treating women with advanced or recurrent gynecological malignancies.

PRIMARY OBJECTIVES:

I. The primary goal of this study is to estimate the rate of grade 3 or higher acute toxicities observed during a 6 month period following CyberKnife radiosurgery for gynecologic cancers.

II. To evaluate clinical response to radio-surgery for gynecologic tumors.

III. To assess general and site specific quality of life (using SF-12, FACT-En, FACT-O, FACT-Cx or FACT-V) and to evaluate patient's level of pain.

SECONDARY OBJECTIVES:

I. As a secondary objective, toxicities during the 2 years following CyberKnife radiosurgery will also be described.

OUTLINE:

Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.

After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.

Eligibility Criteria:
Inclusion

* Pathologically proven gynecologic malignancy
* No prior cryosurgery or radiofrequency ablation, in target lesion
* Patient is able to give and sign study specific informed consent
* Measurable disease, according to RECIST criteria
* Laboratory parameters and appropriate clearance from anesthesia based on other medical co-morbidities for placement of fiducials; these would include CBC, basic metabolic panel, BUN, and creatinine
* \>= 4 weeks from previous treatment (chemotherapy or radiation) of malignancy
* ECOG performance status of 0-3 as this procedure is minimally invasive and considered palliative in these patients

Exclusion

* Any patient with active connective tissue disease such as lupus or dermatomyositis is excluded
* Any patient with active Crohn's disease or active ulcerative colitis is excluded
* Major medical or psychiatric illness, which would prevent completion of treatment or interfere with follow-up is excluded
The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction

Previous studies have evaluated the effects of inspiratory muscle training in patiens with heart failure and reduced ejection fraction; nevertheless,no evidence endorse the therapeutic role of inspiratory muscle training in patients with heart failure and preserved ejection fraction. The investigators sought to evaluate whether 12-week inspiratory muscle training improves exercise capacity (peak exercise oxygen uptake and 6-minutes walk test), as well as left ventricular diastolic function, serum biomarkers and quality of life (Minnesota Living With Heart Failure Questionnaire) in patients with heart failure with preserved ejection fraction and non-reduced inspiratory muscle strength.


Eligibility Criteria:
Inclusion Criteria:

* a) previous history of symptomatic heart failure (New York Heart Association \[NYHA\] functional class ≥II)
* b) evidence of normal left ventricular ejection fraction, defined by an ejection fraction \>0.50 and an end-diastolic diameter \<60 mm by 2D echocardiography
* c) relevant structural heart disease (left ventricle hypertrophy/left atrial enlargement) and/or diastolic dysfunction estimated by 2D echocardiography
* d) clinical stability, including no admissions in the past 30 days

Exclusion Criteria:

* a) Patients unable to perform a valid baseline exercise test.
* b) Unstable angina, myocardial infarction or cardiac surgery within the previous three months.
* c)Known chronic metabolic, orthopedic, infectious disease or previous pulmonary disease;
* d)Treatment with steroids, hormones, or cancer chemotherapy;
* e)Reduced maximal inspiratory pressure according to age and sex;
* f)Active smokers
* g)Acute decompensation;
* h)Other comorbidity with an expectancy of life less than one year
Genotyping 2 SNPs in Chinese Breast Cancers

The purpose of this study is to determine the frequency of two Single Nucleotide Polymorphisms (SNPs) by sanger-sequencing in Breast Cancers and healthy controls .

Since the 1990s breast cancers incidence of china has increased more than twice as fast as global rates. Chinese patients are responsible for 12.2% of all newly diagnosed breast cancers and 9.6% of all deaths to world breast cancers. Breast cancer is now the second frequently diagnosed cancer and is the leading cause of cancer-related death in Chinese women.

Two of the most prevalent breast cancer susceptibility genes are BRCA1and BRCA2. However，because of population based Genetic heterogeneity, the frequency of BRCA1/BRCA2 mutation is not as high in Caucasian population as in China. Anyway, the mean age at diagnosis of breast cancer in China is almost 10 years younger and more cases are diagnosed before 40 than those in Caucasians. Therefore, it is believed that there are certain specific susceptibility loci in Chinese breast cancers.

In preliminary experiments, investigators found two germline mutations may associate with Chinese breast cancers.

The purpose of the study is to determine the frequency of two germline mutations by sanger-sequencing in a larger sample of Chinese breast cancers

Eligibility Criteria:
Inclusion Criteria:

* Woman aged superior to 18 years old Inform consent signed Woman without breast cancer and family history of cancer

Exclusion Criteria:

* No inform consent signed Patient under guardianship, curatorship Psychosocial disorder
Peri-Operative Morbidity and Quality of Life After Coronary Artery Bypass Graft (CABG)

It is the long term objective of this study to preserve or improve the quality of life and to prevent deterioration in physical and mental function following myocardial revascularization among bypass surgery patients.

The objective of this study is to compare the efficacy of two strategies of intra-operative hemodynamic management in preventing peri-operative cardiac, cognitive and neurologic morbidity and mortality and postoperative deterioration in the patient's quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Patients had to be undergoing elective CABG, without concomitant valve or other cardiac surgery.
2. Patients also had to be able to perform the neuropsychologic tests, and to provide informed consent.

Exclusion Criteria:

1. Patients who refused to participate in the study.
2. Patients who live too far away from NYC to be able to come back for follow up at six months post-operatively.
3. Patients who had either valvular replacement and aortic amd mitral an aneurysm repair, or other cardiothoracic surgery.
4. Patients who were unable to complete the neuropsychologic test.
5. Patient who were part of another CABG study.
Pilot Study: Impact of Biomarker-Guided Dietary Supplementation on Quality-of-Life Measures in Subjects With Chronic Pain

The goal of this study is to use pain-specific urine biomarkers to evaluate how daily nutritional supplementation with biomarker guided formulas effect, quality of life and urinary biomarker scores in chronic pain patients. Assessing the effect of biomarker guided supplementation on pain specific biomarkers through changes in urinary biomarker scores may solidify the necessity for identifying deficiencies to create an individualized treatment plan for pain patients. This study aims to evaluate the effect of biomarker-guided supplementation on the three categories of urinary biomarkers using targeted ingredients specifically designed for oxidative stress, inflammation, and nerve health. This study provides subjects with one of three nutritional supplement formulas based on their specific urinary biomarker test results and assesses changes in their urinary biomarker levels and their quality of life as it relates to their pain over a 3-month period.


Eligibility Criteria:
Inclusion Criteria:

* Previously submitted a urinary biomarker sample and agreed to be contacted for research.
* Be seeking treatment for chronic pain as defined as symptoms persisting for ≥ 3 months.
* Be able to take oral medication and/or be willing to adhere to the supplement regimen.

Exclusion Criteria:

* Diagnosis of bacterial or viral infection during or 3 months prior to the study.
* Severe or untreated psychiatric disturbance and/or any psychiatric disorder that required hospitalization in the year prior to the screening visit.
* A history of cancer within 5 years prior to screening visit.
* Be pregnant or breast-feeding or have plans to become pregnant at any time during the study
* Participant has a known sensitivity or allergy to any of the ingredients in the study products.
* Participant has any dietary restriction that prevents the participant from consuming any of the ingredients in the study products.
Urinary Continence of Female POPRC and OIN

To compare the urinary continence rate and long-term oncological outcomes of pelvic-organ preserving radical cystectomy (POPRC) with orthotopic ileal neobladder (OIN) versus standard radical cystectomy(SRC) with OIN.

Radical cystectomy is the gold standard for muscle-invasive bladder. Orthotopic ileal neobladder, as one of the urinary diversion methods, is preferred whenever possible to achieve a better postoperative quality of life.

For standard radical cystectomy (SRC) in females, the uterus, fallopian tubes, ovaries, anterior vaginal wall, and regional lymph nodes undergo en bloc resection with the bladder and urethra . With regard to the wide range of resection, continence disorder and sexual dysfunction are very common after surgery. Pelvic-organ sparing radical cystectomy involves the preservation of the female vagina, uterus, neurovascular bundles, and any enhancement of the aforementioned techniques . Previous studies demonstrated that POPRC might not affect long-term survival and instead improve continence outcomes. However, most of the available studies are retrospective with limited cases in a single center. The current study primarily aims to urinary continence rate and long-term oncological outcomes of POPRC+OIN versus SRC+OIN in a prospective randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients aged between 55-75.
2. Patients those who are diagnosed with organ-confined urothelial carcinoma（\<pT3）
3. Patients those who are capable for radical cystectomy with orthotopic ileal neobladder.
4. ECOG score between 0-2;
5. Normal renal function;
6. Patients those who volunteer to participate in this study and sign the informed consents.
7. Patients those who are able to cooperate in the study.

Exclusion Criteria:

1. Absence of tumour in bladder neck or urethra;
2. Patients thsoe who are diagnosed distant metastasis before surgery.
3. Previous history of malignancy of pelvic organs or surgical resection of pelvic organs;
4. Patients those who are diagnosed with other malignancies.;
5. Patients those who had received pelvic radiotherapy or major pelvic operation.
6. Pregnancy status;
7. Any other conditions that the researcher considers to be excluded from this study
Prospective Clinical Evaluation of Three Prosthesis Re-cap, M2a-Magnum and C2a-taper.

This evaluation is being conducted to evaluate the performance of thee prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* Good general health of age (ASA I-II)
* DEXA-scanning: lower limit for a 55 years old man
* MRI normal vitality in caput
* Willing to return for follow-up evaluations
* Exclusion Criteria:
* Subjects displaying any of the following contra-indications shall be excluded from this evaluation:
* Inability to co-operate with and complete the study
* Collum \< 2 cm
* Large cysts in caput
* Mismatch between caput acetabulum
* Caput necrosis
Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients

Long-term immunosuppression carries potential adverse effects such as risk of infection, malignancy, renal insufficiency, diabetes and hypertension. In clinical liver transplantation, some liver transplant recipients maintain allograft function without immunosuppressive drugs. This is called as "operational tolerance". Many attempts have been made to identify immunological biomarkers predicting operational tolerant patients. Therefore, the investigators aimed to identify patients who have the potential to be operationally tolerant using biomarkers, withdraw immunosuppressant gradually and stop ultimately with monitoring of biomarkers.

Among long term stable liver transplant recipients, we will select some proportion of patients who have the high potential for obtaining operational tolerance using biomarkers.

Then, we will gradually reduce immunosuppressants and monitor biomarkers as well as biochemical tests. The course of tapering off immunosuppressant will take about 1 year.

During withdrawal of immunosuppression, participants will be closely monitored for liver enzyme, immunological profile.

If there are some signs of rejection, liver biopsy will be undertaken and participants will be treated using immunosuppressant.

After complete withdrawal of immunosuppressant, participants will be followed for at least of 1 year.

Eligibility Criteria:
Inclusion Criteria:

* long term stable liver transplant recipients

Exclusion Criteria:

* liver transplant due to autoimmune disease
* liver transplant due to hepatitis C virus (HCV)
* history of graft rejection
* history of biliary infection or stricture
Combination Therapy With Sitagliptin and Lansoprazole to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes

Sanford Research/USD proposes to study the combination therapy of oral administration of sitagliptin and lansoprazole versus placebo for the preservation of pancreatic beta cells still present in patients with recent-onset diabetes and possibly regenerating their beta cells, while safely down-regulating the autoimmune response directed against the beta cells.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 diabetes, based on American Diabetes Association criteria, recently diagnosed (within the 6 months before Screening) and confirmed by the presence of at least 1 diabetes related autoantibody (either glutamic acid decarboxylase \[GAD\], insulinoma-associated protein \[IA 2\], or insulin, the latter measured within 10 days after starting insulin therapy).
* Male or female aged between 11 and 45 years, inclusive.
* Able to swallow study capsules.
* Willing to comply with "intensive diabetes management" as directed by the investigator, with the goal of maintaining blood glucose as close to American Diabetes Association recommendations as possible.
* Willing to comply with the schedule of study visits and protocol requirements.

Exclusion Criteria:

* Use of a GLP 1R agonist or DPP 4 inhibitor within 1 month before enrollment.
* Use of a PPI within 1 month before enrollment.
* Use of an oral hypoglycemic agent within 1 month before enrollment or use of thiazolidinediones within 3 months before enrollment (although thiazolidinediones may be used \<7days before enrollment).
* Females of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
* Females who are pregnant or breastfeeding at the time of enrollment.
* Subjects with any of the following conditions:

  * Renal insufficiency, defined as estimated glomerular filtration rate (GFR) less than 50 mL/min at Screening, calculated using the Modification of Diet in Renal Disease (MDRD) equation.
  * History of a serious hypersensitivity reaction to sitagliptin or lansoprazole, such as anaphylaxis or angioedema.
  * Severe hepatic insufficiency.
  * History of pancreatitis or gallbladder disease
  * Any significant medical condition, which in the opinion of the investigator or medical monitor would interfere with study participation.
Microvention AnEurysm & STroke Real-life Data cOllection

The MAESTRO-1 registry is a post-market, single-arm, non-interventional, multicenter registry

Electronic platform to collect real-world clinical data, evaluate and periodically report safety and effectiveness of CE approved and commercially available Microvention implant devices used for the endovascular treatment of Intracranial aneurysms.

Eligibility Criteria:
Inclusion Criteria:

* Patient or legally authorized representative (LAR) is informed of the data collection and gives non-opposition or consent prior to the data collection in accordance with institutional and geographic requirements.
* Patient is treated for a ruptured or unruptured intracranial aneurysm using a commercially available MicroVention implant device as the primary treatment device and the decision to use this device has been made by the treating physician outside the context of the MAESTRO-1 study.

Exclusion Criteria:

* Patient is or is expected to be inaccessible for follow-up.
* Patient is participating or intends to participate in another study that changes the site practice.
* Patient has been previously enrolled into the MAESTRO-1 study.
Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE)

The purpose of this study is to determine the safety and effectiveness of the Scuba™ stent in subjects with symptomatic claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in the common and/or external iliac artery.

Interventional revascularization strategies for peripheral arterial disease currently available include both surgical and endovascular approaches such as percutaneous transluminal angioplasty (PTA), either as a stand-alone procedure or with the placement of a stent. Cobalt-chromium (CoCr) is an alloy that has been used safely in the manufacture of surgical implants for use in contact with blood, soft tissue and bone for over 10 years. This study will evaluate the SCUBA™ peripheral balloon-expandable cobalt chromium tent system in iliac arteries.

Eligibility Criteria:
Inclusion Criteria:

* Presence of de novo or restenotic lesion(s), located in the common or external iliac artery with ≥50% stenosis
* Subject has lifestyle limiting claudication or rest pain, (Rutherford- Becker scale \[clinical category\] 2, 3, or 4)
* Target vessel reference diameter is 5mm - 10mm by visual assessment
* Target lesion length \< 130mm
* Subject has angiographic evidence of a patent femoral outflow artery in the target limb
* Subject has provided written informed consent
* Subject is able and willing to adhere to required follow-up visits and testing

Exclusion Criteria:

* Subject has lesions in the Common Femoral Artery (CFA), Profundal Femoral Artery (PFA), or Superficial Femoral Artery (SFA) that would require a staged procedure within 30 days of the index procedure (either before or after)
* Target lesion(s) has adjacent, acute thrombus
* Target lesion(s) is highly calcified or was previously treated with a stent
* Subject has a pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery
* Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion
* Subject has a post-surgical stenosis and anastomotic suture treatments in the native iliac vessel
* Subject has a vascular graft previously implanted in the native iliac vessel
* Subject has tissue loss - Rutherford-Becker clinical category 5 or 6
* History of neutropenia (WBC \<3,000/mm3), coagulopathy, or thrombocytopenia (platelet count \<80,000/uL)
* International Normalized ratio (INR) greater than 1.5
* Serum creatinine greater than 2.5 mg/dL
* Subject has a known bleeding or hypercoagulability disorder or significant anemia (Hb \< 8.0 g/dL) that cannot be corrected
* Subject is participating in an investigational study of a new drug, biologic, or device at the same time of study screening
Detection of Microplastics in Cardiac Surgery Patients

The exponential growth in plastic production/use translates into a parallel increase in environmental plastic waste, which is constantly degraded into microplastics and nanoplastics. Information on the effects of microplastics on human health is still preliminary.

Cardiac surgery patients is a population high exposed to plastics. This observational study will obtain biological samples of cardiac surgery patients as a reference and vulnerable group of individuals highly exposed to microplastics and potentially more susceptible.

The objective of this research is to be able to detect microplastics on blood and operation samples of cardiac surgery patients as well as their potential genotoxic and immunological damage.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Elective cardiac surgery

Exclusion Criteria:

* Emergency surgery or limited-term surgery
* Previous cardiac surgery
* Previous severe liver disease
* Pregnant or planning to become pregnant
* Have a malignant tumor