cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Risk Factors and Outcome of Thrombosis in Children

Pediatric thrombosis is multifactorial, and usually risk factors either congenital or acquired are present.

Patient may has one risk factor or more such as sepsis, cancers, congenital heart disease, post surgery , central venous catheter insertion, nephrotic syndrome, systemic lupus erythromatosis and inflammatory bowel disease.

If there's no obvious risk factor for thrombosis, hereditary thrombophilia is suspected which results when an inherited factor, such as antithrombin , protein C or protein S deficiency.

Thrombosis is the formation of a blood clot (partial or complete blockage) within blood vessels, whether venous or arterial, limiting the natural flow of blood and resulting in clinical sequela.

Incidence of childhood thrombosis is 0.07-0.14/10,000 in the general population. This incidence has been reported to be 5.3/10,000 in children presenting to hospital, 0.51/10,000 in all newborns and 0.24/10,000 in children in neonatal intensive care units . Pediatric thrombosis is multifactorial, and usually risk factors either congenital or acquired are present. . Patient may has one risk factor or more such as sepsis, cancers, congenital heart disease, post surgery , central venous catheter insertion, nephrotic syndrome, systemic lupus erythromatosis and inflammatory bowel disease. If there's no obvious risk factor for thrombosis, hereditary thrombophilia is suspected which results when an inherited factor, such as antithrombin , protein C or protein S deficiency.

There are three changes described by Virchow in 1856 are involved in the formation of thrombosis:

1. Changes in blood flow (rheology, stasis)
2. Changes in the vascular wall
3. Changes in the blood levels of coagulation factors The diagnosis of thrombosis is made more frequently and more easily in children due to noninvasive diagnos-tic methods \[Doppler and ultrasonography (US), echo-cardiography, computed tomography (CT) and magnet-ic resonance imaging (MRI)\]. The morbidity and mortality rates are high, although it occurs more rarely compared with adult thrombosis and does not develop in the absence of a triggering factor; the rate of mortality related with direct venous thromboembolism is 2.2%, the frequency of post-thrombotic syndrome is 12.4%, and the recurrence rate for thrombosis is 8.1%.

Eligibility Criteria:
Inclusion Criteria:• All children age from one day to 18 yrs presented with any vascular thrombosis decomented by clinical picture and venous doppler study or radiological study.

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Exclusion Criteria:

* • Persons above 18 years old.
Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study

Recent research has indicated that physical activities incorporating moderate-intensity exercise can be safely performed during treatment and substantially reduces treatment-related side effects, such as fatigue, sleep disturbances, cognitive impairment, and nausea. However, little is known about physical activity levels prior to treatment and whether providing an exercise intervention pre-treatment may improve functional capacity during treatment.

The purpose of this study is to

1. Measure physical activity levels and functional capacity in men newly diagnosed with prostate cancer prior to treatment and
2. Explore whether a 2-week physical activity intervention is feasible during the pre-treatment timeframe:

   1. Examine intervention safety and tolerance by self-report
   2. Examine changes in functional capacity by 6-minute walk test
   3. Examine changes in symptom experience by self-report


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with prostate cancer
* will not start treatment for at least 2 weeks
* able to read and understand English
* capable of giving informed consent
* at least 18 years old

Exclusion Criteria:

* patients who are incompetent for interview (documented diagnosis of active psychosis or dementia)
* unable to provide informed consent as assessed by the interviewer
* too sick to participate, as judged by a member of the research team or the exercise physiologist
* have been treated for another cancer
Effects of Thai Dance Meditation Exercise on Renal and Cerebrovascular Function in Elderly With Diabetic Kidney Disease

Elderly with diabetic kidney disease who practiced Thai dance meditation training more favorable adaptations than normal daily life in improving glycemic control, kidney function, vascular function and cerebrovascular function.

This cross-sectional study was to compare glycemic control, kidney function, vascular function, cerebrovascular function, physical fitness and quality of life between elderly with diabetic kidney disease who practiced Thai dance meditation training and normal daily life.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria included diabetic kidney disease (DKD) (as defined by the KDIGO (Kidney Disease Improving Global Outcomes 2012), a baseline glycosylated hemoglobin (HbA1c) value of 7-9%, albumin-to creatinine ratio (ACR): A3 \[\>300 mg/day; ACR, \>300 mg/g (\>30 mg/mmol)\], GFR category 3 (moderately decreased) has now been divided into categories G3a \[45-59 mL/ min1 /(1.73m2) and G3b \[30 -44 mL/ min1/(1.73 m2) which represent mildly to moderately decreased function and moderately to severely decreased function and no previous exercise training in the past 6 months.
* All participants were free from diabetic retinopathy, severe diabetic neurophathy, severe cardiovascular and cerebrovascular diseases.
* Participants had Montreal Cognitive Assessment - Thai (MoCa-T) scores between 18 24 points.
* Not having uncontrolled high blood pressure (Systolic blood pressure; SBP) \>159 mmHg and Diastolic blood pressure; DBP) \> 99 mmHg

Exclusion Criteria:

- Participants were excluded if they dropped out or completed less than 80% of the training schedule
Resilience Skills Self-Management for Chronic Pain.

The investigators will conduct a randomized controlled trial of an 8-week resilience-enhanced CBT online self-management program for chronic pain plus usual care (PRISM), standard e-CBT self-management plus usual care (e-CBT), and usual care alone. Thus, 300 individuals with chronic pain will undergo a comprehensive pre-intervention assessment that includes a blood draw (T1). Participants will then be randomized 2:2:1 as follows: e-CBT (n=120), PRISM (n=120) and usual care (n = 60). Immediately post-intervention (T2) and at 6 months (T3) and 12 months (T4) after that, participants undergo the same in-person assessment including blood draw. Telomerase activity will be assessed at T1, T2 and T3; and telomere length at T1 and T4


Eligibility Criteria:
Inclusion Criteria:

* Primary back or spine pain diagnosis from the Back \& Pain Center at University of Michigan.
* High scores on the 2011 survey criteria for Fibromyalgia. The survey criteria for FM consist of an assessment of widespread pain and symptom severity.

Exclusion Criteria:

* Co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus erythematosus.
* Medical conditions that can impair health status independent of spine pain and FM, including cardiopulmonary disorders (e.g. CHF, COPD), uncontrolled endocrine or allergic disorders (e.g., thyroid dysfunction, Type I diabetes), or malignancy within the preceding 2 years
* Current psychotic disorder (schizophrenia, etc.), dissociative identity disorder, untreated bipolar disorder, active suicide risk, or current alcohol / drug dependence.
* Planned major surgery in the next 12 months;
* Pregnancy or taking steroid medications
* Recent pain interventions ≤6 weeks prior to study (e.g., back surgery, epidural steroid injections) or planned interventions for the study period (e.g., surgery scheduled). Ongoing physical therapy will be allowed and new physical therapy or exercise regimen will be addressed during data analysis;
* Cognitive impairment or dementia (inability to give consent or meaningfully participate);
* Pending or recently received (within 1 years) pain-related disability or Workman's Compensation;
* Unable to read or fluently converse in English;
* Planning to move from the area in next 14 months;
* In the judgment of the PIs the individual would not be able to meaningfully participant.
Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy

The primary goal of this study is to collect short-term and long-term health outcomes of a robotic transhiatal esophagectomy procedure. Clinical (or health) outcomes measure the effect of the procedure on your overall health status. During this procedure, the surgeon will remove all or part of your esophagus. We want to identify patients who will have this procedure. We will look at data elements before, during, and after your procedure to understand the impact of this surgery on your post-operative clinical outcomes.

Esophagectomy is a complex surgical procedure performed to treat various esophageal disorders. The surgery involves the removal of all or part of the esophagus and reconstruction using other parts of the gastrointestinal tract. Different surgical approaches and techniques have been developed, including open (transthoracic or transhiatal), minimally invasive (video-assisted thoracoscopic surgery or robotic-assisted), and hybrid approaches. These techniques may yield different clinical outcomes, and there is still ongoing debate regarding the optimal approach. Nevertheless, minimally invasive approaches, including robotic esophagectomy, are generally preferred given the lower morbidity. This prospective clinical registry aims to investigate outcomes of elective robotic transhiatal esophagectomy, the preferred approach at Northwestern Memorial Hospital, for adult patients undergoing this procedure. By collecting clinical and demographic data prospectively, we hope to identify factors that contribute to improved outcomes and guide future surgical practice.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years or older)
* Patients undergoing elective esophagectomy for any indication
* Patients who have already had an elective esophagectomy for any indication
* Patients with consent providing capacity

Exclusion Criteria:

* Patients undergoing emergent esophagectomy
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Vulnerable Populations
Healthy Moms for Healthy Babies

HealthyMoms is prototype website with accurate and easily accessible information on the impact of depression, anxiety and stress during pregnancy and the importance of healthy behaviours (physical activity, nutrition, sleep). This clinical trial is to pilot test the implementation of the e-health intervention alongside standard antenatal care.


Eligibility Criteria:
Inclusion Criteria:

* Able to communicate in French or English
* At least 18 years of age
* First child
* Internet and email access

Exclusion Criteria:

* Do not meet inclusion criteria
Development of Vitamin D as a Therapy for Breast Cancer - Phase 2

This study will assess whether levels of vitamin D impact the characteristics of a woman's breast cancer at diagnosis, and whether a short course of vitamin D in women with low levels of vitamin D changes the gene expression of their breast cancers.

Patients undergoing core needle biopsy of breast abnormalities suspicious for breast cancer will be identified and enrolled in study. As well as those who have had a core needle biopsy demonstrating breast cancer, but who have not yet undergone local surgical treatment, chemotherapy, or hormonal therapy are also eligible. patients with breast cancer on core biopsy will be eligible.

Participants will be assigned to treatment (0, 2000, 4000, 6000 IU/day vitamin D by mouth) based solely on their serum vitamin D levels (Normal: \>40 ng/mL; Low-normal: 31-40 ng/mL; Low: 20-30 ng/mL; Very-low: \<20 ng/mL). Prior to definitive breast cancer surgery, vitamin D level, parathyroid level, and calcium will be reassessed. Samples of the patients original core biopsy and pathology specimen from their definitive surgical therapy will undergo gene expression profiling.

The ultimate plan is to correlate baseline vitamin D levels with classic prognostic and predictive markers to see if breast cancer biology is impacted by baseline vitamin D level and by vitamin D supplementation and to see if vitamin D supplementation results in gene expression changes similar to those of the vitamin D sufficient group.

Eligibility Criteria:
INCLUSION CRITERIA:

* Undergoing core needle biopsy for a breast abnormality suspicious for breast cancer.
* Has undergone a core needle biopsy demonstrating breast cancer and has not yet had any further therapy, provided the core needle biopsy is available for analysis.
* No prior therapy for breast cancer within the past 5 years.
* 18 years of age or older.
* Ability to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

* History of parathyroid disease, hypercalcemia, or kidney stones.
* Supplemental vitamin D other than from a standard multiple vitamin or from standard formulations of calcium and vitamin D (eg, calcium citrate with vitamin D) within the prior 6 months.
* History of renal failure requiring dialysis or kidney transplantation.
* Pregnant or nursing
* Receiving supplemental calcium \> 1200 mg calcium per day during study.
* Initial treatment of breast cancer will not be with breast-conserving surgery or mastectomy.
* Locally-advanced breast cancer
* Plans for neoadjuvant chemotherapy, hormonal therapy, or other systemic therapy
* Plans for preoperative radiation therapy
* Plans for breast cancer surgery, and does not allow for at least 10 days of vitamin D intervention.
* Any condition potentially interfering with subjects ability to comply with taking study medication.
* Any medical condition that would potentially interfere with vitamin D absorption, such as celiac sprue, ulcerative colitis.
* Current participation in another research study that would increase risk to subject, in the opinion of the investigators
Clinical Post-operative Assessment of Chronic Signs & Symptoms Related to Infected Primary Molars After Using Rotary Versus Manual Systems in Cleaning the Root Canals

One of the most important concerns in pediatric dentistry is the loss of necrotic primary molars leading to space loss. pulpectomies for primary teeth with severe pulpal involvement should be considered as the treatment of choice.

Bacteria plays an essential role in the initiation and perpetuation of pulpal and periapical disease. The investigator's target when cleaning and shaping the root canal system is to remove bacteria-containing tissue.

The removal of organic debris is the main purpose of instrumentation in pulpectomy procedures in primary teeth, this could be achieved using manual or rotary Ni-Ti files. A practical pulpectomy technique for the primary teeth should include the following:1) Fast procedure with short treatment time and minimal number of appointments.2) Effective debridement of the root canal without weakening the tooth structure or endangering the underlining permanent teeth.3) Minimal procedural complications. 4) Maintaining tooth function until it is naturally exfoliated.

Manufacturers using rotary files highlight their cleaning efficiency for root canal preparations, simple procedures, and decreased procedure time, which is especially important in children.

Considering that preparation time is an important clinical factor in pediatric patient management, the use of rotary instruments for pulpectomies in primary teeth is recommended.


Eligibility Criteria:
Inclusion Criteria:

* primary molars with fistula / chronic abscess
* teeth which if lost possibility of space maintainer construction exists
* pre-operative radiograph showing absence of severe root resorption

Exclusion Criteria:

* teeth with non-restorable crowns
* expected shedding time within one year
Foxiga Korea Local Phase 4 Study

To evaluate the effect of dapagliflozin on body composition in Korean T2DM subjects.12-month, randomised, open-label, parallel-group, multi-centre phase IV study.

This is a 52 weeks, randomized, open-label, parallel-group, multi-centres phase IV study.

Participants will be randomized 1:1 to receive dapagliflozin 10 mg qd or glimepiride 1\~2 mgqd in an open-label manner for 12 months as add-on to metformin 1000 mg.

Parallel group study design was chosen. In order maintain the practicality of the phase IV study, open label design of study drug delivery was chosen. The reading of the DXA scans will be conducted by one expert in blinded manner. Glimepiride is the most frequently used SUs in Korea and therefore this was chosen as comparator.Dapagliflozin treatment will be associated with reduction of total body FM, BW, abdominal VAT and SAT volume compared with glimepiride.

Eligibility Criteria:
Inclusion Criteria:

1. Adults with T2DM (Male or female, ≥ 19 and ≤ 75 yrs)
2. Patients in insufficient glycemic control (HbA1c \> 7.5% and \< 9.5% in recent 4 weeks)
3. Patients with an unchanged dose of metformin (≥ 1,000 mg/day) for \> 8 weeks prior to randomization
4. Written informed consent
5. WOCBP must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose.

   * WOCBP must have a negative urine pregnancy test at screening visit WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal.
   * WOCBP must be willing to use a medically accepted method of contraception that is considered reliable in the judgment of the Investigator.

Exclusion Criteria:

1. Type 1 diabetes or history of diabetic ketoacidosis
2. Pregnant or breast-feeding patients
3. eGFR \< 60 mL/min/1.73 m2 (MDRD) on visit 1.
4. Indication of active liver disease (AST/ALT/total bilirubin \> 3 X upper limits of normal) on visit 1.
5. Acute coronary syndrome, stroke or TIA within 3 months prior to randomization
6. Bariatric surgery within 2 years; treatment of anti-obesity drugs 3 months prior to randomization; any treatment leading to unstable body weight. (Unstable body weight is considered reliable in the judgment of the Investigator.)
7. History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
8. History of any other malignancy within 5 years (with the exception of successfully treated non-melanoma skin cancers)
9. History of alcohol or drug abuse judged by physician within 3 months prior to randomization
10. Concomitant participation in any other clinical study.
NMDA Enhancer for the Treatment of Mild Alzheimer's Disease

NMDA neurotransmission plays an important role in learning and memory. NMDA receptors (NMDAR) were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease (AD). This study is a randomized, double-blind, placebo controlled drug trial for testing the efficacy of NMDAR-enhancer. All subjects will be allocated randomly to 4 groups: (1) DAOI-A group; (2) DAOI-B group; (3) DAOI-C group; (4) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI may yield better efficacy than placebo for cognitive function in patients with AD.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Alzheimer's disease
* MMSE between 10-26
* CDR 1

Exclusion Criteria:

* Hachinski Ischemic Score \> 4
* Substance abuse/dependence
* Parkinson disease, epilepsy, dementia with psychotic features
* Major depressive disorder
* Major physical illnesses
* Severe visual or hearing impairment
Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE)

Primary Outcome Measures:

The primary endpoint was the time to onset of symptom relief of the first attack in the double blind phase. H0: λ icatibant/λ tranexamic acid =1 versus H1: λ icatibant/λ tranexamic acid ≠1 Where: λ icatibant refers to the hazard rate under icatibant and λ tranexamic acid refers to the hazard rate under tranexamic acid.

Secondary Outcome Measures:

* Additional efficacy assessments (Time to Almost Complete Symptom Relief)
* Safety and tolerability
* Pharmacoeconomics

This was a Phase III, randomised, double blind, double dummy, multicentre, controlled,parallel group study of a 30 mg s.c. formulation of icatibant for the treatment of patients with moderate to very severe symptoms of cutaneous and/or abdominal symptoms of HAE.

The study consisted of two parts: controlled phase and OLE phase. For the primary endpoint, Efficacy was determined by evaluating the differences in study outcomes using a Visual Analogue Scale for patients treated with icatibant and tranexamic acid.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years;
* Documented diagnosis of HAE Type I or II (confirmed C1-INH deficiency);
* Current edema in the cutaneous, abdominal and/or laryngeal areas;
* Current edema moderate to severe according to the investigator's Symptom Score.

Exclusion Criteria:

* Diagnosis of angioedema other than HAE,
* Participation in a clinical trial of another investigational medicinal product (IMP)within the past month
* Treatment with any pain medication since onset of the current angioedema attack
* Treatment with replacement therapy, including C1-INH products, less than 3 days before onset of the current angioedema attack
* Treatment with Tranexamic acid replacement therapy within a week before onset of the current angioedema attack
* Treatment with ACE inhibitors
* Contraindications for Tranexamic acid
* Evidence of coronary artery disease based on medical history or Screening examination in particular unstable angina pectoris or severe coronary heart disease
* Congestive heart failure (class 3 and 4)
* Serum creatinine level of ≥ 250 μmol/L
* Serious concomitant illness that the investigator considered to be a contraindication for participation in the trial
* Pregnancy (as assessed prior to treatment) and/or breast-feeding
Comparison of Repeatability Between SS and SD-OCT for Measuring Retinal Thickness in Various Retinal Diseases

Comparison of intradevice repeatability of thickness measurements for macular area in the eyes with normal and various retinal diseases using SS-OCT and SD-OCT

The investigators studied the intradevice repeatability of thickness measurements for total retina, retinal nerve fiber layer (RNFL) and ganglion cell-inner plexiform (GC-IPL) layers of macular area in the eyes with normal and various retinal diseases using SS-OCT and SD-OCT and compared the repeatability between two devices.

Eligibility Criteria:
Inclusion Criteria:

* Age-matched normal group was composed of subjects with age over at least 19 years,
* a best-corrected visual acuity of 20/25 or higher,
* normal fundus and intraocular pressure (IOP) \< 21mm Hg.

Exclusion Criteria:

* an spherical equivalent (SE) larger than ± 6 D,
* cataract graded as more severe than grade 3 (Lens Opacities Classification System III),
* a history of glaucoma and optic nerve diseases, or a history of vitrectomy.