cyrilzakka/clinical-trials huggingface dataset:
Survival Significance of Molecular Pathology and Genetic Variation in Brain Gliomas

This study aims to collect clinical, radiological, pathological, molecular and genetic data including detailed clinical parameters, MR and histopathology images, molecular pathology and genetic data. This study seeks to find the prognostic and clinical significance based on molecular and genetic biomarkers/subgroups of gliomas.

Precise classification based on molecular and genetic biomarkers/subgroups for gliomas is challenging. This study aims to collect clinical, radiological, pathological, molecular and genetic data including detailed clinical parameters, MR and histopathology images, molecular pathology (1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations, etc) and genetic data (Whole exome sequencing, RNA sequencing, proteomics, etc). This study seeks to find the prognostic and clinical significance based on molecular and genetic biomarkers/subgroups of gliomas.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have radiologically and histologically confirmed diagnosis of primary glioma
* Life expectancy of greater than 3 months
* Must receive tumor resection
* Must have sufficient fresh frozen tissues for NGS
* Signed informed consent

Exclusion Criteria:

* No gliomas
* No sufficient amount of tumor tissues for detection of molecular pathology
* Patients who are pregnant or breast feeding
* Patients who are suffered from severe systematic malfunctions
* Do not have sufficient fresh frozen tissues for NGS
A Prospective Birth Cohort of Infants With Allergy and Neurodevelopmental Disorders in China

In this study, a birth cohort was established to demonstrate the causal relationship between allergies and neurodevelopment disorders in infants and young children, and to find out the influencing factors of neurodevelopment disorders in early life.

In this study, a birth cohort was established, and infants were divided into two groups according to inclusion and exclusion criteria ( see study design ). One group was allergic group, and the other group was control group. The two groups will be followed up for up to 6 years, and specimens ( blood, urine, feces ) and test data ( height, weight, GESELL, etc. ) will be retained during the follow-up period. The outcome indicators were ASD, ADHD or LD, and DSM-5 was used as the diagnostic criteria.

Eligibility Criteria:
Inclusion Criteria:

* ①Allergic questionnaire results were positive.

  * The living area is Jinan City and its surrounding areas in Shandong Province, which is convenient for follow-up.

Exclusion Criteria:

* There is a clear diagnosis of brain developmental disorders

  * Psychological diseases

    * History of craniocerebral trauma or brain organic disease ④Major physical diseases ⑤Visual and auditory disorders ⑥ Epilepsy ⑦Intellectual disabilities
A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes

This study is looking at semaglutide in combination with a potential new medicine (NNC0480-0389) in people with type 2 diabetes.

The study is being conducted to see how well semaglutide, in combination with different doses of NNC0480-0389, work to lower blood sugar levels. Results from this study will be used to select the doses of the two medicines for other studies.

Participants will either get:

Semaglutide (a medicine doctors can already prescribe for treatment of type 2 diabetes) in combination with NNC0480-0389 (a potential new medicine) or placebo (a 'dummy' medicine that looks like the medicines but without any medicine).

NNC0480-0389 alone, or semaglutide alone which treatment participant get is decided by chance.

Participant will need to take 2-3 injections once every week during the study. One injection will be with semaglutide or placebo and 1-2 injections will be with NNC0480-0389 or placebo.

Participant must inject the study medicines themself into the stomach, thigh, or upper arm.

The study will last for about 41weeks. Participant will have 20 clinic visits. Participant will have blood samples taken at all clinic visits. At 3 clinic visits, participant will also have an electrocardiogram (ECG). This is a test to check participants heart. Participant will have their eyes checked before or at the start of the study and at the end of the study.

Women can only take part in the study if they are not able to become pregnant


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
* Participants treated with diet and exercise as monotherapy or in combination with stable daily dose(s) greater than or equal to 90 days before screening of any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose
* HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)
* BMI greater than or equal to 25 and below 40 kg/m\^2

Exclusion Criteria:

* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with T2D)
Body Weight Supported Training Study

Successful ambulation at home and in the community is the main goal of gait training after incomplete spinal cord injury. Many different treatment approaches have been recommended to achieve this goal. One established intervention to achieve that in a clinical setting is body weight supported (BWS) treadmill training. However, recent studies have suggested that the most optimal gait training should be conducted overground with appropriate support conditions to enable a physiological gait pattern. The training has to be challenging and patients must participate as active as possible.

In addition becoming a functional walker in real world involves a variety of walking skills like walking on uneven surfaces, walking up and down slopes, climbing stairs and avoid obstacles. It has been shown in humans as well as in animals that greater improvements are achieved in walking function if the training is task specific. Thus a constrained task like BWS treadmill training may not be the optimal training intervention to become a functional community walker.

Even greater improvements can be expected if patients feel safe during the overground walking and train at their individual limits. With FLOAT there is now the possibility to conduct a task specific BWS overground gait training in a safe environment. The robotic device allows patients to perform different walking tasks like walking overground, avoiding obstacles, walking on uneven and sloped surfaces, climbing stairs, walking in narrow spaces. A virtual reality setup was integrated into the system that even can simulate specific walking tasks like target oriented walking or walking in crowded environment. Based on the promising results seen in preclinical and clinical research, the investigators assume that unrestricted transparent BWS overground training that allows task specific training of real world walking tasks will induce greater improvements than conventional BWS treadmill training.

The investigators will compare the effect of an intensive 4 weeks unrestricted BWS overground gait training to 4 weeks of intensive BWS treadmill training. Not only functional outcome like walking speed or capacity will be assessed but also detailed kinematics that will help to identify the mechanisms of the underlying improvements in walking function.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* Chronic spinal cord injury (\>6 months)
* Incomplete traumatic or non-traumatic lesion (AIS C, D) above T12
* Able to walk 10m with or without walking devices or physical assistance
* Mini-Mental state examination score ³26 (test will only be performed if cognitive deficits are suspected)

Exclusion Criteria:

* Walking capacity \> 500m in 6mWT
* Current orthopaedic problems
* History of cardiac condition
* Epilepsy
* Potential pregnancy (pregnancy test must be conducted before
* Each neurophysiological testing)Pressure sore stage 2 or higher, located where a harness could affect healing
* Premorbid major depression or psychosis
* Unlikely to complete the intervention or return for follow-up
* Participation in another training study
* Body weight \> 120kg
Special Drug Use-Results Survey of Lipitor Tablets

This study is to evaluate the controlling effect of atrovastatin on plasma lipid to achieve the category-specific targeted lipid levels.

To confirm the low-density lipoprotein cholesterol (LDL-C)-lowering effect of 24 weeks of treatment with Lipitor®(Generic Name : atorvastatin calcium) Tablets and determine the rate of achievement of the category-specific target LDL-C level in patients with hypercholesterolemia; and to confirm the usefulness (efficacy and safety) of atorvastatin in patients who have not responded sufficiently to other statin therapies

Eligibility Criteria:
Patients with hypercholesterolemia who have not achieved the category-specific target lipid level
China PEACE-Retrospective AMI Study

Coronary heart disease (CHD) and heart attacks pose a serious health risk to men and women, however the knowledge about the real-life AMI management in China is limited. Within a nation-wide and regional representative probability sample of hospitals in China, 27,800 AMI inpatient cases will be sampled randomly from 2001 to 2011. The sampled medical records will be reviewed and abstracted in the national coordinating centre, in order to evaluate the treatment pattern, outcomes, and cost for AMI patients, during the past decade. Basic data and innovative evidence will accelerate evidence-based clinical practice and policy making, and improve AMI patients outcomes finally.

Cardiovascular disease (CVD) is a major concern in public health globally, as well as in China, and remarkable variations of resources available and health system performance have been noted. Relatively limited information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice. In addition, little information is available about the magnitude, prognosis, and optimal management of AMI, which is one of the leading causes of mortality and morbidity, both in rural and urban area. Practical and applied knowledge from large unselected population is needed to guide practice and policy for quality improvement and cost reduction.

To investigate the treatment pattern and outcomes of AMI patients during the past decade in China, using a stratified two-stage cluster sampling design, from 175 sampled hospitals, 13,900 AMI cases will be selected in 2011, and 6,950 in 2001 and 2006 separately. Photocopies of the 27,800 medical records of AMI cases will be sent to the national coordinating centre. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted by well trained professional abstractors. By characterizing differences in patients' features, comparing the use of medications and procedures, and examining the in-hospital outcomes, we'll define the gaps between clinical practice and guidelines, as well as the disparities across different regions and hospitals, to evaluated the treatment pattern and outcomes in the last decade in China. New knowledge will be generated about AMI management all over China, to provide evidence for policy-making and clinical guidelines, and to improve AMI patients prognosis in future finally.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with acute myocardial infarction (AMI) according to discharge diagnosis (ICD-9 codes 410 or ICD-10 codes I21)

Exclusion Criteria:
Promoting Intrafamily Accountability for Reducing Cellphone Use While Driving in Adults and Their Teen Children

Research participants and their parents will be recruited to take part in a randomized control trial. Participants' and their parents' cellphone use will be observed during an initial baseline period. Participants and their parents will then be randomly assigned to one of two conditions: opt-out blocking with parental notification, opt-out blocking with bidirectional notification.

In 2012, 3,328 people were killed and an additional 421,000 were injured in crashes involving a distracted driver. Adults aged greater than 40 years old accounted for 44% of these fatalities. Teen driving behavior is heavily influenced by parental driving behaviors with a recent study showing the proportion of teens that text while driving is 14% higher if they have observed their parents doing the same. The proportion of adults who text while driving has recently surpassed teen rates with a 2013 national poll finding 49% of adult car commuters admit to texting while driving, most stating that they did it out of habit. Based on previous findings, it is unlikely that teens will reduce their texting while driving unless their parents do the same.

The objective of this study is to compare measures of acceptance and feasibility across teen-parent dyads randomized to bidirectional teen-parent (teen monitors parent and parent monitors teen) vs. teen only (parent monitors teen) cellphone use while driving.

Research participants will be recruited to take part in a randomized control trial. Participants' cellphone use will be observed during an initial baseline period. Participants will be randomly assigned to one of two conditions (bidirectional teen-parent monitoring or parental monitoring of the teen only). An exit survey and interview will be administered to both the parent and teen separately at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Both parent and teen will be enrolled together as a pair
* Teen:

  * Is a high school student (age 16 or 17 at start of the study)
  * Holds a valid driver's license
  * Lives in parent/guardian's home
  * Primarily drives one car
  * Drives an average of 4 or more trips per week
  * Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan
  * Admits to texting while driving at least once in the last month
* Parent:

  * Is the parent of a teen driver
  * Drives an average of 4 or more trips per week
  * Primarily drives one car
  * Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan
  * Admits to texting while driving at least once in the last month

Exclusion Criteria:

* Parent and/or teen already uses a smartphone app or hardware device to limit cellphone use while driving
Outcomes in Patients and Their Closest Relatives Treated for Congenital Heart Disease With Catheter Based or Surgical Techniques

This study compares clinical, self- reported and cost outcomes in children and adolescents treated with pulmonary valve implantation, percutaneous versus open surgical technique. Since cardiac surgery in children and adolescents affect the whole family, the experience of the patients and their closest relatives are recorded and analysed separately. Cost may be an important factor in the choice of technology (1). Hence, the present study also aims to compare savings in costs, percutaneous versus open technique, related to the individual, their family and society.

1.2 Research questions

1. Percutaneous pulmonary valve implantation or open heart surgery; what are the patients' and their closest relatives narrative experiences
2. Is there a difference in patient and their closest relatives reported outcomes, measured as health related quality of life, in patients with congenital pulmonary disease before the event, 1, 3, 6 and 12 months after percutaneous intervention versus open heart surgery approach?
3. What is the relationship between patient reported outcomes and clinical outcomes before, 1, 3, 6 and 12 months after the treatment?
4. Are there savings in costs related to the individual and their family and society between the two techniques?


Eligibility Criteria:
Inclusion Criteria:

* secure indication of pulmonary valve dysfunction (stenosis and, or regurgitation)
* an indication of surgical correction
* body weight according to the recommendation from the producer of the device
* moderate to serious dilatation of right ventricle
* considerable leak in the tricuspidal valve
* information from former surgery; conduit size, gradient of the stenosis measured by EKKO/MR/ catheterization, X-ray.
* be able to speak and communicate well in Norwegian.

Exclusion Criteria:

* aggressive endocarditis
* not circumferential deposit of calcium
* \< 20 kg
* not able to understand, speak or communicate well in Norwegian
Thrombosis Outcomes in Pediatric Venous Thromboembolism

'The TOP Study' is a prospective cohort study whose main objective is to develop better prognostic biomarkers and identify children at risk of adverse thrombotic outcomes very early in the course after an initial venous thromboembolic events (VTE). The study will compare biomarkers in children that develop poor VTE outcomes (such as recurrence, postthrombotic syndrome and post PE impairment ) after an initial VTE with those that do not develop such outcomes.

All newly diagnosed patients with a first radiologically confirmed thrombotic event (any site) diagnosed at Children's Medical Center, Dallas will be followed prospectively with global coagulation assessment over a 24-month period, and monitored for development of carefully defined adverse VTE outcomes in a blinded manner. Biomarker assessment will include global coagulation assays (thrombin generation assay and modified thromboelastography to study fibrinolysis) at 3, 6, 12, 18 and 24 months post VTE diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Boys and girls age birth (0 years) to equal to or less than 21 years
* A radiologically confirmed first venous thromboembolism episode (both extremity and non-extremity) who have completed anticoagulation therapy as per the 9th edition of the ACCP guidelines

Exclusion Criteria:

* Known malignancy
* Pregnancy or immediate post-partum period (12 weeks after delivery)
* Sickle cell disease
* Known bleeding disorder
Ultherapy™ Treatment Following Sculptra® Treatment

This clinical trial will evaluate clinical outcomes associated with the non-invasive Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.

This study is a prospective,single-center, randomized clinical trial. Up to thirty (30) subjects will be treated. Enrolled subjects will be assigned to one of three (3) groups. Up to 10 subjects per group.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 35 to 60 years.
* Subject in good health.
* Skin laxity in the lower face and neck.
* Grade 1 and 2 on the Knize Scale

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat in the face and neck.
* Excessive skin laxity on the face and neck.
* No scarring in areas to be treated.
* Any open facial wounds or lesions.
* Acne on the face.
* Patients who have a history with keloid formation or hypertropic scarring
* Patients who have a hypersensitivity to injectable poly-L-lactic acid
* Presence of a metal stent or implant in the facial area to be treated.
Modeling Stress-precipitated Smoking Behavior for Medication Development

The purpose of this study is to examine whether guanfacine will attenuate the ability of stress to precipitate smoking lapse behavior in treatment seeking and non-treatment seeking daily smokers.


Eligibility Criteria:
Inclusion Criteria:

* ages 18-60
* able to read and write in English
* smokers

Exclusion Criteria:

* any significant current medical conditions that would contraindicate smoking
* current Diagnostic and Statistical Manual IV (DSM-IV) abuse or dependence of other substances, other than nicotine (or caffeine) dependence
* positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
* women who are pregnant or nursing
* suicidal, homicidal or evidence of severe mental illness
* participants prescribed any psychotropic drug in the 30 days prior to study enrollment
* blood donation within the past 6 weeks
* participants who have engaged in a quit attempt in the past 3 months
* specific exclusions for administration of guanfacine not already specified include: Hypotensive individuals with sitting blood pressure below 90/50 mmHG; EKG evidence at baseline screening of any clinically significant conduction abnormalities, including a Bazett's corrected QT interval (QTc) \>450 msec for men and QTc\>470 msec for women; known intolerance for guanfacine
Effect of Inorganic Nitrate Supplement on Blood Pressure

The primary purpose of this project is to assess the efficacy (effectiveness) of plant-based nitrate tablets to elevate nitric oxide in your system as measured by saliva and effect on lowering blood pressure (BP), supporting blood vessel function in men and women with hypertension.

This clinical trial is to assess the efficacy of plant-based bioequivalent Nitric Oxide supplement for improving blood pressure and endothelial reactivity over a 12 weeks intervention period in individuals with metabolic syndrome. The study also examines the effect of plant-based bioequivalent Nitric Oxide supplement on other markers of cardiovascular function and cardiovascular disease risk including Total, LDL and HDL-Cholesterol, Triglycerides, and a multitude of inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* age 40-75 years
* Hypertension \>130/85 mmHg; men and women, 1:1 and stable medicated hypertensives
* Subjects must provide written informed consent after the scope and nature of the investigation has been explained to them

Exclusion Criteria:

* Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
* Weight in excess of 250 pounds
* Bleeding disorder
* History of known coronary artery disease, myocardial infarction, stroke or life-threatening arrhythmia within the prior six months
* NYHA Class II- IV heart failure
* History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy
* Serum creatinine \> 1.4 mg/dl
* Triglycerides \> 400 at visit 1
* Drug or alcohol abuse, or current intake of more than 14 standard drinks per week
* Concurrent enrollment in another placebo-controlled trial
* Partial ileal bypass or known gastrointestinal disease limiting drug absorption
* Current tobacco use
* Current use of anticoagulants (except for anti-platelet agents)
* Renal failure
* History of hypertensive encephalopathy or cerebrovascular accident
* Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI
* Pregnancy