cyrilzakka/clinical-trials huggingface dataset:
Safety Study to Evaluate LY3114062 in Participants With Inflammatory Arthritis

The main purpose of this study is to learn more about the safety of LY3114062 and to find out how well it is tolerated in participants with an inflammatory arthritis. The study will also investigate how the body processes the drug and how the drug affects inflammatory arthritis. The study is expected to last about 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Signs or symptoms of an inflammatory arthritis for a duration of at least 8 weeks at screening.
* Presence of at least 3 out of 66 swollen joints at screening and baseline, as determined by the swollen joint count assessment forms.

Exclusion Criteria:

* Synthetic disease-modifying antirheumatic drugs DMARD use as follows:

  * ANY treatment with tofacitinib within 28 days prior to baseline or planned treatment with tofacitinib during the study;
  * Treatment with other synthetic DMARDs (eg, hydroxychloroquine, methothrexate, leflunomide, sulfasalazine, and gold salts) at an unstable dose within 28 days prior to baseline or if the dose of drug is planned to be changed during the study.
* Previous treatment with marketed biologic DMARDs as follows:

  * Etanercept, adalimumab, or anakinra \<4 weeks prior to baseline;
  * Infliximab, certolizumab pegol, golimumab, abatacept, or tocilizumab \<8 weeks prior to baseline;
  * Rituximab \<12 months prior to baseline

Note: Other biologic agents for indications other than an inflammatory arthritis may be allowed after discussion with the sponsor

* Treatment with \>10 mg/day, or unstable dose, of oral prednisone or equivalent within 28 days prior to baseline.
* Confirmed or suspected septic arthritis, crystal arthropathy, systemic lupus erythematosus, reactive arthritis, or certain other rheumatic conditions.
Intravitreal Injection of Ranibizumab Versus Sham Before Vitrectomy in Patients With Proliferative Diabetic Retinopathy

Certain percent of the eyes with proliferative diabetic retinopathymay require pars plana vitrectomy (PPV) due to vitreous haemorrhage, proliferative membrane, and tractional retinal detachment. This study will compare intravitreal injection of anti-vascular endothelial growth factor (ranibizumab) versus sham injection before vitrectomy for PDR. The main focus is to see if pre-operative injection of ranibizuman can reduce peri-operative hemorrahge related complications.

Eyes responding to panretinal photocoagulation can remain stable for decades, but incomplete responses and relapses can occur in a certain percent of diabetic patients showing as proliferative diabetic retinopathy. At present vitrectomy is the main intervention for those eyes with vitreous hemorrhage, proliferative membrane, and tractional retinal detachment. And the surgical procedure might be complicated because of intraoperative bleeding. And post-operative complications might be also involved. Perioperative use of intraocular anti-VEGF might be associated with less hemorrhage related complications and better visula acuity. This study will compare intravitreal injection of anti-vascular endothelial growth factor (ranibizumab) versus sham injection one week before surgery. The investigators tried to make sure whether pre-operative injection of ranibizuman can reduce reduce intra-operative bleeding, reduce the frequency of using endodiathermy, decrease surgical time, improve microcurculation of retina, and elevte best-corrected visual acuity.

Eligibility Criteria:
Inclusion Criteria:

* type I or type II diabetes
* there is clear indications for vitrectomy due to proliferative membrane in the vitreoretinal interface, mild hemorrhage, or tractional retinal detachment
* retinal large vessels could be detected within one PD away from the edge of optic disc by OCT
* microcurculation could be detected by FFA in at least one quadrant
* the patient could tolerant FFA examination

Exclusion Criteria:

* a history of vitrectomy or scleral bucke in the included eye
* retinal laser photocoagulation treatment within 90 days in the included eye
* anti-VEGF treatment with 90 days in either eye
* there is cocurrent neovascular glaucoma in the included eye
* any reason that might hinde the procedure of vitrectomy, FFA OCT or the observation of ocular fudus
* a history of cere-brovascular accident or heart stroke
* renal failure
* could not attend follow up regularly
Effects of Radiotherapy in Borderline and Malignant Phyllodes Tumors After R0 Resection

Breast phyllodes tumors (PT) are rare fibroepithelial neoplasms originating from stromal tissue and account for less than 1% of all breast tumors. The World Health Organization (WHO) classifies PT into benign, borderline, and malignant subtypes based on pathological features such as mitotic activity, cellular atypia, tumor margin invasion, and stromal composition 1. The presence of malignant heterologous elements characterizes the tumor as malignant 2. Surgery is the primary treatment. However, even after R0 resection, borderline phyllodes tumors (BoPT) and malignant phyllodes tumors (MPT) patients remain face a high risk of local recurrence, with rates of 15%-20% and 25%-30%, respectively. Moreover, metastases occur almost merely in MPT, with a distant metastasis rate reaching 22%.

Adjuvant radiotherapy has attracted attention for its potential to improve local control and reduce recurrence, but the role after R0 resection in PT patients remains unclear. Radiotherapy significantly reduces local recurrence rates in BoPT and MPT but shows no substantial benefit in benign cases. However, a meta-analysis by Yu et al. found that this effect is limited to MPT. Additionally, the effect of radiotherapy on survival rates in PT remains controversial. Most existing studies are retrospective and face limitations such as small sample sizes. The rarity of PT and conflicting evidence of impact of radiotherapy necessitate further study. While prospective trials are difficult due to limited cases, well-designed retrospective studies can offer valuable insights. In this study, the investigators also analyzed prognostic factors and identified subgroups to provide a clinical reference for the application of postoperative radiotherapy in BoPT and MPT patients.


Eligibility Criteria:
Inclusion Criteria:

* patients who were initially diagnosed with BoPT or MPT and underwent R0 resection surgery

Exclusion Criteria:

* patients who had their initial surgery at other hospitals without accurate baseline data
* patients who received radiotherapy before surgery
* those presenting with initial distant metastasis before treatment
* patients lost to follow-up after treatment
* patients with a history of or concurrent breast cancer or precancerous lesions in the ipsilateral breast or with breast cancer in the contralateral breast
Effect of Kinetic Control Retraining on Neck Proprioception and Functional Outcome in Patients With Cervical Radiculopathy

The aim of this study is to investigate the effect of kinetic control retraining on neck proprioception and functional outcome in patients with cervical radiculopathy.

Cervical radiculopathy (CR), which is a normal result of degenerative changes such as cervical disc herniation and bone hyperplasia, is characterized by neck pain and radiating pain from the neck to the shoulder. Neck pain has a major physical, psychological, and socioeconomic impact, as it is the fourth most frequent cause of disability, preceded of low back pain, depression, and arthralgia. In fact, up to 50-70% of the entire population will experience (at least) one episode of neck pain clinically important throughout their life.

Prolonged or recurring stress exposure, pain catastrophism, and fear-avoidance behaviors can trigger variable responses to pain thresholds" intolerance depending on the magnitude of the individual stress response.

Regular physical exercise is a key factor for the prevention of many chronic diseases. Physical exercise (PE) can be used as a primary non-pharmacological clinical tool because it can improve antioxidant capacity, reduce oxidative stress and inflammation and increase energy efficiency. Depending on the volume, the intensity and the frequency of exercise, acute or chronic biochemical and physiological responses are induced. Once movement meets control, they can regain the choices lost in the presence of pain and give people the optimal choice in how they move, these choices are lost with movement impairment. So, the movement value is a central theme in the physical therapy profession and functional concepts which build on movement therapy. These concepts are built on kinetic control approach. This study may add missing information to the existing literature and suggests directions for the effect of kinetic control retraining on neck proprioception and functional outcome in patients with cervical radiculopathy.

Eligibility Criteria:
Inclusion Criteria:

* Forty Four patients suffering from chronic cervical unilateral radiculopathy (symptomatic duration) (3 months to 1year).
* Their age ranges 40-55 years, from both sexes.
* Body mass index (BMI) of less than 30 Kg/m2
* Cervical spondylosis (at the levels of C5-C6/C6-C7 confirmed by cervical MRI)..

Exclusion Criteria:

* Cervical myelopathy with evidence of pyramidal, posterior column, and or spinothalamic tract lesions.
* Patients with decreased range of motion of cervical spine secondary to congenital anomalies, musculature contracture, or bony block.
* Previous cervical or shoulder surgery or trauma.
* Cervical instability caused by structural problem (e.g. ligament tear or spondylolithesis.
* Psychological problems interfering with the patient understanding of the orders, or patients who did not have direction preference.
* Vertebro-basilar artery insufficiency, diabetic neuropathy.
* Comorbidities that impact physical activity (e.g., cerebrovascular accidents, severe heart disease). - Double crush syndrome and thoracic outlet syndrome.
Early Intervention Foster Care: A Prevention Trial

The Early Intervention Foster Care \[EIFC\] project is an efficacy trial of the Oregon Social Learning Center Multidimensional Treatment Foster Care Program, a preventive intervention that targets 3 commonly co-occurring variables among young foster children: (1) behavioral problems, (2) physiological dysregulation within the neuroendocrine system (i.e., HPA axis activity), and (3) developmental delays.

The Early Intervention Foster Care project is an ongoing randomized efficacy trial to evaluate the Early Intervention Foster Care Program (EIFC). EIFC, also known at Multidimensional Treatment Foster Care-Preschool (MTFC-P), is a preventive intervention that is specifically designed to address the needs of preschool-aged foster children and their caregivers. Over the first 5 years of the project data was collected from 177 preschool-aged children, 117 of whom were in the Oregon foster care system and 60 of whom were living with their biological families for a community comparison sample. Foster children in the study were randomly assigned to the EIFC experimental intervention condition or a regular foster care condition (RFC). The following hypotheses are under investigation: (1) Relative to children in the RFC condition, children in the EIFC condition will show greater improvements in temporally proximal outcomes (e.g., behavioral/emotional, salivary cortisol, and developmental) and in temporally distal outcomes (e.g., behavioral functioning in the school setting; long-term placement stability, including reunification or adoption; and mental health status, including psychiatric diagnoses). (2) Proximal outcomes over the course of the intervention will predict distal outcomes during the early elementary school years. (3) Proximal outcomes will be mediated by caregivers' childrearing practices-specifically, engagement with and monitoring of the child in the home, the quality and consistency of parental discipline, and the use of positive reinforcement strategies. (4) The same childrearing practices will mediate the psychosocial adjustment of the child in the aftercare setting (i.e., return to family of origin, placement in adoptive home, or continued placement in long-term foster home). (5) The EIFC intervention will cost-effectively reduce the need for mental health and social services for children, decreasing the length of time that children spend in foster care and reducing the need for special education services for children.

Eligibility Criteria:
Inclusion Criteria:

* child age 3 to 6 years currently in foster care
* child has entered new foster placement
* child currently living in Lane County, Oregon

Exclusion Criteria:

* child is medically or developmentally unable to complete assessment tasks
Proton Craniospinal Radiation Therapy vs. Partial Photon Radiation Therapy for Leptomeningeal Metastasis From Solid Tumors

The investigators are doing this study to find out whether proton craniospinal radiation therapy (proton CSI) or partial photon radiation therapy is more effective at preventing leptomeningeal metastasis from worsening. The proton CSI targets the entire space containing the CSF, brain, and spinal fluid. The partial photon radiation therapy treats only areas where the patient is having symptoms, such as the entire brain or part of the spine. The investigators also want to find out if proton CSI improves the symptoms patients may be experiencing because of the leptomeningeal metastasis. In addition, the investigators will compare the side effects of proton CSI and partial photon therapy.

Patients undergoing proton beam RT will receive their treatment at the New York Proton Center in New York, NY. As part of the New York Proton Consortium, MSK has contracted for its faculty to treat patients at the New York Proton Center. If it is unfeasible for patients to get treated at NYPC, patients will have the decision to get treated at ProCure in Summerset, NJ.


Eligibility Criteria:
Inclusion Criteria:

* Patient with solid tumor malignancy with leptomeningeal metastases established radiographically and/or through CSF cytology
* Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastases
* Patients of all ages
* KPS ≥ 60 for participants ≥ 16 years old, and Lansky ≥ 60 for participants \< 16 years old
* For adult patient, the patient/ legally authorized representative is able to provide informed consent. For pediatric patient, a parent is able to provide informed consent.
* Adequate bone marrow function:

  * Hemoglobin \> 8g/dL
  * Absolute neutrophil count \>1,000/mm
  * Platelet count \> 100,000/mm
* Female subjects must either be of non-reproductive potential (i.e. pediatric patients, OR postmenopausal by history \[≥ 60 years old, or with no menses for \>1 year without an alternative medical cause\], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks prior to starting treatment.
* Patient at reproductive potential must agree to practice an effective contraceptive method.

Exclusion Criteria:

* Patient with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy
* Patient with extensive systemic disease and without reasonable systemic treatment options
* Patient who is unable to undergo MRI brain and spine with gadolinium contrast
* Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances
* Pregnant or lactating women.
An Observational Study to Evaluate Lymph Metastases and Prognoses of the Patients With Esophageal Cancer

The real-world observational study was designed to explore lymph metastases and prognoses of the Chinese patients with thoracic T1-T3 esophageal cancer

This trial is a real-world non-interventional observational study. The Chinese patients with thoracic T1-T3 esophageal cancer enrolled from Jan.1999 to Jun.2017 were included and the study data on pathologically diagnosed patient demographic/tumor biological characteristics were collected to evaluate the relevance of lymph metastases and prognoses of the subjects.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>= 18 years old;
* Patients who received radical resection of esophageal cancer;
* Pathologically diagnosed patients with thoracic T1-T3 esophageal cancer after surgeries;

Exclusion Criteria:

* Patients who received upper gastrointestinal surgeries;
* Patients with second primary tumors;
STEP: Enhanced Physical Activity in Children and Youth With Epilepsy

Epilepsy is common in childhood. Children with epilepsy are at increased risk of impaired health, functioning, psychological well-being, and quality of life. There is compelling evidence that physical activity improves the medical and psychosocial aspects of health in adults with epilepsy - but there are no such studies in children. This study is to see if increased levels of physical activity can influence children's functioning, psychological well-being, and quality of life.

There are many unfounded assumptions about the dangers of exercise in children with epilepsy - assumptions that may be seriously detrimental to children's health, and that we have good reason to challenge. This project explores the innovative idea that enhancing physical activity in children with epilepsy will have a positive effect on medical and psychosocial outcomes. The primary purpose of this study is to examine whether increasing physical activity levels through a six-month walking program, that includes behavioral counselling and self-monitoring of physical activity, as compared to varied un-standardized current practices, positively influences health and quality of life over one year. The secondary purposes are to (i) determine which environmental and personal facilitators and barriers to physical activity are experienced when increasing physical activity levels through a six-month walking program; (ii) determine if physical activity levels established during the six-month program will be sustained over a subsequent six-month period that includes self-monitoring of physical activity only; (iii) identify aspects of health that are amendable to change with enhanced physical activity, and explore the relationships among physical activity and impairments, functioning, psychological well-being and quality of life; and (iv) assess if there is a dose-response relationship between physical activity and a variety of health and social factors and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Has epilepsy, as confirmed by a pediatric neurologist, with at least 1 seizure in the previous 12 months
* Ambulatory
* Fluency English or French
* Intellectual functioning at or greater than grade 3 level, as judged by parents
* Access to a computer

Exclusion Criteria:

* Additional diagnoses of psychogenic seizures or autism
* Enrolled in a potentially confounding trial
Non-Invasive Determination of Fetal Chromosome Abnormalities

The overall significance of this study is to develop a laboratory developed test (LDT) to use a new marker in the maternal blood to better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome (trisomy 21), Edward's syndrome (trisomy 18), Patau syndrome (trisomy 13), Klinefelter syndrome, (47, XXY), and other chromosome abnormalities. Accomplishing that task would reduce the need for invasive amniocentesis and CVS procedures.


Eligibility Criteria:
Inclusion Criteria:

* This study is only applicable to women who are between 8 and 30 weeks' gestation and who have been determined increased risk for fetal aneuploidy. In the interest of expediting and simplifying this study, the investigators want only women who have already decided to undergo second-trimester amniocentesis or CVS.

Exclusion Criteria:

* The only exclusion criteria are those mentioned.
Acute Cardiovascular Effects of Cigarette Smoking

Twenty healthy smokers will be subjected to measurement of Pulse, Blood Pressure, electrocardiogram (ECG) and Echo at baseline and after smoking a cigarette. The measurements will be compare for any cardiovascular effects of a cigarette smoking on these parameters.

Twenty male persons habituated to smoking (at least 5 cigarettes/day) will be recruited after an informed consent. Healthy persons with no systemic illness will be included. After a history and a routine examination, subjects will be asked to abstain from smoking for 3 hours and then their pulse, BP, ECG and echo recorded. The measurements will be repeated after 15 min. and the average of these two taken as baseline readings. Then, they will be asked to smoke a cigarette and the measurements taken again. Special focus will be on Doppler measures of left ventricular (LV) function. The measurements are repeated immediately and at 5,10 and 15 min. The data will be analyzed for any cardiovascular effects of smoking a cigarette. Chi square test for proportions and t-test for means will be done. A p value \< 0.05 will be taken as significant.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male smokers (at least 5 cigarettes /day) \>18 years old.

Exclusion Criteria:

* Any cardiac or respiratory or systemic illness,including hypertension.
Epidemiological Study of Floating Hip Injuries in Assiut University Hospitals

Aim of the study is to describe and study the patterns of floating hip injuries and assess the current management in Assiut University Hospitals Trauma Centre to help reach the best approach to plan treatment for these severe and difficult injuries.

Floating hip injuries are defined as ipsilateral fractures of the pelvis, acetabulum and femur . The term "floating" is used in orthopedic literature to describe certain patterns of skeletal injuries that share one common character which is disruption and discontinuity of bones above and below a joint. This type of injury is very rare and occurs due to high-energy trauma most commonly road traffic accidents and falls from height. Patients of the floating hip injuries are usually poly-trauma patients with other associated potentially serious injuries in the head , chest or abdomen or fractures in other sites. Complication rates are high in these patients due to the severe and unstable nature of this injury. The femoral fracture may be associated with pelvic, acetabular fracture or both, this pattern was classified by Liebergall et al into 3 types; A, B and C with type A involving pelvic fracture associated with an ipsilateral femoral fracture and type B involving an acetabular fracture associated with an ipsilateral femoral fracture and type C involving fractures to both the pelvis and acetabulum. The lack of common terminology , probably because of their rarity and relative low incidence of associated vascular injuries , could have been the reason for the underappreciation of the peculiarity of these injuries. Previous studies have been limited in number without deep analysis of the current practice patters and incidence of complications.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged 18 to 60) with ipsilateral fractures of the pelvis, acetabulum and femur

Exclusion Criteria:

* Ages below 18 or above 60
* pathological and fragility fractures