cyrilzakka/clinical-trials huggingface dataset:
A Study of AMG 820 in Subjects With Advanced Solid Tumors

First in human, open-label, sequential dose escalation and expansion study of AMG 820 in subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥ 18 years old
* Subjects must have a pathologically documented, definitively diagnosed, advanced solid tumor
* Measurable disease per RECIST 1.1 guidelines
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
* Part 2 - Dose Expansion only: Subjects must have tumor tissue that is accessible for core needle biopsy by using minimally invasive procedures and must consent to undergo biopsies of the tumor
* Able to fast 4 to 6 hours for FDG-PET/CT scan, except subjects with prostate or bladder cancers
* Competent to sign and date an Institutional Review Board approved informed consent form
* Adequate hematologic, renal and hepatic function as determined by laboratory blood and urine tests

Exclusion Criteria:

* Men and woman of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and an additional 4 months after receiving the last dose of study drug.
* Women who are lactating/breastfeeding or planning to become pregnant during the duration of the study
* Primary central nervous system (CNS) tumors or CNS metastases
* History of presence of hematological malignancies
* History of arterial or venous thrombosis within 6 months of study enrollment
* History of bleeding diathesis
* Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association \> class II), unstable angina, or unstable cardiac arrhythmia requiring medication, or uncontrolled hypertension
* Hypertension not adequately controlled with medication (diastolic \> 90mmHG; systolic \> 140 mmHG)
* Left ventricular ejection fraction (LVEF) ≤ 50%
* Active infection requiring (IV) antibiotics within 2 weeks of study enrollment
* Known positive test for human immunodeficiency virus (HIV)
* Known chronic hepatitis B or hepatitis C infection
* Positive test for hepatitis B surface antigen or hepatitis C antibody
* Known history of tuberculosis (TB), exposure to active TB-infected individuals, or positive TB skin test (tuberculin or purified protein derivative (PPD) test) upon study entry (subjects previously vaccinated for TB are not excluded unless there is evidence of active TB)
* Anti-tumor therapy within 4 weeks of study day 1 including chemotherapy, antibody therapy, retinoid therapy, or other investigational agent
* Concurrent or prior anticoagulation therapy within 28 days of study day 1
* Major surgery within 28 days of study day 1
* Any co-morbid medical disorder that may increase the risk of toxicity, in the opinion of the investigator or sponsor
The Feasibility of a Brief Attention Training Technique in Improving Behaviour and Attention in Children With ADHD

This study aims to investigate the application of the Attention Training Technique in children with ADHD aged 7-11 years old. The research aims to investigate both the feasibility of this technique in this population as well as whether it can improve symptoms, behaviour and executive functioning.

Attention deficit hyperactivity disorder (ADHD) is a neurobehavioural disorder characterised by core symptoms of hyperactivity, impulsivity and inattention. Its prevalence ranges between 3-9% of school-aged children, making it one of the most common presentations in child and adolescent mental health services.

In the last 10 years, research into the effectiveness of attention training as an intervention for children with ADHD has been increasing. This has tended to follow assumptions that children with the disorder either lack skills in focusing and maintaining their attention and/or have neurological deficits in areas responsible for attention functions. Results have been encouraging, with study participants demonstrating improvements in symptoms and behaviour following a course of attention training. However, the method and length of training has varied across studies.

This study aims to investigate a treatment called the Attention Training Technique (ATT) that approaches attention difficulties in this disorder from a different perspective. Instead of viewing inattention as a result of structural or skills deficits, it posits that children with ADHD have these skills, but are perhaps unaware of the flexibility and control they have over them. This treatment aims to increase this awareness and subsequently improve ratings of attention, behaviour and other areas of executive functioning.

Eligibility Criteria:
Inclusion Criteria:

* Children with a formal diagnosis of ADHD as given by a psychiatrist or community paediatrician
* Children between the ages of 7 and 11. This age group was selected as previous research on attention training in this population has used this age group
* Children who are currently on a waiting list at a Child and Adolescent Mental Health Service (CAMHS) or a child psychology service, or being seen by a CAMHS or psychology service for medication review only
* Children who speak fluent English which will ensure they are able to comprehend the tasks instructions adequately.

Exclusion Criteria:

* Children who are not stabilised on stimulant medication and/or willing to maintain their medication type/dose
* Children with a major neurological illness or acquired central nervous system injury
* Children who at the point of referral have a co-existing diagnosis of an Autistic Spectrum Disorder
* Children who are currently in receipt of another non-pharmacological intervention for ADHD or who are currently taking part in another research trial
The Effect of Circadian Timing Program on Obesity Management and Sleep Quality

This study, it was aimed to examine the effect of circadian timing program created for obese individuals with evening chronotype on obesity management and sleep quality.

The importance of chronotype, which reflects individual preferences in sleep timing and other behaviors, for obesity is mostly unknown. Morning types are more successful in long-term weight control than evening type chronotypes. Those with a sleep preference in the evening and a long sleep time have a higher rate of being overweight / obese than those with a morning preference and sufficient sleep time. Evening-type circadian preferences are indirectly related to food addiction. Individuals with the evening chronotype tend to have higher BMI and unhealthy eating habits.

Although a direct link between chronotype and obesity has not yet been demonstrated, based on the negative health consequences in evening chronotypes; In this study, it is assumed that success in obesity management will increase with well-timed circadian / sleep cycles, adequate sleep time and quality sleep in obese individuals with evening chronotype.

Therefore, in this study, it was aimed to examine the effect of circadian timing program created for obese individuals with evening chronotype on obesity management and sleep quality.

This study will be conducted in an experimental design, in a randomized controlled manner, in accordance with its purpose. The universe of the study will be obese individuals followed in Kocaeli University Hospital Obesity Outpatient Clinic. As a result of the power analysis performed to determine the sample size, the number of individuals in each group was determined as n = 18. The sample of the study will be 36 individuals in total. Participants will be selected to the intervention and control groups by simple randomization method.

Eligibility Criteria:
Inclusion Criteria:

* Being followed in Kocaeli University Hospital Obesity Outpatient Clinic
* Being an obese adult (BMI ≥ 30.0 kg / m²)
* Being in the age group of 18 and over
* Having the evening chronotype (Individuals with a late sleep period)
* Having a calorie-based diet according to body mass index and adapting to his diet
* To know how to read and write
* Not to have sensory losses such as sight and hearing
* Not being physically, cognitively or mentally obstructed to participate in the research
* To be open to communication and cooperation
* To have and use internet access
* Having a smart phone

Exclusion Criteria:

* Insomnia, regular sleep, shift work
* Traveling in time zones in the last 4 weeks
* Having an eating or psychiatric disorder
* Alcohol addiction
* Nursing mothers who are pregnant or lactating (giving birth in the past two years)
* Do not use antiobesity medication
* New diagnosis of hyperlipidemia and diabetes and drug initiation (in dose adjustment for less than 3 months)
* Heavy exercise or a sedentary lifestyle
* Being on insulin therapy
* Having a risk of hypoglycemia
* Having Chronic Obstructive Pulmonary Disease, Sleep Apnea, Celiac, Severe Anemia, disease / illnesses
A Phase III Second Line Trial in Advanced Pancreatic Cancer CONKO 003

The purpose of this study is to compare best supportive care plus oxaliplatin/ folinic acid/ 5-FU versus best supportive alone in patients with gemcitabine refractory pancreatic cancer.

Gemcitabine (G) given until progressive disease (PD) is still standard therapy in patients with advanced pancreatic cancer. No standard secondline regimen is available after PD. Best supportive care (BSC) is the main option for these patients. Our phase II study (Pelzer et al, ASCO 2002) showed activity of the OFF (Oxaliplatin/Folinic Acid/5-FU) regimen. To confirm these data we started this multicenter phase III study to examine OFF vs. BSC alone.

165 patients were needed for this study. Following CT/ MRT confirmed PD patients were randomized. Stratification included duration of firstline therapy, Karnofsky Performance Status (KPS) and tumor stage. OFF (outpatient regimen): 5-FU 2g/m² (24h)/FA 200 mg/m² (30min) on d1, d8, d15, d22, additional Oxaliplatin 85mg/m² (2h) on day 8 and 22. Rest on day 23 and 42.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed metastatic pancreatic adenocarcinoma that had progressed during first line gemcitabine therapy were eligible for inclusion in the study.

Other inclusion criteria were:

* Age \> 18 years
* Karnofsky performance status \> 70%
* Bidimensionally measurable reference lesion, adequate laboratory values for hematology (white blood cell \[WBC\] count \> 3.5´109/L, platelet count \> 100´109/L), renal function (creatine clearance \> 30 ml/min) and hepatic function (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \< 2.5 ´ upper normal limit \[UNL\] and in the case of liver metastasis \< 5 x UNL)
* As well as controlled pain

Exclusion Criteria:

* Patients were excluded from the study if they had any severe concurrent medical condition interfering with planned therapy, serious cardiac disease, sensory/ motor neuropathy \> grade 2 or had previous or current malignancies at other origin; besides, pregnant or lactating women were excluded.
* All patients provided written informed consent.
Systematic Review and Meta-Analysis of Venous Thromboembolism (VTE) Risk Assessment in Hospitalized Medical Patients

A systematic review and meta analysis will be performed of risk assessment models for Venous thromboembolism ("VTE" including pulmonary embolism "PE" and deep venous thrombosis "DVT")in hospitalized medical patients. The goal of this study is to evaluate whether the incidence of VTE is lower in patients that are evaluated with a risk assessment model and treated with thromboprophylaxis for their assigned level of risk.

Venous thromboembolism ("VTE" including pulmonary embolism "PE" and deep venous thrombosis "DVT") is associated with significant morbidity and mortality. Only about half of eligible hospitalized medical patients receive appropriate thromboprophylaxis. Understanding VTE risk factors predictive of VTE among hospitalized medical patients may promote superior thromboprophylaxis. To date a systematic review of VTE risk assessment strategies among hospitalized medical patients, and a meta-analysis reporting the rate of VTE among patient groups at varying levels of risk for VTE does not exist.

The investigators will use the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) checklist for reporting systematic reviews and meta-analyses to develop this systematic review and meta-analysis.

The investigators will perform a systematic review of the literature and report VTE risk assessment models that have been derived and validated among hospitalized medical patients. The investigators will perform a meta-analysis of studies that report a rate of VTE among patients identified as being at elevated risk for VTE and those that are not. The investigators pre-specify that they are going to analyze the prospective and retrospective studies captured by the literature search in two ways. First, the investigators will perform an analysis that groups both prospective and retrospective studies together. The investigators will also perform an analysis that separates out the prospective and retrospective studies. While this will decrease our sample size (and thus power), this approach may allow us to identify any bias or confounding present due to the retrospective study design and then control for it. Notably confirmation that both retrospective and prospective studies identified the same findings would enhance the clinical usefulness of our findings.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Hospitalized

Exclusion Criteria:

* Surgical patients
* Pregnant patients
Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy

This Phase I/II study will investigate the safety and tolerability of intravitreally administered 0.5mg and 1.0 or 2.0mg Ranibizumab in three monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month of drug safety follow up in subjects with exudative polypoidal choroidal vasculopathy (PCV) for a total of 24 months.

Twenty eyes will be randomized will receive 3 consecutive monthly intravitreal 1.0 or 2.0 mg/0.5mg (3:1 ratio) Ranibizumab injection with the first injection occuring at Day 0 and second and third injection occuring at month 1 and month 2 respectively. Retreatment with intravitreal Ranibizumab or other therapies will be at the investigators discretion but guidelines for recommended retreatment.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females \>18 years of age. Females of child bearing potential will undergo urine pregnancy testing and be required to use appropriate methods of birth control.
* ICG and fluorescein angiographic characteristics consistent with active, leaking PCV with subfoveal lesions and/or subfoveal hemorrhage, lipid exudates, PED or fluid diagnosed within the past 6 months or diagnosed as newly active within the past 6 months. Subjects who completed the 24 month follow up in the original FVF3671s protocol may enter the study without necessarily demonstrating active exudative PCV at enrollment.
* Best-Corrected ETDRS Visual Acuity at 4 meters between 20/20 - 20/800.
* Lesion size - no limitations.
* Lesions Characteristics - leaking lesions consistent with PCV. No limitations on hemorrhage, fibrosis or atrophy.
* No therapy (includes non foveal laser, PDT, intravitreal steroids, TTT, radiotherapy, or anti-VEGF therapy) or intraocular surgery within the past 30 days for any condition.
* Clear ocular media to allow for photography/angiography.
* Ability to provide written informed consent and comply with study assessments for the full duration of the study.

Exclusion Criteria:

* Patients with features of age related macular degeneration such as abundant drusen and demographic features consistent with this diagnosis.
* Allergy to Fluorescein, ICG, Iodine, Shellfish.
* Pregnancy (positive pregnancy test)
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
* Participation in another simultaneous medical investigation or trial.
* Exclude other anti-VEGF agents as therapy options.
* History of previous subfoveal laser.
* Advanced glaucoma (IOP \> 25 or cup/disc ration \> 0.8)
* Any condition in the opinion of the investigator that would interfere with disease status/progression or jeopardize patients' participation in the study.
Intervention Trial in Early Age-related Macular Degeneration

The purpose of the I-TEAM project is to assess whether there is a change in visual function and status of the retina after a year of intervention in subjects with early signs of Age-related Macular Degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Early AMD (AREDS category 2)

  * many small drusen, or
  * a few intermediate-sized (63-124 micrometres in diameter) drusen, or
  * macular pigmentary changes

OR

* Intermediate AMD (AREDS category 3)

  * extensive intermediate sized (63-124 micrometres in diameter) drusen, or
  * at least one large (\>125 micrometers in diameter) drusen or
  * geographic atrophy not involving the foveal centre
* men and women age ≥50 years
* BMI 18-35 kg/m2
* Vision ≥ 20/40 for Snellen visual acuity
* lutein intake of \< 2 mg/day (including supplements)
* DHA intake of \< 150 mg/day (including supplements)
* must be able to give written informed consent
* have normal hematologic parameters
* normal values of plasma albumin
* normal values for liver and kidney function
* no use of carotenoid, fish oil, or n3 fatty acid supplements (within 1 month of study start)

Exclusion Criteria:

* ocular media opacity (severe cataract)
* history of active small bowel disease or resection
* atrophic gastritis
* history of hyperlipidemia or screening values as follows (LDL \> 5.33mmol/L or 205mg/dL; triglycerides \> 4.52mmol/L or \>400 mg/dL)
* hypertension (\>150/90 mm Hg)
* diabetes mellitus (if also accompanied by signs of diabetic retinopathy)
* alcohol intake of \>2 drinks/day or 14 drinks/week
* pancreatic disease
* dementia or Alzheimer's disease
* anemia, and bleeding disorders
* known allergy to egg or egg products
* known allergy to milk or milk products
* known allergy to cocoa or chocolate products
* known allergy to fish or fish oils
* lactose intolerance
* pregnancy or lactation
* diseases that interfere with fat absorption, e.g. colitis, celiac disease, Crohn's disease, cystic fibrosis (as determined by screening interview)
* medication or supplements that contain a significant level of carotenoids, including an amount of lutein of more than 0.25 mg per day within 1 month of the study start
* medications that interfere with fat absorption, e.g. bile sequestrants (as determined by screening interview)
* use of antipsychotic, anti manic, or dementia medications
* smoking or use of nicotine patches or gum (within the past 6 months)
* subjects having extremely high dietary intakes of carotenoids
* stroke, head injury with loss of consciousness or seizures
* for US and UK center: Non English speaking
Evaluation of Demonstrations to End Childhood Hunger - CN Food Sec

The 2010 Child Nutrition Reauthorization provided funding to test innovative strategies to end childhood hunger and food insecurity. Demonstration projects were funded in Chickasaw Nation, Kentucky, Navajo Nation, Nevada, and Virginia. This study focuses on Chickasaw Nation.

School districts were matched, and then one was randomly assigned to either a treatment (n=20) or control group (n=20). Treatment households received one food box per eligible child, per month, delivered to the household, which contained (1) shelf-stable foods, including 6 protein-rich items, 2 dairy items, 4 grain foods, 4 cans of fruit, and 12 cans of vegetables; (2) a nutrition education handout (e.g., a recipe); and (3) a $15 Fresh Check for frozen or fresh fruits and vegetables that participants could redeem at any of 38 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)-authorized stores or farmers' markets in the study counties. Control households did not receive the treatment benefits but still could participate in other available nutrition assistance programs.

Objective: To reduce childhood food insecurity and hunger, increase families' consumption of nutritious foods, increase the diversity of foods in the home, and ultimately improve diet quality and well-being among children.

Target Population: 40 school districts (115 schools) in 12 counties within the Chickasaw Nation territory in Oklahoma. Within these districts, households with school-age children (both Native American and non-Native American) who were eligible for free school meals or attended a school that participated in the community eligibility provision were eligible to participate in the project.

Intervention School districts were matched, and then one was randomly assigned to either a treatment (n=20) or control group (n=20). Treatment households received one food box per eligible child, per month, delivered to the household, which contained (1) shelf-stable foods, including 6 protein-rich items, 2 dairy items, 4 grain foods, 4 cans of fruit, and 12 cans of vegetables; (2) a nutrition education handout (e.g., a recipe); and (3) a $15 Fresh Check for frozen or fresh fruits and vegetables that participants could redeem at any of 38 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)-authorized stores or farmers' markets in the study counties. Control households did not receive the treatment benefits but still could participate in other available nutrition assistance programs.

Eligibility Criteria:
Inclusion Criteria:

* 40 school districts (115 schools) in 12 counties within the Chickasaw Nation territory in Oklahoma.
* Within these districts, households with school-age children (both Native American and non-Native American) who were eligible for free National School Lunch Program meals or attended a school that participated in the community eligibility provision were eligible to participate in the project.
Efficacy of Nepeta Menthoides Extract on Anxiety of Patients With Depression: a Double-blind Randomized Controlled Clinical Trial

The aim of this study is to assess the efficacy of Nepeta menthoides as an anti anxiety herbal remedy for depressed patients , in a 6 week randomized double-blind controlled trial. A total of 70 adult outpatients between 18-65 ages referring to psychiatry clinic of Shiraz medical university, who having depression according to Persian-language version of the Beck Depression Inventory-Second edition and get score above 11 according to Persian version of Beck Anxiety Inventory (BAI) and diagnosis is confirmed by at two psychiatrists are randomly allocated into two groups and assign to receive 400 mg of freeze dried powder of Nepeta menthoides or 50 mg of sertraline in the uniformed capsules twice daily (in the morning and 1-2 hours before sleeping time at night). Exclusion criteria were pregnancy and lactation, allergy to N. menthoides and Lamiaceae family, patients with suicidal thoughts or previous suicidal attempt, patients with unstable cardiac, renal and hepatic diseases, seizure and hypothyroidism and patients who used substances or alcohol and patients who had indication for electroconvulsive therapy.. Severity of anxiety (by Persian version of Beck Anxiety Inventory (BAI)) and also common possible side effects of drugs will assess in baseline, 2nd week, 4th week and then two weeks after the end of the intervention (in 6th week)


Eligibility Criteria:
Inclusion Criteria:

1. having depression according to Persian-language version of the Beck Depression Inventory-Second edition
2. get score above 7 according to Persian version of Beck Anxiety Inventory (BAI)

Exclusion Criteria:

1. pregnancy and lactation
2. allergy to N. menthoides and Lamiaceae family
3. patients with suicidal thoughts or previous suicidal attempt
4. patients with unstable cardiac, renal and hepatic diseases, seizure and hypothyroidism
5. patients who used substances or alcohol
6. patients who had indication for electroconvulsive therapy -