cyrilzakka/clinical-trials huggingface dataset:
Remicade Safety Line (Ankylosing Spondylitis)(Study P03275)(COMPLETED)

This observational study is in line with the German educational plan with the aim to implement a tool to increase and monitor the awareness of tuberculosis screening and to reinforce the patient eligibility for a treatment with Remicade according to the Summary of Product Characteristics (SmPc).

This study population was chosen from a non-probability sample.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with ankylosing spondylitis.

Exclusion Criteria:

* As per Summary of Product Characteristics (SmPC)
40Hz tACS in Treating Cognitive Function and Modulating Neurophysiology of Patients With Alzheimer's Disease

Gamma brain activity is crucial for cognitive function and intra-brain communication. Gamma frequency stimulation via transcranial alternating current stimulation(tACS) might alleviate memory deficits on both animal models of Alzheimer's disease (AD) and clinical trial. The study aims to assess the safety and efficacy of tACS on cognitive function and modulating neurophysiology in patients with AD.

Gamma brain activity is crucial for cognitive function and intra-brain communication. Gamma frequency stimulation via transcranial alternating current stimulation(tACS) might alleviate memory deficits on both animal models of Alzheimer's disease (AD) and clinical trial. The study aims to assess the safety and efficacy of tACS on cognitive function and modulating neurophysiology in patients with AD.

40mins 10Hz-tACS for daily consecutive sessions will be given.

Eligibility Criteria:
Inclusion Criteria:

* aged 60- to 90-year-old
* clinical dementia rating scale (CDR) of 1 or mini-mental state examination (MMSE) score of 18 to 26.
* Participants were allowed to maintain their anti-dementia medications without changes from at 3 months before and throughout the study.

Exclusion Criteria:

* having contraindications for tACS, e.g., implanted brain medical devices or mental in the head, having arrhythmia and with pacemaker implantation, having history of seizures, having history of intracranial neoplasms or surgery, or severe head injuries or cerebrovascular diseases
* clinical depression measured by Hamilton depression rating scale score equal and over 17
Psychometric Properties of a Mobile Application

Current methods to assess superficial size and area of pressure ulcers are either time-consuming (using Transparency Tracings techniques), costly (computers, softwares), or necessitating to touch the patient's skin (using commun rulers).

A free smartphone application (for IOS or Android) has recently been developed to measures skin lesions. It is called imitoMeasure. It does not require any contact with the patient. A photograph is taken with the smartphone, the limits of the lesion is then drawn with the health carers' finger on the phone's screen. The application computes the length, width and surface of the ulcer.

This technique has not yet been validated, although it has been used to measure various types of skin lesions.

The objective of this study is to validate this measurement technique on a sample of pressure ulcer in a population of patients with spinal cord injury (SCI). Reliability is assessed by comparison to the currently most frequently used techniques (Transparency Tracings and ruler-based), and fiability is assessed by intra-rater and inter-rater correlations.

imitoMeasure is a new smartphone application to measure wounds size. The present study assesses validity of the measure against common measures (ruler-based and transparency tracings), and the inter- and intra-rater reliability.


Eligibility Criteria:
Inclusion criteria:

* complete or incomplete spinal cord injury, all delays or aetiologies
* presence of one or more pressure ulcers stade II to IV
* adults

Exclusion criteria:

* refusal to participate
* local infection
Laser Therapy Effect as Preventive Measure for Oral Mucositis in Children With Hematological Malignancies

Introduction:

Among the most drastic complications of chemotherapy is oral mucositis(OM). It is a painful inflammatory, often ulcerative condition and may increase risk for systemic infections leading to prolonged hospital stays and interruptions of treatment protocol. Many treatment modalities have been introduced for the prevention and treatment of oral mucositis , of which low level laser therapy(LLLT) is gaining popularity. The use of LLLT as a prophylactic treatment for chemotherapy induced oral mucositis in pediatric cancer patients is still lacking robust evidence. Also, the parameters used have not been optimized and no standard method has yet been established. Based on this point, this study will compare photobiomodulation to the conventional preventive program of oral mucositis applied in 57357 children's cancer hospital foundation to determine which will be optimal for the prophylaxis of chemotherapy-induced OM.

Aim:

To assess the effectiveness of low level laser therapy in the prophylaxis of oral mucositis in pediatric patients diagnosed with Hematological cancers.

Methods:

This study is a randomized, prospective, double-blinded trial that will include acute Myeloid leukemia patients admitted to receive chemotherapy cycle between the age of 3 and 18years. These patients will be randomized into two groups: group 1 will receive low level laser therapy and group 2 will receive mock treatment. Patient will be followed to asses the development of oral mucositis on prespecified time points.

This study is a randomized, prospective, double-blinded trial ( patient \& outcome assessor) that will include acute Myeloid leukemia patients admitted to receive chemotherapy cycle between the age of 3 and 18years. These patients will be randomized by the Clinical Epidemiology unit using a computer-based method into two groups.

Group I: will receive Low Level Laser Therapy by Diode laser (Sirrolaser Blue ™, USA) at 44 different points in the oral cavity for 5 consequent days from Day 1 to Day 5 of chemotherapy cycle along with the standard preventive protocol in the hospital.

Group II: will receive a mock treatment which is the exact repetition of the treatment modality but without any laser emission beside the standard preventive protocol applied in the hospital.

All patients will be assessed for oral mucositis grade using NCI-CTCAE scale V4 and WHO score on days 1,5,12,19 and 30 .

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients diagnosed with Acute Myeloid Leukemia.
* Children with a minimum age of 3 years and a maximum 18 years.
* Children with sufficient cooperation to accept the treatment and evaluation periods

Exclusion Criteria:

* Patients with limited mouth openings less than 1 cm, due to difficulty of laser radiation.
* Patients with dysplastic oral lesions.
An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
* Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
* Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria

Exclusion Criteria:

* Subjects with untreated Central nervous system (CNS) metastases are excluded
* Subjects with an active, known or suspected autoimmune disease are excluded
* Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) indicating acute or chronic infection

Other protocol defined inclusion/exclusion criteria apply
Using Text Messages to Improve Oral Chemotherapy for Adolescents and Young Adults With Acute Lymphoblastic Leukemia

The purpose of this section is to learn how text message reminders might help with regularly taking chemotherapy medications for Adolescents and Young Adults (AYA) with Acute Lymphoblastic leukemia (ALL).

This study aims to compare adherence to oral mercaptopurine and methotrexate during the first 84-day cycle of maintenance therapy for adolescent and young adult patients with Acute Lymphoblastic Leukemia on pediatric-based regimens between those who receive the high intensity text message intervention and those who receive standard-of-care. It is believed that high-intensity text messages will increase patient adherence within cycle 1.

Eligibility Criteria:
Inclusion Criteria:

* Age of 15-39 years-old at the time of initial ALL diagnosis
* Diagnosed with ALL
* Currently receiving treatment with pediatric-based regimen that includes maintenance with mercaptopurine and methotrexate (e.g., CALGB 10403). Study participation begins with the start of maintenance, so enrollment occurs prior to the start of maintenance.

Exclusion Criteria:

* Patient or caregiver who would receive text message reminders does not have a cell phone that receives text messages
* Patient does not wish to participate
Online Cognitive Control Training for Remitted Depressed Patients

This study evaluates the effectiveness of an internet-delivered cognitive control training as a preventive intervention for remitted depressed patients. Half of the participants will receive a cognitive control training, while the other half will receive a low cognitive load training that acts as an active control condition.

Prospective studies have linked impaired cognitive control to increased cognitive vulnerability for future depression. Importantly, experimental studies indicate that cognitive control training can be used to reduce rumination and depressive symptomatology in MDD (major depressive disorder) and RMD (remitted depressed) samples. Provided that remitted depressed patients form a high-risk group for developing future depressive episodes, the current study will explore whether an internet-delivered cognitive control training can be used to reduce vulnerability for future depression in remitted depressed patients.

A computer training, consisting of 10 sessions of 15 minutes each, will be administered to participants, which are remitted depressed patients. This training can either be a cognitive control training, using an adaptive paced auditory serial addition task, or an active control training, with a low cognitive load task.

Dependent variables will be assessed pre- and post-training, as well as 3 and 6 months after the training, and consist of depressive symptomatology, related variables and cognitive control measures.

Eligibility Criteria:
Inclusion Criteria:

* History of ≥ 1 depressive episodes (major or bipolar)
* Currently in stable full or partial remission (≥ 3 months)

Exclusion Criteria:

* Major depressive disorder (current or less than 3 months in remission)
* Bipolar disorder (current or less than 3 months in remission)
* Psychotic disorder (current and/or previous)
* Neurological impairments (current and/or previous)
* Excessive substance abuse (current and/or previous)
* No ongoing psychotherapeutic treatment (maintenance treatment is allowed, but with a frequency of less than once every three weeks)
* Use of antidepressant medication is allowed if kept at a constant level
Effect and Efficacy of Onyx™, Zotarolimus-eluting Stent for Coronary Atherosclerosis

The objectives of this study are

1. To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Resolute Onyx™ stent.
2. To evaluate the long-term efficacy and safety of coronary stenting with the Resolute Onyx™ stent.
3. To compare the long-term efficacy and safety of coronary stenting between the Resolute Onyx™ stent and other contemporary drug-eluting stents which had established their own registry.

Secondary endpoints are

1. Stent thrombosis-24 hours(acute), 30 days(subacute), 1 year(late), every 1 year till 3 years(very-late) after index PCI (percutaneous coronary intervention),
2. Target vessel failure
3. Composite rate of cardiac death and any MI, 3 years
4. Composite rate of all death and any MI
5. Composite rate of all death, any MI, and any repeat revascularization
6. Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
7. Clinical device and procedural success

Eligibility Criteria:
Inclusion Criteria:

* Age above 19
* Patients who received PCI with Resolute Onyx™ stent(s)

Exclusion Criteria:

* None
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy

Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are 19 years old or older.
2. Subjects who have voluntarily decided to participate in this clinical trial and signed ICF.

Exclusion Criteria:

1. Subjects with a history of secondary hypertension or suspected secondary hypertension
2. Subjects who require combination administration of antihypertensive drugs other than clinical trial drugs during the clinical trial participation period
3. Subjects with hypersensitivity or history of clinical trial drugs and similar drugs
4. Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period
5. Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening
6. Subjects who received other clinical trial drugs within 4 weeks of screening visit.
7. Pregnant women, lactating women, or Subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last clinical trial drug
8. Subjects who are unable to participate in this clinical trial at the discretion of the investigator.
Knowledge on Preventive Measures of Hypertension

Hypertension among children and adolescents is on the rise in both developed and developing countries. Childhood and adolescent obesity, a key factor for hypertension in this population results largely from unhealthy dietary and physical inactivity behaviours. Adequate knowledge, a component for behavior change, has been found to be crucial to improving one's confidence to tackle these improper behaviours. Despite this, there are gaps in knowledge on hypertension and its risks factors in Ghanaian adolescents. Using an educational intervention (health talk), the study therefore sought to improve knowledge on preventive measures of hypertension among senior high school students in Ghana.

A pre-post interventional study using health talks was carried out among 345 adolescents aged 13 to 20 years. Participants included both male and female students aged 13 to 20 years. Owing to the large number, the students were divided into two groups. The Pre-test was then administered. Following this, two health education sessions were delivered by two registered nurses for each session. A week after these health talks, the research team went back to the school to collect data for the post-intervention. Questionnaires used for both pre and post assessment collected data on demographic factors and knowledge on dietary and physical activity behaviours linked to hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Participants who gave consent
* Minors with parental or guardian assent

Exclusion Criteria:

* Participants already living with hypertension
Assessing a Endoscopic Mucosal Resection Site Using Different Endoscopic Imaging Methods

The purpose of this study is to compare the accuracy of using different endoscopic imaging technique (white light, white light with near focus, narrow band imaging (NBI), NBI with near focus) for detection of residual neoplastic tissue at site of prior EMR

Residual neoplasia after EMR is a common. Optimal surveillance protocols are not clearly defined. There is a need for better imaging modalities to evaluate for residual disease. Suspected residual tissue can be confirmed with repeat colonoscopy or can be empirically treated. However, this can lead to either frequent colonoscopy or overtreatment. This presents more cost and financial burden to the patient. With the introduction of newer colonoscopes that have near focus/zoom capability, it is important to assess whether the near focus technology offers better accuracy for detection of residual neoplastic tissue. With better accuracy to confidently rule out residual neoplasia using newer imaging modality, additional treatment or biopsy at the previous EMR may be avoided. Furthermore, the interval for surveillance colonoscopy can be lengthened.

Eligibility Criteria:
Inclusion Criteria:

* Post-EMR follow up at 6-12 months

Exclusion Criteria:

* Non-corrected coagulopathy
* Pregnancy
* Breast feeding
Oncogenic Role of Engrailed (EN)-2 in Epithelial Ovarian Neoplasms

Detection of the potential oncogenic role of Engrailed-2 in epithelial ovarian neoplasms, in order to detect biological markers that could be targeted and blocked by new medications.

Epithelial ovarian carcinomas represent more than 90% of all ovarian carcinomas. Treatment of these ovarian carcinomas on basis of their histopathological features didn't improve patients' outcomes with very high incidence of relapses and resistance to therapy. Detection of novel biological markers which are involved in tumor progression could have promising results if these biological molecules are targeted and blocked by new medications.

Engrailed-2 is a protein encoded by a gene located on chromosome 7. Engrailed-2 is involved in neural development and neural connections during embryological life. it has been proved that Engrailed-2 is expressed in non neural neoplasms, especially in prostatic and urinary bladder carcinomas. Now estimatiion of urinary and serum levels of Engrailed-2 is used as a non-invasive screening tool in to detect prostatic and urinary bladder carcinomas. We aim to evaluated immunohistochemical expression of Engrailed-2 in normal and neoplastic ovarian tissues and to compare such expression between normal and neoplastic tissues in order to improve its oncogenic role in ovarian carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* All types of epithelial ovarian neoplasms (benign, borderline and malignant).

Exclusion Criteria:

* Non-epithelial and/ or secondary ovarian tumors.
* Cases with poor clinical data.
* Cases who had history of pre-operative chemotherapy.
Prevention of Hip Fractures With Soft and Hard Hip Protectors

The aim of this study is to compliance with and effect of soft and hard hip protectors in Norwegian nursing homes.

Hip fractures are a major cause of disability and functional limitation. Hip protectors have shown to have the potential to lower the risk of a fracture by reducing the impact on the hip region during falls, but low uptake and adherence have been a problem.

Changing the hip protector's design might give a higher uptake and adherence. The aim of this study is to compare uptake, adherence and effect of soft and hard hip protectors in Norwegian nursing homes. Because a soft hip protector seems to be more comfortable, we expect a higher uptake and adherence with the soft hip protector, specially when it comes to 24 hour use. If the soft hip protector has the same protective quality as the hard hip protector, the soft hip protector will be a better alternative than the hard one.

This cluster randomized study is performed in 18 Norwegian nursing homes in 2 municipalities. The study started May 15. 2006 and will end November 30. 2006.

All permanent residents are invited to participate in the study either as a user of hip protector or as a non user.

Eligibility Criteria:
Inclusion Criteria:

* all permanent residents in the the participating nursing homes
A Drug-Drug Interaction Study To Investigate The Potential For Multiple Doses Of Palbociclib (PD-0332991) To Alter The Pharmacokinetics Of Oral Midazolam In Adult Healthy Women of Non-Childbearing Potential.

This is a drug-drug interaction study to compare the pharmacokinetics of a 2 mg oral dose of midazolam in adult healthy women of non-childbearing potential when administered alone and when administered along with 8 daily 125 mg doses of PD-0332991. Volunteers will be randomized to one of two sequences. Volunteers in sequence 1 will receive midazolam alone in treatment period 1, followed by multiple dose PD-0332991 and midazolam in treatment period 2. Volunteers randomized to sequence 2 will receive multiple dose PD-0332991 and midazolam in treatment period 1, and following a washout period of no less than 14 days they will receive midazolam alone in treatment period 2.


Eligibility Criteria:
Inclusion Criteria:

* Healthy females of non-child bearing potential between the ages of 18 and 65 years old.
* A Body Mass Index (BMI) of 17.5 to 32.0 kg/m2 and a total body weight \>50 kg (110 lbs).
* A signed informed consent document.

Exclusion Criteria:

* Any evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* A positive urine drug screen.
* Pregnant or nursing females.
* Treatment with an investigational drug within 30 days or 5 half-lives of the first dose of study medication.
Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients

This study is using the combination of radiation and antiangiogenic agents (agents that destroy existing blood vessels) seems to be an approach to tumor cure.

The combination of ionizing radiation and antiangiogenic agents seems to be a counterintuitive approach to tumor cure because oxygen is a potent radiosensitizer and a reduction in oxygen concentration would be expected following a reduction in tumor vasculature after antiangiogenic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Minimum 2 week course of radiation therapy
* Solid tumors of the central nervous system, head and neck, thorax, and pelvis

Exclusion Criteria:

* Major surgery or radiation therapy within 4 weeks starting study treatment
* Grade 3 hemorrhage within 4 weeks
Expanded Access of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory ITP

C-935788-055 is an open-label, multi-center, expanded access (EAP) study.

The purpose of the program is to provide Fostamatinib in an Expanded Access setting to subjects who meet the selection criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patient with chronic or persistent ITP.
2. Must have failed or are unable to receive standard of care treatments for ITP.
3. Must have at least two platelet counts \< 30,000/µL during the last 2 months prior to screen date.

Exclusion Criteria:

1. ITP associated with lymphoma, chronic lymphocytic leukemia, transplant, or thrombocytopenia associated with myeloid dysplasia.
2. Subject has uncontrolled or poorly controlled hypertension.
3. Any of the following laboratory abnormalities: neutrophil count of \< 1,500/µL, or transaminase levels (ALT, AST) \> 1.5x ULN, total bilirubin \> 2.0 mg/dL.
4. Active HBV or HCV infection.
5. Current or recent enrollment in an investigational drug or device study.