cyrilzakka/clinical-trials huggingface dataset:
A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency

Congenital deficiency of factor XIII (FXIII) is an extremely rare inherited disorder associated with potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose blood is lacking factor XIII. Factor XIII Concentrate works by assisting blood in the usual clotting process, thereby preventing bleeding.

In this study, patients will be treated with FXIII Concentrate (Human) and followed closely to determine that they receive the dose that will best minimize the chance of bruising and bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent/assent for study participation obtained before undergoing any study-specific procedures
* Documented congenital FXIII deficiency which requires prophylactic treatment with a FXIII containing product.
* Males and females of any age with congenital FXIII deficiency
* Received full hepatitis B vaccination and/or is hepatitis B surface antibody positive

Exclusion Criteria:

* Diagnosis of acquired FXIII deficiency
* Administration of a FXIII-containing product, including blood transfusions or other blood products within 4 weeks prior to the planned Day 0
* Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency
* Known or suspected to have antibodies towards FXIII
* Use of any other investigational medicinal product within 4 weeks prior to the Baseline Visit (Day 0)
* Known Positivity for human immunodeficiency virus (HIV) or a positive result for HIV at the Screening Visit of this study or the FXIII study 2002 (NCT00883090).
* Serum aspartate transaminase (AST) or serum alanine transaminase (ALT) concentration \>2.5 times the upper limit of normal at the Screening Visit of this study or at the Day 56 Visit of Factor XIII Study BI71023_2002 (NCT00883090)
* Fibrinogen level less than 85% of the lower limit of normal at the Screening Visit of this study or the Factor XIII Study BI71023_2002 (NCT00883090)
* Active bleeding ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 and/or ≥ moderate between the Screening and Baseline Visits
* Pregnant or breast-feeding
* Intention to become pregnant during the course of the study
* Female subjects of childbearing potential not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study
* Suspected inability (e.g., language problems) or unwillingness to comply with study procedures or history of noncompliance
A Study of 18F-AV-45 in Alzheimer's Disease (AD) and Healthy Volunteers

This study will test if two AV-45 PET scans up to 4 weeks apart in AD subjects and healthy volunteers provide the same results. The study will also test two different AV-45 injection methods in a small subgroup of enrolled AD subjects (slow vs. fast bolus group).


Eligibility Criteria:
Inclusion Criteria (AD group):

* Greater than 50 years of age
* Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
* Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 10 to 24, boundaries included, at screening
* History of cognitive decline gradual in onset and progressive over a period of at least 6 months

Inclusion Criteria (healthy volunteer group):

* 35 to 55 years of age, inclusive
* MMSE of 29 or greater

Exclusion Criteria (both groups):

* Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy
* Diagnosis of other dementing / neurodegenerative disease
* Diagnosis of mixed dementia
* Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
* Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
* Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
* Clinically significant psychiatric disease
* History of epilepsy or convulsions
* Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
* Current clinically significant cardiovascular disease
* Received investigational medication within the last 30 days
Neoadjuvant and Adjuvant Chemotherapy in High-risk Soft Tissue Sarcoma

Neo- and adjuvant chemotherapy is used in high-risk soft tissue sarcoma to improve systemic control. Patients in this trial are treated with 4 cycles of chemotherapy (EIA, etoposide, ifosfamide, adriamycin) preoperatively, followed by local surgery and radiotherapy. An additional 4 cycles of adjuvant chemotherapy is administered. Treatment response is assessed by MRI and CT scans and FDG-PET in a subgroup of patients.

The role of chemotherapy in high-risk soft tissue sarcoma is controversial. Though many patients undergo initial curative resection, distant metastasis is a frequent event resulting in 5-year overall survival rates of only 50 - 60%. Neo-adjuvant and adjuvant chemotherapy has been applied to achieve pre-operative cytoreduction, assess chemosensitivity and to eliminate occult metastasis. The current protocol comprises for cycles of neoadjuvant chemotherapy ((EIA, etoposide 125 mg/m2 iv days 1 and 4, ifosfamide 1500 mg/m2 iv days 1 - 4, doxorubicin 50 mg/m2 day 1, pegfilgrastim 6 mg sc day 5), local surgery and radiotherapy as well as further 4 cycles of adjuvant EIA. Treatment response is assessed by MRI and CT scans and FDG-PET in a subgroup of patients.

Eligibility Criteria:
Inclusion Criteria:

* Soft tissue sarcoma histology
* Tumor size \>= 5 cm
* Deep/extracompartimental localization
* Grade 2/3 (FNCLCC)
* Patients with inadequate previous therapy
* Age 18-65 years
* normal bone marrow function
* normal liver function
* normal renal function
* Karnofsky index \>=80%

Exclusion Criteria:

* Chordoma
* Chondrosarcoma
* Kaposi´ sarcoma
* Neuroblastoma
* Mesothelioma
* Osteosarcoma/Ewings´sarcoma
Parents' Knowledge and Perception of Benefits and Risks Regarding Neonatal Circumcision

The American Academy of Pediatrics changed their stance on circumcision to "health benefits of newborn male circumcision outweigh the risks and that the procedure's benefits justify access to this procedure for families who choose it" (AAP, 2012).

We wonder if parents are aware of guidelines such as those of the AAP. Are parents able to make this medical decision by weighing the risks against the benefits of circumcision, or do they simply use sociocultural/religious reasons to make this decision? We hypothesize that parents are unaware of the specific benefits and risks of circumcision, and make this decision based primarily on sociocultural, religious, and/or familial norms.

Expectant parents' knowledge will be assessed via a Qualtrics survey. Participants will be recruited in the OB/GYN clinic sometime between their 24-28 week prenatal visit. We hope to accrue at least 680 participants for this study in order to achieve statistical significance and acquire a range of demographics. Expectant mothers and fathers (and single mothers) will be encouraged to participate.

This survey will assess their desire to get their child circumcised when they are born. Participants will be asked to list perceived risks and benefits of circumcision. This will hopefully allow us to see two things: if parents are aware and knowledgeable of the risks and benefits or circumcision, and what they perceive to be risky or beneficial from a medical standpoint.

Parents will be randomly given 1 of 2 pieces of information (1 per couple \[or per single mother\]; 1 control, 1 experiment) with different information about circumcision. We will see if there are any outcome differences based on which group the couple randomized into. Follow-up phone call will serve to assess outcome if baby was circumcised and any factors that led up to the decision. This will allow us to see if the AAP stance has any effect on decision making when we compare the control and experiment groups.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be recruited from the Obstetrics clinic. All expectant parents of children are eligible to participate in this study. The study team will include those who do not know the sex of their baby and later exclude those who ultimately have girls from the final survey.

Exclusion Criteria:

* Exclusion is limited to parents with a child that has had a genital anomaly identified via ultrasound before the time of the research study, and parents that definitively know they are having girls.
Relation Between Inflammatory Responses and Sequelae of Pediatric Corrosive Ingestion Cases in Assiut

1. Evaluation of corrosive ingestion cases presented to Assiut university hospitals .
2. To assess the role of leukocytic parameters and inflammatory mediators in determining the severity of pediatric corrosive injuries and their correlation with long-term outcomes.

Inflammatory response plays a vital role in the development of gastrointestinal complications following corrosive ingestion. Leucocytic parameters: neutrophil-to-lymphocyte ratio (NLR), neutrophils count and lymphocytic count from the peripheral blood, has emerged as an easily obtainable biomarker of acute inflammation .

Inflammatory mediators play a significant role in the body's response to injury. They also have a major impact on the pathophysiology of caustic injury, as they modulate the inflammatory response and tissue damage following exposure to corrosive substances. Therefore, they can potentially serve as prognostic biomarkers to assess the severity of caustic injury .

Acute phase reactants (APR) are inflammatory markers that exhibit significant changes in serum concentration during inflammation. These are also important mediators produced in the liver during acute and chronic inflammatory states. Their concentrations increase during inflammation. Serum amyloid A protein (SAA) is a pro-inflammatory mediator, and its concentration can increase from healthy levels of less than 3 mg per liter to more than 1000 mg per liter in the presence of inflammation, and it can remain elevated for as long as the inflammatory disease remains active .

Interleukin 10 (IL-10) is an anti-inflammatory cytokine that plays a crucial role in preventing inflammatory diseases, that generally begins to increase within a few hours after the onset of injury, although its peak may not occur until later (usually within 24-48 hours). Its release is often a part of the body's feedback mechanism to balance the acute inflammatory response .

DROOL caustic ingestion score is a diagnostic tool used to evaluate patients with corrosive ingestion through these parameters: drooling, dysphagia, oropharyngeal burns, others (fever, hematemesis, abdominal tenderness) and leukocytosis. It ranges from 0 to 10, with the best score being 10 .

Eligibility Criteria:
Inclusion Criteria:

* All cases diagnosed with corrosive ingestion presented at Assiut university hospital.

Exclusion Criteria:

* Cases with pre-existing inflammatory diseases
* Cases with emergencies other than corrosive ingestion.
* Patients with delay time more than 48hours.
* Pediatric cases whose legal guardians are unavailable or refuse to provide consent.
Three-year Follow-up Study of Subjects Who Participated in a Previous Lambda (BMS-914143) Chronic Hepatitis C Clinical Trial

The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with BMS-914143 and achieved sustained virologic response


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have received Lambda in a previous trial and have Hepatitis C virus (HCV) Ribonucleic acid (RNA) \< LOQ at the completion of the required post-treatment follow-up (must enter this study within 6 months of completion of the required post-treatment follow-up in the previous trial) NOTE: For blinded parent trials, subjects who have HCV RNA \<LOQ at the completion of the required post-treatment follow-up may enter this study without knowledge of their treatment assignment in the parent study. Subjects who received control agents (eg, pegylated-interferon alfa) in the previous protocol will be allowed to participate until unblinded treatment information is released; at that time subjects will have the option to continue in the study

Exclusion Criteria:

* Subjects must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis C after completion of the previous study of Lambda
Recombinant Factor VII for Intractable Postpartum Haemorrhage

Postpartum haemorrhage remains at the top of the causes of maternal deaths in both developed and developing countries .

Major postpartum haemorrhage is a dangerous complication that accounts for the highest maternal morbidity rate

Eligibility Criteria:
Inclusion Criteria:

* Women with severe resistant postpartum hemorage

Exclusion Criteria:

* women without postpartum hemorage
Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

This study will test the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in patients with binge-eating disorder (BED), with or without obesity.

Binge-eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with BED are needed that can produce sustained clinical outcomes. This study aims to test the efficacy of Naltrexone/Bupropion (NB; FDA-approved anti-obesity combination medication) for the treatment of BED in patients with and without obesity. The RCT will provide new findings regarding the efficacy of NB medication for reducing binge-eating episodes among patients with BED, for reducing weight among patients with BED and obesity, and whether patients with and without obesity derive differential benefit from NB.

Eligibility Criteria:
Inclusion Criteria:

* Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition);
* BMI in the obesity (BMI \>30 and \<50) or non-obesity (BMI \>21.5 and \<29.9) range;
* Available for the duration of the treatment and follow-up (15 months);
* Read, comprehend, and write English at a sufficient level to complete study-related materials.

Exclusion Criteria:

* Currently taking opioid pain medications or drugs; or positive drug screen for opiates
* Currently taking medications that influence eating/weight;
* History of seizures;
* Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality);
* Past or current anorexia nervosa or bulimia nervosa;
* Pregnant or breastfeeding;
* Medical status judged by study physician as contraindication.
Electrical Patient Reported Outcome of Prostate Cancer RadioTherapy

This is an observational study where prostate cancer related PROMs (EPIC-26) is collected using two different methods (by paper questionnaires and electronically) and patient experience and preference is asked.

Prostate cancer patients that are treated with radiation therapy for local prostate cancer receive EPIC-26 before treatment and during follow-up. EPIC-26 is collected both traditionally using paper questionnaires and electronically. Patients experience and preference for these are asked.

Eligibility Criteria:
Inclusion Criteria:

* cT1-4N0M0, gleason 6-10, PSA \< 100, WHO ≤ 2 prostate cancer eligible for radiation therapy
* willing to complete EPIC-26 questionnaires both in paper and electronically
* willing to consent for the study

Exclusion Criteria:

* not able to complete EPIC-26 both in paper and electronically
Prevalence of Psoriasis Alba in Psoriatic Patients

Interdigital psoriasis (psoriasis alba) is atypical and rare form of psoriasis that is often missed as it is commonly mistaken for either dermatoses or fungal infection.In this study we observed and analyzed the prevalence of psoriasis interdigital of palms and soles and brought medical awareness to dermatologists and family doctors this rare form of psoriasis. Thus, you can help to avoid mistaken diagnosis and the start of correct treatment as soon as possible.

Hospitalized patients and outpatient clinic will be included in the study after receiving the signature of a inform consent.Patients groups : 100 patients with psoriasis,100 patients with atopic dermatitis and 100 healthy patients (control group).Patients with atopic dermatitis will be the secondary control group.Patients diagnosed with inflammatory condition of interdigital skin of the palms and soles will be checked by fungal microscopy test.If the fungal test is negative ,we need to prepare to a biopsy of the skin in this area .Following results of the skin biopsy conclusions can be shown about the prevalence of interdigital psoriasis in psoriatic patients enabling suitable treatment to be given to the patients.

Eligibility Criteria:
Inclusion Criteria:

* patients above 18 years old ,hebrew speakers, patients with psoriasis vulgaris or atopic dermatitis without systemic treatment

Exclusion Criteria:

* patients below 18 years old, pregnancy women, patients treated with systemic agents for psoriasis or atopic dermatitis(methotrexate,cyclosporin,neotigason)
Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.

Patients diagnosed with Stevens-Johnson syndrome and Toxic Epidermal Necrolysis were confirmed based on the investigators national diagnostic criteria. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, efficacy of NPB-01 for therapy of Stevens-Johnson syndrome and Toxic Epidermal Necrolysis will be evaluated the disease evaluation score et al.

As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by 20 days after the start of the study treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who the disease evaluation score is more than 14 at study medication received.
2. Patients with corticosteroids over 20mg/day(Prednisolone) at study medication received and continued this treatment more than 2 days.
3. Patients with treatment effect is insufficiency before study medication received and need additional treatment.
4. Patients aged more than twenty years old at informed consent.

Exclusion Criteria:

1. Patients who the SCORTEN score is more than 4 at study medication received.
2. Patients with multiple organ failure at study medication received.
3. Patients with severe respiratory disorder at study medication received.
4. Patients with Drug-induced hypersensitivity syndrome (DIHS) at informed consent.
5. Patients with malignancy during treatment at informed consent.
6. Patients treated with corticosteroids dosage is change at 2 days before study medication received.
7. Patients treated with corticosteroids pulse therapy(including semi-pulse therapy) at 2 days before study medication received.
8. Patients treated with plasmapheresis at 2 days before study medication received.
9. Patients treated with high-dose intravenous immunoglobulin at 28 days before informed consent.
10. Patients with history of shock or hypersensitivity for NPB-01.
11. Patients with IgA deficiency.
12. Patients with severe impaired liver function diagnosed virus hepatitis or cirrhosis et al.
13. Patients with more than 2mg/dL serum creatinine.
14. Patients with severe cerebro- or cardiovascular disorders.
15. Patients with high risk of thromboembolism.
16. Patients with hemolytic/hemorrhagic anemia.
17. Patients with severe decreased cardiac function.
18. Patients with decreased platelet less than 75,000/μL..
Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD

Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. QM in US Black/African American and Hispanic participants with established ASCVD and elevated levels of Lp(a) who are treated for cardiovascular (CV) risk factors according to local practice/guidelines for the reduction of cardiovascular risk.

CTQJ230A12303 is a randomized, double-blind, placebo-controlled, multi-center, Phase IIIb study to evaluate the efficacy ( measured by reduction of the Lp(a) levels) and safety of pelacarsen (TQJ230) 80mg s.c. QM compared to placebo in US Black/African American and US Hispanic participants, with established atherosclerotic cardiovascular disease (ASCVD) as evidenced by history of coronary heart disease, cerebrovascular disease or symptomatic peripheral artery disease (PAD) and elevated levels of Lp(a).

Eligibility Criteria:
Inclusion Criteria:

* Male and female US Black/African American and US Hispanic participants 18 to ≤ 80 years of age
* Lp(a) ≥ 125 nmol/L at the screening visit, measured at the Central laboratory
* On Standard of Care (SoC) therapy for risk factors other than Lp(a), including LDL-C (LDL-C lowering therapy dose stable for at least 30 days), elevated blood pressure and diabetes, at the randomization visit according to local practice/guidelines.
* Established ASCVD disease defined as documented:

  * Coronary heart disease (CHD) and/or
  * Cerebrovascular disease (CVD) and/or
  * Peripheral arterial disease (PAD):

Exclusion Criteria:

* Uncontrolled hypertension
* Heart failure New York Heart Association (NYHA) class IV
* History of malignancy of any organ system
* History of hemorrhagic stroke or other major bleeding
* Platelet count \<140,000 per mm3
* Active liver disease or hepatic dysfunction
* Significant kidney disease
* Pregnant or nursing women