cyrilzakka/clinical-trials huggingface dataset:
Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products

For bridging the available global clinical data of rVIII-SingleChain, with the Chinese population, the aim of this study in China is to investigate the pharmacokinetics (PK) of rVIII-SingleChain after an initial and repeat dose and to assess efficacy and safety during 2 to 3 times weekly prophylaxis treatment with rVIII-SingleChain in male Chinese PTPs with severe hemophilia A (FVIII activity less than \[\<\] 1%).


Eligibility Criteria:
Inclusion Criteria:

* Male Chinese participants \<= 65 years of age.
* Participants with severe hemophilia A (FVIII activity \< 1%).
* Participants who have received FVIII products for \>= 150 EDs (\>= 6 years of age) or \>= 50 EDs (\< 6 years of age).

Exclusion Criteria:

* Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or hamster protein.
* Known congenital or acquired coagulation disorder other than congenital FVIII deficiency.
* Currently receiving intravenous (IV) immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment.
* Receiving any cryoprecipitate, whole blood, or plasma within 30 days before administration of rVIII-SingleChain.
* Use of traditional or herbal Chinese medicine(s) with an impact on hemophilia, including coagulation, within 28 days before Day 1 and / or refusal to abstain from these during the study until the end of the participant's participation in the study.
Liver Elastography in Patients Undergoing Treatment for Hepatitis C

According to the guidelines for treating hepatitis C livers stiffness (LS) measurement is equivalent to liver biopsy to prove grade-2 fibrosis or more by Metavir-score. Also flares of inflammation in other viral hepatitis (B) have been reported to increase the elastography measurements. There are very few reports so far on longitudinal data in a treatment cohort. In this study investigators will follow patients who undergo active treatment for hepatitis C virus (HCV). Investigators will collect longitudinal data of liver elastography and compare this to the current status of liver inflammation by blood samples. This may be important in order to know if transcutaneous US with elastography can be used as a tool to monitor active inflammation in liver disease and to quantify how much the inflammatory component contribute to LS and finally if it is possible to reverse not only inflammation but also liver fibrosis by treating viral hepatitis. Our aim is to assess shear wave elastography (SWE) and investigate if the method can be used, not only to define the indication for treatment through LS measurements, but also if LS due to inflammation and fibrosis may be reversible in treated patients. To investigate what role frequency of measurement obtains in follow up of patients with HCV play.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with HCV
* HCV RNA positive
* Approved for HCV treatment

Exclusion Criteria:

* Excessive alcohol use
* Pregnancy
* information of other cause of chronic liver disease (autoimmune hepatitis (AIH), primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), Alpha-1-antitrypsin deficiency).
Cascade Clinical Data Collection Protocol

This study is a multi-center, single arm, open label, retrospective and prospective clinical data collection of CascadeTM, Non-Occlusive Remodeling Net, in adults with intracranial aneurysms, demonstrating the effectiveness and safety of the CascadeTM in providing temporary assistance for coil embolization of intracranial aneurysms.

All consecutive eligible patients from all participating sites will be included in this clinical data collection. The relevant data of the coil embolization procedure will be collected via an eCRF system.

Peri procedural data on the coil embolization procedure as well as discharge, 30 days and at 3-6 months status will be collected.


Eligibility Criteria:
Patients must fulfill the following eligibility criteria to be included in the study:

1. Patient has been treated or planned to be treated with Cascade (Cascade device was opened).
2. Patient or patient's legally authorized representative or patient's family member (if approved by IEC) has signed and dated an Informed Consent Form (ICF), unless ICF is waived by local IEC.
3. Coil embolization procedure of intracranial aneurysm using temporary assisting device is initiated
Effect of DM on Outcomes and Response Rate in Patients With Advanced NSCLC on ICI

Retrospectively investigating the effect of DM on response rate and outcomes during immunotherapy treatment in patients with NSCLC in the last 5 years.

Lung cancer continues to be the most common cause of cancer-related death worldwide for both males and females despite the identification of clinically-actionable driver mutations in genomic subgroups of patients. Non-small cell lung cancer (NSCLC) is the most common histological diagnosis for 85% of lung cancer patients. Immune checkpoint inhibitors (ICI) has significantly altered the prognosis for patients with advanced non-small cell lung cancer (mNSCLC) as it has been shown to have distinct and long-lasting impacts on survival in first and second line treatment. As a result, immunotherapy has emerged as the backbone of care for people with NSCLC. Although some patients benefit considerably from ICI, not all patients do. A comprehensive research effort exists to identify and characterize variables that could predict or boost the response to ICI.

At the same time, diabetes mellitus (DM) is becoming more prevalent globally and lung cancer patients frequently suffer from a variety of comorbidities, including (DM). However, its effect on treatment outcomes is still unclear, particularly in the era of immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients with advanced Non Small Cell Lung Cancer who received Immune Check Inhibitors alone or in combination with chemotherapy, either as first line or as a subsequent line

Exclusion Criteria:

* None
Third Line Highly Active Antiretroviral Therapy (HAART) in HIV-infected Children

This is an observational cohort study of virologic and immunologic outcome after at least 48 weeks of third line antiretroviral therapy. Upto 150 children at 8 Thai sites will be enrolled. Third line antiretroviral therapy in this study is defined as an antiretroviral (ARV) regimen in a patient who has failure or intolerance to first line NNRTI-based therapy and second line PI-based therapy. Such regimens may contain new drugs or drug classes such as darunavir, tipranavir, etravirine and raltegravir The knowledge gained from this study will help the Thai government in planning its strategy to provide third line ARV therapy to children within the national program.

The primary objective of this study is to assess the virological efficacy, as measured by the proportions of children with HIV RNA below 400 and 50 copies/ml at 48 weeks after initiating third line ARV therapy.

Third line ARV therapy is defined as an ARV regimen in a patient who has failure or intolerance to first line NNRTI-based therapy and second line PI-based therapy. Such regimens may contain new drugs or drug classes such as darunavir, tipranavir, etravirine and raltegravir

Eligibility Criteria:
Inclusion Criteria:

Children (\< 18 years old) with HIV infection may enroll if one of the following criteria is met:

1. Have resistance to at least one drug in each of the 3 classes (NRTI, NNRTI and PI) and have plasma HIV RNA \> 1000 copies/ml prior to switching to third line ARV therapy
2. Have intolerance to the current NRTI, NNRTI or PI treatment and need to receive darunavir, etravirine, tipranavir or raltegravir

Exclusion Criteria:

1. Have hepatic impairment with ALT ≥ 5 upper limit of normal
2. Pregnant or breastfeeding
Interest of the Immunoscore® as a Post-operative Complementary Tool for the Detection of the Risk of Recurrence in Patients With Nonmetastatic Colorectal Cancer

Evaluate the patient care recommandation induced by the IMMUNOSCORE® result


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 inclusive;
* histologically confirmed colon adenocarcinoma;
* having undergone a curative resection of stage I, II or III colorectal cancer;
* diagnosed T1 / T2 / T3 / T4 and N0 / N1 / N2;
* eligible to receive 6 months of adjuvant chemotherapy;
* having given free, informed and written consent;
* agreeing to the use of a tumor sample for research purposes;
* being affiliated to a social security system.

Exclusion Criteria:

* pregnant or breastfeeding women
* legal incapacity or physical, psychological, social or geographical conditions preventing the patient from signing the consent or completing the study.
* history of other solid tumor within 3 years before inclusion, with the exception of in-situ cancer of the cervix and skin cancers (basal or squamous) treated and controlled
* person subject to a safeguard measure.
THE VALUE OF INTERLEUKIN 6 AS A DIAGNOSTIC MARKER IN NEONATAL SEPSIS

Neonatal sepsis is a leading cause of neonatal mortality and continues to be a formidable problem for neonatologists and pediatricians world over. The prevalence of neonatal sepsis varies in different countries; in developed countries it is 1 to 10 cases per 1000 live births and in developing countries the incidence of neonatal septicemia increases to 49 to 170 cases per 1000 live births. The normal fetus is sterile until shortly before birth as the placenta and amniotic sac are highly effective barriers to infections. At birth, the newborn loses the protection afforded to it in the uterus and gets exposed to the microbial world.Neonatal sepsis is broadly divided into two types according to age of onset: Early-onset sepsis (\<72 Hrs) and late-onset sepsis (≥72 hrs-28 days). Early-onset sepsis is acquired during fetal life, delivery, or at the nursery.Bacterial organisms causing NS may differ among countries, however, in most developing countries, gram-negative bacteria remain the major source of infection.To date, blood culture is the gold standard test for diagnosing sepsis, but it has some inherent limitations. It takes at least three or five days to be decisive and can be mistakenly negative because antibiotics are initiated empirically before collection and a well-developed microbiology laboratory is required.CRP is one of the most widely studied and applied acute phase proteins clinically, which can be induced by pre-inflammatory factor interleukin-6 (IL-6) to synthesize by liver cells, and it starts to rise in 12-24 hours of inflammatory response and reaches its peak at 48 hours.Interleukin-6 (IL-6) is a pleiotropic cytokine expressed by different cells in response to infections.


Eligibility Criteria:
Inclusion Criteria:

- Neonates admitted to our hospital NICU with fever, poor feeding and irritability whom suspected to have neonatal sepsis.

Exclusion Criteria:

* Normal white blood cell count, patients whom on antibiotic therapy, negative blood culture
Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy

This trial, evaluating the long-term safety and tolerability of brivaracetam, will give subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity to continue the treatment. The study will also evaluate the maintenance of efficacy over time of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures (PGS).


Eligibility Criteria:
Inclusion Criteria:

* Male/female subjects from 16 years (where legally permitted and ethically accepted) or 18 years onwards suffering from epilepsy and having completed a previous study with brivaracetam as adjunctive treatment, which allowed access to this study
* Subjects with POS/PGS: inpatients or outpatients with epilepsy who participated in previous brivaracetam studies / programs which allow access to the present study
* Subjects with ULD: inpatients or outpatients with epilepsy who were treated with brivaracetam in previous studies / programs which allow access to the present study
* Subjects for whom the Investigator believes a reasonable benefit from the long-term administration of brivaracetam may be expected

Exclusion Criteria:

* Severe medical, neurological and psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
* Poor compliance with visit schedule or medication intake in previous brivaracetam study
* Participation in any clinical study of another investigational drug or device during the study
* Pregnant or lactating woman
Impact of Environmental Nudges on Dietary Quality

Purpose: The overall purpose of this study is to evaluate the impact of a suite of environmentally focused nudges on the nutritional quality of consumers' food selections.

Participants: \~2,000 US adults ages 18-25, at least 25% currently enrolled full-time in college, recruited from CloudResearch Prime Panels.

Procedures: Participants will be randomly assigned to view food products with or without environmental nudges (eco-labels, peer comparison message, and swaps). They will be asked to select items that they most wish to purchase and will then be asked a series of questions about the products and nudges. Questions will also include standard socio-demographic variables.

Participants will be recruited from CloudResearch Prime Panels (an online panel research company). Study participants include 2,000 young adults between 18 and 25 years old with at least 25% currently enrolled in college, recruited to match census distribution of race/ethnicity and gender. Participants will electronically acknowledge their consent to participate in the study.

On the study platform (Qualtrics), participants will be randomly assigned to 1 of 2 arms with equal probability. Participants will complete a shopping task via an online 9-minute survey. They will view products displayed as if they were offered from a grocery store. Products will be frozen meals, such as burritos and pizza, snack items such as dried fruit and chips, and protein items, such as ground beef and chicken breasts. They will then be instructed to select 1 item they most wish to purchase from each category.

Participants in the experimental arm will shop and receive environmental nudges in the form of labels, feedback, peer comparisons, and suggested product swaps. In the control arm, participants will conduct online shopping tasks without any environmental nudges. After selecting products, participants will answer questions about the products and labels, as well as standard socio-demographic questions.

Eligibility Criteria:
Inclusion criteria:

* 18 to 25 years old
* Currently resides in the United States

Exclusion criteria:

* Completion of the survey in \<1/3 of the median completion time
A Phase 1 Study of KHK4083 in Subjects With Atopic Dermatitis

The objective of this study is to evaluate the safety and tolerability of multiple intravenous (IV) infusions of KHK4083 in subjects with moderate or severe atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary written informed consent to participate in the study
2. Atopic dermatitis diagnosed according to the Definition and Diagnostic Criteria for Atopic Dermatitis (Guidelines for Management of Atopic Dermatitis 2016) established by the Japanese Dermatological Association
3. Moderate or severe (≥4.5) symptoms of atopic dermatitis at screening, according to the Rajka \& Langeland Severity Index
4. Investigator Global Assessment(IGA) ≥3 (moderate) at screening

Exclusion Criteria:

1. Any of the following clinically significant concurrent illnesses:

   * Type 1 diabetes
   * Poorly controlled type 2 diabetes (HbA1c \>8.5%)
   * Congestive heart failure (class II to IV of the New York Heart Association classification)
   * Myocardial infarction within 1 year
   * Unstable angina pectoris within 1 year
   * Poorly controlled hypertension (systolic pressure \>150 mm Hg or diastolic pressure \>90 mm Hg at screening)
   * Severe chronic lung diseases requiring oxygen therapy
   * Multiple sclerosis or other demyelinating diseases
   * Active malignancies, or onset or a history of treatment of malignancies within 5 years prior to informed consent (except for resected or surgically cured epithelial carcinoma of the uterine cervix, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or ductal carcinoma)
2. Current or past history of clinically significant cardiovascular, liver, renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders other than those in 1)
3. Alcohol dependence, or drug dependence or a positive result for any of the drug abuse test items
4. Past or current history of drug allergy
5. Any clinically significant infection requiring hospitalization or IV administration of antibiotics within 8 weeks prior to pre-enrollment
6. Any planned surgical treatment during the study
7. Any skin disease that may affect the clinical symptom assessment
8. Pregnant or lactating women, or women willing to have a child during the study period
Treatment of Intimate Partner Violence and Substance Abuse in a Substance Abuse Treatment Facility

Intimate partner violence is a significant societal problem. There is considerable evidence that a strong relationship between the use of alcohol and other drugs and intimate partner violence exists. Besides, a few studies indicate that reducing substance use may have a positive impact on IPV. Therefore, in this study, patients in substance abuse treatment for the use of alcohol, cannabis or cocaine who also admit to perpetrating intimate partner violence will be randomly assigned to either cognitive behavioral therapy addressing substance abuse combined with treatment for offenders of intimate partner violence or substance abuse treatment alone.

Intimate partner violence is a significant societal problem. However, treatment of IPV perpetrators is far from effective, which may be partly due to the fact that the role of substance abuse is not taken into account. There is considerable evidence that a strong relationship between the use of alcohol and other drugs and intimate partner violence exists. Besides, a few studies indicate that reducing substance use may have a positive impact on IPV. Therefore, in this study, patients in substance abuse treatment for the use of alcohol, cannabis or cocaine who also admit to perpetrating intimate partner violence will be randomly assigned to either cognitive behavioral therapy addressing substance abuse combined with treatment for offenders of intimate partner violence or substance abuse treatment alone.

Eligibility Criteria:
Inclusion Criteria:

* Perpetration of intimate partner violence in the past year
* Substance abuse or dependence (current)
* Currently in a relationship

Exclusion Criteria:

* Not sufficient fluency in Dutch to complete treatment and measures
* (Ab)use of crack cocaine and/or heroin
* Psychosis
* Psychopathy
Thrombin Generation in Crohn's Disease

One hundred and fifty patients with Crohn's disease involving the terminal ileum or the colon, in clinical remission, with or without endoscopic activity will be included. Thrombin generation will be measured and correlated with the simplified endoscopic activity score. The patients will be evaluated for development of deep vein thrombosis after one-year of follow-up.

One hundred and fifty patients with Crohn's disease involving the terminal ileum or the colon, in clinical remission defined by the Crohn's Disease Activity Index below 150 and Harvey-Bradshaw Index below 5, with or without endoscopic activity defined by simplified endoscopic activity score for Crohn's disease (SES-CD) will be included in this study (75 patients with a complete mucosal healing defined by SES-CD below 3 and 75 with endoscopic activity defined by SES-CD above 6) in multiple centers specializing in the treatment of inflammatory bowel diseases in Brazil; Study data will be collected and managed using REDCap electronic data capture tools hosted at the Clinical Hospital of University of São Paulo. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies. All thrombin generation tests will be performed at the Clinical Hospital of University of São Paulo, São Paulo, SP through automatically calibrated Thrombogram (CAT- Calibrated Automated Thrombogram®, Maastricht, The Netherlands), with and without thrombomodulin. Those patients will be followed for at least one year after the colonoscopy with measurement of the D-dimer and clinical evaluation every 3 months to verify the developing of deep vein thrombosis.

Eligibility Criteria:
Inclusion Criteria:

* Established Crohn's disease diagnosis for at least 6 months
* Disease involvement of the terminal ileum and/or colon
* Clinical remission
* Stable treatment for at least 3 months

Exclusion Criteria:

* Colectomy
* Neoplasia
* Surgery in the last 6 months
* Anticoagulant treatment
* Major liver disease
Study of Sargramostim in Moderately to Severely Active Crohn's Disease

The purpose of this study is to assess the tolerability, pharmacokinetics and safety of 2 and 6 micro g/kg/day sargramostim administered subcutaneously once daily for 4 weeks, and to assess the efficacy and safety of 6 micro g/kg/day sargramostim administered subcutaneously once daily for 8 weeks in comparison with placebo, in patients with moderately to severely active Crohn's disease.

On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Crohn's disease (endoscopic or radiological evaluation) at least 4 months prior to receiving the first dose of study drug
* Moderately to severely active Crohn's disease at time of screening (i.e., Crohn's disease activity index \[CDAI\] \>220 and \<475 points)

Exclusion Criteria:

* Colostomy or ileostomy
* Immediate need for gastrointestinal (GI) surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage
* GI surgery within 6 months prior to receiving the 1st dose of study drug
* Symptoms of bowel obstruction or confirmed evidence of a clinically-significant stricture within the last 6 months that has not been surgically corrected