cyrilzakka/clinical-trials huggingface dataset:
A Study of Volociximab in Metastatic Melanoma

This is a Phase 2, multicenter, research study determining the effects of an investigational drug called volociximab in metastatic melanoma.

The purpose of the study is to compare the clinical benefit and safety of volociximab. Pharmacokinetics and mechanism of action will also be evaluated.


Eligibility Criteria:
Inclusion Criteria

1. Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information \[PHI\]).
2. Aged \>=18 years old at the time of informed consent.
3. Stage III and Stage IV unresectable melanoma with documented progression during or following the most recent prior melanoma therapy.
4. Must have failed at least 1 prior therapy for metastatic disease.
5. Must have at least 2 cutaneous, subcutaneous, or nodal metastases that are safely accessible for pre treatment and post treatment biopsies.
6. Must agree to pre-treatment and post-treatment biopsies of tumor lesions (subjects in Stage 1 only).
7. Must have at least 1 measurable target lesion for CT/MRI assessment, according to RECIST criteria.
8. ECOG Performance Status \<=1.
9. Acceptable laboratory results
10. Life expectancy \>=12 weeks.
11. Male subjects and female subjects of child bearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after last infusion of study treatment.

Exclusion Criteria

1. Subjects with any other active malignancy in addition to metastatic melanoma.
2. CNS metastases, unless stable for at least 2 months following definitive local therapy (surgery, stereotactic radiation). Subjects may not require treatment with steroids or anticonvulsants.
3. History of any other significant medical condition, including cardiovascular, pulmonary, neurologic, or autoimmune disease; active infections (e.g., bacterial or fungal); or a psychiatric condition within 6 months of Day 1
4. History of hepatitis B or C.
5. Known history of HIV infection or AIDS.
6. History of thromboembolic or cerebrovascular events, such as stroke, transient ischemic attack, deep vein thrombosis, or bleeding disorders within 12 months prior to Day 1.
7. Prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy for melanoma within 4 weeks prior to Day 1.
8. Previous exposure to volociximab.
9. Aspirin, high dose warfarin, or heparin use. (Note: Aspirin \<=81 mg/day, low-dose warfarin 1 mg/day or low-dose heparin for IV catheter patency is allowed.)
10. Major surgery within 4 weeks prior to Day 1.
11. Requirement for immunosuppression, and/or systemic steroid therapy.
12. Investigational therapies within 4 weeks prior to Day 1 or 4 half lives of the prior investigational drug (whichever is longer).
13. Known hypersensitivity to murine or chimeric antibodies.
14. Any condition that, in the opinion of the Investigator, makes the subject unsuitable for study participation.
15. Female subjects who are pregnant or currently breastfeeding.
A Study in Participants With Asthma Initiating Treatment With Omalizumab (Xolair)

This multicenter, prospective study will evaluate the baseline participant characteristics (including biomarkers) associated with a variety of individual and composite clinical outcomes in participants with moderate to severe asthma initiating treatment with omalizumab.


Eligibility Criteria:
Inclusion Criteria:

* Participants identified by the investigator as a candidate for treatment for asthma with omalizumab
* Confirmation of access to omalizumab through insurance or other source of funding

Exclusion Criteria:

* Enrollment in any other concurrent clinical trial or observational study
* Participants for whom omalizumab treatment is contraindicated
* Participants who had a prior allergic reaction to omalizumab or its excipients
* Participants treated with omalizumab within the previous year
* Participants who received an experimental drug as part of another study within 3 months of enrollment
Real-World Study on Adjuvant Therapy Combined With Shenlingcao Oral Liquid in Patients for Stage II and IIIA Non-small Cell Lung Cancer After Radical Resection

This study will establish a multi-center, prospective registration database. The included population are stage II and IIIA NSCLC patients undergoing R0 resection and will be scheduled for adjuvant chemotherapy. Before the first adjuvant chemotherapy, under the recommendation of a doctor, patients will voluntarily choose to use (exposed group) or not to use (control group) Shenlingcao Oral Liquid, which donated by Jiangzhong Group for 30 bottles. The research centers need to be consecutively enrolled patients according to the allocation of the number of cases according to the ratio of 3: 1 in exposure group and control group.

The exposed and control groups will be followed up to 36 months (non-allelic follow-up). Information from patients will be prospectively collected, including baseline, chemoradiation, use of Shenlingcao Oral Liquid and the other complementary drugs, and various outcome measures (the questionnaire of EORTC QLQ, death, tumor recurrence, tumor metastasis, and chemotherapy-induced side effects of the blood system, etc.). Follow-up points included: Baseline (before giving chemotherapy), 2-3 days after each chemotherapy cycle, and 6,12,18,24,30,36 months after enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older;
* Pathological diagnosis of patients with stage II, III A primary NSCLC;
* R0 resection has been accepted;
* Received adjuvant chemotherapy or adjuvant chemotherapy for the first time after surgery;
* Informed consent has been signed.

Exclusion Criteria:

* Incorporation of other malignant tumors (such as leukemia, liver cancer, etc.)；
* Patients with unclear pathological types；
* Patients with unclear pathological staging；
* Preserved Shenlingcao Oral Liquid before R0 resection surgery；
* Received immunotherapy or targeted therapy before R0 resection surgery；
* Radiotherapy and chemotherapy before R0 resection surgery.
Green (Sustainable) VENTOLIN - Pharmacokinetics (PK) Study in Healthy Participants

This study will be conducted to compare the PK of salbutamol administered via metered dose inhalers (MDI) containing propellants 1,1-difluroethane (HFA-152a) and 1,1,1,2-tetrafluoroethane (HFA-134a) in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 55 years, inclusive, at screening
* Body mass index 18.0 to 30.0 kilograms per meter square (kg/m\^2), inclusive, at screening
* Weight: greater than or equal to (\>=)50 kg
* At screening, females must not be pregnant or lactating, or of non-childbearing potential
* Female participants of childbearing potential who have a fertile male sexual partner must agree to use adequate contraception
* Male participants, if not surgically sterilized, must agree to use adequate contraception
* Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, electrocardiogram, and vital signs, as judged by the investigator
* Willing and able to sign the informed consent form

Exclusion Criteria:

* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data
* History or presence of any form of asthma, including childhood asthma and exercise induced asthma
* Current enrollment or past participation in this clinical study
* Participants with clinically significant abnormalities
* A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse
* Positive nasopharyngeal polymerase chain reaction test for severe acute respiratory syndrome-corona virus type 2 (SARS-CoV-2) on Day -1 or any known close contact with a person who tested positive for SARS-CoV-2 or with a coronavirus disease 2019 participant within 2 weeks prior to admission
* Impairment which would prevent the correct and consistent use of an MDI, as determined by the investigator
Prediction of Mortality in Patients Waiting for Liver Transplantation Through Brain Magnetic Resonance Imaging

The purpose of this study is to determine whether hepatic encephalopathy, measured through magnetic resonance imaging, electroencephalogram and neuropsychological evaluation adds prognostic information to patients who are waiting for liver transplantation. If this model improves mortality prediction this might be used in the future for organ allocation.

The only current definitive treatment for end-stage liver disease is transplantation. Due to the scarcity of organs available, the correct prioritization of patients for liver transplantation has a crucial importance. Nowadays, patients are ranked according to severity of liver disease, measured by the MELD score. This index is only derived from objective measures (serum concentration of bilirubin, creatinine and INR). Hepatic encephalopathy (HE) is a serious and progressive disorder in patients with end-stage liver disease. The severity of HE has prognostic implications in those waiting for liver transplantation. However, the prognosis of HE is independent and not correlated to the MELD score. Hepatic encephalopathy triggers multiple changes in brain magnetic resonance imaging (MRI) providing an objective way to evaluate it. Also electroencephalogram and neuropsychological evaluation might increase mortality prediction.

Adding the information provided by MRI, electroencephalogram and neuropsychological evaluation to the MELD score model might increase the prediction of mortality. Increase mortality's prediction has a fundamental importance because in organ allocation.

We will evaluate the predictive value of these variables in predicting mortality of those patients waiting for liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman over 18 years old
* Listed in liver transplantation waiting line
* Patient able and willing to participate in the evaluations of this study

Exclusion Criteria:

* Acute liver failure
* Serious structural brain anomalies
* Condition or situation in which, in the opinion of the investigator, put the patient at significant risk
Results of Bile and Blood Culture in Patients With Acute Cholangitis

Cholangitis is a complication of biliary statsis. Bile juice is sterile when there is no obstruction, however, it can be infected with bacteria when there is a stasis or obstruction. After infection, cholangitis can be developed because of systematic endotoxemia or bacteremia. Though identification of bacteria is very important for selection of adequate antibiotics, treatment with empirical antibiotics is commonly performed when identification of bacteria is not possible.

Identification of bacteria is usually done with blood or bile culture. In the previous studies, the same results from blood and bile were common in patients with cholangitis. However, the data of these studies were based on the bile juice which was aspirated by surgery. Considering that bile duct obstruction is usually treated with endoscopy or radiological intervention without surgery, it is necessary to collect data with endoscopic or radiologic intervention. In addition, the concordant rate of these two tests has not been reported according to severity of cholangitis. As a result, the necessities of bile and blood culture are not agreed among experts in this fields.

Our hypothesis is that concordant rates of bile and blood culture are same in patients with each moderate or severe cholangitis. However, the concordant rates of bile and blood culture are different between patients with moderate and severe cholangitis. This study will assess the positive rates of blood and bile culture in patients with moderate or severe cholangitis, respectively and compare the results according to the different severity.


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate or severe cholangitis which fullfilled the criteria by the Tokyo Guidelines (Tanaka A, Takada T, Kawarada Y, et al. Antimicrobial therapy for acute cholangitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg 2007;14:59-67.)
* Patients who are successfully treated with endoscopic or radiologic biliary drainage
* Patients who undergo both blood and bile culture tests

Exclusion Criteria:

* Patients with other infections except cholangitis or cholecystitis
* Patients who received surgical biliary drainage treatment
* Patients who are treated with endoscopic or radiologic biliary drainage more than 24 hours after using initial antibiotics
* Patients who does not agree with informed consent or who are vulnerable subjects
Interferon α2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis

Brief summary: This study compares the long-term efficacy and safety of interferon (IFN) α2a and cyclosporine (cyclosporin A, CsA) following suppression of acute attack by high-dose oral glucocorticosteroid in patients with refractory Behçet's uveitis (BDU). Half of the participants will receive IFNα2a while the other half will receive CsA.

Detailed description: Both CsA and IFNα2a have been shown to be effective for long-term control of BDU, however, randomized prospective comparative studies are scarce, particularly in East Asian populations. Our preliminary data gave us the impression that IFNα2a might be more effectiveness than CsA in long-term control of refractory BDU, and this study aimed to compare their effectiveness and safety profiles in a well-designed prospective study. Refractory BDU is defined as relapse of posterior or pan- uveitis with at least 10mg daily prednisone (or equivalent) and one traditional immunomodulatory treatment (IMT) agents. The acute attack is controlled with large dose oral corticosteroid (60mg daily prednisone) for 4 weeks, and then the patients are randomly assigned to the IFN arm and the CsA arm, in which patients are treated with IFNα2a (3×10\^6 IU qd for 4 weeks and qod thereafter) and CsA (100mg bid), respectively, along with a fixed tapering regimen of corticosteroid. Patients were followed up until relapse, or for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Refractory BDU patients fulfilling the International Criteria for Behçet's disease (ICBD) published in 2013 with recent recurrence of pan- or posterior uveitis;
* The patient should be on ≥10mg/d oral prednisone or equivalent with at least one of the following IMT agents: cyclophosphamide≥50mg/d, CsA≥100mg/d, azathioprine≥50mg/d, methotrexate≥15mg/w, mycophenolate≥1000mg/d, tacrolimus≥2mg/d.

Exclusion Criteria:

* Previous treatment with interferon-α;
* Pregnancy, breast feeding women;
* Malignancy;
* Renal impairment (creatinine \> 1.5 mg/dl);
* Uncontrolled hypertension or diabetes;
* Depression or other psychic disorders;
* History of acute or chronic inflammatory joint or autoimmune disease;
* Patients with severe extra-ocular involvement other than oral/genital ulcer and skin involvement;
* Organ or bone marrow transplant recipient, cardiac failure \> NYHA III;
* Acute liver disease with ALT or SGPT 2x above normal;
* White blood cell count \< 3500/mm\^3;
* Platelet count \< 100000/mm\^3;
* Hgb \< 8.5g/dl;
* T-SPOT TB: ≥200 SFCs per 10\^6 PBMC;
* Active peptic ulcer, systemic or local infection, moderate to severe osteoporosis or other contraindications of large dose corticosteroids;
* Previous intolerance to CsA;
* Other severe ocular diseases or intraocular surgery within 3 months;
* Media opacity precluding a clear view of the fundus;
* Positive screen test for HBV, HCV, HIV infection or syphilis;
* Body weight \<45 kg;
* Alcohol abuse or drug abuse;
* Mental impairment;
* Uncooperative attitude.
Addiction Risk: Mindset Induction Effect on Brief Intervention

Brief Interventions (BI) based on Motivational Interviewing are effective to reduce alcohol use. In this study the investigators test the hypothesis that that an open Mindset increases the positive effects of BI.

University students take part in a voluntary screened for risky alcohol use. All students with risky alcohol use are eligible to the study and all receive the WHO's ASSIST-linked BI.

Participants receive a brief Mindset induction prior to receiving BI. They are are randomly assigned to either the induction of an open or a closed mindset according to the Mindset theory of action phases (Gollwitzer \& Keller (2016). Mindset Theory. In: V. Zeigler-Hill, T.K. Shackelford (eds.), Encyclopedia of Personality and Individual Differences. New York: Springer).

The investigators measure the change in alcohol-related risk perception, treatment motivation and real alcohol drinking after the Brief Intervention in relation to the mindset induced before receiving the intervention.


Eligibility Criteria:
Inclusion Criteria:

* student status at University of Konstanz
* risky alcohol use in past 12 months

Exclusion Criteria:

* acute psychosis, acute suicidality, illiteracy
Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents

A randomized, crossover, open study in order to compare treatment satisfaction with insulin Glargine plus insulin Apidra Vs NPH insulin plus insulin Apidra in newly diagnosed children and adolescents with type 1 diabetes.

The study will include two consecutive periods: 2 weeks run in period and 24 weeks intervention period, divided into two separate treatment periods of 12 weeks. According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with insulin Glargine and than 12 weeks with NPH insulin or 12 weeks with insulin NPH ad than 12 weeks with insulin Glargine. Patients will complete DTSQ (Diabetes Treatment Satisfaction Questionnaire) at months 0, 12 and 24 weeks, before and at the end of each study arm.

A randomized, crossover, open study in order to compare treatment satisfaction with insulin Glargine plus insulin Apidra Vs NPH insulin plus insulin Apidra in newly diagnosed children and adolescents with type 1 diabetes.

134 Patients with new onset Diabetes type 1, diagnosed 12 months previously at maximum will be enrolled.

The study will include two consecutive periods: 2 weeks run in period and 24 weeks intervention period, divided into two separate treatment periods of 12 weeks. According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with insulin Glargine and than 12 weeks with NPH insulin or 12 weeks with NPH insulin and than 12 weeks with insulin Glargine.

The study will consist of 4 clinical visits, taking place at -2, 0, 12 and 24 weeks. Height,weight,vital signs, HbA1c and insulin doses will be determined during the clinical visits.

Patients will complete DTSQ (Diabetes Treatment Satisfaction Questionnaire) at months 0, 12 and 24 weeks, before and at the end of each study arm.

The DTSQ questionnaires consists of DTSQ parents- for patients below the age of 13, and DTSQ teen for those above age 13.

Eligibility Criteria:
Inclusion Criteria:

1. Type 1 diabetes diagnosed less than 12 months prior to study entry
2. Age: 7-20 years old.
3. HbA1c\>/=8.0
4. Signing inform consent form

Exclusion Criteria:

1. Any significant disease or conditions, including psychiatric disorders that in the opinion of the investigator are likely to effect his compliance or ability to complete the study.
2. Patients participating in other device or drug studies.
3. Any contraindication to insulin glargine and or insulin Apidra and or Insulin NPH according to SmPC.
4. Inability, of adolescent or parent, to understand/complete the Treatment satisfaction questionnaire.
A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer

The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol. Individual clinical trials under this master protocol define drug/disease-specific research goals and activities to test them. New studies will be added as new drugs emerge against different cancers. Participation in the trial will depend on how long the benefit lasts.


Eligibility Criteria:
Inclusion Criteria:

Participants must meet all of the inclusion criteria below. Additional criteria are specified in the protocol amendment (individual addenda) to which the participant will enroll.

* Have either measurable or evaluable disease using standard techniques by the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
* The participant has a Lansky (\<16 years of age) or Karnofsky (≥16 years of age) performance score of at least 50.
* Participants must have discontinued all previous treatments for cancer or investigational agents greater than or equal to (≥)7 days after the last dose and must have recovered from clinically significant side effects.
* The participant has adequate hematologic and organ function.
* Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to first dose.
* Both female and male participants of childbearing potential must agree to use highly effective contraceptive precautions during the trial and for at least 3 months following the last dose of study drug.

Participants will be ineligible if they meet any of the exclusion criteria below. Additional criteria are specified in the protocol amendment to which the participant will enroll.

* Participants with severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that, in the opinion of the investigator, could cause unacceptable safety risks or compromise compliance with the protocol.
* Participants who have active infections requiring therapy.
* Participants who have had allogeneic bone marrow or solid organ transplant.
* Participants who have had, or are planning to have, certain invasive procedures.
* Female participants who are pregnant or breastfeeding.