cyrilzakka/clinical-trials huggingface dataset:
A Study of TQ05105 Tablets in Subjects With Hemophagocytic Lymphohistiocytosis（HLH）

This is a phase I study of TQ05105 tablets in subjects with Hemophagocytic Lymphohistiocytosis.TQ05105 is a JAK2 inhibitors and can be used to treat JAK2 target-related diseases. The activation of the JAK/STAT pathway is related to abnormal proliferation, obstruction of apoptosis, and differentiation disorder of leukemia cells which is caused by genetic abnormalities and viral infection.


Eligibility Criteria:
Inclusion Criteria:

* 1.18 years and older; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3; Life expectancy ≥ 3 months.

  2. Diagnosed as new or relapsed HLH according to the HLH-2004 criteria. 3.Has received other treatments for HLH before two weeks ago, surgery before four weeks ago.

  4. Adequate laboratory indicators. 5. No pregnant or breastfeeding women, and a negative pregnancy test. 6. Understood and signed an informed consent form.

Exclusion Criteria:

* 1. Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. With exception of non-melanoma, skin cancer, and carcinoma in situ.

  2. Has participated in other anticancer drug clinical trials within 4 weeks. 3. Has multiple factors affecting oral medication. 4. Has drug abuse history that unable to abstain from or mental disorders. 5. Has active hepatitis B or C, or immunodeficiency. 6. Diagnosed as hepatic failure. 7. Has arteriovenous thrombosis events within 4 weeks. 8. Has active bleeding, or a persistent decrease in hemoglobin. 9. Has received long-term and large-dose glucocorticoids or other immunosuppressive drugs within 28 days before signed the informed consent form.

  10. Has uncontrolled cardiovascular disease. 11. Has uncontrolled hypertension. 12. Has serious systemic infections. 13. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Clinical Study on Second-eye Pain in Cataract Surgery

The degree of perceived pain in the second-eye surgery of cataract patients is significantly higher than that in the first-eye surgery, which can lead to nervous tension during surgery and affect the surgical outcome and satisfaction. Study suggested that in addition to psychological factors, there might be subclinical sympathetic reactions leading to increased pain in the second-eyes, but the objective indicators and clinical relevance are not clear. Therefore, it is necessary to study the mechanism of second-eye pain in cataract surgery, and to provide a test index that can effectively predict the degree of intraoperative pain in patients, as an important reference for the development of a suitable time for second eye surgery.

This study is based on clinical case studies, recruiting patients with clinically diagnosed binocular age-related cataract and require binocular surgery, to compare the correlation of intraocular inflammatory factors in the second eye and patients' self-pain scores while both eyes' surgery are completed by the same doctor in the same operating room, and the correlation of the change of inflammatory factors and the time interval between the two eyes surgery, to analyze the second-eye subclinical sympathetic reaction changing with the time interval after the first cataract surgery from the molecular biological results. Using the latest international anterior segment vascularization optical coherence tomography(OCT) scan and optical microvascular imaging(OMAG) analysis technology to quantify iris blood flow, this study analyzes the iris blood flow density, vascular density and other indicators before and after cataract surgery, and carry out its correlation with the degree of intraocular subclinical sympathetic reaction, providing a rapid, non-invasive objective examination index of the second-eye subclinical sympathetic response.

1. Coordination and Quality Control Team: The inspection and audit of this research project will be established mainly by hospital clinical research center staff and assisted by the Ophthalmology Reading Center team;
2. The project team member will accept training before the study begins while unified inspection methods and requirements is established in standard operating procedures.
3. The project team double enter the test data independently and establishes an electronic database.
4. The project team randomly selects the data and repeats the measurements to ensure the accuracy as internal audit regularly.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with binocular age-related cataract.
2. Both eyes require phacoemulsification and intraocular lens implantation.
3. binocular surgery was performed by the same physician in the same operating room, and the anesthesia and surgical procedures were consistent.
4. Patients can fully understand the research purpose, research content, accidents and benefits and risks of the clinical trial, and can make their own decisions on participating or not.

Exclusion Criteria:

-
Question Prompt List in Breast Cancer Patients Planned for Neoadjuvant Chemotherapy

Preoperative chemotherapy has been shown to be at least as effective as postoperative chemotherapy in breast cancer patients and has seen increased use over time. The decision regarding neoadjuvant treatment is complex, as various aspects need to be considered, and the patient's role in the decision-making process is central.

The information provided by doctors to patients about preoperative treatment can be complicated, including details about treatment options, treatment plans, and side effects. If this information is not conveyed adequately, there is a risk of misunderstandings, which can lead to increased anxiety and stress for patients regarding their decisions.

In oncology, question prompt lists (QPL) have been used as a tool to support patients by improving the information conveyed by doctors in various contexts where complex decisions need to be made. Studies have shown that QPL can facilitate better information exchange. However, their use in discussions about preoperative treatment for breast cancer patients has not been studied. Furthermore, evidence from randomized studies on the use of QPL in clinical practice is very limited.

The aim of this study is to investigate whether the use of QPL during patient consultations involving discussions about neoadjuvant chemotherapy can improve information exchange in various aspects: understanding of the treatment; anxiety about the decision; participation in the decision-making process; patient-doctor communication; and decision-related conflict.


Eligibility Criteria:
Inclusion Criteria:

* Patients with operable breast cancer eligible for systemic neoadjuvant therapy, according to current treatment guidelines.

Exclusion Criteria:

* Patients with locally advanced breast cancer where neoadjuvant therapy is mandatory rather than a treatment option.
* Patients with cognitive impairment that are assessed from treating physician as unable to participate.
* Patients who cannot speak/read neither Swedish nor English.
Methotrexate-Inadequate Response Study

The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in participants with rheumatoid arthritis and an inadequate response to current methotrexate therapy.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Subjects who are considered methotrexate inadequate responders
* 10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count)

Exclusion Criteria:

* Subjects who failed one or multiple anti-tumor necrosis factor (TNF) therapies
* Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous)
* Subjects with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules)
* Subjects with severe chronic or recurrent bacterial infections
* Subjects who have received treatment with rituximab

An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
Meropenem vs Cefotaxime as Empirical Treatment of SBP

We aimed to evaluate whether meropenem is superior to cefotaxime for treatment of SBP empirically.

Ascites is the most frequent complication of cirrhosis and represents a significant change for the patient because the impact on mortality and quality of life is important.

Spontaneous bacterial peritonitis (SBP) is a dreaded complication in patients with decompensated cirrhosis.

Spontaneous bacterial peritonitis (SBP) is the most frequent and life-threatening infection in patients with liver cirrhosis requiring prompt recognition and treatment. It is defined by the presence of \>250 polymorphonuclear cells (PMN)/mm3 in ascites in the absence of an intra-abdominal source of infection or malignancy.

Spontaneous bacterial peritonitis carries a mortality rate of 30 to 70% in patients with end-stage liver and kidney disease.

Choice of antibiotic is dependent on type of microbes responsible for infection. Gram negative enteric bacteria are considered the most common pathogens responsible for SBP. This is the reason, 3rd generation cephalosporins are the recommended drugs of choice for treating SBP empirically. But recent studies have shown that Cephalosporins are effective only in 70% of community acquired and 56% of hospital acquired SBP.It is most likely due to changing bacterial pathogens of SBP over last two decades as now gram positive bacteria and multi drug resistance organism (MDRO) are increasingly being isolated in SBP. It is the consequence of undue, over the counter misuse of cephalosporins in community and frequent exposure of cirrhosis patients to these drugs during recurrent hospital admissions.

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis patients with ascites Ascitic fluid PMN cell count \>250/mm3 Age: 18:80

Exclusion Criteria:

* : history of abdominal surgery within 4 weeks, secondary peritonitis, tuberculous peritonitis, Malignant tumor, patients who use hormones or immunosuppressants, AIDS patients.
The Effect of Imipramine on Early Information Processing

We wanted to compare the relation of two different psychophysiological paradigms (PrePulse Inhibition of the startle response = PPI and P50 suppression) to each other. Additionally, we wanted to test the effect of the combined serotonin- and noradrenaline re-uptake inhibitor, imipramine, on these measures. The primary hypothesis was that PPI and P50 gating would not correlate with each other at baseline. The secondary hypothesis was that increased noradrenergic and serotonergic activity would disrupt PPI as well as P50 gating.

Schizophrenic patients exhibit impairments in filtering of sensory information, as can be assessed by use of prepulse inhibition (PPI) of the acoustic startle response and P50 suppression paradigms. In the treatment of negative symptoms or depressive syndromes during the course of schizophrenia antidepressants are often combined with antipsychotic medication. However, antidepressants increase monoaminergic activity, of which in turn it has been suggested to decrease sensory gating, although these presumptions are mostly based on results from animal studies. Currently, little is known about monoaminergic modulation of sensory filtering in humans, and the few reports that can be found in literature show discrepancies with animal studies. The current study was designed to study the effects of increased monoaminergic activity on sensory filtering and habituation of healthy volunteers. In a double-blind, placebo controlled cross-over design, twenty healthy male volunteers will receive either placebo or a dose of 50 mg of imipramine (a dual acting antidepressant), after which they will be tested in a P50 suppression-, a PPI-, and a habituation of the startle reflex paradigm.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects
* Good Physical and Mental Health meeting criteria "never mentally ill", which will be evaluated with a medical history checklist, ECG
* Non smokers

Exclusion Criteria:

* Current use of any medication
* Any subject who has received any investigational medication within 30 days prior to the start of this study
* History of neurologic illness
* History of psychiatric illness in first-degree relatives, evaluated with DSM-IV criteria
* History of alcohol and drug abuse. Positive urine screening for amphetamine, cocaine, cannabis, or ecstasy.
Deep Brain Stimulation in Forel's H Field in Tourette's Syndrome

Tourette's Syndrome (TS) is a neurodevelopmental disease characterized tics that start before the age of 18 years. About 5% of cases do not respond to drug treatment and can be classified as refractory and in these cases surgical treatment, with deep brain stimulation, appears as a therapeutic possibility, but with still conflicting results. Our hypothesis is that DBS in Forel's H Field could improve tourette's symptoms, neurological and psychiatric ones.

Sixteen patients with TS will be included in our protocol. The tics must have a negative influence in the quality of life of these patients. Patients will be submitted to a neuronavigation protocol for the precise location of the surgical target. After the surgery all patients will have the device turned ON for 6 months.

After the first 6 months participants will be randomly in two groups, one to stay with device ON or turned OFF at a period of 3 months. After that the groups will cross over for more 3 months. Clinical and video evaluations will be conducted before the surgery, at end of open fase, in the moment of cross over and at end of all.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Tourette's Syndrome diagnosis.
* Age equal to or above 14 years.
* Severe impairment of motor tics (Yale Global Tic Severity Scale ≥ 35/50).
* Patients who are refractory to drug treatment.
* Patients intellectually able to understand and sign the consent form.
* Possibility to adhere to research and periodic medical visits after surgery.

Exclusion Criteria:

* Inability to consent to your participation in the study.
* Patients with non-stabilized psychiatric comorbidities, such as anxiety and depression.
* Concomitant treatment with other experimental drugs.
* Women who are pregnant or breastfeeding.
* Patients undergoing previous neurosurgical procedures for the treatment of Tourette's Syndrome.
Improving Health Outcomes: Blood Pressure

This quality improvement project is focused on improving hypertension care delivery processes in ambulatory clinical practices, 5 in Illinois and 5 in Maryland for a total of 10 practice sites.The primary aim of this quality improvement project is to improve blood pressure control among patients receiving routine care for hypertension in a diverse group of ambulatory clinical practices. A secondary aim is for American Medical Association (AMA) and Johns Hopkins Medicine (JHM) quality improvement staff to figure out the best way to help clinical practices in achieving improved blood pressure control, including working to increase the use of home blood pressure monitoring.


Eligibility Criteria:
The Practice Sites must

* Self-identify as either primary care internal medicine, family practice, or cardiology
* Have an electronic health record
* Serve patient populations that are diverse and representative of the U.S. adult population
* Have a significant number of male and female patients, age 18 or older, voluntarily receiving care for hypertension
* Have the resources, staff, and commitment to complete this quality improvement project
Evaluating Electrocardiogram (ECG) Abnormalities From Young Adulthood Through Middle Age

An electrocardiogram (ECG) is a test that evaluates the electrical activity of the heart and can be used to detect heart problems. By analyzing ECGs collected over a 20-year period, this study will examine ECG abnormalities and the differences in ECG findings between black and white people, from young adulthood through middle age.

An ECG is a test that detects and records the electrical activity of the heart. As a diagnostic tool, it can detect and locate the source of heart problems, including heart attacks, irregular heart beats, cardiovascular disease, or other abnormalities of the heart. An ECG procedure involves attaching electrodes to the skin on the chest, arms, and legs while the electrodes detect electrical signals of the heart, and a machine displays the signals on a computer screen and graph paper. An ECG may be a beneficial way to detect cardiovascular disease because it is a low-cost and non-invasive test that is widely available in the clinical setting.

This study will examine ECGs and other study data from participants in the Coronary Artery Risk Development in Young Adults (CARDIA) study. As ECG abnormalities typically begin to develop in young adults, the CARDIA participants will provide researchers with an excellent study population. As part of the CARDIA study, ECGs were obtained from participants at baseline, and Years 7 and 20. Study researchers will use state-of-the-art technology and standardized Minnesota Code and Novacode methods to electronically code participants' ECGs and accomplish the following: 1) assess the frequency of ECG abnormalities in young adults of different races; 2) examine potential risk factors for the development and progression of ECG abnormalities; 3) investigate the relationship between ECG abnormalities and other measures of heart disease; and 4) assess differences in the frequency and patterns of ECG abnormalities between different racial groups. Study researchers will also analyze additional CARDIA study data, including cardiovascular disease risk factors, measures of atherosclerosis, and echocardiographic ultrasound pictures of the heart.

This research will provide important insights into the ways in which ECG abnormalities are associated with increased risk for cardiovascular disease and how the risk may differ between blacks and whites. Results from this study may ultimately lead to improvements in preventive strategies for cardiovascular disease in young adults.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the CARDIA study
A Study Of SU011248 As Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

The purpose of this study is to find out if SU011248 (sunitinib) provides additional benefit when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and also if sunitinib is safe for patients with locally advanced and metastatic Non Small Cell Lung Cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven NSCLC
* Stage IIIB (locally advanced with malignant effusion) or Stage IV disease
* No prior therapy for NSCLC
* Evidence of unidimensionally measurable disease

Exclusion Criteria:

* Previous treatment with systemic chemotherapy for lung cancer
* History of or known brain metastases
* NCI CTCAE Grade 3 hemorrhage within 4 weeks of starting study treatment
* Evidence of hemoptysis within 4 weeks of starting study treatment
* Serious acute or chronic illness or recent history of significant cardiac abnormality
* Previous treatment with anti-angiogenesis agents including thalidomide, or inhibitors of EGFR and PDGFR
Study Comparing the Use of Laser and of Kinesiotherapy for the Treatment of Female Stress Urinary Incontinence

The purpose of this study is compare the effect of laser and of kinesiotherapy in the treatment of women with stress urinary incontinence

the objective of this project is to compare the effect of laser and of kinesiotherapy in the treatment of women with stress urinary incontinence. A randomized controlled clinical trial is proposed involving 40 women diagnosed with stress urinary incontinence randomized into two groups: 1) treatment with application of Erbium Laser: YAG 2940nm, SMOOTH mode, one session per month for three months (n=20); 2) treatment with kinesiotherapy for three months with supervision twice a week (n=20). At baseline assessment, patients shall undergo anamnesis, general physical and gynecological exam, assessments of the pelvic floor based on the modified Oxford scale and of the presence of prolapse using the Pelvic Organ Prolapse Quantification (POP-Q) system. The following exams shall also be performed: Type 1 urine, urine culture, urodynamic study and 1-hour Pad test. Participants shall complete both the King's Health Questionnaire and Incontinence Quality of Life Questionnaire (IQOL). Post-treatment, patients will be assessed during follow-up visits at 1, 3, 6 and 12 months by physical exam and application of the questionnaires. The Pad test will be re-administered at 6 and 12 months. Data will be grouped and statistically assessed.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women with stress urinary incontinence will be recruited for this study.

Exclusion Criteria:

* Patients presenting detrusor hyperactivity,stress urinary incontinence with sphincter deficiency genital prolapse, stages 3 and 4 on the POP-Q system, genital cancer, history of painful bladder syndrome, previous history of radiotherapy, keloid, use of photosensitive drugs, uncontrolled diabetes mellitus, active vaginal infection (bacterial vaginosis and candidiasis), abnormal genital bleeding or vaginal stenosis shall be excluded.
An Open Phase 3 Study of IV-Globulin SN Inj.10% to Treat Immune Thrombocytopenia

Human immunoglobulin (Ig) is the most commonly used blood product. It has been well-defined the efficacy in patients with immunodeficiencies, Kawasaki disease, asthma and other immune diseases. It is expected that Ig 10% will improve the usefulness and safety profile compared to Ig 5% because it is expected the reduced hospitalization/treatment duration and less adverse events related to volume overload.

GC5107A (IV-Globulin SN Inj. 10%) is a polyvalent intravenous human immunoglobulin G preparation. It is prepared from plasma collected from more than 1000 healthy blood donors and it expresses the large spectrum of antibody specificity.

Eligibility Criteria:
Inclusion Criteria:

* Given written informed consent
* Male or female aged ≥ 19
* Primary immune thrombocytopenia (ITP)
* Platelet \<20x10\^9 /L
* Patients who have taken adrenal cortical hormones and/or other immunosuppressive medications should maintain their stable doses before and during this study

Exclusion Criteria:

* Patients who have participate in other interventional study within 30 days
* Inability in written/verbal communication
* Engaged with an elective surgery
* Pregnant or breast-feeding women
* Women of childbearing potential who do not agree with contraception during this study
* Patients who had experienced any hypersensitivity or shock with study drug or active ingredient
* Refractory to immunoglobulin therapy
* Secondary immune thrombocytopenia

  * HIV-associated ITP
  * Lupus-associated ITP
  * Lymphproliferative disease
  * Hepatitis virus carrier
  * Other disease- or infection-associated ITP
* Drug-Induced ITP
* Hereditary thrombopenia (e.g., MYH9 disorders)
* Hemolytic anemia (Positive direct Coomb's test)
* Clinically significant abnormalities of immunoglobulin
* Immunoglobulin A Deficiency
* Immune disorders or deficiency
* Alcohol or drug abuse within 6 months
* Patients who had taken any medications which may effect platelet function or count for at least 2 days prior study entry
* Patients who had administrated with IVIg or anti-D immunoglobulin agents within 1 month
* Patients who had undergone a splenectomy within 2 months
* Clinically significant underlying disease or medical history at investigator's discretion