cyrilzakka/clinical-trials huggingface dataset:
A Study of Immune Cells in Patients With Rheumatoid Arthritis During Different Types of Anti-TNF Alpha Treatments (Study P05521)

This 14-week study will observe the gene expression of certain immune cells in patients with rheumatoid arthritis who receive etanercept, infliximab, and adalimumab. Patients at the National Institute of Rheumatology and Physiotherapy, Budapest, who are already scheduled to receive an anti-TNF agent will be asked to participate in this study. Patients will receive their treatment (etanercept, infliximab, or adalimumab) as scheduled, and have blood samples collected during the study and analyzed by the laboratory. Patient's response to their treatment will also be studied based on x-rays and other examinations.

Only patients who - regardless of this study - are scheduled and permitted to receive anti-TNF-alpha treatment because of their RA will be asked to participate. No patient will be recruited only for the sake of the study. The prescribing physicians will not be influenced by the study as to what form of anti-TNF-alpha therapy they should select.

Eligibility Criteria:
Inclusion Criteria:

* Must have active RA (DAS28 \>5.1)
* Must have x-ray evidence of an erosive disease,
* Must be eligible for but have never received any anti-TNF treatment,
* Must fulfill the 1987 criteria of the American College of Rheumatology classification criteria for a diagnosis of RA, for at least 3 months,
* Must have failed standard therapy (methotrexate or leflunomide).

Exclusion Criteria:

* Must not be a women who is pregnant or breastfeeding,
* Must not have a history of any malignancy,
* Must not have an active infection,
* Must not be prone to infection,
* Must not have tuberculosis, hepatitis B, hepatitis C, or HIV,
* Must not have septic arthritis of a native prosthetic joint within the last 12 months,
* Must not have NYHA grade 3 or 4 heart failure,
* Must not have a history of demyelinating disease or systemic lupus erythematosis.
A Prospective Cohort Study of Exercise Rehabilitation in the Treatment of Parkinson's Disease

The investigators proposed to conduct a cohort study to observe whether Tai Chi intervention could delay the disease progression of Parkinson's disease (PD).

PD patients were enrolled into 5 Tai Chi classes which began at different timepoints from Jan. 2016 to Jan. 2019. Each participant was assessed before participants joined the Tai Chi class. After the recruitment, participants accepted continuous Tai Chi training in the classes till the last follow-up. The investigators performed three times of follow-up in Nov. - Dec. 2019, Oct. - Nov. 2020 and Jun. - July 2021. Using propensity score matching, the investigators matched PD patients who did not receive Tai Chi training as control group in gender, disease duration, age, and Hoehn - Yahr staging. The aim is to observe the effect of Tai Chi on delaying the disease progression of PD.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of Parkinson's disease according to 2015 MDS diagnostic criteria and United Kingdom Brain Bank diagnostic criteria in 1992;
2. Hoehn - Yahr staging: 1 - 2.5;
3. The medication was stable at least 3 months before recruiting and not changed during follow-up unless increasing antiparkinsonian drugs or the need of deep brain stimulation (DBS) is required according to the disease severity;

Exclusion Criteria:

1. Secondary causes, such as inflammatory, drug-induced, vascular and toxin-induced parkinsonism.
2. Parkinsonism with other neurodegenerative diseases, such as progressive supranuclear palsy, multiple system atrophy, cortical basal ganglia degeneration, Wilson's disease.
3. Other neurological diseases, such as stroke.
4. Patients who were receiving any other clinical trials or regular exercise protocols.
5. Patients who had fall incidents in the 6 months before recruiting due to safety considerations.
6. Patients whose Mini-Mental State Examination (MMSE) scores were less than 24.
7. Patients who had medical history that did not fit to exercise, such as orthopedics diseases or cardiopulmonary dysfunction.
8. Patients who received education less than 6 years.
9. Patients who could not walk and live independently.
10. Patients who received brain surgery (e.g. deep brain stimulation);
11. Patients whose exercise length longer than 50 minutes per week.
Cell-Free DNA and RNA in Blood fromMetastatic Prostate Cancer Patients

This research trial studies cell-free deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) in blood from patients with prostate cancer that does not respond to hormone therapy and has spread to other places in the body. Studying samples of blood from patients with prostate cancer may help doctors to learn more about the changes that occur in tumor cells over time and how they become resistant to anti-cancer drugs.

PRIMARY OBJECTIVES:

I. To document the appearance of androgen receptor isoform splice variant 7 (AR-V7) expression over the course of therapy in castration-resistant prostate cancer (CRPC).

II. To determine whether detectable AR-V7 is associated with a shortened duration of treatment benefit of abiraterone or enzalutamide.

SECONDARY OBJECTIVES:

I. To determine how the presence and expression level of AR-V7 impacts response to docetaxel.

II. To determine at what point AR-V7 arises during androgen deprivation therapy (ADT) and how its presence and expression corresponds to castration resistance.

TERTIARY OBJECTIVES:

I. To determine if androgen receptor isoform splice variants (AR-Vs) other than AR-V7 play a role in resistance and / or response to the therapies explored in this study.

II. To determine if, in patients who do not express mutations in androgen receptor (AR), other genetic alterations are associated with treatment outcomes to the therapies explored in this study.

OUTLINE:

Patients undergo blood collection every 4-12 weeks during ADT, abiraterone and / or enzalutamide and docetaxel. Patients switched from ADT to either abiraterone or enzalutamide during the study will undergo phlebotomy every 6-12 weeks. Samples are analyzed for cell-free ribonucleic acid (cfRNA), cell-free deoxyribonucleic acid (cfDNA), AR-V7, and other AR-Vs via quantitative reverse transcriptase-polymerase chain reaction (RT-PCR).

After completion of study, patients are followed up for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of histologically confirmed prostate adenocarcinoma and falling into one of the following 5 groups:

  * Currently receiving ADT (previously untreated for metastatic disease)

    * These patients will be grouped into 3 cohorts: having received ADT for 3-6 months; for 1-2 years; and for \> 3 years
  * Scheduled to begin treatment with ADT (previously untreated for metastatic disease)
  * Scheduled to begin treatment with enzalutamide (castration resistant / has received ADT / may have received abiraterone)
  * Scheduled to begin treatment with abiraterone (castration resistant / has received ADT / may have received enzalutamide)
  * Scheduled to begin treatment with docetaxel (castration resistant / has received ADT / has received enzalutamide and/or abiraterone)
* Have been diagnosed with either hormone-naive or castrate-resistant metastatic disease
* Ability and willingness to provide written and informed consent

Exclusion Criteria:

* Patients who receive combined ADT with docetaxel for hormone-naive metastatic prostate cancer
* Patients on intermittent ADT
The Effect of Testosterone Replacement on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Hypogonadotrophic Hypogonadism

The study searched for answers to two questions

1. What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance?
2. Regarding the above parameters, is there any difference between daily transdermal testosterone implementation and intramuscular injection performed in three weeks.


Eligibility Criteria:
Inclusion Criteria:

* Men
* Treatment naive
* Hypogonadotrophic hypogonadism

Exclusion Criteria:

* Previous history of androgen replacement
* Chronic metabolic disorders
GM1 Prophylaxis for Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer

The purpose of this study is to evaluate the prophylactic effects of Ganglioside-Monosialic Acid in post-chemotherapy cognitive impairment in patients with early operable breast cancer.

This is a multicenter, prospective, randomized, single-blind, phase III clinical trial. The primary endpoint is the changes of cognitive function from baseline to 4 weeks after the completion of adjuvant chemotherapy in the experimental group and the control group, which were evaluated by HVLT-R scale. This study is designed to recruit up to 306 subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Have provided written and signed informed consent;
2. Histologically confirmed invasive ductal carcinoma;
3. Planned to received (neo)/adjuvant chemotherapy;
4. Eastern Cooperative Oncology Group (ECOG) score of 0 to 1;
5. Can cope with HVLT-RDR and ADAS-Cog evaluation;
6. No prior therapy could induce neurological damage,within 4 weeks
7. Normal blood routine, liver and kidney functions within 1 week before enrollment in this study;
8. Women of childbearing age have a negative serum or urinary pregnancy tests prior to enrollment in this study; Pre-menopause women are contracepted with medically acceptable methods during the study period.
9. Compliance with the study protocol.

Exclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) score ≥ 2;
2. Hypersensitivity to experiment agents or components;
3. Women with pregnancy or breast feeding;
4. A clear past history of neurological or psychiatric disorders, including epilepsy or dementia;
5. Abnormal baseline impairment of cognitive impairment;
6. Poor compliance, unwillingness or inability to follow protocol to continue the study;
7. Any circumstances in which the investigator deemed the subject unsuitable for enrollment in this study.
A New Anticoagulation Method Using Dalteparin in Quotidian and Nocturnal Home Hemodialysis Patients

This study evaluates the optimal dosage and safety of Dalteparin when used as an anticoagulant for hemodialysis therapies.

Routine anticoagulation is required during hemodialysis treatments. In North America, the anticoagulant of choice for hemodialysis therapies is unfractionated heparin (UFH), whereas in Western Europe, it is low molecular weight heparin (LMWH). Dalteparin is more commonly used in Canada and has been approved for use in the in-centre thrice-weekly hemodialysis population at a fixed dose of 5000 units. However, there have been no published studies to assess the use of dalteparin in home quotidian and/or nocturnal hemodialysis therapies. Patients on frequent hemodialysis or nocturnal hemodialysis in the home will be converted to Dalteparin from Heparin for 4 weeks to evaluate the optimal dosage and to assess its safety in this population

Eligibility Criteria:
Inclusion Criteria:

* Currently undergoing short-hour daily and nocturnal hemodialysis through the home dialysis program at London Health Sciences Centre.

Exclusion Criteria:

* Patients with increased bleeding risks
* Currently on full dose anticoagulants
* Active bleeding
* Diabetic retinopathy
* Active cancer receiving treatment within the past 6 months
Phase I/II Clinical Trial of LBL-015 for Injection

A Multicenter, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of LBL-015 in Patients With Advanced Malignant Tumors.

This study is a single-arm, open-label, multi-center, dose-escalation and expansion phase I/II study to evaluate the safety, tolerability, pharmacokinetic characteristics, receptor occupancy, immunogenicity and efficacy of LBL-015 in patients with advanced malignant tumors.About 202 patients with advanced malignant tumor will be enrolled.

The study is divided into Phase I study stage (dose escalation/PK expansion stage) and Phase II study stage (indication expansion stage).

Patients with advanced or metastatic advanced malignant tumor who have failed previous standard treatment, are not suitable for standard treatment or have no standard treatment are included in the phase I study.

After obtaining the RP2D in Phase I study ,Phase II study stage (indication expansion stage) was initiated.

Eligibility Criteria:
Inclusion Criteria:

1. Agree to follow the trial treatment regimen and visit schedule, voluntarily enroll in the study, and sign the written informed consent form；
2. Age ≥18 and ≤75 years old at the time of signing the informed consent form, regardless of gender;
3. Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale；
4. Have a life expectancy of at least 12 weeks；
5. There is adequate organ and bone marrow function,Conforms to laboratory test results;
6. Fertile men and women of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine devices, hormonal contraception, and correct use of condoms) from the signing of the informed consent form to 6 months after the last dose of the investigational drug; women of childbearing age include premenopausal women and women who had menopause less than two years ago. Blood pregnancy test results must be negative for women of childbearing age within 7 days prior to the initial dose of the investigational drug.

Exclusion Criteria:

1. Received other unapproved investigational drug or treatment within 4 weeks prior to first dose of investigational drug；
2. Subjects who underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the initial use of the investigational drug, or require elective surgery during the trial period；
3. Use of immunomodulatory drugs within 14 days prior to the initial use of the investigational drug, including but not limited to thymosin, interleukin, and interferon；
4. Subjects with an active infection that currently requires intravenous anti infective therapy；
5. History of immunodeficiency, including positive HIV antibody test results；
6. Pregnant or lactating women；
7. The investigator's assessment that there may be other factors affecting compliance among participants or that some may not be suitable for inclusion in this study.
Food-Effect Pharmacokinetic Study of PL2200

This trial is a food-effect study to assess fasted versus fed pharmacokinetics of PL2200.


Eligibility Criteria:
Inclusion Criteria:

* Healthy normal male and female volunteers between 21 and 65 years of age.

Exclusion Criteria:

* Abnormal findings on physical examination or clinical laboratories, or significant medical history.
* Subject with hypersensitivity or contraindications to aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drug (NSAID).
Establishment of Risk Indicators and Early Warning System in Infection Patients

Serious infections refer to life-threatening infections with a morbidity and mortality rate of up to 50%, and are the main cause of death in critically ill patients, mainly including systemic inflammatory response syndrome, sepsis, infectious shock, or systemic multiple organ dysfunction syndrome. Patients with severe infections have rapid disease development, which can cause disorders of cellular circulation and metabolism and impairment of multi-organ function in the early stage, mostly accompanied by clinical complications, and despite the progress of medical technology and the popularization of antibiotic application, the mortality and disability rate is high, which is a hot spot of clinical research today. Patients with severe infections are exposed to a wide range of medical risk factors, including patient factors (advanced age, frailty, malnutrition, long hospital stay, prolonged bed rest), disease factors (immune deficiency, malignancy, diabetes, renal failure, liver failure), drug factors (long-term use of steroid hormones, chemotherapeutic drugs, NSAIDs, etc.), interventional factors (central venous catheter, recent invasive surgery, hemodialysis, endotracheal intubation or mechanical ventilation, etc.), which bring great challenges to clinical treatment. Therefore, early identification of risk indicators for deterioration of infected patients provides a strategic basis for the medical team to take early warning measures to prevent deterioration and poor prognosis, and to reduce the risk of deterioration of patients, which is also the key to reduce the risk of death of infected patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with infection

Exclusion Criteria:

* Case information is incomplete
* Do not accept follow-up
BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)

Alcoholic hepatitis is a disease with a high mortality rate with few treatment options improving survival. Recently certain bacterial strains has been correlated to survival in patients with alcoholic hepatitis.

In the BATTLE-trial the investigators will investigate if certain bacteria are correlated to decreased chance of survival in patients with alcoholic hepatitis.

Patients with alcoholic hepatitis who are admitted to Copenhagen University Hospital Hvidovre and Herlev will be invited to participate.

Blood and fecal samples following hospital admission will be collected. Through one-year follow-up correlation of certain bacteria in fecal samples with survival will be investigated.

In particular whether patients with cytolysin producing E. faecalis has a decreased chance of survival compared to patients without this bacteria.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Bilirubin \> 50 micromol/L
* History of large alcoholic consumption in period prior to hospital admission (in the last six months)
* No bile-duct obstruction (investigated through US, CT og MRI)

Exclusion Criteria:

* Hepatocellulary carcinoma
* Viral hepatitis
* Autoimmune hepatitis
* Portal vein thrombosis
* Pregnancy
* Expected survival for less than one year caused by other diseases (based on decision from project responsible doctors
Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia

There has been an increased interest in the association between ADHD and sleep disorders over the past years. A high incidence of sleep disturbance, ranging from 10% to 70%, has been identified in ADHD children regardless of whether or not they are receiving stimulant therapy. This study will assess the safety and efficacy of zolpidem in children with ADHD associated insomnia.

The study is being conducted in the United States. It consists of 3 segments:

* Segment A: 2 to 21 day screening period
* Segment B: 8-week double-blind treatment period
* Segment C: 1-week follow-up period

Subjects will have a polysomnography in a sleep lab two times during the study (at baseline and between visit 4-5) and also be required to wear an actigraphy monitoring tool. There will be several questionnaires completed throughout the study: CGI-child, CGI-parent/legal guardian, ADHD Rating Scale-IV, and the Pediatric Daytime Sleepiness Scale.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 6 and 17 years, inclusive
* Children with diagnosed ADHD (as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision \[DSM-IV-TR\] criteria)
* Complaint of childhood insomnia as defined by repeated difficulty with sleep initiation or consolidation that occurs despite adequate age, appropriate time, and opportunity for sleep
* The sleep disturbance must not be attributable to either the direct physiologic effect of drug abuse or misuse of a prescribed medication.
* Subjects should be stabilized on all long-term therapy, including treatment of ADHD, for at least one month prior to study entry.
* Subjects, if females of childbearing potential (as determined by the initiation of menses), must have confirmed negative pregnancy test prior to randomization and be using a recognized effective method of birth control (oral, implant, depot or transdermal oestroprogestatives, intrauterine device, double-barrier with spermicide). Abstinence is an acceptable method of birth control for this study.

Exclusion Criteria:

* Mental retardation
* Autistic spectrum disorder
* A history of sleep apnea
* A history of bipolar disorder, conduct disorder, major depression, or generalized anxiety disorder (not obsessive compulsive disorder), as determined by clinical interview and DSM-IV-TR criteria
* Current history of substance abuse/dependence
* Known hypersensitivity to zolpidem or previous adverse experience with zolpidem
* Pregnant or breast-feeding
* Current use of hypnotics, antihistamines, melatonin, herbal products, or other sleep aids
Perioperative Complications of Deep Extubation in Adults

The investigators propose a prospective observational cohort study in order to investigate the perioperative respiratory complications of deep extubation in adults undergoing eye and head-and-neck surgery at Massachusetts Eye and Ear. Data pertaining to perioperative respiratory complications from adult patients presenting to MEE for eye and head and neck surgery who undergo deep extubation will be collected for this study.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women who present to MEE for eye and head-and-neck surgery and undergo deep extubation will be included.

Exclusion Criteria:

* The study does not exclude anyone from the study.
Paraneoplastic Syndrome in Hepatocellular Carcinoma Patients

Hepatocellular carcinoma (HCC) is the sixth most common cancer in the world with rising incidence. Globally, there has been substantial variation in prevalence of risk factors for HCC over years, like control of viral hepatitis in developing countries but growing epidemic of fatty liver disease in developed world. Changing epidemiology of HCC is related to trends in these risk factors, Paraneoplastic syndromes (PNS) are defined as systemic, metabolic, or other distant consequences of malignancy resulting, either directly or indirectly, from production by the neoplasm of substances that gain access to the blood stream, thereby exerting their effects on distant organs or tissues There is four major HCC-associated paraneoplastic syndromes among Cirrhotic patients,i.e.hypercholesterolemia,hypoglycemia,hypercalcemia,and erythrocytosis .


Eligibility Criteria:
Inclusion Criteria:

* - Cirrhotic Patients with HCC.
* HCC will be diagnosed based on Alpha -feto protein (AFP) and dynamic imaging.

Exclusion Criteria:

* - Patient known to have primary parathyroid disease, patients with bone metastasis or excessive use of antacids.
* Patients with secondary polycythemia (as chronic hypoxia) and patients with polycythemia rubra vera.
* Patients with acute infections or GIT bleeding.
* Patients with preexisting dyslipidemia.
* Patients with significant cholestasis.