cyrilzakka/clinical-trials huggingface dataset:
Safety and Immunogenicity of a Cell Culture-derived Influenza Vaccine in Healthy Adults and Elderly

The present study aims to evaluate the safety and immunogenicity of the new influenza subunit vaccine produced in Madin Darby Canine Kidney (MDCK) cells in healthy adult and elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 60 years of age (first age group) OR over 60 years of age (second age group)
2. mentally competent to understand the nature, the scope and the consequences of the study
3. able and willing to give written informed consent prior to study entry
4. available for all the visits scheduled in the study
5. residence in the study area
6. in good health as determined by:

   1. medical history,
   2. physical examination,
   3. clinical judgment of the investigator.

Exclusion Criteria:

1. unable or unwilling to give written informed consent to participate in the study
2. suffering from an acute infectious disease
3. any serious disease such as:

   1. cancer (except for benign or localized skin cancer and non metastatic prostate cancer not currently treated with chemotherapy),_
   2. autoimmune disease (including rheumatoid arthritis),
   3. advanced arteriosclerotic disease or complicated diabetes mellitus,
   4. chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,
   5. acute or progressive hepatic disease,
   6. acute or progressive renal disease,
   7. congestive heart failure
4. surgery planned during the study period
5. bleeding diathesis
6. history of hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
7. known or suspected impairment/alteration of immune function resulting from:

   1. receipt of immunosuppressive therapy (any cortical steroid or cancer chemotherapy),
   2. receipt of immunostimulants,
   3. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,
   4. high risk for developing an immunocompromising disease within the past 6 months
8. history of drug or alcohol abuse
9. laboratory confirmed influenza disease in the past 6 months
10. received influenza vaccine within the past 6 months
11. received another vaccine or any investigational agent within the past 60 days, or planned vaccination within 3 weeks following the study vaccination
12. any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) or experienced fever ≥ 38°C within the past 3 days
13. pregnant women or women who refused to use a reliable contraceptive method throughout the study (180 days)
14. any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.
Urinary Markers of Detrusor Overactivity in Spina Bifida Patients

The purpose of this study is to assess diagnostic performance of urinary markers of detrusor overactivity (Nerve Growth Factor (NGF), Brain-Derived Neurotrophic Factor (BDNF), adenosine triphosphate (ATP), Prostaglandine E2) in detected high pressure bladder un spina bifida patients.


Eligibility Criteria:
Inclusion Criteria:

Study arm:

* Spina bifida patient
* Seen consecutively in outpatient clinics
* Age \> 18 years-old

Control arm:

* Patients with multiple sclerosis or spinal cord injury or overactive bladder
* Seen consecutively in urodynamics
* with lower urinary tract symptoms
* Age \> 18 years-old

Exclusion Criteria:

* Positive urine culture
* History of urologic neoplasms
* History of interstitial cystitis
The Effects of Chiropractic Care and Children With Subclinical Spinal Pain

There is growing evidence that chiropractic care positively impacts various aspects of central and autonomic nervous system function.This study aims to investigate short term and long-term effects of Chiropractic care (CC) on neurological, behavioral, immunological functions and health-related quality of life in children with subclinical spinal pain.

There is growing evidence that chiropractic care positively impacts various aspects of central and autonomic nervous system function. A single chiropractic adjustment session has been shown to alter pre-frontal cortex (PFC) activity in adults, but there is a lack of robust research investigating any long-term benefits of such PFC changes in children. This study aims to investigate short term and long-term effects of Chiropractic care (CC) on neurological, behavioral, immunological functions and health-related quality of life in children with subclinical spinal pain. In this parallel-group randomized controlled trial, participants aged 10-18 years with subclinical spinal pain will be randomly allocated to receive either 12 weeks of CC intervention or control intervention. Primary outcomes include functional near-infrared spectroscopy, heart rate variability (HRV) and resting-state electroencephalography (EEG). The secondary outcomes include executive functions measured by cognitive testing, immune and inflammation status, and health-related quality of life. As data collected in the project is the combination of extrinsic (sociodemographic, clinical questionnaires etc.) and intrinsic physiological data (physiological measures like EEG, HRV etc.), we will utilize the advances in machine learning or artificial intelligence (AI) to help inform the development of optimal chiropractic care plans in future.

Eligibility Criteria:
Inclusion Criteria:

* aged between 10 and 18 years
* have subclinical spinal pain

Exclusion Criteria:

* no evidence of spinal dysfunction is present
* they are in current pain (above 3/10 on VAS)
* have sought previous treatment for their spinal issues
* are unable to perform the assessment procedures due to contraindications or movement limitations
* diagnosed immune dysfunction
* utilizing a prescribed immunosuppressive medication
* have uncontrolled asthma
* nasal polyps
* use of an intranasal steroid spray one month or less before the study
* are HIV-positive
* are participating in another research study at the time of data collection
* have any diagnosed comorbidity or concomitant disease
* have allergies to yeast or yeast-derived products
* have chronic sinusitis or recent (within the last six weeks) episode of acute sinusitis.
Open Randomized Prospective Clinical Study of R-FPD Versus R-MAD Regimen in the Treatment of Primary Central Nervous System Lymphoma

Comparison of the efficacy and safety of rituximab combined with fotemustine, pemetrexed, dexamethasone and rituximab in combination with methotrexate, cytarabine and dexamethasone as first-line regimens in the treatment of primary central nervous system lymphoma

This is an open, randomized, prospective, multicenter clinical study designed to compare the efficacy and safety of R-FPD and R-MAD as first-line regimens in the treatment of primary central nervous system lymphoma. A total of 20 patients plan to participate in the study. The primary endpoints were objective response rate (ORR) and progression-free survival (PFS) and secondary endpoints including overall survival (OS), and adverse events.

Eligibility Criteria:
Inclusion Criteria:

Age 14-75 years old; KPS score ≥ 60 points or ECOG score ≤ 2 points; expected survival period of more than 3 months; CD20 positive; PCNSL confirmed by tissue biopsy pathology (limited to brain, spinal cord, meninges and eyes, without lymphoma involving other parts of the body); no chemotherapy contraindications (blood and physiological examination results \<7 days); At least one measurable lesion according to the RECIST criteria; There are no other serious diseases that conflict with this plan; There is a possibility of follow-up; When using other anti-tumor drugs at different times during this treatment, bisphosphonate anti-bone transfer therapy and other symptomatic treatments may be applied; Can understand the situation of this study and sign the informed consent form.

\*: Pathological histology is subject to consultation by pathologists at provincial hospitals.

Exclusion Criteria:

Currently receiving other chemotherapy, radiotherapy and targeted therapy (chemotherapy within 3 weeks, radiotherapy within 2 weeks, or recovery from acute toxicity of any previous treatment); Pregnant or lactating women; There are any uncontrollable medical diseases (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia); combined with chemotherapy and other contraindications for chemotherapy; Those who have had other malignant tumors in the past; There are uncontrolled infected patients; Those who have a history of mental illness that is difficult to control; The investigator believes that it is not appropriate to participate in this test.
Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension

This is a multicenter, randomized (2:1 oral treprostinil: placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are currently receiving background dual therapy (ambrisentan, tadalafil) for at least 30 days at randomization for their PAH. Once randomized, subjects will return for 5 study visits up to Week 28 during the blinded period. After the Week 28 Visit, eligible subjects will transition to the open-label period of the study for up to 20 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Between 18 and 79 years of age, inclusive
2. PAH that is idiopathic / heritable, PAH associated with connective tissue disease, HIV infection, repaired congenital systemic-to-pulmonary shunts (repaired \> 1 year), or appetite suppressant / toxin use
3. Receiving dual therapy (ambrisentan and tadalafil)
4. Previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of PAH

Exclusion Criteria:

1. Nursing or pregnant
2. PAH due to conditions other than noted in the above inclusion criteria
3. Received PAH-specific drug therapy for \>2 years
4. History of uncontrolled sleep apnea, severe liver disease, severe renal impairment, left sided heart disease, uncontrolled systemic hypertension
5. Participated in an investigational drug or device study within 90 days prior to signing consent.
A Phase II Study With Tumor Molecular Pharmacodynamic (MPD) Evaluation of Oral mTOR-inhibitor Everolimus (RAD001) 10 mg Daily in Patients Suffering From Classic or Endemic Kaposi's Sarcoma

Classic Kaposi's sarcoma (CKS) is an angioproliferation associated with human herpes virus 8 (HHV8), which sometimes requires systemic treatment. Rapamycin and everolimus are mTOR inhibitors. The PI3K-AKT-mTOR pathway is activated in CKS.The aim of this study is to evaluate the rate of clinical response and tolerance to everolimus 10mg/d in CKS. Patients suffering from CKS will be enrolled in a multicenter two-stage phase II trial. At inclusion, all patients will have at least 10 lesions or more than one limb or 3% of body surface affected, in the absence of symptomatic visceral CKS. The primary endpoint is objective response to everolimus after 6 months therapy (complete or partial response per ACTG criteria). The trial is planned using Simon's minimax two-stage design to demonstrate a response rate of 50% as compared to 20% with type I error rate 2.5% and power of 90%. Accordingly, 11 patients will to be enrolled in the first stage and provided at least 3 patients responded, 15 patients will be accrued in a second stage.

The primary endpoint is objective response to everolimus after 6 months therapy (complete or partial response per ACTG criteria).

Secondary endpoints are response according to physician global assessment, lesions size , lesions infiltration, lymphedema, tolerance, pharmacodynamic (pathologic, angiogenic and lymphangiogenic biomarkers, HHV8 viral load sequential evaluation in the lesions, pharmacokinetic evaluation.

Eligibility Criteria:
Inclusion Criteria:

Histologic confirmed classic or endemic KS (non transplant non HIV patients) \> 18 Years old at least 10 lesions or more than one limb or 3% of body surface affected, in the absence of symptomatic visceral KS Presence of at least 4 targets lesions \> 5mm At least 4 weeks wash out from any KS specific therapy ECOG \< 2

Exclusion Criteria:

immunosupressive regimen patients HIV positive creatinine clearance \<40ml/mn,AST ALT\>3N, neutropénia\<1500, thrombopenia\<150000, anemia\<8g/dL
CYP2B6 Polymorphisms in Methadone Disposition

This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes methadone.

This investigation determined the influence of CYP2B6 genetic variation, specifically CYP2B6\*6 polymorphism, on clinical methadone plasma concentrations, clearance, and metabolism. The hypothesis was that CYP2B6\*6 heterozygotes or homozygotes would have reduced metabolism and clearance. A secondary objective was to evaluate other less common genotypic variants, when encountered. Healthy volunteers in genotype cohorts CYP2B6\*1/\*1, CYP2B6\*1/\*6 , and CYP2B6\*6/\*6, and also CYP2B6\*4 and CYP2B6\*5 carriers, received single doses of IV and oral methadone. Plasma and urine methadone and metabolite concentrations were determined by tandem mass spectrometry. The primary outcome measure was methadone metabolism, measured as plasma metabolite/patent area under the concentration-time curve ratio and metabolite formation clearance.

Eligibility Criteria:
Inclusion Criteria:

Each subject must meet all of the following criteria:

* 18-50 yr old
* CYP2B6\*1/\*1, CYP2B6\*1/\*6 or CYP2B6\*6/\*6 genotype
* Good general health with no remarkable medical conditions
* BMI \< 33
* Provided informed consent

Exclusion Criteria:

Subjects will not be enrolled if any of the following criteria exist:

* Known history of liver or kidney disease
* Use of prescription or non prescription medications, herbals or foods known to be metabolized by or affect CYP2B6
* Females who are pregnant or nursing
* Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
* Direct physical access to and routine handling of addicting drugs in the regular course of duty (this is a routine exclusion from studies of drugs with addiction potential)
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

In this open-label single arm study the safety and efficacy of Mabthera will be evaluated in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and background methotrexate (10-25mg po or sc weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years and target sample size is \<50


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>/= 18 years of age
* rheumatoid arthritis DAS28 \>/= 3.2
* receiving treatment on an outpatient basis
* experienced an inadequate response to previous or current treatment with methotrexate

Exclusion Criteria:

* rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
* history of or current inflammatory joint disease other than RA
* previous treatment with any cell-depleting therapies
A Study of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor

The objective of this study is to evaluate efficacy and safety of TQ-B3101 in subjects with advanced malignant tumor.


Eligibility Criteria:
Inclusion Criteria:

-1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.

2. Understood and signed an informed consent form. 3. Histologically or cytologically confirmed advanced malignant solid tumors. 4. Adequate organ system function. 5. Patients need to adopt effective methods of contraception.

Exclusion Criteria:

* 1. Has multiple factors affecting oral medication. 2. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1. 3. Other malignancies occurred within 3 years, with exception of cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors.

  4. Has a history of hypertension, hypertensive encephalopathy or uncontrolled hypertension.

  5. Has cardiovascular and cerebrovascular diseases. 6. Has received radiotherapy, chemotherapy, surgery less than 4 weeks before the first dose.

  7. Has central nervous system metastasis and / or spinal cord compression, cancerous meningitis, and meningeal disease.

  8. Active hepatitis, HIV positive, syphilis positive. 9. Has a history of psychotropic substance abuse. 10. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Clinical Trial of SB-509 in Subjects With Amyotrophic Lateral Sclerosis (ALS)

The purpose of the study is to evaluate the effects of the investigational drug, SB-509 on progression of the disease in subjects with ALS

SB-509 contains the gene (DNA-a kind of biological "blueprint") for a protein. When a study doctor injects SB-509 into the muscles of your neck, arms and/or legs, the drug enters the muscle and nerve cells around the injection sites and causes these cells to make a protein. This protein causes your cells to increase production of one of your own protein called vascular endothelial growth factor(VEGF-A), which may improve the structure and function of nerves and muscles. In addition, there are changes in the levels of 28 additional proteins in your cells. These proteins function to promote the growth of cells, are structures in cells, help synthesize products, and affect immune cells, and some have unknown functions. This increase in your own VEGF proteins may protect and repair the damaged nerves and muscles caused by ALS.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 18 and 85 with clinical diagnosis of ALS
* Forced Vital Capacity (FVC) \> 60% of predicted
* Less than 3 years of ALS since the onset of the first symptom with clinical evidence of limb muscle atrophy and weakness.
* Subjects taking Riluzole must have been at a stable dose for at least 30 days with no evidence of toxicity
* Female of childbearing potential and male of child-creating potential must agree to use a medically acceptable physical barrier (condom, diaphragm, and cervical cap) through the treatment phase and for at least 30 days after the last study treatment.

Exclusion Criteria:

* Women who are pregnant or currently breast-feeding
* Dependent upon invasive or non-invasive artificial ventilation
* Patients with bulbar onset ALS or with other active neuromuscular/ neurodegenerative diseases.
* Type 1 or Type 2 diabetes.
* Evidence of chronic or active heart, liver, kidney, or lung diseases, or Age-related macular degeneration.
* Current or history of known immune or immunodeficiency disorders
* Patients with cognitive impairment with significant decision making incapacity, or major depression, or schizophrenia, or dementia (e.g. Alzheimer's disease).
* Malignancy or history of malignancy, except it has been in complete remission for at least 5 years
* Pre-cancerous conditions (e.g. Barrett's Esophagus, dysplasias) or benign tumors which have the potential for significant growth due to VEGF stimulation.
Trial of Safe Water Storage Among People Living With HIV

Environmental health-related pathogens include faecal-oral, diarrhoeagenic microbes that may be transmitted via drinking water and are related to sanitation and hygiene. Previous research has suggested that safeguarding household drinking water against recontamination may be a critical intervention that can reduce risks of diarrheal diseases and may be especially important for people living with HIV/AIDS (PLWHA) and other vulnerable populations (Clasen et al. 2007). The investigators propose here a randomised, controlled trial of a household safe storage container for drinking water in a well defined, HIV-impacted population in peri-urban Lusaka, Zambia. After a baseline data collection period (9 months) half of all households (150 households) will be given a safe water storage container specifically designed to prevent recontamination of water in household use. All households will be followed for an additional 9 months. Results of this study will help determine whether this promising water quality intervention can reduce diarrhoea and related outcomes in this and similar vulnerable populations.

Specific Aim #1: To assess environmental health-related risk and outcomes in a low income peri-urban area of Zambia with a high percentage of people living with HIV/AIDS (PLWHA) (longitudinal observational cohort study and baseline) (Year 1). We will assemble a rich dataset on environmental health-related risk factors in a well defined population, with a focus on household drinking water quality and other water, sanitation, and hygiene (WSH) exposures.

Specific Aim #2: To quantify the WSH-related disease burden among PLWHA, compared with those without HIV/AIDS (individual and household level stratification) (conclusion of baseline). After nine months of data collection, we will perform an initial analysis to determine WSH-related risk by HIV status.

Specific Aim #3: To assess the impact of a water quality intervention on the longitudinal prevalence of Highly Credible Gastrointestinal Illness (HCGI) among PLWHA (randomized controlled trial, year 2). We will conduct a randomised, controlled trial of a safe water storage intervention. We will assess the health impacts of this intervention, with particular focus on the high-risk groups of PLWHA and children under 5 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Resident of Misisi compound, Lusaka
* Willing to participate in the study
* Is able to give informed consent and does so
* Household has one or more children who are aged 48 months or less at the start of the trial
* The household stores drinking water in the home

Exclusion Criteria:

* Not a resident of Misisi compound, Lusaka
* Unwilling to participate in the study
* Unable to give informed consent or chooses not to participate
* Household does not have one or more children aged 48 months or less at the start of the trial
* The household does not store drinking water in the home
Reliability of Hand Held Dynamometer for Assessing Isometric Lumbar Muscle Strength in Asymptomatic Healthy Population

To determine intra-rater and inter-rater reliability of hand held dynamometer for assessing isometric lumbar

After being informed about the study and potential risks, all participants given informed consent underwent a 1-week screening period to determine eligibility for study entry. Two raters assessed isometric strength of lumbar flexor and extensor muscles, by a hand-held dynamometer. Strength was measured and recorded by each of the two raters and re-assessed after a week.

Eligibility Criteria:
Inclusion Criteria:

* age between twenty one to twenty five years

Exclusion Criteria:

* subjects with the history of acute, subacute or chronic low back pain, history of trauma, neurological disorders, spinal surgery, lumbar spine pathology were excluded.