cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the PhageTech Virus BioResistor

To evaluate the effectiveness of the PhageTech Virus BioResistor to detect bladder cancer biomarkers.

This study will sample urine provided by bladder cancer patients as part of their normal routine surveillance screening. No additional effort will be required from the patients and only modest additional effort from the study staff. Some de-identified patient medical information may also be requested, including concominant medications, relevant current or previous diseases, prior bladder cancer interventions and other relevant information to ensure there are no interfering substances or other confounders that could affect study results. There is no risk to patients as the normal diagnostics for bladder cancer will be followed.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients ≥ 18 years
2. Previous bladder cancer diagnosis; any stage and histological type, undergoing cystoscopy
3. Patients with suspected bladder tumor undergoing surveillance cystoscopy
4. Patients must provide written Informed Consent.

Exclusion Criteria:

1. Patients unable or unwilling to sign the informed consent
2. Age \< 18 years
3. Known HIV/HCV/HBV (information from clinical history).
Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients

The purpose of this study is to determine whether the addition of an investigational medication, axitinib, to radiation therapy will improve the outcome of treatment in patients, above the age of 70.

The addition of axitinib to standard treatment is experimental and has not been approved by the United States Food and Drug Administration (FDA). Axitinib works by preventing new blood vessels from forming, and tumors need to make new blood vessels in order to grow. The study will find out what effects, good or bad, axitinib has on the tumor. In addition, this study will try to determine whether the response to axitinib and the overall outcome depends on certain characteristics of your tumor.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with histologically proven glioblastoma multiforme
* Age above 70 years
* Karnofsky score of 50-80
* Adequate organ function as defined by laboratory values
* Life expectancy of \>12 weeks
* No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be 140 mm Hg, and the baseline diastolic blood pressure readings must be 90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.

Exclusion Criteria:

* Prior treatment with chemotherapy or radiation for glioblastoma multiforme
* Patients with extensive tumor hemorrhage
* Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism
Tracking Biologics Along the Silk Road

The objective of this study is to explore and describe the disease characteristics, treatment and outcomes of participants with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's Disease or ulcerative colitis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have a confirmed diagnosis of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's Disease, or ulcerative colitis. A participant can be included for one disease only; participants with multiple diagnoses should be included for their major disease only
* Initiation of treatment with REMICADE, SIMPONI, or STELARA should be planned at the time of enrollment into this observational study (such treatment should be started within 30 days of enrollment)
* Participant must be either treatment-naïve to biologics or have been treated with no more than 2 different biologic agents before enrollment
* Participant must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements

Exclusion Criteria:

* Participant who have previously received treatment with REMICADE, SIMPONI, or STELARA must not be enrolled if they start the same therapy a second time
* Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before baseline data collection
* Participant is currently enrolled in an investigational study
The Relationship Between Obesity-related Molecular Typing and Traditional Chinese Medicine Constitution

Obesity is an epidemic and a growing problem in the world. There are numerous causes of obesity, the most novel and personalized of which is genetic inheritance. Single nucleotide polymorphisms are the most common type of genetic variation among people, regulating the response between the diet and the body. Meanwhile, Traditional Chinese medicine pattern differentiation is also personalized and usually influenced by inheritance, living habits, character and environment and so on. The common constitutions in obesity are Qi deficiency, Yang Deficiency, and Phlegm dampness, which are correlated with oxygen, sugar and fat metabolism, also affected by gene expression. Therefore, the relationship between constitution, metabolism and genetic molecular typing may be significant in obesity with obstructive sleep apnea patients.

Method The adults whose age between 20\~65 years old, BMI between 27kg/m² and 35kg/m², and also have snoring during sleeping are able to be enrolled in the study. Then, the general data questionnaire, Body Constitution Questionnaire, physical examination, blood test, and genetic test are provided to subjects. The blood test includes High-density lipoprotein- cholesterol, Low-density lipoprotein- cholesterol, Total cholesterol, Triglyceride, Leptin, Glucose AC, Hemoglobin A1C, Insulin; the DNA test includes FTO、MC4R、BDNF、PPARG、ADRB3、UCP1. Epworth Sleepiness Scale, laryngoscope and polysomnography are also performed in the patients enrolled. The Traditional Chinese medicine constitution can be classified and its relationship between different figure types, serum lipid level as well as obesity-related gene can be analyzed. The results will be described after a statistical analysis.

Aim The aim of this study is to analyze the constitution, finding the association between obesity patients with obstructive sleep apnea and their related molecular typing and Traditional Chinese Medicine constitution.

Eligibility Criteria:
Inclusion Criteria:

1. 27≦BMI≦35 kg/m² and with snoring during sleeping
2. 20y/o\<age\<65y/o with conscious clear
3. no recognition impairment
4. could accept blood test and questionnaire
5. willing to sign Informed consent

Exclusion Criteria:

1. age\<20 years old
2. pregnancy or women under breastfeeding
3. patients have been diagnosed with endocrine disorders such as thyroid, adrenal and autoimmune disease
4. patients have been diagnosed with neurological or psychological disorders with recognition impairment
5. Patients with severe visual, hearing, or physical impairment that would interfere with questionnaire processing.
6. Patients are under other experimental medication
7. Patients are under weight-loss drug in recent one month
Aerobic Exercise in Children With Moderate and Severe Asthma

Regular aerobic physical activity in short-term moderate asthma and severe:

* Reduce the levels of inflammatory mediators
* Improves functional capacity
* Improves Quality of Life
* Improved lung function
* Reduces the sensation of dyspnea
* Improves symptoms scores and medication use

Methods: Is designed a randomized clinical trial, efficacy, outpatient physical therapy developed in the Institute of Integrative Medicine Teacher Fernando Figueira (IMIP). A pilot study with 20 participants will be made initially to obtain a sample calculation. Subjectively estimated it will take about 50 participants, with possible losses. Will include children older than eight years, diagnosis of moderate and severe persistent asthma according to criteria of Global Initiative National Asthma (GINA) and forced expiratory volume in one minute (FEV1) below 80% predicted. Will be excluded from the study associated with disease that limits physical activity, such as neuromuscular diseases, congenital or acquired heart disease, chronic lung disease associated exacerbation of the crisis and significant cognitive deficit, which makes the participant to respond adequately to the questionnaire and / or inability to meet the commands. Eligible patients will be randomized into two groups: control group, which is not subjected to any kind of exercise and the intervention group, which will be submitted to aerobic exercise for 30 minutes three times a week for six weeks. The two groups will be evaluated before and at the end of six weeks by testing for 6-minute walk, analysis of dyspnea, questionnaire of quality of life, pulmonary function test (FEV1, FVC), inflammatory markers (cytokine ).

Eligibility Criteria:
Inclusion Criteria:

* Age greater than eight and less than nineteen years
* Diagnosis of moderate to severe persistent asthma according to criteria of GINA
* forced expiratory volume in one minute (FEV1) below 80% of predicts
* Initiation of treatment with inhaled corticosteroids for at least eight weeks before the start of collection.

Exclusion Criteria:

* associated disease that limits physical activity, such as neuromuscular disease, congenital or acquired, severe cor pulmonate, severe congenital malformation
* associated with chronic lung disease (cystic fibrosis, bronchiectasis, bronchopulmonary dysplasia, interstitial lung diseases
* significant cognitive deficit, which makes the participant to respond adequately to the questionnaire and / or failure to meet the commands
* exacerbation of crisis (This will be a temporary exclusion criterion, as having taken action as directed by medical routine, the participant can return to training)
* mental deficit.
Competency-based Assessment of Ultrasound-guided Joint Injection Skills

Ultrasound-guided joint injections and aspirations are frequently used in the treatment of rheumatological diseases. Studies have shown that intra-articular glucocorticoid injections (IAGCs) in the early treatment of rheumatoid arthritis is essential and leads to improved disease control and earlier achievement of remission. Unfortunately, many rheumatologists feel insecure performing IAGC due to poor and unstructured training opportunities, which can result in suboptimal treatment and potentially poorer patient outcome.

Nowadays, the gold standard training method has shifted towards competency-based education were objective assessment tools are necessary. A previous study has developed a scale for assessment of invasive ultrasound procedures, the Interventional Ultrasound Skills Evaluation (IUSE) tool. Although expert consensus supports evidence of content validity of the assessment tool, it is not known if the tool can discriminate differences in performance scores between the different levels of experience.


Eligibility Criteria:
Inclusion Criteria:

* Physicians attending the yearly international conference EULAR (Denmark 2022)

  1. Novices: No or little experience with ultrasound guided joint injections.
  2. Intermediates: Participated and completed at least one formal musculoskeletal ultrasound course and performed more than 100 ultrasound guided joint injections.
  3. Experts: Physicians with a long experience with musculoskeletal ultrasound and ultrasound guided joint injections doing the procedure almost daily and providing teaching and/or research within this field.

Exclusion Criteria:

* No informed consent
* Novices/Intermediates: extensive experience with musculoskeletal ultrasound and/or ultrasound guided joint injections.
Fatty Acid Amide Hydrolase (FAAH) Inhibitor Treatment of Cannabis Use Disorder (CUD)

A Phase 2B, 8-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of the Fatty Acid Amide Hydrolase (FAAH) Inhibitor PF-04457845 in Adults with DSM-5 Current Cannabis Use Disorder (CUD)

The efficacy, safety and tolerability of the FAAH Inhibitor PF-0447845 in reducing cannabis use will be studied in a 4-site randomized, double-blind, placebo-controlled, parallel-group, outpatient clinical trial comparing PF-04457845 (4mg) and placebo in DSM-5 CUD individuals. Participants will be randomized in a 1:1 ratio to either PF-04457845 or placebo using random block sizes of 2 and 4, stratified by site and degree of cannabis use. Participants will receive motivational interviewing for 2 weeks before being randomized to receive study medication to make a quit attempt within the first week of treatment. Participants will receive active or placebo PF-04457845 for 8 weeks during which time they will be evaluated weekly in face to face visits. In addition, daily assessment of adherence to study medication and cannabinoid use will be conducted daily by cellphone. Measures of cannabinoid exposure (self-reported and urine toxicology), and problems related to the use of cannabis, will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-60 years, inclusive.
2. Male or Female.
3. Individuals with DSM-V criteria for Cannabis Use Disorder .
4. Positive for urinary THC-COOH at both screening visits.
5. Must express a willingness at screening to set a date within the first week of randomization to attempt to quit using cannabis.

Exclusion Criteria:

1. Clinically significant unstable medical disorders (as determined by the site investigator).
2. Laboratory tests with clinically significant abnormalities (as determined by the site investigator)
3. Pregnancy by history and or laboratory confirmation (serum HCG).
4. Lactation.
5. Physiological dependence on another substance.
High-Resolution Optical Coherence Tomography for Detection of Retinal Nerve Fiber Layer Loss in Band Atrophy of the Optic Nerve

The purpose of this study is to compare the abilities of high-speed,high-resolution (HR) optical coherence tomography (OCT) and Stratus OCT for detection of retinal nerve fiber layer (RNFL) loss in eyes with band atrophy (BA) of the optic nerve.


Eligibility Criteria:
Inclusion Criteria:

* Visual acuity better than 20/30
* Refractive error less 5 spherical diopter and 3 cylinder diopter
* Temporal field defect

Exclusion Criteria:

* Presence of glaucoma and optic nerve anomalies
* A normal nasal field
Improving Sleep and Quality of Life in Adults With HIV Disease

The purpose of this study is to see if yoga or music therapy can improve the sleep of adults with HIV.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* HIV seropositive
* current sleep disturbance
* able to speak, read, and write in English
* a phone number to maintain contact with research team
* willing to provide copy of most recent CD4 and viral load values
* willing to wear actigraph for 1 week per month for 3 months
* willing to participate in group intervention sessions 3 times per week for 8 weeks

Exclusion Criteria:

* pregnancy
* psychiatric diagnosis, such as schizophrenia, dementia, bipolar disorder (depression not excluded)
* sleep disorder diagnosis, such as apnea or narcolepsy (insomnia not excluded)
* current yoga practice
Effects of Motor Imagery on Autonomic Function

Most studies on motor imagery suggested the effects of motor imagery are related to neuroplastic changes in the brain. In addition to that the neuroplastic changes, it is thought that motor imagery can alter metabolic responses just like in actual exercise. However, the level of evidence about the effect of motor imagery on autonomic functions is limited.

The aims of this study;

1. The primary aim of this study is to investigate the effects of activating and relaxing kinesthetic motor imagery on autonomic function in healthy individuals and to compare these two methods.
2. The secondary aim of this study is to explore the effects of these methods on motor imagery skills of individuals will also be investigated.

The participants will randomly be allocated into three groups: (1) Activating kinesthetic motor imagery training, (2) Relaxing kinesthetic motor imagery training, and (3) Control group.

Participants in the activating kinesthetic motor imagery training group will imagine high effort exercises (e.g. planking, boxing, jumping, squats, push-ups) in the sessions in home using the study audio-video motor imagery script. The relaxing kinesthetic motor imagery training group will imagine relaxing (low effort) exercises (e.g. breathing exercises, stretching, body awareness exercises) in home using the study audio-video motor imagery script. Prior the sessions, the participants will receive an introductory lecture about motor imagery. The intervention groups will practise 5 times per week for 17 minutes per day for 2 weeks. Phone calls will be performed for support and as a reminder for the assessment (after one week). The control group will receive no specific training. Data will be collected at baseline and after the two-week intervention by masked outcome assessors.


Eligibility Criteria:
Inclusion Criteria:

* Being healthy (not having any known chronic disease)
* Volunteer to participate in the study

Exclusion Criteria:

* Pregnancy
* Previous disorder/surgery history that can alter physical performance
How Many Patients Are in Need of Vitamin B12 Injections?

The clinical consequences of vitamin B12 deficiency include megaloblastic anemia and neurological disorders. Therefore, a proper and timely diagnosis and treatment is important. The use of sensitive biochemical markers such as methylmalonic acid for the diagnosis of vitamin B12 deficiency have increased since the 1980s. Consequently, the number of individuals treated with vitamin B12 has increased significantly.

The objective of this project is to study the actual need for vitamin B12 injections in the group of individuals who have already started treatment. In order to investigate this, the investigators stop vitamin B12 treatment in this group, and look for signs of vitamin B12 deficiency by monitoring changes in biochemical and hematological markers. Furthermore, they will test if the individuals are able to absorb a physiological dose of vitamin B12 using a recently developed absorption test (CobaSorb). If a physiological dose can be absorbed, the vitamin B12 injections can be replaced with tablets. In the end, the investigators hope to be able to divide the patients into three groups:

1. need life long injections with vitamin B12,
2. only need supplementations with a small dose of oral vitamin B12, and
3. no need for further vitamin B12 treatment.

The perspective is that the new information from this study might be used for a future strategy for vitamin B12 treatment.

The clinical consequences of vitamin B12 deficiency include megaloblastic anemia and neurological disorders. Therefore, a proper and timely diagnosis and treatment is important. The use of sensitive biochemical markers such as methylmalonic acid for the diagnosis of vitamin B12 deficiency have increased since the 1980s. Consequently, the number of individuals treated with vitamin B12 has increased significantly.

The objective of this project is to study the actual need for vitamin B12 injections in the group of individuals who have already started treatment. In order to investigate this, the investigators stop vitamin B12 treatment in this group, and look for signs of vitamin B12 deficiency by monitoring changes in biochemical and hematological markers. Furthermore, they will test if the individuals are able to absorb a physiological dose of vitamin B12 using a recently developed absorption test (CobaSorb). If a physiological dose can be absorbed, the vitamin B12 injections can be replaced with tablets. In the end, the investigators hope to be able to divide the patients into three groups:

1. need life long injections with vitamin B12,
2. only need supplementations with a small dose of oral vitamin B12, and
3. no need for further vitamin B12 treatment.

The perspective is that the new information from this study might be used for a future strategy for vitamin B12 treatment.

Eligibility Criteria:
Inclusion Criteria:

* Above 17 years old
* Have received vitamin B12 treatment for at least one year
* Capable of reading and understanding Danish

Exclusion Criteria:

* Pregnant or nursing women
* Not capable of giving informed consent
* Acute infection during the 3-day examination of vitamin B12 absorption
HIT-Stroke Trial 2

People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at 3-month follow up (3moPOST), by raters who are unaware of the participant randomization.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-85 years at time of consenting
* Hemiparesis from ischemic and/or hemorrhagic strokes
* Most recent stroke for which participant sought treatment, at least 6 months prior to study consent
* Walking speed \<1.0 m/s on the 10-meter walk test
* Able to walk 10m over ground with assistive devices as needed and no continuous physical assistance from another person (guarding and intermittent assistance for loss of balance allowed)
* Able to walk at least 3 minutes on the treadmill at ≥0.13m/s (0.3 mph)
* Stable cardiovascular condition (AHA class B, allowing for aerobic capacity \<6 metabolic equivalents)
* Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions

Exclusion Criteria:

* Exercise testing uninterpretable for ischemia or arrhythmia (e.g. resting ECG abnormality that makes exercise ECG uninterpretable for ischemia and no other clinical testing from the past year available to rule out these conditions)
* Evidence of significant arrhythmia or myocardial ischemia on treadmill ECG graded exercise test in the absence of recent (past year) more definitive clinical testing (e.g. stress nuclear imaging) with negative result
* Hospitalization for cardiac or pulmonary disease within past 3 months
* Implanted pacemaker or defibrillator with an upper heart rate limit that would interfere with exercise testing or prescription, or with unknown limit
* Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
* Severe lower limb spasticity (Ashworth \>2)
* Known recent history (\<3 months) of unstable substance abuse or unstable mental illness
* Major post-stroke depression (Patient Health Questionnaire \[PHQ-9\] ≥ 10) in the absence of depression management by a health care provider
* Currently participating in physical therapy or another interventional study targeting walking function
* Recent (\<2 weeks) or planned changes in lower limb orthotic or spasticity management
* Foot drop or lower limb joint instability without adequate stabilizing device, as assessed by a physical therapist
* Clinically significant neurologic disorder other than stroke or unable to walk outside the home prior to stroke
* Unable to walk outside the home prior to stroke
* Other significant medical condition likely to limit improvement or jeopardize safety as assessed by a physical therapist (e.g. joint contracture, gait limited by pain)
* Pregnancy
* Previous exposure to fast treadmill walking (\>3 cumulative hours) in the past year