cyrilzakka/clinical-trials huggingface dataset:
Examining Effects of Aerobic Exercise on Pain Sensation

By doing this study, researchers hope to learn effects of aerobic exercise on over activated nervous system in people with chronic low back pain.

Chronic low back pain is a common condition in the world. About 85% of people with low back pain do not know the cause of their pain. This leads to ineffective treatments.

Recently, the idea of an over activated nervous system is thought to be one of the main reasons for chronic pain. Over activated nervous system means pain processing areas in the spine or brain might be more sensitive. Aerobic exercise, such as walking and cycling, is often used to decrease chronic pain. Aerobic exercise is a form of physical exercise that strengthen the heart and lungs in order to improve the body's utilization of oxygen.

The researchers want to examine if aerobic exercise is effective in decreasing over activation of the nervous system. Gaining a better understanding of effects of aerobic exercise on the nervous system may lead to more effective treatments for low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Lower back pain (LBP) for more than 3 months
* A minimal pain level of 3 on the 0-10 pain numerical rating scale (NRS) in the last 7 days
* Can read and understand English.

Exclusion Criteria:

* Nerve root compression that resulted in numbness or decrease in sensation in the areas for the pain sensitivity tests as reported by the subject
* cervical or thoracic pain as a main complaint
* spinal pathologies such as fracture, tumor, infection, and severe inflammation
* severe spinal deformity
* severe cardiovascular and neurological diseases
* cancer
* history of spinal surgery
* currently seeking active treatments for LBP other than medications
* resting blood pressure more than 160/90 mmHg 49
* currently taking blood thinning medications
* uncontrolled diabetes
* cannot have blood pressure taken
* participated in a similar trial in the past
Diagnostic Performance of a Commercial Assay for the Detection of Neuronal Antibodies

Detection of autoantibodies targeting neuronal surface or intracellular antigens is a keystone for the diagnosis and the treatment of auto-immune encephalitis and paraneoplastic neurological syndromes. A strategy commonly used for their detection is to perform a screening with a tissue-based immunofluorescence assay or immunohistochemistry assay and a second line test to confirm and identify the autoantibody. Since several years, commercial kits are used by a growing number of laboratories to screen the presence of these autoantibodies. However, the diagnostic performance of these commercial kits is highly variable and several studies reported a high prevalence of false-positive and false-negative results with commercial immunodots and cell-based assays. It is therefore essential to explore commercial kits limitations in order to avoid false-positive and false-negative results that could lead to misdiagnosis and/or to delay the treatments.

To assess the diagnostic performance of commercial kits, the investigators performed a prospective study in which the investigators screened patients neuronal autoantibodies in cerebrospinal fluid and sera using commercial tissue-based indirect immunofluorescence assay and CBAs in comparison with an in-house tissue-based indirect immunofluorescence assay.


Eligibility Criteria:
* Inclusion Criteria \* : Sera and/or CSF with sufficient volume to perform both in-house and commercial assays
* Exclusion Criteria \* : Sera and/or CSF with insufficient volume to perform both in-house and commercial assays
Therapeutic Response Evaluation by CTC Expansion System

Among biomarkers, CTCs are a convenient, sensitive and biologically informative option. CTC detection could be considered a real-time "liquid biopsy" approach and contains several advantages such as minimally invasive, easy and safe to perform, and multiple samples can be taken over time, better prognosis to indicate an elevated risk of metastases, improved therapy monitoring, providing live disease status information., However, the number of CTCs is very low, so the establishment of cell culture from CTCs becomes the most challenging over the past year. In this study, we develop a short-term CTC expansion protocol combined with a new surface coating technique. Expanded circulating tumor cells will provide genetic information and develop oncology drug screening platform, which provides an opportunity to monitor response to therapy noninvasively.

CTC detection could be considered a real-time "liquid biopsy" approach and contains several advantages such as minimally invasive, easy and safe to perform, and multiple samples can be taken over time, better prognosis to indicate an elevated risk of metastases, improved therapy monitoring, providing live disease status information., However, the number of CTCs is very low so the establishment of cell culture from CTCs becomes the most challenging over the past year. In this proposal we will develop a short-term CTC expansion protocol through combine with a new type of surface coating technique. Expanded circulating tumor cells will provide genetic information and develop oncology drug screening platform which provide an opportunity to noninvasively monitor response to therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with malignant tumors

Exclusion Criteria:

* Unsuitable for recruitment by clinical judgement or non-compliance with regular follow-up.
Enhancing Quality of Life in Cancer Patients Through Tailored Nutrition Support: a Comprehensive Approach

The study aims to investigate the impact of a dedicated nutritional assistance tool on patients with cancer and to measure its effects on several proposed indicators.


Eligibility Criteria:
Inclusion Criteria:

* Patients affected by cancer, who decided to participate to the study, signed the informed consent and whose life expectancy is higher than 1 (one) year.

Exclusion Criteria:

* Patients with an eating disorder of psychiatric or psychological origin, diagnosed before cancer treatment.
* Any other exclusion criteria as determined by the oncologist based on the patient's ability to successfully complete the program.
Smartphone App and CO Self-monitoring for Smoking Cessation

This randomized controlled trial is going to evaluate whether an intervention consisting of a smartphone application to assist smokers living with HIV to quit in combination with CO self-monitoring compared to stop smoking counselling by physicians during usual care results in higher self-reported and biochemically verified smoking cessation rates at 6 months.

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Eligibility Criteria:
Inclusion Criteria:

HIV-infected smokers ≥ 16 years and smoking ≥ 3 cigarettes /day enrolled into the Swiss HIV Cohort Study Willingness to quit smoking Speaking one or more of offical Swiss national languages or English Users of smartphone (specifically iPhone 5, 5c, 5s, 6, 6+ running iOS Version 8.0+; smartphones with resolution of at least 800x400 pixels running, Android Version 5.0+, and Android smartwatches) Informed consent

Exclusion Criteria:

Limitations in hearing, comprehension or vision problems that preclude full study participation Participants with a life expectancy of less than 12 months due to any serious medical condition
A Phase 2 Study of the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma

The purpose of this study is to evaluate IOP response to experimental dose of Latanoprost- PPDS in subjects with ocular hypertension or open-angle glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 yrs of age with ocular hypertension or open-angle glaucoma
* Subjects who have a best corrected visual acuity of 20/100 or better

Exclusion Criteria:

* Subjects who wear contact lenses.
* Uncontrolled medical conditions
* Subjects requiring chronic topical artifical tears, lubricants and/or requiring any other chronic topical medications
* Subjects who have a history of chronic or recurrent inflammatory eye disease
Pharmacokinetics and Pharmacodynamics of ACP-001 (TransCon PEG hGH)

Double-blind, randomized, placebo and active controlled dose-ascending study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-001 (TransCon PEG hGH).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* 20 to 45 years old
* Body Mass Index of 18.5 kg/m2 and less than or equal to 29.9 kg/m2
* Others

Exclusion Criteria:

* Known history of hypersensitivity to human growth hormone (hGH)
* Known history of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, immunological, hepatic or renal disease, or malignancies
* Others
The EXPLORE MG Registry for Myasthenia Gravis

The purpose of this study is to create a Yale University Department of Neurology Myasthenia Gravis (MG) registry that will be used for current and future research projects involving the study of Myasthenia Gravis.

This registry will allow for the research of several mechanisms of Myasthenia Gravis (MG) by studying peripheral blood, stool, disease status and course, and treatment of subjects with MG. The EXPLORE-MG Registry focuses on varied aspects of MG such as disease management, health care utilization, health costs, disease characteristics, and diagnostic tools. As such, it will aid in a broader understanding of MG, while providing a registry from which questions about the disease may be better answered.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients diagnosed with Myasthenia Gravis presenting to the Yale Department of Neurology for clinical care or research interventions will be invited to donate their biological specimens/clinical data.

Exclusion Criteria:

* Failure to meet the Inclusion Criteria.
Study for the RevLite Laser System for Facial Solar Lentigines

The purpose of this study is to evaluate the effects of the Revlite Laser System for treatment of facial solar lentigines

Prospective facial study using the revlite laser to treat pigmentation caused by sun damage.

Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy male or female between 18 and 60 years old.
2. Is Fitzpatrick Skin types I-III
3. Is willing to consent to participate in the study.
4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.
5. Has clinically determined mild to severe facial mottled pigmentation (solar lentigines) on the face.

Exclusion Criteria:

1. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
2. Is hypersensitive to light exposure OR takes photo sensitized medication.
3. Has active or localized systemic infections.
4. Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}).
5. Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
6. Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
7. Has used Accutane within 6 months prior to enrollment.
8. Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
9. Has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
10. Has a history of keloids.
11. Has evidence of compromised wound healing.
12. Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
13. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.
MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation on Pre-pubertal Children

1. To test for equivalence in terms of catch-up growth between the 2 therapeutic regimens
2. To specify the best period of treatment
3. To assess the efficacy of treatment based on final adult height of these children


Eligibility Criteria:
Inclusion Criteria:

* Pre-pubertal children of either sex presenting with severe early onset intrauterine growth retardation (I.U.G.R.)
* Height Less Than or Equal to -3 SD

Exclusion Criteria:

* Age less than 3 years

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study of Efficacy and Safety of AX-8 in Chronic Cough

This is a randomized, double-blind, placebo-controlled, crossover, multicenter study of AX-8 in participants with unexplained or refractory chronic cough designed to evaluate the effectiveness of AX-8 in reducing cough frequency.


Eligibility Criteria:
Inclusion Criteria:

* Chest radiograph or computed tomography (CT) of the thorax approximately 12 months before screening not demonstrating any abnormality considered to be significantly contributing to the chronic cough
* Have a diagnosis of refractory chronic cough (RCC) or unexplained chronic cough (UCC) for at least one year
* Women of childbearing potential and their male partners must use 2 acceptable methods of contraception
* Male subjects and their female partners of childbearing potential must use 2 acceptable methods of contraception
* Have provided written informed consent

Exclusion Criteria:

* Positive diagnostic nucleic acid test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
* Current smoker (including e-cigarettes), individuals who have given up smoking within the past 12 months, or individuals with a smoking history of 20 pack-years
* Treatment with an ACE-inhibitor as the potential cause of a subject's cough or requiring treatment with an ACE-inhibitor during the study or within 12 weeks prior to the Baseline Visit
* History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks
* History of cystic fibrosis
* Positive test for any drug of abuse
* History of malignancy within 5 years prior to the Baseline Visit
* History of infection or known active infection with human immunodeficiency (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
* History of hypersensitivity or intolerance to AX-8 or other TRPM8 agonists or any of the excipients
Impact of Hip Activation Compared to Hip Plus Balance Training on the Forward-Step-Down Test

The purpose of this research is to determine the impact of a hip activation home exercise program (HEP) compared to a hip activation + single leg balance HEP on performance of the Forward-Step-Down Test (FSDT) in healthy females. Participants will be assigned to the control (hip activation HEP only) or experimental (hip activation + single leg balance HEP). Following the pre-test data collection, participants will complete their HEP for 8 weeks. They will return to the lab for post-test measurements.


Eligibility Criteria:
Inclusion Criteria:

* first or second year students at the institutions's School of Allied Health Professions
* healthy
* female

Exclusion Criteria:

* participating in another research study
* current knee pain or pathology on the dominant leg
* known diagnosis of vestibular impairment
* known pregnancy
Rotational Stability of V4C Toric Implantable Contact Lenses After On Axis Implantation Measured With OPD Scan 3

The recently introduced toric V4c toric ICL (STAAR Surgical Company, Monrovia, CA, USA) has been designed with a 360-µm central hole to allow aqueous humor to flow without the need for an iridotomy. As far as the investigators certain, there have been not well-established prospective studies on the role of the V4c toric ICL for myopic astigmatism correction. Therefore, the present study aimed to investigate the clinical outcomes and rotational stability and to analyze factors that influence the rotational stability in V4c toric ICL implanted eyes prospectively.


Eligibility Criteria:
Inclusion Criteria:

* Age 19-45 years
* Presence of myopia with a manifest refraction spherical equivalent between -5.00 and -20.00 diopters (D)
* Astigmatism between -0.75 and -5.00 D

Exclusion Criteria:

* Previous ocular or intraocular surgery (other than ICL implant)
* Anterior chamber depth from the endothelium \< 2.8 mm
* Corneal endothelial cell density \< 2000 cells/mm2
* Evidence of acute or chronic corneal infection, corneal inflammation
* Glaucoma, amblyopia, retinal detachment, diabetic retinopathy, macular degeneration, or neuro-ophthalmic disease
DIATEST - mHealth and Type 2 Diabetes Mellitus

Dietary modification is effective in the prevention and treatment of type 2 diabetes mellitus (T2DM). However, the access to dieticians in primary care is limited. While mHealth tools have been shown to improve diet and clinical management of patients with T2DM, there are currently no mobile health (mHealth) tools that are effective in improving diet and clinical management of T2DM in Sweden. The aim of this project is to study the effect of the FoodSwitch app, an mHealth intervention for patients with T2DM.

This randomized controlled trial will determine the effect of the FoodSwitch app for healthier food choices on HbA1c, blood lipids, renal function and low-grade inflammation in individuals with T2DM. The effect of the mHealth tool on HbA1c and cardiovascular risk factors, will be compared to standard dietary advice for patients with T2DM. Randomization will be performed in a 1:1 ratio to receive the FoodSwitch app intervention or control and stratified by age (\<50 years/≥50 years), sex, and baseline insulin use (Yes/No). The intervention group will scan all their purchased packaged food with the FoodSwitch app for one week at 6 and 12, 18 and 26 weeks. The control group will photograph and upload images of their receipts or share digital shopping receipts for one week at 6 and 12, 18 and 26 weeks. All participants in both the intervention and control group will report symptoms, functions, and quality of life, as often as they like as well as at 6 and 12, 18 and 26 weeks. All participants will be mailed a blood and urine collection kit and instructed to use it and to self-measure waist circumference at the start of the study and at 26 weeks. The primary outcome (HbA1c) and secondary outcomes (blood measurements of total cholesterol, LDL and HDL cholesterol, eGFR, TNF-α, IL-1β, IL-6, CRP, proteomics, and metabolomics; microalbuminuria; self-measured waist circumference; self-reported quality of life, 24-hour dietary recall, as well as other present symptoms; smartphone-obtained physical activity levels and patterns) will be evaluated at 26 weeks. National registry-obtained data on medication use, hospitalizations and deaths will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* age 18-75 years
* regularly participate in grocery shopping
* self-report of having T2DM, with or without diabetes medication

Exclusion Criteria:

* no access to BankID (a digital identification system commonly used in Sweden), thus unable to consent to the study
* fail to complete the run-in procedures
* HbA1c \<48 mmol/mol in combination with no ongoing diabetes treatment
A Pharmaco-epidemiological Study of Short Patients Born Small for Gestational Age (SGA), Treated With Saizen® (Recombinant Somatropin)

This one-arm, multi-centric, non-randomized, observational, open label, prospective study was designed to study short subjects born SGA, by pediatricians, endocrinologists or physicians in private, mixed private and hospital practice treated with Saizen.

The term "small for gestational age" (SGA) is a pathological medical condition known since about two decades supported by two consensus conferences of 2001. It inhibits the height and/or weight of the child at birth without prejudging the mechanisms that alter these. This study will be carried out by hospital pediatricians, endocrinologists or physicians in private, mixed private and hospital practice in metropolitan France. Subjects will be monitored by doctors in accordance with the normal scope of follow-up of pathology until their final growth and until they reach adult height and/or until the treatment is discontinued. The participating doctors will include all the short SGA subjects coming for consultation or the follow-up (for less than 12 months) of their treatment by Saizen in this study. The inclusions will take place over a period of 21 months.

OBJECTIVES

Primary objective:

* To describe the characteristics of short children born SGA (SGA subjects) treated with Saizen

Secondary objectives:

* To describe the terms and conditions for the prescription of Saizen in terms of dosage, duration of treatment, reason for discontinuation and compliance
* To describe the effects of Saizen on growth and final height
* To describe the tolerance of Saizen. For each subject and during each visit, the participating doctor will complete an electronic data collection form.

Eligibility Criteria:
Inclusion Criteria:

* Short children born SGA requiring treatment with Saizen, new to growth hormone treatment or being treated with growth hormones for less than 12 months of inclusion
* Subjects whose parents have given their written consent for participation in this study

Exclusion Criteria:

* Contra-indication in the treatment with Saizen
Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema

Acute cardiogenic pulmonary edema (ACPE), one of the most severe forms of acute heart failure, represents 5% of hospital admissions. One of the most frequent phenomena encountered during ACPE is hypertensive crisis (hypertensive ACPE) but the mechanisms and causes of hypertensive ACPE are insufficiently understood. Few studies have evaluated the cardiac function during hypertensive ACPE, and these studies used only conventional echocardiography methods. New methods of evaluation of cardiac function in hypertensive ACPE (such as Tissue Doppler imaging) have not been used.

The objectives of this study are to evaluate presence and role of the following potential mechanisms of hypertensive ACPE: 1. acute myocardial dysfunction (systolic and diastolic); 2. silent transient myocardial ischemia; 3. acute mechanical left ventricular dyssynchrony; 4. dynamic mitral regurgitation; 5. inter-ventricular interaction. Conventional and Tissue Doppler echocardiography will be used to assess cardiac function.


Eligibility Criteria:
Inclusion Criteria:

* acute onset of dyspnea within the preceding 8 hours
* respiratory distress and pulmonary rales at any level
* pulmonary congestion confirmed by chest radiography
* systolic blood pressure \> 160 mmHg before treatment
* sinus rhythm
* signed informed consent

Exclusion criteria:

* acute myocardial infarction confirmed by myocardial necrosis markers (either CKMB or troponin I). Angina pectoris alone will not be excluded
* significant left sided valvular disease (more than moderate). Mitral regurgitation of any severity will not be excluded, due to the hypothesis of the role of dynamic mitral regurgitation in the pathogenesis of acute hypertensive pulmonary edema
* congenital heart disease
* cardiac tamponade
* rhythm and conduction disturbances that may have precipitated pulmonary edema, like sustained ventricular tachycardia and complete heart block