cyrilzakka/clinical-trials huggingface dataset:
Dual-energy Contrast-enhanced (2D and 3D Mammography Versus Contrast-enhanced MRI)- A Pilot Study

This is a pilot study to evaluate 2D contrast-enhanced mammography image and 3D (tomosynthesis) contrast-enhanced images to contrast enhanced MRI in women with greater than 95% probability of breast cancer (BIRADS 5) or confirmed breast cancer (BIRADS 6).This study will then be used to design additional studies.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a female of any race and ethnicity.
* Subject is at least 25 years old
* Subject has or will have a contrast enhanced breast MRI +/- 31 days of enrollment with no interval treatment or procedure between the two studies
* Subject has BIRADS 6 or BIRADS 5 cancer or as determined by the radiologist
* \>50% of the biopsied cancer mass must remain following biopsy OR
* A calcification must be at least 2cm in maximum dimension prior to biopsy or at least 1cm in maximum dimension following biopsy

Exclusion Criteria:

* Subject is unable or unwilling to undergo informed consent
* Subject has breast implant in the breast to be imaged
* Subject is pregnant
* Subject is breast feeding or lactating
* Subject has a known allergy to gadolinium contrast agents.
* Subject has a contraindication for MRI.
* Subject suspected to be at risk to complication from the contrast agents.
* Subject has a documented renal insufficiency,
* Subject requires renal dialysis.
* Subject has had a prior reaction to iodinated contrast.
* Subject has had a prior episode of anaphylactic reaction to any substance.
* Subject has taken metformin (Glucophage) within 48 hours of study procedures.
* Subject has multiple allergies and/or severe asthma regularly treated with medication (prescription and/or over-the-counter).
Monochromatic Digital-Pupillometry With Two Automated Devices in Comparison to Manual Measurements on Digital Photographs

Retrospective, analysis of three different methods to measure patients' pupil diameters


Eligibility Criteria:
Inclusion Criteria:

* usable measurement values from three different examinations

Exclusion Criteria:

* bad image quality
The Effect of Dry Needling on Trunk Muscle Function in Low Back Pain Patients

The study will establish data on the function of trunk muscles in healthy and low back pain patient's pre and post dry needling treatment. This will help in understanding the underlying mechanism of this treatment and reveal the effect of dry needling on muscle performance.

Study hypothesis is that an improvement of back muscle function following dry needling procedure will be found.

Dry needling of muscles is mainly used for the management of pain in musculoskeletal disorders. Yet, the association between dry needling and motor performance of muscles is still unclear.

This study aims to investigate the immediate effect of dry needling on lumbar multifidus muscles' function in healthy and low back pain subjects.

The sample will be divided into: low back pain group and control (healthy) group. Both groups will receive dry needling to the lumbar multifidus muscles using a deep insertion technique with 4 needles (2 on each side of the spine). The needles will be left in situ for 10 minutes. Ultrasound imaging will be used to measure multifidus muscles' thickness, pre and post- procedure during rest in a prone position and during contralateral active straight leg extension.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-60 years.
* Healthy individuals or individuals with main complaint of low back pain (LBP)

Exclusion Criteria:

* Patients with "red flags" for a serious spinal condition, for example: tumor, compression fractures, infection, cancer.
* Signs of nerve root compression (positive straight leg raise \<45 degrees, decreased reflexes, decrease sensation or decreased strength in the lower extremities).
* Pregnancy.
* Previous surgery to the lumbar spine
* History of congenital lumbar or pelvic anomalies
* Physical therapy for LBP was provided in the 6 months prior to participation in the study
* Patients who are unable to lie prone for 30 minutes.
Genetics of Beta Cell Failure in Mexican Americans

This is a family based genotype-phenotype study designed to assess genetic and environmental influences on obesity, insulin resistance and beta cell function in the context of gestational diabetes.

Mexican American women with prior gestational diabetes and their first degree relatives and Mexican American women with prior normal glucose tolerance in pregnancy are studied with detailed phenotyping consisting of oral and intravenous glucose tolerance tests, body composition studies, diet and physical activity assessments, and circulating biomarkers potentially related to obesity, insulin resistance, pancreatic beta cell function, gestational diabetes and type 2 diabetes. Spouses of the gestational diabetic and control probands are studied with oral glucose tolerance tests. Offspring of the gestational and control probands have fasting glucose determinations. All participants provide DNA for genetics testing. A subset of the gestational diabetic probands and their first degree relatives return 3-5 years after baseline testing for repeat phenotyping.

Eligibility Criteria:
INCLUSION CRITERIA

1. Probands with Prior Gestational Diabetes Mellitus ("GDM PROBANDS")

   * Mexican American (parents and at least 3/4 four grandparents
   * age \>18 years
   * GDM in singleton pregnancy in prior 5 years
   * impaired glucose levels or sum of five OGTT glucose values \>625 mg/dl on 75 gram oral glucose tolerance test
   * Fasting plasma glucose \<126 mg/dl
   * At least two adult siblings of cousin not known to have diabetes and available for phenotyping; .
2. Siblings and Cousins of GDM Probands

   * Full sibling or first cousin of GDM proband
   * Age \>18 yrs
   * Fasting plasma glucose \<126 mg/dl.
3. Parents, Uncles and Aunts of GDM Probands

   * Full blooded parent, uncle or aunt of GDM proband
4. Control Proband

   * Mexican American as defined for GDM probands
   * One glucose challenge test result \<120 mg/dl at \>24 weeks gestation
   * No diabetes in first degree relative
   * Frequency matched to GDM probands by distributions of age, BMI and parity.
5. Spouse of GDM or Control Proband

   * Spouse of GDM proband
   * Age \>18
   * At least one child with proband able to provide DNA
6. Child of Proband

   * Child of GDM or control proband and spouse who provided DNA

EXCLUSION CRITERIA

1. PROBANDS (GDM OR CONTROL):

   * Chronic medical illness or medication known to alter glucose/insulin metabolism
   * Current pregnancy or breastfeeding
   * Ilicit drug or alcohol abuse,
   * Inability or unwillingness to give informed consent.
2. SIBLINGS AND COUSINS OF PROBANDS:

   * Chronic medical illness or medication known to affect glucose/insulin metabolism
   * Current pregnancy or breastfeeding,
   * Ilicit drug or alcohol abuse
   * Inability or unwillingness to give informed consent.
3. PARENTS OF PROBANDS

   * Inability or unwillingness to give informed consent.
4. SPOUSE OF GDM or CONTROL PROBAND

   * Inability or unwillingness to give informed consent.
5. CHILD OF GDM or CONTROL PROBAND

   * Lack of parent consent or child assent.
A Comparison of the ASHC and CDSMP

The arthritis-specific Arthritis Self Help Course (ASHC) and the more generic Chronic Disease Self Management Program (CDSMP) teach generalizable skills for managing arthritis and other chronic diseases. In some locations it may be more feasible to combine efforts and offer the generic course rather than the arthritis-specific program. However anecdotal evidence has questioned whether people with arthritis obtain as much benefit from the more generic course as they do the arthritis-specific course. The primary purpose of this research study is to compare health outcomes among people with arthritis who participate in either ASHC or the CDSMP. The University of Illinois Project is emphasizing recruiting a balance of uran and rural participants. The results of this research will be used to guide Arthritis program recommendations on the use of ASHC and CDSMP to improve the quality of life for people with arthritis.


Eligibility Criteria:
Inclusion Criteria:

Adult with self reported arthritis-

Exclusion Criteria:

-
Evaluation of the Efficacy of VR on Pain and Anxiety When Performing an Ultrasound-controlled Ankle Block.

The purpose of this study is to observe or not a reduction on pain and anxiety felt by the patient when performing an ultrasound-controlled ankle block in preparation for forefoot surgery, using a virtual reality device instead of drug sedation.

Currently, in preparation for forefoot surgery, the realization of the ankle block is accompanied by drug sedation.

The investigator's randomized study aims to compare the anxiety and pain experienced by patients who have benefited from drug sedation with those of patients who benefited from the virtual reality device at the time of the realization of the ankle block.

Eligibility Criteria:
Inclusion Criteria:

* Patient with medical insurance
* Major patient requiring a Hallux Valgus surgery
* Patient who received information about study and signes a consent to participate in the study

Exclusion Criteria:

* Minor patient
* Patient participating in another interventional study
* Patient refusing to sign the consent form
* Patient for whom it is impossible to give informed information
* Patient who had previously undergone forefoot surgery under locoregional anesthesia
* Patient with poor skin condition or infection at puncture sites
* Patient refusing locoregional anesthesia
* Patient under the protection of justice, under curatorship or under tutorship
* Patient undergoing anxiolytic or antidepressant treatment
* Photosensitive epileptic patient
Comparison of Skin Sympathetic Nerve Activity According to Different Anesthetics

Skin sympathetic nerve activity (SKNA) has recently been discovered from the electrocardiogram obtained from healthy volunteers. The raw physiologic electric signal from electrodes placed on the skin was reprocessed through filtering and integration using software to produce the SKNA signal. However, no study has yet provided knowledge on the effect of anesthetics on SKNA during general anesthesia.

The most commonly used anesthetic techniques during general anesthesia are the total intravenous anesthesia (TIVA) and anesthesia using inhalants such as sevoflurane or desflurane. For TIVA, the combination of propofol and remifentanil has been used and remifentanil is known for increasing vagal tone and inhibiting sympathetic nervous system as other opioids do. Sevoflurane is presumed to have no effect on parasympathetic or sympathetic tone. On the other hand, desflurane induces tachycardia and is noted for activating sympathetic activity. Previous studies on sympathetic nervous activity according to different anesthetics did not directly measure sympathetic tone but have relied on indirect measures such as blood pressure, heart rate, and heart rate variability.

In order to evaluate skin sympathetic nerve activity according to different anesthetics, we will be recruiting patients undergoing transurethral procedures, where the sympathetic tone is expected to be activated during anesthesia and surgery. The transurethral procedures consist of transurethral resection of bladder (TURB) and transurethral resection of prostate (TURP). During transurethral surgery, about 300mL of fluid is used to fill the bladder to secure surgical view and for irrigation. Bladder expansion causes sympathetic nerve activation and vasoconstriction, which will also increase SKNA signals. The purpose of this study is to measure skin sympathetic nerve activity according to different anesthetics during intraoperative events that stimulate sympathetic tone.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo elective transurethral procedures under general anesthesia

Exclusion Criteria:

* Diagnosed with autonomic dysfunction
* Current use of beta blockers
* Cardiac arrhythmia
* Absolute indication for either TIVA or inhalants, absolute contraindication for either TIVA or inhalants (adverse effects on either propofol or remifentanil, risk of malignant hyperthermia)
Concentration and Attentional Deficits in POTS and Other Autonomic Neuropathies

People with POTS, autoimmune autonomic neuropathy (AAN), pure autonomic failure (PAF), SFN and Ehlers Danlos Syndrome (EDS) do not only suffer from orthostatic symptoms such as dizziness, headache, neck pain, blurred vision or (pre-) syncope. They also experience deficits in attention and concentration (more precisely deficits in selective perspective, operating speed, executive functions and memory performance) mainly in upright position. Only few studies concerning cognitive impairment in autonomic neuropathies, their frequency, aetiology and therapy exist. Many patients concerned, especially with POTS, report attention deficits and "brain fog" with problems in their everyday life and work, predominantly in upright posture. Specific symptomatic or medical therapies do not exist. Medical treatment with Modafinil is discussed and part of a current study at Vanderbilt Autonomic Dysfunction Centre (1-5). The investigators want to investigate if problems of concentration, attention and/or cognitive dysfunction exist in people with POTS, AAN, SFN and EDS compared to healthy controls (HC). Thus the investigators use detailed clinical, autonomic and neuropsychological tests in different body positions (lying, sitting and standing) as also acute therapy (leg crossing).

We are still recruting healthy controls and patients with autoimmune autonomic neuropathy in order to perform titl table examination and laboratory testing on day one, ono an empty stomach, without morning medication. Cognitive testing is performed on day two after randomization in three groups: lying, standing and standing with legs crossed.

Eligibility Criteria:
Inclusion Criteria:

* AAN, SFN, hEDS, POTS or healthy control
* diagnosis in our clinic on the basis of anamnesis, clinical data as neurological examination, tilt table, QST, skin biopsy, norepinephrine values, vitamine B12, antibodies

Exclusion Criteria:

for all participants

* pregnancy, nonage,severe heart insufficiency, deep brain Stimulation, pace maker, drug consumption, large fibre polyneuropathy for controls
* medication influencing blood pressure, psychiatric disease, synkopes or dizziness, neurological disorders esp. polyneuropathy, dementia, vitamine or iron deficiency
A Study to Investigate Whether Pharmacokinetic and Pharmacodynamic Interactions Exist Between Metformin and Canagliflozin (JNJ-28431754) in Healthy Volunteers

The purpose of this study is to investigate whether there is a drug-drug interaction between multiple doses of canagliflozin (JNJ-28431754) and a single dose of metformin. The safety and tolerability of canagliflozin will also be assessed.

This study is an open-label (all volunteers and study staff know the identity of the assigned treatment), fixed sequence (all volunteers receive the same medication on the same days), single and multiple-dose study to determine how metformin (a blood glucose-lowering agent used to treat patients with diabetes) affects the pharmacokinetics (ie, how the body affects the drug) and the pharmacodynamics (ie, how the drug affects the body) of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus). The effect of canagliflozin on the pharmacokinetics and pharmacodynamics of metformin will also be evaluated. The study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of-study (or follow-up) phase. Each volunteer will participate in the study for approximately 39 days.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers must have a Body Mass Index (BMI \[weight (kg) / height (m)2\]) between 18.5 and 35 kg/m2, inclusive
* Volunteers must be non-smokers or non-tobacco users

Exclusion Criteria:

- History of or currently active illness that the Investigator considers to be clinically significant and should exclude the volunteer from the study or that could interfere with the interpretation of the study results
Clinical Test for Blood Pressure Meter of CH-101

Blood pressure meter model CH-101 was to be assessed against the standard mercury sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.


Eligibility Criteria:
Inclusion Criteria:

* 85 subjects with a wide range of blood pressure were selected.

Exclusion Criteria:

* Subjects could be taking antihypertension medication, but excluded in atrial fibrillation or with any sustained arrhythmia.
An STD Prevention Intervention for Men Newly Released From Jail

Study participants who are exposed to the intervention will: 1)report more condom use during sexual episodes; 2) have fewer new and repeat STD infections 3)demonstrate greater risk reduction, communication, and anger management skills; 4) report fewer substance use behaviors, and 5)report more health care seeking activities, than the participants in the control group

The MISTERS study is a randomized control trial of a cognitive-behavioral skill building multi-session intervention that targets men who are newly released from jail and have a history of drug use. Men 45 days or less post release with self reported HIV negative and substance use histories were randomized into either a 5-session intervention or control group. Study participation included four time-sensitive interviews and STD testing at three time periods. The interview questions included demographics, STD history and knowledge, sexual risk behaviors, as well as an assessment of anger management, communication, and condom use skills.

Eligibility Criteria:
Inclusion Criteria:

* ages 18 to 60, English speaking, not in jail for sexual offenses (rape or child molestation), reported risk behavior in two months prior to incarceration, weekday and evening availability, viable contact information, self-reported HIV negative status, released from jail no more than 45 days prior, and not visibly under the influence of drugs or alcohol at the time of eligibility determination

Exclusion Criteria:

* Opposite of the above
Physical Activity Before Obesity Surgery

There are limited knowledge about the impact of increased pre-operative physical training on postoperative physical activity levels as well as on recovery and complication rates after bariatric surgery.

The primary aim of this study is to investigate whether an intervention including individual coaching to improve level of physical activity before and after gastric bypass surgery leads to a changed of level physical activity post-operatively at eight weeks, one and two years.

Secondary aims of the study are to investigate whether increased physical activity has effects on complication rates, re-admissions and re-operations, post-operative weight-loss, gastrointestinal pain, recovery measured as hospital stay, sick-leave and QoL, resumption of normal physical activity.

METHODS 300 patients will be recruited and randomized to an intervention group or control group. The patients in the intervention group will receive individual coaching by a physical therapist to:

* increase physical activity 30 minutes/day (At least 150 min/week)
* decrease time spent sitting/lying The patients in the control group will receive standard care.

Before surgery, 6 weeks, and one year after surgery patient will fill in a questionnaire including level of physical activity, sick leave, quality of life and gastrointestinal pain. In addition blood test will be taken and complication rates recorded.


Eligibility Criteria:
Inclusion Criterion:

- Patients at including hospitals scheduled for gastric bypass surgery

Exclusion Criteria:

* Inability to understand given information.
* Inability to perform the intervention
Online Pilates in Individuals With Chronic Low Back Pain

The purpose of this study is to evaluate the effects of the Pilates method, performed online, in individuals with chronic low back pain. This is a randomized controlled trial consisting of two arms.

Low back pain is one of the main causes of disability in the world, and physical inactivity is associated with its development. In this sense, Pilates can be used both in the treatment and preventively for this symptomatology. Thus, the aim of this study is to evaluate the effects of the Pilates method, performed online, in individuals with chronic low back pain. This is a randomized controlled trial involving men and women between 18 and 60 years of age with a history of non-specific chronic low back pain and a minimum pain intensity equal to 3 points on the numeric pain scale. Research participants will perform a pre-intervention (EV1) and post-intervention (EV2) assessment, both online. Pain sensation, functional performance, kinesiophobia and perception of global change will be the outcomes evaluated through the following instruments: Numerical Pain Scale, Roland Morris Questionnaire, Tampa Scale for kinesiophobia and Patient Global Impression of Change Scale. Participants included in the study will be randomized into two groups with separate interventions, both lasting eight weeks: online Pilates group and control group. The control group will receive information about self-management of low back pain, pain education, and changes in lifestyle habits; the Pilates group, besides having access to the same information as the control group, will undergo 16 Pilates sessions performed online (2 times/week). The statistical analysis will be done through the independent t test and the Mann-whitney test to investigate the differences between the groups (Pilates online x control), while the paired t test and the Wilcoxon test will be applied to evaluate the effect of the time variable (Pre x Post), considering a significance level of 5%.

Eligibility Criteria:
Inclusion Criteria:

* Men and women with a history of chronic nonspecific low back pain (for more than 12 weeks) and minimum pain intensity of 3 on numerical pain rating scale.

Exclusion Criteria:

* Symptoms related to serious pathologies (such as fever, changes in sensibility, weight loss, constant pain);
* Recent history of spinal fracture, cancer, inflammatory diseases, nerve root involvement, spinal pathologies (such as ankylosing spondylitis, herniated disc with radiculopathy, advanced osteoporosis, spondylolysis, spondylolisthesis);
* Central neurological diseases (such as Parkinson's and stroke), psychiatric (such as depression or schizophrenia);
* Autoimmune diseases;
* Orthopedic surgery in the last year;
* Severe cardiovascular diseases;
* Decompensated metabolic diseases;
* Pregnancy.