cyrilzakka/clinical-trials huggingface dataset:
State vs. Trait Alterations in Low Back Pain

The primary goal of this study is to investigate whether different alterations observed in patients with non-specific episodic low back pain (compared to healthy volunteers), detected using several assessments: psychophysical and neurophysiological testing, imaging, and blood sampling, are dependent or independent of the presence and type of pain experienced at the time of investigation.

The study consists of three visits (healthy volunteers will only have one pain-free visit), in which patients will be tested in a different "pain state" at each visit:

1. Pain-free visit: will be carried out when the patients have no or little (Numerical Pain Rating Scale (NPRS) \</= 2/10) clinical pain.
2. Clinically relevant Low Back Pain visit: will be carried out with patients experiencing a low back pain episode with an intensity of 3/10 or more on the NPRS.
3. Experimental pain / Clinically irrelevant pain visit: will be carried out with the application of a high concentration (8%) Qutenza® capsaicin patch at the arm.

Each of the visits will consist of psychophysical testing, neurophysiological assessement of sweat activity in response to pain, brain resting state magnetic resonance imaging and magnetic resonance spectroscopy. Additionally, and depending on the type of session, a lumbar spine magnetic resonance image (only pain-free session, as characterization) and a blood sample (only pain free and low back pain visit) will be performed.

Eligibility Criteria:
Inclusion Criteria:

* German or English proficiency
* Informed consent
* Low back pain for more than 3 months
* Low back pain clinically not attributable to "red flags" (e.g. infection, fractures, inflammation)
* Fluctuating course of pain (with on and off pain periods).

Exclusion Criteria (applicable to both groups):

* Inability to give informed consent / follow study instructions (e.g. due to language problems)
* Major medical or psychiatric condition. E.g. severe heart disease, diabetes, autoimmune disorders, rheumatic disorders, major depressive disorder, etc.
* Symptomatic radiculopathy, manifested through motor and/or sensory deficits / or signs of nerve root involvement on lumbar MRI.
* Back operation
* BMI \> 30
* Pregnancy
Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer

The purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), with breast magnetic resonance imaging imaging (MRI) for predicting the effect of neoadjuvant chemotherapy on pathologic complete response rates. The device used to obtain CEDM+CEDBT images is called Siemens MAMMOMAT. This device produces two-dimensional (2D) images, as in a normal mammogram, but also collects additional images for digital breast tomosynthesis (DBT), which produces a three-dimensional (3D) image of the breast in the form of image slices. DBT allows the radiologist to "see through" the breast tissue for better detection and localization of breast cancer. By looking at both the CEDM images and the CEDBT images, a radiologist may be able to better detect residual breast cancer in a more cost-effective manner.

Participation may last up to 18 weeks.

Study procedures for this research are:

* Undergoing 1-2 mammograms during and/or after your chemotherapy, but before primary breast surgery.
* Before each mammogram, have a radiology technician inject a liquid contrast agent by inserting a needle into a vein. The chemotherapy port cannot be used to receive the contrast agent
* Let the research team record information from your medical record related to your condition and the treatment you receive.
* Give permission to collect leftover tissue from your diagnostic biopsy and breast surgery.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis with either type of invasive locally advanced breast cancer regardless of hormone receptor or Her2 status
* Plan to receive at least 4 cycles of neoadjuvant chemotherapy ahead of definitive surgery

Exclusion Criteria:

* Pregnancy
* Allergy/sensitivity to contrast agent
* Decreased kidney function
* Diabetes
The Impact of Erigo®Pro Therapy and Motor Imagery on the Balance of Stroke Patients.

The aim of the study is to examine the impact of motor imagery, Erigo®Pro tilt table intervention, and classic rehabilitation on the balance of people after a stroke.

DESIGN: randomized observational study. SETTING: A hospital Rehabilitation Department. POPULATION: Sixty-six post-stroke patients mean, 64.85 ± 18.62 years. METHODS: 66 stroke patients were randomly assigned to three groups (22 people each) with different therapies (conventional, with the addition of Erigo®Pro and enriched with motor imagery). The therapy duration was two weeks. Patients underwent assessment before and after completion of therapy. The study used the Trunk Stability Test, Berg Balance Scale to assess balance, as well as the Riablo device to measure static balance. Additionally, an evaluation of the superficial tension of the transverse abdominis and multifidus muscles was conducted.

Eligibility Criteria:
Inclusion Criteria:

1) patients 6-8 weeks post-stroke, 2) aged 38-85 years, mean, 3) males and females, 4) walking with or without assistance (modified Rankin scale = 3), 5) with slight neurological deficits (NIHSS ≤7).

Exclusion Criteria:

1) stroke up to six weeks after the episode, 2) epilepsy, 3) no possibility to sit and stand, 4) persistent deficit of speech and cognitive functions, lack of attention, 5) visual disturbances, 6) depression, 7) high or very low blood pressure, dizziness, malaise.
Retrospective Study Chimaera Long Nail in Adult Patient

The CHIMERA study intends to evaluate the clinical benefits of the study medical device in the standard clinical practice.

The CHIMERA study intends to evaluate the clinical benefits of the study medical/investigational device in the standard clinical practice. The study will be conducted in two sites located in Italy; both considered reference sites for the treatment of adult patients with pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur, where the usage of Orthofix® Chimaera Hip Fracture SystemTM (from now on CHIMAERA) was part of the normal clinical practice. The CHIMAERA, is an internal fixation system intended for insertion into the medullary canal of a femur in individuals suffering from stable and unstable pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur alone or when these fractures occur in combination with shaft fractures extending distally to a point approximately 10cm proximal to the intercondylar notch. The participant investigators will retrospectively include a maximum of 44 patients meeting inclusion and exclusion criteria (considering an imprecision of 5%) that will contribute for approximately 44 patients in which CHIMAERA was used.

The study is designed to analyze medical records of adult patients who underwent CHIMAERA implantation from 2018 to 2023 in the standard clinical practice setting.

Eligibility Criteria:
Inclusion Criteria:

1. The patient expressed his willingness to participate in the Study by signing and dating informed consent.
2. Patients who had a regular indication for surgical intervention with the long variant of CHIMAERATM according to the manufacturer's IFU.
3. Patients equal or older than 18 years at the time of surgery.
4. Patients who underwent surgery performed with CHIMAERATM.
5. Patients with clinical data registered in her/his medical records sufficient to assess the safety and efficacy endpoints of the study.

Exclusion Criteria:

1. Patient who had/has a medical condition that is a contraindication according to the manufacturer's IFU leaflet.
2. Patient has been diagnosed with bilateral proximal femur fractures.
3. Patient who needed the application of, or ha already in-situ a concomitant not permitted device which cannot be safely removed.
4. Patient with other concurrent medical or non-medical condition that in the opinion of the participating investigator may prevent participation or otherwise render the patient ineligible for the study.
5. The patient is participating in other clinical studies, or he/she has participated in other clinical studies in the 3 months prior signing the informed consent .
Phase II Study of the Effect of Leuprolide Acetate and Spironolactone on Insulin Resistance in Hyperandrogenic Women With Polycystic Ovarian Disease or Hyperandrogenism Insulin Resistance Acanthosis Nigricans Syndrome

OBJECTIVES: I. Evaluate insulin resistance in thin and obese hyperandrogenic women with polycystic ovarian disease or hyperandrogenism insulin resistance acanthosis nigricans syndrome and in thin and obese controls, using an estimation of tissue sensitivity to insulin.

II. Evaluate the effect of androgen suppression with leuprolide acetate and spironolactone on insulin secretion and resistance.

PROTOCOL OUTLINE: Participants are treated with subcutaneous leuprolide acetate followed by oral spironolactone. Each treatment is administered daily for 6 weeks, with a 6-week washout between drugs.

Patients and controls are alternately assigned to begin treatment with leuprolide acetate or spironolactone.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Polycystic ovarian disease Oligomenorrhea or amenorrhea Hirsutism Hyperandrogenism Hyperandrogenism insulin resistance acanthosis nigricans syndrome Hyperandrogenism Oligomenorrhea or amenorrhea Insulin resistance Acanthosis nigricans Hematocrit at least 30% Women with normal menstrual cycles not using oral contraception entered as controls
Epigenetic Mechanisms and Symptom Clusters Associated with Resolution of Pain Following Spinal Cord Stimulation

Spinal cord stimulation (SCS) is indicated for selected patients with chronic pain who have not responded to conventional medical management.

Forty (40) patients indicated for SCS placement and presenting to the University of Arkansas for Medical Sciences (UAMS) Interventional Pain Management Clinic in Little Rock, Arkansas will be recruited for this study. Prior to temporary stimulator placement, patients will complete symptom-related questionnaires and provide a blood sample. Demographic and clinical characteristics will be obtained through medical record review. Patients will complete the same questionnaires and provide a blood sample at each of the routine clinical care follow-up visits.

Neuromodulation has emerged as a minimally invasive therapy effective for the treatment of refractory neuropathic pain conditions. Epidural placement of electrodes provides long term analgesia through electrical stimulation of the spinal cord which alters expression of genes involved in synaptic signaling in the dorsal horn. Patients who receive SCS represent a unique opportunity to study the physiological mechanisms associated with the resolution of chronic pain.

This is a descriptive, prospective, longitudinal study that will consist of individuals with persistent pain and meet criteria for implantation of a neurostimulation device. One hundred patients indicated for neurostimulation device placement and presenting to the University of Arkansas for Medical Sciences Interventional Pain Management Clinic in Little Rock, Arkansas will be recruited for this study. Patients who meet study inclusion criteria will be recruited to participate prior to stimulator placement procedure. Following an initial consultation and exam by a physician, patients will have necessary imaging and neuropsychological evaluation. Prior to SCS placement procedure, the patient will complete preoperative labs.

At baseline, patients will be asked to complete the demographic questionnaire, and physical functioning questionnaires, and provide a blood sample. Blood samples will be drawn and stored until sample processing is completed. Medical records will be reviewed and abstracted for research-related data elements from electronic medical records. Questionnaire and form responses are collected and recorded for study use.

Study time points for data collection and sample collection are Baseline (Pre-treatment), routine follow-up visit \< 60 days after baseline, 3 months, and 1-year post-implant procedure.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age greater than or equal to18 years) who meet clinical criteria for implantation of a neuromodulation device
* Able to speak, write, and understand English

Exclusion Criteria:

* Evidence of monetary gain related to the outcome of the procedure (example worker's compensation, ongoing litigation, pending disability claim)
* Pain greater than 4/10 on pain scale at a bodily site not being treated by the neuromodulation procedure
Association Between a Peri-traumatic Dissociation State and the Occurrence of Post-traumatic Stress Syndrome

Patients will be selected after studying clinical records.Patients who had general anesthesia due to an injury related to severe trauma within 6 to 12 months prior to inclusion will be included.

Three self-survey will be completed by the patient: PDEQ, PCL-5 and a demographic questionnaire. According to the PDEQ and PCL-5 scores, an association between a peri-traumatic dissociation state and a post-traumatic stress disorder can be established.


Eligibility Criteria:
Inclusion Criteria:

* Patients with general anesthesia for a surgical wound with violent trauma in the road, a fall of more than 6 meters, burn, accident at work, explosion, aggression) in the 6 to 12 months before the inclusion
* Time between trauma and general anesthesia should not exceed 48 hours
* Patient agreeing to participate in the study.

Exclusion Criteria:

* Minor patients
* Patients under curatorship, and tutorship
* Patient deprived of liberty
* Patients who do not speak French
* Patients who are not in satisfactory neurological state to answer the questionnaire (pyschotic, demented states)
* Patients who have been sedated (apart from general anesthesia) when receiving or having a Glasgow score \<14
Health Outcomes in Rheumatoid Arthritis in Greece

Rheumatoid Arthritis (RA) is a chronic debilitating disease, causing severe pain and progressive joint destruction and leading to partial loss of mobility. The disease has a severe impact on patients' quality of life, due to the pain and physical impairment it causes, which can also result in psychological and social difficulties. Moreover, the chronic nature of the disease deems necessary the long-term use of medication, causing significant costs to the patient and the healthcare system. The decline in functional ability can cause problems at work, with reduced productivity or even unemployment. In addition, RA can limit the patients' ability for self-care, hence imposing a further burden on the patients' families and the society.

Many international studies have confirmed the reduced quality of life for people suffering from RA \[1-3\], as well as the large economic impact of the disease on the patients, the health system and society \[4-6\]. However, no assessment of the above impact of RA on the Greek population has been published so far.

A wide research of the literature confirms the relationship between costs and quality of life on the one hand and functional ability (as measured by the Health Assessment Questionnaire) on the other hand. \[7-8\] The impact of functional ability on quality of life is straightforward, however studies also demonstrate that as disease symptoms progress, without proper treatment, the overall costs undertaken by the patient or the healthcare system can rise significantly. On the other hand, if effective treatment can lessen or postpone the most serious consequences of the disease (such as extensive joint damage that could lead to surgical replacement), the savings on healthcare can offset some of the costs of the more effective drug therapies.

In the light of the above findings, it seems important that in order to properly assess therapeutic strategies for RA patients it is necessary to have an accurate view of the total burden of RA on the population. It is also important to be able to establish a robust relationship between functional ability and impact of RA on costs and quality of life.

The study will use a prevalence-based approach, recruiting patients at various stages of disease. Subjects will be enrolled sequentially as per their order of appearance at the site, until the maximum allowed number of subjects is reached at each site.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 years or older
* Confirmed diagnosis of theumatoid arthritis by investigating physician.
* Evidence of a personally signed and dated informed consent document (or legally acceptable representative).

Exclusion Criteria:

* Simultaneous participation in an interventional clinical trial.
Phase 2 Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 vs Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension

The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 ophthalmic solution in lowering intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. Three different concentrations of NCX 470 ophthalmic solution (0.021%, 0.042%, and 0.065%) will be compared to latanoprost 0.005% ophthalmic solution.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
* Qualifying IOP at 3 time points throughout the day at 2 visits following washout of IOP-lowering medication, if applicable
* Qualifying best-corrected visual acuity (BCVA) using the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol in each eye
* Ability to provide informed consent and follow study instructions

Exclusion Criteria:

* Pigmentary or pseudoexfoliative glaucoma
* Narrow anterior chamber angles or disqualifying corneal thickness in either eye
* Clinically significant ocular disease in either eye
* Previous complicated surgery or certain types of glaucoma surgery in either eye
* Incisional ocular surgery or severe trauma in either eye within the past 6 months
* Uncontrolled systemic disease
Is Self-action Observation More Effective Than Observing Another Person's Action?

The aim of the study is to compare the possible effects of self-action observation and observation of another person's action on upper extremity functionality, cognitive functions and reaction times.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* willingness

Exclusion Criteria:

* any kind of neurological or musculoskeletal problems
* sight problems
* pain in the upper limb
Infection With Respiratory Syncytial Virus in Infants

IRIS (Infection with RespIratory Syncytial Virus) is an observational, multi-center study enrolling infants with severe RSV infection and healthy controls. Inclusion criteria are age below two years and hospitalization due to RSV infection at three German sites. Exclusion criteria are premature birth, congenital or acquired bronchopulmonary or cardiac diseases, and immunodeficiency. Blood and respiratory specimens are collected upon admission, and RSV and other pathogens are analyzed by multiplex polymerase chain reaction (PCR). Further biomaterials including plasma, nasal lining fluid, blood cells, DNA, and RNA specimens are sampled in a dedicated biobank. Detailed information on demographic characteristics and medical history is recorded, as well as comprehensive clinical data including vital signs, medication, and interventions.

The IRIS study is designed as a multicentric, prospective, observational study initiated at Hannover Medical School, Germany. Upon enrollment, detailed data on demographic background, case histo-ry, clinical presentation, physical examination, diagnostic findings, treatment, and other patient related items is collected. Data on disease course, treatment, and complications is gathered. Blood and respiratory specimens are collected upon admission, and RSV and other pathogens are analyzed by multiplex polymerase chain reaction (PCR). Further biomaterials including plasma, nasal lining fluid, blood cells, DNA, and RNA specimens are sampled in a dedicated biobank (Hannover Unified Biobank). The study enrolls hospitalized children with confirmed RSV infection between the first month of life and second year of life. The diagnosis of RSV is evaluated by point-of-care testing (POCT, Sofia, Quidel, Kornwestheim, Germany), and positive findings are confirmed by polymerase chain reac-tion (PCR). Exclusion criteria are premature birth, congenital or acquired bronchopulmonary or car-diac diseases, and immunodeficiency. Healthy control probands are enrolled via recruitment of patients undergoing routine surgical procedures. Written informed consent is obtained from all parents and caregivers. Three local study centers in northern Germany (Hannover, Oldenburg, and Hildesheim) are contributing. All study sites are secondary or tertiary care hospitals and undergo extensive training in recruitment, biosample acquisition and processing, data collection and data entry, logistics, and security.

Eligibility Criteria:
Inclusion Criteria:

* RSV Infection, confirmed by polymerase chain reaction (PCR)
* Need for hospitalisation

Exclusion Criteria:

* premature birth
* bronchopulmonary diseases
* cardiac diseases
* immunodeficiency
Study of the Performance of Stroke Management in the Rhône Area

Acute stroke management represents a true medical emergency that requires prompt diagnosis and urgent treatment. However, only a small percentage of patients access to thrombolysis on time. Various actions have been implemented since 2006 in the Rhone area as part of research projects and of the 2010-2014 national stroke action plan: training of health professionals involved in the stroke management, increase of public awareness through sensibilization campaigns, implementation of telemedicine and increase of the number of hospital beds dedicated to stroke (stroke units beds).

The main objective of the STROKE 69 study is to assess the impact of these actions on intra-hospital acute stroke management times in the Rhône area. The secondary objectives are to assess the impact of these actions on the rate and place of thrombolysis, the rate of post- thrombolysis hemorrhage, the rate of thrombectomies, mortality in the acute phase, at 3 and 12 months, the level of disability at 3 and 12 months, pre-hospital times, the number of calls to SAMU centre 15 (French mobile emergency medical services, equivalent to 911) and management channels.

The investigator will perform a prospective cohort study between 06/11/2015 and 06/06/2016 and data will be compared to data collected in a previous cohorts study, the AVC-69 cohort study (Porthault Chatard et al, Int J Stroke. 2012 Oct;7(7):E13), between 06/11/2006 and 06/06/2007, before the implementation of the actions in the Rhône area.

The cohort will be constituted of all consecutive patients treated for a stroke suspicion by the Rhône SAMU centre 15, or in one of the emergency unit or stroke unit of the Rhône area, and presenting a symptom-onset (the last time the patient was seen without deficit) less than 24 hours.

After collecting data in the acute phase, patients with a confirmed diagnosis of stroke or transient ischemic attack (TIA) will be followed for 12 months after their inclusion by telephone calls at 3 and 12 months to assess the level of disability and mortality.

AVC 69 study allowed us to include 1306 patients between 2006 to 2007, the investigator plan to include at least 1300 patients in the STROKE 69 cohort with approximately 1000 confirmed strokes or TIAs.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients treated for a stroke suspicion at the acute phase ,
* with symptom onset (the last time the patient was seen without deficit ) less than 24 hours,
* Managed by the SAMU centre 15, in one of the emergency unit or stroke unit of the Rhône area
* Regardless of their geographical origin

Exclusion Criteria:

* Age under 18 years
* Symptom onset exceeding 24 hours
* Stroke during hospitalization