cyrilzakka/clinical-trials huggingface dataset:
Pain Quality Study

One way to better understand how various treatments for pain differ is to determine the effects of these treatments on different pain qualities or characteristics. For example, pain can be described as "hot", "electrical", "cold", "achy", and "piercing." In order to determine which pain quality/qualities that a pain treatment affects, researchers must develop measures of these pain qualities or characteristics. The purpose of this study is to learn more about the different pain qualities individuals who have low back pain, headaches and fibromyalgia experience. Identifying the common qualities of pain experienced by these groups will help researchers evaluate and develop more comprehensive pain quality measures, which will ultimately help them to be able to test the effectiveness of treatments for these different pain qualities.


Eligibility Criteria:
Inclusion Criteria:

* Speaks and understands English;
* At least 18 years of age;
* Confirms a diagnosis from a physician or certified medical provider of one of the three medical conditions (low back pain, headache, fibromyalgia), and that pain related to this diagnosis is still bothersome.
* Has experienced bothersome pain associated with their diagnosis in the past three months of a sufficient intensity;
* English is their first and primary language.

Exclusion Criteria:

* Individuals would be excluded if they have more than one of the three pain diagnoses to be studied.
Comparison of Sequential Fluoroscopy Guidance With Spiral Guidance in Terms of Safety, Effectiveness, Speed and Radiation in Interventional Chest-abdomen-pelvic Procedures

The purpose of the study was to compare sequential fluoroscopy guidance with spiral guidance in terms of safety (number of major complications), effectiveness (number of targets reached), speed (procedural time) and radiation (DLP) in interventional chest-abdomen-pelvic procedures.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (\> 18 years),
* indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control

Exclusion Criteria:

* MRI contra indication
* persons referred to in Articles L1121-5 to L1121-8 of the French Public Health Code
The Impact of the SENSE Program on NICU

The SENSE program will be applied to babies receiving treatment in the neonatal intensive care unit and the effect of the application on the baby and parents will be examined.

For the growth and health of the baby, the intrauterine environment provides the fetus with protective physical barriers and sensory exposures timed appropriately for its development. These early exposures occur during sensory development in the intrauterine environment, and there are differences in the timing of development of each sense. When the baby is born prematurely, the intrauterine environment is replaced by the Neonatal Intensive Care Unit environment. The sensory environment of the preterm baby includes the experiences of touch, movement, smell, sound, light, frequent nociceptive pain and disruption of sleep. The mismatch between the infant's underdeveloped coping skills and the stimulating NICU environment can cause physiological imbalance, negatively impact growth and development, and ultimately predispose to the development of long-term neurodevelopmental consequences. Although harmful sensory exposures can negatively affect the development of the preterm baby, appropriate positive sensory exposures positively affect brain development.

Eligibility Criteria:
Inclusion Criteria:

* Being in the first week of life

Exclusion Criteria:

* Congenital anomaly,
* Preterm babies who are not predicted to survive,
* Babies who cannot be followed regularly,
* Parent having a psychiatric problem
* Parents who wish to withdraw from the study
Detection and Cytotoxic T Lymphocyte Therapy of Post-Transplant Lymphoproliferative Disorder After Liver Transplant

Despite advances in medical and gene therapy, orthotopic liver transplantation remains the only definitive therapeutic option for children with end-stage liver disease. Recent advances in pre-, intra-, and early post-transplant care have resulted in a dramatic improvement in survival of the pediatric liver transplant patient. The broad long-range goal of our research program is directed at enhancing the patient's long-term survival. Our primary focus relates to obligate life-long immunosuppression, with its inherent complications including severe infection and development of cancer. These two complications come together in a single disease, Epstein-Barr Virus (EBV)- associated post-transplant lymphoproliferative disorder (PTLD). EBV, a latent human lymphotrophic herpes virus infects and immortalizes B cells. Primary infection usually occurs via salivary exchange and results in a mild, self-limited illness followed by life-long EBV-specific T cell controlled EBV latency. T cell-based immunosuppression prevents allograft rejection, however, it also suppresses cytotoxic T lymphocyte (CTL) function, generating an environment in which EBV-infected cells can proliferate. Patients receiving life-long T cell-based immunosuppression have an increased risk of developing PTLD due to their inability to produce normal immunoregulatory responses. This disease is particularly devastating to the pediatric patient as its incidence is at least 4-fold greater than in the adult liver transplant patient population. In fact, PTLD is the number one cause of death following pediatric liver transplantation. At this time, there is no definitive method of prospectively detecting, diagnosing, or treating PTLD, and current treatment protocols place the liver allograft and patient at risk. Therefore, a diagnostic tool that is both sensitive and specific, and a treatment strategy with low toxicity are greatly needed to decrease the morbidity and mortality suffered by the pediatric liver transplant patient with PTLD. Our proposed studies will support our hypothesis that the combination of a persistently elevated EBV load in the setting of a diminished immune response to EBV will be an early risk indicator associated with PTLD development, and that pre-emptive treatment utilizing autologous adoptive EBV-specific CTL immunotherapy will provide a low toxicity treatment option.


Eligibility Criteria:
Pediatric patients s/p orthotopic liver transplantation
BONVIVA(Ibandronate) Injection PMS(Post-marketing Surveillance)

This is an open label, multi-centre, non-interventional post-marketing surveillance

This is an open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety of Ibandronate injection administered in postmenopausal osteoporosis patients according to the prescribing information

Eligibility Criteria:
Inclusion Criteria:

All subjects must satisfy the following criteria at study entry:

Subjects administered with BONVIVA(ibandronate) injection following the locally approved prescribing information Women diagnosed with postmenopausal osteoporosis. Subjects who the investigator believes that they can and will comply with the requirements of the protocol Subjects with no experience of treatment using ibandronate injection Note: Subjects, who have experience of other bisphosphonates treatment, can be included.

Subjects who are indicated and administered of ibandronate injection according to the Prescribing Information in normal prescription use

Exclusion Criteria:

Considering the nature of this non-interventional PMS, there is no strict exclusion criteria set up. The doctors participating this study to enrol the subjects prescribed with ibandronate injection following the locally approved Prescribing Information.

The following criteria should be checked at the time of study entry.

According to contraindication on the prescribing information, ibandronate injection should not be administered to the following patients:

Patients with known hypersensitivity to ibandronate injection or to any of its excipients Uncorrected hypocalcemia Note: Ibandronate injection is not recommended for use in patients who have a serum creatinine above 200 μmol/l (2.3 mg/dl) or who have a creatinine clearance (measured or estimated) below 30 ml/min, because of limited clinical data available from studies including such patients.
Effects of an Amino Acid and Chromium-picolinate Containing Drink on Glucose Metabolism on Healthy Subjects

It has previously been shown in healthy overweight subjects, that table water including a defined amount of amino acids and chromium can decrease the postprandial glucose. In this study, the effect of this table water on glucose excursions after a test meal containing a defined amount of available carbohydrates, protein and fat will be studied in healthy subjects. The study will be conducted in a cross -over design, double blinded and placebo controlled including 20 participants. The primary endpoint of the study is the incremental area under the curve for plasma glucose (iAUCgluc) within 180 minutes after ingestion of the meal.


Eligibility Criteria:
Inclusion Criteria:

* Stable body weight (no changes above 3 kg during the last 2 months)
* Good general health
* Body mass index 19 - 30 kg/m2 (normal to overweight)
* Fasting blood glucose below 6.1 mmol/L

Exclusion Criteria:

* Any medication that could influence the study. Such as medication against diabetes, hypoglycemia, hypertension or hypercholesterolemia
* Psychiatric Disease
* Alcohol or drug abuse
* Smokers or people consuming snus
* Acute infections
* Vegetarians/vegans
* Suffering from Lactose or Gluten intolerance
* Pregnancy or Lactation
* Participation in another study at the same time
* Any other parameter that the PI will judge as inadequate
BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration

The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod administration in addition to standard therapy in patients with biopsy proven IgA Nephropathy with persistent proteinuria of between 1-6 g/day.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 65 years of age, inclusive
* Biopsy-proven IgA nephropathy
* Receiving stable, clinically-optimized ACEI and/or ARB
* Proteinuria ≥ 1g/24hr but ≤ 6g/24hr at 2 consecutive time points

Exclusion Criteria:

* Clinical or histologic evidence of non-IgA-related glomerulonephritis
* IgA nephropathy with greater than 50% glomerulosclerosis or cortical scarring
* Meets eGFR criteria
* History of treatment with oral or parenteral corticosteroids within 3 months or immunosuppressants within 6 months
* Malignancy within past 5 years
* Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C
* Liver disease
* Neutropenia
* Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections
* History of active tuberculosis or a history of tuberculosis infection
* Pregnant or nursing
A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years

Migraine is a disease that most often causes moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age.

Atogepant is a medicine currently approved in the United States and Europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. Participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. This study is double-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. Approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world.

Participants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks.

Participants will attend regular visits during the study at a hospital or clinic and the effects of treatment will be checked by completion of a daily diary, medical assessments, blood tests, checking for side effects, and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* History of chronic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018) for at least 6 months as of Visit 1.
* During the last 28 days of the screening/baseline period, and as per eDiary:

  * Participant must have completed the eDiary for a minimum of 20 out of 28 days.
  * Participant has \>= 15 headache days.
  * Participant has \>= 8 migraine days.

Exclusion Criteria:

* Clinically significant hypertension per investigator's judgment.
* History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.
Post-Operative Pain Management Following Spine Surgery

The primary objective of this pilot study is to assess the feasibility of comparing two standardized approaches to manage post-operative pain following spine surgery: one approach using Patient Controlled Analgesia (PCA) devices to deliver opioid analgesics, and the other approach using EXPAREL® infiltration at the site of surgery and nurse-administered opioid analgesics.

The study will assess the feasibility of the methods proposed, including recruitment, eligibility, standardization of both post-operative pain management approaches, and assessment of clinical, hospital efficiency, medication use, health services use, and economic outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Ability to speak, read, and write in English or Spanish
* Primary indication is low back pain, radiculopathy, disc degeneration, disc herniation, foraminal stenosis, or mild 1-level spondylolisthesis or deformity
* Scheduled to undergo primary, single level, lumbar fusion surgical procedure at the study center in the next 30 days
* Willing to provide informed consent, participate in study, and comply with study protocol

Exclusion Criteria:

* Body mass index \>35
* Pregnant or contemplating pregnancy prior to surgery
* Current or previous psychiatric, behavioral, or emotional disorder that may interfere with postsurgical pain, analgesia, or opioid use according to treating surgeon
* Prior treatment for alcohol, recreational drug, or opioid abuse
* Chronic inflammatory conditions (e.g. Crohn's, lupus, rheumatoid arthritis)
* Chronic neurologic conditions (e.g. multiple sclerosis, Parkinson's)
* Serious spinal conditions (e.g. cauda equina syndrome, infection, tumor, fracture)
* Hypersensitivity or allergy to local anesthetics
* Previous surgery in lumbar spine (i.e. other than microdiscectomy);
* Continuous (e.g. daily) opioid consumption for more than 30 days prior to surgery
Rhythmic Light Therapy for Alzheimer's Disease Patients

The investigator will investigate how light delivering 40 hertz (Hz) affects subjective sleep and cognition in a controlled laboratory study. A lab study will allow the collection of electroencephalogram (EEG) data, perform cognitive tests, and observe the response in those with mild cognitive impairment (MCI) compared to a healthy control group (HC).

Participants will attend two study sessions over the course of two weeks. During both sessions, all participants will experience 10 minutes of a low-level light, followed by a data collection period which involves a sleepiness rating, an electroencephalogram (EEG) recording, and a computerized memory test. Participants will then experience either a RL or a placebo RL condition for one hour, after which there will be a second data collection.

The investigator will demonstrate the effect of 40 hertz (Hz) rhythmic light (RL) to promote gamma wave entrainment (rhythmic light \[RL\]) on: brain response (electroencephalography \[EEG\]); cognitive performance (working memory task); and subjective sleepiness (questionnaires). The study will recruit 20 adult mild cognitive impairment (MCI) patients and 20 healthy, age-matched controls (HC) to participate in this study.

Sessions will initiate with a 10-minute adaptation period to a low-level ambient light providing illuminance of 15 lux at participants' eye level on a vertical plane, followed by a pre-exposure data collection period, including Karolinska Sleepiness Scale (KSS), EEG, and a working memory task. Participants will experience either 40 Hz RL or placebo RL conditions for a duration of 1 hour, followed by the second data collection period. On the second data collection day, participants will experience the other condition, so that all participants experience both lighting conditions. The experimental sessions will start at 14:00 on each experimental day which will be separated by 1 week.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be diagnosed with amnestic mild cognitive impairment or mild Alzheimer's disease, as defined by a Montreal Cognitive Assessment (MoCA) score between 17 and 25
* For the age-matched healthy controls, participants must not be diagnosed with mild cognitive impairment or Alzheimer's disease related dementias (MoCA score above 25).
* Participants must score a 5 or less in the Pittsburgh Sleep Quality Index (PSQI)

Exclusion Criteria:

* All participants must not be taking sleeping medication or oral melatonin
* Presence of another brain disease that fully explains the dementia (extensive brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis)
* residence in a skilled nursing facility or long-term care
* Major organ failure (e.g., kidney failure)
* Uncontrolled generalized disorders such as hypertension or diabetes
* Obstructing cataracts, macular degeneration, and blindness
* Severe sleep apnea or restless leg syndrome
* History of epilepsy
Effect of Ureteral Stents Length and Location on Related Symptom

This is a prospective randomized clinical trial, evaluating the effect of the intra-ureteral placement of the stent's distal end versus the conventional stent placement on the postoperative LUTS and pain.

Intravesical stent mass has been considered to cause stent-related symptoms, such as LUTS and pain. The current study hypothesized that the total intra-ureteral placement of the stent's distal end could decrease postoperative LUTS and pain. We proposed a prospective randomized trials, investigating the effect of intra-ureteral stent placement versus conventional stent placement. The primary end point was postoperative LUTS. The secondary end points were postoperative pain and quality of life. We used USSQ questionnaire as the assessing tool.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of unilateral ureteral stone
* Plan to undergo unilateral URS lithotripsy
* Adult patients (\>18 years old)

Exclusion Criteria:

* Pre-stented cases
* Distal ureteral stones
* Preoperative urinary tract infection
* With medications known to influence stent-related symptoms, including alpha-blockers, antimuscarinics, beta3-agonist
* Pregnancy
* Other procedures required during the procedure of lithotripsy
* A stent was expected to be indwelled for more than 10 days (ureteral stricture, ureteral tumors/polyps, ureteral trauma, and a large amount of stone fragments)
Early Nutrition in Acute Pancreatitis

The aim of the study is to assess the effect of the early oral refeeding and fat content in the diet on the length of stay, clinical course (included pain severity) in pediatric patients with mild and moderate AP. Patients will be randomized to groups: refeeding within 24 hours or after 24 hours from the hospital admission. Biochemical tests and pain severity will be evaluated.

Prospective, randomized study. Research in the adult population shows that early enteral feeding in acute pancreatitis (AP) both oral and via the feeding tube is safe, shortens the length of hospital stay, prevents the multi organ failure (MoF) and reduces mortality. The pediatric population lacks prospective data concerning refeeding modes in AP. The aim of the study is to assess the effect of the early oral refeeding and fat content in the diet on the length of stay, clinical course (included pain severity) in pediatric patients with mild and moderate AP. Patients will be randomized to groups: refeeding within 24 hours or after 24 hours from the hospital admission. Biochemical tests including CRP, amylase, lipase and proinflammatory cytokines levels and zonulin level as well as severity of pain will be assessed again in the second, the third and the fifth hospital day.

Eligibility Criteria:
Inclusion Criteria:

* AP diagnosis according to the generally accepted criteria ie. fulfilling two out of three criteria:

  * Abdominal pain of pancreatic origin
  * Radiologic findings supportive of AP on imaging
  * Amylase or lipase levels elevation three times above the upper limit of normal
* Mild or moderate AP Mild AP: AP without organ failure, local or general complications Moderate AP: AP that may be accompanied by intermittent organ failure, local complications or concomitant disease worsening
* No contradictions to enteral treatment
* Informed consent from the parents or legal guardian and from the patient if older than 16 years

Exclusion Criteria:

* Severe general condition
* Severe AP
* Kidney insufficiency, cardiac insufficiency
* Diabetes type 1
* Cystic fibrosis
* Contraindications to enteral feeding
* Lack of required informed consent
Treatment of Monosymptomatic Nocturnal Enuresis

A prospective randomized trial to study the effect of spinal magnetic stimulation versus posterior tibial neuromodulation in the treatment of monosymptomatic nocturnal enuresis.

Nocturnal enuresis is defined as "nighttime bedwetting in children aged five years or older.Currently available treatment options for nocturnal enuresis include medication, wetting alarms, lifestyle changes, sacral magnetic stimulation, and posterior tibial neurmodulation.

Magnetic stimulation is a valid method for stimulation of sacral as functional electrical stimulation. It generates a more powerful and deeper electrical field than that produced by conventional electrical stimulators. So, magnetic stimulation could be considered an attractive form of electrical therapy, being relatively painless, non-invasive and free from side effects.Peripheral neuromodulation is the modulation of the physiologic behavior of the nerve by electrical stimulation. Posterior tibial neuromodulation is an effective method in treatment of urinary incontinence

Eligibility Criteria:
Inclusion Criteria:

* All subjects were diagnosed as patients with MNE according to the Diagnostic and statistical manual of mental disorders, 4th revised edition (DSM-IV) (American Psychiatric Association's DSM-IV, 1994): bed-wetting ≥3 times a week; lasting more than 6 months; can control urination during the day but cannot control urination after falling asleep.

Exclusion Criteria:

* - Patients younger than 5 years old.
* Patients who have any abnormality in blood or urine biochemistry.
* Patients with other urinary symptoms.
* Patients with neurological or endocrinal abnormalities (such as cerebral palsy, spinal cord lesion, peripheral neuropathy or diabetes mellitus)