cyrilzakka/clinical-trials huggingface dataset:
A Dose-ranging Study in Patients with Diabetic Peripheral Neuropathic Pain (DPNP)

Evaluation of the efficacy of LX9211 compared to placebo in reducing DPNP. Please see study website: https://diabeticpainstudy.com/


Eligibility Criteria:
Inclusion Criteria:

1. Participant has given written informed consent to participate in the study in accordance with local regulations
2. Adult male and female participants ≥18 years of age at the Screening Visit
3. Body mass index ≥18.0 to ≤40.0 kilogram per meter square (kg/m\^2) at Screening
4. Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with chronic DPNP, at Screening
5. Pain from DPNP present for at least 6 months prior to Screening
6. At the Screening Visit, glycosylated hemoglobin (A1C) must be ≤11%.
7. Stable regimen for the treatment of T1DM or T2DM for ≥3 months prior to Screening
8. Willing to adhere to the prohibitions and restrictions specified in the protocol.

Exclusion Criteria:

1. Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
2. History of neurolytic or neurosurgical therapy for DPNP
3. Use of opioid medications for management of DPNP within the 2 months prior to the Screening Visit.
4. Use of prescription topical analgesics (eg, capsaicin) indicated for neuropathic pain within 3 months prior to Screening
5. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to Screening
Does a Low Volume Ultrasound-Guided Technique Reduce Common Complications of Interscalene Brachial Plexus Block?

Peripheral nerve blocks provide many advantages for patients (excellent pain control and reduction in nausea) undergoing upper and lower limb surgery however several commonly occurring complications can produce annoying but sometimes serious adverse effects. The interscalene brachial plexus block (ISBPB) is one such technique, commonly performed for shoulder surgery, but also produces paralysis of the diaphragm, Horner's syndrome and sometimes vocal cord paralysis with standard volumes of local anesthetic. This threat of these side effects limits the use of ISBPB in many patients who would particularly benefit e.g. patients with lung disease. Recently the use of ultrasound guidance is allowing practitioners to place smaller volumes of local anesthetic with much greater accuracy. This can potentially avoid anesthetizing important adjacent nerves to the target structure. If ultrasound-guided techniques with smaller volumes of local anesthetic could be demonstrated to reduce the incidence of complications without reducing effectiveness this would be very beneficial for patients.This will be the first randomized, double blind study to evaluate if an ultrasound-guided ISBPB with low volumes of local anesthetic can reduce complications for patients whilst maintaining quality of anesthesia and pain relief in the intra-operative and postoperative period.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective shoulder surgery.
* Patients aged \>=18 and \<=70 years
* ASA I-III
* BMI\<35

Exclusion Criteria:

* Preexisting COPD
* Unstable asthma
* Psychiatric history
* Allergy to ropivacaine.
* Opioid tolerance (\>30mg oral morphine or equivalent/day)
Detection of Bacteria in Herniated Nucleus Material in Lumbar Disc Herniations by Culture and PCR

The aim is to investigate if herniated nucleus material in lumbar disc herniations is infected with bacteria, and if so, to determine their prevalence (control group), and to determine if patients with pre-existing Modic changes type 1 have a higher incidence of bacterial growth in relevant lumbar disc samples than patients without Modic changes.

A cohort of 15 patients with pre-existing Modic and 15 without-undergoing primary surgery will be examined.

The nucleus material will be evacuated and divided into 5 biopsies, each with a new set of sterile instruments and placed in separate sterile glass vials with one drop of sterile saline to prevent drying of biopsy.

The primary outcome, i.e., bacterial growth on a per-patient basis. Bacterial growth shall be detected in minimum 3 out of 5 biopsies for the patient to be scored as positive for bacteria.

Eligibility Criteria:
Inclusion Criteria:

* MRI-confirmed lumbar disc herniation.
* Age between 18 and 65 years.
* No prior spine surgery.
* No diagnosed dementia.

Exclusion Criteria:

* Antibiotic treatment within the previous two weeks.
* History of alcohol abuse, illicit drug use or drug abuse, or significant mental illness
* Known immune deficiency state (e.g., positive for human immunodeficiency virus) or in treatment with immunosuppressive drugs including high dose steroids or cyclosporine.
* Concurrent infections (infections of skin, urinary tract infection, other skin diseases, e.g. Acne vulgaris).
* Previous epidural instrumentation.
* Uncontrolled, unstable or recently diagnosed autoimmune disease, including but not limited to systemic lupus erythematosus, inflammatory bowel disease, sarcoidosis, rheumatoid arthritis, or psoriasis.
Neonatal Experience of Social Touch

The purpose of this randomised control trial is to determine the efficacy of CT-optimal touch (gentle stroking at 3cm/s) for newborn's who require a heel prick.

Newborn infants are subject to several novel experiences that cause physiological, biochemical and behavioural indicators of stress; even routine and common events such as handling, changing a diaper or being bathed can increase salivary cortisol levels. Excluding surgery and mechanical ventilation, the most common procedural pain sources in newborns are heel-lancing and venepuncture. Tactile interventions such as skin to skin care and 'still containment hold' are widely used in clinical care with apparent positive results such as lower mean respiratory heart rate and pain measures, and higher oxygen saturation; yet, dynamic touch interventions have reported to be more beneficial than static touch interventions.

A distinct type of nerve fibres, CT (C tactile) afferents, found exclusively in hairy skin, that respond optimally to gentle stroking at a velocity of \~1-10cm/s, are part of a system for processing pleasant and social rewarding touch. CT fibre activation also plays a role in pain inhibition and may be linked to the development of self-regulation, thereby, serving a neuroprotective function for the developing infant brain. Here we will investigate whether tactile stimulation at CT-optimal velocity will reduce biochemical and physiological indicators of stress in infants, as determined by salivary cortisol, heart rate and blood oxygenation levels.

Eligibility Criteria:
Inclusion Criteria:

* The infant is born between 35 and 42 weeks.
* Require a heel prick
* Infants may be treated with antibiotics.
* Infants may be supported with non-invasive respiratory support.
* Infants may require blood sugar monitoring.
* Infants may be monitored for jaundice or infection.
* Written consent has been obtained from the person(s) with parental responsibility.

Exclusion Criteria:

* Have a history of neurological problems.
* Receiving pharmacological analgesics.
* Known genetic condition.
* Breastfed babies
* Admitted to high dependency or intensive care
* Invasive respiratory support
* Receiving parenteral nutrition
* Has received any treatment for seizures
* Clinical instability in the judgment of nurses/midwives and paediatricians looking after the baby and mother.
A Study of Selinexor Monotherapy in Subjects with JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia

The main purpose of this study with corresponding optional expansion is to evaluate the efficacy of selinexor in JAKi-naïve participants with myelofibrosis (MF) and moderate thrombocytopenia based on spleen volume reduction (SVR). Additional efficacy and safety parameters will also be assessed during the study.


Eligibility Criteria:
Key Inclusion Criteria:

* A diagnosis of MF or post-ET or post-PV MF according to the 2016 World Health Organization (WHO) classification of MPN, confirmed by the most recent local pathology report.
* Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than equal to (\>=) 450 cubic square centimeter (cm\^3) by MRI or CT scan (results from MRI or CT imaging performed within 28 days prior to screening are acceptable).
* Participants with DIPSS risk category of intermediate-1 with symptoms, or intermediate-2, or high-risk.
* ECOG Performance Status less than or equal to (\<=) 2.
* Platelet count of 50 to less than (\<) 100 x 10\^9/L without platelet transfusion within 7 days prior to the first dose of selinexor.
* Absolute neutrophil count (ANC) \>=1.0 × 10\^9/L without need for growth factors within 7 days prior to the first dose of selinexor.
* Adequate liver function as defined by the following: aspartate transaminase (AST) and alanine aminotransferase (ALT) \<= 2.5 × upper limit normal (ULN) and serum total bilirubin \<= 3×ULN.
* Calculated creatinine clearance (CrCl) greater than (\>) 15 milliliter per minute (mL/min) based on the Cockcroft and Gault formula.
* Active symptoms of MF as determined by presence of at least 2 symptoms with a score \>= 3 or total score of \>= 10 at screening using the MFSAF V4.0.
* Participants must provide bone marrow biopsy samples (samples obtained up to 3 months prior to C1D1 are permitted) at screening and during the study.
* Participants currently not a candidate for stem cell transplantation.
* Participants must be willing to complete the MFSAF V4.0 daily during the study for evaluating the symptom response (i.e., TSS50).

Key Exclusion Criteria:

* More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase).
* Previous treatment with JAK inhibitors for MF.
* Previous treatment with selinexor or other XPO1 inhibitors.
* Female participants who are pregnant or lactating.
* Prior splenectomy, or splenic radiation within 6 months prior to C1D1.
* History of myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG), cerebrovascular accident (stroke or transient ischemic attack \[TIA\]), ventricular arrhythmias, congestive heart failure New York Heart Association (NYHA) class \> 2 within 6 months of C1D1.
* Participants unable to tolerate two forms of antiemetics prior to each dose for the first two cycles.
Optimizing Surgical Conditions During Gynecologic Laparoscopic Surgery With Deep Neuromuscular Blockade

To investigate if deep neuromuscular blockade improves intraabdominal volume compared to no neuromuscular blockade in patients scheduled for gynecologic laparoscopic surgery with pneumoperitoneum 12 mmHg.

Hypothesis:

Deep neuromuscular blockade improves intraabdominal space (the distance from promontorium to skin surface, cm) compared to no neuromuscular blockade.


Eligibility Criteria:
Inclusion Criteria:

* patients \> 18 years old
* elective laparoscopic operation
* can read and understand Danish
* informed consent

Exclusion Criteria:

* BMI \> 30 kg/cm2
* known allergy to medications that are included in the project,
* severe renal disease, defined by S-creatinine\> 0,200 mmol/L, GFR \< 30ml/min or hemodialysis),
* neuromuscular disease that may interfere with neuromuscular data,
* lactating or pregnant,
* impaired liver function,
* converting to laparotomy,
* perioperative use of neuromuscular blocking agents before randomization,
* pneumoperitoneum set to \>12 mmHg on the insufflator
Different Dose of Esketamine Inhibiting Response to Laryngeal Mask Airway Insertion

Objective To prospectively determine the median effective dose (ED50) of propofol for inhibiting a response to laryngeal mask airway (LMA) insertion when combined with different doses of esketamine in female patients.

Methods Fifty-eight female patients (aged 20-60, ASAⅠ-Ⅱ) scheduled for elective hysteroscopy were enrolled and randomly divided into two groups, one administered 0.2 mg/kg of esketamine (K1 group, n = 28) and the other 0.3 mg/kg of esketamine (K2 group, n = 30). The two groups received the corresponding doses of esketamine intravenously, followed by an intravenous injection of propofol (injection time was 30 s). The initial dose of propofol was 2 mg/kg, and the dose ratio of propofol in the adjacent patients was 0.9. If there was a positive reaction to LMA insertion, the dose ratio in the next patient was increased by one gradient, and if not, the dose ratio was decreased by one gradient. The median effective dose (ED50), 95% effective dose (ED95) and 95% confidence interval (95%CI) of propofol for inhibiting a response to LMA insertion in the two esketamine groups were calculated using a probit analysis.


Eligibility Criteria:
Inclusion Criteria:

* women undergoing gynaecological hysteroscopy and surgery resulting from any indication
* age: from 20 to 60 years old
* body mass index (BMI): 18-30 kg/m2
* American Society of Anesthesiologists Physical Status score: grade I-II
* voluntary participation in this study

Exclusion Criteria:

* pregnant and lactating women
* patients with a history of propofol allergy, uncontrolled hypertension, hyperthyroidism, severe cardiopulmonary diseases, airway stenosis and mental diseases
* those who have recently taken or are taking psychotropic drugs or analgesic drugs
* patients allergic to or addicted to esketamine
Comparison of Two Rapid Antigen Detection Tests for the Detection of Group-A Streptococcal Pharyngitis in Children

Group A streptococcal (GAS) pharyngitis in children represents a frequent diagnostic challenge in pediatric emergency departments, since isolated signs and clinical prediction rules are insufficient to accurately discriminate between GAS and non GAS infections. Rapid antigen detection tests (RADTs) therefore remain essential, simple and rapid tools, allowing for rapid GAS identification and prompt antibiotic prescription. However, their sensitivity is not optimal. The aim of the present study is to test the accuracy of a new fluorescent immunoassay (Sofia Strep A FIA) using the optical technology for GAS detection in children 3-15 years old with pharyngitis, compared to a standard RADT, using throat culture as the gold standard (or PCR for discrepant results, i.e. negative culture with any positive RADT).


Eligibility Criteria:
Inclusion Criteria:

* Patient age between 3 and 15 years
* Clinical diagnosis of pharyngitis
* McIsaac score ≥2

Exclusion Criteria:

* Antibiotic treatment in the two weeks preceding the consultation
Efficacy and Safety of Deferiprone in Patients With Chronic Kidney Disease Undergoing a Cardiac Catheterization and Receiving Contrast Agent

This trial will evaluate whether treatment with CRMD001 (unique formulations of the iron chelator, Deferiprone) will reduce morbidity and mortality in subjects with Chronic Kidney Disease (CKD) and additional risk factors. Adult subjects with moderate to severe CKD who are undergoing diagnostic or interventional coronary angiography will be randomized to either placebo or CRMD001 and followed for 90 days. Subjects will receive 8 days of randomized therapy starting 1-3 hours prior to angiography. The primary endpoint of the trial will be the difference in a composite of specified renal and cardiovascular clinical events occurring through Day 90.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. eGFR between 15 ml/min/1.73 m2 and \< 60 ml/min/1.73 m2
3. Presence of at least one additional risk factor:

   * Diabetes Mellitus type 1 or 2
   * Age ≥ 75 years
   * Left Ventricular Ejection Fraction ≤ 40%

Exclusion Criteria:

1. End-Stage Renal Disease
2. Primary PCI for STEMI
3. Currently receiving mechanical ventilation
4. Known active liver disease or liver failure
5. Evidence of hemodynamic instability, such as a requirement for pressor agents
6. Exposure to contrast media within prior 10 days
7. Currently receiving fenoldopam, dopamine, theophylline, aminophylline, mannitol, or Ascorbic acid (\> 2 g/day)
8. Absolute neutrophil count \< 1500
Study of the Clinical Effect of External Oblique Muscle Intercostal Muscle Plane Block in Abdominal Surgery

This study intends to apply external oblique intercostal muscle plane block in thoracoabdominal resection, and to explore its effect on perioperative analgesia and rehabilitation quality in patients undergoing thoracoabdominal surgery.

Approved by the hospital ethics committee, 60 patients undergoing thoracic and abdominal surgery were selected in this study. They were divided into experimental group (n=30) and control group (n=30). The experimental group was given 0.5% ropivacaine intercostal nerve block, 2.0ug/kg sufentanil and tropisetron 5mg intravenous analgesia, and the control group was given 2.0ug/kg sufentanil and tropisetron 5mg intravenous analgesia. MAP, HR and SPO2 were recorded at admission (T0), completion of induction (T1), skin incision (T2), 30min after operation (T3) and 30min after extubation (T5). The block range of nerve block in the experimental group was recorded. The VAS score and the number of patient-controlled analgesia pump were recorded 30min after extubation, 6h, 24h and 48h after operation in resting state and cough state. Postoperative adverse reactions such as respiratory depression, expectoration weakness, nausea, vomiting, and skin itching were recorded. The first time to get out of bed after operation was recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASA Physical Status Classification of I-II Aged 18-60 years old ; Will be scheduled to undergo elective LC

Exclusion Criteria:

* Coagulation disorders, Liver/kidney disease, Abdominal surgery history, Infection in the block application area, Chronic opioid use.
Dry Needling of the Trapezius Muscle in Office Workers With Neck Pain

Deep dry needling of active myofascial trigger points of trapezius muscle is effective in the dimminution of pain of patients

EVALUATION:

A blind assesor does a complete evaluation of the patients to determine if they take part of the study. An assesment of pain (by visual analogue scale), Pain pressure theshold (kg/cm2 by algometry, Range of motion (CROM goniometer in degrees) and strength (digital dinamometry in Newtons) are performed. In this evaluation inclusion criteria is checked too.

INTERVENTION:

-TREATMENT GROUP(Deep dry needling group (DDN)):

An experienced physical therapist performed this treatment. The intervention included DDN of every active MTrP found in the trapezius muscle using a 4 cm x 0.32 mm acupuncture needle with guided tube. ). In the case of upper trapezius active MTrPs, DDN was performed in the prone position. For medium and lower trapezius muscle MTrPs, DDN was performed in a side-lying position as described by Simons et al. (Simons et al., 1999). Once the needle was inserted into the MTrP previously marked by the blinded assessor, local twitch responses (LTRs) were obtained by using Hong's fast-in and fast-out technique, which involves rapid movements of the needle in and out of the MTrP.

After that, the stretch is performed

- Passive stretch of the trapezius muscle (both groups)

Another experienced physical therapist, after taking part of training-sesions to do the same stretch as in DDN group, performed the stretch.Participants in this group received the same stretch as patients in treatment group.

Eligibility Criteria:
Inclusion Criteria:

* over 18
* present myofascial trigger points in trapezius muscle

Exclusion Criteria:

* to be under anti-inflammatory, analgesic, anticoagulant, muscle relaxant or antidepressant medication at the start of the study or one week before it (Simons, 2004)
* to suffer from fibromyalgia syndrome, or to have any contraindication to conservative or invasive physiotherapy (infection, fever, hypothyroidism, fear of needles, wounds in the area of the puncture, metal allergy, cancer, systemic disease) (Baldry, 2005).
Clinical Management of Neuropathic Pain With Ramelteon

This proposal is to conduct a double-blinded, randomized, placebo-controlled, crossover clinical study to examine the hypothesis that ramelteon would reduce pain score and improve functional status in subjects with neuropathic pain.

Neuropathic pain is a chronic pain condition resulting from injury to the peripheral and/or central nervous system. Despite extensive research over the last several decades, neuropathic pain remains poorly managed due to the lack of effective pharmacological tools. To date, little has been known regarding the effect of melatonin and its analogues on clinical neuropathic pain. We propose to conduct a randomized, placebo-controlled, double-blinded, and crossover clinical trial to examine the effect of ramelteon \[a melatonin (MT) 1/ MT2 receptor agonist\] on neuropathic pain. We hypothesize that ramelteon would reduce pain score and improve functional status in subjects with neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:

1. Subject will be between ages 18 to 65 years.
2. Subject has not been on ramelteon for at least one month.
3. Subject agrees to make no change in his/her current pain medications during the entire study period (5 weeks). This requirement will ensure that valid comparisons of primary and secondary measures can be made before and after the study.
4. Subject has a VAS pain score of 5 or above at the beginning of the study.
5. Subject has had a neuropathic pain condition as listed above for at least three months. This requirement is to avoid clinical uncertainty from an unstable pain condition and to minimize the study variation.
6. Female subjects of childbearing potential must have a negative urine pregnancy test at the initial visit.

Exclusion Criteria:

1. Subject has moderate to severe liver impairment.
2. Subject has Liver Function Tests (LFT's) \>1.5X normal.
3. Subject has a history of renal impairment.
4. Subject has moderate or severe cardiac or pulmonary disease including a base line oxygen saturation of less than 95% on room air or any requirement for supplemental oxygen.
5. Subject has a history of glaucoma.
6. Subject has obstructive sleep apnea.
7. Subject is taking medications for sleep disorders including insomnia.
8. Subject has a major psychiatric disorder (major depression requiring a recent hospitalization within three months prior to the study; bipolar disorder; schizophrenia; psychotic disorders; substance abuse).
9. Subject has a history of dementia or delirium.
10. Subject has a history of falls.
11. Subject is pregnant or lactating.
12. Subject is using an illicit drug detected by a screening test.
13. Subject is currently taking Fluvoxamine.
14. Subject has been taking Ketoconazole in the past two weeks.
15. Subject has known hypersensitivity to ramelteon.
16. Subject has pending litigation related to his/her neuropathic pain condition.
17. Subject has Concurrent participation in other research drug trials or other study participation within 30 days of enrollment in this study.