cyrilzakka/clinical-trials huggingface dataset:
Surgical Stress Measured by Microdialysis

Paraspinal muscle damage is inevitable during conventional posterior lumbar fusion surgery. Minimal invasive surgery is postulated to result in less muscle damage and better outcome. The aim of this study is to monitor metabolic changes of the paraspinal muscle and to evaluate paraspinal muscle damage during surgery using microdialysis (MD).

Posterior approach is a common and important surgical procedure for various lumbar diseases. Owing to the anatomy, the damage of paraspinal muscle is inevitable during conventional posterior lumbar fusion surgery. Degeneration and malfunction of the paraspinal muscle might associate with pain and inferior postoperative clinical outcome.

Eligibility Criteria:
Inclusion criteria:

* patients who undergo conventional instrumented posterolateral lumbar fusion.

Exclusion criteria:

* previous fusion
* chronic metabolic disease
* tumor or metastasis
* postoperative surgical complications and complications during surgery
The Effectiveness of Diabetes Patient Education and Self-Management Education in Persons With Type 2 Diabetes

The goal of this randomized controlled trial is to determine if greater effectiveness can be achieved by the addition of lay-led self-management patient education to regular professionally-led diabetes patient education in comparison to regular professionally-led diabetes patient education only.

In the current health care environment, it is unacceptable for patient education programs to merely provide information. Rather, educational programs must concentrate on behavior change and on supporting patients to become more confident and motivated in participating in managing their health. Persons with type 2 diabetes attending a Diabetes Education Centre will be assigned to either a group that receives regular professionally-led diabetes patient education (control group) or to to a group that receives regular professionally-led diabetes patient education augmented by lay-led self-management education i.e., the Stanford six-session Chronic Disease Self-Management Program (experimental group). Data will be collected at two points in time (0 and 6 months). Outcome measures will show if participants who receive self-management training in addition to regular patient education are able to:manage their diabetes more effectively; engage in the specific behaviors that keep the condition from worsening; achieve more control over their condition; and use the health care system more effectively.

Eligibility Criteria:
Inclusion Criteria:

* adults with type 2 diabetes

Exclusion Criteria:

* cognitive impairment
* unable to speak English
Use of Non Invasive Hemodynamic Cardiovascular Monitoring to Evaluate Emergency Department Patients

This study is an observational prospective pilot trial that utilizes finger cuff non invasive hemodynamic monitoring (NexfinHD Monitor) to assess 4 different groups (CHF/COPD, Trauma, Sepsis, Stroke) of patients on arrival to the Emergency Department and to document the changes seen in these hemodynamics with acute therapies.

There has been little very early (after Emergency Department presentation) hemodynamic monitoring of acutely ill or injured patients secondary to the lack of non invasive technologies that could be reliably applied to this patient population.Thus all assessments of hemodynamics have been made by physicians on clinical information including intermittent pulse and blood pressure measurements. It is not known what the underlying continuous cardiac output, systemic vascular resistance, etc are in these patients and how these change with current Emergency Medicine therapeutic interventions. Currently there is available a finger cuff devise (NexfinHD Monitor, BMEYE, Amsterdam) that can measure these hemodynamics on a beat to beat basis and that can be easily applied to acutely ill individuals. This prospective pilot study of 48 patients (4 groups of 12 each) will document the hemodynamics of patients on arrival and continuously for 2 hours, blinded to the treating physician. Treating physicians will be asked to estimate these hemodynamic parameters at various time points. The study will characterize the hemodynamics of patients, compare them to the estimates of treating physicians and determine whether they predict the need for life saving interventions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute CHF/COPD (n=12)
* Patients with acute trauma and a trauma ISS\>15 (n=12)
* Patients with acute sepsis (n=12)
* Patients with acute stroke (n=12)

Exclusion Criteria:

* Patients in cardiopulmonary arrest
* patients with STEMI
* Patients with known peripheral vascular disease
* Pregnant patients
* Age\<18
* Excessively agitated patients
* Interference with current standard of acre
Study to Analyze the Efficacy of Acute Intake With a β-alanine Supplement in Recreational Cyclists

Randomized, controlled, double-blind, single-center, double-blind clinical trial with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) to measure the efficacy of a sustained release beta alanine on physiological physical performance efficacy in recreational cyclists.

Subjects meeting the selection criteria will be randomly assigned to each of the study groups (investigational product dose 1 or dose 2, or placebo, depending on the group to which they have been assigned).

The product to be consumed is beta alanine. Participants will consume the product for 1 day. They will have to take four intakes every hour and a quarter, on the same day.

The study subjects will have to make 2 visits to the laboratory. In the first one, they will have to perform a 10-minute time trial, without consumption. In the second visit, they will perform the same performance test but with acute consumption of the product. Their physical and physiological performance will be evaluated.

The two tests will be separated by 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Male cyclists with more than two years of cycling experience.
* Perform tests without fatigue.
* Road bike training at least twice a week.

Exclusion Criteria:

* Participants with chronic illness.
* Have a long-term injury that prevents you from training in the previous month.
* Inability to understand informed consent.
* Have consumed beta alanine in the three years prior to the start of the study.
* Consumption of other supplements that may alter performance.
Macular Pigment Optical Density in Primary Angle-closure Disease

Glaucoma is the leading cause of irreversible blindness in the world, and primary angle-closure glaucoma (PACG) is the most important type of glaucoma in Asia. Primary angle closure disease (PACD) is a group of diseases related to PACG, and the pathogenesis is still unclear. Macular pigment has the functions of filtering short-wavelength waves and anti-oxidation, which are related to visual function. Previous studies have found that the macular pigment density (MPOD) is significantly reduced in primary open-angle glaucoma. This project uses the single-wavelength reflection method to measure MPOD, observes the characteristics of PACD and the normal control group's changes in retinal MPOD, and explains the relationship between PACD's MPOD changes and angle-closure glaucoma optic nerve damage

Observation index： Visual acuity，Intraocular pressure，Ophthalmoscope，MPOD，Visual field and OCT.

Inspection parameters of OCT：

1. Retinal nerve fiber layer thickness
2. Ganglion cell complex thickness
3. Mean thickness of the central retina
4. Mean defect

Eligibility Criteria:
Inclusion Criteria:

* Experimental group：
* (1) According to the diagnostic criteria of PACD
* (2)History of peripheral iridectomy or trabeculectomy
* (3)Over 40
* (4)Phakic eyes
* (5)Intraocular pressure is less than 21mmhg, more than one week
* (6)Eyes with clear optical media.
* Control group：
* (1)No history of glaucoma and other eye diseases
* (2)Phakic eyes
* (3)Over 40
* (4)Intraocular pressure10\~21mmHg

Exclusion Criteria:

* (1)History of corneal diseases
* (2)History of eye tumor or other ophthalmic surgery
* (3)Cataract
* (4)Taking supplements containing lutein within 6 months
* (5)Snellen's visual acuity was less than 6 / 20，the diopter is beyond ± 6 degrees
Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis

This clinical study will be a multi-center, randomized, open-label, active-controlled, parallel-group study comparing dalbavancin to standard of care (SOC) therapy in osteomyelitis.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of osteomyelitis (first episode) defined by:
* Pain or point tenderness upon palpation or probing to bone
* Plain radiograph or Magnetic resonance imaging (MRI) consistent with osteomyelitis (indistinctly marginated edema-like pattern of bone marrow hypointensity on unenhanced T1-weighted sequences, hyperintensity on fat-saturated T2-weighted and Short tau inversion recovery (STIR) sequences and/or abnormal enhancement on gadolinium-enhanced fat-saturated T2-weighted sequences, with or without visible periostitis or cortical bone destruction) OR Gram-positive cocci documented on a baseline Gram-stain from a bone specimen
* Elevated C-reactive protein (CRP) (low sensitivity) above the upper limit of normal (ULN) (reference range for low sensitivity CRP is 3-10 mg/L)
* Subjects must be willing and able, if discharged from the hospital, to return to the hospital or a designated clinic for scheduled visits, treatment, laboratory tests, and other outpatient procedures as required by the protocol.

Exclusion Criteria:

* Treatment with an investigational drug within 30 days preceding the first dose of investigational product.
* Receipt of \> 24 hours of potentially effective IV antibacterial therapy for osteomyelitis within 96 hours of randomization, unless the pathogen isolated was documented to be Methicillin-resistant Staphylococcus aureus (MRSA) that was resistant to the administered antibiotic.
* A prior episode of osteomyelitis, or a failed course of therapy for osteomyelitis.
* Infection associated with a burn wound, with a sacral decubitus ulcer, or with multiple sites of osteomyelitis.
* Septic arthritis that is non-contiguous to osteomyelitis, as diagnosed by isolation of a pathogen from synovial fluid culture.
* Immunosuppression/immune deficiency
* Evidence of Gram-negative bacteria by Gram stain in the absence of Gram-positive organisms.
* Gram-negative bacteremia
* Patients with concomitant endocarditis, necrotizing fasciitis, or prosthetic material at the site of infection at the time of study initiation.
* Infection due to an organism known prior to study entry to not be susceptible to dalbavancin (dalbavancin mean inhibitory concentration \[MIC\] \> 0.25 μg/mL) or vancomycin (vancomycin MIC \> 2 μg/mL).
* Concomitant systemic antibacterial therapy for Gram-positive infections (eg, rifampin, gentamicin).
* Known or suspected hypersensitivity to glycopeptide antibiotics.
* Patients with a rapidly fatal illness, who are not expected to survive for 3 months.
* Pregnant or nursing females; positive urine (or serum) pregnancy test at Screening (pre-menopausal females only) or after admission (prior to dosing)
* Sexually active females of childbearing potential who are unwilling or unable to use an acceptable method of contraception from at least the first dose of study drug until the last pregnancy test.
Revival of Stem Cells in Addison's Study

Autoimmune Addison's disease (AAD) is a rare and debilitating disease in which an autoimmune attack progressively destroys the adrenal cortex. Untreated it is universally fatal and treated people are absolutely dependent upon steroid medications lifelong, with a consequent excess in morbidity and mortality. A key feature of the adrenal cortex is that its cells are responsive to changes in circulating adrenocorticotrophic hormone (ACTH) concentration. This study aims to regenerate adrenocortical steroidogenic cell function in patients with established autoimmune Addison's disease (AAD) by stimulating proliferation and differentiation of their progenitor cells, the adrenocortical stem cells (ACSCs) (1,2). Using daily subcutaneous ACTH, administered according to two different regimens over 20 weeks, we will investigate whether regeneration of adrenal steroidogenic function through revival of ACSC activity is a realistic possibility.


Eligibility Criteria:
Inclusion Criteria:

* Established autoimmune adrenal failure for \>1yr age 16 to 65

Exclusion Criteria:

* Significant cardio-respiratory, chronic renal or non-autoimmune liver disease; malignancy
* Asthma, current infectious disease, recent live vaccination, acute psychosis, peptic ulcer disease
* Pregnancy, breast feeding or plan for pregnancy within 9 months
* Known non-autoimmune cause for adrenal failure (haemorrhage, adrenoleukodystrophy etc.)
* Known hypersensitivity or allergy to Synacthen
Assessment of Pulmonary Function in Relation to the Anesthetic Used in Patients Undergoing Bariatric Surgery

It is known that more or less pronounced impairment of pulmonary function occurs after anesthesia. It has been demonstrated in the postoperative period in both patients undergoing general and regional anesthesia, in patients after intra-abdominal and superficial procedures, in overweight and normal-weight patients. It has also been shown that when general anesthesia is performed with the inhalation anesthetic sevoflurane, there is a slightly smaller reduction in lung function parameters than when only intravenous anesthetics are used.

The purpose of this study is to evaluate lung function before induction and after awakening from general anesthesia depending on the inhalational anesthetic used in obese patients undergoing bariatric surgery


Eligibility Criteria:
Inclusion Criteria:

* Obese patients qualified for bariatric surgery.

Exclusion Criteria:

* Patients who have absolute contraindications to spirometry testing, i.e:

  * with aneurysms of the aorta or cerebral arteries threatening to rupture, after recent vascular surgery
  * with increased intracranial pressure, after recent intracranial bleeding or head surgery within the cranial cavity
  * after acute conditions within 6 months prior to surgery such as stroke, myocardial infarction, unstable angina, pneumothorax
  * with uncontrolled hypertension
  * after recent eye surgery or a history of retinal detachment
  * with hemoptysis of unknown etiology. And patients unable to perform spirometry testing
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD0914

The purpose of this study is to assess the safety and tolerability of orally administered AZD0914 in healthy adult subjects.

A Phase I, Randomized, Placebo-controlled, Single-center Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD0914 After a Single Oral Administration and to Assess the Effect of Food in Healthy Adult Volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female (of non-childbearing potential)subjects aged 18 to55 years (inclusive).
* Have a body mass index (BMI) between 18.00 and 30.50 kg/m2 and weigh at least 50 kg and no more than 100 kg
* Male subjects should be willing to use barrier contraception, ie, condoms, from the day of dose administration until at least 3 months after dose administration of the IP

Exclusion Criteria:

* History of any important clinically significant disease or disorder which, in the opinion of the PI, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks from the first administration of IP as judged by the PI
* History of gastrointestinal ulcer disease, inflammatory bowel disease, indigestion symptoms \>3 times a week, or blood in stool in previous 6 months not related to anal trauma
One Year Study of Rifaximin Delayed Release (DR) Tablets in Crohn's Disease

The primary objective is to determine the efficacy of rifaximin DR also referred to as Extended Intestinal Release (EIR) tablets vs. placebo for the induction of clinical remission and endoscopic response following 16 weeks of treatment in participants presenting with active moderate Crohn's disease. A key secondary objective is to evaluate clinical and endoscopic remission following an additional 36 weeks of treatment.

RECD3125 is a double-blind, placebo-controlled, parallel-group, multicenter, multiregional, 52-week study to assess the efficacy and safety of rifaximin DR tablets for the induction of clinical remission and endoscopic response at 16 weeks followed by clinical and endoscopic remission after 52 weeks of continuous therapy in participants with active moderate Crohn's disease.

Participants will be randomized in a 1:1 allocation to rifaximin or placebo at the beginning of the treatment period and will maintain treatment assignment throughout the duration of the study. Ileocolonoscopy will be performed on all participants at baseline, between Weeks 16 and 17 (end of the Induction Phase), and following completion of the 36-week Long Term Treatment Phase (Week 52).

Eligibility Criteria:
Major Inclusion Criteria:

* Moderate, non-fistulizing Crohn's disease in the ileum and/or colon prior to randomization; and a SES-CD score of ≥7 (confirmed by centralized endoscopy reading).
* During the screening period, the participant will need to have certain average daily scores for abdominal pain and average number of liquid/very soft stools.

Major Exclusion Criteria:

* Pregnant or lactating females. Females of childbearing (reproductive) potential must have a negative serum pregnancy test at screening and agree to use a highly effective method(s) of contraception throughout their participation in the study. Diagnosis of ulcerative or indeterminate colitis.
* Diagnosis of Celiac Disease.
* Bowel surgery within 12 weeks prior to screening and/or has surgery planned or deemed likely for Crohn's disease during the study period.
* Presence of an ileostomy or colostomy.
* Known fixed symptomatic stenosis/stricture of the small or large bowel.
* Had more than one segmental colonic resection.
* Had more than 3 small bowel resections or symptoms associated with short bowel syndrome.
* Current evidence of peritonitis.
* History or evidence of colonic mucosal dysplasia.
* History or evidence of adenomatous colonic polyps that have not been removed.
* Unwilling to be tapered off corticosteroids by Week 8 or the participant is known by the Investigator to be steroid-dependent.
* Has used a biologic within 12 weeks of randomization.
* Used cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or similar drugs within 8 weeks prior to randomization.
* Had rectal administration of 5-aminosalicylic acid (5-ASA) or corticosteroid enemas/foams/ suppositories within 2 weeks prior to screening visit.
Bacterial Contamination in Transrectal Hybrid NOTES Sigmoidectomy

Transrectal Hybrid natural orifice translumenal endoscopic surgery sigmoidectomy has gained popularity. It is an appealing technique as a minilaparotomy in order to retrieve the specimen is avoided. Therefore less postoperative pain and a better cosmetic result are expected. The feasibility of the technique has been demonstrated.

Still an open question is the risk of intraperitoneal contamination as in this procedure the colon has to be opened. This is the case for (a) retrieval of the specimen thru the opened rectal stump and (b) for intracorporeal insertion of the anvil of the circular stapler in order to fashion an anastomosis.

In this study the bacterial contamination in the rectal stump as well as in the peritoneal cavity is assessed. The results are compared to bacteriological samples taken in a comparison group consisting of conventional laparoscopic assisted sigmoidectomies.


Eligibility Criteria:
Inclusion Criteria:

* Status post several episodes of diverticulitis
* Status post contained diverticulitis

Exclusion Criteria:

* not able to give informed consent
* \<18 years of age
* pregnancy
* emergency operation
* acute diverticulitis
Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis

This is a non-inferiority, Phase III, open-label, randomized, parallel trial to evaluate the new intervention Dapaconazole cream 2% versus Ketoconazole cream 2% in patients with Tinea pedis. Sample size is 140 participants (70 per treatment group), male or female, aged between 16 and 60 years-old.

Primary objective is to evaluate non-inferiority of Dapaconazole cream 2% compared to Ketoconazole cream 2% in Tinea pedis treatment. Secondary objective is to evaluate safety and tolerability of Dapaconazole cream 2% after multiple administrations.

Participants will receive either new intervention or active control during 14 consecutive days, which will be followed by 2 follow-up visits.

Primary efficacy endpoint is clinical and mycological lesion cure, and secondary efficacy endpoint is time (days) until clinical diagnosis of lesion cure. Additionally, safety will be assessed by adverse events occurrence and laboratory exams evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female study participants, aged between 16 and 60 years-old. Patients aged between 16 and 18 years-old will provide additional Assent Form before enrollment in the trial;
* Presence of a skin lesion characteristic of Tinea pedis, with diagnosis confirmed by direct mycological exam;
* Absence of previous antifungic treatment for the lesion under study;
* Absence of other significant diseases which, at the physician's discretion, could have an impact on subject's participation in the trial, according to protocol requirements, and study evaluations: medical history, blood pressure and heart rate measurements, physical examination and screening laboratory tests;
* Ability to understand the nature and objectives of the trial, including risks and adverse events; willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by Informed Consent Form signature.

Exclusion Criteria:

* Known hypersensitivity to ketoconazole or chemically related compounds; history of serious adverse reactions;
* Screening laboratory tests results showing clinically relevant deviations that, at the researcher discretion, prevent the subject to participate in the trial due to possible risks;
* Drugs addiction, including alcohol;
* Use of any previous treatment to the lesion under study that, according to principal investigator best judgement, might interfere in study objectives;
* Treatment, within 3 months before the trial, with any drugs known to have a well-established toxic potential to major organs;
* Participation in any other experimental research or administration of any experimental drug within 6 months before this trial;
* Pregnancy, labor or miscarriage with 12 weeks before study treatment;
* Any conditions, according to investigator's best judgement, that prevents the subject to participate in the trial.