cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Antibiotic Treatment for Patients with Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial

The goal of this clinical trial is to learn if antibiotics (amoxicillin) work to treat chronic low back pain in adults. In some patients, this type of back pain may be caused by bacteria in the vertebrae, resulting in a condition known as "Modic type I change."

The main questions the trial aims to answer are:

* What is the efficacy (primary objective) of antibiotic treatment for patients with chronic low back pain and Modic type I changes?
* What is the cost-effectiveness (secondary objective) of antibiotic treatment for patients with chronic low back pain and Modic type I changes?

Researchers will compare amoxicillin to a placebo (a look-alike substance that contains no active drug) to see if amoxicillin works to treat chronic low back pain.

Participants in the trial will:

* Be invited for an MRI scan to determine if they have a Modic type I change; those who do will be included in the study.
* Take either amoxicillin or a placebo daily for 100 days.
* Take probiotics daily for 100 days to reduce the occurrence and impact of any side effects from the antibiotics.
* Attend clinic visits at baseline (the start), 4 weeks, 3 months, and 12 months for checkups and tests.
* Complete questionnaires at baseline, 3 months, 6 months, and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years.
* Chronic low back pain (i.e. duration \>6 months) after a previous (MRI confirmed) disc herniation within the past 6 months to 2 years.
* At least 2 of the following questions should be answered with "Yes":

  * Does training and/or exercise increase your pain?
  * Is your sleep during the night disturbed due to your back pain?
  * Is it painful to turn over in bed at night?
  * Do you suffer from morning pain?
* The mean pain intensity should be at least 5 points on a 0-10 NRS-scale, calculated as the mean pain intensity of 3 indices: current pain, worst pain within the preceding two weeks, and the usual mean pain within the preceding two weeks.
* Modic Type I changes visible on the MRI-scan in the vertebrae adjacent to the previous herniated disc.

Exclusion Criteria:

* Received antibiotic treatment in the past month.
* Current pregnancy, lactation or pregnancy-wish.
* Severe physical or psychiatric co-morbidities.
* LBP resulting from a specific cause such as a tumor or fracture.
* Surgery or epidural injection in the past 6 months.
* Previous antibiotic course of 100 days.
* Contra-indication for amoxicillin use: allergy to penicillins/amoxicillin, cephalosporin or carbapenem; mononucleosis; leukemia; phenylketonuria (PKU)
* Contra-indication for MRI.
* Current use of any of the following medications: allopurinol, methotrexate, phenylbutazone or probenecid.
* Hepatic or renal (eGFR≤30) impairment.
* Inability to swallow capsules.
Blood Pressure Monitoring in Postpartum Women at Risk of Hypertension

Cardiovascular disease and hypertensive disorders of pregnancy (HDP) are the leading causes of maternal morbidity and mortality in the United States. Postpartum, in office care has demonstrated to be an insufficient model of hypertensive management postpartum, largely due to barriers that women face in accessing in office care, with stark racial disparities in access. The care of postpartum patients with HDP following delivery is made up of either a single postpartum visit at 6 weeks postpartum or a fragmented and non-standardized series of in-person appointments depending on the patients' medical complications and the clinicians' experience. Further, current society guidelines outline inpatient thresholds for initiation of antihypertensive medication but do not provide recommendations for titration thereafter. The proposed study will investigate the acceptability and effectiveness of an algorithm-based, outpatient treatment model for the management of postpartum hypertension utilizing an asynchronous text-based platform as compared to the standard of care for postpartum women with a diagnosis of Hypertensive disorder of pregnancy at Massachusetts General Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Diagnosis of gestational hypertension (Systolic Blood Pressure (SBP)≥140 or Diastolic Blood Pressure (DBP) ≥90 on at least two occasions at least 4 hours apart after 20 weeks gestation in previously normotensive women) and or preeclampsia (SBP≥140 or DBP ≥90, proteinuria with or without symptoms of preeclampsia (headache, vision changes, right upper quadrant pain), and presentation of symptoms/lab abnormalities but no proteinuria)
* English and Spanish-speaking
* Delivering at Massachusetts General Hospital

Exclusion Criteria:

* Chronic hypertension or underlying cardiovascular disease
Teen Driving Translation Study (NIH)

To translate our evidence-based, parent-engagement safe teen driving intervention to a high-risk, rural and urban teen drivers with a traffic violation, and to test the implementation, effectiveness, and cost-effectiveness of the proposed intervention.

For this study, 290 teen and parent/guardian dyads will be randomized into one of three study groups for 12 months with 6 months of active data collection. Teens will be aged 16-17 who committed a moving-related traffic violation and their parent/legal guardian who is most involved with their driving. Dyads will be recruited from both urban and rural counties in Ohio following the teen's moving violation conviction. The study will determine the effectiveness and cost-effectiveness of the intervention on teens' risky driving events, unsafe driving behaviors, traffic violation recidivism, and motor vehicle collisions (MVCs), as well as frequency and quality of parent-teen communications about safe driving practices. Additionally, the study will determine the effectiveness and cost-effectiveness of the peer-delivered intervention vs. expert-delivered intervention on the outcomes of the interest. Finally, the study will assess the barriers/facilitators to the adoption and implementation of the intervention in rural and urban families.

Eligibility Criteria:
Inclusion Criteria:

* Teen must be 16 or 17 years old at the time of the moving-related violation
* Teen must be a first-time offender and be found guilty of committing the violation
* Teen must possess a valid Ohio provisional driver's license and proof of car insurance
* Teen must have access to a vehicle with an On-board Diagnostics II system port (i.e., cars made after 1996) in which they are the primary driver
* Teen must have a smart phone with Bluetooth capabilities

Exclusion Criteria:

* Teen is unable to drive due to injury, has a suspended driver's license, and/or car damage
* Teen has previously received a traffic citation
* Vehicle already has an in-vehicle driving feedback system installed
* Teen has non-English speaking parents
* Teen is currently enrolled in another driving-related study
* Teen is a ward of the State
* Adults unable to consent
* Pregnant women
* Prisoners
Treatment of Heart Failure Using Human Umbilical Cord Mesenchymal Stem Cells(hUC-MSC)

This study is an exploratory clinical study to observe the improvement of heart function before and after the treatment by human umbilical cord mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in the treatment of heart failure. The study is a randomized parallel controlled study. Patients receive a review of which main content includes symptom improvement, cardiac function improvement, and adverse events.

This study is an exploratory clinical study to observe the improvement of heart function before and after the treatment by human umbilical cord mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in the treatment of heart failure. The study is a randomized parallel controlled study. The research process is as follows: 1. Twenty eligible patients with ischemic heart disease were recruited, fully informed, and signed a consent form, and randomly divided into CABG group (n=10) or CABG + stem cell treatment group (n=10); 2. CABG was performed under general anesthesia in both groups. In the cell therapy group, 1×10\^7 human umbilical cord Mesenchymal Stem Cells were injected to the edge of the myocardial infarction area at 20 points at the same time in CABG; 3. Use vasoactive drugs and antibiotics to prevent infection one week after surgery. After the operation, before discharge, 1 month, 3 months, 6 months, 12 months after discharge, and once a year thereafter, until the death of the patient. Patients receive a review of which main content includes symptom improvement, cardiac function improvement, and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* The patients with coronary heart disease, the effect of drug treatment is not good, and the clinical manifestations of left ventricular insufficiency occur, EF\<40%;
* Coronary angiography confirmed that there is a chronic occlusive disease of the coronary artery, which is manifested as severe stenosis of single or multiple coronary vessels (≥75%), or even complete occlusion;
* After the doctor explained the treatment process and possible toxic and side effects, he was willing to treat and agreed to cooperate in the observation of the efficacy. But patients can withdraw from clinical trials and long-term follow-up observation at any time and unconditionally;
* The patient has no mental illness and language dysfunction and can fully understand the treatment method.

Exclusion Criteria:

* Does not meet the above selection criteria;
* Unable to sign the informed consent form, unable to comply with the agreed timetable of this study;
* There are reasons to suspect that the patient was forced to join the trial;
* Acute left ventricular insufficiency, cardiogenic shock;
* The patient has any infectious diseases (including bacterial and viral infections);
* Others who are clinically considered unsuitable for this treatment.
Light at Night Study

The purpose of this mechanistic study is to examine light sensitivity (melatonin suppression) in people with bipolar depression I, and compare it to healthy controls. This is not a treatment study.

The bipolar disorder I and healthy control arms are recruited from the existing Heinz C. Prechter Bipolar Research Program at the University of Michigan.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18-30 kg/m2
* Appropriate sleep schedules according to study staff. Sleep schedule is self-reported and confirmed through a sleep diary
* Healthy eyes as ascertained by eye exam at University of Michigan Kellogg Eye Center
* Willing and able to maintain stable sleep schedule during study.
* Participants will be breathalyzed and undergo urine drugs screens at every lab visit
* Acknowledge and understand that participants cannot drive themselves home after certain lab visits. Note that the research team will provide a travel stipend of $10 per visit to offset potential rideshare/taxi costs

Exclusion Criteria:

* Color blindness
DeVilbiss AutoAdjust With SmartFlex Comparative Study

There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device.


Eligibility Criteria:
Inclusion Criteria:

* Epworth Sleepiness Scale \>10
* Body Mass Index \> 26
* Apnea-hypopnea index (AHI) ≥15 (mod to severe range)
* AHI ≤ 10 at therapeutic continuous positive airway pressure (CPAP) pressure
* CPAP naïve patients
* Polysomnogram (PSG) within 3 months of enrollment
* Average oxygen saturation by pulse oximetry (SpO2) \> 90% during titration
* Sleep efficiency on titration night ≥ 78%

Exclusion Criteria:

* Diagnosis of mild obstructive sleep apnea (OSA)
* Co-morbid conditions which render participation to be at risk these may include patients with congestive heart failure, chronic obstructive pulmonary disease (COPD) or psychiatric illness
* Allergies to mask materials
* Difficulties with nasal breathing
* Evidence of another primary sleep disorder
* Evidence of arousing periodic limb movements during titration
* Contraindications as listed on product labeling.
* Pregnant
* Currently diagnosed with depression if symptomatic
* Predominately central sleep apnea
* Deemed medically unsuitable by investigator
* Evidence of any type of infection or treatment of an infectious condition during the period of research participation
* Full Face Mask during titration
* Have a bi-level requirement
* CPAP pressure \>15cmH2O
* Subjects with tracheotomy
* Uncontrolled hypertension
* Require supplemental oxygen
* Stimulants, major tranquillizers or antipsychotics.
Effects of Heparin on Arteriovenous Fistula Patency

Arteriovenous fistula (AVF) is now the optimal method of obtaining vascular access for dialysis. Measures such as systemic anticoagulation have been proposed as means of increasing patency rates but enough evidence does not exist to support their use. The investigators aimed to evaluate the efficacy of preoperative heparin injection on patency of AVF during the first 24 hours after surgery and to determine whether such measure can be used to prevent early thrombosis of the vascular access.

The study was carried out on patients admitted to Shohada-e-Tajrish hospital for permanent vascular access placement since April 2011 through September 2012. The exclusion criteria consisted of having a contraindication of administration of anticuagulant agent. 150 patients were enrolled in the study.

All patients were operated on by a single surgeon (Dr Mozafar. The non dominant upper extremity (mostly the left arm) was generally used unless unfavorable vasculature or previous fistula placement changed the preference. The anastomosis technique was either end-to-side or side-to-side using a number 6.0 prolene suture. 75 patients were randomly assigned to receive 100units/kg of heparin after dissection prior to anastomosis while the other 75 received no intraoperative heparin injection. Auscultation of bruit and palpation of thrill was used to assess arteriovenous fistula patency in the first 24 hours after AVF placement.

Data analysis was performed using SPSS v.20. A p-value of less than 0.05 was considered as statistically significant. Bivariate analysis in the form of Chi-square tests, T-test and Fischer's exact test were calculated.

Patient enrollment was voluntary and no costs were imposed on the patients. The study protocol was in accordance with 1975 Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Kidney Disease, In need of AVF placement

Exclusion Criteria:

* Contraindications for anticoagulant therapy
Effect of Age and Device on Delivery of Fluticasone

To determine the effect of age and device on delivery of HFA-Fluticasone Propionate (FP) in children of different ages. Hypothesis -- passive inhalation in younger children through a valved holding chamber/mask (VHC) will reduce the relative amount of FP delivered to airways.

The objective was to determine the effect of age and device on delivery of fluticasone propionate delivered by HFA-pMDI in children of different ages. The one-hour steady-state fluticasone plasma concentration which is an indirect measure of airway delivery and direct measure of systemic exposure, was determined. Sixty children with well-controlled persistent asthma received two actuations of 110 mcg twice daily for at least 3 days. A blood sample was collected one hour after the last dose when 100% adherence was documented by electronic monitor. Five groups of 12 each were studied: 1) 12-18 yr by actuator alone; 2) 5-9 yr by actuator alone; 3) 5-9 yr by antistatic VHC/mouthpiece; 4) 5-9 yr by antistatic VHC/mask and 5) 1-4 yr by antistatic VHC/mask. Fluticasone concentrations were measured by LC-MS/MS assay. Fluticasone plasma concentration between groups was compared using one way ANOVA.

Eligibility Criteria:
Inclusion Criteria:children 1-18 yr, adequately controlled persistent asthma, demonstrate effective administration technique in accordance with the group assigned -

Exclusion Criteria:inadequately controlled asthma: nocturnal awakening \>2 nights/month, prn albuterol use \>2x/week, more than 2 short courses of oral corticosteroids in previous 3 months, missing a dose on more than one occasion, increase in asthma symptoms during study, inability to discontinue intranasal or dermal fluticasone for 3 days

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Deep Anterior Lamellar Keratoplasty (DALK) Using Acellular Corneal Tissue Promotes Corneal Allograft Survival in High Risk Patients

The purpose of this study is to study whether deep anterior lamellar keratoplasty (DALK) using acellular tissue will promote corneal graft survival in high risk patients.


Eligibility Criteria:
Inclusion Criteria:

* severe bacterial keratitis
* Herpes simplex keratitis
* severe fungal keratitis
* partial limbal deficiency after chemical burn

Exclusion Criteria:

* posterior stroma involved in severe bacterial and fungal keratitis
* dry eye
* glaucoma or intraocular pressure greater than 21 mmHg
* amblyopia
* retinal abnormalities
* patients with severe systemic diseases not good for ocular surgery
Relationship Between Hemodynamic Changes and Cardiopulmonary Fitness in Type 2 Diabetes Mellitus Patients

Diabetes mellitus being metabolic disorder, chronic in nature, is characterized by high levels of glucose in our blood, which often lead to organ dysfunction. Approximately 10.5 % of adult (20-79 years) have diabetes according to international Diabetes federation. Cardiorespiratory fitness (CRF) is the capability of our cardiopulmonary system to make oxygen available to our skeletal muscles during physical activities for prolonged time, and is known to be decreased with diabetes. Hemodynamic parameters are correlated with various cardiovascular disorders but little evidence of hemodynamic changes in diabetes patients is present and more studies must be done. This study aims to establish the link between hemodynamic changes and cardiopulmonary fitness in T2DM patients, which could inform clinical practices and interventions to improve management, reduce cardiovascular risks, and enhance the quality of life for these patients.

Diabetes mellitus being metabolic disorder, chronic in nature, is characterized by high levels of glucose in our blood, which often lead to organ dysfunction.\[1\] Diabetes statistics highlight the increasing worldwide impact on individuals, families and nations. Approximately 10.5 % of adult (20-79 years) have diabetes according to international Diabetes federation. \[2\] Cardiorespiratory fitness (CRF) is the capability of our cardiopulmonary system to make oxygen available to our skeletal muscles during physical activities for prolonged time. \[3\] Diabetes and cardiorespiratory fitness are inter related. According to a 2023 studies on Cardiorespiratory fitness in individuals with T2DM, it was found that T2DM was associated with decreased cardiorespiratory fitness.

Hemodynamic characteristics have been linked to diseases like stroke,, hypertension, and vascular stenosis. Only a few modest studies have investigated the relationship between hemodynamics and diabetes mellitus (DM). The evidence for a link between hemodynamic alterations and CRF in type 2 diabetic individuals needs to be demonstrated. The study aimed to identify the relationship between hemodynamic changes and CRF in type 2 diabetic patients; the findings will help us form inform clinical practices and intervention strategies, ultimately leading to better T2DM management, lowering the risk of cardiovascular complications, and improving T2DM patients' quality of life and longevity.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who agreed to sign the informed consent form.
* Subject with an age group 30-50yrs.
* Female and male.
* Controlled type 2 Diabetes Mellitus patients.

Exclusion Criteria:

* Patient performing any exercise.
* cardiovascular diseases.
* Patients with Cerebrovascular diseases.
* Patients with Peripheral artery diseases.
* Patients with pulmonary dysfunction.
The Effect Of Wound Irrigation With Irrisept™ Delivery System On Abscess Healing In Patients Presenting To The Emergency Department

The purpose of this study is to determine if wound cleansing and irrigation using the IRRISEPT Chlorhexidine Gluconate(CHG)solution, applying a given volume with a pressurized stream, will improve the outcome for infected abscesses in patients that present in the emergency department.


Eligibility Criteria:
Inclusion Criteria:

* Immunocompetent individuals 12 years of age or older with an uncomplicated abscess
* Patient must be able to answer questions and be medically stable as defined by the Emergency Department physician
* Patient must voluntarily participate in the study

Exclusion Criteria:Patients with any of the following are excluded:

* Currently receiving antibiotics or received antibiotics within last 72 hours
* Evidence of systemic infection (fever, aches, chills, nausea)
* Requires admission to the hospital for infection or for any other reason(s)
* Abscess caused by a human or animal bite
* Prior history of hypersensitivity or allergy to Chlorhexidine Gluconate (CHG)
* Immunodeficiency (Examples: HIV Positive, Crohns Disease, Systemic Lupus Erythematosus, Addison's disease, psoriasis, splenectomy, leukemia, cancer on chemotherapy)
* Currently on any immune-modifying medication (Examples: prednisone, antivirals)
* History of chronic skin infection (3 or more in the past year)
* Chronic medical problem, for example end-stage heart, liver, kidney, or lung disease, diabetes mellitus, peripheral vascular disease, history of organ transplant
* Mental illness including but not limited to substance abuse, dementia, schizophrenia or mentally handicapped or challenged
* Incarcerated
* Patient is pregnant or thinks she may be pregnant
Saginil in vs. Placebo for Gynecologic Oncology Patients Affected by Vaginitis

We hypothesise that the use of Adelmidrol (Saginil in vaginal cannulas) can reduce the incidence and magnitude of vaginitis in patients affected by gynecologic malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Gynecologic malignancy
* Current administration of chemotherapy

Exclusion Criteria:

* Colpectomy
* Vaginal cancer
* Vulvar cancer
* Bacterial vaginitis
Effects of Exercise Therapy on Ventricular and Endothelial Function in Patients After Coronary Artery Bypass Surgery

The purpose of this study was (1) to compare the peak exercise capacity and left ventricular diastolic function between patients with and without diabetes and (2) to investigate the interrelation among peak oxygen consumption, left ventricular diastolic function, blood sugar, and lipid profile.


Eligibility Criteria:
Inclusion Criteria:

* well-controlled diabetes
* no history of myocardial infarction
* stable post coronary artery bypass surgery for at least 3 months

Exclusion Criteria:

* heart failure,
* valvular disease,
* abnormal kidney or liver function,
* cerebrovascular disease,
* primary pulmonary disease,
* other systemic or acute illness that may impede the testing or training