cyrilzakka/clinical-trials huggingface dataset:
Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction

This study will consist of 80 patients ages 18 to 50 at the Emory Orthopaedic and Spine Center who are undergoing Anterior Cruciate Ligament (ACL) reconstruction with a quadriceps tendon autograft or bone patellar tendon bone autograft by Dr. Karas or Dr. Xerogeanes. Patients will be randomized into treatment and control arms. The treatment arm will include 40 patients receiving liposomal bupivacaine intra-operatively in addition to the current standard pain control regimen. The control group will include 40 patients receiving the standard post-operative pain control regimen. Patients will be assessed to identify differences in post-operative pain, satisfaction, as well as concomitant pain medication use. Post-operative range of motion will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Ages between 18 and 50 chronological years undergoing ACL reconstruction using a quadriceps tendon or BTB autograft.

Exclusion Criteria:

* Patients with known allergies to local anesthetics
* pregnant patients
* patients with a history of liver disease
* patients undergoing bilateral procedures
* Patients undergoing revision ACL surgery and patients undergoing ACL reconstruction using pediatric physeal sparing techniques
* Patients will also be excluded if any clinically significant event or condition is discovered during the time of, or after surgery that may render them medically unstable, or subject them to a surgical complication.
A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.

This study is intended to assess safety and tolerability of ASP1941 compared to placebo in adult subjects with type 2 diabetes mellitus

Trial includes a two week washout period before entering the treatment period for subjects on oral anti-diabetic medication.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of type 2 diabetes mellitus
* HbA1c value between 7.0 and 10.0%
* Body mass index between 20 and 45 kg/m2

Exclusion Criteria:

* Established diagnosis of type 1 diabetes mellitus
* Serum creatinine \> upper limit of normal range
* Proteinuria (microalbumin/creatinine ratio \> 300 mg/g)
* Urinary tract infection
* Severe uncontrolled Hypertension
* Significant renal, hepatic or cardiovascular disease
* HIV Positive
* History of drug or alcohol abuse/dependency
After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet

This study analize the incidence of acute renal failure after performing total knee arthroplasty with or without use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial

This study analize the incidence of acute renal failure after performing total knee arthroplasty with or without (using local intraarticular anesthesia) use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial

Eligibility Criteria:
Inclusion Criteria:

* Patients knee arthrosis
* Required a surgical treatment with Total Knee Arthroplasty

Exclusion Criteria:

* Not accept to be in the study
* Not signed consent form
* Not having blood sample for creatinin meassure
Delayed Cord Clamping in VLBW Infants

This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants. The study also tested whether delaying cord clamping by 30-35 seconds and holding the newborn approximately 10 inches below the birth canal would result in increased hematocrit at 4 hours of age.

This study tested the hypothesis that delaying clamping of the umbilical cord in extremely low birthweight (ELBW) infants would result in additional blood transfusion from the placenta to the baby, increasing the infant's blood volume and blood pressure. Higher blood pressure may improve blood flow to the brain that may reduce potential the risk of hypoxic ischemic encephalopathy (HIE) and/or intraventricular hemorrhage (IVH). The additional placental flow may also increase the amount of stem cells and cytokines flowing to the baby, improving immune status and reducing the risk of infection, while at the same time reducing the need for blood transfusions in the neonatal period.

This was a pilot study to test the feasibility of having obstetricians delay cord clamping for 30-45 seconds, and to confirm whether the procedure significantly increases the baby's hematocrit during the first 4 hours of life.

Eligibility Criteria:
Inclusion Criteria:

* Infants born at participating centers at 24-27 weeks gestation
* Singletons
* Obstetrician approval for enrollment
* Parental consent

Exclusion Criteria:

* Prenatally diagnosed major congenital anomalies
* Intent to withhold or withdraw care
* Significant bleeding due to placenta previa or abruption
The Protective Effect for Liver Organ in Patients With Anti-TB Drugs Using of Acetylcysteine (NAC)

Animal studies have shown that INH-RIF-induced oxidative injury can be prevented by supporting the cellular antioxidant defense mechanism by N-acetylcysteine (NAC). However, there are few published data and large sample sizes regarding the protective effect of NAC against hepatotoxicty induced by anti-TB drugs in humans, to our knowledge.

Therefore, the investigators designed a clinical trial with the aim to see whether NAC could protect against anti-TB drug-induced hepatotoxicity (DIH)

Isoniazid (INH), rifampicin (RIF), and pyrazinamide (PZA), the first-line drugs used for tuberculosis (TB) chemotherapy, are associated with hepatotoxicity. A high rate of hepatotoxicity has been reported in some developing countries compared with advanced countries with a similar dose schedule. Sharifzadeh et al. reported an incidence of 27.7% in Iran. The reasons for this higher rate of hepatotoxicity are not completely clear. Ethnic variations, advanced age, female sex, alcoholism, underlying liver disease, acetylator phenotype, hepatitis B and C virus, HIV infection, extensive pulmonary parenchymal disease, and hypoalbuminemia have been observed to be the risk factors for the development of drug-induced hepatotoxicity (DIH) because of anti-TB treatment.

The mechanism of DIH induced by anti-TB treatment is not yet fully understood. Sodhi et al. proposed oxidative stress as one of the likely mechanisms for INH-RIF-induced hepatic injury. It is well established that by augmenting a cellular antioxidative defense system, especially nonprotein thiols, that is, glutathione (GSH), cells can be protected against oxidative injuries produced by various drugs and chemicals.

The study will be performed with randomized trial for assessment and protective effects over liver function in patients receiving anti-TB agents and using NAC.

Eligibility Criteria:
Inclusion Criteria:

1. new diagnosed to have tuberculosis
2. age \>20 years -

Exclusion Criteria:

1. acute hepatitis in a previous one year
2. TB drugs induced urticaria or Steven-Johnson syndrome
3. life less than one year due to advanced cancer status
4. non-tuberculosis mycobacteria，NTM patients
5. HIV patients
6. patients can not cooperate
7. Allergic reaction for NAC
Comparative Bioavailability Between Two Tramadol Formulations: Study of the Better Controlled Release of a New 200 mg Once A Day (OAD) Formulation Versus Zytram® 200 mg

The main purpose of this study is to compare the pharmacokinetic profile to establish the better controlled liberation of the test product (Tramadol HCL OAD tablets of 200 mg, Labopharm) and its bioavailability in relation with the commercialised reference (Zytram® tablets of 200 mg, Zambon), single dose administered.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects of either gender
* Age between 18 and 45 years
* Body mass index between 19 and 27kg/m2
* Normal medical history
* Normal or no clinically significant physical examination findings
* Normal or no clinically significant findings in analytical tests
* Negative hepatitis B, hepatitis C or HIV serology
* Negative drugs of abuse in urine
* Negative pregnancy test in females
* The subject understands and accepts the study procedures and grants in writing his/her informed consent

Exclusion Criteria:

* Did not fulfill the inclusion criteria
* Organic disorders or underwent major surgery, within 90 days before study screening
* Psychiatric history
* Alcohol drink intake greater than 30gr/day
* Cigarette smoking greater than 10 cigarettes/day
* Excessive consumption of food or beverages containing xanthines (more than five units of coffee, tea or cola per day)
* Medical treatment within 30 days before screening, and/or any medication 7 days before starting the study
* Participation in other clinical study or donate blood within 90 days before starting this study
* Antecedents of gastric, hepatic, renal and other kind of disorder that could affect ADME (absorption, distribution, metabolism or excretion of the study drug)
* Hepatitis B, hepatitis C or HIV positive serology
* Pregnant or breastfeeding
* Clinically relevant hypersensitivities (in particular to drugs)
* Woman taking oral contraceptive drugs
* Incapable of communicating and cooperating with investigators
FMT in the Treatment of IBS

52 adult IBS patients were recruited. 50% were given a fecal microbiota transplantation in colonoscopy and 50% were given an FMT made of their own feces as placebo. follow up time was 1 year after FMT.

52 adult IBS patients of any subgroup(IBS-D, IBS-C or IBS-M), were recruited and given an FMT in colonoscopy. Neither the patient nor the care taking personnel did know in which group the patients belonged to. The patients were screened with fecal samples for 16RNA sequencing and they were repeatedly done IBS-SSS questionnaire and questionnaires for quality of life and psychical condition. Follow up time was 1 year after the colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IBS based on Rome III criteria
* Having received traditional treatment for at least 1 month
* Availability of consecutive fecal samples over one year.
* Compliance to attend ileocolonoscopy and FMT procedure.
* 18-75 years

Exclusion Criteria:

* Unable to provide informed consent
* Antibiotic therapy in past 3 months
* Inflammatory bowel disease (IBD)
The Use of Ultrasound to Measure Depth of Thoracic Epidural Space

The purpose of the study is to evaluate the use of ultrasound scanning of the thoracic spine to define the point of insertion and the depth of the epidural space compared to the blind technique.

The study hypothesis is the use of Ultrasound will improve the success rate of epidural placement and may also decrease the rate of complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years and older having a thoracic epidural catheter
* Both male and female patients.

Exclusion Criteria:

* Pediatric population \< 18 years of age
* Pregnancy
* Prisoners
* Absolute Contraindication to thoracic epidural placement severe scoliosis or deformity,
* Patients with previous spine surgery or hardware implanted at level of epidural placement,
* Anticipated ventilation postoperatively for a period more that 24 hrs
* Lack of patient consent to enroll in the study
A Phase I/II Clinical Trial with SENS-501 in Children Suffering from Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations

This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.

It is a multicenter, adaptive open-label, non-randomized, dose-escalation, and expansion study to assess safety, tolerability, and efficacy following intracochlear administration of SENS-501.

Eligibility Criteria:
Inclusion Criteria:

* Children (male or female) ≥ 6 to ≤ 31 months at the time of inclusion
* Severe to profound hearing loss assessed by auditory brainstem response (ABR)
* Biallelic mutation in the Otoferlin gene
* Presence of Otoacoustic emissions (OAEs)
* Documented normal cochlea and internal auditory canals
* Patients with intact vestibular function

Exclusion Criteria:

* History of chronic, acute, or major disease, or unspecified reasons, that in the opinion of the Investigator, makes the participant unsuitable for participation in the study or constitutes an unacceptable risk.
* Have been dosed in a previous gene therapy clinical trial
* Patients with a prior or current cochlear implant
* Any contraindication to the surgery determined by the surgeon or anesthesia determined by the anesthesiologist, or designee, or history of therapy known as ototoxic (e.g., cisplatin, high dose and long treatment with aminoglycosides, etc.) for an extended period (more than 2 weeks).
* Participation in any other interventional clinical trial
* Any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the participant or would preclude the participant from successful completion of the study or might interfere with the evaluation of study treatment
* Anticipated noncompliance with the protocol requirements
Safety and Efficacy of Remote Ischemic Preconditioning in Patients with Aneurysmal Subarachnoid Hemorrhage After Aneurysm Clipping

This study was designed to evaluate the safety and efficacy of remote ischemic regulation (RIC) in patients with aneurysmal subarachnoid hemorrhage (aSAH) undergoing craniotomy.

Aneurysmal subarachnoid hemorrhage is a life-threatening condition that occurs when an aneurysm ruptures in the brain causing bleeding in the Subarachnoid space. Cerebral aneurysm clipping are usually needed to stop the bleeding and stabilize the patient's condition.

Remote Ischemic regulation (RIC) is a non-invasive treatment that uses a blood pressure cuff to temporarily block and restore blood flow to the arm or leg. Research suggests that this process may help protect the brain and improve recovery from brain injury or surgery. Although RIC has shown potential to improve outcomes in patients with other types of brain injury, its effect on patients with aSAH who undergo cerebral aneurysm clipping is unclear.

This study will evaluate whether RIC can reduce complications, improve brain function, and enhance overall recovery in patients. The findings will help determine whether RIC should be included in the standard treatment regimen for patients with aSAH.


Eligibility Criteria:
Inclusion Criteria:

1. Imaging examination confirmed aneurysmal subarachnoid hemorrhage.
2. Responsible aneurysms received craniotomy clipping within 24 hours.
3. 18≤ age ≤80 years old.
4. Informed consent of the participant or legally authorized representative

Exclusion Criteria:

1. Patients with other types of cerebral hemorrhage.
2. Prior neurological impairment (mRS Score \>1) or mental illness may confuse neurological or functional assessment.
3. Severe comorbidities with a life expectancy of less than 90 days.
4. Refractory hypertension (systolic blood pressure 180\>mmHg or diastolic blood pressure 110\>mmHg).
5. RIC contraindications: severe soft tissue injury of lower limbs.
6. Simultaneously participate in another research program to study a different experimental therapy.
7. Any condition that the investigator believes may increase the patient's risk.
Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure

A study to determine the effect on renal function in renal transplant patients with biopsy proven Chronic allograft nephropathy (CAN) nephropathy who are switched from a Calcinerin inhibitor (CI) triple drug regimen to a Rapamycin based triple drug regimen or maintained on their CI protocol


Eligibility Criteria:
Inclusion Criteria:

1. Patient is the recipient of a cadaveric or living donor renal transplant.
2. Patient was \> 12 years of age at the time of transplant.
3. Patient is at least 3 months post-transplant.
4. Patient has been on a calcineurin inhibitor based immunosuppression since the transplant.
5. Patient has one of the following risk factors for chronic renal allograft failure:

   I. Serum creatinine \> 2.0 mg/dL 3 months or later post-transplant in males patients.

   II. Serum creatinine \> 1.7 mg/dL 3 months or later post-transplant in female patients.

   III. Serum \> 30% increased over post discharge nadir.
6. Patients had a renal biopsy that shows chronic allograft nephropathy.
7. Patient or legal guardian had signed and dated an Institutional Review Board (IRB) approved informed consent document and is willing and able to follow study procedures.
8. If female and of child bearing potential, patient has a negative pregnancy test and agrees to practice effective birth control while receiving mycophenolate mofetil (MMF), Rapamycin and other immunosuppressants.

   -

Exclusion Criteria:

1. Patient is the recipient of a solid organ transplant other than the kidney.
2. Patient is dialysis dependent.
3. Patient has recurrence of primary renal disease, or de novo renal disease.
4. Patient has an estimated creatinine clearance \<25ml/min calculated using the Cockcroft/Gault formula.
5. Patient has changed maintenance immunosuppressant therapy (e.g., azathioprine to MMF) within three months of randomization.
6. Baseline biopsy shows acute rejection Banff Grade \> Class 2 (IIB).
7. Patient required anti-lymphocyte therapy to treat rejection found on baseline biopsy.
8. Patient has received an investigational immunosuppressant within three months.
9. Patient is pregnant or lactating.
10. Patient is a known carrier of any of the HIV viruses.
11. Patient has known hypersensitivity to Rapamycin, or any of the excipients of the drug.
A Canadian Study of Persistence on Ofatumumab Using Patient Support Program Data

This was an observational, non-interventional, real world study involving secondary use of de-identified aggregate data from patients prescribed ofatumumab, collected by the Kesimpta Go Program in Canada. This study utilized a cohort design. The study period included all available data captured by the Kesimpta Go Program from program inception (April 2, 2021) to the time of data transfer (May 1, 2024). Patients were indexed into the study on the date they started their medication, from April 2, 2021 to May 1, 2024. The baseline period represented the period prior to ofatumumab treatment initiation. Baseline variables were collected from the enrollment form, which include demographic and clinical history, such as whether the patient had prior treatment with disease-modifying therapy (DMT). Patients were followed until the first of the following censoring events: ofatumumab discontinuation; end of the study period; or leaving the Kesimpta Go Program.


Eligibility Criteria:
Inclusion criteria:

Patients were included if they met all of the following criteria:

* Patients enrolled in the Kesimpta Go Program
* Patients with documented informed consent from enrollment in the Kesimpta Go Program
* Patients who started treatment with ofatumumab

Exclusion criteria:

Patients were excluded if they met any of the criteria below:

* Patients with no demographic information
* Patients who could not be linked across the data sources required for analysis (Kesimpta Go Program Enrollment Form, Pharmacy Claims Forms, Kesimpta Go Program Database)
* Patients with 3+ treatment interruptions (patient was "on hold" - i.e., not currently receiving the treatment in the patient support program)
Retrospective Study of Invasive Fungal Infections With Filamentous Fungi in Heart Transplant Patients

Invasive filamentous fungal infections (aspergillosis, scedosporiosis, mucormycosis, fusarium wilt) are common and serious in immunocompromised subjects and particularly organ transplant patients. There is little recent data in heart transplantation, particularly on the incidence and risk factors of fungal infections. . It is therefore important to have recent data on incidence, risk and prognostic factors in order to improve the management of this severe complication.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient ≥18 years old
* Heart transplant
* Invasive fungal infection with filamentous fungi during the period from January 1, 2008 to December 31, 2022
* Proven or probable infection with filamentous fungi according to EORTC/MSGERC criteria (20):

  * Invasive aspergillosis
  * Mucormycosis
  * Fusarium wilt
  * Scedosporiosis
  * Other filamentous fungus infection
* Subject who has not expressed, after information, his opposition to the reuse of his data for the purposes of this research.

Exclusion Criteria:

* Patient having expressed his opposition to participating in the study
* Patient not having a liver transplant
* Subject under guardianship, curatorship or safeguard of justice.
Quality Control: A Prospective Analysis of EVD Effectiveness

The purpose and/or hypothesis: To decrease the amount of external ventricular drain (EVD) related catheter infections by comparing the efficacy of Oklahoma University Medicine standard EVD catheters, both impregnated and non-impregnated, in three principle areas: incidence of infection, cost analysis, and average durations of placement, all while maintaining the standards of technique.

Experimental design: Track external ventricular drain (EVD) associated infections and through quality prospective analysis and compare the usage of standard catheters used by the department here at Oklahoma University, 1) the 35cm Codman Bactiseal rifampin and clindamycin impregnated catheter, 2) the Ventriclear EVD Antibiotic Catheter, and 3) the 36 cm Integra Hermatic large style ventricular catheter, in terms of incidence of infections, cost, duration of placement, and differences in placement technique.

Proposed procedure: Monitor for infections associated with and related to EVD placement in patients and assess if infections rates are affected by usage of antibiotic impregnated EVD catheters.

Importance of knowledge reasonably expected to result from the research: While use of sterile techniques and periprocedural antibiotics have traditionally been used to combat infection, infection rates remain above goal leading to the question of whether the antibiotic impregnated catheter should be added to the standard of care. With the knowledge gained, the investigators hope to decrease the amount of external ventricular drain related catheter infections and reduce use of prolonged antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Patients who require placement of external ventricular drain.

Exclusion Criteria:

* Prisoners and/or those who may be pregnant.