cyrilzakka/clinical-trials huggingface dataset:
Liposomal Bupivacaine With Bupivacaine in Ankle Fracture Open Reduction Internal Fixation (ORIF)

This study is a randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. Patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively.

This study is a prospective, randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. Patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively. Patients are to remain blinded to the treatment arm. The surgeon is non-blinded and administers the bupivacaine solution locally, intra-operatively.

Patients pain scores and pain medication usage is documented. A trained research coordinator contacts each patient at 24, 48, and 72 hours post-operatively to assess pain levels on a visual analog scale (VAS) and pain medications taken. Patients return for followup at standard intervals of 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post-operatively to assess healing and functional outcomes. Patients are queried as to satisfaction with pain control at 2 weeks post-operatively. The study will compare outcomes including pain levels, pain medications taken, operating room (OR) and post-anesthesia care unit (PACU) times, length of stay (LOS), satisfaction with pain control, clinical outcomes, and complication rates.

Eligibility Criteria:
Inclusion Criteria:

1. Patients at least 18 years old.
2. Male or Female
3. All racial and ethnic groups
4. Fractures and fracture/dislocations of the ankle
5. Patients who opt for surgical treatment of their fractures.
6. Patients who consent to be randomized.
7. Patients who are willing to follow-up for a minimum of 52 weeks.

Exclusion Criteria:

1. Patients younger than 18 years old
2. Patients who are on chronic opioids
3. Patients who abuse opioids
4. Patients who are unwilling to follow-up for a minimum of 52 weeks
5. Neurologic condition that could interfere with pain sensation
Improving Quality of Life of Fibromyalgia Patients

Comparison of two treatments of fibromyalgia; the QOL score should improve rather and, twelve months after the end of the program, remain higher in "Plurifocal educational group" than in control group

Comparing two forms of non-drug treatment of fibromyalgia: "Information" (an information group session on the fibromyalgia management modalities) versus "Plurifocal educational program " (intensive group program of 8 weeks, including, in addition to the briefing, measures and exercises for the implementation of the principles of managing fibromyalgia, and cognitive-behavioral therapy).

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia Patients according to the criteria of the American College of Rheumatology defined by:

  * diffuse pain evolving for over three months
  * pain on palpation of at least 11 of the 18 sites listed
* age between 18 and 65
* FIQ Score higher than 35/100 at inclusion
* Ability to respond to questionnaires
* monitoring possibility for at least a year
* Affiliation to the French Health System (social security)

Exclusion Criteria:

* Association with chronic pain from other sources which can interfere with fibromyalgia assessment
* Inability to follow the full educational program
* previous participation in an educational program of same nature
* psychological disorder (personality disorder or behaviour, schizophrenia), preventing participation in the program group
Assessing Barriers and Increasing Use of Immunization Registries in Pharmacies

The purpose of this study is to identify barriers to utilization of immunization registries within a pharmacy context and tailor the information into a novel immunization registry training program.

The purpose of this study is to identify barriers to utilization of immunization registries within a pharmacy context and tailor the information learned about barriers into a novel immunization registry training program with strategies specific to individual subsets of pharmacies, independent pharmacies in rural areas. Doing so will help achieve the long-term goal which is to increase the use of immunization registries in community pharmacies in Alabama.

The specific aims are to

1. identify barriers and best practices of immunization registry implementation,
2. use a participatory design approach to develop an immunization registry training program, and
3. disseminate and assess the impact of the immunization registry training program among community pharmacies' registry participation rates.

The impact of the training program on registry participation rates will be assessed using a randomized controlled trial design comparing Alabama community pharmacies' registry data as well as intention to participate.

Eligibility Criteria:
Inclusion Criteria:

* not currently enrolled in ImmPRINT
* currently provide at least one type of vaccination in addition to influenza
* independently owned
* agree to provide requested data for assessment

Exclusion Criteria:

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Assessing the Cortical Response to Noxious and Auditory Stimuli Using Near Infrared Spectroscopy in Subjects Under General Anesthesia

The primary aim is to utilize near-infrared spectroscopy (NIRS) in patients under general anesthesia to measure changes in brain blood flow in the bilateral somatosensory cortices and the prefrontal cortices in response to noxious stimulation.


Eligibility Criteria:
Inclusion Criteria:

* 12-30 years of age
* Structurally normal heart
* Right-handed
* English-speaking

Exclusion Criteria:

* Unable to cooperate or understand the study
* Neurologic disease
* Diabetes mellitus
* Syndrome of greater than minor severity.
* Smoker
* Scalp or hair does not permit sufficient optical light detection
* Unable to keep his/her head still for a period of 200 consecutive seconds
The Brain Stimulation and Physical Therapy Study

This pilot work will determine the feasibility of tDCS intervention as an effective adjunct intervention to PT aimed at improving gait, balance, and mobility in older adults at risk of falling.

Falls are correlated with both physical and cognitive declines in older adults. Recurrent fallers and those at high risk of falls are often referred to physical therapy (PT) for gait and balance training. Although physical therapists are aware of the importance of cortical control of gait and balance, there is no available tool to directly yet non-invasively intervene brain in the clinical setting.

Transcranial direct current stimulation (tDCS) is a noninvasive and safe mean of modulating the excitability of specific brain regions and their connected neural networks. Our group and others have shown that tDCS intervention designed to facilitate the excitability of the left dorsal lateral prefrontal cortex (DLPFC) improves numerous aspects of executive function related to mobility in older adults. However, no studies to date have assessed the feasibility and effectiveness of applying tDCS as an adjunct to PT to improve gait and balance within the geriatric rehabilitation setting.

This study aims to 1) assess the feasibility of implementing tDCS prior to each of their first 10 PT sessions, and 2) gather estimates of variability in outcomes related to gait, balance, cognition, and quality of life over time within older adults referred to PT for recurrent falls.

Eligibility Criteria:
Inclusion Criteria:

* Ages 65 years old and above
* Admitted to Physical Therapy for gait and balance training due to the high risk of falls

Exclusion Criteria:

* Inability to stand or walk unassisted for 60 seconds
* Severe cognitive impairment defined as a Montreal Cognitive Assessment (MoCA) score \< 18
* Any unstable medical condition
* Any unstable psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
* Active cancer for which chemo/radiation therapy id being received
* Significant vision and hearing problems that cannot be corrected with visual and hearing aids
* Contraindications to tDCS, including seizure within the past two years, use of neuro-active drugs, the risk of metal objects in the brain, implanted medical devices, or the presence of dermatological conditions such as eczema on the scalp.
EFFICACY OF ANSA (Experimental Drug) & CRAN MAX (Control Drug) SACHET

I

This clinical trial aims to VIVO AND IN VITRO COMPARATIVE STUDY ON EFFICACY OF ANSA (experimental drug) \& CRAN MAX (control drug) SACHET IN UNCOMPLICATED UTI in females. The main question\[s\] it aims to answer are:

• Hypothesis I ANSA is an effective therapy for uncomplicated UTI treatment and inhibits or kills E.coli and other organisms in vitro and in vivo Null Hypothesis ANSA is not an effective therapy for uncomplicated UTI treatment and couldn't inhibit or kill E.coli and other organisms in vitro and in vivo Hypothesis II Cran Max is an effective therapy for uncomplicated UTIs and inhibits or kills E.coli and other organisms in vitro and in vivo Null Hypothesis Cran Max is not an effective therapy for uncomplicated UTI treatment and couldn't inhibit or kill E.coli and other organisms in vitro and in vivo

In this study, the emphasis is to evaluate the in vivo \& in vitro efficacy of Ansa sachet having three APIs (Vaccinium macrocarpon, Saraca indica, Cimicifuga racemosa) in comparison with Cran max sachet in female patients having uncomplicated UTI. It is a single-blinded, randomized controlled trial. UTI (urinary tract infection) is mainly caused by E.coli and other associated organisms about 80% in females of fertile age and it occurs with less percentage in males. Uncommon recurrent UTIs is more prevalent in females than males. Post-menopausal women have higher rates of UTIs because of pelvic prolapse, lack of estrogen, loss of lactobacilli in the vaginal flora, increased peri-urethral colonization by Escherichia coli (E. coli), and a higher incidence of medical illnesses such as diabetes mellitus (DM).The microorganism that causes UTIs is similar, in most cases, to the sporadic infection. Most uro-pathogens from the rectal flora ascend to the bladder after colonizing in the peri urethral area and urethra. Keeping in mind that Helix Pharma designed ANSA in such a combination that it not only helps in the prevention of UTIs but also decreased recurrent UTIs as other APIs in ANSA have the capacity to normalize hormonal levels in females which is the basic cause of peri-menopausal and menopausal woman. The objective is to do a comparison of whether the Ansa sachet (experimental drug) or cran max sachet (control group) is a clinically good choice.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients of age 15 to 70 years
2. Patient suffering from complain of burning micturition and will be diagnosed as a case of uncomplicated UTI by Urine D/R
3. Female patients from Karachi related to any discipline
4. All socioeconomic classes included in the study

Exclusion Criteria:

* 1. Males are not included in this study 2. Pregnant females 3. Patient having surgical history related to renal disorder are excluded 4. Patients with co-morbidities like diabetes, uncontrolled hypertension and liver disorder are excluded 5. Patient having any drug reaction from any of the study drug is excluded 6. Patient suffering from serious illness like encephalitis, coma, meningitis or head injury are excluded
Efficacy and Safety of Itolizumab in COVID-19 Complications

Randomized, Parallel Group, Active Controlled Trial

This is a Multi-Centric, Open label, Two Arm Randomized, Phase 2 Study.

All eligible patients entering into the study will be randomized in 2:1 ratio to receive the treatment A (Best supportive care + Itolizumab) / B (Best supportive care) respectively. Each patient will undergo the treatment based on their assigned treatment for a month along with battery of tests that includes, but not limited to, cytokines and chemokine, along with recording of TLC; DLC, ANC, ALC; Platelet count; S. creatinine; T.Bilirubin; morning Vitals -pulse, BP, RR; Temperature, PaO2/FiO2, MAP, GCS.

As Itolizumab is an investigational drug, the benefit to COVID-19 patients experiencing complications such as Cytokine Release Syndrome is not known. However, findings from this study may be beneficial to the society at a large at the National and International Level.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female adults above 18 years (not tested in children yet)
2. Informed consent for participation in the study
3. Virological diagnosis of SARS-CoV2 infection (PCR)
4. Hospitalized due to clinical/instrumental diagnosis of COVID-19 infection
5. Oxygen saturation at rest in ambient air ≤94%
6. Patients who are in moderate to severe ARDS as defined by PaO2/Fio2 ratio of \< 200

Key Exclusion Criteria:

1. Known severe allergic reactions to monoclonal antibodies
2. Active tuberculosis (TB) infection
3. History of inadequately treated tuberculosis or latent tuberculosis
4. In the opinion of the investigator,progression to death is highly probable, irrespective of the provision of treatments
5. Have received oral anti-rejection or immune-suppressive drugs within the past 6 months
6. Participating in other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor)
7. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
8. Patients with known history of Hepatitis B, Hepatitis C or HIV
9. Absolute Neutrophils count (ANC) \<1000 / mm3
10. Platelets \<50,000 / mm3
11. Absolute Lymphocyte count (ALC): \<500/mm3
Advancing the Role of the Neonatal Registered Dietitian Nutritionist

This observational study aims to identify the needs, engagement levels, and expertise of NICU RDNs and provide insights into their job satisfaction and career longevity.

This cross-sectional examination was conducted in March - April 2024 using a national, online, IRB-approved survey sent to established Neonatal and Pediatric Dietitian practice groups. A Qualtrics link was provided for current and former NICU RDNs to complete a 10-minute online survey.


Eligibility Criteria:
Inclusion Criteria: Current and former Neonatal Registered Dietitian(s)

-

Exclusion Criteria:

Practice outside of the USA and Canada.
Docetaxel and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Has Been Completely Removed By Surgery

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy drugs after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving docetaxel together with cisplatin works in treating patients with stage I, stage II, or stage III non-small cell lung cancer that has been completely removed by surgery.

OBJECTIVES:

Primary

* Compare the efficacy and safety of a new dosing schedule and dosing level of docetaxel and cisplatin with the chemotherapy regimens used in the International Adjuvant Lung Cancer Trial (IALT) in patients with completely resected stage IA-IIIB non-small cell lung cancer.

Secondary

* Explore the relationship of time to recurrence, disease-free survival, and overall survival of these patients with levels of circulating DNA and proteomic analysis of serum.

OUTLINE: This is an open-label study.

Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 8 hours on day 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Pathologically proven non-small cell lung cancer (NSCLC)

  * Stage IA-IIIB disease
* Underwent prior complete surgical resection (R0) no more than 2 months ago
* Eligible for cisplatin-based adjuvant chemotherapy

PATIENT CHARACTERISTICS:

* Karnofsky performance status ≥ 70%
* Absolute neutrophil count ≥ 1,500/mm\^3
* Hemoglobin ≥ 8.0 g/dL
* Platelet count ≥ 100,000/mm\^3
* Creatinine clearance \> 55 mL/min
* Total bilirubin normal
* Alkaline phosphatase, AST, and ALT must meet 1 of the following criteria:

  * Alkaline phosphatase (AP) normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
  * AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
  * AP ≤ 5 times ULN AND AST and ALT normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* No peripheral neuropathy \> grade 1
* No hearing deficit at baseline, even if it does not require a hearing aid or intervention or interfere with activities of daily life (i.e., CTCAE grade 2 or higher)

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior postoperative radiation therapy
* No prior chemotherapy for NSCLC
* No prior docetaxel or cisplatin
* No concurrent prophylactic filgrastim (G-CSF) or pegfilgrastim
WallFlex Biliary Fully Covered (FC) Benign Stricture Study

The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct strictures.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study
* Chronic pancreatitis or prior liver transplantation or prior other abdominal surgery (to include cholecystectomy)
* Indicated for ERCP procedure with stent placement for: Symptomatic bile duct stricture (i.e. obstructive jaundice, persistent cholestasis, acute cholangitis) confirmed by cholangiogram and/or Bile duct stricture confirmed by cholangiogram and/or Exchange of prior plastic stent(s) for management of benign stricture

Exclusion Criteria:

General:

* Placement of the stent in strictures that cannot be dilated enough to pass the delivery system
* Placement of the stent in a perforated duct
* Placement of the stent in very small intrahepatic ducts
* Patients for whom endoscopic techniques are contraindicated
* Biliary stricture of malignant etiology
* Biliary stricture of benign etiology other than chronic pancreatitis or liver transplant anastomosis or other abdominal surgery
* Stricture within 2 cm of duct bifurcation
* Symptomatic duodenal stenosis (with gastric stasis)
* Prior biliary self-expanding metal stent
* Suspected stricture ischemia based on imaging of hepatic artery occlusion or endoscopic evidence of biliary cast syndrome
* Known bile duct fistula
* Known sensitivity to any components of the stent or delivery system
* Participation in another investigational study within 90 days prior to consent or during the study

Additional Specific to Chronic Pancreatitis Patients:

* Developing obstructive biliary symptoms associated with an attack of acute pancreatitis

Additional Specific to Post-Abdominal Surgery Patients:

* History of hepatectomy
* History of liver transplant

Additional Specific to Liver Transplant Patients:

* Live donor transplantation
Frequency of Florid Hyperthyroidism In Patients Taking Iodinated Salt

Thyroxin a vital hormone for life lot of body functions depend on proper functioning on pituitary thyroid axis. it exists in two major forms Thyroxine (T4) and (T3) , each of them containing two iodine atoms on their inner (tyrosine) ring. Synthesis of reasonable quantities of thyroid hormones requires adequate iodine intake to allow sufficient thyroidal uptake. The World Health Organization (WHO) recommendation for daily intake of iodine is 150 μg for children ≥12 years and adults, and 250 μg for pregnant and lactating women. However as we know optimum amount of iodine is required for normal pituitary thyroid axis like wise excessive intake may cause over functioning of axis hence over production of hormone that can be manifested both clinically and biochemically.

This study is designed to observe the frequency of over hyperthyroidism in patients taking iodinated salt.

All patients presenting to endocrine clinic fulfilling inclusion and exclusion criteria will be recruited. They will be examined, their vitals including blood pressure pulse will be noted, thyroid clinical examination including eye signs and thyroid status will be done biochemical Thyroid profile (TSH, Free T3 \& Free T4) will be noted in predesigned proforma.

Statistical Analysis will be done ,after data is entered in Statistical Package for the Social Sciences (SPSS) version 25 .qualitative data will be presented as frequencies and percentages while quantitative data will be presented as mean medians and standard deviations.

Eligibility Criteria:
Inclusion Criteria:

1. All patients presenting with biochemical hyperthyroidism
2. Who are taking Iodinated salt.
3. Treatment naïve patients
4. Both genders included
5. All patients who can give consent (18-60 years)

Exclusion Criteria:

1) Pregnant females 2) Lactating mothers

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The Effects of PXR Activation on Hepatic Fat Content

This study investigates the effects of pregnane X receptor (PXR) activation on hepatic fat content in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR activator) and placebo will be given for a week to volunteers. Hepatic fat content is measured with magnetic resonance imaging and blood samples are collected at the end of each study arm. The investigators' hypothesis is that rifampicin causes accumulation of fat to the liver.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Body mass index (BMI) 18.5-25 kg/m2

Exclusion Criteria:

* Systolic blood pressure over 150 mmHg
* Any continuous medication (hormonal intrauterine device is permitted)
* Any significant medical condition
* Insensitivity to rifampicin
* Pregnancy and lactation
* Previous difficult venipuncture
* Alcohol and medicine abuse and drug use
* Participation to any other pharmaceutical trial within on month of screening
* Claustrophobia
* Metal and other implants which are contraindications to MRI
Risk Factors for Nausea and Vomiting After Cesarean

Investigators will observe the incidence of post-cesarean nausea or vomiting and try to associate it with some risk factors.

A single prospective cohort of women submitted to cesarean section who received spinal anesthesia will be assessed for the proposed risk factors and the incidence of nausea or vomiting will be observed during the first 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* Cesarean section indicated
* Spinal anesthesia indicated

Exclusion Criteria:

* Cesarean section did not occur
* Spinal anesthesia was not provided
* Another spinal technique was added to spinal