cyrilzakka/clinical-trials huggingface dataset:
Incidence of Postoperative Neuromuscular Blockade in Post-Anesthesia Care Unit at Parkland Hospital: Does Size Matter?

This prospective, observational study will assess 100 subjects in the post-anesthesia care unit (PACU) at Parkland Hospital. Upon arrival to the PACU, patients' train-of-four (TOF) ratio will be calculated using the StimPod NMS450 accelerometer to determine the presence of any residual paralysis. Any patient with a TOF ratio \< 0.9 will be reassessed every 10 minutes until the ratio is ≥0.90. The time it takes to reach a TOF ratio ≥0.9 will be recorded. Subjects will be classified according to BMI categories: lean as \<30 kg/m2, obese as 30≤BMI≤39.9 kg/m2, and morbidly obese as BMI ≥40 kg/m2. This data will serve as a baseline to assess the incidence of residual NMB that currently occurs in our PACU so that we may use this pilot data to design future studies that aim to reduce the incidence of residual NMB.

Upon arrival to the PACU, patients enrolled in the study will be evaluated for residual paralysis with train-of-four (TOF) stimulation using the StimPod NMS450 accelerometer set to 30 mA. Any patients who have residual paralysis will be assessed Q10 minutes until the TOF ratio is ≥0.9. The time to achieve a TOF ratio ≥0.9 will be recorded. Any adverse events (e.g., hypoxia, reintubation, aspiration) that arise during the patient's PACU stay will be documented.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* Undergoing non-emergent surgery with general endotracheal anesthesia
* ASA physical status classification 1 to 4
* Willing and able to consent in English or Spanish
* No personal history of neuromuscular disease

Exclusion Criteria:

* Age less than 18 or older than 80
* Patient does not speak English or Spanish
* Planned postoperative intubation or ICU admission
* Allergy to sugammadex, neostigmine, glycopyrrolate, or rocuronium
* Family or personal history of malignant hyperthermia
* Patient refusal
* Monitored anesthesia care (MAC) or regional anesthesia planned
* Pregnant or nursing women
* "Stat" (emergent) cases
* Estimated creatinine clearance \<30 mL/min
* Pre-existing muscle weakness of any etiology
Artificial Intelligence to Detect Early Total Knee Replacement Implant Failure

The goal of this trial is to investigate whether Machine Learning (ML) can be used to detect small degrees of loosening, lucent zones, or any other changes on radiographs that might predict early failure following NexGen total knee replacement.

Researchers will identify plain AP and lateral plain film radiographs from two groups of patients. Those who has NexGen total knee replacements (TKRs) that went on to failure, and those who has well performing TKRs. Radiographs from these two groups will be labelled as 'failure' and 'well performing' and will be processed through a machine learning algorithm.

The algorithm will be successful if it is able to detect a NexGen TKR that went on to failure or went on to perform well. This will be determined by using a test set.

The population will be adults who had the recalled a NexGen Total Knee Replacement with a standard tibial tray. It will include adults only, who has the TKR at University Hospitals Southampton between 2003 and 2022.

Failure will be defined as revision of tibial or femoral components which is likely due to aspectic loosening. It will exclude washouts, exchange of poly, peri-prosthetic fractures, microbiologically confirmed infection.

Well performing TKRs will be defined as patients who have had their TKR in situ for 10 years and have reported no significant symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Had a NexGen TKR between 2003 and 2022.

Exclusion Criteria:

* Below 18 yrs old.
* Revision surgery for any reason other than aseptic loosening
* patients who have not had a revision but who do not have a well functioning TKR.
Evaluation of Tibial and Femoral Tunnel Position After Arthroscopic Reconstruction of the Anterior Cruciate Ligament

The purpose of this study is to evaluate the accuracy of tunnel positions in anterior cruciate ligament reconstruction

The tunnel placement in ACL reconstruction is the most important predictor of clinical outcome and there is a high rate of inaccurate tunnel placements, even when performed by experienced surgeons.Tibial and femoral tunnel positions are one of the major concerns in anterior cruciate ligament reconstruction which have a great impact on the final surgical results

Eligibility Criteria:
Inclusion Criteria:

* anterior cruciate ligament rupturing

Exclusion Criteria:

* none
The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

The purpose of this study is to see if it is safe and effective to give calanolide A to HIV-infected adults who have not used anti-HIV drugs in the past.

Patients are randomized to receive (+)-calanolide A or placebo for 21 days. All patients may elect to receive an open-label, 3-month course of approved retroviral therapy (up to triple-drug therapy) to be selected by, and administered under the care of, the patients' physicians. If the patient has no insurance coverage or does not wish to utilize his/her insurance for anti-HIV medications, Sarawak MediChem Pharmaceuticals will provide these medications at no charge for up to 3 months.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 18 years old.
* Agree to use effective methods of birth control during the study.
* Have a CD4 cell count of 200 cells/mm3 or more.
* Have HIV levels of 5000 copies/ml or more.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have abnormal blood tests.
* Have had a reaction to study medication.
* Have a history of opportunistic (AIDS-related) infection or cancer.
* Are being treated for active pulmonary tuberculosis.
* Have a fever of 39 degrees C or more within 14 days of beginning study treatment.
* Are unable to take medications by mouth.
* Have an abnormal chest X-ray or ECG within 30 days of beginning study treatment.
* Have hepatitis, hemophilia, or other blood disorder.
* Have significant heart, stomach, intestinal, liver, nerve, or kidney problems.
* Have a condition which may affect ability to participate in this study, such as drug or alcohol abuse or a serious mental disorder.
* Have taken anti-HIV drugs in the past.
* Are taking certain medications.
* Have had a blood transfusion within the 3 months prior to entering the study.
* Have had radiation or chemotherapy within 16 days before the screening visit or plan to receive such treatment during the study.
* Are pregnant or breast-feeding.
Comparison of Hip Resurfacing to Large Femoral Head Total Hip Arthroplasty

This study evaluates femoral head resurfacing versus a large femoral head (Durom®) total hip system. This is a prospective randomized trial.


Eligibility Criteria:
Inclusion Criteria:

1. Indication for hip resurfacing because of osteoarthritis or avascular necrosis
2. Aged 19 to 65 years old
3. Ability to give informed consent

Exclusion Criteria:

1. Previous fracture requiring internal fixation of the hip
2. Previous hip osteotomy (pelvic or femoral)
3. Dysplasia requiring structural bone graft
4. Inability to respond to questionnaires in English (or French, Montreal centre only)
5. The presence of osteopenia or osteoporosis
6. Evidence of hepatic/renal insufficiency or failure from medical history or laboratory assessment
A Study of Pegcetacoplan in Pediatric Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

The purpose of this study is to evaluate the safety, effectiveness, and biological activity (how the investigational medication is processed by the body) of pegcetacoplan in 12-17 year-olds (adolescents) who have paroxysmal nocturnal hemoglobinuria (PNH).

This is an open-label study to evaluate pegcetacoplan in people with PNH who are 12-17 years old. The study will consist of a 4-week screening period followed by a 16-week treatment period. Participants switching from a C5 inhibitor will have an additional 4 week run-in period between the screening and treatment periods. At the completion of the study treatment period, participants will either enter a long-term extension period or a 2-month follow-up period.

All eligible study participants will receive pegcetacoplan, administered via subcutaneous infusion twice a week at home. The subcutaneous infusion requires two small needles to be inserted into the fatty layer of tissue under the skin and the investigational medication will flow into the body. Study participants and/or caregivers will be trained on home administration of pegcetacoplan.

Eligibility Criteria:
Inclusion Criteria:

* Are 12-17 years old at the time of screening
* Weigh at least 20 kg (approx. 44 lbs)
* Have the diagnosis of PNH, confirmed by high-sensitivity flow cytometry (granulocyte or monocyte clone \>10%)
* EITHER:

  * Not being treated with an approved complement inhibitor (eculizumab or ravulizumab) prior to start of pegcetacoplan dosing, AND have hemolytic anemia. Hemolytic anemia is defined as hemoglobin (Hb) less than the lower limit of normal (Hb \< LLN) and LDH \>1.5 times the upper limit of normal (ULN); OR
  * Currently receiving treatment with an approved complement inhibitor (eculizumab or ravulizumab) AND have evidence of ongoing anemia. Ongoing anemia is defined as Hb \< LLN and ARC \> ULN
* Have a platelet count \>75,000/mm3 and an absolute neutrophil count \>1000/mm3

Exclusion Criteria:

* Are an adult, 18 years of age or older, with PNH
* Known or suspected hereditary fructose intolerance (HFI)
* History of hereditary complement deficiency, bone marrow transplant, or meningococcal disease (meningitis, bacteremia or septicemia)
* Females who are pregnant or breastfeeding
Amitriptyline vs GON and SON Blocks in Migraine

Comparison of efficacy and safety of amitriptyline and nerve blocks

This study aims to compare the efficacy and safety of amitriptyline and nerve blocks (greater occipital nerve and supraorbital nerve)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with migraine according to ICHD-3

Exclusion Criteria:

* Being over 50 years or under 18 years
* Malignancy and other systemic diseases
A New Protocol for Continuous Vancomycin Infusion Dosing.

This observational study prospectively collect data on chosen dosing, renal function, measured plasma concentrations and adherence to the recommended clinical protocl for ICU patients treated with continuous vancomycin infusion.


Eligibility Criteria:
Inclusion Criteria:

- Start of continuous vancomycin infusion during the course of intensive care and at least one measurement of plasma concentration.

Exclusion Criteria:

* Vancomycin treatment within 96 h before admission to the unit.
* Vancomycin treatment started with intermittent bolus infusions.
The Variation of Movement Related Cortical Potential, Cortico-cortical Inhibition, and Motor Evoked Potential in Intracerebral Implantation of Antologous Peripheral Blood Stem Cells(CD34)in Old Ischemic Stroke

Stem cell theray in old stroke patients is a study to treat stroke patients approved before in our hospital. We recruit these patients who received stem cell therapy and completed the study. We adopted movement-related cortical potential,and cortico-cortical inhibition to assess the stroke patients with or without stem cell therapy. Further analyzing the correlation of the motor related cortical potential and cortico-cortical inhibition among them. We wanted to find out if there are changes in cortical excitability in subjects with chronic stroke after stem cell therapy.


Eligibility Criteria:
Inclusion Criteria:

* 1.old cerebral infarction (middle cerebral artery territory as documented on the T2 weight image \[T2WI\] of MRI) 2.between 6 months and 5 years of onset 3.National Institute of Health stroke scale (NIHSS) of between 9 and 20.

Exclusion Criteria:

* 1.Seizure history 2. Pacemaker insertion
The Healthy Cookie Study: Understanding How Healthy Cookies Affect Fat in the Blood,

The purpose of this study is to understand how consuming healthy cookies every day for two weeks will affect different types of fat in the blood. Specifically, the overall goal of this study is to find out if the healthy cookies can increase a polyunsaturated fat called linoleic acid in plasma, red blood cells and white blood cells.

Overall, linoleic acid has many health benefits including altering body composition and energy metabolism, possibly through its impact on cardiolipin. It is therefore imperative to develop foods products that allow for Americans to easily increase their intake of linoleic acid. It's also important to understand the mechanism in which linoleic acid exerts these positive health effects, particularly in states of muscle mass and quality loss associated with mitochondria dysfunction.

The investigators plan to test the central hypothesis and accomplish the overall objective of this research by pursuing the following three specific aims

Aim 1: To determine the extent to which cookies, made with grapeseed oil , increase linoleic acid in plasma, red blood cells (RBCs), and peripheral blood mononuclear cells (PBMCs) fraction of blood after two weeks consumption

Aim 2: To determine the extent to which cookies, made with grapeseed oil, increase cardiolipin and linoleic acid content of cardiolipin in PBMCs after two weeks of consumption

Aim 3: To determine and compare the acceptability of consuming cookies made with grapeseed oil or high oleic safflower oil every day for two weeks

Eligibility Criteria:
Inclusion Criteria:

* Nonsmokers

Exclusion Criteria:

* Current or previous diagnosis of diabetes, heart (including stroke or heart attack), kidney, liver or circulatory diseases and/or current treatment for cancer.
* Gastrointestinal diseases or disorders (including pancreatic) or gastric bypass surgery
* Food Allergy or Intolerance \& Bee allergy
* Any dietary restriction where consumption of these healthy cookies or any ingredient would be contraindicated
* Use of medications where consuming the healthy cookies would be contraindicated
* Use of supplements/oils high in linoleic acid in the past 4 weeks prior to enrolling
* Pregnancy
Clinical Efficacy Of 810 Nanometer Diode Laser As An Adjunct To Mechanical Periodontal Treatment Of Residual Periodontal Pockets

Background: Aim of this randomized controlled parallel-designed study was to evaluate the effects of diode laser as an adjunct to mechanical periodontal treatment on clinical parameters and gingival crevicular fluid (GCF) volume of the residual pockets diagnosed following initial periodontal treatment in chronic periodontitis (CP) patients.

Methods: A total of 84 residual pockets on single-rooted teeth in 11 CP patients were included and randomly assigned into 3 groups. Residual pockets were treated either only by mechanical treatment (Group M) (n=28), only by diode laser disinfection (Group L) (n=28) or by combination of these techniques (Group M+L) (n=28). Plaque index, gingival index (GI), bleeding on probing (BoP), probing depth (PD), clinical attachment level and gingival recession were assessed at baseline and 8 weeks after treatment of residual pockets. GCF samples were collected at baseline, 1 and 8 weeks after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy,
* Non-smoker,
* Chronic periodontitis diagnosed according to Armitage 1,
* Aged between 35 and 65,
* Not received any periodontal treatment within the last 3 months,
* Have horizontal bone loss radiographically,
* Presence at least 20 natural teeth except third molars
* Consent to participate in the study.

Exclusion Criteria:

* Any systemic disease that might interfere with the prognosis of periodontal disease (i.e. diabetes mellitus, HIV infection),
* Smoking,
* Antibiotics, anti-inflammatory drugs or any other medication taken within the previous 6 months that may affect the outcome of the study,
* Any physical limitations or restrictions that might preclude normal oral hygiene procedures.
Effect of Selenium Supplementation on Glycemic Control in Patients With Type 2 Diabetes or Prediabetes

Although it has been suggested that selenium (Se) increases the risk of T2DM, most evidence comes from observational studies that cannot prove causality. A systematic review assessed randomized clinical trials and found that the risk of T2DM was not greater in those randomized to Se supplementation than in those randomized to placebo. Se is a toxic element in animals and humans, and overexposure to Se has also been linked to detrimental health effects in humans. Previous studies were mostly conducted in Se-sufficient areas. Moreover, the effectiveness of low-dose Se supplementation on participants with elevated glycemic status was unknown. This cross-over, double blinded, randomized controlled trail aimed to investigate the effectiveness of Se supplementation for glucose control among participants with diabetes or prediabetes. Moreover, we also aimed to examine whether selenoprotein P genotypes, Se-related gut microbiota and their related metabolite modified the effectiveness.


Eligibility Criteria:
Inclusion Criteria:

1. FPG ≥ 5.6 mmol/L;
2. HbA1c ≥ 5.7%;
3. OGTT 2h or postprandial blood glucose ≥ 7.8 mmol/L.
4. T2D patients with stable anti-diabetic medication and blood glucose controlled well for 4 weeks prior.

Exclusion Criteria:

1. Under 30 years old or above 70 years old;
2. Pregnancy;
3. Major surgery in the previous 6 months or planned to occur during the trail;
4. Insulin injection for diabetes;
5. Suffering from severe obesity (BMI \> 40 kg/m2), immunodeficiency syndrome, thyroid disease, coronary heart disease, stroke, malignant neoplasm, kidney or liver disease, or other serious diseases, such as mental illness;
6. Reduced kidney function (GFR \< 60 mL/min/1.73m2, creatinine \> 1.2 times the normal upper limit \[male, \> 133.2 μmol/L; female \> 100 μmol/L\]);
7. Systolic or diastolic blood pressure greater than 160 or 100 mmHg;
8. Taking dietary supplements (e.g., selenium, vitamin, fish oil, etc.) for nearly one month before the intervention;
9. Taking antibiotics or probiotics within 12 weeks of screening.
The Body's Response to Food Intake in Older Adults

We propose to critically evaluate the effects of energy-yielding fluids and solids on acute appetite variables, daily food intake, and specific endocrine and metabolic response to food in the elderly. The results of these studies will provide further evidence to support that nutrition may provide safe and effective non-pharmacological therapies to counter the compromised regulation of energy balance experienced by many elderly people.


Eligibility Criteria:
Inclusion Criteria:

* Age range: 60 years and older
* Body mass index between 20-29 kg/m2
* Weight stable (\< 2 kg weight change within last 6 months)
* Non-smoking
* Constant habitual activity patterns within last 3 months
* Clinically normal blood profiles (specifically, normal liver and kidney function; normal complete blood count (non-anemic); fasting blood glucose \<110 mg/dl)
* Not taking medications known to influence appetite or metabolism
* Non-diabetic
* Resistive exercise training (≤2 times a week) based on reported physical activity levels (questionnaire)
* Active fitness level (≤3, 30-minute aerobic exercise sessions/week)
* Confirmation of acceptability of eating the study test foods (solids and fluids)

Exclusion Criteria:

* Age: \<60 years
* Body mass index: outside of the 20-29 kg/m2 range
* Gained or lost \> 4.5 kg within the last 6 months
* Smoker (currently or within the last year)
* Intermittently been involved in a diet and/or exercise program within the last 3 months
* Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD
* Taking medications (currently or within the last 3 months) known to influence appetite or metabolism
* Abnormal heart function (interpreted by a cardiologist) and assessed (for study exclusion) by our study physician, Arthur Rosen, MD
* Clinically diagnosed as diabetic
* Did not perform resistive exercise training (currently or within the last 3 months) based on reported physical activity levels (questionnaire)
* Perform ≥ 2, 30-minute aerobic exercise sessions/week (currently or within the last 3 months) based on physical activity levels (questionnaire)
* Study foods are found to be unacceptable for consumption by the subject
Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp

This is a phase 4, multi-centre, randomized, two group, open label, active controlled, parallel group, 17 week trial.

All subjects who qualify for this trial are to have 4 to 8 clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the face or scalp.

Eligible subjects will be randomised in a 1:1 ratio to the following treatment groups:

* Treatment Group A: Ingenol mebutate gel 0.015%, once daily for 3 consecutive days for the first treatment course. At 8 weeks after treatment initiation, subjects who present with existing AKs or newly emergent AKs in the treatment area will receive one more treatment course of ingenol mebutate gel 0.015%, daily for 3 consecutive days.
* Treatment Group B: Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days.

Eligibility Criteria:
Inclusion Criteria:

1. Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures
2. Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp

Exclusion Criteria:

1. Location of the selected treatment area:

* on the periorbital skin
* on the perioral skin/around the nostrils
* within 5 cm of an incompletely healed wound
* within 10 cm of a suspected BCC or SCC or other neoplasia
Advanced Hemodynamic Monitoring for Goal-directed Hemodynamic Management During Radical Cystectomy

The purpose of this study is to determine whether increasing cardiac output by a combination of intravenous fluids and inotropic drugs can reduce mortality and morbidity in radical cystectomy operations.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18yo) scheduled for elective radical cystectomy and ileal conduit formation

Exclusion Criteria:

* Creatinine level above 200 mcg/dl
* single functioning kidney
* s/p kidney transplant
* heart rhythm other than sinus
* known allergy to lithium chloride
* chronic lithium therapy
* weight below 40 kg
* mental or language problems that precludes obtaining informed consent
TOT, TVT And Burch Colpo-Suspension for Treatment of Female Mixed Urinary Incontinence

This prospective interventional randomized controlled trial will recruit women with MUI scheduled for surgical treatment where patients will be randomized to either Burch colposuspension, TOT or TVT. Regular postoperative follow up will be planned for at least 2 years. The primary outcome measures will be the objective and subjective cure rates.


Eligibility Criteria:
Inclusion Criteria:

* Women with mixed urinary incontinence.

Exclusion Criteria:

* Women with associated gynecological surgery e.g. uterine prolapse, previous anti-incontinence surgery, intrinsic sphincter deficiency (ISD), and medical disorders affecting the bladder innervation as diabetes mellitus were excluded from the study.
* Women who improved on medical treatment with persistence of stress element only were also excluded.