cyrilzakka/clinical-trials huggingface dataset:
An Analysis of the Efficacy of a Pre-Emptive Multimodal Pain Regimen in Reducing Acute Post-Operative Pain and Narcotic Pain Medication Requirements in Spine Surgery

The aim of this study is to investigate the hypothesis that multimodal pain regimen (consisting of acetaminophen, celecoxib, gabapentin, and oxycodone) administered pre-operatively before elective spine surgery significantly decreases acute pain post-operatively as well as decreasing requirements of post-op opioids for pain control in PACU as compared to patients undergoing elective spine surgery without a pre-operative pain regimen.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective spine surgery at NYU Winthrop
* Age over 18 years

Exclusion Criteria:

* History of neuromuscular disorders
* History of inflammatory arthropathies
* History of spine metastases or active cancer in spine
* Medical History including any of the following: renal dysfunction, gastric ulcers, hepatic dysfunction, coagulopathic/bleeding disorders, prior adverse or allergic reactions to any of the medications in the study
* Age less than 18 years
Comparison of Two Different Doses of Vitamin D in Preterm Infants

randomized clinical trial comparing two different doses of vitamin d supplementation in preterm infants

after randomization each group of preterm neonates (28-32) weeks consisting of 40 neonates

within 48 hrs of birth baseline ca.phosphorus, alkaline phosphatase and vitamin D level were withdrawn from each neonate

then babies started to take oral vitamin d in different doses (400 IU /day in the 1st group and 1000 iu per day in the 2nd group) after they reach 100 cc per kg per day enteral feeding

after they complete 40th week gestational age the investigators repeat the labs again ( serum ca, phosphorus,alp and vitamin D and compare the rate of rise in vitamin D and calcium

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants delivered at a gestational age ≤ 32 weeks
* Birth weight ≤1500 kg

Exclusion Criteria:

* Neonates with major congenital anomalies,
* maternal condition or medications likely to influence vitamin D or calcium metabolism
* neonates not receiving 100 ml/ kg / day of enteral feeds by 14 days of life
Real-Time CAD for Colonic Neoplasia: A RCT

This study assesses the sensitivity and added benefits of computer-aided detection compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.

Failure in polyp detection leads to colon cancer after colonoscopy. Artificial intelligence systems allow real-time computer-aided detection of polyps with high-accuracy. This study will compare GI-Genius, a real-time CAD system to standard colonoscopy in terms of how many colonoscopies detect an adenoma.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing colonoscopy at RUHS
* Age \> 45 years
* No contraindications to colonoscopy

Exclusion Criteria:

* Prior history of subtotal colectomy
Neural Changes in Stroke Patients During Challenging Walking Tasks.

For stroke patients, a challenging, unfamiliar, and more difficult task may increase the likelihood of brain activation to stimulate recovery. Pedal walking and walking with eyes-covered are both difficult and challenging tasks for stroke patients. The investigators intend to study the biomechanics and neural mechanisms of challenging pedal walking and walking with eyes covered.

Stroke participants will wear electroencephalogram electrode caps and perform three tasks: walking on a flat surface for 60 seconds, walking on pedal for 60 seconds, and walking with eyes covered for 60 seconds.

Stroke participants will wear a 32-lead electroencephalogram electrode cap (Zhentai Technology Company, Xi 'an, China), first walk on a flat ground for 60 seconds, rest for 2 minutes, then walk on the pedal for 60 seconds, rest again for 2 minutes, and walk for 60 seconds with eyes-covered.

Eligibility Criteria:
Inclusion Criteria:

* First-time occurrence of stroke confirmed by computed tomography or magnetic resonance imagingClinical diagnosis of stroke
* Disease duration of more than 14 days， less than 1 year
* Able to walk independently but with a lingering abnormal gait

Exclusion Criteria:

* Lesions accumulate in the brainstem
* Lesions accumulate in the cerebellum
* Impaired vision
* Severe cognitive impairment
The Effect of an Aerobic Exercise Programme in Stroke Patients

This study aims to investigate the effect of aerobic exercise on the aerobic capacity, the daily functioning, post-stroke fatigue , depression and cardiovascular risk factors in stroke patients.

People with neurologic impairments after stroke often show decreased aerobic exercise capacity. The etiologies of which are assigned to physiologic changes in paretic muscle, gait deficits and disability-related deconditioning. This declares that stroke patients live an inactive lifestyle and therefore stay cardiovascular risk patients.

The usefulness of aerobic training on aerobic capacity is recently been proved in clinical stroke research. However, no study can shown the long-term effect of aerobic exercises. Also the effect of aerobic exercises on daily functioning, fatigue and depression in stroke needs to be established.

Eligibility Criteria:
Inclusion Criteria:

* First CVA according to the WHO definition (A primary, first ever stroke ash revealed by rapidly developing clinical signs or focal or global disturbance or cerebral function, with symptoms lasting 24 hours or longer or leading to death, with no apparent cause other than or vascular origin.) This includes ischemic infarct or an intracerebral haemorrhage
* The offense can be maximum 3 up to 6 weeks after onset
* Patient must be able to follow simple verbal instructions
* To cycle during 1 minute at 20 Watt, 50RPM,
* Cardiac stable

Exclusion Criteria:

* Have another neurological impairments with permanent damage such as former cranial trauma, multiple sclerosis, epileptic status... which already present were for current CVA
* Having on CVA resembling symptoms as a result of subdural haemorrhage, a tumour, encephalitis or a trauma
* Barthel index \< 50 before the stroke onset
* Age \> 80 year
* No authorisation form of the patient or of the family
* Absolute contra-indications for effort test (ACC/AHA guidelines)
Efficacies of Entecavir Add on HBeAg Negative Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment

The aim of interferon therapy in HBeAg negative chronic hepatitis B was to make patients obtain immune control to hepatitis B virus defined as sustained viral response after treatment. However this target could not be get if patients keep HBV DNA positive during interferon treatment and offend relapse after treatment withdraw. In this trail, entecavir will add on patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon alpha 2a treatment, and the efficacies of the combine treatment will be evaluated by the rate of sustained viral response after 48 weeks of treatment and 24 week follow up.

HBeAg negative patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon alpha 2a treatment would be randomize enrolled into two groups, in Interventional group, patients will receive entecavir combine with peginterferon alpha 2a treatment for 48 weeks and followed 24 weeks. Patients in control group will be continue treated only by peginterferon alpha 2a for 48 weeks and followed 24 weeks after treatment. Serum HBV DNA load, HBsAg/anti-HBs level, HBeAg/anti-HBe will be tested at enrollment and every 3 months during the treatment course. Parameters of Liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. The efficacies of combined therapy were evaluated by the rate of sustained viral response after 48 weeks treatment and 24 weeks follow up compared with control group.

Eligibility Criteria:
Inclusion Criteria:

* HBeAg negative patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon a-2a treatment

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver
Comparison of the Efficacy of Transversus Abdominis Plane Block and Erector Spinae Plane Block in Postoperative Analgesia Management After Abdominoplasty

Introduction: Abdominoplasty involves the removal of excess skin and fat from the abdominal region, rectus sheath plication, and umbilical transposition. The number of cosmetic abdominoplasty procedures has been steadily increasing in recent years. Due to extensive tissue manipulation and large incisions during surgery, postoperative pain has become a significant concern. Studies report that up to 80% of patients experience postoperative pain; however, fewer than half of these patients receive adequate analgesia. Improving postoperative pain control has been shown to facilitate early mobilization, reduce hospital length of stay, lower healthcare costs, and enhance patient satisfaction. Therefore, ensuring effective postoperative analgesia has become a critical aspect of patient management.

Transversus abdominis plane (TAP) block and erector spinae plane (ESP) block are peripheral nerve block techniques that can be used as part of a multimodal analgesia approach for postoperative pain management after abdominoplasty. In this study, we aimed to compare the effects of TAP and ESP blocks on postoperative pain in patients undergoing abdominoplasty.

Aim/Hypothesis:

H0: There is a significant difference in the analgesic efficacy between ultrasound-guided ESP and TAP blocks in postoperative pain management after abdominoplasty.

H1: There is not a significant difference in the analgesic efficacy between ultrasound-guided ESP and TAP blocks in postoperative pain management after abdominoplasty.

Materials and Methods: Our study was designed as a retrospective analysis. Patient records and hospital database will be reviewed to identify all patients who underwent abdominoplasty and received TAP block or ESP block for postoperative analgesia. Demographic data including age, gender, weight, height, body mass index (BMI) and American Society of Anesthesiologists (ASA) classification, as well as comorbidities and medications used will be recorded on case report forms. The type of block performed (TAP or ESP) and postoperative pain scores obtained from pain assessment forms using the Numerical Rating Scale (NRS) at 0, 2, 4, 6, 12 and 24 hours postoperatively will be documented. In addition, data from the patient-controlled analgesia (PCA) device will be recorded, including number of doses demanded (DEM) and number of doses delivered (DEL). Other parameters such as additional analgesic requirements, postoperative nausea and vomiting, itching and patient satisfaction will also be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent abdominoplasty and received TAP or ESP blocks for postoperative analgesia, followed by monitoring with IV PCA.

Exclusion Criteria:

* Cases in which IV PCA was not used, VAS scoring was unavailable, or complications occurred.
Systematic Laryngoscopic Evaluation of Upper Airways in Ventilated ALS Patients in Portugal and in Norway

The study examines if titration of Non-Invasive mechanical ventilation (NIV) settings during ongoing laryngoscopic visualization can improve the compliance of NIV in subjects with Amyotrophic Lateral Sclerosis (ALS). The study is a multicentre study between Norwegian National Advisory Unit on Long-term Mechanical Ventilation at the Thoracic Department, Haukeland University Hospital, Bergen, Norway and Centro Hospital Tras-os-Montes e Alto Douro, Vila Real, Portugal.

ALS, amyotrophic lateral sclerosis, is a rare and fatal disease causing gradual loss of motor neurons and thus loss of function in all skeletal muscle, eventually also in the breathing muscles, leading to respiratory failure and ultimately death. There is no causal treatment. The treatment provided aims to improve life quality as long as possible. Non-invasive ventilation (NIV) compensates for respiratory failure as breathing deteriorates.

ALS patients with bulbar innervated muscle dysfunction (mouth, tongue, jaw, throat, larynx) have poor compliance to the use of NIV. It is not completely understood why bulbar ALS patients fails NIV, although the upper airways have been a suggested cause also of this treatment failure. The investigators in the Norwegian study group has previously examined laryngeal response patterns (using transnasal fiberoptic laryngoscopy ) during mechanically assisted cough in ALS. The studies revealed that Transnasal fiberoptic laryngoscopy was safely performed with ongoing mechanically assisted cough, and it appeared a feasible tool to visualize the laryngeal responses to mechanical cough therapy.

The further hypothesis is that the use of transnasal fiberoptic laryngoscopy during ongoing NIV titration could improve the compliance of NIV treatment in ALS.

Since ALS is a relatively rare disease and it is difficult to perform large clinical studies, a project group has been established and agreed to a common protocol of a population-based multicenter-study including two hospitals, in Bergen in Norway and Vila Real in Portugal.

Aims of the study are:

To investigate the feasibility of video-recorded Transnasal fiberoptic laryngoscopic evaluation of the upper airways applied during NIV titration, and to describe the upper airway responses to NIV treatment in patients with ALS.

To explore whether the endoscopic view of the upper airways will influence the titration of NIV settings in ALS patients.

To explore whether NIV titration with endoscopic evaluation will influence NIV compliance and ventilation effectiveness in ALS patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed Amyotrophic Lateral Sclerosis (ALS) due to El Escorial criteria
* Must have already established Non-invasive ventilation (NIV)

Exclusion Criteria:

* Ages under 18 years
* Unstable ischemic heart disease
* Oncological disease
* Ventilatory support dependency (more than 16h per day)
Male Circumcision and HIV Rates in Kenya

The Luo tribe of Kisumu, Kenya, does not traditionally practice male circumcision (MC). This study will work with the Luo tribe to test the effectiveness of MC on reducing the risk of HIV infections in young men.

Since 1989, numerous epidemiological studies have reported a significant association between lack of male circumcision (MC) and risk for HIV infection through heterosexual intercourse. These results have led to calls for male circumcision to be considered as an additional HIV prevention strategy. However, there is a consensus among the international health community that a randomized controlled trial of MC is needed to control for possible confounding factors. Additionally, known risks associated with MC need further investigation. This study will assess the effectiveness of male circumcision in reducing HIV incidence and will evaluate complications of the MC procedure, changes in sexual behavior following circumcision, and the biological mechanisms by which the foreskin may increase HIV susceptibility. The study will be conducted in Kisumu, Kenya, where the Luo tribe is the main ethnic group and less than 10% of adult men are circumcised.

Uncircumcised men aged 18 to 24 years old will be offered voluntary HIV counseling and testing. HIV negative men will be asked to enroll in the study. All study participants will be interviewed to obtain socio-demographic information and assess behavioral risk factors. Participants will be examined for significant medical conditions. All men will be counseled in strategies to reduce their risk for HIV infection. Consenting men will be randomly assigned to either the treatment (circumcised) arm or the control (uncircumcised) arm of the study. After circumcision, men will be monitored for complications. They will be counseled to abstain from sex until healing is complete. Follow-up visits will occur every 6 months for 2 years. Uncircumcised men will be offered circumcision at the end of follow-up.

The primary study endpoints will be HIV incidence and surgical complications. Additional outcomes will be the incidence of other sexually transmitted diseases and behavioral risks. Additional laboratory studies of foreskin tissue will evaluate the number and density of specialized cells rich in HIV receptors in order to illuminate the biological mechanisms by which presence of foreskin may increase HIV susceptibility.

Eligibility Criteria:
Inclusion Criteria

* HIV uninfected and willing to be tested
* Live in Kisumu District, Kenya
* Uncircumcised but willing to be circumcised
* At least one sexual partner in the 12 months prior to study entry
Nailfold Capillary Blood Flow With Latanoprost Bunod

The purpose of this study is to look at the relationship of small blood vessels irregularities observed with an imaging system called video nailfold capillaroscopy in people with primary open-angle glaucoma. Nailfold capillaroscopy (NFC) is a video camera with a magnifying lens used for studying the movement of blood in small blood vessels. It is simple, safe and does not penetrate the skin. The skin fold that is at the tip of the finger is called the "nailfold". NFC has been used to assess blood vessel narrowing in patients with glaucoma.

In this study, the study team investigates the effect of topically-applied latanoprostene bunod (LTB) on the blood flow at the nailfold of the 4th finger in patients with primary open angle glaucoma. LTB is a new anti-glaucoma eye drop which received FDA clearance in early November 2017. It has two components: the prostaglandin analog (PGA) which decreases intraocular pressure (IOP) by enhancing the drainage of the aqueous (the fluid in the front part of the eye) from the eye, and the nitric oxide (NO) moiety which naturally dilates arteries in the body. The capillaries at the nailfold are comparable to those of the optic nerve head, which makes them a reasonable surrogate for evaluation of the effect of LTB on the blood flow. Therefore, this study may provide indirect evidence for the beneficial effect of LTB on blood flow to optic nerve which can potentially save the optic nerve from glaucomatous damage. Primary open angle glaucoma is a progressive condition and is the most common cause of irreversible blindness worldwide. Primary open angle glaucoma (POAG) is a subset of the glaucomas defined by an open, normal appearing anterior chamber angle and raised intraocular pressure (IOP), with no other underlying disease.

In addition to LTB, the study team will use latanoprost (L), an-FDA approved PGA anti-glaucoma eye drop and normal saline (NS: the physiologic solution composed of 0.9% salt and water), as controls to make sure the effects of LPB on nail fold capillary blood flow is not due to its PGA (as L is) or due to the placebo effect (as NS is).

This study may also serve as background information for the development of new anti-glaucoma medications which can be injected into the eye to facilitate blood flow to the optic nerve.

Eligibility Criteria:
Inclusion Criteria:

* 40 years old to 80 years old
* All participants will have open angles and no signs of secondary glaucoma such as exfoliation syndrome
* Untreated intraocular pressure (IOP) may be ≤ 21mmHg or ≥ 21mmHg in both eyes
* The cup-to-disc ratio (CDR) ≥ 0.6 in both eyes and CDR asymmetry ≤ 0.2.
* POAG patients will have reliable Humphrey Visual Field (HVF) loss consistent with optic nerve damage
* POAG patients can have any stage of POAG and be on any form of treatment for their disease.
* Willingness to sign informed consent and comply with study procedures.

Exclusion Criteria:

* History of non-POAG forms of glaucoma
* Pregnancy
* Inability to give informed consent
Comparison of Urinary Flow Study

The purpose of this research study is to compare the urinary flow speed of two different female catheters in patients that use intermittent catheters to empty their bladder. The "14 Fr Two Eyelet Coloplast Female SpeediCath Urinary Catheter" will be compared to the "14 Fr Coloplast Micro Zone Luja Female Catheter." Participants will have one study visit that should take about an hour and will also receive a follow-up telephone call about one week after the visit.

The purpose of this crossover study is to compare the urinary flow speed of two different female catheters manufactured by Coloplast, the "14 Fr Two Eyelet Coloplast Female SpeediCath Urinary Catheter" vs "14 Fr Coloplast Micro Zone Luja Female Catheter" in patients that use intermittent catheters to empty their bladder. Patients will be randomly assigned to group A or group B using a closed-envelope randomization method. Group A will self catheter with Luja, backfill with sterile fluid volume equal to amount of urine collected, then self-catheter with SpeediCath. Group B will self catheter with SpeediCath, backfill with sterile fluid volume equal to amount of urine collected, then self-catheter with Luja. Outcomes will be measured with office uroflow device.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Regular use of intermittent catheters to empty bladder, for at least 1 month before enrolment
* Age 18 years or older
* Required to adhere to the intervention procedure and not participate in any other clinical studies throughout the duration of this study

Exclusion Criteria:

* Severe urinary tract abnormalities (e.g. excessive production of urinary mucus/sediments/debris)
* Hypersensitive to the ingredients in the catheters being tested
* Recent surgery, within 3 months
* Currently being treated for urinary tract infection
* Being pregnant or breastfeeding
* Non-English speaking
Scorpio Non Restricted Geometry (NRG) Study in Japan

The purpose of this study is to evaluate the range of motion (ROM), mid-flexion stability (gap balance), and implant position (size and angle) for the Scorpio NRG device. Relationship between these parameters and clinical outcomes will be evaluated as well as the importance of rotational tolerance. It is expected that the Scorpio NRG will have good clinical outcomes and perform the same or better than other total knee implants.


Eligibility Criteria:
Inclusion Criteria:

1. Patient who is candidate for primary total knee arthroplasty (TKA).
2. Patient who has diagnosis of osteoarthritis or rheumatoid arthritis.
3. Patient who is age 20 or over.
4. Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
5. Patient who is willing and able to comply with postoperative scheduled evaluations.

Exclusion Criteria:

1. Patient who has a bacterial infectious disease or has a risk high of a bacterial infection.
2. Patient who requires revision surgery.
3. Patient who is morbidly obese, defined as having a Body Mass Index (BMI) \> 40.
4. Patient who is or may be pregnant female.
5. Patient who has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
6. Patient with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
7. Patient who is immunologically suppressed or receiving chronic steroids.
8. Patient who is judged ineligible with specific reason by primary doctor.