cyrilzakka/clinical-trials huggingface dataset:
Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery

Chronic postoperative pain is one of the common perioperative complications, which seriously affects the prognosis of patients. Currently, no specific perioperative pain management strategy has been found to be effective in preventing and treating chronic postoperative pain in patients undergoing spinal surgery. At present, oxycodone has been widely recognized in different surgical populations for the control of acute postoperative pain, but its contribution to chronic postoperative pain remains unknown. Meanwhile, whether pregabalin can reduce the occurrence of chronic postoperative pain remains controversial, and whether the combination of the two drugs can control the occurrence of chronic postoperative pain in a more comprehensive way remains unknown. Therefore, we intend to conduct this randomized-controlled, factorial design study to determine the efficacy and safety of oxycodone combined with pregabalin in the treatment of chronic postoperative pain in patients undergoing spinal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing elective spinal surgery
* Ages equal to or more than 18 years old
* ASA I-III
* Signed informed consent

Exclusion Criteria:

* Previous allergic history to gabapentinoids or oxycodone;
* Patients with aphasia or inability to cooperate with scales assessments;
* Patients with a diagnosed history of psychiatric disorder;
* Known severe insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
* Patients treated with gabapentin/pregabalin in the last three months;
* History of drug abuse;
* Body Mass Index more than 35 kg/㎡;
* Pregnant or breastfeeding woman.
Immunogenicity and Safety Study of SCB-2019 Vaccine as a Booster to COVID-19 Vaccine in Adults

The purpose of this study is to assess the immunogenicity and safety of the investigational SCB-2019 vaccine, administered as a booster dose, to adults who:

* Received primary series with one of the selected authorized or investigational COVID-19 vaccines at least 3 months prior to enrollment.
* Received primary series and a booster dose of CoronaVac at least 3 months prior to enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants at least 18 years of age;
* Individuals willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures;
* Individuals willing and able to give an informed consent, prior to screening;
* Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition;
* Individuals who received primary vaccination series with one of the selected COVID-19 vaccines (Comirnaty, Vaxzevria, or CoronaVac) ≥3 months prior to enrollment; or received primary series and a booster dose (≥3 months after primary series) of CoronaVac, ≥3 months prior to enrollment.

Exclusion Criteria:

* Individuals with fever \>37.5°C (axillary), or any acute illness at baseline (Day 1) or within 3 days prior to randomization;
* Individuals with laboratory-confirmed SARS-CoV-2 infection at Visit 1 (determined by positive Rapid Antigen Test or RT-PCR);
* Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1 (except for primary series with Comirnaty, Vaxzevria, CoronaVac vaccines, or primary and booster dose of CoronaVac), or plan to receive COVID-19 vaccine during the study period;
* Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines;
* Individuals who have received any other investigational product within 30 days prior to Day 1 or intend to participate in another clinical study at any time during the conduct of this study.
Correlation Between MRS (Magnetic Resonance Spectroscopy) and Tumor Response to Radiation Therapy in Breast Cancer

Correlation between MRS and Tumor Response Therapy in Breast Cancer.

Correlation between MRS (Magnetic Resonance Spectroscopy and Tumor Response to Radiation in Breast Cancer

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosed Breast cancer
* Patient is 18 years or older
* Karnofsky performance score \> 70
* No previously irradiated or recurrent breast cancer
* No contraindication to MRS/MRI
* Signed informed consent.
High Dosage Esomeprazole and Baclofen for Therapy of Gastroesophageal Reflux Disease

It has been reported that Baclofen is an appropriate tool in the therapeutic management of Gastroesophageal Reflux Disease. To objectify gastroesophageal reflux combined pH-metry/impedance monitoring was applied to patients with persistent reflux-associated symptoms despite PPI-therapy (40mg esomeprazole for 2 weeks). After provement of pathological findings in the test PPI-dosage was escalated to double standard-dosage for another for weeks. In case of persistent symptoms another ph-metry/impedance monitoring was performed. In case of pathological findings additional baclofen was administered to the therapeutic regime. After 3 months another ph-metry/impedance monitoring was performed. At the time point of the tests a questionnaire was completed.

Aim of the study was to evaluate the influence of high dosage PPI-therapy and additional baclofen in patients with persistent symptoms and objectified gastroesophageal reflux.


Eligibility Criteria:
Inclusion Criteria:

* age between 18-70 years
* informed consent
* patients with persistent reflux-associated symptoms despite PPI-therapy

Exclusion Criteria:

* epilepsy
* synthetic liver diseases
* renal failure
* disability to understand informed consent
Promoting In-Home Activities At a Memory & Aging Clinic

The objective of the proposed study, "Promoting In-Home Activities at a Memory \& Aging Clinic (Pro-Home MeC)", is to assess and improve the feasibility of a physical activity (PA) intervention and the measurement of cognitive outcomes in a memory clinic setting for inactive older adults with mild cognitive impairment (MCI) or mild dementia and to examine how and improve the feasibility and acceptability of the procedures.


Eligibility Criteria:
Inclusion Criteria:

* Age 50+
* Fluent in English
* Diagnosed with MCI or mild dementia
* Physically inactive (\< 150 min/wk of planned PA)
* Able to sit in a chair independently for 15+ minutes

Exclusion Criteria:

* Have significant mental or physical disabilities that lead to inability to perform PA safely (e.g., major stroke)
* Severe uncompensated hearing or visual loss
* Having insufficient decisional capacity to consent to participate in research.
* Lack of safety awareness
* Unwilling to be assigned to Pro-Home MeC or control group
* Currently participating in PA intervention research
Sentinel Lymph Node Biopsy Versus Lymphadenectomy in Endometrial Cancer

To compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage endometrial cancer.

This retrospective study aims to compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage endometrial cancer by reviewing the medical records.

Eligibility Criteria:
Inclusion Criteria:

* ≧ 20 years
* early stage endometrial cancer (FIGO stage I)

Exclusion Criteria:

* Did not receive a complete course of treatment in this hospital, interrupted the treatment halfway (except if the disease continued to deteriorate or caused death during treatment), and did not follow up in this hospital after the course of treatment.
Impact of Body Mass Index on Serum Maternal and Fetal Magnesium Level

Magnesium sulphate is an inorganic salt with multiple therapeutic applications in medicine it has been widely utilized and studied on a diverse set of conditions such as asthma, cardiac arrhythmia and stroke. In pregnant women ,MgSo4 has been used in many cases such as for seizures prophylaxis in preeclampsia, tocolysis in preterm labour and for fetal neuroprotection in immenint preterm delivery.MgSo4 has been used as the standard drug for tocolysis in preterm labour and other drugs have been compared to it.


Eligibility Criteria:
Inclusion criteria:

pregnant women 34 weeks or less admitted to Women's Health Hospital with a diagnosis of :

* sever preeclampsia. It is defined as 1- blood pressure 160/110 mmHg or more 2- proteinurea (+3 or more by dipstick) 3-HELLP syndrome
* threatened preterm labour that will receive Magnesium Sulphate either for tocolysis or neuroprotection.

Exclusion criteria:

- women with more than 34 weeks gestation and with any contraindication for Magnesium Sulphate intake like severe renal impairment or myasthenia gravis.
A Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis

The purpose of this study is to investigate the efficacy of two different corticosteroid ointment application regimens for the treatment of eczema (atopic dermatitis).


Eligibility Criteria:
Inclusion Criteria:

* Meet the clinical criteria for the diagnosis of atopic dermatitis
* Have disease over at least 5% of their total body surface area.
* Less than 18 years of age.
* Families able to comprehend written instructions in English and able to complete questionnaires with assistance if needed.
* Parents/guardians able to understand and willing to sign a parental permission form.
* Children between the ages of 7-17 years willing to sign an age-appropriate assent form.

Exclusion Criteria:

* Patients who are allergic or intolerant of the topical medications employed in this study.
* Lack of follow-up after initial visit or regimen noncompliance.
* Patients who do not have access to a bathtub.
Study Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Psoriasis

The primary objective is to assess the efficacy and safety of etanercept 50 mg administered once weekly in subjects with psoriasis over 12 weeks.


Eligibility Criteria:
Inclusion Criteria: -Adults greater than or equal to 18 years of age with clinically stable plaque psoriasis involving greater than or equal to 10% of the body surface and a minimum Psoriasis Area and Severity Index (PASI) score of 10 at screening. -Failure to respond to, or have a contraindication to, or intolerant to at least 1 of the following systemic or phototherapies at an adequate dose of sufficient duration: Methotrexate (MTX), Acitretin, Cyclosporine, Ultraviolet A (UVA), Ultraviolet B (UVB), Psoralen and Ultraviolet A (PUVA), Fumarate Exclusion Criteria: -Previous treatment with etanercept, antibody to TNF or other TNF inhibitors. -Active guttate, erythrodermic, or pustular psoriasis at the time of the screening or baseline.\&#xd;
Systems Oncology Approach to Optimize Ovarian Cancer Treatment

The overall aim is to identify effective therapeutic strategies to ovarian cancer (OC) using serial tumor, ascites and blood samples, and carry out state-of-the-art sequencing approaches, functional assays and associated bioinformatics to understand mechanisms behind chemoresistance in OC and identify new treatment options for OC patients. In this observational trial, we will systematically collect, analyze and interpret functional, molecular and clinical data from real-world ovarian cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with ovarian cancer
* Available tumor tissue/blood samples

Exclusion Criteria:

* Inability to consent to the study
A Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)

This is an exploratory, randomized, double-blind, multicentre, placebo-controlled study of RTP-026.

The study population will consist of men and women with documented evidence of ST-elevation myocardial infarction (STEMI) referred to primary Percutaneous Coronary Intervention (PCI).

An exploratory, randomized, double-blind, multicentre, placebo-controlled study of RTP-026 to assess safety, tolerability, and efficacy in patients with (STEMI).

The study population is men between 18-80 years and post-menopausal women up to 80 years with documented evidence of STEMI referred to primary PCI with acute onset of chest pain lasting \<12 hours and neutrophil to lymphocyte ratio (NLR) in the range of 7-17 at hospital admission/right after the PCI.

They will be given three 30-minute intravenous infusions of RTP-026 or placebo (the investigational product). The first dose is to be initiated within 2 hours following the establishment of reflow after PCI, and the following two study treatments with 8-hour intervals.

The purpose of this study is to evaluate the safety, tolerability and efficacy of RTP-026 versus placebo in multiple doses.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent for participation in the study has been obtained prior to initiating any study-specific procedures
* Men between 18-80 years of age and post-menopausal women up to 80 years of age
* Acute onset of chest pain of \< 12 hours duration
* STEMI as characterized on ECG by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with a minimum of 1 mm concordant ST elevation or 1 mV ST elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST depression in 2 or more V1 through V4 leads indicating posterior acute myocardial infarction (AMI)
* Eligible for primary PCI
* NLR in the range of 7-17 at hospital admission or right after the PCI

Exclusion Criteria:

* Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry
* Previous exposure to RTP-026
* Time from symptoms onset to primary PCI \> 12 hours
* Previous CABG
* Evidence of active malignant disease
* Ongoing treatment with immune suppressive compounds
* Any condition that, in the view of the investigator, would suggest that the patient is unable to comply with the study protocol and procedures
* Known contraindications to CMR
* ORBI Risk Score \> 10
Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients

This is a Pilot study designed to set up for an randomized clinical trial (RCT) comparing the SeND Home pathway to a standard of care nutrition delivery in critically ill older adult trauma patients. Subjects will be randomized 3:1 to either SeND Home precision nutrition pathway or control arm. Subjects randomized to the SeND Home arm will receive oral nutrition supplements (ONS) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass.

This is a Pilot study designed to set up for an randomized clinical trial (RCT) comparing the SeND Home pathway to a standard of care nutrition delivery in critically ill older adult trauma patients. The SeND Home Pathway supports patients from ICU admission to 2-weeks post-hospital discharge, providing a comprehensive and personalized plan of care carried to completion.

Subjects will be randomized 3:1 to either SeND Home precision nutrition pathway or control arm. Subjects randomized to the SeND Home arm will receive oral nutrition supplements (Ensure shakes) up to 3 times per day while in the hospital and for 4 weeks after discharge. Some subjects in this arm will be asked to participate in an interview after being discharged from the hospital. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers.

Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass. They will also be asked to complete walking and strength tests, and surveys about quality of life.These will be done every 3-7 days during hospitalization, at hospital discharge, and at a 3 month post-discharge follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are at least 60 years old and admitted to the trauma service
* Patients who have had a standard of care CT scan

Exclusion Criteria:

* Expected withdrawal of life-sustaining treatment within 48 hours
* Prisoners
* Unable to provide informed consent
* Non-English speakers
* Traumatic Brain Injury
* Allergic to milk or soy ingredients (Common allergen in Ensure shakes).
* Pregnancy
High-frequency-ultrasound Annular Arrays for Ophthalmic Imaging

The objective of this research is to improve the care of ocular disease and disorders, in particular the changes in the eye associated with diabetes, by providing clinicians with dramatically improved ultrasonic images of the entire eye. The research combines advanced high-frequency, high-resolution ultrasonic annular arrays transducers with new processing techniques designed to overcome several limits that have been reached with conventional high-frequency ultrasound systems. We propose that diagnosis of eye diseases using annular arrays can be more effective than the conventional ultrasound images by at least 50%; i.e., that for every 2 posterior vitreous detachments detected conventionally, 3 will be detected with the annular arrays.

In this study, we will deploy annular-array systems and assess their experimental and clinical utility for ophthalmic imaging. We hypothesize that a 20-MHz annular array will detect posterior vitreous detachment (PVD) more reliably than a conventional single element ultrasound system. Clinically, we will test the hypothesis that 20-MHz annular arrays improve detection of PVD, an important risk factor for disease progression in diabetic retinopathy. Diabetic retinopathy is the leading cause of blindness in the working population (25 to 65 years) and the third major cause of legal blindness in the U.S.

We propose to carry out a study of 30 human subjects, aged 60 years or above, in whom PVD is likely to be present as a consequence of normal aging. The study will compare the ability to detect PVD using a commercial ophthalmic ultrasound system equipped with 10- and 20-MHz sector scan probes (Cinescan A/B-S, Quantel Medical), and OCT (OCT/SLO, Ophthalmic Technologies, Inc.), and the 20-MHz annular array. The annular array will be used with synthetic focusing and simulated single-element mode. The end point will be the fraction of eyes in which the PVD is visualized with each technique. This comparison is designed to demonstrate the improvement in our ability to visualize this pathologic entity using the advanced signal processing modes to be explored in this study. PVD can represent a risk factor for retinal detachment and retinal neovascularization in diabetics and localization of vitreoretinal traction points may be crucial for management. The present study, however, is limited to visualization of PVD in older normal subjects, about 75% of which would be expected to have PVD present. Thus, our aim is purely to develop an improved imaging modality rather than demonstrating its clinical efficacy in management of diabetic retinopathy or other ocular diseases.

The imaging technologies that we are developing could potentially result in patents or other intellectual property, which would be managed by the Cornell Research Foundation and Riverside Research Institute. This is alluded to in the consent form for the sake of completeness.

Eligibility Criteria:
Inclusion Criteria:

* Subjects should be age 60 or older with possible posterior vitreous detachment in the back of the eye.

Exclusion Criteria:

* none
NGS Assessment of Congenitally Deafned Children and Neonatal Deafness Screnning

To assess the diagnostic value of NGS screnning in prelingually deafned children using a new designed chip, and to evaluate its interest in a the neonatal screening program for ddetecting congenitally deafned children.

The aim of the study is to evaluate the diagnostic value of a new panel of gene in NGS study in children presenting :

1. A congenitally deafness : it is a retrospective study in children aged 0 to 17 yrs with hearing thresholds over 40 dB in the best ear using adapted audiometric assessment,
2. A suspicion of deafness in babies aged 0 to 6 months having an abnormal response after otoacoustic emissions and automated ABR assessment.

The main outcomes studied will be the finding of a pathogenic mutation (or several mutations).

Eligibility Criteria:
Inclusion Criteria:

* Retropective study

Inclusion criteria:

* Age of onset of deafness between 0 and 17 years
* With a hearing loss of one or two senses with, on the ear most affected, a hearing loss more than 40 dB in mean audiometric loss in behavioural audiometry
* Availability of detailed information in Appendix 1: History, history and course of disease, associated symptoms, otoscopy data, radiology, treatments and hearing aids implemented.
* Availability of DNA samples stored in an existing collection.
* Consent to participate in the study (non-opposition) by the legal representative

Exclusion Criteria:

* Exclusion criteria:

  * Child with a known cause of observed deafness (meningitis, post-surgery or drug iatrogenic, trauma, infections, tumor)
  * Family not willing to participate in the study

Prospective study

Inclusion criteria:

* Age of the child 0 to 6 months including corrected age having had on at least one of the two ears a lack of acoustic otoemissions and a lack of response in automated PEA, and a threshold of PEA at least on one ear at more than 40 dB.
* Availability of detailed information in Appendix 2: Personal history, family history of deafness, associated symptoms, tympanometry, otoscopy data, neonatal deafness test data.
* Collection of the consent of the legal representative

Exclusion criteria:

· Family not willing to participate in the study
Pendant Position and Traditional Sitting Position for Successful Spinal Puncture in Spinal Anaesthesia

The aim of this study was to compare the successful spinal puncture among patients with pendant position in comparison with those who used traditional sitting position for caesarean section.

Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Subjects were divided into Group A for traditional sitting position (n=154) and Group B for pendant position (n=154). The outcome parameters recorded were the number of attempt for the successful spinal puncture, the number of spinal needle-bone contact and the duration to perform spinal puncture. Data were analyzed by using Statistical Package for Social Scientist (SPSS) version 21.0. Numerical data was served in median with minimal and maximal value. Numerical data was analyzed by using Mann-Whitney test. Categorical data was served by using relative risk (RR) with 95% confidence interval (95% CI) and was analyzed by using Chi-Square test.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women aged 18-45 years old
* Body Mass Index (BMI) 18-35 kg/m2
* physical status American Society of Anesthesiologists (ASA) I-III
* planned to undergo cesarean section with spinal anesthesia and signed the informed consent form

Exclusion Criteria:

* Patients with any contraindication for spinal anesthesia (infection on injection site, coagulation disorder, severe hypovolemia, increased intracranial pressure, aortic and/or mitral stenosis)
* pregnancy with head entrapment of the fetus, umbilical cord prolapse, feet presentation,
* Patient with eclampsia
* Patient with cardiovascular diseases
* Patient with scoliosis
* Patient with history of lumbar surgery
* Patient with unpalpable intervertebral space due to thick fatty tissue or edema.

Drop out criteria:

- spinal block was failed or only partial block