cyrilzakka/clinical-trials huggingface dataset:
The Aim of Study is to Identify the Predictive Factors for the Success of Transforaminal Epidural Injection in Treatment of Patients with Lumbosacral Radiculopathy

the aim of the study is to identify predictive factors for the success of transforaminal epidural injection in the treatment of patients with lumbosacral radiculopathy

Lumbar radicular pain (known as sciatica) represents a prevalent medical and socioeconomic problem.

More than half of the patients with sciatica report a decline in their activities of daily living and ability to work.

Mixed Pathologies as foraminal stenosis, spondylolisthesis, and space-occupying lesions in the lumbar spine can cause Sciatica but the most common cause is lumbar disc herniation. (1) Overall, the vast majority of patients with lumbosacral radiculopathy recover with conservative care as trial of bed rest, oral medications, lumbar corsets and physiotherapy. (2) The involvement of inflammation has attracted the use of steroids (corticosteroids) to reduce the inflammation and, thereby, relieve the pain. Injections of steroids, by various routes, have been used as an alternative to surgery, and as an alternative or complement to conservative therapy, for the treatment of lumbar radicular pain. (3) Steroids are believed to have a therapeutic effect due to their anti inflammatory properties.

This belief is supported by evidence from in vitro studies that show that steroids have a role in decreasing inflammatory mediators such as cytokines and chemokines another study suggests that steroids may provide a stabilizing effect on nociceptive signaling in C-fibers and suppression of ectopic neural discharges. (4) The most widely used injection therapy is epidural injection of steroids, by either the interlaminar route or the caudal route. More contentious are transforaminal injections of steroids. These involve the injection of steroids directly and accurately onto the affected spinal nerve, under radiologic guidance. Meanwhile, transforaminal injection of steroids has been shown to be more effective than interlaminar injection of steroids (5) Transforaminal epidural injection may be by autologous Platelet Rich Plasma (PRP) as a novel pharmaceutical agent that has strongly emerged in recent years to treat patients of lumbar disc herniation.(6)

Eligibility Criteria:
Inclusion Criteria:

- 1.Patients who underwent lumbosacral transforaminal epidural injection at the level of L4-5, L5-S1, or S1 neural foramina 2.Patients age 18 to 60 years 3.Patients had been symptomatic longer than 6 Weeks with Leg pain more than back pain with failure conservative treatment.

4.Patients had undergone an MRI Lumbosacral imaging scan documenting disc prolapse

Exclusion Criteria:

* 1- Patients had previous lumbar surgery 2- Patients had a large herniated disc with severe central or foraminal stenosis on magnetic resonance imaging 3- Patients had Scoliosis , spondylolisthesis or malignancy 4- patients with neurological deficit. 5-Patients had a blood coagulation disorder, or had experienced an allergic reaction to local anesthetics or corticosteroids.
Vaccine-Related Pain in Infants

This is a randomized double-blind controlled study and was performed to compare effects of rapid injection without aspiration and 10-second manual pressure before injection on pain severity and crying time in 4-6-month-old infants given the vaccine DTaP/IPV/Hib.

The study population included all the infants presenting for DTaP/IPV/Hib to two family health centers between April and August in 2015. The study sample included 128 infants based on confidence interval of 95% and statistical power of 80%. The sample was divided into four groups; i.e. manual pressure, rapid injection without aspiration, manual pressure combined with rapid injection without aspiration and control groups. There were 32 infants in each group. Gender was adjusted in all groups. Stratified and block randomizations were used.

Study design: this is an experimental, double-blind, randomized controlled trial.

Study population and study sample: The study was conducted in two family health centers of Cankiri Public Health Directorate, Turkey, between April and August in 2015. The study population included infants aged 4-6 months and presenting to the family health centers for the second and third doses of DTaP/IPV/Hib. The study sample comprised of 128 infants based on confidence interval of 95% and statistical power of 80%. Analysis made at the end of the study showed a statistical power of 0.83 based on confidence interval of 95%.

Outcome Measures

Pain severity: Video recordings obtained were evaluated by two pain specialists separately by using Neonatal Infant Pain Scale. The specialists were blinded to the groups to eliminate possible mistakes in observations and the possibility of taking sides and to avoid bias. The scores assigned by the specialists were used to determine pain scores before, during and after vaccine injections.

Crying time: Video recordings taken were watched by the same researcher and crying time before, during and after vaccine injections was calculated for each infant.

Physiological Changes (heart rate and oxygen saturation): the probe of pulse oximetry was attached to the foot not injected vaccine to measure oxygen saturation and heart rate before, during and after the injections in each child.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants who were aged 4-6 months, had the percentiles of 3P - 97P, were born at term and were not given any analgesics before immunization and whose mothers gave written informed consent were included.

Exclusion Criteria:

* Infants whose percentiles were below 3P and above 97P and who had acute infectious diseases, underwent topical anesthesia and/or took analgesics were excluded from the study.
Intravitreal Aflibercept for Macular Edema Due to Central Retinal Vein Occlusion

Central retinal vein occlusion (CRVO) is a common retinal vascular disorder, occurring when there is a blockage to the main blood vessel that transports blood away from the retina. CRVO may cause visual impairment, especially due to macular edema (swelling of the macula due to fluid accumulation) and macular non-perfusion.

Aflibercept has been found to improve visual acuity and reduce macular thickness in pivotal trials.

The purpose of this study was to evaluate the efficacy and safety of intravitreal aflibercept in real-world, using a patient-fitted treatment regimen. Additionally, imaging parameters have been assessed before and after treatment with intravitreal aflibercept.


Eligibility Criteria:
Inclusion Criteria:

* Treatment naive center-involved macular edema secondary to CRVO for no longer than 3 months.
* Patients \>18 years of age, who are diagnosed with macular edema secondary to CRVO who are scheduled to be treated with intravitreal aflibercept in real-life conditions
* BCVA of Snellen of 20/40 to 20/200 in the study eye

Exclusion Criteria:

* Previous PRP or macular laser photocoagulation in the study eye.
* Any prior ocular treatment in the study eye for macular edema secondary to CRVO.
* Prior systemic anti-VEGF or corticosteroid therapy, within the last 3 months before enrollment to the study.
* Any active or previous inflammation, ocular trauma
* Uncontrolled glaucoma (IOP\>30 mmHg)
MR Radiomic Features in Prostate Cancer

A combination of correct interpretation of imaging and biopsy has given promising results in terms of detecting clinically significant cancer at radical prostatectomy.

Quantitative approaches to medical image analysis have been developed in recent years with the aim to overcome the limitation of qualitative image interpretation, and provide biomarkers for disease characterization. In particular, the new paradigm, "radiomics", is emerging as the high-throughput extraction of quantitative features from imaging which can aid in characterizing phenotype as in vivo expression of tumoral genotype. The goal of radiomics is to extract accurate and reliable quantitative biomarkers which enhance diagnostic confidence in oncology. A combination of correct interpretation of imaging and biopsy has given promising results in terms of detecting clinically significant cancer at radical prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* In house MRI with contrast medium
* PCa (prostate cancer) biopsy proven diagnosis
* In house radical prostatectomy

Exclusion Criteria:

* \< 18 years of age
* MRI without contrast medium
* Radical prostatectomy executed not in Institution
Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)

The purpose of this study is to assess the efficacy and safety of MK-8237 (SCH 900237) in the treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis (AR/ARC) in children and adults.

The primary hypothesis of this study is that administration of MK-8237, compared to placebo, results in significant reduction in the average total combined rhinitis score (TCRS).


Eligibility Criteria:
Inclusion Criteria:

* History of AR/ARC to house dust of 1 year duration or more (with or without asthma)
* If female of childbearing potential, has a negative urine pregnancy test at Screening and agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the study
* Able to read, understand and complete questionnaires and diaries

Exclusion Criteria:

* Clinically relevant history of symptomatic ARC caused by animal dander, molds and/or cockroach (e.g. present in the home, job, daycare, etc.) or other perennial allergen
* History of symptomatic seasonal ARC and/or asthma due to an allergen to which the participant is sensitized and regularly exposed
* Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyposis)
* Received an immunosuppressive treatment within 3 months prior to screening
* Unstable or severe asthma, or has experienced a life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids (but allowing short-acting beta agonists \[SABAs\]) at any time within 3 months prior to screening
* Asthma requiring high-dose inhaled corticosteroids (ICS) within 6 months prior to screening
* History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause or inhalant allergen
* History of chronic urticaria and/or angioedema within 2 years prior to screening
* History of chronic sinusitis during 2 years prior to screening
* Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study
* Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening
* Previous exposure to MK-8237
* Receiving ongoing treatment with any specific immunotherapy at screening
* Known history of allergy, hypersensitivity or intolerance to investigational medicinal products (except for D. pteronyssinus and/or D. farinae), rescue medications or self-injectable epinephrine
* Unable to meet medication washout requirements prior to screening
* Unable or unwilling to comply with the use of self-injectable epinephrine
* Business or personal relationship with investigational site personnel or Sponsor who is directly involved with the conduct of the study
* Likely to travel for extended periods of time during the efficacy assessment period
* Participating in a different investigational study at any site during this study
Invasive PGT-A Embryo Selection Versus Non Invasive PGT-A Assisted Embryo Selection

This is a prospective randomised study of the evaluation of the clinical IVF results after invasive PGT-A embryo selection versus Non-invasive PGT-A assisted embryo selection in subfertile women.

A randomized prospective study focusing on subfertile women undergoing IVF treatment followed by embryo transfer on the blastocyst stage.

Women assigned to group A proceed to embryo transfer, after invasive PGT-A embryo selection, while women of group B after non-invasive PGT-A assisted embryo selection.

IVF outcomes, regarding the success rate of the trasnfer and the time required to achieve conception is studied in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Women who followed IVF treatment
* 40 years old or older
* Single embryo transfer
* blastocyst stage cultured embryos

Exclusion Criteria:

* women under the age of 40 years
* not blastocyst transfer (transfers performed at earlier embryo stage)
* double embryotransfer
* women who had embryotransfer according to morphological criteria women whose embryos were not time-lapse monitored
Does Low Flow Anesthesia Reduce Postanaesthetic Emergence Agitation?

In this study, the investigators aimed to compare postanesthetic agitation in patients undergoing laparotomic gynecological surgery under general anesthesia using sevoflurane at a fresh gas flow rate of 2 L / min with fresh gas flow rate of 0.5 L / min.

Emergence agitation is a temporary state of mental anxiety that occurs during general anesthesia recovery. It is characterized by emergence agitation, hallucination, excitation, delusion and confusion. Increased hemorrhage due to hypertension may cause serious complications such as injury to the surgical site, patients' self-removal of surgical drains and catheters, and self-extubation. Due to these, emergence agitation results need for additional treatment, psychological stress and increased medical workload for patients and their families.

Emergence agitation after general anesthesia in adult patients was reported up to 20%. However, the ratios are very wide.

In our operating room, the investigators observed that patients with low flow anesthesia were less agitated in the recovery phase than patients with normal flow anesthesia. In our researches, the investigators have not found any studies on the agitation values of patients who underwent low flow anesthesia in the literature.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1 and 2, underwent gynicological laparotomic surgery under general anesthesia, followed up in PACU(postoperative care unit)

Exclusion Criteria:

* ASA 3 or 4, mental retardation, psychiatric disease, history of malignant hyperthermia in patient or her family, neurological disease, morbid obesity, history of asthma and follow-up in the intensive care unit.
Determination of the Biological Activity of Enriched Serums on Healthy Volunteers After Consumption of the Kera-Diet® Ingredient

The main objective of this study is, after collecting serum enriched with metabolites of interest resulting from the ingestion of the Kera-Diet® food supplement, to determine the influence of these sera enriched with circulating metabolites (versus naïve sera) on the behavior of human cell cultures, placed under stress conditions or not, in order to evaluate the benefit of these metabolites in maintaining cellular functions.


Eligibility Criteria:
Main inclusion Criteria:

* Liver function tests within reference norms.
* Kidney function tests within reference norms.
* Complete blood count (CBC) within reference norms.
* C-reactive protein (CRP) within reference norms.
* Blood pressure compatible with study requirements.
* Non-smoker or occasional smoker (max 5 cigarettes/day or max 10 ml per week of e-liquid with a nicotine concentration of 3 mg/ml).
* Max 5 hours of intense sports per week.
* Weight ≥ 60 kg.
* BMI between 20 and 28 kg/m² (exclusive).

Main exclusion Criteria:

* Any type of vaccination within the past month.
* Alcohol consumption exceeding WHO standards (Sup. 3 drinks per day for men).
* Ongoing treatment (medication, dietary supplement, or probiotic) and within the four weeks prior to inclusion.
* Known pathology (including seasonal).
* Allergy to the study product, particularly to keratin or certain amino acids.
* Individuals following a diet unsuitable for the study (e.g., vegetarian, vegan, or plant-based diets).
* Change in eating habits within the 4 weeks prior to inclusion.
* Medical and/or surgical history deemed incompatible with the trial by the investigator or their representative.
Reading Ability in Childhood Obesity

There is some evidence about the negative impact of overweight and obesity on reading ability, with negative consequences on quality of life and school success.

In this neuropsychological research, the relationship between the characteristics of reading abilities in individuals with obesity (age range between 11 and 16 years) and the skills of motor coordination, postural stability, manual dexterity, including graphomotor skills, and estimation of time is investigated according to the cerebellar deficit theory.


Eligibility Criteria:
Inclusion criteria

• diagnosis of overweight or obesity

Exclusion criteria:

• concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.
Lifestyle Hub Pilot Study

This study will examine the effects of a smartphone-based lifestyle medicine (LM) for improving psychological well-being in Chinese population. Since a range of lifestyle factors are involved in the pathogenesis and progression of common mental disorders (e.g., depression and anxiety), modifying different lifestyle factors simultaneously may be effective to improve our psychological well-being. Chinese dietary recommendations will be integrated into the app to increase the acceptability towards mental health intervention. Through this study, we aim to promote evidence-based patient care and to improve help-seeking and access to evidence-based interventions for improving psychological well-being.

This study will be a randomized controlled trial on the effects of a culturally adapted self-help smartphone-based lifestyle medicine for improving psychological well-being in Chinese population. Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). Around 30 eligible participants will be randomly assigned to either smartphone-based lifestyle medicine (LM group) or the waitlist control group (WL group) in a ratio of 1:1.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong residents
* Aged ≥ 18 years
* Able to read Chinese and type in Chinese or English
* Have an Internet-enabled mobile device (iOS or Android operating system)
* Are willing to provide informed consent and comply with the trial protocol

Exclusion Criteria:

* Have a Patient Health Questionnaire (PHQ-9) score ≥ 10
* Have a Generalized Anxiety Disorder 7-Item Scale (GAD-7) ≥ 8
* Current involvement in psychotherapy or unstable medication for depression and/or anxiety
* Beck Depression Inventory (BDI-II) Item 9 score of at least 2 indicating a current moderate suicidal risk that requires active crisis management (referral information to professional services will be provided to those with serious suicidal risk)
* Are having unsafe conditions and are not recommended for physical activity or a change in diet by physicians
* Having major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to the lifestyle modification
Motivational Interviewing for PrEP Uptake

The aim of the proposed supplemental study is to test a single session motivational interviewing (MI) program designed to promote the acceptance and use of PrEP for high-risk young Black men who have sex with men (YBMSM) and to determine whether previous assignment to study condition moderates these outcomes.

The aim of the proposed supplemental study is to test a single session motivational interviewing (MI) program designed to promote the acceptance and use of PrEP for high-risk young Black men who have sex with men (YBMSM) and to determine whether previous assignment to study condition moderates these outcomes. In the parent study we had the foresight to include a cross-sectional survey of men's attitudes toward PrEP use as part of their first follow-up assessment. Using that data, we will identify the predictors of readiness to accept PrEP and we will use these findings to inform the design of a brief Motivational Interviewing session (MI-PrEP) that will promote uptake of PrEP. We will enroll 65 YBMSM who have completed the 12-month follow-up assessment from the parent study and 35 YBMSM (same inclusion criteria) from either of two clinics used in the parent study (the Crossroads Clinic or the Open Arms Clinic) who did not participate in the parent study. Using small block randomization, these 100 men will be assigned to the MI-PrEP condition or to the standard of care only control condition. At the conclusion of the enrollment session men will be asked if they would like to schedule an appointment to begin taking PrEP. This same offer will be made again approximately 14 days after the enrollment session. The dependent variables will thus include measures of whether men made/kept an appointment to begin PrEP and, if so, how much time elapsed before doing so and whether they filled the prescription for PrEP. For those who do fill the prescription we will test their blood for levels of tenofovir and emtricitabine after 3 months of time has elapsed. Group differences (Intervention vs. Control) in uptake, time to uptake, and actual use/adherence of PrEP are hypothesized to favor those receiving the MI-PrEP intervention program. If this is the case then an initial body of evidence will exist supporting the potential efficacy of a Motivational Interviewing-based, single session intervention that can be delivered to YBMSM in clinical settings.

Eligibility Criteria:
Inclusion Criteria:

self-identify as being Black/African American and they must be 18 to 29 years of age. In addition, these men must answer yes to the following screening question: "have you had anal sex with a male in the past 6 months?" Also, to be eligible all men (including those having completed the 12-month follow-up assessment in the parent study) must have an HIV-negative test result in the past 30 days.

Exclusion Criteria:

already taking PrEP
Identifying Landmark Factors of Anal Fistulas

The goal of this observational study is to understand the effects of anatomical factors, etiology, and complexity of anal fistula on the prognosis of patients undergoing anal fistula surgery within one year post-operation.The main question it aims to answer is:

Which factors are indicative of the prognosis of anal fistula surgery? Which factors are landmark factors of anal fistulas?

Participants who have already undergone anal fistula surgery at our hospital will receive outpatient and telephone follow-up to assess their prognosis.

The search function of the electronic medical record system and surgical records were used to screen patients. For the enrolled patients, the electronic medical record system, imaging report query system, medical order system, outpatient follow-up and telephone follow-up were used to collect data Data were entered into Excel 2021 (Microsoft Corp., Redmond, WA, USA) and checked for errors before conducting statistical analyses using R software (version 4.2.2; The R Foundation, Vienna, Austria).

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with an anal fistula through clinical and radiological examinations; surgeries performed by physicians at our hospital who had at least a title of Associate Chief Physician, with operative records completed after surgery; patients with complete clinical data; and patients who completed post-operative outpatient follow-up and agreed to participate in telephone follow-up surveys.

Exclusion Criteria:

* Patients who were assessed clinically as unable to tolerate surgery; patients who refused surgical treatment; and patients who failed to complete the outpatient follow-up, refused telephone follow-up, or were lost to follow-up.