cyrilzakka/clinical-trials huggingface dataset:
Exploring 8-iso Prostaglandin F2α and Adenosine Deaminase Levels in Periodontal Health and Disease

This study aims to assess the diagnostic potential of gingival crevicular fluid (GCF) biomarkers, specifically 8-iso Prostaglandin F2α (8-iso-PGF2α) and adenosine deaminase (ADA), in evaluating periodontal health and disease conditions.

Conducted as a single-blind, cross-sectional investigation, this study comprised 26 individuals categorized as periodontally healthy, 27 with gingivitis, and 27 diagnosed with periodontitis. The participant pool included individuals with various periodontal concerns who were referred to the Department of Periodontology Clinic at Kahramanmaraş Sütçü İmam University. The classification of periodontal health, gingivitis, and chronic periodontitis adhered to the 2018 criteria outlined by the European Federation of Periodontology

Eligibility Criteria:
Inclusion Criteria:

* Patients having more than 20 teeth, minimum age 18, maximum age 65

Exclusion Criteria:

* Patients with systemic disease, Active smokers, Pregnant women, individuals with a history of orthodontic treatment, or those who had undergone periodontal treatment, regardless of whether it was surgical or non-surgical (within the last one year),
Prospective Study to Determine the Factors Influencing Infant Colic

Randomized study to determine the effect of a commercialized combination of 2 probiotic strains (Bifidobacterium Longum and Pediococcus pentosaceus) and the impact of feeding type in babies diagnosed with colic under Roma IV criteria when administered for 21 days.

Randomized, single-blind, interventional study with two parallel groups to determine the effect of two different commercialized probiotic products (Lactobacillus reuteri or a combination of two different strains (Bifidobacterium longum and Pediococcus pentosaceus)) and the impact of feeding type in babies diagnosed with colic under Roma IV criteria. Infants meeting selection criteria are randomized 1:1 and stratified according to the type of feeding (breastfed or formula).

Probiotics are administered once a day (5 drops) for 21 days. Parents must document clinical parameters during this 21 days. This parameters include colic-related symptoms, other functional gastrointestinal disorders symptoms, parental anxiety and adverse events.

Moreoever, stool samples are collected to determine intestinal microbiota and calprotectin levels.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants from 2 to 12 weeks of age
* Infants diagnosed with infant colic following Roma IV criteria for clinical research
* Gestational age greater or equal to 37 weeks
* Birth weight greater than 2100 g
* Exclusively breastfed or formula fed with a maximum of one daily intake of breast milk.

Exclusion Criteria:

* Infants that are fed with solid food.
* Infants whose parents can not appropriately follow the requirements of the study.
* Antibiotics or probiotics administration to the infant (including infant formula with probiotics) 2 weeks prior the inclusion in the study.
* Breastfed infants whose mothers have taken antibiotics and/or probiotics 2 weeks prior the inclusion in the study.
* Infants fed extensively hydrolyzed infant formula
* Specific medication use for the treatment of functional digestive disorder: antacids (IBP type or H2 blockers), laxative Polyethylene glycol (8PEG), lactulose, magnesia), lactase or simeticone.
* Infants going through therapies related with acupuncture, homeopathy, medicinal herbs, or taking anti-inflammatory or antispasmodic drugs.
The MONITOR Study: Remote Monitoring Of a Nutrition Intervention To Optimize Treatment Response

The purpose of the study is to evaluate the feasibility and acceptability of a remote nutrition coaching and monitoring intervention during the 12-weeks of active chemotherapy for borderline resectable and locally advanced pancreatic cancer participants.


Eligibility Criteria:
Inclusion Criteria:

* Men or women 18 years of age or more
* Newly diagnosed, in place tumors of the pancreas
* No documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis)
* Able to speak and read English
* Able to consume food orally
* Chemotherapy naive
* Scheduled to receive treatment with chemotherapy
* Able to provide verbal informed consent

Exclusion Criteria:

* Women who are pregnant
* Pancreatic cancer not the primary diagnosis
* Patients on enteral or parental nutrition
* Patients with metastatic pancreatic cancer
* Patients with evidence of impeding bowel obstruction
* Patients presenting with ascites
Ketamine Versus Morphine Change Pain Profile

The aim of this study is to evaluate the efficacy of intravenous low dose ketamine infusion versus morphine infusion analgesia for pain reduction in Abdominoplasty surgery

Abdominoplasty is considered one of the most commonly performed cosmetic procedures. According to statistics from the International Society of Aesthetic Plastic Surgery, a total of 758,590 abdominoplasties were performed in the world in 2016. This is an increase of 72.95% in comparison with 2011, making it the fourth most common cosmetic procedure. Given the increasing number of abdominoplasties performed, the importance of understanding the possible complications and morbidity associated with the procedure is critical. One of these complications is the postoperative pain. With adequate postoperative pain control, the patients met discharge criteria sooner and this helps in shortening the hospital stay, better overall patient satisfaction, and decreased hospital costs. Therefore, the severity of this problem and the all drug agent used to prevent and treat postoperative pain best interest to be aware in the anesthesiologists. Traditionally, analgesia for abdominal wall surgery is provided either by systemic drugs such as opioids, nonsteroidal anti-inflammatories, alpha 2 agonists and paracetamol or by epidural analgesia. However, Opioids, such as morphine or fentanyl, remain the mainstay of postoperative analgesic regimens for patients after abdominal wall surgery. The pain is not always fully relieved by such agents, and often patients develop tolerance to them. The ever-increasing doses of opioids are clearly not without their adverse effects. (5) For this Alternative approaches, which reduce the requirement for strong opioids post-operative, are required. Recently, interest has focused on the use of N-methyl-D-aspartate (NMDA) receptor antagonists for the management of postoperative pain. Ketamine exerts its main analgesic effect by antagonism of NMDA receptors that not only abolishes peripheral afferent noxious stimulation, but it may also prevent central sensitization of nociceptors as shown in animal studies with the excellent analgesic property even in subanesthetic doses. (6) Various recently published studies have talked about the analgesic effect of low-dose ketamine (7,8) however, all of this study are relatively short procedure time, reduced surgical stimulation and small sample size. The aim of this study is to evaluate the efficacy of intravenous low dose ketamine infusion versus morphine infusion analgesia for pain reduction in Abdominoplasty surgery

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II
* patients aged between 18-50 years old. -

Exclusion Criteria:

* those who refused to participate
* ASA physical status III, IV, patients younger than 18 years or older than 50 years old
* super morbid obesity with BMI 50, history of epilepsy
* patients having a history of parenteral or oral analgesics within the last 24 hours before
* initiation of operation
* those having an allergy to study agents.
Evaluation of the Impact of Hospitalization in Intensive Care for COVID-19 Infection

To evaluate the psychological, physical, social, professional and family impact of a hospitalization in intensive care for a covid 19 by analysis of the verbatim during a semi-structured interview.


Eligibility Criteria:
Inclusion Criteria:

* All patients hospitalized in intensive care at CH Dron for a COVID 19 who have given their agreement during their follow-up consultation

Exclusion Criteria:

* Minor patient
* Patient does not speak French
* Refusal to participate
Latent TGF-β-binding Proteins Affect the Fibrotic Process in Renal Impairment and Cardiac Dysfunction

The project is planed to explore the impact of LTBP4 and other matrix protein and potentially related biomarkers on renal outcomes, cardiac outcomes and all-cause mortality in patients with suspected acute coronary syndrome (ACS).

The investigators will collect the blood samples from patients with suspect ACS. LTBP4 will be the first matrix protein that are going to understand. Upon hospital arrival, blood samples around 8 ml will be collected and the 2nd collection will be two weeks to one month after the event. The third collection will be one year later. In the between, if any ACS event develop, blood samples will be collected as protocols.

Eligibility Criteria:
Inclusion Criteria:

- acute coronary syndrome patients

Exclusion Criteria:

- cardiogenic shock, pregnancy, end-stage renal disease
ER/LA Opioid Surveillance for Emergency Department Visits and Hospitalizations for Overdose and Poisoning

Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency Department visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.

As part of the FDA-approved plan to evaluate the effects of the REMS program, the REMS Program Companies (RPC) are required to submit FDA assessment reports on a regular basis. The present study is one of several program evaluation components carried out in support Assessment 5: Surveillance monitoring for misuse, abuse, overdose, addiction, death and intervention taken. This study will evaluate the impact of the ER/LA opioid REMS program on the incidence of ED visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.

Eligibility Criteria:
Inclusion Criteria:

1. At least one dispensing of an ER/LA opioid after 01 July 2010
2. At least six months of continuous health plan eligibility prior to the first recorded dispensing of an opioid that occurs during an included REMS period

Exclusion Criteria:

1. Missing or implausible values for age
2. Missing or implausible values for gender
Impact of Group Size in Weight Loss Interventions

The present study will assess whether the size of treatment groups (groups of 10 vs. 30 participants) affects short- and long-term weight loss. It is hypothesized that participants assigned to a small group will exhibit similar short-term and long-term weight losses (i.e., weight loss at months 6 and 12) as compared to those assigned to a large group.


Eligibility Criteria:
Inclusion Criteria:

* Adults (at least 21 years-old)
* Health insurance coverage with Capital Health Plan (CHP)
* Body mass index BMI between 30-45 kg/m2

Exclusion Criteria:

* BMI is less than 30 kg/m2 or greater than 45 kg/m2
* Weight loss \> 10 pounds in past 6 months
* Acute or chronic illnesses for which weight loss is contraindicated
* Unwilling or unable to give informed consent
* Unwilling to accept random assignment
* Unwilling or unable to travel to CHP clinic for assessments and groups
* Likely to relocate out of the area in the next 12 months
An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women

The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women, aged ≥ 55 to ≤ 90.
* Received oral bisphosphonate therapy for at least 3 years immediately prior to screening
* BMD T-score ≤ -2.50 at the lumbar spine, total hip or femoral neck
* History of nonvertebral fracture after age 50, or vertebral fracture.

Exclusion Criteria:

* Use of other agents affecting bone metabolism including Strontium ranelate, fluoride (for osteoporosis), odanacatib (MK-0822) or any other cathepsin K inhibitor, IV bisphosphonates, denosumab, teriparatide (TPTD) or any parathyroid hormone (PTH) analogs, Systemic oral or transdermal estrogen, selective estrogen receptor modulators (SERMs), activated vitamin D3, vitamin K2, calcitonin, tibolone, cinacalcet, systemic glucocorticosteroids:
* History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of study results, such as sclerosteosis, Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome.
* Vitamin D insufficiency, defined as 25 (OH) vitamin D levels \< 20 ng/mL, as determined by the central laboratory.
* Current hyper- or hypocalcemia
* Current, uncontrolled hyper- or hypothyroidism
Ureteric Identification Using Indocyanine Green Dye Versus Conventional Ureteric Stenting to Reduce Post-operative Pain and Surgical Morbidity During Endometriosis Surgery

Endometriosis is a common (around 1 in 10 women), non-cancerous condition where tissue similar to the womb lining is found growing elsewhere, most commonly inside the pelvis. Symptoms vary but can include intense pelvic pain and infertility.

Endometriosis that is very deep and painful may need surgery, which risks damage to the tubes that drain urine from the kidneys to the bladder (ureters). To reduce this risk, surgeons may put tiny plastic tubes called "stents" inside the ureters. These stents can stay for up-to 4 weeks following surgery but can cause severe pain and blood in the urine. Squirting a dye into the ureters, rather than using stents, may cause less pain for women after surgery whilst not making the removal of endometriosis worse, the operation take longer, or increasing the rates of complications (such as bleeding or damage to internal organs). Before a full clinical study can be run, the investigators need to understand whether this is possible, by doing a feasibility study


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 to 50 years
* Scheduled for laparoscopic or robotic-assisted surgical excision of deep endometriosis (DE) where ureteric stenting is planned.
* Willing and able to provide consent for participation in the study

Exclusion Criteria:

* Confirmed or suspected pregnancy at the time of enrolment.
* Suspicion or confirmation of malignancy.
* History of ureteric injury from prior surgery or trauma
* Medically unfit for surgery due to the following conditions:

  * Uncontrolled diabetes mellitus.
  * Severe Chronic Obstructive Pulmonary Disease (COPD).
  * Hypertrophic cardiomyopathy or significant cardiac conditions (e.g., recent myocardial infarction, aortic stenosis).
  * History of stroke or severe kyphoscoliosis.
  * Uncontrolled hypertension.
* Body mass index (BMI): BMI greater than 45
EMLA Cream as Analgesic for Outpatient Gynecological Procedures

The goal of this clinical trial is to compare pain perception in the study participant population undergoing the following gynecological procedures: Intra Uterine Device (IUD) insertion, hysteroscopy, and endometrial biopsy and given either Eutectic Mixture of Local Anesthetics (EMLA) cream or a placebo. The main question to answer is:

• Does EMLA cream reduce pain when administered during the following gynecological procedures: IUD insertion, hysteroscopy, and endometrial biopsy?

Participants will be asked to do assess their pain on the Visual Analogue Scale through 3 times during the procedure. Researchers will compare the study group with those receiving placebo group to see if there is a difference in pain scores.

Gynecologic outpatient procedures such as intra-uterine device (IUD) insertion, hysteroscopy and endometrial biopsies (EMB) have no standard of care for pain management. This has resulted in acute pain for patients. One local anesthetic, Eutectic Mixture of Local Anesthetics (EMLA) cream (Lidocaine 2.5%/Prilocaine 2.5%), has shown to decrease perceived pain during hysteroscopy and IUD placement when compared to a placebo. The purpose of this study is to evaluate whether EMLA cream reduces pain during the following outpatient procedures: EMB, hysteroscopy, and IUD placement. Through a randomized control double-blind trial, study participants will have either 5 grams of EMLA cream or 5 grams of placebo applied to their cervix 7 minutes prior to the procedure. Patients' intensity of pain will be assessed using the Visual Analogue Scale (VAS) immediately after speculum placement, during the procedure, and immediately after completion of the procedure. Pain scores will be compared between the study and placebo group.

Eligibility Criteria:
Inclusion Criteria:

* Patient will undergo one of the following procedures: intra-uterine device insertion, hysteroscopy, or endometrial biopsies

Exclusion Criteria:

* Known hypersensitivity to amide anesthetics
* Pre-existing methemoglobinemia
Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy

The purpose of this study is to observe whether micropulse laser (MPL) is noninferiority to traditional laser therapy in central serous chorioretinopathy.

Central serous chorioretinopathy (CSC) is characterized by serous detachment of neurosensory retina which can cause lose in visual acuity. Some studies have shown that traditional laser treatment (TLT) is effective on CSC, although accompanied with side-effects, such as scar. Recent retrospective studies suggest micropulse laser (MPL) therapy may also be effective without obvious complications in this disease. But to date, there is no study on effectiveness of CSC between TLT and MPL.

The study is the first prospective randomized controlled trial about 577nm micropulse laser versus traditional laser treatment in central serous chorioretinopathy. It is a noninferiority study. The investigators hypothesize that application of 577nm micropulse laser in patients with CSC will prompt resolution of CSC as measured by ocular coherence tomography and best corrected visual acuity.This will be a pilot study to establish sound methods and provide some insights to the safety and efficacy of CSC treatment. The primary outcome measures is the change of BCVA in 12 week.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with CSC；
2. age\>=18 years old;
3. Duration is less than 6 months；
4. the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT), and CRT\>=250um;
5. active leakage located at ring 2 and ring 3 (ETDRS rings) on fluorescein angiography (FA).

Exclusion Criteria:

1. Patients with no case of CSC；
2. Patients with other macular comorbidities including but not limited to diabetic retinopathy, macular degeneration；
3. Patients with prior retinal treatment less than 3 months；
4. Inability to obtain photographs or to perform FA
Live Validation of the Lower Eyelid Steatoblepharon Severity (LESS) Scale

This observational study will test the inter-rater and test-retest reliability of the LESS scale in a live context.


Eligibility Criteria:
Inclusion Criteria:

* Must provide informed consent

Exclusion Criteria:

* Unable or unwilling to complete study procedures
Exercise Preconditioning to Protect Against Dialysis-induced Cardiac Injury

The goal of this study is to determine what happens to the heart muscle contraction when people cycle before their hemodialysis treatment. Will pre-dialysis exercise protect the heart from a decrease in pumping of the heart muscle (called stunning) that can happen during hemodialysis. We will study whether pre-dialysis exercise decreases heart stunning, decreases the number and severity of symptoms commonly associated with hemodialysis, and other outcomes

This will be the first randomized crossover-controlled trial with two experimental conditions assessing the impact of exercise preconditioning in the HD population. If proven effective exercise preconditioning could be developed as a therapeutic option to reduce rates of heart failure in the dialysis population.

Eligibility Criteria:
Inclusion Criteria:

* must be on chronic hemodialysis for at least 3 months
* age 18 years or older
* willing and able to provide informed consent
* assessed to be safe and able to exercise by unit HD Nephrologist

Exclusion Criteria:

* regular vigorous exercise outside of hemodialysis
* over 79 years of age
* intradialytic exercise \< 3 months
* poor echogenicity
* acute coronary syndrome in the past 3 months
* unstable arrhythmia/angina
* shortness of breath at rest or with minimal activity
* symptomatic hypoglycemia (\>2x/week in the week prior to enrolment)
The Efficacy and Safety of Early MSAT on Radiating Pain in the Upper Extremity

This study is a double blind, randomized controlled trail. condition/disease: radiating pain in the upper extremity. treatment/intervention: motion style acupuncture treatment

"Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation. This treatment is known to relieve the pain and increase the range of motion(ROM). However, there has been no specific value for the effect of this treatment.

So, we conducted a randomized controlled trials to verify the efficacy and safety of MSAT on radiating pain in the upper extremity. From October 2023 to December 2024, we collected 100 inpatients who were suffered from radiating pain in the upper extremity with the numeric rating scale(NRS) over 5 after injury by acute traffic accident(TA). For experimental group(n=50), we conducted MSAT three times(on 2nd, 3rd and 4th day of hospitalization) and other Korean medical treatment. For control group(n=50), just Korean medical treatment except MSAT was conducted. For these two groups, we compared NRS, Visual Analogue Scale(VAS), Neck Disability Index(NDI), C-SPINE MRI, EuroQol 5-Dimension (EQ-5D) and Patient Global Impression of Change (PGIC)."

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19-69 years on the date they sign the consent form.
* Patients who are suffered byradiating pain in the upper extremity that occurred within 3 days after traffic accident.
* Patients who are hospitalized due to traffic accident.
* Patients with NRS of radiating pain ≥ 5.
* Patients who provide consent to participate in the trial and return the informed consent form.

Exclusion Criteria:

* Patients with a specific serious disease that may cause radiating pain: malignancy, spondylitis, inflammatory spondylitis, etc.
* Patients with progressive neurological deficits or with severe neurological symptoms.
* Patients with medical history of cervical surgery or thoracic surgery within the last three weeks.
* Patients who have radiating pain in upper extremity before the traffic accident.
* Patients with a specific serious disease that may interfere with the interpretation of the therapeutic effects or results: malignancy, spondylitis, inflammatory spondylitis, etc.
* Patients who are taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect the results of the study.
* If acupuncture is inadequate or unsafe: patients with hemorrhagic, receiving anticoagulants, severe diabetes and cardiovascular disease.
* Patients who are pregnant or planning to become pregnant.
* Patients who are participated in clinical trials other than observational studies without therapeutic intervention.
* Patients who are difficult to complete the research participation agreement.
* Other patients whose participation in the trial is judged by a researcher to be problematic.