cyrilzakka/clinical-trials huggingface dataset:
The Predictive Role of Immune-inflammatory Biomarkers and Their Interaction With the Oxytocin System in Trauma-related Psychotherapy Responsiveness

Despite a range of treatments for posttraumatic stress disorder (PTSD), only a small proportion of patients reach full symptomatic remission. Recent developments in the field of neuroscience have been providing compelling evidence to suggest that neurobiological determinants might influence not only the emergence of PTSD, but also its resistance to treatment. Immune-inflammation regulatory processes were found to be active during recovery from PTSD, potentially through interactive relationship with the oxytocin secretion system. This innovative longitudinal study aims to examine the role of inflammatory biomarkers and their interactive effect with the oxytocin (OT) system on the development of PTSD and on treatment response among patients with PTSD symptoms undergoing psychotherapy treatment. Patients (N = 100) suffering from trauma-related distress will be recruited from the trauma clinic in Shalvata Mental Health Center. Participants will be followed for 12 weeks of once-a-week psychotherapy sessions. They will be measured for endogenous OT level and cytokines levels in saliva before and after sessions 1, 6, and 12, and will complete psychotherapy outcome self-report questionnaires following each of these sessions.


Eligibility Criteria:
Inclusion Criteria:

* Minimum score of 33 on the PTSD symptoms questionnaire (PCL-5).
* Anticipated 12-24 psychotherapy sessions.

Exclusion Criteria:

* Psychotic episode.
* Female patients: pregnancy or breastfeeding (according to self-report).
Methylphenidate in Myotonic Dystrophy Type 1

The purpose of this study is to determine whether methylphenidate is effective in the treatment of excessive daytime sleepiness due to myotonic dystrophy type 1 (DM1).

Myotonic dystrophy type 1 (DM1) is a multisystemic disorder characterized by muscle weakness, myotonia, and the involvement of several systems. Hypersomnolence is one of the most frequently reported symptoms in patients with DM1 and often lead to handicap such as cessation of employment and withdrawal from social activities.The current investigation represents a prospective, double-blind, randomized, crossover, placebo-controlled study designed to evaluate the efficacy of methylphenidate for the treatment of excessive daytime sleepiness (EDS) in adults with DM1.

Eligibility Criteria:
Inclusion Criteria:

* adults
* Epworth score ≥ 10
* Diagnosis of myotonic dystrophy type 1

Exclusion Criteria:

* hypersensibility to methylphenidate
* Pregnancy
* Patients who receive drugs that interfere with methylphenidate
* Cognitive impairment
* Sleep apnea
Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis

high-quality evidence is needed to add to current knowledge and also assess the long-term outcomes for full/complete pulpotomy after carious pulpal exposure in patients with signs and symptoms indicative of irreversible pulpitis


Eligibility Criteria:
Inclusion Criteria:

* a mature permanent tooth
* symptoms indicative of IRP
* responsive to cold and EPT sensibility testing
* restorable and can be adequately isolated during treatment
* One tooth (molar or premolar) per patient.

Exclusion Criteria:

* active periodontal disease
* complex medical histories
* unable to consent
* pregnant or breast-feeding
* excessive bleeding that cannot be controlled
Efficacy and Safety Study of HU00701/HU007 Eye Drops in Patients With Dry Eye Syndrome

A multicenter, Placebo controlled, Restasis® referenced, Randomized, Double blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Adult Patients with Dry Eye Syndrome


Eligibility Criteria:
Inclusion Criteria:

* age over 19
* Corneal staining score(Oxford grading) \> 2 or Schirmer test \< 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test \> 3mm/5min)
* Volunteer who went through menopause more than 1 years ago before screening or has surgical menopause
* Volunteer who has negative result of pregnancy test or use effective contraception

Exclusion Criteria:

* Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
* The patients with systemic or ocular disorders affected the test result
* Being treated with systemic steroid
* Wearing contact lenses within 3 days of screening visit
* Pregnancy or Breastfeeding
Postoperative Pain Reported to Nurses and Physicians

Effective pain control following surgical procedures is a goal for both the patient as well as the medical staff caring for them. There have been numerous studies evaluating differing treatment pathways, but most studies have relied on the Visual Analog Scale (VAS) or Numerical Rating Scale (NRS) to evaluate outcomes. These scales are subjective score given by the patient with no objective data input, therefore making comparisons subject to possible bias. There are no known studies comparing the pain scores provided by the patient to the surgical team compared to the nursing staff caring for the patient. The aim will be to compare these values to see if patients are consistent in their pain rating.

The project will be conducted as a prospective study comparing numerical rating scale pain scores reported by the patients to the surgical team and the nursing staff. All orthopedic inpatients will be eligible for the study. Subjects will not be consented for the study prior to data collection in order to prevent bias. At the conclusion of the patient's involvement in the study they will be informed that their data has been collected and will have the opportunity to opt out of the study, at which time the collected data will be destroyed.

Postoperatively the surgical team will ask the patient to provide a pain score during morning rounds as part of routine care. The pain score will be recorded by a member of the surgical team. Within 60 minutes of their rounds and prior to any pain inducing events (such as physical therapy or repositioning), the surgical team will ask the nurse caring for the patient to enter the room by his/her self and ask the patient the same routine questions including the pain score. The nurse will record the pain score. No member of the surgical team will enter the room while the nurse is present in order to prevent bias. This process will be repeated once a day up to three days for each patient after the patient's operation.

Eligibility Criteria:
Inclusion Criteria:

* All inpatient postoperative orthopedic patients will be eligible for the study.

Exclusion Criteria:

* If a patient is unwilling to participate in the study.
Randomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy

RATIONALE: The use of bipolar energy sealing system or ultrasonic coagulation for hemostasis during thyroidectomy may reduce blood loss and hypocalcemia and may be more cost-effective.

PURPOSE: This clinical trial is studying how well bipolar energy sealing system and ultrasonic coagulation for hemostasis during thyroidectomy reduce blood loss and hypocalcemia, as well as which device is the most cost-effective approach for thyroidectomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring thyroidectomy

Exclusion Criteria:

* Patients unwilling or unable to provide informed consent
* Age less than 18 years old
* Reoperative case
* Patients who use pacemakers
The Effect of Education and Counseling on Reducing Pain and Anxiety in Women Undergoing Hysterosalpingography

This study investigates the effect of education and counseling on anxiety and pain in women undergoing hysterosalpingography as part of the infertility process.

Fertility and having a child is a significant experience for most individuals; however, many struggle to achieve pregnancy. Infertility is defined as the inability of a couple to conceive after 12 months of regular unprotected sexual intercourse or to carry a pregnancy to term. It is estimated that 10-15 % of the couples globally experience infertility. In Turkey, it is estimated that 10-20% of the couples are diagnosed with infertility. In the evaluation of infertile couples, hysterosalpingography (HSG) is a simple, safe, and minimally invasive radiologic procedure to visualize uterine cavity and tubes after contrast enhancement. HSG plays an important diagnostic role in finding the cause of infertility and in deciding the line of management. The aim of this study was to investigate the effect of education and counseling on anxiety and pain before the treatment of women who will have HSG procedure with the diagnosis of infertility.

This randomized controlled study was conducted at Gulhane Training and Research Hospital, Obstetrics and Gynecology clinic between May 2016 and January 2017. Volunteer women undergoing HSG as part of infertility evaluation have been included. Participants were randomly assigned to the intervention or the control group using a computer-generated list. A data collection form including socio-demographic and obstetric characteristics such as age, educational status, duration of infertility, previous pregnancies, births, abortion/curettage numbers, Spielberger State Anxiety Scale and Visual Analog Scale scores was used for each patient. After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale were applied to both groups by face to face interview during the day giving appointment for HSG. Immediately after the questionnaires were applied, the nurse gave individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (education and counseling) was performed.The IBM SPSS (Statistical package for the Social Sciences) 22.0 package program was used to evaluate the data obtained in the study.

Eligibility Criteria:
Inclusion Criteria:

* being diagnosed with infertility
* negative the result of the B-HCG testing
* being able to understand, read and write in Turkish

Exclusion Criteria:

* not wanting to be included in the study
* not accepting education/counseling
* not knowing Turkish
* having additional diseases related to pelvic pain
The Triad of Nutrition, Intestinal Microbiota and Rheumatoid Arthritis (TASTY)

The main goal of this trial is to investigate whether a dietary intervention based on a typical Mediterranean Diet enriched with fermented foods (MedDiet+) can impact gut microbiota and RA-related outcomes.

100 RA patients will be recruited at ULS Santa Maria in Lisbon, Portugal, and randomly assigned to either the intervention (MedDiet+) or the control group. The 12-week nutritional intervention will include a personalized dietary plan based on the MedDiet+ pattern, educational resources, food basket deliveries, and clinical culinary workshops, all developed and monitored weekly by registered dietitians. The control group will receive general recommendations for a healthy diet at baseline. The intervention's effects will be assessed by evaluating disease activity, functional status, quality of life, intestinal permeability, endotoxemia, inflammatory biomarkers, intestinal and oral microbiota, serum proteomics, and serum glycome profile characterisation.

Eligibility Criteria:
Inclusion Criteria:

* RA patients (ACR/EULAR2010 criteria)
* Age \>18-years
* Disease duration \>1-year
* Active disease (DAS28 \> 2.6units)
* On stable medication for 12 weeks
* Low/medium MedDiet adherence (PREDIMED\<10)
* Willing to comply with study protocol

Exclusion Criteria:

* Prednisolone dose ≥ 7.5 mg/day
* Antibiotic therapy 4-weeks prior to baseline
* Persistent use of NSAID's
* Inflammatory or irritable bowel disease
* Celiac disease
* Chronic diarrhea
* Diabetes
* Other immune-mediated inflammatory diseases besides RA
* Major organ dysfunction
* Cancer diagnosed in the last five years
* Health conditions which may difficult participation (cognitive impairment/psychiatric disease)
* Pregnant or lactating individuals
Understanding the Late Effects of Surviving a Pediatric Brain Tumor

The goal of this study is to learn about the cognitive and behavioral functioning of children being treated for cancer.


Eligibility Criteria:
Inclusion Criteria:

Children Treated for Posterior Fossa Tumors:

* As per medical record or clinical report, successfully completed all medical treatment for either an M0 posterior fossa medulloblastoma without dissemination or posterior fossa low-grade astrocytoma without relapse or evidence of residual disease.
* For medulloblastoma survivors only: Previously treated with gross total resection (GTR), craniospinal irradiation with conformal posterior fossa boost radiotherapy (CSI + Boost) and chemotherapy
* For low grade astrocytoma survivors only: Previously treated with gross total resection ONLY (no chemotherapy or radiotherapy).
* As per medical record or clinician report, between 1-10 years post completion of their medical treatment for their posterior fossa brain tumor.
* Subject is between the ages of 6 through 16 years at time of consent.
* As per medical record or parent report, subject is able to tolerate an MRI without sedation.

Healthy Control Participants:

* No major medical illness, as determined by medical interview by study physician.
* As per parent report, subject is between the ages of 6 through 16 years at time of consent.
* As per parent report, subject is able to tolerate an MRI without sedation.

Exclusion Criteria:

All Participants:

* Full Scale IQ as documented to be below a standard score of \<70 based upon the study IQ assessment completed after consent.
* As per self or parent report, completed any portion of the neuropsychological battery used in this study within the last year.
* MRI contraindications (e.g., implanted ferromagnetic devices, claustrophobia) as per radiology clinical operating procedures.
* As per self or parent report or medical record, currently taking medications that have CNS effects (i.e., antidepressants, neuroleptics, anti-seizure medications, drugs that affect blood pressure or heart rate, alpha-agonists, adrenergic blockers, lithium, sedating antihistamines, and some medications for the treatment of asthma).
* As per self or parent report, non-fluency in English language as demonstrated by current educational placement in a non-English-speaking classroom setting.
Nationwide Utilization of Danish Government Electronic Letter System for Confirming the Effectiveness of Behavioral Nudges in Increasing InFLUenza Vaccine Uptake Among Older Adults

In randomized clinical trials and observational studies, influenza vaccination has been shown to be effective in reducing influenza-related illness, hospitalizations, cardiovascular events, and mortality in select populations. However, the real-world effectiveness of influenza vaccination is limited by its uptake. Conducted during the 2022/2023 influenza season, the first NUDGE-FLU trial demonstrated the effectiveness of two electronic behavioral nudging letter strategies in increasing influenza vaccination rates among older adults in Denmark - a letter highlighting potential cardiovascular benefits of vaccination and a standard informational letter sent at baseline and repeated at day 14. This present study will once again investigate whether digital behavioral nudges delivered via the official, mandatory Danish electronic letter system can increase influenza vaccine uptake among older adults including whether the effectiveness of previously successful strategies can be confirmed during a subsequent influenza season.

The study is a prospective, randomized, open-label implementation trial. The study population will consist of persons aged \>=65 years at January 15, 2024 - this age group is eligible for free-of-charge influenza vaccination in the official Danish vaccination program. Subjects will be identified through Danish nationwide health registries including the Danish Civil Registration System. Individuals will be randomized to 1 of 7 arms (1 usual care arm and 6 intervention arms) with each testing different nudging strategies employing various behavioural economic principles. The interventions will be delivered through the official, mandatory Danish electronic letter system. All subject data will be retrieved from the Danish nationwide registries with the exception of information on intervention allocation. Endpoints will be retrieved at prespecified dates using prespecified search algorithms.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>=65 years at January 15, 2024 (eligible for free-of-charge influenza vaccination in the Danish public health system)
2. Access to the official, mandatory Danish electronic mailbox system

Exclusion Criteria:

1. Persons living in nursing homes (approximated as any person living at an address with \>=6 inhabitants aged 80 years and above)
2. Known to have already scheduled influenza vaccination appointment
Ranibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery

The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing corneal transplantation.

As a secondary objective, this study also aims to establish the corneal and anterior chamber concentration of ranibizumab when delivered subconjunctivally at the limbus in patients undergoing corneal transplantation. The effects of ranibizumab on corneal epithelial healing will be examined following adjunctive use in corneal transplantation. Finally, clinical characteristics including recurrent corneal neovascularization will be studied.

Eligibility Criteria:
Inclusion Criteria:

Subjects will be eligible if the following criteria are met:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 18 years
* Patient related considerations
* All patients of both genders will be considered for enrollment.
* Disease related considerations
* Patients meeting accepted criteria for undergoing corneal transplantation will be considered if peripheral corneal neovascularization exists in 2 or more contiguous clock hours

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from this study:

* Pregnancy (positive pregnancy test)
* Women seeking to become pregnant
* Lactating women
* Prior enrollment in the study
* Prior glaucoma surgery in the region of the corneal neovascularization
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another simultaneous medical investigation or trial
Decitabine and Peripheral Stem Cell Transplantation in Treating Patients Who Have Relapsed Following Bone Marrow Transplantation for Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia

RATIONALE: Peripheral stem cell transplantation may be an effective treatment for leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia that has relapsed following bone marrow transplantation.

PURPOSE: Phase I/II trial to study the effectiveness of decitabine and peripheral stem cell transplantation in treating patients who have leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia that has relapsed after bone marrow transplantation.

OBJECTIVES: I. Determine the maximum tolerated dose of decitabine in patients with relapse post allogenic bone marrow transplant. II. Determine the toxicity of decitabine combined with filgrastim (G-CSF) primed allogeneic peripheral blood stem cells in patients who relapsed within 1 year after allogeneic bone marrow transplantation. III. Determine the effectiveness in reinducing remission in these patients.

OUTLINE: Patients receive decitabine IV for 6 hours every 12 hr for 5 days. Peripheral blood stem cells (PBSC) are administered 5 days after last dose of decitabine. Donors receive filgrastim subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to first PBSC collection. If insufficient number of cells are collected, bone marrow can be harvested for supplementation. Donor cells should be collected prior to decitabine infusion. Patients receive filgrastim SQ administered daily starting 1 day after PBSC infusion until blood counts recover. For GVHD prophylaxis, patients receive cyclosporine IV daily on day -2, then orally once dose is tolerable. Dose of decitabine is escalated in cohorts of 3-6 patients. If dose limiting toxicity occurs in 2 of 6 patients at a given dose level, then that dose is declared the maximum tolerated dose. Patients are followed weekly. If none of the first 5 patients survive in remission for more than 100 days, the study will be terminated.

PROJECTED ACCRUAL: At least 15 patients will be accrued for this study over 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Acute leukemia, myelodysplastic syndromes or chronic myelogenous leukemia (CML) in accelerated phase or blast crisis and relapsed within 1 year after allogeneic bone marrow transplantation Must not be candidates for second course of high dose chemoradiotherapy

PATIENT CHARACTERISTICS: Age: 60 and under Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3 mg/dL Renal: Creatinine less than 2 mg/dL Cardiovascular: Greater than 40% ejection fraction per MUGA scan or ECHO Other: Not pregnant No serious intercurrent illness No active CNS disease Must be ineligible for protocols of higher priority No active acute graft vs host disease (GVHD) greater than grade 2 or extensive chronic GVHD No active uncontrolled infection Original marrow donor must undergo filgrastim primed peripheral blood stem cell collection

PRIOR CONCURRENT THERAPY: See Disease Characteristics