cyrilzakka/clinical-trials huggingface dataset:
Mindfulness and Placebo for Pain (MAPP) Study

This study proposes a three-arm randomized-controlled trial (RCT) that evaluates the feasibility and acceptability of combining a mindfulness-based therapy (MBT) and open-label placebo (OLP) treatment for individuals with chronic pain. Individuals with chronic pain will be recruited to participate in an 8-week trial, with a subsequent 3-month post-treatment follow-up.

Participants will be randomly assigned to one of the following three conditions:

1. Mindfulness-Based Stress Reduction (MBSR)
2. OLP treatment
3. combination of MBSR and OLP treatment


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old;
2. ability to speak, write, and read in English;
3. physical pain present on at least half the days in the past 3 months; and
4. average past week pain severity rating ≥3 on a 0-10 Numerical Rating Scale.

Exclusion Criteria:

1. acute pain due to recent injury or surgery;
2. self-reporting of chronic malignant pain (e.g., cancer, HIV);
3. self-reporting of Raynaud's disease (those who can be contraindicated for cold pressor testing);
4. severe psychopathology (e.g., a psychotic disorder) or significant cognitive deficits judged to interfere with study procedures;
5. currently pregnant or breastfeeding;
6. inability to discontinue use of vitamin B2 supplements or a multivitamin containing vitamin B2 throughout the study period (these interfere with riboflavin tracer-OLP treatment adherence-monitoring);
7. inability to commit to study period.
My MS and My Menstrual Cycle

The goal of this observational study is to understand how MS symptoms change during different phases of the menstrual cycle in individuals who menstruate living with MS (Multiple Sclerosis).

The main questions it aims to answer are:

1. Does fatigue get worse during certain phases of the menstrual cycle?
2. How do symptoms like thinking skills, pain, and mobility change throughout the cycle?

Participants will:

* Use the My Normative app to track their menstrual cycle and MS symptoms.
* Complete symptom check-ins at five points during their cycle for six months.
* Answer questions about fatigue, thinking skills, mood, sleep, and other MS symptoms at the start and end of the study.

These findings may help researchers better understand MS symptom patterns and improve symptom management.


Eligibility Criteria:
Inclusion Criteria:

* Female participants diagnosed with MS based on the 2024 McDonald Diagnostic criteria (biologically sex-based, any gender as long as not on hormonal gender-enhancing therapy)
* Aged 16 or older
* Experiencing menstruation with cycles ranging from 21 to 35 days
* Have entered menarche, still experiencing menstrual cycles, and have not yet entered menopause
* May be using hormonal contraceptive methods (e.g., oral contraceptives or hormonal IUDs)
* Able to speak English
* Willing to provide informed consent (mature minors will be assessed by their physician for consent eligibility)
* Able to complete questionnaires and operate the app

Exclusion Criteria:

* Diagnosed with CNS inflammation disorders other than MS, such as:

NMOSD (Neuromyelitis Optica Spectrum Disorder) or MOGAD (Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease)

* Male or intersex individuals, given the inclusion criteria of requiring a uterus
* Females under 15 years of age
* Females who have not started menstruation
* Females who have stopped menstruation due to menopause or hysterectomy
* Pregnant or postpartum individuals within one year of delivery,
* Individuals currently breastfeeding
* Unable to provide informed consent, or not deemed a mature minor
* Unable to complete questionnaires and operate the app
Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study

In Denmark, around 12,700 patients undergo Cesarean delivery (CD) annually, constituting approximately 20% of all childbirths in the country. Worldwide, the number is increasing each year, with more than 20 million CD performed annually.

Postoperative pain after CD is typically moderate to severe in intensity and still constitutes a significant challenge, balancing effective pain relief and potential side effects. Correlations between moderate to severe acute pain and the development of persistent pain after CD is still unclear.

Postsurgical persistent pain is a significant, often unrecognized clinical problem that causes distress and diminishes the quality of life for patients. Despite advances in understanding the factors contributing to persistent postsurgical pain and an increased focus on identifying patients at risk, the management and prevention of postsurgical persistent pain are still inadequate.

It is important to gain further insights into this population, and we have a unique opportunity to do so by following the national cohort from the ongoing Danish multicenter cohort study on pain after cesarean section (ClinicalTrials.gov Identifier: NCT06012747) over an extended follow-up period.

This involves continued prospective registration of Patient-Reported Outcome Measures (PROM) collected by SMS-based questionnaires in the months and years after the CD, thereby investigating the occurrence of both acute and persistent pain after CD.

The outcomes are focused on pain levels, the impact of pain on physical function and neuropathic pain characteristics in the months and years following the CD. The study also aims to explore the relationship between persistent and acute pain.

The Study Protocol is attached in full-text (Study Documents).

Eligibility Criteria:
Inclusion Criteria:

* Patients who, after participating in the Danish multicenter cohort study on pain after cesarean delivery (ClinicalTrials.gov Identifier: NCT06012747), consent to continue to receive questionnaires about persistent pain.
* Planned cesarean delivery in spinal anesthesia
* Patients who speak and read Danish
* Patients with a smartphone that can receive an SMS with a link to a questionnaire that can be opened online.

Exclusion Criteria:

• \<18 years of age
Genetic Analysis of Patients Responsive to Ranibizumab But Resistant to Aflibercept

A cohort of patients responsive to treatment with ranibizumab but resistant to

aflibercept were identified in a previously conducted retrospective study. Identified

patients will have their blood drawn for genome wide sequencing. The sequencing

data will be compiled and analyzed in an attempt to identify a common genetic basis

for patients susceptible to ranibizumab but resistant to aflibercept.

A cohort of patients responsive to treatment with ranibizumab but resistant to

aflibercept were identified in a previously conducted retrospective study. Identified

patients will have their blood drawn for genome wide sequencing. The sequencing

data will be compiled and analyzed in an attempt to identify a common genetic basis

for patients susceptible to ranibizumab but resistant to aflibercept.

Blood samples will be drawn for genetic analysis for all patients enrolled in the study.

The sample (1 tube- 6mL of blood) will be collected using - 8.5mL PAXgene Blood DNA

Tubes (http://www.qiagen.com/products/catalog/sample-technologies/dna-sample-

technologies/genomic-dna/paxgene-blood-dna-tubes).

Samples will be stored at -80 until time for analysis. Note that some blood draws will be performed at

satellite clinics and transported to main facility for storage in -80 freezer. It is the understanding of

ARC PI and staff that the PAXgene Blood DNA Tubes keep samples stable at room temp for 1-2

days.

However, staff will transport samples in timely fashion (room temp, on ice, dry ice,

etc), to -80 freezer for storage until all samples are collected. Once all samples are

collected, they will be shipped to Genentech for analysis. DNA extraction, the generation of genetic

data, and subsequent analysis will be performed at Genentech or via third party. DNA will be assayed

for polymorphisms through genome wide SNP chip or whole genome sequencing. The subject's

genotype or haplotype will be correlated with their visual response and OCT response.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be eligible if the following criteria are met:

  * Demonstrate worsening of exudation when switched from ranibizumab to aflibercept
  * Ability to provide written informed consent and comply with study assessments for the full duration of the study

Exclusion Criteria:

* Any other condition that the investigator believes would pose a significant hazard to the subject
Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal Women

This trial is conducted in Europe. The aim of this trial is to investigate the preventive effect of treatment with estradiol vaginal tablets on recurrent urinary tract infections (RUTI) in post-menopausal women with signs of urogenital ageing (UGA).


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal woman with Urogenital ageing (UGA)
* Recurrent urinary tract infections defined as three or more urinary tract infections within the past twelve months

Exclusion Criteria:

* Known or suspected allergy to trial product or related products
* Present UTI
* History of RUTI during fertile period of life
Multi-omics Characteristics and Prognosis of Idiopathic Sudden Sensorineural Hearing Loss

The goal of this observational study is to describe the multi-omics characteristics and to learn about the prognostic factors in patients with idiopathic sudden sensorineural hearing loss (SSNHL). The main problems it aims to deal with are:

* if there is a difference in data of exome and targeted sequencing among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls
* if there is a difference in the parameter of MRI among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls
* to find out which factor from multi-omics data relates to outcomes of SSNHL
* to develop the best prognostics model based on the multi-omics data.

Participants will be received audiological tests, blood specimen collection and radiological examination. Researchers will explore the relationship between the multi-omics data and the prognosis and develop the predictive model.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 4
* Participants with SSNHL: unilateral or bilateral sensorineural hearing loss of \> 30 dB HL (decibel) involving at least 3 continuous test frequencies developing within 72 hours
* Healthy controls: people with PTA thresholds of all test frequencies ≤ 20 dB HL and without otologic disease in the last 3 months
* Completed informed consent and promised to finish follow-ups

Exclusion Criteria:

* Hearing loss with explicit causes, including noise-induced, Ménière's disease, ototoxicity exposure, mumps infection or history of syphilis infection and so on.
* A history of head trauma or otologic surgery.
* Malformation of temporal bone discovered by computed tomography (CT)
* Retro-cochlear lesion discovered by magnetic resonance imaging (MRI)
* Pregnant women
First in Human Study of EI-001 Monoclonal Antibody in Healthy Volunteers

A First-in-Human, Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of EI-001 in Healthy Volunteers.

To assess the safety and tolerability of single ascending intravenous (IV) doses of EI-001 in healthy volunteers

To assess the pharmacokinetics (PK) of single ascending IV doses of EI-001 in healthy volunteers

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female 18 to ≤ 55 years old at the time of consent.
2. Healthy on the basis of physical examination, medical history, vital signs, laboratory values and 12-lead ECG performed at Screening. The participant may be included only if the investigator judges any abnormalities or deviations from normal to be not clinically significant.

Exclusion Criteria:

1. Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, may require treatment or render the participant unlikely to fully complete the study, or any condition that presents undue risk from the IP or procedures or interfere with study assessments.
2. Have received any IP within 30 days or 5 half-lives prior to Screening (4 months if the previous drug was a new chemical entity), whichever is longer.
Stroke Education Intervention Trial - Pilot

The objectives of the trial of a medication-coach program for patients with stroke or transient ischemic attack are to pilot test the study design, the intervention components and the data collection forms and refine them for a larger trial whose goal will be to improve long-term adherence to stroke prevention medications.


Eligibility Criteria:
Inclusion Criteria:

* Patients at Wake Forest University Baptist Medical Center (WFUBMC) over age 18
* Diagnosed with acute ischemic stroke, transient ischemic attack or intracranial hemorrhage
* provide consent to participate

Exclusion Criteria:

* discharged to nursing home, acute rehabilitation center, inpatient hospice, or other acute hospital
* homeless
* non-English speakers
* patient and proxy unable to participate in telephone conversation
The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens

The aim of this study is to evaluate the clinical performance of stenfilcon A toric lenses compared with etafilcon A toric lenses for astigmatism. If it is valuable, the clinical performance of stenfilcon A toric lens is also evaluated compared with habitual lenses.

This is a multi-sites, 50 subjects, randomized, open labeled, bilateral wear, dispensing study. Participants will be randomized to wear first lens pair for two weeks, and then crossover to second lens pair for two weeks.

Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Is between 18 years of age and 42 years of age.
* Soft contact lens wearers who are not required to have Presbyopic correction.
* Soft contact lens wearers without trouble.
* Soft contact lens wearers who have the correctable astigmatism by lenses used in this study in the both eyes.
* Has a prescribed SCL (Soft Contact Lens) power within the range of powers of the SCL for astigmatism which is used in this study.
* Can achieve a corrected visual acuity of 1.0 or better.
* Can read and understand the study information document, and sign the participation consent form.
* Can visit the clinic at designated examination visits.
* Has received periodical examinations at an eye clinic within the past two years.

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Has a systemic disease that may affect the ocular health.
* Is pregnant or lactating.
* Has received a systemic or local medication that may affect this study.
* Has an infectious eye disease.
* Has eye and systemic active allergic diseases that interferes with SCL wear.
* Has an eye disease which is clinically judged to be severe such as corneal vascularization, limbal hyperemia, and corneal epithelium disorder
* Has a history of hard contact lens wear within 30 days.
* Is currently participating in another clinical research study.
* Has undergone refractive surgery.
Bone Healing in Immediate Dental Implants

To study the effect of platelet-rich plasma concentrate on marginal bone loss and bone mineral density in immediate implant placement through CBCT.

12 subjects were equally categorized into two groups. Group, I was the control group; whereas, the subjects in Group II received Platelet Rich Plasma (PRP) therapy. All subjects were given a standard treatment with single implant system. Inserted implants were analyzed through Cone Beam Computerized Tomography (CBCT). Records were registered at the baseline, at 12th week before functional loading and 26th week after functional loading.

Eligibility Criteria:
Inclusion Criteria:

* patients maintaining good oral hygiene, having adequate bone quantity at the implant site, uneventful extraction

Exclusion Criteria:

* Active infection around implant site, immunocompromised state, with current major systemic disease (uncontrolled diabetes, rheumatoid arthritis, etc.) or oral pathologies, history of bleeding disorders or on anticoagulant therapy, or patients on bisphosphonates were excluded from the study
Testing the Effect of the Youth Mindful Awareness Program on Negative Affect

Randomized controlled trial comparing a coached, app-based mindfulness intervention versus a no-intervention control condition. Primary outcome: adolescents' reports of affect as measured with ecological momentary assessment (EMA) at post-intervention. Participants will include 120 youth ages 12-17 years old.

This is a randomized controlled trial testing a 9-session, coached, app-based mindfulness intervention on adolescents' reports of affect as measured with ecological momentary assessment (EMA). Participants will include 120 youth ages 12- to 17-years-old randomized to either the Youth Mindful Awareness Program (YMAP) or to an assessment only control condition. Participation is open to all genders and youth of all races and ethnicities.

Eligibility Criteria:
Inclusion Criteria:

* ages 12- to 17-years-old
* has access to a smartphone, tablet, or other mobile device on which they can access the mindfulness app and complete EMA reports. Youth without a device will be provided with one for their time in the study.

Exclusion Criteria:

* current DSM5 diagnosis of an anxiety or depressive disorder with significant clinical impairment
* current alcohol or substance use disorder; currently suicidal
* lifetime diagnosis of bipolar disorder, schizophrenia, autism, conduct disorder, or developmental delay
* reading level below 4th grade
* not English speaking at a level that would allow them to participate in the intervention and assessments.
The Gonial Angle as a Predictive Marker of Mandibular Fossa Depth

The aim of the study is to evaluate the relationship between submandibular fossa depth and gonial angle measurements in cone beam computed tomography examinations in terms of dental implant applications. Cone-beam computed tomography images of 51 dry human mandibles were included in the study.

Gonial angle and fossa depths were determined and evaluated separately for left and right sides. Gonial angle was measured on Cone-beam computed tomography images as the angle between the tangent line drawn posterior to the border of the ramus of the mandible and the tangent line drawn to the lower border of the mandible. Determination of the submandibular fossa depth was made with a line was drawn to connect the most dislocated upper and lower points on the inner surface of the mandible in the coronal plane sections, and the length of the line drawn at a right angle from the deepest point of the fossa to this line. Measurements were made separately for left and right sides.

Eligibility Criteria:
Inclusion Criteria:

* Dry mandibles with sufficient bone integrity to make the necessary measurements

Exclusion Criteria:

* Dry mandibles which were dentate in the posterior region
Seoul National University Hospital Gangnam-Real Time Optical Diagnosis Program 2: Gangnam-READI2

Accurate optical diagnosis of colorectal polyps could allow a "resect and discard" strategy based on the results of the optical biopsy. Even though intensive training for optical diagnosis, there is still wide variability in individual endoscopists to meet the PIVI thresholds. The investigators with experience of prior optical diagnosis training perform new education and drill to apply proper high confidence according to their decision time. After the education program, the investigators prospectively evaluate real-time optical biopsy analysis of polyps in 8 academic gastroenterologists.

This study is an extension of the Gangnam-READI program (NCT02516748) in Seoul National University Hospital Healthcare System Gangnam Center. This study is composed of two periods. First, an education program on predicting polyp histology and real-time optical diagnosis will be performed by 8 endoscopists From February to March 2020. In the second period from April 2020 till October 2020(total 6 months), real-time optical diagnosis with time drill for diminutive and small colorectal polyps will be activated. Endoscopists will have 3 seconds rule to make high confidence diagnosis and have feedbacks on their accuracy of optical diagnosis for polyps per 3 months. The performance will be evaluated by comparing the optically predicted diagnosis with the actual histologic diagnosis. Negative predictive value for the prediction of non-neoplastic polyp and concordance of surveillance intervals for diminutive polyps diagnosed optically with high confidence will be measured. In addition, the characteristics of the endoscopist affecting the performance of optical diagnosis were investigated.

Eligibility Criteria:
Inclusion Criteria:

1. Board-certified gastroenterologists
2. Endoscopists who finished ex-vivo optical diagnosis training

Exclusion Criteria:

1. Inflammatory bowel disease
2. Previous colon cancer history
3. Previous colon op. history
4. Melanosis coli
Diaplacental Transfer of Anti-HCMV- and Anti-VZV-immunoglobulin G (IgG) -Antibodies at Premature and Mature Newborns

The aim of the study is to determine the total concentration of HCMV- and VZV-specific IgG-antibodies and the total concentration of neutralizing antibodies against HCMV in neonatal bloodstream depending on gestational age at birth.

For data gathering the investigators measure the main concentration of specific HCMV-/VZV-IgG-antibodies and the concentration of neutralizing IgG-antibodies against HCMV and VZV in maternal blood and in fetal bloodstream. Then the investigators compare the data of mother and newborn. Therefore, the investigators use the following blood samples:

Mother: Venous blood sample taken at birth (+/- three days)

Newborn: Blood sample of umbilical cord (= fetal bloodstream) taken immediately after birth.

The investigators assign the data of each newborn (gestational age at birth) to the data of their respective mother for statistical evaluation. After finishing the study the investigators will destroy all residual blood.

Eligibility Criteria:
Inclusion Criteria:

* HCMV and/or VZV-seropositive pregnant woman who signed written informed consent form.

Exclusion Criteria:

* Newborns of underage mothers.
* Newborns whose mother did not sign the written informed consent.
* Pregnant women with a known hereditary or acquired immune deficiency