cyrilzakka/clinical-trials huggingface dataset:
The Effect of N-Acetyl-L-Cysteine, on Inflammatory and Oxidative Stress Markers in Pulmonary Sarcoidosis

This is a pilot study investigating the effect of an antioxidant, N-Acetyl-L-Cysteine (NAC), on inflammation and oxidative stress in sarcoidosis.

Sarcoidosis is a granulomatous lung disease predominantly affecting the lungs. Reactive oxidative species are produced secondary to oxidative stress and inflammation and can affect key cellular processes. The investigators have shown a role for oxidative stress in chronic beryllium disease (CBD), a granulomatous disease that resembles sarcoidosis, and have also shown that antioxidant therapy reduces inflammation in CBD. Oxidative stress also plays a role in sarcoidosis but the exact mechanism and potential effect of antioxidant therapy on sarcoidosis is unknown. The investigators propose conducting a pilot study investigating the effect of an antioxidant, N-Acetyl-L-Cysteine (NAC), on inflammation and oxidative stress in sarcoidosis. The investigators will measure and compare markers of inflammation and oxidative stress in the lungs of sarcoidosis patients before and after treatment with NAC. The results of this study will prepare the investigators for a larger study investigating the role of NAC as a therapy for sarcoidosis with changes in lung function and x-ray as our primary outcome. This will provide the investigators with a new non-toxic therapy for sarcoidosis that can be used on its own or to supplement other therapies minimizing their toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven sarcoidosis.
* Pulmonary parenchymal involvement with a Scadding chest x-ray stage II, III or IV.
* Abnormal spirometry and/or DLCO (\< 80% of predicted).
* Consenting adults : Age 18 years and above

Exclusion Criteria:

* Positive lung washing or biopsy cultures for fungi or mycobacterial disease;
* Presence of other co-morbid conditions that may affect the patient's outcome.
* Patient inability to undergo venipuncture and BAL procedures.
* Current use of tobacco (smoking or otherwise) in the past 6 months
* Treatment with immunosuppressive therapy within the past 6 months.
* On oral anti-oxidant supplements.
* Active peptic ulcer disease.
The Impact of Immersive Virtual Reality Training in Thyroid Surgery

Up to this date, there have been no reports on virtual reality (VR) training in thyroid surgery. The purpose of this study is to determine the impact of VR training in residents' education.

Investigators intend to include general surgery residents in the trial, subgrouped in a VR training group and another one with traditional learning, utilizing a technical textbook as a control. For the purpose of this study, a commercial available VR mask will be given for training in the VR group. Randomization will be used to secure balance in the distribution of residents according to their experience. The task which will be examined include surgical steps from neck incision up to the placement of the C-IONM electrode and will be evaluated by a blinded FEBS certified endocrine surgeon in the operating theatre.

Training superiority will be assessed by the outcome measures of Objective Structured Assessment of Technical Skills (OSATS) score, need for the main surgeon to intervene (NTI), verbal answers and time to task completion. Participants will complete questionnaires regarding satisfaction of the whole educational process.


Eligibility Criteria:
Inclusion Criteria:

* Residents of the 2nd Surgical Department of Aristotle University of Thessaloniki
* Residents who have completed their 1st year of training programm.

Exclusion Criteria:

* Disagreement of participants' randomisation
* Prolonged surgical time of completion
* Participant's experience beyond the included limits
* Participants who are completely incapable of using VR devices or have specific helath restrictions of using these
* Patients with complex thyroid disease such as recurrent disease, concominant primary hyperparathyroidism, lymph node disease or metastasis, Graves disease and intrathoracic goiter
Evaluation of Stepping Stones

The goal of this randomized trial is to learn if the Stepping Stones (StSt) intervention has a positive impact on the sexual health and relationship behaviors of sexually active youth between the ages of 12 and 22 years old who are at risk for or involved in the legal or child welfare systems. The primary research questions it aims to answer are:

* Three months after being offered the intervention, does StSt impact youth's receipt of sexually transmitted infection testing in the past four months?
* Nine months after being offered the intervention, does StSt impact youth's frequency of having vaginal and anal sex without condoms in the past four months?
* Nine months after being offered the intervention, does StSt impact youth's perpetration of emotional abuse in the past four months?

Researchers will compare participants randomized to receive StSt (treatment group) to participants randomized to receive a control condition that contains no sexual or reproductive health information (control group).

Participants randomized to the treatment group will be offered StSt as an-person, individual-based intervention delivered over four sessions during a 6-8 week period. Participants randomized to the control group will be offered a virtually delivered control condition.

This is an individual-level, randomized control trial to rigorously evaluate the impact of the Stepping Stones (StSt) intervention. Participant outcomes will be assessed using self-reported, individual-level data gathered using a structured questionnaire administered at three time points: baseline (enrollment); three months post-intervention (five months after baseline); and nine months post-intervention (eleven months after baseline).

Eligibility Criteria:
Inclusion Criteria:

* At risk for or involved in the legal or child welfare systems
* Has had vaginal or anal sex in the past 3 months
* Comfortable reading, speaking, and writing in English

Exclusion Criteria:

* Currently trying to start a pregnancy
* Currently in jail or being detained in a facility
Effectiveness of a 24 Hour Phone Line on the Rate of Suicide Attempts in Borderline Patients

This randomized multicentric clinical trial assesses the effectiveness of 24 hour phone line on the rate of suicide attempts and self-injurious behaviors in borderline patients.

Borderline personality disorder is very frequent among psychiatric populations, and chronic suicidality is a major problem in clinical practice with borderline patients. In a lot of countries, suicide prevention centers are available, but most of these centers are not supervised by professionals of mental health, and none is specifically oriented to the borderline population.

The main goal of this study is to assess the effectiveness of a 24 hour crisis phone line on the rate of suicide attempts in a clinical population of borderline patients (the effectiveness of this phone line access on the rate of self-injurious behaviours will also be studied).

In this multicentric controlled trial, 600 borderline patients (men or women, in or out-patients, between 18 and 40 years-old) are randomized in two arms :

* one with treatment as usual
* one with treatment as usual, PLUS one year of access to a 24 hour crisis phone line (with a team of psychiatrists specialized in borderline personality disorder).

All patients are assessed with standardized instruments (interviewers are blind to the patient's status), at entry (T1) and one year later (T2).

Eligibility Criteria:
Inclusion Criteria:

* 18 to 40 years old
* in or out-patient in one of the recruiting center
* men or women
* with a borderline personality disorder
* written informed consent

Exclusion Criteria:

* inferior to 18 or superior to 40 years old
* schizophrenia
* severe somatic disorder
* participation refusal
* participation to another interventional study
Changes in the Tear Film With Scleral Contact Lens Wear for Keratoconic Eyes

The purpose of this study is to investigate changes in the level of inflammatory mediators in the tear film of scleral contact lens wearers in a keratoconic population.

Scleral contact lenses are rigid gas permeable lenses designed to rest on the sclera while vaulting over the cornea with a fluid reservoir. The use of scleral contact lenses has become the current standard of practice as a nonsurgical management of corneal ectasia and ocular surface diseases. Cases have been recently presented of scleral lens wearers exhibiting adverse corneal findings and conjunctival injection from lens wear. These findings are likely associated with the mechanical and hypoxic effects due to poor fitting characteristics at the limbal area. Tear film analysis detecting changes in the levels of proteinases and cytokines have helped researchers gain a better understanding of the pathophysiology of complications in soft contact lenses wearers, dry eye, and keratoconus. Ultimately, this study will provide insights in relating scleral lens fitting characteristics and corneal and limbal physiological responses.

Eligibility Criteria:
Inclusion Criteria:

* Had been diagnosed with keratoconus in at least one eye.
* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read and understood the information consent letter.
* Is willing and able to follow instructions and maintain the appointment schedule.

Exclusion Criteria:

* Is using any topical medications that will affect ocular health.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (severe dry eyes) that would affect the wearing of contact lenses.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
* Has any clinically significant lid or conjunctival abnormalities and active neovascularization.
* Is aphakic.
* Has undergone any corneal surgery.
* Is participating in any other type of eye related clinical or research study.
* Has any known allergies or sensitivity to the diagnostic pharmaceuticals or products, such as fluorescein, used in this study.
BC Risk Assessment Before Top Surgery

The population of transgender and gender-diverse (TGD) persons in Wisconsin and the U.S. is steadily increasing. As this population grows, the number of individuals seeking gender-affirming therapies, including gender-affirming operations and gender-affirming hormone therapy, is also growing. An example of gender-affirming surgery is chest masculinization surgery, in which most breast tissue is removed in a person assigned female or intersex at birth to allow the chest to appear masculine. Gender-affirming chest masculinization surgery is not generally considered equivalent to an oncologic mastectomy, which aims to removal all breast tissue for future breast cancer reduction or current breast cancer treatment.

The goals of this investigation are to 1) determine the percent of TGD persons considering chest masculinization surgery who have an elevated lifetime risk of breast cancer development and/or a pathogenic genetic mutation; 2) measure the percent who are at risk and choose to undergo risk-reducing mastectomies as part of chest masculinization surgery; and 3) assess and compare self-perceived breast cancer risk with calculated risk.

The results of this study will substantially inform TGD patients and surgeons on the utility of personalized breast cancer risk assessment prior to chest masculinization surgery and the accuracy of self-perceived breast cancer risk in TGD persons.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old.
2. Assigned female or intersex at birth and identify as non-cisgender.
3. Any individual considering undergoing gender-affirming chest masculinization surgery
4. Ability to communicate in English.
5. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

1. \<18 years old.
2. Assigned male sex at birth.
3. Previously underwent chest masculinization surgery or any form of oncological mastectomy for the purposes of risk-reduction or cancer treatment.
4. Any previous or current history of breast cancer, including ductal carcina in situ (DCIS).
5. Inability to communicate in English.
Oxycodone for Labor Pain - Pharmacokinetics (PK), Safety and Efficacy

Childbirth is one of the most painful events that a woman is likely to experience, and thus is a major concern for most parturient. Severe pain releases stress mediators and may thus compromise fetus well-being if placental perfusion is decreased. Epidural analgesia is the golden standard for the management of severe labor pain. However, it could not always be used both due the parturient related factors and the organizational reasons.However, the knowledge on safety and efficacy of oxycodone involving mother, fetus and newborn is limited.

Aim of the study is firstly, to evaluate the efficacy and safety of oxycodone in labor pain healthy parturients. Secondly, to measure parturient's blood oxycodone concentration during labour and fetal concentration from placental umbilical vein and artery right after birth.


Eligibility Criteria:
Inclusion Criteria:

* Labouring healthy women
* Early labour
* Age 18-45 years

Exclusion Criteria:

* Sleep apnea or other central deficit affecting breathing
* Pulmonary insufficiency
* Liver of kidney insufficiency
* Use of mono amine oxidase medication
* Thyroid, pituitary insufficiency
* Paralytic ileus
* Other contraindication specified by the investigator
Reducing Self-stigma Using Brief Video Intervention

Stigma is a profound obstacle to care. Self-stigma decreases sense of self-competency, as well as healthcare seeking and treatment adherence and creates barriers to pursuing employment, independent living, and fulfilling social life. For example, people with mental disorders avoid, delay, or drop out of treatment due to a fear of labeling and discrimination or experience treatments as ineffective or disrespectful. Therefore, reducing self stigma can reduce self-blame, improve self-confidence and provide support for people living with mental illness.

In a prior study, the investigators developed a short video intervention to reduce self-stigma among people with schizophrenia. The investigators would like to test the efficacy of this video using Prolific (a crowdsourcing platform). Specifically, the investigators are interested in recruiting 1,200 Prolific participants, ages 18-35, who mentioned in their profile while enrolling to Prolific that they have a mental health condition, and randomized them into watching the newly developed video to reduce self-stigma or participate in the non-intervention control arm. Participants will be invited to participate in a follow-up survey 30 days after completing the first survey.

The primary objective of this study is to test the video efficacy in reducing self stigma among 1,200 Prolific users who mentioned in their profile while enrolling to Prolific that they have a mental health condition (600 in an intervention group, and 600 in a non-intervention control group). The study participants will be invited to participate in a 30-day follow up questionnaire. The investigators hypothesize finding a reduced level of self-stigma among those who watch the intervention video.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* 18-35-year-old
* US residents
* Those who answered yes to "Do you have or have you had a diagnosed, ongoing mental health/illness/condition?"

Exclusion Criteria:

* Non English-speaking
* Non US residents
* Age younger than 18 or older than 35
* People who replied no to the question on ongoing mental health
Diagnostic Performances of Computed TomographIc Coronary Angiography and Intravascular Ultrasound

Diagnostic purposes of the coronary angiography is to detect stenosis (anatomy) and to detect ischemia related stenosis (function). Coronary angiography (CAG) is a gold standard invasive techniques, but has several limitations. Intravascular ultrasound (IVUS) provides tomographic intra-luminal images. Coronary computed tomographic angiography (CCTA) is helpful to assess precise anatomical information. Optimal functional criteria and their accuracy of IVUS and CCTA by fraction flow reserve (FFR) have not been compared yet.

Correlation between CCTA, IVUS and FFR will be evaluated. The presence of myocardial ischemia will be assessed by fractional flow reserve (FFR).

Diagnostic performance (sensitivity, specificity, positive predictive/negative predictive values and diagnostic accuracy) of each modality will be assessed and compared.

Eligibility Criteria:
Inclusion Criteria:

* patients presenting chest pain suspected stable angina or unstable angina
* patients permit informed consents
* patients performed all the procedures including CCTA, IVUS and FFR and present coronary artery stenosis

Exclusion Criteria:

* acute myocardial infarction
* ejection fraction less than 40%
* infarct related artery
* chronic renal insufficiency
* left main stenosis, in-stent restenosis and grafted vessels
* allergy in contrast agent and adenosine
* unable to get a informed consents
Measurments Of BBB Breakdown In The Pathogenesis Of Psychiatric Disorders

BBB dysfunction has been indicated in some groups of schizophrenia patients by measuring increased albumin and immunoglobulin (IgG) cerebrospinal fluid (CSF) levels. Most of the authors described a raised protein level in 5-20% of the schizophrenic patients (Muller \& Ackenheil, 1995). Increased S100B levels were demonstrated in the serum of patients suffering from schizophrenia as well as depression, and this may reflect increased BBB permeability. Furthermore, this increase remains in those patients who develop a residual state with relevant negative symptoms, whereas S100B levels normalize in recovering patients (Shalev, Serlin \& Friedman, 2009). CSF albumin and CSF IgG values correlate significantly with some of the SANS (Scale for the Assessment of Negative Symptoms) subscales and the SANS total score, this shows the correlation between BBB permeability and behavioral changes. It is important to say that although negative symptoms are often signs of chronicity of the disease, the abnormal CSF findings in Muller's experiment (1995) are not related to the duration of the disease, because the patients were quite young and the duration of the disease was less than 3 years.

The investigators hypothesize that a primary vascular pathology, which leads to BBB breakdown, will result a leakage of serum-derived vascular components in to the brain tissue and may cause brain dysfunction such as disturbed thinking processes, mood and behavior, as we can see in psychiatric patients.


Eligibility Criteria:
Inclusion Criteria: Psychotic, affective disorders or anxiety disorders patients admitted to Soroka Medical Center from the psychiatric hospital or self admissions to the Psychiatric department.

Patients were evaluated by study psychiatrist. Signed informed consent by the patient or his legal custodian. Subjects Age 16-65 years.

-

Exclusion Criteria:1. Patients with neurological disease, including epilepsy, ischemic stroke, multiple sclerosis, Parkinson's disease, etc.

2. Drug or alcohol abuse. 3. Patients that will need anesthesia in order to perform the MR study (not including patients who are already ventilated).

4. Patients with metal foreign body, or other contraindication to MR (according to the MR regulations).

5. Tourists or foreign residents that long terms follow up is not feasible for them.

6. Patients with renal failure / any other kind of kidney problems. 7. Pregnant women. 8. Patient with brain-injury. 9. Suicidal patients/patients with high risk for suicide/violent patients or patients that their condition might deteriorate due to participation in this study.

-
The California Home Abortion by Telehealth (CHAT) Study

This study aims to assess efficacy and safety outcomes of a telehealth model of abortion care. The study will compare efficacy of this model to usual in-clinic care based on published rates. It will also investigate participant acceptability and feasibility of this model of care.

There are 2 components to the study:

1. A clinical records review on all patients
2. A survey study on a subset of patients who agree to participate.

Clinical Records Review: We will examine medical chart data on all patients from partnered telehealth providers to analyze efficacy and safety outcomes for medication abortion. These medical chart data will include medical/pregnancy history and abortion outcome and de-identified apart from date of birth, zip code, and dates of service.

Survey Study: Following completion of the telehealth provider's standard medical screening, all patients eligible to receive care through the telehealth provider will be directed to a page providing detailed information about the CHAT Evaluation Study and given the option to participate. Participation in the study involves completing our online questionnaires only. Being in the research study will not affect their care or treatment plan. Declining to participate in our research study will not affect their care.

If interested, the patient will provide electronic consent and complete a baseline survey to report socio-demographic characteristics, pregnancy history, and reasons for interest in telehealth medication abortion services. An online follow-up survey will be administered 3-7 days after receiving mifepristone and then once again 4 weeks after taking mifepristone; assessments will include self-report of medication administration, adverse events, and satisfaction.

Among those who complete the study surveys, we will investigate the feasibility, time to abortion, efficacy, safety, and acceptability of telehealth provision of mifepristone, measured using a 4-week follow-up though open-ended and closed-ended survey questions. Individuals who opted not to take the medications will be asked a separate set of follow-up questions to collect data related to diversion, to better understand potential risks.

Eligibility Criteria:
Inclusion Criteria:

1. Current patient of a participating telehealth platform for medication abortion (includes ages 13-64 years)
2. Able to read and write in English or Spanish
3. Willing to participate in enrollment survey and two follow-up surveys

Exclusion Criteria:

1. Not a current patient of a participating telehealth platform for medication abortion
2. Unable to read or write in English or Spanish
3. Unwilling to participate in study surveys