cyrilzakka/clinical-trials huggingface dataset:
Computer Tailored Program for Smoking Cessation Among Romanian Adults

The research aim is the development, implementation and evaluation of the first computer tailored smoking cessation progam for Romanian adult smokers. It will be implemented among smokers from Romania aged 20-60 years. The participants will beneficiate of tailored information received in letters generated by using sophisticated computer algorithms, allowing the creation of highly individualized messages that address each individual's unique needs, motivations and beliefs related to smoking .

Program implementation will comprise of :

1. ''diagnosis'' by means of questionnaires at the individual level of characteristics that are relevant for a person's smoking behavior
2. development of the ''message library'' that contains all education messages that may be needed
3. development of an ''algorithm'', a set of decision rules that evaluates the diagnosis, selects and generates messages tailored to the specific needs of the individual user
4. generating of personalized letters for each participant
5. sending of theses personalized letters to the participants. The participants will receive three personalized letters during a period of six months after registration into the program.

The effects of the program will be evaluated with a randomized controlled trial which will assess the changes in smoking behaviour as well as smoking related attitudes, self-efficacy and quiting attempts at 6 months after the enrolment into the program.

A process evaluation will assess participants' opinion about the program.


Eligibility Criteria:
Inclusion Criteria:

* smokers (smoked in the last 7 days)who intend to quit smoking in the next 6 months

Exclusion Criteria:

* non-smokers
* smokers who do not intend to quit smoking in the next 6 months
Evaluation of the Relationship Between Air Bubbles Depth and Pregnancy Rate in ICSI Cycles

The aim of this work is to assess the effect of air bubbles localization inside the uterus on embryo transfer outcome in ICSI cycles.

Is there a relationship between embryo transfer outcome and the distance between fundal endometrial surface and air bubbles assessed by trans-abdominal ultrasound?

All ET will be performed on day 3 after oocyte retrieval at the blastocyst stage by one operator under trans-abdominal US guidance performed by one physician, without any anesthesia or sedation with moderate bladder filling. Two embryos will be transferred using the same type of catheter which is Labotect embryo transfer catheter. It's a semirigid catheter that's less likely to induce endometrial trauma and uterine contractions.

The tip of the inner catheter will be placed approximately 1.5-2 cm from the fundal endometrial surface.The distance between the fundal endometrial surface and air bubbles will be measured and categorized as:

* Group 1: air bubbles depth \<10 mm.
* Group 2: air bubbles depth \>10 mm. The primary outcome will be biochemical pregnancy rate based on serum quantitative beta-hCG level at 14 days after ET. Secondary outcome will be clinical pregnancy rate using trans-vaginal US examination at 6 - 8 weeks of amenorrhea to detect the presence of fetal sac \& pulsation.

Eligibility Criteria:
Inclusion Criteria:

* Women in reproductive period (age 18-38 years).
* Infertility due to bilateral tubal block or unexplained infertility programmed for ICSI.
* BMI \< 25 kg/m².
* FSH level on cycle day 3 of \< 12 mIU/mL

Exclusion Criteria:

* Previous failed ICSI or IVF attempts.
* Infertility due to male factors.
* Presence of an abnormal uterine cavity due to endometrial polyps, myomas distorting the uterine cavity, Mullerian malformations, endometrial synechiae, etc. (assessed by transvaginal US and/or hysterography).
* Patients with hydrosalpinx or pyosalpinx.
* Patients undergoing ET after cryopreservation.
* Patients with blood present on the catheter during the transfer procedure.
* Patients with difficult transfer or with suspicion of touching the fundus.
* Poor responders.
Quality of Life and Disease-related Symptoms in Individuals With Systemic Mastocytosis

Systemic Mastocytosis is a rare and complex disease caused by accumulation of mast cells. The skin, bones, gastrointestinal tract, bone marrow and liver are the organs most often affected. Symptoms can vary greatly between patients. The study aims to describe the Swedish cohort's self-rated quality of life and levels of disease-related symptoms.

Systemic Mastocytosis (SM) is a rare and complex disease caused by accumulation of mast cells leading to release of mediator substances (e.g., cytokines, prostaglandins, histamine and tryptase). The skin, bones, gastrointestinal tract, bone marrow and liver are the organs most often affected. Symptoms vary between patients and can include e.g., allergic reactions with anaphylaxis, rashes, osteoporoses, cognitive difficulties, fatigue, depression, anxiety, nausea, vomiting, stomach pains and diarrhea. In this cross-sectional observational study, the aim is to include the Swedish cohort of persons diagnosed with SM to gather a wide range of information on self-rated health-related quality of life, gastrointestinal symptoms, pain, anxiety, depression and self-care.

Eligibility Criteria:
Inclusion Criteria:

* Swedish-speaking individuals aged 18 years or older and diagnosed with indolent systemic mastocytosis (ISM) or advanced systemic mastocytosis (AdvSM), verified by a bone marrow biopsy

Exclusion Criteria:

* An assessment by the treating physician that the individual has a cognitive impairment making participation impossible
* The patient has undergone an allogeneic stem cell transplant
Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis

5-Fluorouracil (5FU) is proven to be the most effective therapy in field directed treatment for AK, with Jansen et al. reporting a 1-year probability of treatment success of 74.7%. However, treatment with 5FU is associated with side effects, like erythema, itching, a burning sensation and crusting, and a burdensome dosing regimen of twice daily application for four weeks. This long treatment duration in combination with side-effects and overall lifestyle adjustments during treatment can be the reason for poor adherence and premature termination, and it can also lead to future refusal of 5FU therapy. Therefore, room for improvement lies in increasing the tolerability, in terms of side effects or treatment duration, while maintaining the efficacy of 5FU in the treatment of AK.

Addition therapy, which can shorten the duration of treatment, might be the key to success. Calcipotriol (CAL) enhances thymic stromal lymphopoietin (TSLP), an epithelium-derived cytokine, which promotes antitumor immunity. Therefore, it is known to have a synergistic effect when combined with 5FU in the treatment of AK. This suggests that short-term treatment with 5FU-CAL is effective and provides the opportunity to shorten duration of treatment, thereby improving tolerability of treatment and full adherence to the treatment regimen.

However, no study compared 5FU-CAL combination therapy with standard 5FU treatment for a duration of 28 days. This study aims to evaluate whether a short course of combination therapy with 5FU-CAL is non-inferior to a full course of 5FU monotherapy with respect to the 1-year probability of treatment success.


Eligibility Criteria:
Inclusion Criteria:

* Adults above 18 years of age
* Clinical and dermoscopical diagnosis of AK by a dermatologist, in one or more area(s):

  * Face, ears, (balding) scalp
  * Neck/Shawl area, including the sun-exposed chest area
  * Upper extremities
* Number of AK lesions ≥4 in a continuous treatment area of up to 100 cm2
* AK Olsen grade I-III

Exclusion Criteria:

* Previous field treatment for AK within 2cm of the treatment area, within 3 months
* (non) melanoma skin cancer in treatment area
* Mucosal lesions
* Genetic skin cancer disorder
* Women who are pregnant or breastfeeding
* Women of childbearing potential, who are not willing to use effective contraceptive measures
* Previous allergy or intolerance to either 5FU or calcipotriol
* Patients with known contra-indications for calcipotriol use: previous diagnosis of hyper-calcemia, disturbed calcium metabolism, severe kidney or liver dysfunction
* Concurrent use of oral capecitabine or any other topical or systemic chemopreventive agent for any indication
* Concurrent use of other topical treatments registered as treatment for AK
* Limited understanding of the Dutch language and not being able to give informed consent (incapacitated patients)
Outcome of Endodontic Treatment in Patient Treated With a Hydraulic Sealer

The objective of the study is to evaluate and compare, clinically and radiographically, the outcome of non surgical primary/secondary root canal treatment using a hydraulic sealer or a zinc oxide-eugenol sealer.


Eligibility Criteria:
Inclusion Criteria:

* a permanent, single or multi-rooted mature tooth
* clinical diagnosis of irreversible pulpitis
* diagnosis of apical periodontitis

Exclusion Criteria:

* subjects with immune-compromised status
* subjects with an overall poor prognosis for their treatment
Packaging PrEP to Prevent HIV Among WWID

Evidence suggests women who inject drugs (WWID) are disproportionately vulnerable to HIV. If HIV incidence continues unchecked, 1 in 23 WWID in the United States will acquire HIV. This observational study will evaluate a novel approach for the delivery of pre-exposure prophylaxis (PrEP) care: pairing PrEP with community-based syringe exchange program (SEP) services. The rationale is that (1) SEPs may currently provide prescription medications and long-term monitoring for other conditions such as buprenorphine for opioid dependence, so providing PrEP care is a natural extension of what is already being done successfully; (2) SEPs are a viable access point for many HIV-uninfected WWID who would be considered eligible for PrEP under current clinical guidelines; and (3) PrEP interventions, delivered in settings already utilized and trusted by WWID, will increase uptake, adherence and retention in PrEP. We will enroll a cohort of 125 women and follow-them over six months. At their first study visit, they will educated about and offered a prescription for PrEP. Those who indicate an interest in PrEP will be able to return to the SEP one week later to obtain a paper PrEP prescription or medication. All participants will be followed for six months using qualitative interviews and surveys to understand facilitators and barriers to PrEP uptake and engagement over time. In addition, we will collect urine and test it to detect the level of drug concentration among women who initiate PrEP. This will allow us to know whether their level of adherence translated to prevention effective drug levels.

This prospective mixed methods study will be initiated within the largest SEP in the mid-Atlantic region. Over six months, we will use semi-structured and in-depth interviews based on the Behavioral Model for Vulnerable Populations, and drug-level monitoring for emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) adherence, to address the following specific aims: (1) Describe WWID's engagement in the PrEP care continuum (focusing on critical moments when women could disengage or need additional support to remain in care). (2) Identify factors from the Behavioral Model for Vulnerable Populations that are associated with WWID's engagement in the PrEP care continuum. (3) Explore how and why model factors are associated with WWID's decisions and ability to engage in PrEP care. A paired model of PrEP and SEP services has yet to be tested.

Eligibility Criteria:
Inclusion Criteria:

* HIV sero-negative
* Females
* Age ≥18 years
* Reporting non-prescription injection drug use and any of the following:

  1. Syringe sharing
  2. Injecting drugs with a HIV-positive partner
  3. Recent opioid agonist treatment but still injecting drugs
  4. Sex exchange
  5. Inconsistent condom use
  6. Recent bacterial sexually transmitted infection (STI)
  7. and/or sex with a HIV-positive partner

Exclusion Criteria:

* HIV seropositivity
* Currently taking PrEP
* Pregnant, breastfeeding or trying to become pregnant
* Previous enrollment in the study
Ovarian Hyperstimulation Syndrome and Cabergoline

Cabergoline prevents ovarian hyperstimulation syndrome in high risk patients by disrupting follicular fluid hormone microenvironmentally altering the follicular fluid levels of insulin like growth hormone -I (IGF-I), antimullerian hormone (AMH), inhibin B and hepatocyte growth factor (HGF) levels in women with PCOS and high risk of ovarian hyperstimulation syndrome (OHSS).

Dopamine agonists have been proposed as a prophylactic treatment for OHSS in women with high risk of OHSS, however the possible mechanism of action has not been clearly known. In experimental studies, inhibition of vascular endothelial growth factor based pathway was proposed as a possible action of mechanism of dopamine agonists. However the role hepatocyte growth factor (HGF), insulin like growth factor-I (IGF-I), inhibin B and antimullerian hormone (AMH) on cabergoline action in OHSS prevention has not been known.

Eligibility Criteria:
Inclusion Criteria:

* Development of more than 14 leading follicles larger than 10 mm and serum estradiol more than 3000 pg/ml at the end of ovulation induction with long luteal ovulation induction protocol.
* Having the criteria of PCOS

Exclusion Criteria:

* Not having the inclusion criteria.
Impact of Non-surgical Periodontal Therapy on Oral and Gut Microbiome

Periodontitis is an inflammatory disease characterized by a dysbiotic microbiome which can lead to bone destruction and tooth loss. Several studies had been reported the association to periodontal disease with systemic conditions and this relation suggests and axis that links oral and gut microbiome. In order to clarify the impact of periodontal condition on gut microbiome, we aim to evaluate the clinical, immunological parameters and the microbiological condition by sequencing of subgingival biofilm and stool samples both before and after non-surgical periodontal treatment with and without antibiotics as adjunct.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Stage III/IV and grade C Periodontitis
* Presence of at least 20 teeth
* Good general health

Exclusion Criteria:

* Pregnant or lactating
* Were suffering from any other systemic diseases (e.g., cardiovascular, diabetes)
* Received antimicrobials in the previous 6 months
* Received a course of periodontal treatment within the last 6 months
* Were taking long-term anti-inflammatory drugs
* Smoking habits
Motion of Kids on Radiation Treatment

At Princess Margaret Cancer Centre, a comprehensive approach to help children stay still during radiation treatment (RT) such as audio-visual distraction (television) is routinely used. These techniques help reduce the need for sedation or general anaesthesia to keep children still to avoid the chance of missing the tumour during RT. This approach has not been systematically evaluated to determine its effectiveness at reducing movement of children receiving RT. The purpose of the study is to measure the movement of children between the beginning and the end of RT to see how much they moved during treatment.

Cone beam CT (CBCT) is a low-dose imaging technique routinely used at Princess Margaret Cancer Centre to check the position of patients before RT. Using CBCT, the doctor is able to reduce the amount of tissues that receive RT because patients can be set-up with greater accuracy to only target the tumour and not harm the surrounding healthy tissue. In this study, children will receive one CBCT scan before starting RT as part of standard approach. Then after RT, another CBCT scan will be used to measure movement between the beginning and end of RT. The information gathered from this study will benefit other patients and cancer centres in the future, who can learn from these methods of using audio-visual distraction so that children have minimal or no motion for a more precise delivery of radiation during cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient (paediatric or adolescent) age 18 or under receiving RT without anaesthetic or procedural sedation (anaesthetic gas or intravenous sedative medication)

Exclusion Criteria:

* Patients receiving oral midazolam or ketamine are ineligible
* Patient is receiving total body irradiation without CBCT
Use of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Breast Cancer

The primary objective of this study is to assess the feasibility of randomizing breast cancer patients to quantitative ultrasound to guide adaptive Neoadjuvant Chemotherapy as compared to standard clinical monitoring and therapy. The Investigators have previously demonstrated that high-frequency ultrasound and spectroscopy, and recently conventional-frequency ultrasound and spectroscopy may be used to detect cell death in vitro, in situ and in vivo. The method can detect different forms of cell death and has been demonstrated to be sensitive to apoptotic, necrotic and mitotic cell death. By detecting cell death early in a treatment on the order of hours to days, rather than traditional anatomical assessments that take place weeks to months after the completion of therapy, ineffective therapies could be switched to more efficacious treatments or aggressive salvage therapy which has shown to already benefit patients. The overarching goal of this research is to transform the delivery of neoadjuvant chemotherapy using quantitative ultrasound (QUS), which is non-invasive, inexpensive and portable.

This study phase II will demonstrate the use of quantitative ultrasound to guide adaptive chemotherapy for patients with breast cancer. The primary endpoint will be measurement of improved response rate locally. This trial will enroll 240 randomized breast cancer patients to be assess with quantitative ultrasound to guide adaptive neoadjuvant chemotherapy as compared to standard clinical monitoring and therapy. We will evaluate the safety of its use and expect equivalence in this small patient population. This will allow for more accurate estimation of a needed sample size for a phase III superiority trial.

Eligibility Criteria:
Inclusion Criteria:

1. Women ≥ 18 years of age
2. Diagnosis of breast cancer with a primary tumour \>2cm in size
3. With conditions meeting criteria for chemotherapy administration
4. Normal hematological blood counts (hemoglobin ≥ 100 g/l, platelet count ≥ 100 x 109, absolute neutrophil count ≥ 2.0 x109 cells per L)
5. Creatinine ≤175 µmol/L
6. Liver enzymes (AST and ALT) ≤ 1.5 times upper limit of normal
7. Cardiac function (left ventricular ejection fraction) ≥55%
8. Eligible for neoadjuvant chemotherapy.

Exclusion Criteria:

1. Inflammatory breast cancer
2. Contraindications to neoadjuvant treatment including pregnancy or lactation
3. Past medical history of connective tissue disease
4. Past history of dermatologic disease involving the breast
5. Eastern Cooperative Group Status (ECOG) ≥3
6. No peripheral neuropathy of a severity of grade ≥2
7. Evidence of distant metastatic disease
8. Known sensitivity to components present in ultrasound gel.
Assessment of Outpatient Digital Follow-up of Patients Over 70 Years of Age Undergoing Chemotherapy Treatment

adherence of digital follow-up in a population of elderly patients.

The use of digital self-questionnaires adapted to elderly patients but also to BrC and Bac could detect the toxicities of chemotherapy and we formulate the hypothesis that the continuous monitoring of these different variables in elderly patients treated with chemotherapy is possible and acceptable to this population.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 70 years,
2. Patient with an indication of adjuvant chemotherapy showing:

   * Breast cancer
   * Colorectal cancer
   * lung cancer

4. WHO ≤ 3 (WHO index - World Health Organization) 5. Estimated life expectancy\> 6 months 6. patients with a smartphone or tablet with an internet connection. It can also be offered to patients whose primary caregiver or the person of trust (including the partner) has a smartphone, an internet connection or a tablet provided that he or she is present more than three times during the week. during chemotherapy to ensure smooth weekly data transfer and filling of questionnaires 7. Signed consent to participation 8. Affiliation to, or beneficiary of, a social security scheme

Exclusion Criteria:

1. Person in emergency situation, person of legal age subject to a legal protection measure (major under guardianship, guardianship or court order), or unable to express his / her consent
2. Impossibility of submitting to the medical examination of the test for geographical, social or psychological reasons
3. Contraindications to the procedure of the study: patient or caregiver living with a patient who does not have a smartphone with an internet connection (patient or caregiver living with a patient)
4. Concurrent participation in another clinical trial
5. Patient unable to understand the quality of life survey and Patient Reported Outcome
Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS

The goal of this clinical trial is to evaluate the efficacy and safety of Sivelestat sodium and dexamethasone in the treatment of patients with moderate to severe ARDS. The main questions it aims to answer are:

* Is Sivelestat sodium more effective in the treatment of patients with moderate to severe ARDS compared with placebo?
* Is dexamethasone more effective in the treatment of patients with moderate to severe ARDS compared with placebo? Participants will receive Sivelestat sodium, dexamethasone or placebo. Researchers will compare the efficacy and safety of Sivelestat sodium, dexamethasone and placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate-to-severe ARDS in the acute exacerbation phase who meet the diagnostic criteria for moderate-to-severe ARDS
* Receiving tracheal intubation for mechanical ventilation within 72 hours after an episode of moderate-to-severe ARDS
* ARDS onset to randomized grouping within 72 hours (starting at the time of onset documented in the medical record)
* Patient volunteers to participate in the study and signs an informed consent form

Exclusion Criteria:

* Pregnancy or breastfeeding
* brain death
* Advanced cancer or other terminal disease
* History of allergy to Sivelestat Sodium and Dexamethasone
* Severe chronic obstructive pulmonary disease
* History of severe cardiovascular disease, such as heart failure, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled cardiac arrhythmia, uncontrolled hypertension, or history of heart or cerebral infarction within the past six months
* Organ transplant or allogeneic stem cell transplant recipients
* Fatal active fungal infections
* neuromuscular disease that affects voluntary breathing
* Genetic or acquired severe immunodeficiencies such as human immunodeficiency virus (HIV) infection, chronic granulomatous disease, severe combined immunodeficiencies
* Patients and/or legal representatives who sign a Do Not Resuscitate (DNR) advance directive, or who abandon treatment
* Participating in other clinical trials