cyrilzakka/clinical-trials huggingface dataset:
Sorry Not Sorry: Apologizing and Its Effect on Discomfort During Dressing Removal

Use of dressing is common place following surgery, allowing for wounds to be covered and protected. Dressing material with adhesive contact layers or adhesive tape is integral to sealing off the wound. Mechanical stripping of stratum corneum during dressing removal causes pain and discomfort. During dressing removal, practitioners may at times apologize as a function of empathy. Previous study investigated speed of dressing removal and its effect on discomfort during dressing change. In this study, the investigators aim to investigate how empathy expressed in form of saying "sorry" affect the perception of pain during dressing change?


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers, age \>18.

Exclusion Criteria:

* individuals with sensitivity to tape or dressing, anxiety disorders, or pain syndromes.
Study of Amrubicin With or Without Cisplatin Versus Etoposide-cisplatin for Extensive Stage Small Cell Lung Cancer

The purpose of the study is to document the activity and safety of single agent amrubicin, amrubicin combined with cisplatin, and etoposide combined with cisplatin as first-line treatment in extensive disease small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically/cytologically proven small cell lung cancer
* Extensive disease
* Measurable disease
* World Health Organization (WHO) performance status 0-2
* Age 18 years or older
* Normal baseline cardiac function
* No prior systemic chemotherapy for small cell lung cancer
* Adequate organ function including bone marrow, kidney, and liver
* No history of interstitial lung disease or pulmonary fibrosis
* No history of prior malignancy unless patient has been disease free for greater than 5 years, or the tumour was a non-melanoma skin cancer or in-situ carcinoma of the cervix
* No pregnancy or breast feeding; patients of child-bearing potential must agree to use an appropriate method of contraception
* Written informed consent before randomization

Exclusion criteria:

* Pre-existing peripheral neuropathy (greater than Grade 1, CTCAE version 3.0)
* Uncontrolled or severe cardiovascular disease
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Comparison of Two Rescue Therapies for Helicobacter Pylori Infection

From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.

The H pylori-infected adult patients with failure of standard triple therapy and H pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either EALT (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.) therapy or EAL (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.) for 10 days. Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-H pylori therapy.

Eligibility Criteria:
Inclusion Criteria:

* positive results of both rapid urease test and histology,
* a positive result of urea breath test,
* or a positive result of culture.

Exclusion Criteria:

* ingestion of antibiotics, bismuth, or proton pump inhibitor（PPI）within the prior 4 weeks,
* patients with allergic history to the medications used,
* patients with previous gastric surgery,
* the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
* pregnant women
Chlorhexidine Against Sodium Hypochlorite as Skin Antiseptics

The physicians have few options for skin antisepsis. Alternatives for common use antiseptics are costly or ineffective. In order to have more options, this study is needed. The investigators want to know if there are differences between the use of 2% chlorhexidine gluconate in 70% isopropyl alcohol or 10% sodium hypochlorite.

Sodium hypochlorite at 10% has been widely used as antiseptic in patients on dialysis as well as for irrigation of wounds and burns. Since it has been used successfully in caring for the exit side of hemodialysis catheters, it is reasonable to propose its use for the insertion and care of central intravascular catheters, as well as for skin preparation before surgery. Alternatives for povidone-iodine, which is the agent most commonly used, are costly or ineffective. In a recent study perform by our group it was demonstrated that 10% sodium hypochlorite was not inferior than povidone-iodine.

It has been demonstrated as well that 2% chlorhexidine gluconate in 70% isopropyl alcohol is superior to povidone-iodine. The aim of this study is to know if 10% sodium hypochlorite has a similar effect that the best current option for skin antisepsis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers

Exclusion Criteria:

* History of skin allergies or atopy, as well as reactions to soaps, chlorine or latex
Prevalence of Advanced Fibrosis in Patients Living With HIV

Monocentric, cross-sectional study to define the prevalence of advanced fibrosis in an HIV infected outpatient population. Follow-up over 10 years to assess clinical relevance.

Globally a shift in the spectrum of diseases has occurred. While in earlier year's infectious (communicable) disease were the main contributors to morbidity and mortality, today non-communicable diseases (NCD) exhibit a dramatic increase and have reached epidemic proportions, even in developing countries. Diabetes, cardiovascular disease, and cancer are the most frequent NCDs and the underlying risk factors including Insulin resistance, dyslipidemia and obesity have been increasing over the last decades. The current study explores the prevalence of advanced fibrosis in an HIV-infected outpatient study population.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* age \>18

Exclusion Criteria:

* pregnancy
* disease with expectation of life under 12 months
T-DM1 in HER2-positive Metastatic/Relapsed Breast Cancer

This is a retrospective, multicenter, non-interventional study for the evaluation of real-world efficacy and safety of T-DM1 in metastatic/relapsed HER2-positive breast cancer as part of the establishment of hospital medical record collection system to evaluate drug effectiveness by Health Insurance Review \& Assessment Service (HIRA). The medical records in approximately 1,000 patients of HER2-positive locally-advanced unresectable or metastatic breast cancer, who have received Kadcyla(Trastuzumab Emtansine, T-DM1) previously, will be collected.

T-DM1 therapy has shown a survival benefit in previously trastuzumab-treated HER2-positive locally-advanced unresectable or metastatic breast cancer patients from clinical trials. However, the real-world efficacy and safety of T-DM1 in KOREA were not evaluated outside the controlled clinical trials. Therefore, this large multicenter retrospective analysis was designed to evaluate the real-world efficacy and safety of T-DM1 under the Korea National Health Insurance System. The medical records in approximately 1,000 patients with relapsed or De Novo metastatic breast cancer, who have received T-DM1 between Aug 03, 2017 and Dec 31, 2018 will be collected. Eligibility criteria included age ≥ 19 years, histologically confirmed HER2-positive, relapsed after primary surgery or initially metastatic breast cancer, and previous trastuzumab treated. Efficacy was evaluated by overall survival, progression free survival, time to progression, objective response rate, disease control rate, duration of response and time to next treatment. Safety was evaluated by hematologic or non-non hematologic toxicities and adverse events of special interest with T-DM1 therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥19 years at the time of study registration
2. Participants must have histologically confirmed HER2-positive breast cancer
3. Locally advanced unresectable or metastatic patients
4. Patients who have received T-DM1 therapy between Aug 2017 and December 2018 under the Korea National Health Insurance System

Exclusion Criteria:

• Patients who have received T-DM1 therapy outside of the Korea National Health Insurance System
Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)

The objective of this study is to evaluate the performance of Masimo RD SET® SpO2 sensors in subjects with light and dark skin pigmentation in the intensive care therapeutic area.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older.
* Subject is receiving care in an intensive care unit.
* Subject with an arterial catheter in place.
* Subject is experiencing hypoxemia as defined by 1) need for supplement oxygen or 2) peripheral oxygenation ≤ 94% on room air

Exclusion Criteria:

* Subjects in whom pulse oximetry cannot be reliably performed on both the third and fourth digit on the hand ipsilateral to the arterial line, precluding application of the sensor (e.g., amputation and deformity).
* Subjects with a skin condition affecting the digits, where the sensor is applied, which would preclude sensor placement as standard of care (e.g., psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.).
* Subjects with distinct geographic variances in skin pigmentation (e.g., vitiligo) on the digit where the sensor is applied, which would preclude sensor placement as standard of care.
* Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied.
* Subjects with known allergic reactions to adhesive tapes.
* Subjects with arterial catheter placed in a lower extremity.
* Subjects not suitable for the investigation at the discretion of the investigator or the clinical team.
Lifestyle Change in Women with Polycystic Ovary Syndrome

This project aims to compare "diet" and "diet and exercise combination" interventions in obese women with polycystic ovary syndrome.

This project will be carried out in the Dokuz Eylül University Research and Application Hospital gynecology outpatient clinic between June 1, 2022 and June 1, 2024. The purpose of the project will be explained to women who meet the sampling criteria, and their informed consent will be obtained. A prospective and randomized comparison of "diet" and "diet and exercise combination" interventions, which are among the first-line treatment lifestyle changes recommended for PCOS, will be done. In the project, 33 women in the first group will receive "diet" intervention for 12 weeks, and 33 women in the second group will receive "diet and exercise combination" intervention. "Descriptive Characteristics Form" will be filled in for both groups, then at the beginning and at the end of the project, routine ultrasonography and laboratory test parameters for PCOS diagnosis criteria and menstrual cycle characteristics will be recorded, hirsutism score, alopecia score and acne level will be evaluated, the Utian Quality of Life Scale, Body Appreciation Scale, and the Short Form of the Oxford Happiness Questionnaire will be filled out. Body composition analysis will be performed in both groups at the beginning of the project, in the fourth and eighth weeks, and personal dietary recommendations will be given. Kitchen scales will be given to both groups to adapt to dietary recommendations and a mobile nutrition application will be used to record their diets. Person-specific exercise recommendations will be given to the second group at the beginning of the project, in the fourth and eighth weeks. In addition, women will be informed with a guide to behavioral changes specific to PCOS, which will be prepared specific to their group. Exercise parameters will be recorded by giving the same mobile application. Mobile nutrition application data will be collected via e-mail in the fourth, eighth and twelfth weeks of the project.


Eligibility Criteria:
Inclusion Criteria:

* Being between 20-41 years old,
* Diagnosis of polycystic ovary syndrome,
* Having a secondary education or higher education,
* Having a body mass index of 30 and above,
* Volunteering to participate in the research

Exclusion Criteria:

* Having a psychiatric diagnosis,
* Using a contraceptive method containing hormones in the last three months,
* Presence of one or more of the etiologies of hyperprolactinemia, thyroid dysfunction, Cushing's syndrome, congenital adrenal hyperplasia and other hyperandrogenemia,
* Diagnosis of hypertension, Type 1 or Type 2 Diabetes Mellitus,
* Using one or more of the drug types such as antiandrogen, steroid, antidiabetic, ovulation induction agents in the last three months,
* Impairment of liver, kidney or heart functions,
* Limited physical exercise
Prospective Study Evaluating the Clinical Tolerance of Skin Tattoos During MRI Examinations (TATOU - IRM)

MRI examinations are potential sources of complications related to the displacement of ferromagnetic objects, but also to heating effects that can go as far as burns. This overheating can be caused by contact with external equipment (sensors, cables, etc.). Patients with skin tattoos may experience specific complications as tingling or "burning" felt at the site of the tattoo. They can be followed by a transient erythema with edema around the reversible tattoo in 12 and 72 hours. One observation of severe 2nd degree burns has been reported. They would be linked to the presence of metallic salts in the dermis, resulting from interactions between the pigments and the magnetic field but their mechanisms are poorly identified and divergent.

The aim of this study is to assess the rate of MRI causing complications in patients with tattoos.


Eligibility Criteria:
Inclusion Criteria:

* Major patient
* tattoo patient
* Ability to answer the questionnaire
* Affiliated patient or beneficiary of a social security scheme
* Patient having been informed and not objecting to the research

Exclusion Criteria:

* Minor
* Patient unable to understand and respond to questionnaires due to language difficulties or cognitive impairment
* Patient objecting to research
* Pregnant or breastfeeding woman
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
Tapping in Together: A Pilot Study on Group Acupuncture for Ketamine Experience Integration

The goal of this pilot trial is to learn about using acupuncture for ketamine experience integration in adults aged 21-65 who are medically cleared for a ketamine prescription. The aim is to inform future controlled trials investigating efficacy by evaluating the success of:

* recruitment
* retention
* assessment procedures
* implementation of group acupuncture interventions performed just after a ketamine experience

Participants will be given acupuncture in a group setting after a small-group ketamine experience. The following day, participants will be asked to complete a few brief surveys about their experience.

The study will solicit participants to enroll in a physician-supervised ketamine experience directly followed by group acupuncture administered in New York City, between October 1, 2023 and February 28, 2024. A group of 12-28 participants will be enrolled in the study and assigned a participant ID once screened by the researcher and medically approved by the prescribing physician.

Group acupuncture treatments will be conducted one hour after a group ketamine experience commences. The group acupuncture sessions will start with the researcher approaching each participant individually and asking to examine their pulse and tongue. The participants will be given an opportunity to share any information they would like to about specific issues they would like to address with acupuncture. If nothing is shared, the researcher will select treatment points based on their pulse, tongue, body palpation, and intake data. The general location of the points selected will be shared with the participant to gain their consent for treating those areas prior to needle insertion. While the acupuncture needles are retained, participants will rest with music playing. The needles will then be removed, one at a time, from each patient in order of treatment (unless a participant requests needle removal before then). After needle removal, the participants will be asked to sit up for a few minutes before exiting the treatment room. Both the licensed acupuncturist researcher and a psychotherapist will be in the treatment room throughout the 1-hour group acupuncture session.

Participants will be emailed a validated survey via a REDCap secure link before the group acupuncture session (if they had a previous ketamine experience), after their group acupuncture session as well as 3 months from the date of their group acupuncture session. Participants will also be sent optional feedback forms through REDCap after each acupuncture session.

Eligibility Criteria:
Inclusion Criteria:

* between ages 21-65
* participant in a group ketamine experience between October 1, 2023 and February 28, 2024

Exclusion Criteria:

* currently pregnant or breastfeeding
* has a terminal illness
* does not pass medical clearance for ketamine prescription
Microbiota in Dietary Approach to Obesity

Main aim: Study the anthropometric, metabolic, cardiovascular and neurocognitive and gut microbiota changes of different approaches for the weight reduction that increase the ketone bodies in a different proportion in relation to the classic hypocaloric diet.

Objective 1: Study the effect of hypocaloric diets that increase the ketone bodies on gut microbiota and its relationship with anthropometric changes and of the Brown adipose tissue, Objective 2: with the metabolic and inflammatory changes, Objective 3: on the cardiovascular system, Objective 4: on the neurocognition, Objective 5: if they are associated to epigenetic changes that may explain the changes found in the other objectives. Objective 6: Determine the safety of the diets that increase the ketone bodies compared to the classic hypocaloric diet, Objective 7: if the effects of the different dietary approaches are maintained during the medium time, and Objective 8: Verify in experimental models (microbiota transplants from humans with different diets to germ-free mice, ketosis dietary models, and ketone bodies administration) the causality of the gut microbiota of these findings.

Methodology: Model 1: Dietary intervention in humans with 4 types of diet with a different increase of the ketone bodies: classic hypocaloric diet (DH); diet with 8h of feeding and 16h of starving in periods of 24h (D16); diet with intermittent caloric restriction (DA); and normal in protein and low in carbohydrates hypocaloric ketogenic diet (DC).


Eligibility Criteria:
Inclusion Criteria:

* Obesity (BMI≥30-45 kg/m2)

Exclusion Criteria:

* Type 2 diabetes mellitus
* Patients with major cardiovascular events in the 6 months prior to the study beginning.
* Previous or current history of inflammatory disease.
* Active infectious disease.
* The refusal of the patient to participate in the study
* Consumption of probiotics or prebiotics
* Antibiotic therapy in the 3 months prior to the study
Emotional and Physical Health Status of Adults

To investigate the comparison of differences between emotional and physical health status of adults in COVID-19 isolation period and controlled normalization period.


Eligibility Criteria:
Inclusion Criteria:

* To speak Turkish
* Living in Turkey in pandemic process.
* Between the ages of 20-60 years.
* No communication problems.
* Being volunteer to participate in study.

Exclusion Criteria:

* Having communication problems.
* Not completion the assessments.
COVID-19 - SARS-CoV-2 Community Contamination in Children and Adults (Dyn3CEA_Nosocor)

Unlike other respiratory viruses such as influenza and Respiratory Syncytial Virus (RSV) where the child is the essential reservoir and central vector of intrafamilial contamination, the child is likely to be a small player in the transmission of Severe Acute Respiratory Syndrome CoronaVirus 2 (SRAS-CoV2) infection. This study aims to describe the age category of the first contact, within 14 days before the appearance of the first symptoms of the index case in order to describe the age categories of this first contaminant, globally, in the group of children and finally in the group of adults. This work is intended to provide food for discussion and to justify the distancing and containment measures imposed on children when their isolation has a deleterious impact that has now been established for some children.


Eligibility Criteria:
Inclusion Criteria:

1. Children after hospitalized in Hospices Civils de Lyon with Polymerase Chain Reaction (PCR) positive SARS-CoV2,
2. Adults hospitalized in Hospices Civils de Lyon and included in the NOSO-COR study with matching criteria described below.

   * Matching will be performed on family age characteristics and on the period of contamination included in the containment period to minimize bias, and if possible frequency matching according to admission in Intensive Care Unit ICU/Pediatric Intensive Care Unit (PICU), and to family structure (n of children / n of adults in the family).

Exclusion Criteria:

1. Any patient suspected of nosocomial infection.
2. Any patient death during the Covid-19 infection.
3. Any adult patient without children living home.
4. Opposition to participate.
Social Emotional Development in Young Children With Cancer

Many children with cancer are diagnosed in early childhood, and as such, will likely miss key social experiences such as participation in preschool or kindergarten, playing on playgrounds, and other normative experiences. In typically-developing children, it is known that these experiences - and the skills that are learned during them - are critical to later well-being. Very little is known about the psychological functioning of young children with cancer, as studies have predominantly focused on those who are older (at least 8 years of age). This study will explicitly assess social functioning in preschool-aged children with cancer and follow the development of their social functioning from the end of treatment into survivorship.

The goals of this pilot study are to begin to assess the impact of missed early childhood social experiences, as well as the interaction with developing neurocognitive problems.

PRIMARY OBJECTIVE: Explore the impact of cancer in the central nervous system on social functioning of young children (ages 4-6) after completion of therapy.

Participants will be evaluated using the same or similar questionnaires at two time points. The first assessment will take place when they are 6-12 months post the end of treatment. Participants and their parents/legal guardian will complete an assessment of social and cognitive functioning by completing questionnaires about social, emotional, behavioral, and executive functioning. If the study participant agrees, they will identify another adult (that is, teacher or daycare employee) who may be contacted to complete questionnaires about the participant's social and behavioral functioning. A follow-up study visit will occur about two years later.

Eligibility Criteria:
Inclusion Criteria:

* Primary Diagnosis of a brain or non-CNS solid tumor
* Between 4 and 6 years of age at enrollment
* Between 6 and 12 months post-therapy at the time of enrollment
* Treatment plan included chemotherapy
* English speaking
* Cognitive and language capacity to complete measures

Exclusion Criteria:

* Diagnosis of a genetic disorder/pre-existing neurodevelopmental condition associated with neurocognitive or social impairment (e.g., autism, Neurofibromatosis Type 1 (NF1), Down syndrome)
* Solid tumor patients who required CNS-directed therapy (e.g., radiation, intrathecal chemotherapy)
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.