cyrilzakka/clinical-trials huggingface dataset:
The Effect of Informing Relatives of Patients With Short Messages

Surgical intervention is a planned or unplanned procedure performed to eliminate the existing or subsequent abnormal conditions in the individual's body, to reduce the effects of these conditions, or to remove the abnormal structures from the individual's body to eliminate the existing distress. While surgical interventions also cause anxiety in patients, it is known that they also cause significant anxiety in patients' relatives.This study was planned as a randomized controlled experimental study in order to examine the effect of this information on the anxiety level of the relatives of the patients by informing the relatives of the patients about the operation process with a short message during cardiovascular surgery.

In data collection; Introductory information form for the patient and patient relatives, a short message follow-up form, state and trait anxiety inventory will be used during the surgical intervention.

The sample of the study will be the relatives of the patients who are willing to participate in the study. Considering the change in the state anxiety scale scores between the experimental and control groups in the study of Baydemir S. (2019), it is calculated that there is a large effect size difference. Based on this finding, in order to test a large effect size (d=0.8) difference in anxiety scale scores of patient relatives between our experimental and control groups with 5% margin of error and 95% power, a total of 84 relatives of patients, 42 from each group, were included in the study. needed was calculated.

H0: Informing by text message has no effect on the anxiety of patient relatives.

H1: Informing by text message has an effect on the anxiety of patient relatives.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and over,
* To know Turkish,
* Being literate
* Having mental adequacy,
* Willingness to participate in the research,
* Having an active mobile line,
* Ability to use a telephone
* Being in the hospital before, during and after the operation

Exclusion Criteria:

* Be under the age of 18,
* Not knowing Turkish,
* Being illiterate
* Lack of mental adequacy,
* Lack of active mobile line,
* Inability to use the phone
* Absence from the hospital before, during and after the operation
Virtual Reality Distraction for Reduction

Using a randomized controlled design, the investigators goal is to estimate the effect of VR on postoperative analgesia and opioid consumption.

Specifically, the investigators propose to test the primary hypothesis that the use of AppliedVR software in Pico G2 4K headsets decreases acute postoperative pain scores (with a 1 point difference considered clinically important) compared to sham treatment on a 0-10 scale 15 minutes after each use in the first 48 hours after surgery or hospital discharge, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology Physical Status 1-3;
* Scheduled for elective, primary total hip arthroplasty;
* Anticipated hospitalization of at least 1 night;
* Expected to require parenteral opioids for postoperative pain;
* Able to use IV PCA systems.

Exclusion criteria:

* History of chronic pain or care by a pain management specialist;
* Use of more than 30 mg/day of oral oxycodone (or equivalent);
* Greater than 12 weeks of current and continued opioid use;
* History of seizures, epilepsy, motion sickness, stroke, dementia;
* Non-English speaking;
* Women who are pregnant or breastfeeding;
* History of substance use disorder.
Identification of Optimal Stimulation Site for Cervical Dystonia Symptoms: An Exploratory Study

The overall objective of this application is to therapeutically target the dysfunctional premotor-motor interaction in dystonia-and to provide a focused treatment of specific anatomical networks in order to reduce side effects and to improve symptom control over conventional therapies.

We propose using repetitive transcranial magnetic stimulation (rTMS) over distinct premotor areas in patients with cervical dystonia (CD) with the goal of improving symptoms and reducing unwanted side effects. The knowledge gained in this proposed research will identify a specific premotor area to be targeted with rTMS that is expected to result in a novel intervention that could enhance or replace current treatments for CD. rTMS could be included as an adjunct treatment to botulinum toxin that could sustain treatment effect and decrease the frequency of re-injection, potentially resulting in cost savings without a decrease in symptom control. In addition to medical cost reduction, improved quality of life could be expected with the successful development of therapies that extend dystonia symptom control. rTMs has been FDA-approved for the treatment of depression and our proposal uses an even lower stimulation rate, suggesting continued use within clearly safe parameters. Successful completion of this research could lead to rapid adoption of this therapeutic modality.

We will test the hypothesis that rTMS of a distinct premotor site will provide more effective treatment of CD than non-specific activation of the entire premotor region. This will be done by performing a randomized, observer-blinded exploratory pilot study to determine the optimal site of rTMS over various sites of the premotor and motor cortex to improve the symptoms of cervical dystonia. Completion of this aim should lead to development of targeted TMS therapy for CD.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of idiopathic cervical dystonia
* Age 18 years or older
* Normal findings in the medical history, physical and neurological examination, except for dystonia
* Last treatment with botulinum toxin more than two months ago

Exclusion Criteria:

* History of seizure disorder
* Pregnancy- a pregnancy test will be performed for women of childbearing potential
* History of any other neurological disorders or conditions requiring the use of anti-depressants that are known to increase seizure threshold, neuroleptic medication, anticholinergic drugs and muscle relaxants
* History of neuroleptic medications/ prior use of neuroleptics
The Role of Glutathione Deficiency and MSIDS Variables in Long COVID-19

The purpose of this research study is to assess if glutathione, along with NAC (N-acetyl cysteine) and Alpha lipoic acid (ALA), can help reverse some of the COVID long-haul symptoms.Subjects will be randomized in to one of two groups. Depending on the group they are randomized in to, subjects will be taking either a combination of NAC, Alamax CR, and liposomal GSH or the same three nutritional supplements with a multivitamin and magnesium. Regardless of the group, subjects will be asked questions to assess their COVID symptoms, physical and mental health status. They will also be asked to take blood samples.


Eligibility Criteria:
Inclusion Criteria:

• Patients with positive COVID testing (AB, RT PCR) and mild-severe symptoms based on COVID symptom list

Exclusion Criteria:

• History of a severe sulfa sensitivity (i.e., anaphylaxis, Stevens Johnson Syndrome), allergy to meat products and/or gelatin (alpha gal allergy) and/or a history of an allergic or adverse reaction to NAC, alpha lipoic acid and/or GSH.
The Contribution of a Smartphone Application to Acceptance and Commitment Therapy Group Treatment for Smoking Cessation

The purpose of this study is to evaluate the efficacy of a smartphone application in enhancing Acceptance and Commitment Therapy group treatment for smoking cessation. This study also aims to elucidate the processes through which the treatment promotes smoking cessation and for whom it is most effective.

Smoking is the single biggest preventable cause of death in Ireland and costs the exchequer approximately €1-2 billion per annum. Currently, 19.2% of Irish people aged 15 and over smoke. Given the magnitude of human suffering and economic cost associated with smoking, the systematic empirical development of cost-effective smoking cessation interventions is a major public health need. Combining a group-based treatment for smoking cessation with a theoretically-consistent smartphone application has the advantage of augmenting therapeutic content delivered in the clinic with on-the-spot assistance in the individual's natural environment. In accordance, this study will evaluate the efficacy of a smartphone application in enhancing Acceptance and Commitment Therapy group treatment for smoking cessation. This study will also elucidate the processes through which the treatment promotes smoking cessation. Identifying such mediators of change can inform the enhancement of subsequent interventions, enabling them to retain efficacious elements and disregard redundant elements. Furthermore, this study will identify the participant characteristics associated with differential response to the treatment. Clarifying such treatment moderators can facilitate practitioners in selecting optimal treatments for individual service users.

Participants will attend a baseline assessment on an individual basis prior to their smoking cessation attempt. During this session, participants will provide a breath sample and complete a series of self-report measures: Fagerström Test of Nicotine Dependence, Commitment to Quitting Scale, smoking-related variables (e.g., years smoking, previous quit attempts, etc.), Avoidance and Inflexibility Scale, Mental Health Continuum-Short Form, Valuing Questionnaire, Present Moment Awareness Subscale of the Philadelphia Mindfulness Scale, and the Cognitive Fusion Questionnaire. Participants will then be randomly allocated to the combined treatment, ACT group treatment or group based Behavioural Support Programme. A post-treatment assessment will be conducted to investigate changes in the variables measured at baseline. In addition, a six-month follow-up assessment will determine whether the effects of the treatments are sustained over an extended period of time.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Interested in quitting smoking in the next 30 days
* Smoking 10 or more cigarettes per day for at least the past 12 months
* Daily access to a smartphone that is compatible with applications from iTunes (iPhone) or Google Play (Android)

Exclusion Criteria:

* Currently participating in another smoking cessation intervention
* Failure to the meet inclusion criteria
White Matter Plasticity in Schizophrenia

Schizophrenia spectrum disorders are associated with impairment in the microstructure of white matter, the key brain tissue responsible for fast communication between different brain regions necessary for any complex task. This white matter impairment is linked to problems with cognition in schizophrenia, especially slower processing speed. This project aims to study the potential for correcting white matter deficits in schizophrenia by examining mechanisms underlying white matter structure changes in response to training on playing a mock musical instrument.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychosis NOS
* age 15-45
* able to provide informed consent

Exclusion Criteria:

* contraindications to MRI (metal implants, claustrophobia)
* medical condition that limits use of hands (ie, arthritis)
* Active or recent (within 6 months) substance use disorder other than nicotine
Contextual Associations During Episodic Recall of Everyday or Virtual Reality

The project is dedicated to development of new paradigms to investigate memory and attention in the rich and realistic environments. The investigator will use modern interactive digital technologies for encoding complex episodes either using mobile phone technology in everyday life or using a virtual reality life-like simulation.

He aims to characterize the role of the medial temporal lobe and prefrontal cortex during recall of naturalistic episodic experiences, using functional neuroimaging (fMRI) in healthy participants. The secondary aim is assess how the allocation of attention during memory encoding contribute to mechanisms of the subsequent recall. He will achieve this by monitoring gaze direction during encoding and by analyzing the retrieval data as a function of the elements that participants attended / fixated during encoding.

The protocol will involve, first, behavioral testing of memory performance with encoding in the real-life or in virtual reality, followed by the main hypothesis testing phase when fMRI will be used to measure brain activity during retrieval.


Eligibility Criteria:
Inclusion Criteria:

* Possession a Smartphone compatible with GPS 3-rd generation and exploitation system Android 4.2 with user-activated geolocation (for mobile phone studies).
* Able to navigate in virtual reality with a help of the keyboard (for virtual reality studies).
* Not using glasses.
* All subjects will give their written consent for participation in the study.
* They will be right-handed
* They will have French social coverage.

Exclusion Criteria:

* Previous neurologic or psychiatric disease.
* Cognitive deficits restricting understanding of the tasks.
* Pregnant or breath-feeding women.
* Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights or liberty.
* Subjects currently participating in other study.

Additional exclusion criteria for an fMRI recording

* Neurologic, cardiac electrostimulation or defibrillator.
* Cardiac prostheses
* Intracranial clips or clamps
* Cerebrospinal fluid disorders
* Metal particles in the eyes
* Metal dental or articular prostheses
* Diffusion pomp or other infusion system
* Claustrophobia
* Head tattoo , makeup, hair gel
Single-center Investigator Initiated Pilot Study Investigating the Tumor Response of Squamous Cell Carcinoma Lesions in Patients Under Lapatinib Treatment

Primary cutaneous squamous cell carcinomas (SCCs) are epithelial carcinomas with a high frequency of EGF-R expression. EGFR is an important regulator of tumour progression and proliferation in several types of cancer. Mechanism of action of Lapatinib in the EGFR and/or HER2 expressing oesophageal squamous cell carcinoma (ESCC) cells is attributed to inhibition of cell proliferation and induction of apoptosis. Based on the data from oesophageal SCCs the investigators hypothesise that EGFR signalling pathway and its interactions play an important role in the SCC pathogenesis and represent a good therapeutic target from these tumours.

Primary Objectives:

To evaluate the tumour response macroscopically in patients with primary cutaneous SCC lesions and in concomitant SCC in situ (AK).

Secondary Objectives:

* To evaluate tolerability of a single dose regimen of systemic lapatinib therapy in patients with SCC as measured by time to first AE or SAE within the study period.
* To investigate the molecular tumour response of squamous cell carcinoma lesions in patients under lapatinib treatment using a set of variables.
* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18 years
* Diagnosis of histologically confirmed cutaneous SCC stage Tis-T2N0 for which surgical treatment is considered suitable.
* In case of SCC, patients must present with a minimum of two co-existing AK lesions. In case of Keratoacanthoma, one lesion of sufficient size (=1cm) is acceptable.
* All included patients must have both FFPE and frozen material available.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ system function

Exclusion criteria:

* Subjects who have current active hepatic or biliary disease
* Other non-controlled malignancy
* Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding.
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study treatment.
* Presence of uncontrolled infection
* History of any one or more of the following cardiovascular conditions within the past 6 months:Cardiac angioplasty or stenting;Myocardial infarction;Unstable angina;Coronary artery bypass graft surgery;Symptomatic peripheral vascular disease; Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
* Poorly controlled hypertension
* History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
* Prior exposure to the study drug lapatinib
* Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer
Menstrual Cycle on Injection Pain of Rocuronium

This study evaluates the effects of rocuronium injection pain to menstrual cycle phases.Half of participants will receive follicular phase, while the other half will receive luteal phase.

Menstrual period includes a spectrum of emotional and somatic symptoms observed in luteal phase of menstrual cycle, which are disappeared after menstruation.

During menstrual cycle, fluctuation in sexual hormones results in attitude change and alteration in pain perception.

Different studies reported some interactions between sex hormones and central nervous system, which might be linked to activity of serotonin and beta-endorphin in the brain.

Pain perception differs during menstrual cycle.

It has been recommended that estrogens might have an influence on somatic sensory process.

Some studies reported a significant effect of pain sensitivity with higher levels of progesterone and some other studies reported similar patterns for pain perception.

There are reports of more complaint of pain in luteal phase of menstruation, which is suggested as the reason for functional changes in women during menstrual cycle.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology Classification (ASA) I-II
* 18-45 years
* Regular menstrual cycle

Exclusion Criteria:

* Irregular menstrual cycles
* Patients receiving hormones or drugs affecting the ovulatory cycle
* Amenorrhea
* Pregnancy
* Climacteric patients
The Effect of Pranayama Breathing Technique on Asthma Control, Pulmonary Function and Quality of Life

Most of the asthma patients prefer complementary and integrative applications as they continue to experience asthma symptoms despite pharmacological treatment. Pranayama, one of these treatments, is a breathing-based technique and is a part of yoga, an ancient Indian science. This study was carried out as randomized controlled single blind study in order to analyze the effect of pranayama breathing technique applied to individuals suffering from asthma on asthma control, pulmonary functions and quality of life. The study comprised 50 patients in total, as 25 patients in pranayama group and 25 patients in control group. The approval of ethics committee, permissions from the institutions, and informed voluntary approval of the individuals were obtained to conduct the research. The data of the research were collected through the application of Asthma Control Test (ACT), Asthma Quality of Life Questionnaire (AQLQ), pulmonary function test (PFT), and patient observation chart. Pranayama breathing technique was applied to pranayama group 20 minutes once a day for four weeks, and relaxation technique was applied to relaxation group similarly in addition to standard treatment. ACT, AQLQ, and PFT were evaluated twice as before and after the one month of application process. Meanwhile, the patients' PEF measurements were followed with individual PEF meter on daily basis. The value of p\<0.05 was accepted statistically significant in the data analyses.


Eligibility Criteria:
Inclusion Criteria:

* Can communicate,
* To have an increase of %12 or 200 ml in FEV1 value after inhaler bronchodilator at breathing function test,
* To have chronic asthma diagnose with 6 months approved by doctors and receiving treatment,
* Asthma controls are not under control or partly under control in relation to GINA (Global Initiative for Asthma) values,
* Taking beta2-agonist and/or ICS twice a week or more to control asthma symptoms,
* There is not any chance in inhaler bronchodilator drug potions during the last four weeks,
* Can use a smart phone.

Exclusion Criteria:

* To have lung diseases such as COPD,
* To have tuberculosis and respiratory infection,
* To have diabetes and coronary artery disease,
* Smokers
* Pregnant or nursing mother,
* Doing regular exercise,
* Benefitng from other complementary and integrative health applications during treatments
Study of Growing Biofilm by an Antiplaque Mouthrinse

The objective of this study is to evaluate the efficiency of a new mouthrinse on dental plaque deposits.

The study is carried out on 50 volunteers that are asked to use the mouthrinse without any other oral hygiene measure, during 4 days. It is a double bind, cross-over, randomized design: the same subjects test the active product and the placebo.

The prevention of oral diseases is mainly targeted at the control of dental plaque. While tooth brushing is an effective method to remove plaque mechanically, it is not always sufficient and chemical antiplaque agents could be helpful. Some of them are used for their antibacterial action, the gold standard being chlorhexidine. Despite the great benefit of this bactericidal approach, the search continues for active ingredients that could prevent dental plaque formation without affecting the biological equilibrium within the oral cavity.

The aim of this study is to evaluate the efficiency of a mouthrinse, containing red grape seed extract and nicométhanol fluorhydrate, in the control of dental plaque deposit in a 4-days plaque regrowth model.

The study is a double blind randomized cross-over design, involving 50 healthy volunteers. During the treatment periods (4 days) no oral hygiene, measures excepting rinsing with the allocated product (active/non active) are permitted.

On day 1, the subjects receive professional prophylaxis. The mouthrinse is used pure, three times per day, after each meal. On day 5, subjects will be scored for disclosed plaque using the Quigley Hein index (modified by Turesky).

After a 2 weeks wash-out period, the subject receives the other product (active/non active) and uses it as in the first period.

On day 5, subjects will be scored again for disclosed plaque

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer
* without caries
* with at least 20 natural teeth excluding third molars
* Women using contraceptives for at least twelve weeks and while on study
* Protected by French social security system
* Written informed consent

Exclusion Criteria:

* Pregnancy or breast feeding
* Volunteers with partial denture or orthodontic appliance
* Person protected by the law who
* Person unable to give their consent to participate to the study.
* Under aged
* Current participation in another clinical trial
* Oral pathologies
* Systemic diseases
* Volunteers allergic to of the componentst of the tested products
* Volunteers with hyposalivation or xerostomia
* Treatment with antibiotics o intestinal antiseptics within 3 month before inclusion
* Treatment with oral antiseptics within 1 month before inclusion
* Alcoholic consumption more than 20 g/day (or 2 glasses)
* Heavy smokers
* Volunteers drinking a lot of tea or coffee