cyrilzakka/clinical-trials huggingface dataset:
Cognitive Function Evaluation and Rehabilitation by a Digital Game: MentalPlus®

Cognitive dysfunction is a frequent adverse event in the postoperative period, especially in elderly patients. The tests commonly used for the detection of postoperative cognitive dysfunction (POCD) are time-consuming, which limits routine use. Consequently, there is a limitation to adopting measures to increase preoperative cognitive reserve and rehabilitation of POCD. That situation incentivizes searching for alternative diagnosis methods to overcome that limitation. Digital games have potential neuromodulator effects and have been used as an alternative to psychotherapeutic treatment. However, the tests used to detect postoperative cognitive dysfunction (POCD) are time-consuming, making it difficult to implement routine screening measures. This presents a challenge for increasing preoperative cognitive reserve and rehabilitating POCD. Researchers are exploring alternative diagnostic methods, such as digital games, to address this challenge. Digital games have potential neuromodulator effects and are an alternative to psychotherapeutic treatments and cognitive rehabilitation. This study aims to validate MentalPlus®, a digital game, as a tool for cognitive assessment, POCD evaluation, and POCD rehabilitation-habilitation of mental skills. It is hypothesized that a digital game could replace the usual neuropsychological tests for detecting POCD.

METHODS: The research subject that will be studied might present some characteristics: over 20 years old, literate, of both genders, and candidate for surgery under general anesthesia in the Hospital das Clínicas of the Faculty of Medicine, University of São Paulo. Reliability MentalPlus® analysis will be performed as the first part of the study with healthy volunteers. Later, the volunteers assess cognitive functions, like memory, attention, and executive functions, using a usual psychological test battery. Compare the psychological test battery results with MentalPlus® video game scores. The MentalPlus® digital game will be applied to all study phases. A third project will use functional magnetic resonance imaging (fMRI) to assess the association between brain response and cognitive training by MentalPlus®.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who accept the invitation will be first submitted to the TICS Instrument (Telephone Interview Cognitive Status), which aims to verify the global cognitive status of the subject evaluated. Will be included subjects with TICS score \>25.

Exclusion Criteria:

* Patients who do not meet the TICS inclusion criteria will be excluded at this stage and informed that they did not fulfill all the requirements for the study.
Development of a New Neuroimaging Method Aimed to Differentiate Mnesic Abilities of Alzheimer and Depressed Patients

The purpose of this study is to use a new method to differentiate mnesic abilities of early alzheimer patients and patients with a depressive disorder.

This method is based on the recording of cerebral activity while patients listen to familiar, unfamiliar and newly-learned music.


Eligibility Criteria:
Inclusion Criteria:

* Being right-handed
* recorded consent
* For Alzheimer patients: Mini Mental Status Examination (MMSE) score \>= 18
* For patients with a depressive disorder : Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM IV) and Montgomery-Asberg depression rating scale (MADRS) score \>= 25
* For healthy controls : no cognitive deficit, MADRS score \< 25, no depressive disorder according to DSM IV

Exclusion Criteria:

* Auditory deficit
* contraindication to a high-density electroencephalography exam
* refusal to participate in the study
Quality of Pain Management at the Ziv Medical Center

The purpose of this study is to compare attitudes and knowledge of the staff of various departments in our Medical Center in regards to pain treatment. With the results of our survey we will then draw up a protocol on pain management.

Our belief is that the establishment of a pain protocol at the Ziv Medical Center will improve effectiveness of pain treatment. The present study involves surveying the current knowledge and attitudes of caregivers who are responsible for evaluating pain in patients and subsequent treatment in various departments of the hospital without a pain protocol.

According to the IASP (International Association for the Study of Pain) :" Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage". According to WHO, assessment is necessary in every situation that involves pain, excluding pain that is life threatening. Valid and reliable assessment is essential for effective pain management. The very nature of pain makes it impossible to measure objectively. There are different types of pain, and as caregivers, we need to diagnose the pain accurately in order that each patient gets the most effective treatment and continued evaluations, as needed. When caregivers decide on a treatment for pain, they are relying on the relatively objective VAS (Visual Analogue Scale.) According to recent studies most patients were dissatisfied with the pain treatment they had received. Approximately eighty percent of patients who present to emergency departments worldwide come because of pain.

Often the patient and the caregiver have different ideas about what pain is and how to treat it. Cultural differences, gender differences, even age differences may affect reactions of both the caretaker and the patient. There are many ways to treat pain, and various reasons for how people react to pain.

The present study is designed to measure the knowledge and attitudes of caregivers and in regard to the pain of their patients. An assessment of patient satisfaction to pain management will be also be performed.

Staff members working in wards involved with pain will be asked to fill out anonymous questionnaires concerning knowledge and attitudes toward pain. Patients will also be asked to fill out anonymous questionnaires in regard to their pain treatment. Informed consent will be requested. Responses will be collated and recorded. A future study is planned using a new pain protocol. The questionnaires will be repeated after the protocol has been in place for 12 months, at which time responses will be compared.

Eligibility Criteria:
Inclusion Criteria:

Staff from the Ziv Medical Center and patients

Exclusion Criteria:

Staff members that do not deal with pain treatment
Combined Modality Exercise and Appetite in Breast Cancer Survivors

The overall aim of this research is to assess the feasibility of a 12-week combined aerobic exercise (AEx) and resistance exercise (REx) intervention and elucidate the impact of AEx/REx on several physiological and behavioral components of energy balance among breast cancer survivors (BCS).


Eligibility Criteria:
Inclusion Criteria:

* Female sex
* Age: 18 - 45 years
* Body mass index \[BMI\]: 25 - 35 kg/m2
* Pre-menopausal before cancer diagnosis and treatment
* \<1 hour/week of planned physical activity by self-report in the previous 12 months
* Diagnosis of primary stage I - III estrogen receptor/progesterone receptor-positive (ER/PR+) breast cancer, according to institutional standards.
* All chemotherapy, radiation, and surgery completed at least two weeks (14 days), but less than 6 months prior to registration

Exclusion Criteria:

* Self-reported diabetes mellitus, untreated/uncontrolled thyroid disease, history of cardiovascular disease or symptoms suggestive of cardiovascular disease (chest pain, shortness of breath at rest or with mild exertion, syncope), cancer diagnosis in the last 5 years before breast cancer (any site, excluding skin cancer), or any other medical condition affecting weight or energy metabolism.
* Uncontrolled hypertension defined as: systolic blood pressure \>160 mmHg or diastolic blood pressure \>100mmHg, as measured during the screening visit. Participants who are deemed ineligible based upon uncontrolled hypertension criteria will be referred to their primary care physicians for treatment. If this condition becomes controlled they will be allowed to be re-evaluated for inclusion in the current trial.
* Unable to exercise due to cardiac, pulmonary, neurological, orthopedic reasons.
* Currently smoking and/or nicotine use.
* Treatment with medications known to significantly affect appetite, weight, energy intake or expenditure in the last 3 months (e.g. appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants).
* Corticosteroid use within the last two weeks
* History of surgical procedure for weight loss at any time (e.g. gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve); history of extensive bowel resection for other reasons
* Currently pregnant, lactating or less than 6 months post-partum.
* Score of ≥ 2 on the CAGE (cut-annoyed-guilty-eye opener) questionnaire adapted to include drug use55
* Score of \> 20 on the Eating Attitude Test - 26 (EATS-26), indicative of disordered eating. Participants with a score \>20 on the EATS-26 will be referred to their primary care physician for further evaluation.
* Significant food intolerances/allergies that cannot be accommodated by the University of Colorado Hospital Clinical Translational Research Center Metabolic Kitchen.
* Currently participating in any formal weight loss or physical activity programs or clinical trials for weight loss.
* Other medical, psychiatric, or behavioral limitations that may interfere with participation (as determined by study physician).
* Unable or unwilling to undergo study procedures
Study Evaluating AMG 706 in Subjects With Advanced Solid Tumors

This study will determine the safety and pharmacokinetics of AMG 706 in subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria: Exclusion Criteria:
Anti-nucleosome B Lymphocytes in Lupus

Lupus disease is characterized by the production of pathogenic autoantibodies, which participate in end-organ damages. The phenotype of B cells producing the pathogenic autoantibodies in lupus patients is today unknown. Antinucleosome antibodies are characteristic of lupus disease.This project proposes to detect antinucleosome B cells in lupus patients and to analyse their phenotype and their frequency.


Eligibility Criteria:
Inclusion criteria for SLE patients:

SLE patient : diagnostic based on ACR criteria

* SLE patient producing seric anti-nucleosome antibodies (ELISA)
* SLEDAI-2K activity score : inferior to 5 for quiescent patients, superior to 8 since at least 2 months for active patients

Exclusion criteria for SLE patients:

-- Other autoimmune diseases than SLE- Induced lupus

* Treatment with corticosteroids \>10mg/d (prednisone) for quiescent patients
* Treatment with corticosteroids \>20mg/d (prednisone) for active patients
* Oral immunosuppressive treatment during the last 6 months (methotrexate, azathioprine, ciclosporine, mycophénolate mofétil) for all patients, treatment during the last year with cyclophosphamide or monoclonal antibodies (rituximab, belimumab) for pour quiescent patients
* Disease which can modify B and T lymphocyte functions: primary immune deficiencies, evolutive infections, chronic viral infection (VIH in particular), chemotherapy or neoplasm antecedent
Conotruncal Cardiac Defects and Nutrigenetic Etiopathogeny

The investigators planned to study the etiopathogenic factors of conotruncal cardiac defects regarding the relations between the metabolic, the genetic and the environmental factors which lead to these cardiopathy.


Eligibility Criteria:
Inclusion Criteria:

* Conotruncal cardiac defects patients and theirs mothers
* Weight: \> 3750 g

Exclusion Criteria:

* Syndromic conotruncal cardiac defects
* 22q11 deletion Holder's
* Patients whose mother's took anti-folates before and during first pregnancy semester
Evaluation of the Impact of Eating Habits on Children's Corpulence

Childhood obesity has been rising steadily over the past 40 years. In 2016, the World Health Organization (WHO) observed around 340 million overweight or obese children and adolescents worldwide, including one in five in France. The causes are complex, both individual (genetic, biological, behavioral) and collective (social, economic, cultural). Childhood obesity encourages the development of chronic diseases such as diabetes and hypertension, and can affect mental health. Without early treatment, the risk of obesity persisting into adulthood is high.

In the Alpes-Maritimes region, the commune of Mouans-Sartoux has been promoting a local diet in line with PNNS-4 recommendations since 2011.

We wish to study the impact of these actions on the health of Mouans children. We propose a preliminary observational study to assess the relationship between family adherence to PNNS recommendations and the prevalence of overweight and obesity in Mouans-Sartoux elementary school children.


Eligibility Criteria:
Inclusion Criteria:

* The child must be enrolled in one of Mouans-Sartoux's three public elementary school (A. Legall / F. Jacob / Orée du bois) at the start of the 2023 school year
* Social Security affiliation
* Non-opposition of the legal representative(s) of parental authority

Exclusion Criteria:

* Opposition to participation in research involving the human person
* In the event of disagreement between the parents, we will take non-participation into account
The Effect of Manual Acupuncture and Standard Therapy on Anxiety and Quality of Life Scores in Cancer Patients

The goal of this clinical trial is to prove that the combination of acupuncture therapy and standard therapy is more effective in reducing anxiety and improving the quality of life of cancer patients. The main questions it aims to answer are:

1. Can the combination of manual acupuncture and standard therapy reduce anxiety based on Hamilton Anxiety Rating Scale (HAM-A) scores in cancer patients compared to the sham acupuncture and standard therapy group?
2. Can the combination of manual acupuncture and standard therapy improve the quality of life of cancer patients based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC-QLQ C30) compared to the sham acupuncture and standard therapy group?

Participants will:

Get manual acupuncture therapy and also standard therapy, such as oral Benzodiazepin and supportive psychotherapy or sham acupuncture therapy and the standard therapy (Benzodiazepin and supportive psychotherapy) every day for 6 days.

Researchers will compare the changes of anxiety scores and quality of life between cancer patients who received manual acupuncture therapy and standard therapy, and cancer patients who received sham acupuncture and standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-59 years.
* Diagnosed with cancer in the last 6 months
* Experiencing moderate to severe anxiety (assessed by HAM-A Score \> 24)
* Willing to participate in this study until completion and sign an informed consent.

Exclusion Criteria:

* Cancer patients with unstable hemodynamics
* Cancer patients with brain metastases
* Patients who have been diagnosed with anxiety disorders and have received pharmacological therapy from psychiatrists before.
* Patients who have contraindications to manual acupuncture (there are wounds or infections at the point to be punctured, patients are allergic to stainless steel, patients are phobic of needles)
* Patients who are uncooperative and do not allow acupuncture therapy (patients who are restless, angry)
* Patients with poor liver function (SGOT (Serum Glutamic Oxaloacetic Transaminase) /SGPT (serum glutamate pyruvate transaminase)values increase 2-3 times the normal value)
* Patients with blood clotting disorders (platelets \<50,000, INR (International Normalized Ratio) \> 2)
* Patients with neutropenia (Absolute neutrophil count \<1000)
* Patients with overt DIC (disseminated intravascular coagulation) and acute venous or arterial thrombosis
Results of Distal Clavicle Graft in Shoulder Dislocation Clavicle Auto Graft in Patient With Recurrent Anterior Shoulder Dislocation

to evaluate the clinical and radiological Outcome of Distal Clavicle Auto graft in patient with recurrent Shoulder dislocation

The glenohumeral joint is the most commonly dislocated joint of the human body,The stability of GH joint relies on a complex network of static and dynamic structures,The anterior labrum plays a key role in antero posterior stability as it deepens the glenoid cavity up to 50% There option for glenoid reconstruction including: Distal Clavicle Auto graft (DCA), proven is a good option to coracoid transfers

Eligibility Criteria:
Inclusion Criteria:

* Recurrent Traumatic anterior shoulder dislocation (≥ 3 times).

Exclusion Criteria:

.On-track Hill-Sachs lesion. .Multi directional instability.

* Voluntary dislocation.
A Single and Multiple Ascending Dose Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2389 in Healthy Participants

This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD2389 following single and multiple dose administration (SAD/MAD) to healthy participants.

This is a Phase I, First In Human (FIH), randomized, single-blind, placebo-controlled, single and multiple ascending dose study in healthy male and/or female participants of non-childbearing potential including healthy participants of Chinese and Japanese ethnicity performed at a single center.

The study consists of 2 parts: Part A and Part B. Part A has been planned to be conducted with 78 participants and Part B has been planned to be conducted with 32 participants.

Each participant in Part A and Part B will be involved in the study for up to 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture.
* For the healthy Japanese cohorts (Parts A2 and B2): healthy participants are to be Japanese (e.g., natives of Japan or Japanese Americans), defined as having both parents and 4 grandparents who are Japanese. This includes healthy second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.
* For the healthy Chinese cohort (Part A3): healthy participants are to be Chinese defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than China.

Exclusion Criteria:

* Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
* Known or suspected history of alcohol or drug abuse and smokers.
* Plasma donation within one month of the Screening Visit or any blood donation/blood loss \> 500 mL during the 3 months prior to the Screening Visit.
* History of coagulation or bleeding disorders or use of anti-platelets/anti-coagulants during the 3 months prior to the Screening Visit, as judged by the investigator.
* History of hypersensitivity as judged by the investigator, to drugs with a similar chemical structure or class.
* History of severe dermatological disorders, eg, bullous pemphigoid or Stevens-Johnson syndrome, or clinically significant new or healing wounds in areas of the body not always covered by clothing such as face, forearm, and lower leg, as judged by the investigator.
Comparative Study Between Photodynamic Therapy with LED Associated with Probiotics in the Treatment of Halitosis

Halitosis is a term that defines any odor or bad smell coming from the oral cavity, which can have a local or systemic origin. This project aims to verify if there is a difference in the effectiveness of treatment with antimicrobial photodynamic therapy (aPDT) with LED associated with treatment using probiotics in reducing halitosis. 92 participants, aged 18 to 60 years, diagnosed with halitosis, presenting sulfhydride (SH2) ≥ 112 ppb in gas chromatography will be selected. Participants will be randomly divided into 4 groups (n=23), which will receive different treatments: Group 1 (control): brushing, dental floss and tongue scraper; Group 2: brushing, dental floss, tongue scraper and aPDT with blue LED and annatto; Group 3: brushing, dental flossing, tongue scraper and aPDT with blue LED, annatto and probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12®); Group 4: brushing, dental flossing, tongue scraper and probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12®). The results of the halimetry will be compared before, immediately after the treatments, thirty days after and sixty days after. The microbiological analysis will be performed by counting the colony forming unit of viable bacteria in the tongue coating at these same times. The microbiome analysis will be performed before, thirty days after and sixty days after the treatments after DNA extraction. All groups will be treated with oral hygiene instructions with a toothbrush, toothpaste and dental floss as well as receiving material for this practice. The normality of the data will be measured by the Shapiro-Wilk test, and in the case of normality the Analysis of Variance (ANOVA) test will be applied, and in the case of non-parametric data, the Kruskal-Wallis test will be used. The Wilcoxon test will be used to analyze the results of each treatment in the two study periods.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of halitosis showing sulfhydride (SH2) ≥ 112 ppb in gas chromatography.

Exclusion Criteria:

* Individuals with dentofacial anomalies (such as cleft lip, cleft palate and nasopalatine);
* Undergoing orthodontic and/or orthopedic treatment;
* Undergoing oncological treatment;
* With systemic alterations (gastrointestinal, renal, hepatic)
* Undergoing antibiotic treatment up to 1 month before the research;
* Pregnant women.
Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia

Main purpose of this study is to compare comfort level of patients, after otosclerosis surgery, under local or general anesthesia.

The care system will not differ from the usually treatment of patients. Patients will decided about the type of anesthesia (local or general) after detailed description of both procedures.

All operations will be performed by the same surgeon and the same basic surgical technique.

The only difference is that patients included in thi study will have to complete a satisfactory survey 10 days after surgery and a GBI questionnaire 3 months after surgery, during the post operative consultations .

Eligibility Criteria:
Inclusion criteria:

* Patients older than 18 years suffering from otosclerosis who have surgical indication.
* Patients who want surgical treatment for their otosclerosis
* Clinic : Deafness with social prejudice and normal otoscopic exam
* Audiometric : conductive or mixed hearing loss with abolition of the aural reflex. Audiometric threshold more than 30decibel (dB) and air bone gap more important than 20dB.
* Pré operative scan in favor of otosclerosis
* Diagnosis confirmation during the surgery with stapes sclerotic's attachments to the oval window

Exclusion criteria:

* History of ear surgery
* No medical objection to local anesthesia
* No medical objection to general anesthesia
* No medical objection to ear surgery
* No legal protection for adults
* No participation refusal