cyrilzakka/clinical-trials huggingface dataset:
Correlation Analysis of Hearing Thresholds, Validated Questionnaires and Psychoacoustic Measurements in Tinnitus Patients

Objective: To evaluate the correlation between audiometric thresholds, pitch matching (PM), minimum masking level (MML), Tinnitus Handicap Inventory (THI) and the Beck Depression Inventory (BDI) in tinnitus patients.

Subjects: 48 patients with tinnitus as the main complaint from OTOSUL, Otorrinolaringologia Sul-Fluminense, Volta Redonda, RJ, Brasil and Centro de Tratamento e Pesquisa em Zumbido, Belo Horizonte, MG, Brasil.

Method: Subjects performed tonal audiometry, Pitch Matching (PM) and Minimum Masking Level (MML) for tinnitus. They also fulfilled the Tinnitus Handicap Inventory (THI) and Beck Depression Inventory (BDI). Data was statistically compared for correlation between audiometric thresholds, psycho-acoustic measures and questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* tinnitus for more than 6 months
* sensorineural hearing loss
* normal otoscopy

Exclusion Criteria:

* conductive or mixed hearing losses
* A-r, A-d, B and C tympanograms
* tinnitus treatment in the last 6 months
* pregnant woman
* Vestibular Schwannoma
Fermentation Rate of Infant Formula

It is hypothesized that there will be no difference in the breath hydrogen excretion between the 2 different prebiotic formulas.

This pilot study is looking at how a formula with one of two different prebiotic blends may alter the hydrogen level in an infant's exhalations in the hours after feeding. Higher levels for a longer period may signal higher levels of short chain fatty acids and bifidobacteria, both beneficial for gastrointestinal health. The higher levels may be the result of the formula undergoing a slower digestion, producing more fermentation.

The study will compare a formula, similar to one currently on the market, with added prebiotics using a special breathing mask designed to be held to the infant's mouth and nose long enough to capture the infant's exhaled breath which will then be tested for Hydrogen content.

Eligibility Criteria:
Inclusion Criteria:

* 2-6 months of age,
* healthy,receiving standard cow-milk based infant formula weight,
* greater than 5th percentile

Exclusion Criteria:

* on no antibiotics,
* breastfed,
* on solid foods
The Resting-state EEG Gamma Oscillations in Alzheimer's Disease

The literature suggests a strong association between amyloid accumulation and gamma alterations, emerging gamma activity as a biomarker candidate for Alzheimer's pathology. The present study aims to investigate resting-state gamma activity changes in Cerebrospinal fluid (CSF)-proven early-onset Alzheimer's disease (EOAD) patients with a holistic approach that employs structural and functional brain neuroimaging techniques, and neuropsychological aspects.

This cross-sectional study included 24 drug-naive CSF-proven EOAD patients and age-, sex, and education-matched healthy controls. All participants underwent a detailed neuropsychological evaluation, resting-state electroencephalography (EEG) recording, and Magnetic Resonance Imaging (MRI). Gamma power and coherence were measured in total gamma (30-48 Hz), gamma-1 (30-35 Hz), gamma-2 (35-40 Hz), and gamma-3 (40-48 Hz) frequency bands. Gray matter volumes were extracted for 54 regions of interest (ROIs) and compared between groups. Discriminant analysis was performed to determine the classification accuracy of gamma activity for EOAD. Finally, correlations between CSF, neuropsychological tests, EEG, and MRI measures were explored.

Eligibility Criteria:
Inclusion Criteria:

* For all participants: Age \< 65
* For EOAD patients: Meeting National Institute on Aging-Alzheimer's Association diagnostic criteria.
* For healthy controls: Mini-Mental State Examination (MMSE) \>25 Instrumental Activities of Daily Living Scale (IADL) = 8

Exclusion Criteria:

* For EOAD patients: MMSE \> 24 Geriatric depression scale (GDS) \> 14 Having treatment with antipsychotics and comorbidities that may affect cognitive abilities.
* For healthy controls: Having neurological and/or cognitive abnormalities Having a history of neurological, psychiatric, or systemic disorders, and alcohol/drug abuse. GDS \> 14
* For all participants: Having neurological (other than AD) or any other serious disease (cancer, systemic disease)
Safety and Immunogenicity of CHP-HER2 and CHP-NY-ESO-1 Protein With OK-432 in Antigen-Expressing Cancers

Mixed cancer vaccines, CHP-HER2 protein and CHP-NY-ESO-1 protein, are to be studied to evaluate the safety and immune responses in patients who are positive either or both antigens. Nine patients will be enrolled, who are refractory to standard therapies for cancer or at high risk to relapse. CHP-HER2 and CHP-NY-ESO-1 are subcutaneously given on bimonthly basis, together with OK-432(Picibanil) as an immunoadjuvant. Six doses will be given. Toxicity profiles will be monitored, and antigen specific humoral anad T cell responses will be described.


Eligibility Criteria:
Inclusion Criteria:

1. Histological confirmation of cancer.
2. HER2 expression in tumor cells scored as 1+ or more which should be confirmed by IHC using at least two antibodies (archived issue; see Appendix 1 and Reference 1 for methodology).

   or NY-ESO-1 expression by reverse transcriptase and polymerase chain reaction (RT-PCR) analysis (Appendix 2), preferably, or immunohistochemistry
3. Patients must

   1. are at high risk of recurrence, more than 25% of probability, after complete resection or even after post-operative adjuvant treatment, and effective adjuvant therapy is not available or refused; or
   2. have metastatic disease, and treatment has failed, or in the situation where effective therapy is not available, or has been refused.
4. Complete recovery from surgery (at least 4 weeks).
5. Laboratory values within the following limits:

   Hemoglobin 9.0 g/dL or more, or 10.0 g/dL or more if \<50 kg Neutrophil count \>1.5 x 109/L Lymphocyte count \>0.5 x 109/L Platelet count \>100 x 109/L Serum creatinine ≤ 1.8 mg/dL Serum bilirubin ≤ 2 mg/dL
6. Performance status \> 70 (Karnofsky Scale) and life expectancy \>3 months.
7. Age 18 years or more.

Exclusion Criteria:

1. Clinically significant heart disease (NYHA Class III or IV).
2. Cardiac dysfunction; less than 50% of ejection fraction by echocardiogram.
3. Immunodeficiency disease.
4. Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders.
5. Previous bone marrow or stem cell transplant.
6. Metastatic disease to the central nervous system, unless treated and stable.
7. known HIV antibody positivity.
8. Anaphylactic reaction to previous vaccination.
9. Hypersensitivity to penicillin
10. Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas).
11. Concomitant treatment with steroids. Topical or inhalational steroids are permitted.
12. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
13. Pregnancy or nursing .
14. Refusal, by women of childbearing potential, to use medically acceptable means of contraception.
15. Mental impairment that may compromise the ability to give informed consent.
16. Lack of availability for immunological and clinical follow-up assessment.
Use Of Oral Itraconazole In Patients With Locally Limited Basocellular Carcinoma Of Skin.

Patients with localized basocellular carcinoma of the skin, will receive oral Itraconazole, 200 mg twice daily, for 60 days, prior to curative intent surgery.

Patients with localized basocellular carcinoma of the skin, will receive oral Itraconazole, 200 mg once daily, for 60 days, before surgery with curative intent.

Tumor area regression will be measured through dermatologic evaluation and photographic documentation on baseline and at the end of the 60 day treatment period.

The activity of the Hedgehog pathway will be measured on tissue samples obtained at the time of diagnosis and at the time of curative intent surgery, through the measuring of the Ki67 index.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of Basocellular Carcinoma (BCC) of the Skin, histologically confirmed.
* At least one BCC lesion with 10 mm in the longest diameter
* Disease amenable to surgical intervention with curable intent.
* Signed Informed Consent
* PS ECOG 0 to 3

Exclusion Criteria:

* Chronic renal disease, with a glomerular filtration rate of less than 30 ml/min
* Acute or chronic liver disease, as measured by: total bilirubin \> than 1.5 x ULN and AST and ALT \> than 5 x ULN.
* Symptomatic cardiac insufficiency or an ejection fraction lower than 50% measured through echocardiography,
* Other active malignancies in the last year.
* Uncontrolled systemic hypertension,
* Any chronic infections such as tuberculosis, viral hepatitis and HIV.
* Pregnancy, suspected or confirmed.
* Known intolerance to the use of Itraconazole.
Gastric Bacterial Colonization of Preterm Neonates

This prospective cohort study was conducted in the Christiana Care Health System Neonatal Intensive Care Unit. It occurred at two time periods: Time period 1 included infants admitted to the traditional, open bay NICU. Time period 2 included infants admitted to the new private, single family room NICU. There was a 3 month period between Time period 1 and Time period 2 to ensure that there was no patient overlap. Stool samples and environmental samples were collected at 1 and 4 weeks after birth in both time periods. The objective of this study was to establish the gastrointestinal microbiome of infants born at less than 32 weeks gestation admitted to the exiting open bay NICU and compare it to the gastrointestinal microbiome of infants born at less than 32 weeks admitted to the new private, single family room NICU.


Eligibility Criteria:
Inclusion Criteria:

* Less than 32 weeks gestation at birth

Exclusion Criteria:

* Infants in Time period 2 that were admitted to the traditional, open bay NICU
Awareness About Breast Cancer Screening

Breast cancer is the most common cancer in French women, with 52000 new cases each year.

Shift work and night work is recognized by International Agency for Research on Cancer as a potential risk factor. Epidemiological studies find, for most of them, an increased risk of breast cancer compared with general population. Physiological hypothesis rely on the melatonin role in defense against tumorigenesis.

According to High Authority of Health clinical good practice guidelines, the risk does not justify more screening than the organized screening. We do not have information about awareness level of workers in health structures, specially in the Hospices Civils de Lyon.

Investigators would like to know how employees take part to breast cancer screening, specially in night workers.

This study, as a survey, is a first step to evaluate the need for specific actions to increase the participation to breast cancer screening.


Eligibility Criteria:
Inclusion Criteria:

* employees HCL
* women

Exclusion Criteria:

* \<18 years old
Glioblastoma Radiotherapy Using IMRT or Proton Beams

Radiation therapy is an integral part of the multimodal primary therapy of glioblastomas. As the overall prognosis in this tumor entity remains unfavorable, current research is focused on additional drug therapies, which are often accompanied by increases in toxicity. By using proton beams instead of photon beams, it is possible to protect large parts of the brain which are not affected by the tumor more effectively. An initial retrospective matched-pair analysis showed that this theoretical physical benefit is also clinically associated with a reduction in toxicity during therapy and in the first few months thereafter. The aim of the GRIPS study is to prospectively test this clinical benefit in a randomized, open-label Phase III study. Patients are treated in the study using either modern photon radiation techniques (standard arm) or proton beams (experimental arm). The primary endpoint is the cumulative toxicity CTC grade 2 and higher in the first 4 months. Secondary endpoints include overall survival, progression-free survival, quality of life, and neurocognition.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed gliomblastoma WHO IV (operated or after biopsy)
* Indication for radiotherapy / radiochemotherapy
* Informed consent
* KI ≥ 60% or ECOG 0/1
* Age ≥ 18 years
* Sufficient effective contraception

Exclusion Criteria:

* Patient is not able to consent
* Previous radiotherapy in the brain or skull base
* Active medical implants for which there is no ion radiation authorization at the time of treatment (e.g., cardiac pacemaker, defibrillator, ...)
* Contraindication to MRI imaging
* Simultaneous participation in another clinical trial that could influence the outcome of this study or other study
Pill Swallow Study

A prospective, single-center, open-label, single-arm, observational study assessing participant experience with swallowing the Mock-RP


Eligibility Criteria:
Inclusion Criteria:

1. Participant age is 21 - 75 years
2. Participant understands the nature of the study, is willing to comply with protocol defined evaluations, and provide written informed consent
3. Participant currently taking injections to treat a chronic disorder
4. Non-pregnant, non-lactating female NOTE: Females who are of childbearing potential must have had a negative pregnancy test on day of screening

Exclusion Criteria:

1. Active case of COVID-19
2. History of Dysphagia
3. History of dementia (e.g., Alzheimer's, vascular dementia, dementia with Lewy bodies, etc.)
4. Participant self-reports issues with swallowing pills.
5. History of drug or alcohol abuse or any other factor that, in the Investigator's opinion, may interfere with the participant's ability to cooperate and comply with the study procedures
6. History of allergic reaction to a component of the Mock-RP
7. History which, in the investigator's judgement, makes the participant ineligible or exposes the participant to unacceptable risks
Impact of Neuro-linguistic Programming on Schoolchildren's Performance

Neuro-Linguistic Programming (NLP) is a methodology developed in the 1970s by Richard Bandler and John Grinder, based on the idea that language and behavior are interconnected and can be systematically modeled and changed. NLP is often used as a form of psychotherapy, coaching, or personal development, although its effectiveness has been debated in the scientific community.

NLP practitioners believe that our thoughts, emotions, and behavior are influenced by our internal representations of the world, which are constructed through language and sensory experiences. Changing the use of language and the perception of experiences, thoughts, emotions, and behavior can be adjusted accordingly. NLP uses various techniques to achieve this, including reframing, anchoring, and rapport-building. Reframing involves changing the perception of a situation by putting it in a different context or perspective. Anchoring consists in associating a particular state of mind or emotion with a specific physical or sensory stimulus, such as a touch or a smell. Rapport-building involves establishing a connection and a sense of trust with another person through mirroring and matching their body language, tone of voice, and language patterns.

Neuro-Linguistic Programming (NLP) techniques have been used in various contexts, including education. Some educators and practitioners believe that NLP can help children develop their communication skills, self-confidence, and self-awareness and improve their learning outcomes. Some NLP techniques adapted for children include: (1) Anchoring involves linking a particular emotional or sensory state with a physical stimulus, such as a touch or a visual cue. For example, a teacher might use a specific gesture or word to help a child feel more confident before a test. (2) Reframing: This technique involves helping a child see a situation or problem differently. For example, a teacher might help a child reframe a difficult math problem as a fun challenge. And (3) Meta-modeling: This technique involves helping children become more aware of their language patterns and the language patterns of others, which can improve communication skills and self-awareness.

Eligibility Criteria:
Inclusion Criteria:

* Schoolchildren aged between 5 and 11 years attending the same school for at least a year.
(Bispecific) Antibodies in Cancer Patients

The aim of this project is to provide (bispecific) antibodies to individual patients with advanced solid and hematological malignancies without any available approved treatment options.

Ethics: Patient treatment will be conducted according to §13 Absatz 2b, AMG (German law).

All (bispecific antibodies) applied are developed and manufactured by the principle investigator Prof. Helmut Salih.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of advanced malignant disease
* Advanced malignant disease without any available standard of care treatment option
* Live expectancy \> 3 month
* Ability to understand and voluntarily sign an informed consent form.
* Ability to adhere to the visit schedule and other protocol requirements
* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.

Exclusion Criteria:

* Pregnant or lactating females.
* Treatment regimens inducing severe T cell deficiencies
* Treatment-related side effect from prior cancer treatment \> CTC grade 2 (CTCAE V5.0)
* Participation in any clinical study or having taken any investigational therapy, which would interfere with the studys primary and secondary end points within 2 weeks prior to Ab treatment.
PLATFORM to Maximize Patient Knowledge of Health Goals After Acute Myocardial Infarction

The goals of this study are two fold: 1) To learn whether a personalized patient health goal and reminder tool helps patients to learn more about their condition and to make changes in behavior and medication taking to reduce the risk of another heart attack. 2) To examine a blood sample to learn how patients are responding to their medications. The study team will enroll approximately 220 patients in the hospital recovering from a heart attack. Half of the patients will receive the educational tools and a copy will be sent to their outpatient provider.

The goals of this study are two fold: 1) To evaluate the impact of a personalized patient health goal education and reminder tool on patient adherence to evidence based therapies and subsequent cardiovascular risk factor modification after acute myocardial infarction (AMI); 2) To assess age-related heterogeneity in antiplatelet response among AMI patients. This is a prospective study of \~220 AMI patients, with at least half over age 65 years. Patients will be surveyed with questionnaires (at baseline and 6 months post discharge) and biomarkers (baseline only) to assess the status of their physical function, depression, nutrition, inflammation, and response to antiplatelet therapies. Patients will also be administered a walking test and a grip strength test at baseline. About 1 week after hospital discharge, and again about 3 months after hospital discharge, about half of the patients and their outpatient providers will receive the personalized post-AMI health goal education and reminder tool on patient adherence to evidence-based secondary prevention therapies. Data will be analyzed in aggregate using descriptive statistics. The primary endpoint of interest is a composite measure of adherence at six months to secondary prevention therapies described as the sum of measures received divided by the sum of available opportunities. The secondary endpoint will be analyzed to describe platelet response profiles as a function of age. The study team anticipates the risks for this study to be minimal, since the patient does not receive any investigational therapies.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with either ST-elevation MI (STEMI) or non-ST-elevation MI (NSTEMI) who are on antiplatelet therapy at the time of enrollment.
2. English language literacy and
3. Able to provide written informed consent.

Exclusion Criteria:

1. Patients less than 18 years of age.
2. Patients who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements
3. Life expectancy less than 6 months or discharged on hospice care.
4. Patients without at least 1 scheduled outpatient follow-up visit inside the Duke University Affiliated Physicians network.
5. Patients who receive a coronary artery bypass grafting (CABG) during the eligible enrollment hospitalization.
6. Active chronic inflammatory conditions (e.g., inflammatory bowel disease, lupus, rheumatoid arthritis)
Identification and Characterization of Monogenic Diabetes

Type 1 Diabetes is a multifactorial disease, with a strong genetic contribution of HLA genes, and minor contributions of many additional genes. The investigators hypothesis is that in addition to multifactorial inheritance, there are subtypes of diabetes that are caused by defects in single genes (monogenic diabetes). The aim of this project is to identify these genes, based on detailed clinical and characterization of patients, and to describe the corresponding genetic diabetes entities with respect to the genetic and molecular defect, clinical features and biochemistry. Based on the investigators study design, most of these diabetes entities will be caused by mutations affecting the two copies of the corresponding gene. In addition, the investigators will study the relatives of the patients, and explore if carriers of these genetic defects (i.e. only one copy of the gene being defective) may have a predisposition to common forms of diabetes, mainly type 2 diabetes.

In the first phase of the study the investigators will recruit patients and families, with a strong bias for "extreme" forms of diabetes (very early onset and/or syndromic diabetes) and familial context suggestive of monogenic inheritance (e.g. consanguinity, multiplicity of diabetic siblings) and perform genetic studies on these to identify the genes. After obtaining informed consent, the investigators will collect clinical information on diabetes and other associated diseases and features, family information on diabetes, and collect blood samples for DNA, RNA, serum and cell lines. The investigators will then perform genetic studies to identify the genes responsible for these monogenic forms of diabetes.

After identification of genes, the second phase of the study will be to test the consequence of carrier status for the identified mutations on metabolic traits related to glucose metabolism. For this, after obtaining informed consent, the investigators will extend the recruitment of the initial families (after gene identification) to recruit relatives who may be carriers of these mutations. The investigators will determine the carrier status of these subjects and perform a detailed clinical description as well as metabolic studies to evaluate their glucose metabolism.

This study will lead to the identification of new monogenic diabetes entities, and their corresponding genes, and may also result in the identification of new genes predisposing to common forms of diabetes. This project has implication for diagnosis of these monogenic forms of diabetes, and may result in some cases in improved care for the patients, including prevention and treatment.

Eligibility Criteria:
Inclusion Criteria:

* First phase: to have an "extreme" form of diabetes, based on clinical, phenotypic and familial criteria. Parents and siblings of the proband will be sampled.
* Second phase: (after gene identification): to be a relative of the proband, potential carrier of the mutation

Exclusion Criteria:

* Non consent to participate to the study