cyrilzakka/clinical-trials huggingface dataset:
Acute Exercise on Neurocognitive Function Among Adults With/Without Generic Risk of AD

This study explores the acute exercise effect on neurocognitive function and also its potential moderators in an exercise setting and Apolipoprotein E (APOE) genetic risk.

Acute exercise has emerged as a modifier to multiple aspects of cognitive function; however, its effect on populations with different risks of Alzheimer's disease (AD) and the role of exercise variance and APOE genotype within the effect reminds underestimated. The current study aimed to examine the acute exercise effect on neurocognitive function from behavioral and neuroelectric perspectives among cognitively normal late-middle-aged adults. Additionally, we determined whether variations in exercise intensity and duration and the presence of the APOE ɛ4 allele modulated the effect.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged between 50 and 70 years old
2. Normal or corrected-to-normal vision based on the minimal 20/20 standard
3. Cognitively normal as mini-mental state examination scores (MMSE) \> 26

Exclusion Criteria:

1. Neurological or psychiatric disorders
2. Cardiovascular disease
3. Risk of cardiovascular fitness assessment based on the Physical Activity Readiness Questionnaire (PAR-Q)
4. Red-green color blindness.
Phase 3 Placebo Controlled Study of Nolasiban to Improve Pregnancy Rates in Women Undergoing IVF/ICSI

The primary objective of this study is to confirm the efficacy of a single oral 900mg dose of nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post embryo transfer (ET) day.

The study is a prospective, randomized, parallel group, double-blind, placebo-controlled study to confirm the efficacy and the safety of the oxytocin receptor antagonist, nolasiban, in 760 women undergoing fresh embryo transfer following in vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI).

Eligibility Criteria:
Key Inclusion Criteria:

* Indicated for IVF/ICSI in the context of assisted reproductive technology (ART)
* Follow a gonadotropin releasing hormone (GnRH) antagonist protocol, single injection of human chorionic gonadotropin (hCG) for triggering final follicular maturation and luteal phase support with vaginal micronized progesterone.
* Single, fresh D3 or D5 embryo transfer

Key Exclusion Criteria:

* Frozen-thawed embryo transfer
* More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle
* Serum P4 greater than 1.5 ng/mL on the day of hCG administration
18F-Florbetaben PET Amyloid Imaging in Case of Intermediate CSF Biology for the Diagnosis of Alzheimer's Disease : a Pilot Study

The diagnosis of Alzheimer's disease (AD) is based on clinical and neuropathological criteria.

Some patients have a contributive CSF biology to determinate a high level risk of AD (Tau + phospho-tau ratio increased and Ab42 / decreased Aβ40), but others have an intermediate CSF biology (Tau and/or phospho-tau increased but Ab42 ratio / normal Aβ40) and are unclassifiable.

18F-Florbetaben (Neuraceq®), a radioisotope in positron emission tomography (PET), selectively binds to amyloid plaques, with high detection sensitivity (98%).

Detection of amyloid plaques by PET imaging separate patients according to the criteria of Dubois, as with AD and allow them to benefit a cholinesterase inhibitor treatment.

If negative, the diagnosis of AD can be excluded with a high level of confidence to prevent initiating unnecessary treatment, expensive for the community.

This is the first imaging study of amyloid plaques targeting population whose diagnosis of AD is uncertain according to the CSF biology.

The aim of this study is to describe the results of amyloid PET in case of intermediate CSF biology and to separate patients as AD or not according to the criteria of Dubois


Eligibility Criteria:
Inclusion Criteria:

* Major subjects who have given their consent to participate in the study.
* Patients with suspected AD and whose CSF markers give intermediate results (CSF punction less than 6 months): meaning tau and/or phospho-tau increased and Ab42 / Aβ40 normal (Ab42 / Aβ40 \> 0.07).
* Non-indication to perform a PET 18F-Florbetaben.
* Affiliation to the french social security .

Exclusion Criteria:

* Patients under guardianship.
* Inability to perform a PET 18F-Florbetaben (agitated patient, confused, ..).
* Pregnancy, lactation.
Serum Amyloid A Protein And Fetuin A Levels

The purpose of this study was to evaluate acute phase proteins (APPs) Fetuin-A and Serum Amyloid A (SAA) levels in gingival crevicular fluid (GCF) and serum samples in periodontal health and disease.

The study population consisted totally 60 subjects consulted to Bulent Ecevit University, Faculty of Dentistry, Department of Periodontology whose age and sex were matched.

According to study design, subjects were divided into three groups based on their periodontal parameters. Patients suffering from chronic periodontitis formed the group 1 (n: 20), patients with plaque induced gingivitis formed the group 2 (n:20) and periodontal healthy patients were inserted in group 3 (n:20).

After gently drying the area, GCF was sampled with filter paper using the intracrevicular method (Periopaper, ProFlow, Inc., Amityville, New York, USA).Two milliliters (ml) of peripheral blood was collected from each individual with sterile syringe from the antecubital fossa by venipuncture, and to separate serum component sample centrifuged at 3000g for 5 min, and immediately stored at -40°C until assayed.

The quantity of Fetuin-A and SAA protein concentration in the samples were analyzed by sandwich enzyme-linked immunosorbent assay (ELISA) procedures using commercially available kits.

The Spearman's rank correlation test was used to detect the relationship between GCF and serum SAA and Fetuin-A with GI and CAL. All tests were performed using statistical software (SPSS Inc., version 22.0, Chicago, IL, USA). The mean ± standard deviation with mean rank values were calculated for each parameter, based on the patients as the statistical unit. P \< 0.05 was considered to be statistically significant.

Eligibility Criteria:
Group 1 Inclusion Criteria:

* GI\>1, PPD≥5mm, CAL≥5mm with alveolar bone loss radiographically.
* Systematically healthy patients

Group 2 Inclusion Criteria:

* No alveolar bone and attachment loss
* Inflammation signs such as redness, edema and increased BOP levels,
* GI≥2, PPD≤3mm, CAL≤3mm.
* Systematically healthy patients

Group 3 Inclusion Criteria:

* No bone and attachment loss,
* GI=0, PPD≤3mm, CAL≤3mm
* Systematically healthy patients

Exclusion Criteria for all groups:

* Aggressive Periodontitis,
* Oral pathologies,
* Patients with any other systemic diseases,
* Pregnant women and those in the lactation period,
* Patients with smoking habit and taking medication
* Patients received periodontal therapy in last 6 months
Xpede Clinical Study

The purpose of this clinical study is to confirm the efficacy and safety of the Kyphon®Xpede™ Bone Cement in human use in China.


Eligibility Criteria:
Inclusion Criteria:

1. Subject being diagnosed as having painful pathological vertebral body fracture, who is suitable for VP/BKP procedure (1-3 levels) according to clinic practice.
2. Subjects who are willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration.
3. Subjects are at least 18 and ≤80 years old .

Exclusion Criteria:

1. Subject has a local or systemic infection.
2. Subject has pains caused by other spine disease than painful pathological vertebral compression fracture.
3. Subject has a medical condition with less than 1 year of life expectancy.
4. Subject is grossly obese, i.e. BMI≥40.
5. Subject has medical conditions that represent contraindications for the use of bone cement by investigator's decision.
6. Subject has an allergy or an intolerance to bone cement component.
7. Subject has past spinal surgeries at the target level(s) for which the VP/BKP procedure is suitable.
8. Subjects who are currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when document pre-approval is obtained from the Medtronic study manager and Medtronic Medical Advisor.
9. Pregnant women or breastfeeding women, or women of child bearing potential who are not on a reliable form of birth regulation method or abstinence.
10. Subjects with exclusion criteria required by local law (age or other).
11. Subjects with medical condition which precludes them from participation in the opinion of the Investigator.
Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis

LOW-TAVR is a real-world, retrospective and prospective, multicenter Italian registry aimed at evaluating the characteristics and clinical outcomes of patients with severe low flow, low gradient aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) and, in particular:

* risk factors
* gender differences
* comorbidities
* pharmacological treatment
* TAVR procedural characteristics
* periprocedural and in-hospital complications
* clinical outcome at 30-day, 1-year, 2-year and 5-year follow-up

LOW-TAVR is a real-world, retrospective and prospective, multicenter Italian registry aimed at evaluating the characteristics and clinical outcomes of patients with severe low flow, low gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR).

The register aims to include at least 1,500 patients diagnosed with LFLG-AS undergoing TAVR at the participating centres.

The inclusion criteria are:

* LFLG-AS diagnosis according to current European Society of Cardiology guidelines
* Age 18 years or older
* Written informed consent

The exclusion criteria are:

* LFLG-AS pseudo-severe or non-confirmed severe aortic stenosis
* LFLG-AS referred for medical treatment or undergoing surgery

Clinical outcome is evaluated at a 30-day, 1-year, 2-year, and 5-year follow-up.

The primary endpoint of interest of the registry is the assessment of the incidence of the composite of all-cause mortality and hospitalization for heart failure at one year.

The secondary endpoints are the assessment of:

* periprocedural TAVR complications: complete atrioventricular block, stroke, acute myocardial infarction, acute aortic insufficiency, cardiogenic shock, acute pulmonary edema, cardiac tamponade, aortic rupture;
* adverse events during hospitalization: major and minor bleeding, major and minor vascular complications, definitive pacemaker implantation, cardiogenic shock, myocardial infarction, stroke, and death;
* adverse events at 30 days, one year, two years, and five years: all-cause mortality, hospitalizations for heart failure, cardiovascular mortality, myocardial infarction, stroke, major and minor bleedings.

Eligibility Criteria:
Inclusion Criteria:

* LFLG-AS diagnosis according to current European Society of Cardiology guidelines
* Age 18 years or older
* Written informed consent

Exclusion Criteria:

* LFLG-AS pseudo-severe or non-confirmed severe aortic stenosis
* LFLG-AS referred for medical treatment or undergoing surgery
Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis Media Who Had a Middle Ear Surgery

The objective of this multicentre study is to evaluate the standard of care of participants diagnosed with Chronic Otitis Media that have already gone through a first middle ear surgery but still have at least a moderate hearing loss. The study has a retrospective part (extraction of medical chart data) and a prospective part with a survey and three questionnaires collecting data on the use of health care services, on health related quality of life and hearing performance.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects, 18 years or older.
* Subjects with conductive or mixed hearing loss.
* Subjects with historically documented diagnosis of Chronic Otitis Media (COM) with or without cholesteatoma in the operated ear.
* Subjects who have undergone primary tympanoplasty type I-V to improve hearing between 2010-2016.
* Subjects with a Pure Tone Average (PTA)4 air-bone gap ≥30 decibels (dB) OR PTA4 air-bone gap between 25-30 dB with an air conduction threshold PTA4 ≥40 dB HL within 12 months after primary tympanoplasty in the operated ear.
* Subjects who have been recommended by their health care professional to try a hearing aid to improve hearing in the operated ear.
* Pre-op audiogram, maximum 1 year prior to the primary tympanoplasty, and post-op audiogram for the primary tympanoplasty are available.
* Aided audiogram, unaided if no hearing device is used, available between 2018 and the point of enrolment.
* Subjects are fluent in the language used for study questionnaires: German, French, Spanish.
* Subjects are willing and able to provide written informed consent. For France: subjects do not oppose to participate in the study.
* Medical Record data is available throughout the defined data search period, from primary tympanoplasty to point of enrolment.

Exclusion Criteria:

* Subjects are unable or unwilling to comply with the requirements of the study as determined by the investigator.
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this study.

For France only:

* Subjects who are not affiliated to social security.
* Subjects who are under legal protection.
Cellular Immune Responses in Triple-negative Breast Cancer - High Throughput Immunogenetic Studies

This project introduces a novel methodology for the in-depth immunogenetic characterization of the TR gene repertoire in solid tumors, holding the promise to offer unprecedented insights into the TR anti-tumor specificity and the prognostic/predictive value of TR gene repertoire signatures.

The goal of this observational study is to address the role of T cells in the tumor microenvironment of TNBC.

In detail, this study aims to:

(i) explore the immunogenetic characteristics of the TR gene repertoire as informative prognostic/predictive biomarkers in TNBC (ii) identify immunogenic neoepitopes arising from common tumor-specific non-synonymous gene mutations, as well as the corresponding neoepitope-specific T cells (iii) describe, in single-cell resolution, the spatial organization of the intricate crosstalk between tumor cells and neoepitope specific-T cells, and (iv) delineate the functional properties of T cells within the TME.

All the experimental results, regarding the TR repertoire features and the spatial organization of the TME, will be correlated with clinical outcome measurements (e.g. overall survival, progression time), which are available from the detailed patients medical record.

Eligibility Criteria:
Inclusion Criteria:

- Confirmed TNBC diagnosis

Exclusion Criteria:

-
The Neurobehavioral Effects of Anesthetics on Infants With Hearing Impairment

The long-term effect of general anesthesia on developing brain is the focus of clinicians when infants exposed to general anesthesia for a long time during operation. A retrospective study showed that children exposed to long-term or repeated operations, the anesthetics had a higher incidence of cognitive impairment in adolescence than those did no. When infants with hearing impairment undergo bilateral cochlear implant surgery, they are at high risk of long-term neurobehavioral abnormalities caused by anesthesia. In this study, investigators intend to observe the long-term behavioral abnormalities of hearing-impaired infants after unilateral or bilateral cochlear implantation.


Eligibility Criteria:
Inclusion Criteria:

1. Infants aged between 6 months and 2 years old undergoing cochlear implantation under general anesthesia in 9th hospital
2. Patients who have not participated in other clinical trials
3. ASA class I-II selective operation without any acute infectious diseases or systematic diseases
4. Infant's family members agree to participated in the trials and sign the informed consent

Exclusion Criteria:

1. Reject to sign the informed consent and participate in the trials
2. Patients with severe liver and kidney damage or other heart, lung and nervous system diseases
3. The Gesell developmental scale is less than 86 in motor behavior and physical energy
4. With a history of intrauterine distress, umbilical cord around the neck, hypoxia and jaundice
5. Infant who is allergic to egg and milk
6. Family history of malignant hyperthermia
7. Allergy to anesthetic drugs
Clinical Effect of Massage Chair on Older Adults

The use of massage chairs is becoming more popular in many countries. According to the previous reports, some manual massages have positive effects on the mood, pain, fatigue, and sleep quality. However, the clinical benefits of the massage chair have not been fully understood. In this trial, it is aimed to evaluate the clinical effectiveness of the 6-month regular use of massage chair twice a day. It is hypothesized that long-term regular use of massage chair has positive effects on the hormonal level related to the stress, inflammation, and aging, as well as physical, psychologic, and muscle quality.

A total of enrolled 80 patients after randomization(1:1) in intervention(Massage chair)group and Control groups, will be provided

* Massage chair group

  * lifestyle modification education + using massage chair twice per day during 24weeks
* control group: only lifestyle modification education

  1. Screening visit

     * collection demographic data, BMD, vital sign, Medication history
  2. Visit 1 (0-week)

     1. Vital sign
     2. Charlson comorbidity index
     3. Laboratory test

        * WBC diff count, Hb, creatinine, ALT, albumin, hsCRP, ESR cortisol, serotonin, DHEA-s, IGF-1, NK cell, Telomere length
     4. Questionnaire: K-MMSE, SGDS-K, BEPSI-K, EQ-5D-5L
     5. Physical\& muscular assessment

        * SPPB, Grip strength, Muscle tone, Bioimpedance analysis
  3. Visit 2-6 (4,8,12,16 weeks) via Phone contact: assess compliance and adverse events
  4. visit 7 (24weeks)

     1. Vital sign
     2. Laboratory test

        * WBC diff count, Hb, creatinine, ALT, albumin, hsCRP, ESR cortisol, serotonin, DHEA-s, IGF-1, NK cell, Telomere length
     3. Questionnaire: K-MMSE, SGDS-K, BEPSI-K, EQ-5D-5L
     4. Physical\& muscular assessment

        * SPPB, Grip strength, Muscle tone, Bioimpedance analysis
     5. Compliance
     6. Adverse events

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling healthy adults between 50-75 years old

Exclusion Criteria:

1. Unable to sign his/her own informed consent
2. Any disability or damages in 4 extremity.
3. Who have exercised regularly more than twice a week during the last 24 weeks
4. Who have received regular massage during the last 24 weeks
5. Confirmed osteoporosis of T score \<-2.5 from BMD or history of compression fracture
6. Cortisol-metabolism disorders or other diseases that can affect steroid secretion
7. Who have taken any medication related with steroid secretion or metabolism within 2 weeks
8. Expected life expectancy less than 12 months (Symptomatic heart failure, end-stage renal failure)
9. Spouse is already enrolled in this research
HMGB1 in ICU-survivors

Is HMGB1 (High Mobility Group Box 1) elevated in sepsis patients for weeks after recovery from severe sepsis/septic shock, similar to what has been observed in mice? Do patients recovering from severe sepsis/septic shock suffer from cognitive impairment and is such impairment associated with prolonged HMGB1 levels in plasma? Is there a difference from patients recovering from critical illness without prior sepsis?


Eligibility Criteria:
Inclusion Criteria:

* Male/Female age 18-17
* Expected ICU-stay more than 24 hours

Exclusion Criteria:

* Dont understand the language
* Substance abuse, alcohol or drugs
* Blind, deaf or suffering from aphasia
* Ongoing psychiatric illness or psychopharmacological treatment
* Suffering from dementia och mentally impaired
* Structured brain damage or meningitis
* Palliative Care
* ICU-treated for more than 48 hours
* Transferred from other ICU
* Being treated with ECMO
* Not having residency in Stockholm
Cycling Exercise in Mechanical Ventilation

Prolonged critical illness renders survivors with increased long-term morbidity associated with high healthcare costs. Muscle weakness and fatigue are reported as the main contributors to long-term poor functional outcomes. Emerging evidence for early mobilisation demonstrates reduction in the number of ventilator days and hospital length of stay. It has been demonstrated that daytime motoring (passive and active) can improve functional capacity in intensive care patients. The aim of the proposed study is to evaluate the effect of cycling exercise in patients on mechanical ventilation appointed to weaning process.

This prospective randomized study is being performed at the Department of Anesthesiology, Resuscitation and Intensive Care (CARIM) of the University Hospital Ostrava.

All mechanically ventilated patients are followed. At the time of weaning initiation, the randomization into two groups (the study (cycling) and control group) is performed. The physiotherapy will be carried out twice a day in both groups according to the mobility protocol. The cycling exercise is performed only in the study group, once a day. Before a patient is released from the ICU, a cycling test, dynamometry test will be performed on both groups.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* ICU admission
* Mechanically ventilated for more than 5 days
* Indications for starting weaning
* Informed consent for participation

Exclusion Criteria:

* Inability to use cycling exercise: trauma or operation of lower limbs, pelvis, open abdomen, non-cooperation (qualitative and quantitative disturbance of consciousness)
* Encephalopathy (ischemic, traumatic)
* Extreme obesity (body mass index ≥ 40)
* Anticipated survival time ≤ 7 days
* Patient height ≤ 1.5 m
* More than 48 hours of mechanical ventilation outside of the department