cyrilzakka/clinical-trials huggingface dataset:
Intracranial Pressure and Brain Function: Effects of Head Down Tilt Upon Brain Perfusion and Cognitive Performance

The aim of the study is to understand the relationship between intracranial pressure regulation, cerebral tissue oxygenation and cognitive functioning. More specifically, the study tests the hypothesis that head down tilt will increase intracranial pressure (not measured in this study, but demonstrated in previous studies), will induce venous congestion and facial swelling, decrease intracranial tissue oxygenation and hamper brain functioning. The objectives of the study therefore are to assess young healthy people during head-down tilt (HDT), and to assess cognitive brain functioning, cerebral tissue oxygenation (non-invasively), frontal skin thickness, cerebral perfusion and neuronal functioning via event-related potentials.


Eligibility Criteria:
Inclusion Criteria:

* Physically and mentally healthy male test subjects that are able and declare in writing their willingness to participate in the entire study and successfully passed the psychological and medical screening
* Aged between 18-55 years old with a Body Mass Index (BMI) of 20-28 kg/m2, weight between 65-100 kg, and a height between 158-195 cm
* Demonstrable medical insurance and official certificate of absence of criminal record

Exclusion Criteria:

* Inability to sleep on the back
* Drug, medication or alcohol abuse (regular consumption of more than 20-30 g alcohol/day)
* Smoking within the past 6 months prior to study commencement
* Migraine or other chronic head aches
* Previous psychiatric illness
* Subjects suffering from weak concentration
* History of psychological or central nervous disorders
* Hiatus hernia
* Gastro-oesophageal reflux
* Diabetes mellitus
* Pronounced orthostatic intolerance (\< 10 min standing)
* Kidney disorder: deviations from normal values for creatinine in plasma. (Normal value: Creatinine \< 1.20 mg/dl)
* Thyroid gland disorder: deviations from normal values for thyroid stimulating Hormone (TSH) in plasma. (Normal range: TSH 0.55-4.80 mUnits/l)
* Anaemia: Hb under normal values (Normal values of Hb for men: 13.5-17.5 g/l)
* Elevated risk of thrombosis
* High likelihood of coagulopathy assessed by a clinical standard questionnaire
* Chronic back complaints
* History of lumbar surgery
* History of lumbar spine trauma
* Motor or sensory deficits as assessed by neurological examination
* Contraindications against MRI
* Imprisoned at the time of the study
* Taking medications that may impair cognitive function, autonomic function or any of the study procedures
* Ophthalmological conditions including glaucoma, retinopathy, severe cataracts, eye trauma or implants
* Any other medical condition that the investigators consider a contraindication to the study procedures that would make it unsafe or confound the measurements.
Quality of Life of Periodontitis Patients Visiting Supportive Periodontal Therapy

The present prospective study aims to assess the QoL of periodontitis patients during supportive treatment and to relate it to periodontal health (clinical and radiographic data) and treatment stability. Follow-ups after the first cross-sectional assessment are planned after approximately 2.5, 5, 7.5, and 10 years.


Eligibility Criteria:
Inclusion Criteria:

* All patients returning for supportive therapy on a regular basis after active periodontal treatment will be asked for participation if they are in supportive therapy for at least 1 year.
Role of Endothelin-1 Modulating Insulin-stimulated Blood Flow and Sympathetic Nervous System Activity in Obesity

The aim of this project is to determine role for ET-1 in individuals with obesity.


Eligibility Criteria:
Inclusion Criteria:

* 18-55 years of age
* Male sex
* Obese (BMI ≥30 kg/m2)

Exclusion Criteria:

* Female sex
* Current smoking/Nicotine use
* Nerve/neurologic disease
* Cardiovascular, hepatic, renal, respiratory disease
* Blood pressure ≥140/90 mmHg
* Diabetes
* Vigorous exercise \>3 times/week
* Communication barriers
* taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic
Comparison of Anatomically Aligned and Conventional Total Knee Arthroplasty in the Same Patients

Total knee arthroplasty(TKA) is a successful orthopedic surgery with excellent clinical outcome and survival. However, there are concerns about patient satisfaction in previous reports, and dissatisfaction rate of 15-30% is reported in clinical outcomes(PROMs) of some studies. Therefore, for improving the patient's outcome and satisfaction after total knee arthroplasty, it is necessary to change the design of the conventional total knee arthroplsaty implant. The knee is a joint structure with several dynamic functions, and not only the skeletal structure but also the soft tissue balance plays an important role in the function of the knee joint. New implants are being developed to overcome the limitations of conventional TKA implant, including the Journey II Bi-cruciate substituting total knee system (JII-BCS; Smith \& Nephew). JII-BCS implant has normal articular geometry, more anatomical femoral shape, lateral tibial convex geometry, and asymmetrical tibial plateau, anterior and posterior cams, which has been shown in experimental studies to produce nearly normal knee movement by reproducing the actual normal anatomical alignment in vivo.

The clinical results of the kinematic effects of this anatomcally aligned change are insufficient, and there is also a lack of comparative studies with conventional total knee arthroplasty implant. The purpose of this study is to compare outcomes between anatomically aligned TKA(JII-BCS) and conventional TKA(Legion total knee system, Smith \& Nephew). This study is a randomized controlled study in patients undergoing total knee arthroplasty per day. Radiologic parameter, patients preference and clinical results was investigated in both knee of same patients who received TKA during minimum 2 year follow up.


Eligibility Criteria:
Inclusion Criteria:

* Patients for bilateral total knee arthroplasty
* having medicare insurance

Exclusion Criteria:

* Rheumatoid arthritis
* Other inflammatory arthritis
* Crystal-induced arthritis
* Septic arthritis
* Neuropsychiatric patients
* Previous knee operation history
* Neuropsychiatric patients
* Patients with preoperative severe limitation of motion (Flexion contracture ≥ 20, range of motion ≤ 90)
* Patients with preoperative severe defomity of knee alignment (Varus or valgus angle ≥ 15)
* Severe obese patients (BMI ≥ 40)
Construct Validity of a Diagnostic Hysteroscopy Training Model

In a prospective case-control study, the investigators compare the Objective Structured Assessment of Technical Skills (OSATS) scores in medical students and gynecologic experts performing a hysteroscopy on a training model for diagnostic hysteroscopy. The investigators hypothesize that OSATS on a hysteroscopy training model has construct validity to discriminate between experts and novices.

In a prospective case-control study, 140 medical students (,novices') and 10 senior gynecologists (,experts') will watch a demonstration detailing how to perform a hysteroscopy on a training model. All probands will perform a hysteroscopy themselves within 1 hour after the demonstration. Their performance will be judged using an Objective Structured Assessment of Technical Skills (OSATS) assessment. Using metrical and non-metrical measurements, construct validity of the hysteroscopy training model to distinguish between experts and novices will be assessed. Secondary endpoints are differences in OSATS scores within the group of novices based on gender and handyness, as well as satisfaction of the novices with the learning experience.

Eligibility Criteria:
Inclusion Criteria:

* medical Student
* no previous experience in gynecologic surgery
* no previous gynecologic surgery Training
* gynecologist with a personal history of at least 50 hysteroscopies)

Exclusion Criteria:

* language barrier
* unwillingness to participate
Alternate Day vs. Daily Iron Supplementation in Iron Depleted Women in the Philippines

Iron is very important for our body and performs vital tasks. Iron deficiency is a worldwide health problem. The prevalence of anemia in women of reproductive age in Southeast Asia is estimated to be 46.6% in 2019, with iron deficiency being one of the main reasons for anemia. There are different approaches to treat iron deficiency. One of them is the use of iron supplements. Recommended iron supplement treatments today often differ in dose, regimen and length. Experts recommend a dose of 80-200 mg of iron taken either daily or on several days per week, depending on the severity of the iron deficiency (with or without anemia). From certain guidelines lower amounts of iron are also recommended, as this could lead to fewer side effects.Previous studies have shown that both daily and multiple days per week administration can be effective in treating iron deficiency. Recently, several successive iron supplementation studies in Zurich showed that 24 h after ingestion of an oral dose of \>60mg iron, the absorption of iron in the body is impaired. In addition it was measured that iron supplements taken only every other day instead of every day are absorbed about 30-50% better and have fewer side effects. Little is known about the long-term effect of this alternating regimen on iron status and side effects.With this 6-months study in the Philippines, the investigators want to compare two different supplementation regimens with oral iron to see if there is any difference in the iron status, intestinal inflammation levels, and side effects, and therefore if it would be better to take the iron supplements every 2 days instead of daily.


Eligibility Criteria:
Inclusion Criteria:

* Female, 18 to 45 years old,
* SF levels \<25 µg/L,
* Hb levels 11-15.5 g/dL
* Normal Body Mass Index (18.5-25 kg/m2),
* In possession of a mobile phone on which the study app can be loaded
* Signed informed consent

Exclusion Criteria:

* Elevated CRP \> 5 mg/L
* Any metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) affecting iron metabolism,
* Use of medication which may interfere with iron absorption, gut physiology and iron metabolism
* Consumption of iron supplements within 2 weeks prior to study start and of additional iron supplements during the study period
* Difficulties with blood sampling,
* Known hypersensitivity or allergy to iron or placebo capsules in the given amount (ferrous sulfate, mannitol, silica)
* Pregnancy, breastfeeding
* Known or suspected non-compliance, drug or alcohol abuse
* Cigarette smokers
Long-term Study of SYR-472

To evaluate the safety and efficacy of long-term treatment with SYR-472 in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

1. The participant is an outpatient.
2. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
3. Diabetes Mellitus

Exclusion Criteria:

1. The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
2. The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.
Pediatric Bipolar Depression

The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating children or adolescents aged 10 to 17 with bipolar depression and if so, how it compares with placebo (a non-active tablet, like a sugar pill, that looks like quetiapine).


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent by one or both parents or legal guardian and written assent by the patients before any study procedures are performed.
* The patient must have a documented clinical diagnosis for bipolar I or bipolar II disorder, and including current episode depressed.
* Patients are required to be in outpatient status at the enrollment and randomization visits and believed likely to remain an outpatient for the duration of the study.
* Patients must be able to swallow the study medication tablets.

Exclusion Criteria:

* The patient must not have been diagnosed with Tourette's Disorder, Obsessive-Compulsive Disorder, acute Post-traumatic Stress Disorder, Panic Disorder, Autistic Disorder and/or Asperger's Disorder.
* Patient can not have a history of non-response to an adequate treatment to more than 2 antidepressants during the current episode.
* The patient must not have received electroconvulsive therapy (ECT) within 30 days before participating in the study.
* Patients who in your doctors judgement pose a current suicidal or homicidal risk.
Continuous Monitoring of Physiology and Self-reported Pain Score Amongst Post-surgical Knee Patients

The aim of this observational study is to assess whether patient reported pain levels correlate with a Pain Index derived from deviations in multivariate physiology biomarkers captured in real-world setting. This study will be conducted using a clinical-grade wearable sensor to continuously monitor patient's physiology (pain related biomarkers) and allow subject participant to actively report their pain score, symptoms and quality of life using a mobile-based application.

The designated clinical-grade wearable sensor used in this study is the Biovotion Everion MD (See Annex for product description), a Bluetooth-compatible device that will automatically sync with the mobile application used in this study.

This study will recruit 55 patients aged 21 to 80 years who will be undergoing knee replacement, Anterior Cruciate Ligament(ACL), Knee Arthroscopy and Foot \& Ankle related surgery. All study participants will be followed for an estimated total of 30 days(+6/-2 days, if visit schedule is fall on weekend), beginning four days before surgery, the entire period as an in-patient (four to five days), and 20-days post-discharge.

The changes in multivariate physiological biomarkers will be used to generate a Pain Index, and the Pain Index will be assessed against patient reported Numerical Rating Scale (NRS) pain.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 21 to 80 years
* Patients undergoing knee replacement surgery ( Total Knee Replacement (TKR), Unicompartmental Knee arthroplasty (UKA), Bilateral knee replacemenent, Patello-Femoral-Joint (PFJ) Knee replacement), Anterior Cruciate Ligament(ACL), Knee Arthroscopy and Foot \& Ankle related surgery such as bunions, hammer toes, metatarsal, ankle fusion, triple fusion, ankle replacement, achilles tendon \& tibialis posterior disorder
* Ability to provide informed consent
* Able to commit to using the app and inputting data as needed during the study duration
* Has access to an iPhone (minimum requirement iPhone 5S)

Exclusion Criteria:

* Previous myocardial infarction (MI)
* Known coronary artery disease - prior coronary revascularization
* Previous stroke. Stroke is defined as new focal neurological deficit perspective more than 24 hours.
* More than ongoing use of 2 or more anti-hypertensive agents.
* Expected life expectancy less than 1 year.
* Asthma or chronic lung disease requiring long-term medications or oxygen
* Mental illness that in the clinical judgment of the investigator will affect participation in the study e.g. dementia
* Inability to comply with the study protocol
* Any other acute or chronic medical or physical condition deemed by the investigator to affect study outcomes
Effect of a Locally Delivered Probiotic in Periodontitis

Saccharomyces boulardii is commonly employed as a live non-pathogenic probiotic microbial feed or food supplement. S. boulardii reduces the secretion of key pro inflammatory cytokines and promotes the production of anti-inflammatory cytokines such as IL-10, which is pertinent in the context of pathogenic mechanisms in periodontitis.

One method of altering the subgingival environment is by using probiotics. Probiotics are live microorganisms, which when administered in adequate amounts, confer a health benefit on the host by passively occupying a niche that may otherwise be colonized by pathogens. This tends to limit a pathogen's ability to bind to tissue surfaces and to produce virulence factors.8 In the past few years, probiotics have been investigated for periodontal health. Studies have shown that certain gut bacteria can exert beneficial effects in the oral cavity by inhibiting pathogenic species. Teughels et al., in a study showed that application of beneficial oral bacteria subgingivally after scaling and root planing led to a more host compatible subgingival microbiota which may also effect the promotion of a beneficial host response.10 Studies have revealed that probiotic Lactobacillus strains (L. reuteri, L salivarius, L. casei, L. acidophilus) were useful in reducing gingival inflammation and the number of black-pigmented rods, including Porphyromonas gingivalis, in the saliva and subgingival plaque. Streptococcus sanguinis \& S. uberis were found to inhibit the growth of periodontopathogens \& a strong negative between Aggregatibacter actinomycetemcomitans and S. sanguinis. Weissella cibaria isolates in the form of probiotic rinse possess the ability to inhibit biofilm formation, both in vitro and in vivo.

Eligibility Criteria:
Inclusion Criteria:

* Subjects having at least one pocket ≥5 mm in each quadrant were included in the study.

Exclusion Criteria:

* Medically compromised patients and patients having received any form of surgical or non-surgical therapy in the 6 month period leading to the study were not included.
Concomitant Treatment with Topical Hyaluronic Acid and High Concentration Oxygen Therapy (Vaginal Natural Oxygenation Device - VNOD) in the Improvement of Symptoms Related to Genitourinary Syndrome of Menopause in Women with Natural and Oncological Postmenopause: Open-Label, Single-Center, Randomize

The Caress study is a single-center, open-label, randomized controlled trial (RCT) evaluating the efficacy of a combined treatment using topical hyaluronic acid and high-concentration oxygen therapy (Vaginal Natural Oxygenation Device - VNOD) in improving symptoms of Genitourinary Syndrome of Menopause (GSM) in postmenopausal women, including those with a history of breast cancer. The primary objective is to assess vaginal dryness improvement one month after treatment, comparing two groups: an experimental group receiving VNOD therapy with hyaluronic acid and a control group using a hyaluronic acid-based gel (Hydeal-D®). Secondary endpoints include the evaluation of additional vaginal symptoms (pain, irritation, itching, sexual health, quality of life) up to six months post-treatment. The study will enroll 80 women (40 with a history of breast cancer and 40 without). Statistical analysis will use chi-square tests and logistic regression to compare symptom severity reduction between the two groups. With a duration of 18 months, the study aims to provide an innovative, non-hormonal treatment option to improve the quality of life for postmenopausal women, particularly those with a history of breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Informed consent signature
* Willingness to undergo treatment and follow-up evaluations according to the schedule outlined in the protocol
* Age \> 18 years

Cohort 1:

* Diagnosis of non-metastatic breast cancer (M0/Mx according to TNM system) who have undergone surgical and/or chemotherapy and/or immunotherapy and/or radiotherapy and/or endocrine treatment.
* Postmenopausal women (FSH \> 30 UIIU/L, E2 \< 20 pg/ml), either naturally or surgically induced, or iatrogenic post-chemotherapy with absent menstrual cycle for at least 6 months; or premenopausal women on treatment with LHRH analog +/- tamoxifen and/or aromatase inhibitor for at least 6 months.
* At least a score of 2 (moderate) for vaginal dryness associated with vulvovaginal atrophy (score 2-3 on the MBS scale).
* Signs of pelvic static alterations not exceeding POP-Q score 2 (POP-Q).

Cohort 2:

* Postmenopausal women (FSH \> 30 UI/L, E2 \< 20 pg/ml), with absent menstrual cycle for at least 6 months, or women who have undergone bilateral adnexectomy at least 6 months ago.
* At least a score of 2 (moderate) for vaginal dryness associated with vulvovaginal atrophy (score 2-3 on the MBS scale).
* Signs of pelvic static alterations not exceeding POP-Q score 2 (POP-Q).

Exclusion Criteria:

* Other current therapy aimed at resolving symptoms associated with vulvo-vaginal atrophy, with the exception of the use of lubricants if sexual activity is present;
* HRT in progress or discontinued for less than 6 months;
* Ongoing vulvo-vaginal and urinary infections;
* Bleeding of ndd;
* Pathological pap-test within the previous 12 months.
PET Study With 11 C-PIB to Evaluate Amyloid Protein Deposits in Mild Cognitive Disorder, Alzheimer's Disease and Early Frontotemporal Degeneration.

Preclinical and clinical data have demonstrated the ability of the 11C-PIB tracer to selectively bind accumulations of amyloid protein, a neuropathological marker characteristic of the neurodegenerative pathologies covered by this study.

The validation in larger groups of patients, and the comparison between the different clinical syndromes included in the spectrum, will allow the diagnostic and prognostic potential of the tracer to be evaluated, with important consequences for the clinical management of patients.

In particular, the tracer could play a central role in the clinical management of patients with neurodegenerative diseases and cognitive impairment.

Numerous pharmacological trials are currently underway, worldwide, for the validation of anti-amyloid drugs. In the future we could think about early monitoring with imaging of the effectiveness of the treatment.

T he FDG PET technique can be of great help in obtaining relationships between radiation damage to the brain and possibly neurological and neuropsychological deficits associates.


Eligibility Criteria:
Inclusion Criteria:

* Alzheimer's diagnosis according to the diagnostic criteria in use.

Exclusion Criteria:

* current or previous treatments with neuroactive drugs;
* pregnancy or breastfeeding.