cyrilzakka/clinical-trials huggingface dataset:
Improving Effects of Fish Oil Combined With Pine Bark Extract on Cognitive Decline

The purpose of this study is to evaluate the improving effects of ω-3 fatty acid from fish oil combined with polyphenolic extract from pine bark (PE) on cognitive functions and biological parameters in healthy people aged 55 to 75.

Sixty participants who meet the inclusion criteria will be randomly divided into two groups. Participants in FO group will be provided one capsule of fish oil (350mg EPA + 250mg DHA) per day for 6 months. Moreover, participants in FOPE group will be provided one capsule of fish oil (350mg EPA + 250mg DHA) combined with PE (100mg Oligopin) per day for 6 months. A cognitive function evaluation, blood biological analysis and antioxidative status will be carried out at the baseline, 3 th month and the end of the supplementation period. On the other hand, blood fatty acid composition will be measured at the baseline and the end of the supplementation period. All participants will come to laboratory and receive the supplements every month. At the same time, they will accept the measurement of body weight and blood pressure, also be interviewed with 24 hours dietary recall questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* I. 55\~75 years old
* II. No severe diseases, such as hyperlipidemia, diabetes, heart diseases, cancer etc.
* III. Mini-mental state examination (MMSE) score is more than 26
* IV. Clinical dementia rating scale (CDRS) score is less than 0.5

Exclusion Criteria:

* liver disease, kidney disease, hypertension, hyperlipidemia, anemia, cancer
Analgesic Effects of Expectation and Deep Brain Stimulation in Patients With Parkinson's Disease

The study investigates analgesic effects of expectations and deep brain stimulation on chronic and evoked pain in patients with Parkinson's disease.

The study includes patients with Parkinson's disease that are exposed to pain stimuli through injection of hypertonic saline. During pain induction and chronic pain evaluation deep brain stimulation treatment is regulated. Pain stimuli and regulation of deep brain stimulation are accompanied by verbal suggestions as to the analgesic effect of deep brain stimulation or no suggestions. During the test session patients evaluate their chronic and evoked pain and expectations.

The study procedure is repeated on two separate test days to investigate pain during deep brain stimulation treatment with or without verbal suggestions. All participants will complete all study conditions with no suggestions and verbal suggestions, respectively.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of PD (confirmed by a neurologist)
* Bilateral implanted DBS in the STN during the study or for a minimum of 6 months

Exclusion criteria

* Other neurological or medical disorders (e.g. stroke, neuropathy, diabetes) or other disorders (e.g. musculoskeletal diseases) with expected influence on pain
* Dementia
* Untreated depression
* Patients unable to pause anti-parkinsonian medication
* Patients unable to cooperate
* Patients treated with painkillers except paracetamol and NSAID (except if pain and treatment is adequately stable as evaluated by a doctor)
Fear of Falling in Patients With Chronic Stroke

The aim of the study is to evaluate whether combining cognitive-behavioral therapy (CBT) with task-oriented balance training (TOBT) is more effective than general health education (GHE) together with TOBT in promoting fear of falling and reducing activity avoidance behavior.

The null hypothesis of this study will be that no significant difference in the efficacy of the two treatments (CBT + TOBT; GHE + TOBT) in promoting fear of falling and reducing fear avoidance behavior, and thus no significant difference in improving balance ability, reducing fall risks, improving health-related quality of life and community reintegration of people with stroke.

Eligibility Criteria:
Inclusion criteria: Subjects will be included if they

* are between 55 and 85 years of age;
* have been diagnosed with a first unilateral ischemic brain injury or intracerebral hemorrhage by magnetic resonance imaging or computed tomography within the previous 1 to 6 years;
* have been discharged from all rehabilitation services at least 6 months before program begins;
* are able to work independently at least 10 meters with or without an assistive device;
* have low balance self-efficacy (The Activities-specific Balance Confidence scale score of \<80);
* are able to score \> 7 out of 10 on the Chinese version of Abbreviated Mental Test; and
* are able to follow instructions and provide written informed consent.

Exclusion criteria: Subjects will be excluded if they

* have any additional medical, cardiovascular, orthopaedic, or psychiatric or psychological condition that would hinder proper treatment or assessment;
* have receptive dysphasia;
* have significant lower peripheral neuropathy; or
* are involved in a drug studies or other clinical trial.
Evaluation of the Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly

The purpose of this observer-blind clinical trial is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in the elderly. Subjects were previously vaccinated (NCT00529516).


Eligibility Criteria:
Inclusion Criteria:

* A male or female subject previously enrolled in study 109821 (NCT 00529516) in the \>= 65 years and 18-41 years of age groups and having received the study vaccine.
* Subjects of whom the investigator believes that they can and will comply with the requirements of the protocol. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
* Written informed consent obtained from the subject.
* Free of an acute aggravation of the health status as established by medical history and clinical examination before entering into the study
* If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
* Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
* Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
* Any vaccination against influenza since January 2008 with any seasonal influenza vaccine.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of hypersensitivity to a previous dose of influenza vaccine.
* History of allergy or reactions likely to be exacerbated by any component of the vaccines.
* Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period.
* Any medical conditions in which intramuscular injections are contraindicated.
* Pregnant or lactating females.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
Growth Mindset Psychoeducation for Modifiable Risk Factors for CMD

The present study aims to determine the effect of presenting psychoeducation emphasizing "growth-mindset," and information on modifiable risk factors (e.g., social contact, physical activity) on engagement with modifiable risk factors. The investigators hypothesize that psychoeducation emphasizing that mental health is malleable will increase the participant's engagement with risk factors outlined in the intervention.


Eligibility Criteria:
Inclusion Criteria:

* College freshmen

Exclusion Criteria:

* Not fluent in English
Guided Placement of CRT-Leads

In this open, prospective, randomized, parallel group, German-American, two-center, Phase I study the standard-approach CRT-implantation will be compared to a guided CRT-implantation after determining the site of latest contraction and placement of the electrode as close as possible to this site, using a 5-step-scheme of imaging methods determining the site of latest contraction prior to implantation.

Patients will be allocated to two groups with either

1. Guided implantation of the left ventricular lead
2. Empirical implantation of the left ventricular lead (current clinical standard)

For Treatment Group a) the target vessel, which is the vessel with smallest distance between RLC and CVS is determined in advance and provided to the implanting physician. In case, this vessel is not amenable for lead positioning, a second vessel which is the second closest to the RLC is defined.

For Treatment Group b), the physician has to choose the vessel where to place the electrode without knowing the exact spatial orientation between that particular side-branch and the RLC.

In all patients, standard biventricular devices and leads are to be used. Aspects that are evaluated are:

1. Technical success in placing the electrode in the target vessel.
2. Failure due to dislocation during the implantation procedure or phrenic nerve stimulation.

Also, procedure duration, radiation exposure, and complications occurring during the procedure as well as post- operatively will be documented.

Eligibility Criteria:
Inclusion Criteria:

* Congestive heart failure,
* Ejection fraction \<35%,
* Complete left bundle branch block \>120ms,
* NYHA II,III or IV

Exclusion Criteria:

* Patients not fulfilling the inclusion criteria or not capable/mental able to understand and follow the instructions;
* Impaired kidney function (GFR \<30ml/min;
* Pregnant or breastfeeding women
Effect of Desflurane on Cardiac Function During Cardiac Surgery: Tissue Doppler Imaging of Mitral Valve Annular Velocity

The purpose of this study is to determine desflurane's dose-dependent effect on left ventricular (LV) function in cardiac surgery. The change of tissue Doppler imaging (TDI) of lateral mitral valve annular velocity at three different desflurane concentrations would be analyzed by using intraoperative transesophageal echocardiography (TEE) in cardiac surgery patients

Tissue Doppler imaging (TDI ) of mitral annular velocity during the cardiac cycle has been introduced as a reliable method for analysis of systolic and diastolic LV ling-axix function , efficacy of diastolic TDI profile, including early early relaxation (E') and atrial contraction (A') and has been suggested to be useful in predicting the postoperative clinical outcomes and the impact of isoflurane on LV diastolic function.

Desflurane is widely used in cardiac surgery patients due to its beneficial effects , but many studies have shown that desflurane reduces myocardial contractility in a dose-dependent manner, and compromises left ventricular( LV) function We hypothesized that desflurane , even at a clinical dosage, would affects intraoperative LV systolic function in a dose-dependent manner and thus produce significant changes int the TDI profiles of mitral annular velocity.

So we planned to study the changes in TDI profiles of lateral mitral annular velocity at the clinical desflurane dosage during remifentanil based anesthesia for cardiac surgery

Eligibility Criteria:
Ages eligible for study : 20 years to 65 years Genders eligible for study : Both

Inclusion Criteria:

* Patients undergoing cardiac surgery

Exclusion Criteria:

* Low ejection fraction \<50% in preoperative transthoracic echocardiography
* Atrial fibrillation
* Pacemaker
* Pericardial and infiltrative myocardial disease
* Mitral annular calcification, surgical rings, prosthetic mitral valves
* Lateral left ventricular regional wall motion abnormality
* Esophageal spasm, stricture, laceration, perforation, and diverticulum
* Diaphragmatic hernia
* History of extensive radiation to mediastinum
* Upper gastrointestinal bleeding
Reverse Engineering of Exclusive Enteral Nutrition

Primary: Nutritional therapy in the form of a whole-food based smoothie can be used to induce remission of active Crohn's disease.

Secondary: Consuming a whole foods based smoothie will result in measurable changes to the microbiome of individuals with Crohn's disease and healthy controls.

The specific aims of this proposal are:

1. To develop a whole-food based smoothie, based on principles of the specific carbohydrate diet, that is comparable in macronutrients and micronutrients to formulas used for exclusive enteral nutritional (EEN) therapy in Crohn's disease.
2. To evaluate the ability of a whole-food based smoothie to induce remission of active Crohn's disease.
3. To evaluate changes to the intestinal microbiome in healthy individuals consuming a whole-food based smoothie diet.

This will be an open label, pilot study over 4 weeks in children with newly diagnosed Crohn's disease treated with a smoothie designed to emulate formulas used for exclusive enteral nutritional therapy. In place of formula, whole-foods based smoothie recipes and the food to create the smoothies will be given to each participant/family. The smoothies will be based upon the concept of reverse-engineering of exclusive enteral nutrition (RE-EEN). The smoothie recipes will involve whole foods that can be blenderized to liquid consistency. Similar to the formulas used for EEN, the smoothies will provide calories, protein, fat, and carbohydrates in a distribution to support growth and development.

Eligibility Criteria:
Inclusion Criteria:

1. Age 8 -21 years old
2. Diagnosis of Crohn's disease within 4 weeks of study entry
3. Active Crohn's disease, as defined by Pediatric Crohn's Disease Activity Index (PCDAI) ≥10.
4. Participant capable of giving informed consent, or if a minor the parent/guardian is capable of giving informed consent

Exclusion Criteria:

1. History of surgery for Crohn's disease
2. Perianal disease as part of Crohn's disease phenotype
3. Prior treatment with EEN or the specific carbohydrate for Crohn's disease
4. Prior treatment with any immunosuppressive medication (corticosteroids, anti-TNF-alpha agent, azathioprine, methotrexate, etc.)
5. Prior treatment with antibiotics for Crohn's disease
6. Known allergies to any of the food components in the smoothie
7. Admission to hospital due to severity of Crohn's disease and associated symptoms
8. Unwillingness to provide informed consent
Follicular Phase Stimulation vs. Luteal Phase Stimulation in Patients Diagnosed With Suboptimal Response

This study aims to investigate the difference in the number of oocytes obtained by performing ovarian stimulation in follicular phase vs. luteal phase in a population of patients with previous suboptimal response.

This is a controlled randomized clinical study.

We aim to include 41 patients diagnosed with suboptimal response who will undergo an ovarian stimulation in order to vitrify and accumulate oocytes.

The main variable for evaluating the efficacy in this exploratory study will be the number of oocyte cumulus complexes obtained.


Eligibility Criteria:
Inclusion Criteria:

* Meets Bologna criteria to be diagnosed as poor responder
* Less than 10 oocytes obtained in a prior controlled protocol of conventional ovarian stimulation
* Age \< 41 years
* Body Mass Index (BMI) between 18 and 32 kg/m2
* Regular menstrual cycles between 21 and 35 days.
* Indication for in vitro fertilization
* Indication to start stimulation with 150mcg of corifollitropin alpha
* Presence of both ovaries
* Ability to participate and comply with study protocol
* Signing an informed consent form

Exclusion Criteria:

* Presence of follicles larger than 10 mm in the randomization visit
* Endometriosis stage III/IV
* Patients with less than 4 oocytes in previous ovarian stimulation and poor ovarian reserve parameters (as per Bologna criteria)
* Concurrent participation in another study
A Study to Evaluate the Safety, Tolerability, Kinetics and Repeatability of 18F-BMS-986327

The purpose of this study is to assess the safety, tolerability, kinetics and test-retest repeatability of the novel LPA1 positron emission tomography (PET) ligand 18F-BMS-986327 in healthy participants and participants with idiopathic pulmonary fibrosis (IPF).


Eligibility Criteria:
Inclusion Criteria:

All Participants:

· Body mass index of 18.0 to 34.0 kg/m\^2, inclusive, and body weight ≥ 50 kg

Healthy Participants:

* Male and female healthy volunteers ages 18 or age or older
* No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory determinations

Idiopathic Pulmonary Fibrosis (IPF) Participants:

* Male and female participants aged 40 to 90 years
* Diagnosis of IPF less than 6 years before randomization
* Have no features supporting an alternative diagnosis on transbronchial biopsy, bronchoalveolar lavage or surgical lung biopsy

Exclusion Criteria (all participants):

* Severe motor problems that prevent the ability to lie still for PET imaging procedure
* Significant acute or chronic medical illness in the opinion of the investigator in consultation with the BMS Medical Monitor, could jeopardize the subject's safety, tolerability, or pharmacokinetics of 18F-BMS-986327
* Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
* Any major surgery within 4 weeks of study drug administration

Other protocol-defined criteria apply
Preoperative Corticosteroids in Autoimmune Thyroid Disease

This study proposes to randomize patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of corticosteroids decreases the inflammation of the gland and makes surgery less difficult.


Eligibility Criteria:
* Inclusion Criteria:

  ■ Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb) undergoing total thyroidectomy for their disease.
* Exclusion Criteria:

  * Pediatric patients \< 18
  * Prior treatment with RAI
  * Prior neck surgeries
  * Known diagnosis of thyroid cancer
  * Diabetic patients on medications
  * A history of adverse reactions to corticosteroids.
  * Patients on any immunosuppressive regimen (such as organ transplant patients or patients treated for other autoimmune conditions). This includes patients with recent history of steroid therapy, or a history of adverse reactions to corticosteroids.
Nursing Students and Artificial Intelligence

The aim of this observational study is to examine nursing students\&#39; readiness for medical AI and their anxiety about AI using a mixed method.

The main question it aims to answer is:

Nursing students\&#39;;

1. What is their level of awareness of medical artificial intelligence?
2. What is their level of artificial intelligence anxiety?
3. Is there a relationship between artificial intelligence awareness and anxiety levels?
4. What are the opinions of those who have artificial intelligence anxiety about artificial intelligence?

In the 1st stage, nursing students answered the related survey questions online. In the 2nd stage, qualitative interviews were conducted with those with high AI anxiety scores and evaluated.


Eligibility Criteria:
Inclusion Criteria:

To be a student of Necmettin Erbakan University Faculty of Nursing To be a student of Necmettin Erbakan University Kamil Akkanat Faculty of Health Sciences, Department of Nursing

Exclusion Criteria:

Students who did not consent to participate were excluded
The Effects of Acute Caloric Deprivation on Odour Identification and Food Reward

The purpose of this study is to determine how the modality of energy depletion can differently impact appetite hormones, ad libitum food intake, food hedonics, and olfaction.

The objectives of the current randomized controlled study were to examine how the modality of an acute 3 day isocaloric -25% energy depletion by dieting alone or by aerobic exercise alone differently impacts appetite and appetite-related hormones, ad libitum energy intake (EI), food hedonics and food reward, and olfaction. It was hypothesized that independent of modality of depletion, that relative to the control, there would be increased ad libitum feeding and food reward, improvements in smell performance, and a decline in fasting leptin and increase in fasting total ghrelin. It was also hypothesized that the increased food reward would prove to be a predictor of ad libitum EI and that relative to the depletion by aerobic exercise alone, the depletion by diet alone would produce greater compensatory increases in appetite, ad libitum EI, and food reward.

Statistics

To test for differences in body weight, plasma hormone concentrations, relative-reinforcing value of food (RRVF), and olfaction across each condition of the study, repeated measures ANOVA controlling for day 1 as a covariate was employed. Pairwise comparisons at day 4 using Sidak adjustment to account for multiple comparisons are reported when the ANOVA was significant. One way repeated measures ANOVAs with Sidak adjustments for multiple comparisons were used to test for differences in variables measured only at day 4: body composition (fat mas, %Fat, and fat free mass), appetite, palatability, and ad libitum EI.

Eligibility Criteria:
Inclusion Criteria:

* Free from any illness that could influence outcome of the experiment
* Weight-stable for \>6months
* aged between 18-40 years

Exclusion Criteria:

* diabetic
* smoker
* medication