cyrilzakka/clinical-trials huggingface dataset:
Effect of Two Years of Resistance Training on Health Status in Postmenopausal Women: Longitudinal Study Active Aging.

Aging is a natural process of the life cycle that can result in morphological, neuromuscular, metabolic, physiological, cognitive and behavioral changes that can compromise quality of life, autonomy, self-esteem, health and life expectancy, especially in the elderly. On the other hand, resistance training (RT) has been widely recommended for the elderly population, due to the numerous health benefits it brings, such as increased strength and muscle mass, reduced body fat, increased bone mineral content and density, and improved cardiometabolic profile, among others. However, the effectiveness of RT in attenuating or reversing the deleterious effects of aging has been analyzed by studies conducted, in most cases, over relatively short periods, i.e., eight to 24 weeks. Considering that recent investigations have demonstrated a wide variation in the adaptive responses to RT in this population, it is likely that many of these responses are time-dependent. Additionally, the influence of important mediators and moderators in this process, especially training intensity and volume, dietary habits, the presence or absence of diseases and degenerative processes that cause disability, and the use of polypharmaceuticals, has not yet been well established. Therefore, based on the Active Aging Longitudinal Study, a research project initiated in 2012, it is intend to analyze whether or not RT practice can produce positive and lasting adaptive responses on muscle strength, body composition, functional fitness, cognition, cardiometabolic biomarkers, and cardiac function in postmenopausal women, based on a randomized controlled clinical trial over a long period of time (two years). In addition, mediation and moderation analyses will be used to understand the real impact of RT on the outcomes to be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* 60 years of age or older;
* physically independent;
* not have cardiovascular, musculoskeletal or metabolic limitations that prevent the practice of physical exercises or the execution of motor tests;
* not being on hormone replacement therapy;
* not being involved in physical exercise more than once a week, over the six months prior to the start of the study.

Exclusion Criteria:

* not participating in at least 85% of the training and not attending the assessments.
Investigating Accelerated Learning in Healthy Subjects: Trigeminal Nerve Stimulation

The purpose of this study is to investigate whether it is possible to accelerate learning and improve associative memory performance in healthy subjects, by applying transcranial Direct Current Stimulation (tDCS) targeting the trigeminal nerve during a verbal paired-associate learning task

Associative memory refers to remembering the association between two items, such as a face and a name or a word in English and the same word in another language. It is not only important for learning, but it is also one of the first aspects of memory performance that is impacted by aging and by Alzheimer׳s disease. For decades, neuroscientists have investigated associative learning and memory and ways to accelerate and enhance associative learning and memory.

Transcranial Direct Current stimulation (tDCS) is a non-invasive and painless electrical stimulation technique that has demonstrated to accelerate learning and improve memory in some studies. To investigate whether it is possible to accelerate learning and improve associative memory using tDCS, the performance in a Verbal Paired-Associate memory task of 2 groups will be compared. The first group will get active tDCS during the verbal paired-associate learning task. The second group will get sham tDCS during the verbal paired-associate learning task.

Eligibility Criteria:
Inclusion Criteria:

* Native English Speaker

Exclusion Criteria:

* History of severe head injuries, epileptic insults, or heart disease.
* Severe psychiatric disorders and severe untreated medical problems
* Acquainted with the foreign language used in the learning task
* Contraindications for tDCS (e.g. pregnant, implanted devices)
Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)

The purpose of this trial was to establish the safety, tolerability and PK of nilotinib in this population and to test the hypothesis that 6 months treatment with nilotinib will significantly reduce pulmonary artery resistance.

The purpose of this trial was to establish the safety, tolerability and PK of nilotinib in this population and to test the hypothesis that 6 months

Eligibility Criteria:
Inclusion Criteria:

* World Health Organization (WHO) Functional Class II or III
* 6MWD ≥ 150 m and ≤ 450 m at screening
* Current diagnosis of PAH according to Dana Point 2008 Meeting
* Inadequate clinical response on one or more class(es) of PAH drug
* Stabilization of pulmonary hypertension medications for ≥ 2 months on approved therapeutic dose of at least one PAH drug and still symptomatic with WHO functional Class II or III performance.

Exclusion Criteria:

* Women of child-bearing potential not practicing birth control
* In treatment with chronic nitric oxide therapy
* Pre-existing lung disease
* Use of drugs prolonging the QT interval or strong CYP3A4 inhibitors
* Long QT syndrome or QTc \> 450 ms males; \> 470 ms females.
* WHO Class IV
* Pulmonary capillary wedge pressure \> 15 mm Hg
* Other diagnosis of PAH in WHO Diagnostic Group 1
* PAH associated with: venous hypertension (WHO Diagnostic Group II), hypoxia (WHO Diagnostic Group III), chronic pulmonary thromboembolic disease (WHO Diagnostic Group IV) or other miscellaneous causes (WHO Diagnostic Class V, which includes sarcoidosis, histiocytosis X, lymphangiomatosis, compression of pulmonary vessels)
* Thrombocytopenia \< 50 x109/L (50 x 103/µL)
* Uncontrolled systemic arterial hypertension, systolic \> 160 mm Hg or diastolic \>90 mm Hg
* Any advanced, severe, or unstable disease of any type that may interfere with the primary and secondary endpoint evaluations.

Other protocol-defined inclusion/exclusion criteria may apply
75 or 150 mg Clopidogrel Maintenance Doses Following PCI (ISAR-CHOICE-2)

The purpose of the study is to test whether an increase of the maintenance dose of clopidogrel from 75 to 150 mg per day results in an additional suppression of ADP-induced platelet aggregation

In patients treated with coronary stents clopidogrel therapy is usually initiated with a 300 to 600 mg loading dose. In the CREDO trial it was shown that a 300 mg loading dose results in a reduction of ischemic events after percutaneous coronary intervention (PCI) if given 6 hours prior to the procedure. An antiplatelet effect similar to that achieved by chronic therapy with 75 mg/day is reached within 2 hours when the high 600 mg loading is administered. The 600 mg loading dose has been shown to be safe and effective in preventing thrombotic events following coronary stent implantation. Recently, it was shown that in patients with stable angina and administration of the 600 mg loading dose at least two hours prior to PCI concomitant therapy with a GP IIb/IIIa antagonist does not result in a further reduction of the incidence of thrombotic events. In contrast to a number of investigations with different loading doses, no trials have been performed comparing different clopidogrel maintenance doses. Recently, it was shown that administration of a 600 mg loading dose in patients already on chronic clopidogrel therapy (75 mg/day) results in an additional significant increase in inhibition of adenosine diphosphate (ADP-) induced platelet aggregation. Therefore, it is possible that an increase of the clopidogrel maintenance dose in patients with chronic clopidogrel therapy also results in a more pronounced inhibition of platelet aggregation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic aspirin therapy who are treated with percutaneous coronary intervention at least 2 hours after administration of a 600 mg loading dose of clopidogrel

Exclusion Criteria:

* Major alterations of blood count (particularly platelet count \< 100x10\^9/l, haemoglobin \< 10 mg/dl
* Recent bleeding diathesis
* Presence of a hematologic or malignant disorder
* Oral anticoagulation with coumarin derivates
* Use of glycoprotein (GP) IIb/IIIa antagonists during the intervention or during the preceding 14 days
* Therapy with clopidogrel within the last 28 days
Micro-RNA Expression Profiles in Localised Prostate Cancer

Recurrence free survival The patients will be followed in regular time intervals in accordance with the EAU-Guidelines (2010) and the S-3 Guideline for Prostate cancer of the German Urological Association. Data will be updated once yearly for until death.


Eligibility Criteria:
Inclusion Criteria:

* 35 Years to 80 Years
* Male
* Patients with clinically localised high risk prostate cancer

Exclusion Criteria:

-
Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children

Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral rehydration therapy is the key treatment. According to the 2014 guidelines developed by the ESPGHAN probiotics may be considered in the management of children with AGE in addition to rehydration therapy. Considering that evidence on L reuteri remains limited, the investigators aim to assess the efficacy of L reuteri DSM 17938 for the treatment of AGE in children. Children vaccinated and not vaccinated against rotavirus will be evaluated separately.

Two independent reports (rotavirus-vaccinated and non-vaccinated children) are planned.


Eligibility Criteria:
Inclusion Criteria:

1. Acute gastroenteritis (AGE) defined as a change in stool consistency to loose or liquid form (according to the Bristol Stool Form (BSF) scale or in the case of infants, the Amsterdam Stool Form (ASF) scale) and/or an increase in the frequency of evacuations (typically ≥3 in 24 h), lasting for no longer than 5 days.
2. Age: older than 1 month and younger than 60 months.
3. A caregiver must provide written informed consent.

Exclusion Criteria:

1. Use of antibiotics within two weeks prior to enrolment.
2. Use of gelatine tannate, diosmectite, probiotics, racecadotril, or zinc (including zinc containing ORS) within a week prior to enrolment (a single dose is allowed).
3. Breast feeding (\>50%)
4. Chronic diarrhoeal gastrointestinal disease (e.g., inflammatory bowel disease, cystic fibrosis, coeliac disease, food allergy)
5. Immunodeficiency
6. Malnutrition (weight/height/length under 3rd percentile) (WHO Child Growth Standards will be used)
A Proof of Concept Study to Evaluate the Dose Response for the Systemic Benefit Risk Ratio of Inhaled Fluticasone Propionate in Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD) is a major worldwide problem.Steroids inhalers are now an established treatment for COPD. Inhaled steroids can have a number of bad effects including suppression of the adrenal glands because of absorption. A previous study in patients with COPD.

C-reactive Protein (CRP) is a peptide produced in the liver in response to inflammation. Elevated circulating levels of CRP are associated with heart conditions. High levels of CRP have also been found in patients with COPD. In some studies, steroid inhalers have reduced CRP levels, and that of other inflammatory mediators, in patients with COPD. It is unknown whether this reflects a reduction in lung inflammation or an effect of systemically absorbed corticosteroid.

It is proposed to investigate the link between inhaled corticosteroid and serum CRP, lung inflammation (measured by exhaled nitric oxide) and systemic absorption of steroids.


Eligibility Criteria:
Inclusion Criteria:

* Current or ex-smokers
* Aged over 50years
* FEV1/FVC ratio \<0.7
* FEV1\<80% predicted
* Improvement in FEV1 following short acting beta-agonist not greater than 15% and 200ml.

Exclusion Criteria:

* Diagnosis of asthma, bronchiectasis or ABPA
* Inability to perform study procedures or give informed consent
* Known sensitivity to trial medications
Shotblocker and Breastfeeding on Pain/Comfort During Heel Lance

Shotblocker and breastfeeding are an attempt to reduce pain during invasive procedures in newborns. This study was planned to evaluate the effect of non-pharmacological interventions on the pain and comfort level of newborns, whose heel blood will be taken in the 1st Level Neonatal Intensive Care Unit.

Hypotheses H1: Newborns who undergo breastfeeding attempt during heel lance procedure feel less pain and have a higher comfort level.

H2: Newborns who undergo breastfeeding attempt and are applied shotblocker during heel lance procedure feel less pain and have a higher comfort level.

H3: Newborns who undergo shotblocker intervention during heel lance procedure feel less pain and have a higher comfort level.

H4: There are a difference between the comfort levels, HR and PO2 of newborns in terms of group, group-time and time according to the intervention applied.

Data collection process Mothers of newborns whose heel blood will be taken will be informed about the research. Consent will be obtained from the mother regarding the video recording during the heel lance precedure. After informed consent is obtained, it will be determined which group the newborn belongs to by stratified randomization.

A standard approach will be applied to all newborns. Standard approach involves performing the heel lance procedure on the caregiver's lap. Heel lance procedure will be scheduled between 09:00 and 10:00 in the morning, one hour after babies are breastfed. Babies to be included in the study in each group; they will be in their beds, in the undisturbed rest period, until 30 minutes before the start of the test. All babies; 2 minutes before, during and up to 2 minutes after blood collection; they will be video-recorded including their heart rate, faces, and upper and lower extremities (especially the heel to be operated). No additional care will be given to ensure physiological stability during each intervention (breastfeeding, shotblocker, etc.)

Eligibility Criteria:
Inclusion Criteria:

* Birth week is between 34-42 weeks,
* Postnatal in the first 10 days
* Birth weight is between 2500-4000 grams,
* Stable general condition,
* Being with her mother and literate,
* Breastfeeding,
* Newborns of mothers who agreed to participate in the study

Exclusion Criteria:

* In need of oxygen support,
* Unsuccessful heel lance attempt, patients whose heel lance cannot be taken in 30 sec.(in groups with shotblocker)
* Needing parenteral nutrition,
* Receiving analgesic treatment,
* Having physical, metabolic and genetic diseases,
* Having a mental or mental health problem in the mother
* Non-breastfed newborns
* Newborns hospitalized in the 3rd and 4th level neonatal intensive care unit
Monitoring Brain Perfusion and Cerebral Oximetry in Carotid Endarterectomy Surgeries

The goal of this study is to demonstrate Or-Nim's CerOx monitor ability to monitor changes in cerebral blood flow and oximetry during CEA surgery.

Procedures include:

Screening:

ECG, blood draw, neurological assessment, NIHSS

study: CerOX and TCD clock during CEA procedure, data collection from the medical record/monitors, neurological assessment, NIHSS

30 day follow-up


Eligibility Criteria:
Patients scheduled to undergo a CEA procedure that have consented to participate in the study will be included in this observational study.

Research Subjects: Indications for monitoring include patients scheduled for CEA that comply with the inclusion and exclusion criteria.

Inclusion Criteria

To be considered eligible to participate in this study, a patient must meet the inclusion criteria listed below:

1. Consenting patients over 18 years, undergoing elective carotid endarterectomy at Barnes Jewish Hospital.

Exclusion Criteria

To be eligible for entry into the study, the patient must not meet any of the exclusion criteria listed below:

1. Emergency surgery
2. National Institute of health Stroke Scale (NIHSS) score \>=10
3. Sub-cutaneous hematoma at the ipsilateral intended area of the CerOx probe location.
4. Laceration or scalp injury at the ipsilateral intended area of the CerOx probe location which contraindicates placement of the adhesive on the skin.
5. Patient with implants located in the intended area of the CerOx probe location.
6. Prisoners
7. Non-consenting patient Or non-participating surgeon schedule of assessments and procedures
8. Pregnant or lactating women
Toric Intraocular Lenses for Cataract Patients in the NHS

To assess visual performance, refractive outcome, and patient satisfaction with the use of "off the shelf" toric lenses, with a set cylindrical correction of 2.00 or 4.00 diopters, and combined limbal relaxing incisions and/or off-axis intraocular lens rotation, compared to fully targeted toric intraocular lens correction.

The aim of this study is to evaluate a simplified, more cost-effective procedure for the use of toric intraocular lenses, with a focus on suitability for NHS cataract surgery. This study will involve the use of standard, "off-the-shelf" toric lenses rather than having them specifically tailored and ordered for each individual patient. Eligible participants (\>1.25 D of corneal astigmatism) will be randomised, receiving a toric IOL with either a 2.00 or 4.00 diopter (D) correction, depending on the degree of pre-operative astigmatism, or a toric IOL individually tailored to and ordered for each patients' precise degree of corneal astigmatism. With the "off the shelf" toric IOL group the correction of the astigmatic refractive error will be refined with the use of adjunctive limbal relaxing incisions LRIs and/or off axis rotation of the toric IOL (based on a standardized protocol) so the full amount of corneal astigmatism can be targeted for correction for each patient. The clinical outcome will then be measured and compared between the 2 groups. Independent safety monitoring will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Bilateral or unilateral cataracts requiring surgical intervention
2. Age over 18 years
3. Able to understand informed consent and the objectives of the trial
4. Not pregnant, not breast feeding
5. No previous eye surgery
6. Corneal astigmatism greater than 1.5 diopters in one eye.

Exclusion Criteria:

1. age-related macula degeneration
2. glaucoma
3. previous retinal vascular disorders
4. previous retinal detachment or tear
5. any neuro-ophthalmological condition
6. any inherited retinal disorder or pathology
7. previous strabismus surgery or record of amblyopia
8. previous TIA, CVA or other vaso-occlusive disease
9. already enrolled in another study
Study of a Novel Antipsychotic ITI-007 in Schizophrenia

The purpose of this study is to evaluate whether ITI-007 is effective in reducing symptoms associated with schizophrenia in patients who are having an acute worsening of their psychosis. Patients will be randomly assigned to receive one of two doses of ITI-007, placebo, or a positive control. The primary goal will be to assess the effects of ITI-007 on psychosis. The safety of ITI-007 will also be assessed.

The study will be conducted as a randomized, double-blind, placebo-controlled, multi-center study in patients diagnosed with schizophrenia and an acute exacerbation of psychosis. The efficacy and safety of two dose levels of ITI-007 administered daily for 28 days will be evaluated as compared to placebo; risperidone has been included as a positive control.

Upon completion of the inpatient 28-day Study Treatment Period, patients will be started on standard antipsychotic medication and will be stabilized over a 5-day period before discharge from the study clinic. Patients will be seen for a final outpatient safety evaluation at the End-of-Study visit approximately 2 weeks after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patient's age is 18-55
* Patient has current diagnosis of schizophrenia and is experiencing an acute exacerbation of psychosis
* Patient has a history of at least three months exposure to one or more antipsychotic therapy(ies) and a prior response to antipsychotic therapy within the previous five years

Exclusion Criteria:

* Any female patient who is pregnant or breast-feeding
* Any patient presenting with concurrent dementia, delirium, mental retardation, epilepsy, drug-induced psychosis, or history of significant brain trauma
* Any patient presenting with schizoaffective disorder, bipolar disorder, acute mania, or major depression with psychotic features
* Any patient considered to be an imminent danger to themselves or others
* Any patient with hematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or substance abuse as defined by protocol
* Any patient judged by the Investigator to be inappropriate for the study
Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product

To compare the pharmacokinetics (PK), and pharmacodynamics (PD) of single subcutaneous (SC) doses of 300 mg LIB003 Process 1 (P1) and Process 2 (P2) drug product in subjects with or without statin therapy

Comparison of the pharmacokinetics (PK), and pharmacodynamics (free PCSK9 and LDL-C) of single subcutaneous (SC) doses of 300 mg of both LIB003 drug product manufactured by Process 1 (P1) and Process 2 (P2) in subjects with or without statin therapy

Eligibility Criteria:
Inclusion Criteria:

* Provision of written and signed informed consent prior to any study-specific procedure
* LDL-C 70 mg/dL or above on stable diet alone or diet plus statin
* Weight of 40 kg (88 lb) and body mass index (BMI) between 17 and 42 kg/m2
* Females of childbearing potential must be using a highly effective form of birth control
* Male subjects will either be surgically sterile or agree, or partner agrees, to use highly effective form of birth control

Exclusion Criteria:

* Fasting triglyceride \>400 mg/dL
* excluded lipid lowering medication
* severe renal impairment (eGFR \<30 ml/min)
* fasting glucose \>200 mg/dL plus HbA1c \>9%
* hepatic transaminases \>2.5 x ULN for laboratory
* History of any prior or active clinical condition or acute and/or unstable systemic disease compromising subject inclusion, at the discretion of the Investigator,
* NYHA class III-IV heart failure or last documented left ventricular EF \<30%
* Any severe or clinically significant advert event, laboratory abnormality, intercurrent illness, or other medical condition which indicates to the Investigator that continued participation is not in the best interest of the subject
Impedance Cardiographic (ICG) Assessment of Pregnant Women With Severe Hypertension to Assess Impact of Standard Therapy

The utilization of external cardiohemodynamic patient assessment, applying non-invasive stick-on contact patches to the mother's neck on either side and chest wall on either side, enables the practitioner to have information about the patient's cardiac function and vascular status beyond simply blood pressure and pulse. This information, once collected, should open the practitioner's eyes to better assess the patient's disease status and her response to therapy. We will use this information to compare the effectiveness of the two standard medications used for treatment of maternal high blood pressure.

Pregnant patients with severe acute hypertension due either to superimposed preeclampsia, severe preeclampsia or severe gestational hypertension will be randomized to receive either of two antihypertensive agents (hydralazine or labetalol). Just before drug administration and immediately thereafter impedance cardiography of the patient will be undertaken and the results analyzed relative to the cardiac profile and the drug administered to reduce the severe hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous or parous patients with severe hypertension
* Singleton gestation
* Gestational age greater than 20 weeks

Exclusion Criteria:

* Multiple gestation
* Gestational age less than 20 weeks