cyrilzakka/clinical-trials huggingface dataset:
Research on Aging Project in Iceland: Second Stage

Background:

- Researchers are interested in studying the environmental and genetic factors that play a role in health and living conditions as people age. Since 2002, the U.S. National Institute on Aging and the Icelandic Heart Association Research Institute have been conducting a long-term study known as the Research in Aging project to collect personal data and samples from Icelandic men and women in order to study risk factors related to disease and disability in old age. Researchers plan to initiate a second stage of the study.

Objectives:

- To collect additional personal information, medical records, and blood samples from individuals who have previously provided materials for the Research in Aging Project in Iceland.

Eligibility:

- Individuals who have previously participated in the Research in Aging project in association with the U.S. National Institute on Aging and the Icelandic Heart Association Research Institute.

Design:

* Participants will have a physical examination with imaging analysis procedures and hearing and eye tests, provide information on health and diet, and provide a 100-ml blood sample for testing.
* Participants will also provide consent for researchers to consult data and samples collected during the first stage of the Research on Aging project.

In anticipation of the sequencing of the human genome and description of the human proteome, the Age, Gene/Environment Susceptibility-Reykjavik Study (AGES) was initiated in 2002. AGES was designed to examine risk factors, including genetic susceptibility and gene/environment interaction, in relation to disease and disability in old age. The study is multidisciplinary, providing detailed phenotypes related to the cardiovascular, neurocognitive (including sensory), and musculoskeletal systems, and to body composition and metabolic regulation. Relevant quantitative traits, subclinical indicators of disease, and medical diagnoses are identified by using biomarkers, imaging, and other physiologic indicators. The AGES sample is drawn from an established population-based cohort, the Reykjavik Study. This cohort of men and women born between 1907 and 1935 has been followed in Iceland since 1967 by the Icelandic Heart Association. The AGES cohort, with cardiovascular risk factor assessments earlier in life and detailed late- life phenotypes of quantitative traits, will create a comprehensive study of aging nested in a relatively genetically homogeneous older population. This approach should facilitate identification of genetic factors that contribute to healthy aging as well as the chronic conditions common in old age.

Eligibility Criteria:
* INCLUSION CRITERIA:

Individuals who have previously participated in the Research in Aging project in association with the U.S. National Institute on Aging and the Icelandic Heart Association Research Institute.
Quadratus Lumborum Block Versus Transversus Abdominis Block

The advent of laparotomy replacement by minimally invasive techniques brought the obvious benefit of postoperative pain reduction. The application of transversus abdominis block has already demonstrated to reduce postoperative pain in laparoscopic hysterectomy. The comparison between it and quadratus lumborum block in cesarean sections showed that the latter was superior in relation to postoperative analgesia. The aim of this trial is to compare postoperative analgesia in patients receiving one or the other of these regional anesthesia techniques to prevent postoperative pain in gynecological laparoscopic surgeries. The recruited sample will be randomly distributed in three groups to receive placebo, transverse abdominal plan block or quadratus lumborum block, in a covert way for the patients and team. The primary outcome evaluated will be the postoperative consumption of opioid and the secondary outcome will be the evaluation of postoperative pain scores.

: the sample will be divided into three groups and all participants will receive general anesthesia. Patients in the placebo group (PG) will be referred to the post-anesthesia recovery room after extubation and adequate hemodynamic and respiratory recovery. Patients in the tap block group (TBG) will receive 0.2 ml of 0.25% ropivacaine between the transverse and oblique internal muscles guided by ultrasound (US), on one side and after the other (the same dose), after the end of surgery. Patients in the quadratus lumborum group (LQG) will receive 0.2 ml/kg of 0.25% ropivacaine inside the middle layer of the thoracolumbar fascia guided by US, on one side and after the other (the same dose), after the end of the surgery. In all participants, the monitoring will include cardioscope, oximetry, non-invasive blood pressure and monitor of hypnoses level. After peripheral venous puncture, antibiotic prophylaxis with 2g cefazolin, and pre-anesthetic medication with midazolam 0.05 mg/kg. After 5 min pre-oxygenation, the patients will receive venous anesthetic induction with 2% lidocaine 1mg/kg without vasoconstrictor; fentanyl 4 µ/kg; propofol 2 mg/kg, or even adequate hypnosis guided by proper monitor; cisatracurium 0.15mg/kg, with tracheal intubation and mechanical ventilation after anesthetic plan confirmed with proper monitor and adequate muscle relaxation. Anesthesia will be maintained with propofol in continuous infusion guided by hypnoses monitor and remifentanil in continuous infusion between 0.1 and 0.5 µg/kg/min, according to patient need. All study participants will receive ondansetron 8 mg, dipyrone 2 g, ketoprofen 100 mg, dexamethasone 10 mg and morphine 3 mg. At the end of the surgery, after partial recovery from neuromuscular blockade, patients will receive atropine 0.01 mg/kg and neostigmine: 0.02mg/kg before tracheal extubation.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to gynecological video laparoscopy.

Exclusion Criteria:

* Allergy to any component of the study protocol, coagulopathies.
Epidermal Growth Factor Receptor (EGFR) Status Based Gefitinib Neoadjuvant Therapy in Non Small Cell Lung Cancer (NSCLC)

This study aims to investigate the efficacy and safety of gefitinib as neoadjuvant therapy in stage IIIA NSCLC patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients pathological diagnosed with NSCLC,with EGFR sensitive mutation;
* Stage IIIA patients with technical operable disease evaluated by image and lab results;
* Patients without chemotherapy or targeted-therapy before;
* Inform Consent.

Exclusion Criteria:

* Patients with malignant tumor other than lung cancer;
* Patients with other diseases such as cardiovascular disease that may hamper follow up;
* Patients that may not coordinate well,judged by researcher.
18F-FDG PET/TC in TIR3A E TIR3B

The primary objective of this study is to evaluate the diagnostic performance of 18F-FDG PET/CT performed by normal care pathway in the identification of malignancy of undetermined resulting thyroid lesions at cytology (TIR3A and TIR3B) comparing the 18F-FDG PET/CT result with histological data.

The secondary objective is to identify possible PET/ultrasound/genetic/radiomics variables that can more accurately define the potential malignancy of undetermined nodules and create a predictive model of malignity fed by standard parameters (derived from the normal care path).

The identification of the prognostic value of 18F-FDG PET/CT in such patients setting could, in fact, make the PET useful in the future in the selection of patients for surgery/ follow-up.

To better stratify the malignancy risk of the resulting undetermined cytological lesions (TIR3A and TIR3B), it is proposed to perform an 18F-FDG PET/TC survey in these patients by which semiquantitative parameters are derived (SUVmax, SUVmean, SUVpeak, MTV, TLG) and perform radiomatic analysis. In the case where the above mentioned PET/CT survey has been recently performed, the survey will not be repeated but the images will be reviewed with visual and semi-quantitative analysis. The results will be compared with those derived from ultrasound and genetic analysis (currently proposed in cases of TIR3A), with the subsequent histological examination derived from surgery (currently indicated by the normal care path in TIR3B cases and in case of reconfirmation of TIR3A cytology to a second needle aspiration on the nodule). It is expected that an algorithm with multiple parameters combined can be created to correctly point towards surgery or a conservative attitude of follow up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with undetermined cytology (TIR3B and TIR3A candidates for surgery) and 18F-FDG PET/CT;
* Obtaining informed consent for data collection and processing.
* Patient aged 18 years

Exclusion Criteria:

- Pregnant/breastfeeding women
Quadratus Lumborum Block Versus Erector Spinae Plane Block in Extracorporeal Shock Wave Lithotripsy(ESWL)

This study is designed to compare analgesic effect of both the ultrasound (US)-guided QLB and ESPB blocks during ESWL and their effect on stone fragmentation.

Urinary tract calculi, one of the most common benign urological diseases, is seen in 12% of patients and has a recurrence rate of approximately 50%.

Management of renal calculi is known to be affected by many factors, specially tolerance of pain during ESWL and how it is controlled.

Pain experienced during ESWL is thought to occur when shock waves from the lithotripter reach superficial structures such as skin and also deeper structures such as the ribs, nerves and the kidney capsule. There are three main factors that contribute to the propagation of pain at these structures: shock wave (SW) pressure, distribution, and focal area size .

Conventionally, pain during ESWL is managed by basic analgesics such as NSAIDs, which can also aid in stone clearance. Other methods of analgesia also have been studied and tested.

Quadratus lumborum block (QLB) was first described by Blanco in 2007, it blocks T7-L1 nerve fibres in most of the cases. Studies have reported its use in the management of postoperative pain after hip surgeries.

"Erector Spinae Plane Block" (ESPB) is another such block, that is increasingly tried for the management of postoperative pain for breast surgery, thoracic surgery, and also upper abdominal surgeries. ESPB when given at the lumbar region gives blockade from C7-T2 to L2-L3.

Eligibility Criteria:
Inclusion Criteria:

* Informed written consent obtained
* Age 18-60
* Both sex
* American Society of Anesthesiologists(ASA) physical status: I, II
* Stone pelvis less than 2.5 cm
* Indicated for ESWL

Exclusion Criteria:

* refusal of participation by parents or caregivers.
* ASA physical status: \> II
* Stone pelvis \>2.5 cm
* Chronic pain
* On chronic NSAID or opioid
* Substance addict
* Known local anesthetic drug sensitivity.
* Preexisting infection at block site
* Coagulopathy or anticoagulation.
A 3D Hydrogel Model to Assess Endothelial Cell-macrophage Interactions in Simulated Microgravity (OR-DRPD-SRI2019)

The proposal contained herein seeks to examine the effect of simulated microgravity on important cell-cell interactions that govern vascular health. The interest lies in endothelial cell (EC) and macrophage cell interactions. The investigators are proposing to first understand how microgravity effects the macrophage and EC function or pro-healing capabilities. Next, the study team plans to develop a 3D tissue regeneration model in which macrophages and ECs are co-cultured in a hydrogel matrix. Utilizing this model, the team will assess how microgravity influenced macrophage-EC interactions in 3D. The investigators will assess EC tubule volume (or blood vessel development), macrophage spreading and the interactions with endothelial tubule sprouts. This model will serve as a critical foundation for future grant opportunities as it allows the assessment of tissue regeneration and vascular health in a 3D tissue microenvironment

While some knowledge has been gained with regards to macrophage alterations during space travel, most of this work has been limited to macrophage cell lines and has not considered how the effects of microgravity alter macrophages' ability to stimulate tissue repair and regeneration. Specifically, how the macrophage secretion profile and/or interaction with endothelial cells is altered during microgravity culture. Given the extensive data showing the consequence of simulated microgravity to alter endothelial cells, and the mounting evidence that simulated microgravity affects macrophage cells, the investigators hypothesize that microgravity alters the functional response of macrophages in close association with endothelial cells. To test this hypothesis, the study team has established 2 specific aims:

Specific Aim 1: Assess the effect of simulated microgravity on endothelial and macrophage pro-healing states.

Specific Aim 2: Assess the effect of simulated microgravity on the pro-healing states of 3-dimensional co-cultured macrophages and endothelial cells.

Completion of the above described aims will lay a strong foundation of knowledge about the impact of simulated microgravity in important cell-cell interactions involved in tissue regeneration and healing

Eligibility Criteria:
Inclusion Criteria:

* Self-reported healthy individuals
* Willingness to have 50mls of whole blood collected

Exclusion Criteria:

• Unwillingness to have blood used in microgravity study
Awareness of Patients Having Diabetes Mellitus About Oral Health

Diabetic patients will be asked to answer a group of questions about the predictors (age, type of diabetes, level of education) and about the outcomes \[knowledge and awareness of the link between diabetes and oral health, and attitude towards maintaining their oral health as diabetics.

The study will recruit patients having diabetes mellitus; where they will be asked to answer a questionnaire after obtaining an informed consent. Diabetic patients will be asked to answer a group of questions about the predictors (age, type of diabetes, level of education) and about the outcomes knowledge and awareness of the link between diabetes and oral health, and attitude towards maintaining their oral health as diabetics.

Eligibility Criteria:
Inclusion Criteria:

* aged at least 18 years and being diagnosed with diabetes mellitus

Exclusion Criteria:

* individuals who refuse to participate in the study
Unloading Respiratory Muscles During NIV: Comparison of a Spontaneous and Auto-adjusting Controlled Mode

Measurement of Work of breathing (WOB), as well as pressure time product (PTP) of transdiaphragmatic pressures to evaluate the degree of muscle activity and muscle unloading during non-invasive ventilation.

The study makes comparison of a new developed auto adjusting controlled mode and a regular spontaneous mode.

Non-invasive ventilation (NIV) reduces carbon dioxide in hypercapnic respiratory failure by unloading the respiratory muscles. Spontaneous modes of NIV are usually being used in these situations. Spontaneous modes have the disadvantage, that the patient has to trigger the ventilator. The work to activate the trigger (WT) is estimated to be as high as up to 50% of the total work of breathing dependent on the underlying disease. Elimination of WT would increase the degree of respiratory muscle unloading.

A new pressure controlled mode incorporated into the ventilogic mechanical ventilator (Weinmann, Germany) is capable of self adjusting respiratory parameters in a preset range according to the patient requirements.

After a short period where the patients spontaneous respiratory parameters are being analyzed, the ventilator slowly implements a pressure controlled mode that matches the patients requirements.

This study intends to investigate if this new mode achieves a higher degree of respiratory muscle unloading compared to a spontaneous mode.

Eligibility Criteria:
Inclusion Criteria:

* Healthy voluntary individuals
* PFT within normal limits

Exclusion Criteria:

* Disease of the upper GI-tract
* Any form of lung disease or disease of the upper airways
* Any form of muscular disease, especially neuromuscular disease pregnancy
Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)

Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis. Subjects with confirmed exocrine pancreatic insufficiency will use a novel enteral feeding in-line digestive enzyme cartridge (RELiZORB) connected to enteral pump sets.

Protocol ALCT-0000497 consists of three distinct study periods as follows:

1. In Period A (7 days), subjects will receive Peptamen 1.5 enteral feedings at home.
2. In Period B (11 days), subjects will be randomized to either Group A (active investigational then placebo control) or Group B (placebo control then active investigational) and receive Impact Peptide 1.5 on Days 1 and 9. During the 8-day washout period between Days 1 and 9, subjects will receive Peptamen 1.5.
3. In Period C (9 days), subjects will use RELiZORB during nocturnal enteral feedings with Impact Peptide 1.5.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed CF diagnosis with 2 clinical features
2. Documented history of EPI
3. Enteral formula use minimum of 4x/week
4. Written informed consent or assent, as applicable

Exclusion Criteria:

1. Uncontrolled diabetes mellitus
2. Signs and symptoms of liver cirrhosis or portal hypertension
3. Lung/liver transplant
4. Active cancer currently receiving cancer treatment
5. Crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerant, inflammatory bowel disease
6. DIOS or fibrosing colonopathy
Effects of EVT 302 With or Without NRT on Craving and Withdrawal in Healthy Male Smokers Deprived of Cigarettes

This randomised, placebo-controlled study is designed to explore the effects of EVT 302 both with and without concomitant nicotine replacement therapy (NRT) on craving and withdrawal in smokers after short term deprivation of cigarettes.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects between 18 and 55 years of age, inclusive
* BMI between 18 and 30, minimum weight of 50 kg
* Negative urine drug \& alcohol screen
* Able to comply with tyramine-restricted diet
* Smoking of ≥17 and ≤34 cigarettes per day for the past year and have not tried to quit smoking in the 3 months prior to screening
* Subjects are willing and able to quit for about 12 hours in each of three subsequent study periods
* Previous experience of craving following smoking cessation
* Breath CO between 15 ppm and 20 ppm and cotinine in saliva and plasma at least 250 ng/mL at screening
* Liver function test results not above 1.5 times the upper normal limit (UNL) at screening visit and at re-assessment during the study.

Exclusion Criteria:

* Participation in another clinical study within 60 days of screening
* Evidence of active significant psychiatric or neurological disease or dependency other than cigarettes
* Are known to have or are a carrier of the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, has a positive result to the human immunodeficiency virus-1 and/or 2 (HIV-1 and/or HIV-2) antibodies
* Known hypersensitivity to MAO inhibitors or any substance that is contained in the study formulations
* Known allergy to plasters or NRT patches
* Previous participation in another study with EVT 302
* Currently receiving treatment for smoking cessation
* Current use of tobacco products other than cigarettes
* Require treatment with any medication
* Subject with a clinically relevant abnormal 12-lead ECG recording or QTcB/F \>430 ms
* Use of a prescription medicine within 14 days or 5 half-lives, whichever is the longer, of the start of dosing, or use of an over-the-counter medication during the 7 days before the study, including herbal remedies, but excluding paracetamol and vitamin supplements (provided intake does not exceed the daily recommended allowance)
* Subjects must not be planning to father a child or donate sperm, during the study and 3 months after the end of the study. Acceptable methods of contraception comprise barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least 2 month)
* Daily consumption of more than 5 cups of tea or coffee, or more than 1.0 litre of xanthine-containing drinks
* Recent myocardial infarction, unstable or worsening angina pectoris, prince metal angina, severe arrhythmias, recent stroke.
* Creatinine clearance (CLR) calculated according to the formula by Modification of Diet in Renal Disease (MDRD) of \<80 mL/min
Our Study Aims to Determine If Nerve Alterations in Acute GBS and CIDP Detectable by Ultrasound Match Electrodiagnostic Findings and If This Method Aids Early Diagnosis, Predict Their Outcomes and Differentiate Between Axonal and Demyelinating Subtypes.

Neuromuscular ultrasound (NMUS) is emerging as a valuable non-invasive diagnostic tool. In GBS, NMUS can detect proximal nerve enlargement early, before neurophysiological changes. Persistent nerve enlargement can be observed up to 15 years, though its correlation with disability varies. Research is needed to clarify NMUS findings in GBS and CIDP over time. Early detection of nerve root enlargement via NMUS could facilitate earlier diagnosis and intervention, improving patient outcomes and understanding of these conditions\&amp;#39; pathophysiology.

This study aims to determine if nerve alterations in acute GBS and CIDP detectable by ultrasound match electrodiagnostic findings and if this method aids early diagnosis. The investigators will perform serial nerve ultrasounds and NCS to investigate nerve morphology, predict outcomes, and differentiate between axonal and demyelinating subtypes.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of patient group:

   * GBS Patients: Diagnosed according to the criteria of the National Institute of Neurological Disorders and Stroke (NINDS) and the Brighton Collaboration (2011).
   * CIDP Patients: Diagnosed according to the criteria of the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS).
2. Age: Participants aged 18 to 75 years.
3. Onset:

   * GBS Patients: Recent onset of GBS within the first 2 weeks of symptom onset.
   * CIDP Patients: Either relapsing or progressive course consistent with CIDP diagnosis.
4. Gender: Both male and female participants are eligible.
5. Participation: Willingness to participate in the study, including undergoing disease-related examinations and assessments.
6. Consent: Ability and willingness to provide informed consent

Exclusion Criteria:

1. Patients unable or unwilling to provide informed consent.
2. Patients with metabolic disorders or malignancies.
3. Patients with other causes of peripheral neuropathy.
4. Patients with other causes of acute flaccid paralysis.