cyrilzakka/clinical-trials huggingface dataset:
Baclofen Effects in Cigarette Smokers

The proposed project will utilize perfusion functional magnetic resonance imaging (fMRI), a functional candidate gene association approach (of dopaminergic addictions-targeted polymorphisms), and the dopamine-modulating and gamma-aminobutyric acid (GABA) B receptor agonist, baclofen, to examine the brain and behavioral responses in smokers to appetitive smoking reminders (cues that motivate continued smoking and relapse). These studies will provide a means to identify an appetitive cue-sensitive pharmacologic-responsive endophenotype. Once brain/behavioral/genetic endophenotypes can be determined prior to treatment, smoking cessation treatments can be structured to meet individual needs, which will significantly improve treatment outcome.


Eligibility Criteria:
Inclusion Criteria:

* Physically healthy, as determined by a comprehensive physical examination and approval of the study physician males or females who smoke cigarettes, ages 18-60.
* Smoke ≥ 6 cigarettes per day for at least 6 months prior to study start date.
* Females must be non-pregnant, non-lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 1 year post-menopausal) or of child bearing potential but practicing a medically acceptable method of birth control. Examples of medically acceptable methods for this protocol include barrier (diaphragm or condom) with spermicide, an intrauterine device (IUD), the Nuvaring, oral contraceptives, levonorgestrel implant, hormonal injection or complete abstinence.
* Provide voluntary informed consent.
* Must be able to read. \[Subjects are required to be able to read because there are several self-administered measures that they must read, understand and provide written answers.\]
* Intelligence quotient of ≥ 80.

Exclusion Criteria:

* History of head trauma or injury causing loss of consciousness, lasting more than five (5) minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI.
* Current Diagnostic and Statistical Manual-IV (DSM-IV) Axis I diagnoses other than nicotine dependence.
* Presence of magnetically active irremovable prosthetics, plates, pins, permanent retainer, bullets, etc. (unless a radiologist confirms that it's presence is unproblematic). An x-ray may be obtained to determine eligibility given the possibility of a foreign body.
* History of psychosis.
* Claustrophobia or other medical condition preventing subject from lying in the MRI for approximately one (1) hour.
* Current diagnosis of or treatment within the last 3 months for alcohol dependence.
* Current use of any smoking cessation treatments such as Zyban, Chantix, Wellbutrin, patch, gum, inhaler, electronic cigarettes, herbal preparations.
* Vision problems that cannot be corrected with glasses.
* Weight exceeding 300 pounds \[Imaging data acquisition is impaired with high weight individuals\].
* History of stroke.
Comparison of Prasugrel and Clopidogrel in Very Elderly and Non-Elderly Patients With Stable Coronary Artery Disease

The 5-milligram (mg) maintenance dose (MD) of prasugrel in very elderly patients with coronary artery disease produces a pharmacodynamic response within the same therapeutic range as 10-mg MD in non-elderly patients.


Eligibility Criteria:
Inclusion Criteria:

* Participants (Either: at least 45 years of age, but less than 65 years of age OR 75 years of age or older) with a history of stable coronary artery disease who are not currently indicated for treatment with a thienopyridine (that is, prasugrel, clopidogrel, or ticlopidine)
* Provision of written informed consent
* Body weight greater than or equal to 60 kilograms (kg)
* For women of child-bearing potential only (that is, women who are not surgically or chemically sterilised and who are between menarche and 1 year post menopause), test negative for pregnancy (based on a urine or serum pregnancy test to be performed before randomisation) and agree to use a reliable method of birth control during the study

Exclusion Criteria:

* Unstable coronary artery disease
* Myocardial Infarction (MI) within the previous 30 days
* Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft Surgery (CABG) within the previous 90 days
* History of refractory ventricular arrhythmias within the last 6 months; an implanted defibrillator device; congestive heart failure within 6 months prior to screening; major surgery, or severe trauma, fracture or organ biopsy within 3 months prior to enrollment
* Any planned surgical procedure or any coronary revascularisation (surgical or percutaneous) planned within 60 days following randomisation
* Any known contraindication to treatment with an antiplatelet agent
* Significant hypertension at the time of screening or randomisation
* Clinically significant out-of-range values for platelet count or haemoglobin at screening, in the investigator's opinion, or results of clinical laboratory tests at the time of screening that are judged to be clinically significant for the study population, as determined by the investigator
* Prior history or presence of significant bleeding disorders, abnormal bleeding tendency, or personal history of coagulation or bleeding disorders
* Prior history or clinical suspicion of cerebral vascular malformations, intracranial neoplasm, Transient Ischemic Attack (TIA) or stroke
* Prior history of thrombocytopenia or thrombocytosis
* Use of antiplatelet agents (besides aspirin) within 10 days prior to screening; the use (or planned use) of heparin, oral anticoagulants, or fibrinolytic agents within 30 days of screening; or participants receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDS) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study
Neurofeedback to Improve Working Memory in Mild Cognitive Impairment

Mild cognitive impairment (MCI) has been identified as an early phase of Alzheimer's disease (AD), a neurodegenerative disorder expected to affect 13.9 million Americans by 2060. AD causes a progressive cognitive decline, including problems related to learning and memory, that adversely affects life quality. Treatment intervention at the MCI stage of the disease could potentially slow down the rate at which people may convert from MCI to AD. Increasing evidence suggests that abnormal activity in frontal regions of the brain is associated with cognitive deficits observed in AD. Furthermore, previous research has shown that neurofeedback (NFB) training targeting these regions can improve memory, making it a potential treatment for AD. NFB is a technique where an individual learns to change his/her brain function in a particular direction, once that function has been made accessible through a visual or auditory metaphor. We are proposing a novel, computer-based brain-training program to enhance frontal gamma oscillatory activity in individuals with MCI. Results from this study will build the scientific foundation necessary for larger clinical trials dedicated to improving treatment options and outcomes for patients with MCI.

This is a randomized, double-blind, clinical trial to test the efficacy of gamma-neurofeedback (G-NFB) compared to a placebo (P-NFB) in individuals with MCI. 112 consented participants will be randomized to receive G-NFB (n=56) or placebo-NFB (n=56) during 30-45 minute sessions twice per week for 12 weeks (24 total sessions). Memory and other cognitive domains will be measured using paper and pencil and computerized tests every 4 weeks during the study and at 4 weeks post completion of study.

Eligibility Criteria:
Inclusion Criteria:

1. Meet criteria for mild cognitive impairment (MCI).
2. Living independently.
3. Literate in English.
4. Competent to participate in the informed consent process and provide voluntary informed consent.

Exclusion Criteria:

1. Frontal temporal dementia
2. Active alcohol or substance use disorder within the past year.
3. Brain cancer
4. Stroke within the last 2 years
5. Anti-epileptic medication
6. Prior head injury involving loss of consciousness
7. Seizure disorder
8. Use of medications likely to affect cognitive function (cf. donepezil, memantine). We will not exclude for other medications but will examine their effects and include medications as covariates as appropriate (e.g., presence v. absence; anticholinergic load).
9. The potential benefits of the study do not outweigh the potential risks of the study, as determined by the PI.
A Study of the Clinicopathologic Behaviour of the Different Types of Unsafe Chronic Otitis Media

The purpose of the study is to study the clinicopathologic behaviour of the 3 dangerous types of chronic otitis media that are prone for complications. In which type are the complications more common? Which type gives rise to more hearing loss? How does the disease process in the 3 types evolve? should the 3 types of otitis media be managed differently?

Design: prospective cross sectional study setting: tertiary referral medical college hospital No of groups: 3 group 1: primary acquired atticoantral disease group 2: secondary acquired atticoantral disease group 3: mixed atticoantral disease

Interventions:

1. Diagnostic nasal endoscopy
2. Eustachian tube function tests
3. Pure tone audiometry
4. biopsy of middle ear mucosa
5. culture and sensitivity of ear discharge

Eligibility Criteria:
Inclusion Criteria:1. Atticoantral chronic otitis media 2. complicated unsafe otitis media 3. Otitis media with cholesteatoma, polyp, granulation tissue 4. Ear with retraction pockets leading to attic -

Exclusion Criteria:

1. tubotympanic otitis media alone
2. otitis media with effusion
3. Acute otitis media -
Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers

First aim: PARIS study

The main aim of the current study is to determine the association between abdominal aortic aneurysm (AAA) progression and the evolution of proteases and cytokines levels.To achieve this aim, we will prospectively collect blood, aortic tissue, patient data, and imaging data. Aortic tissue will only be obtained when patients undergo conventional open repair. The other biomaterials will be collected during regular patient follow-up visits, with a maximum frequency of once per year.

Second aim: Pearl AAA biobank

For future research purposes, a new biobanking infrastructure will be created to collect and store additional blood and urine samples in a biobank. This biobank will be embedded within the infrastructure of the 'Parelsnoer Institute' (PSI) and will be called Pearl AAA. The Pearl AAA will be established in the extension of the PARIS study

The PARIS study aims to determine the correlation between AAA progression (growth or rupture) and the evolution of serum levels of proteases and cytokines over time. A repeated measures analysis will be done to use all longitudinal data available.

The Pearl AAA biobank will be established to enable the PARIS study, but also aims to facilitate future research. Such future research should fall under the scientific aims of the Pearl AAA, which are:

* To gain insight in the pathogenesis of AAA
* To gain more knowledge in the rupture risk of AAA
* To evaluate and potentially improve treatment of AAA

The 'Parelsnoer Institute' will facilitate the biobank Pearl AAA with certain aspects such as, but not limited to the following:

* Standardized operating procedures for the collection and storage of the biosamples across all participating hospitals
* Information architect to establish a data dictionary in which all variables are defined
* Standardized procedures for coding of patient data before storage
* Standardized digital infrastructure to enhance storage of patient data and imaging data

Eligibility Criteria:
Inclusion Criteria:

* Adult participant (18 years or older)
* Participant has an AAA or has previously been treated for an AAA
* Adequate comprehension of the Dutch language to provide written informed consent

Exclusion Criteria:

* A patient who is decisionally impaired. The only exception to this are the patients who are decisionally impaired due to the effects of an acute AAA. This particular group is eligible for which a separate recruitment and consent procedure exists.
Study of Pemetrexed in the Treatment of Patients With Ovarian Cancer Who Have Failed Prior Platinum-Based Chemotherapy

The purposes of this study are to determine: - whether standard or higher doses of pemetrexed should be given to patients with ovarian or primary peritoneal cancer that has recurred; - the safety and side effects of standard and higher doses of pemetrexed given to patients with ovarian or primary peritoneal cancer that has recurred; - whether standard or higher doses of pemetrexed can help patients with ovarian or primary peritoneal cancer that has recurred.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have been diagnosed with ovarian or primary peritoneal cancer
* Patient must have had 1 or 2 prior platinum-based chemotherapeutic regimens.
* Patient must have adequate health status.
* Patient compliance and geographic proximity that allow for adequate follow up is required.
* Signed informed consent from the patient or legal representative is required.

Exclusion Criteria:

* Patient is pregnant or breast-feeding
* Patient has received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Patient has previously participated in another study investigating pemetrexed.
* Patient is unable or unwilling to take folic acid, vitamin B12 supplementation, and corticosteroids.
* Patient cannot be taking nonsteroidal anti-inflammatory drugs around the time of administration of study drug.
Chronic Kidney Disease and Myocardial Injury After Non Cardiac Surgery

Investigators will conduct a retrospective chart review, examining the impact of chronic kidney disease on risk of myocardial injury after non cardiac surgery (MINS). The objective of this study is to examine interactions between preoperative Estimated Glomerular Filtration Rate (eGFR) and the association between preoperative N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) and post operative cardiac events in patients undergoing major non cardiac surgery.

In recent years some authors have shown a correlation between increased post operative troponin and increased 30 day mortality in patients with kidney disease that mirrors the known correlation in those with normal renal function. In patients undergoing non cardiac surgery, Walsh et al demonstrated a 4 to 6 fold increased risk of death associated with elevated post operative troponin in patients with reduced (\<60 ml/min, but \>30ml/min) preoperative estimated glomerular filtration rate (eGFR). A second, more recent study by Liem et al, also found post operative troponin elevations were associated with higher morbidity and mortality risk in patients with chronic kidney disease undergoing non cardiac surgery. Investigators aim to build upon the findings of these authors by examining the relationship between pre operative eGFR, post operative troponin and risk of post operative cardiac events in patients undergoing non cardiac surgery at St Paul's hospital. Investigators will conduct a retrospective chart review of electronic records for all patients undergoing non cardiac, inpatient surgery at St Paul's Hospital from June 1, 2020 to December 31, 2021). Investigators will include all patients for whom preoperative eGFR values are available, and patients on chronic dialysis. Patients are to be stratified by preoperative eGFR and primary outcomes compared between patients with normal vs abnormal preoperative eGFR. Primary outcomes to be reviewed are myocardial injury after non cardiac surgery (MINS) and troponin elevations.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing non cardiac surgery, at St Paul's Hospital, during the period spanning June 1 2020 to November 30 2020
* Preoperative eGFR data is available, or chronic dialysis status is known (these patients will not reliably have eGFR measured, and it is not relevant)
* Inpatient surgeries (elective, urgent, and emergent)

Exclusion Criteria:

* Patients undergoing cardiac surgery.
* Patients undergoing day surgery
* Patients for whom Estimated Glomerular Filtration Rate (eGFR) results are not available
A Clinical Trial of Chemotherapy With Lobaplatin and 5-FU in Recurrent Local or Distant Advanced NPC.

The purpose of this study is to evaluate the efficacy and safety of chemotherapy with Lobaplatin and 5-FU, in Recurrent Local or Distant Advanced Nasopharyngeal Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* NPC diagnosed by pathology, with measurable lesions and imaging results, such as MRI and CT. Patients with no other lesions but bone metastasis are excluded.
* Recurrent locally or distant advanced NPC (rT3-4N0-3M0-1)
* ECOG 0 or 1
* Expected survival ≥ 1 year
* Without dysfunction of heart, lung, liver, kidney and hematopoiesis
* Patients are voluntary and signed informed consent
* No other anti-tumor treatment (including steroid)

Exclusion Criteria:

* Allergy history to platinum
* Use of 5-FU in last 6 months
* Had major surgery in last 4 weeks, or the wound has not completely healed
* Toxicity from previous treatment is still ≥CTC AE grade 3
* History of other carcinoma in the past 5 years, except for treated carcinoma in situ of cervix, as well as basal cell carcinoma or squamous cell carcinoma of the skin
* Dysfunction of heart
* Bleeding ≥CTC AE grade 3
* Use of anticoagulant or vitamin K antagonists, except for small dose of aspirin and warfarin for prevention
* Patients participated in clinical trials of other drugs within last 4 weeks
* Mental illness
A Trial of Closed Hemorrhoidectomy Under Local Perianal Block Versus Spinal Anesthesia

Hemorrhoidectomy can be carried out under several modes of anesthesia. In western country hemorrhoidectomy usually be performed under general anesthesia, however there may be the complications resulted from general anesthesia together with associated diseases in advanced age, caudal or spinal anesthesia has been used as an alternative to general anesthesia (GA) for hemorrhoid surgery but they all require a trained anesthetist and have numerous known complications. Since, anesthesiologists are not always available then local anesthesia is an alternative mode of anesthesia that surgeon can safely carry out by their own. Local anesthetic produce a loss of sensation and muscle paralysis in a circumscribed area of body by localized effect on peripheral nerve endings. The local anesthesia is able to provide fully relaxation of the anal canal which is an ideal setting for various anal surgical procedures. The results of hemorrhoid surgery under this mode of anesthesia have been demonstrated in many publications. Local anesthesia is a safe and effective technique while fewer risks and complications compared with general or spinal anesthesia. In Thailand both spinal anesthesia and local perianal block have routinely been used for various kinds of anorectal surgery. However, so far there has no any trial conducting to compare between these two techniques.

Objectives: To study analgesic efficacy, postoperative voiding problems, patients' satisfaction, and other complications after closed hemorrhoidectomy comparison between local perianal block and spinal anesthesia.

Research design: Randomized controlled trial Setting: Phramongkutklao Hospital Research methodology: A total of 64 subjects (32 males and 32 females) underwent elective hemorrhoidectomy were randomly allocated into two groups. Thirty-two patients were randomly allocated to receive spinal anesthesia (SA group) while 32 patients received local perianal block (LA group). Duration of analgesic effect, pain measurement with visual analogue scale (VAS) at 6 and 24 hours, quantity of analgesic medication administered, postoperative complication, and patient's satisfaction with the anesthetic technique were recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between 18 and 60 years with grade 3 or 4 hemorrhoid.
2. Had no history of bupivacaine allergy.

Exclusion Criteria:

1. Complicated hemorrhoid e.g. prolapsed or incarcerated hemorrhoid, gangrenous hemorrhoid.
2. Associated anorectal disease.
3. Patients whose characteristics of his/her buttock were difficult to gained adequate exposure when performing surgery under local anesthesia such as the mounds of his/her buttock is very high and rise almost straight up from the anal verge.
4. Patient was unfit for surgery e.g. heart disease, liver cirrhosis, or coagulopathy.
5. Patients who had symptoms of benign prostatic hypertrophy or bladder neck obstruction.
6. Pregnancy.
7. Patients with neuropsychotic problems.
8. Did not agree to participate this study
Predictive Ability of PEEP Induced Changes in CVP to Predict Volume Responsiveness in Mechanically Ventilated Patients After Major Abdominal Surgery

Interventional study which will assess whether an positive end expiratory pressure induced increase of central venous pressure is a valid predictor of volume responsiveness in mechanically ventilated patients after major abdominal surgery assessed by increase of cardiac output after passive leg raise.

Interventional study which will assess whether an positive end expiratory pressure induced increase of central venous pressure is a valid predictor of volume responsiveness in mechanically ventilated patients after major abdominal surgery assessed by increase of cardiac output after passive leg raise.

Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated and sedated patients admitted to the ICU after major abdominal surgery

Exclusion Criteria:

* Heart failure NYHA III or more
* Severe obstructive or restrictive lung disease
* Hypotension with MAP \< 60 mmHg
* Tachycardia \> 140 beats / min
Peri-operative Assessment of Coagulopathy in Neonates and Infants Undergoing Cardiac Surgery

This prospective study will aim to globally assess the coagulopathy induced during cardiac surgery with cardiopulmonary bypass (CPB) in a large pediatric population. The investigators primary objective will be the understanding of CPB-induced coagulopathy based on demographic and surgical characteristics, and coagulation assays. Secondary objective will aim at determining the relationship between coagulation assays, postoperative blood loss, and transfusion requirements. The ultimate goal will be to design an algorithm using point-of-care monitoring that could be used to guide hemostatic therapies in neonates and children undergoing cardiac surgery.To do this, investigators will examine the coagulation in the laboratory based setting.


Eligibility Criteria:
Inclusion Criteria:

* Neonates weighing greater than 2.5 kg
* Patients equal to or less than 12 months of age
* Undergoing elective cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Emergent procedure
* The patient is deemed to be in a moribund condition (American Society of Anesthesiology (ASA 5))