cyrilzakka/clinical-trials huggingface dataset:
Smoking Cessation And Reduction in Depression

It is well established in studies across several countries that tobacco smoking is more prevalent among depressed patients than the general population. Electronic cigarettes are becoming increasingly popular with smokers worldwide. To date there are no large randomized trials of electronic cigarettes in depressed smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population.

We have designed a randomized controlled trial investigating the efficacy and safety of electronic cigarette. The trial will take the form of a prospective 12-month randomized clinical study to evaluate smoking reduction, smoking abstinence and adverse events in depressed smokers not intending to quit. We will also monitor quality of life, neurocognitive functioning and measure participants' perception and satisfaction of the product.

Outcome measures: A ≥50% reduction in the number of cigarettes/day from baseline, will be calculated at each study visit ("reducers"). Abstinence from smoking will be calculated at each study visit ("quitters"). Smokers who leave the study protocol before its completion and will carry out the Early Termination Visit or who will not satisfy the criteria of "reducers" and "quitters" will be defined "non responders".


Eligibility Criteria:
Inclusion Criteria:

1. Patients with Major Depressive Disorder (MDD) (according to DSM 5 criteria) from throughout Sicily (Italy), who smoke tobacco cigarettes.
2. smoke ≥10 factory made cig/day, for at least the past five years
3. age 18-65 years
4. in good general health (in absence of cancer, acute myocardial infarction, unstable angina, severe cardiac arrhythmia, recent cerebrovascular incident, or severe atherosclerosis )
5. not currently attempting to quit smoking or wishing to do so in the next 30 days (a specific test will be included to check their unwillingness to quit) 6 months
6. committed to follow the trial procedures.

Exclusion Criteria:

1. use of smokeless tobacco or nicotine replacement therapy or other smoking cessation therapies
2. pregnancy or breastfeeding
3. current or recent (less than 1 yr) past history of alcohol and/or drug abuse
4. active suicidal intention
5. other significant co-morbidities according to the Investigator's clinical assessment (e.g. cancer, acute myocardial infarction, unstable angina, severe cardiac arrhythmia, recent cerebrovascular incident, or severe atherosclerosis
Exploring Brain Damages After COVID-19 Infection

Although direct evidence is currently lacking, the high identity between SARS-CoV-1 and SARS-CoV-2 suggests, that the latter viral strain could also infect the Central Nervous System (CNS). Indeed, some cases of SARS-COV2 encephalitis begin to be described and CNS damages are increasingly highlighted in the literature, but still not objectified by imaging and do not allow to explain the entire clinical patterns. We hypothesise that these CNS damages are not always objectified by Magnetic Resonance Imaging (MRI) but could be indirectly observed by a physiological dysfunction of neural conduction in the brainstem. We will explore brainstem disruption through an electrophysiological approach.

Clinical and preclinical data from studies with other coronaviruses suggest an evident neurotropism, which may result in more complex clinical scenarios. Can the SARS-CoV-2 enter the Central Nervous System (CNS) and infect neural cells ? And if yes, how the CNS damage contributes to pathophysiology of the COVID-19, to its signs, symptoms and progression as well as to its sequelae. It has been demonstrated that coronaviruses such as SARS-CoV and MERS-CoV do not limit their presence to the respiratory tract and frequently invade the CNS. The intranasal administration of SARS-CoV-1 or MERS-COV resulted in the rapid invasion of viral particles into the brain of mice, possibly through the olfactory bulb via trans-synaptic route. The brainstem, which hosts the respiratory neuronal circuit in the medulla, was severely infected with both types of viruses, which may contribute to degradation and failure of respiratory centres.

Eligibility Criteria:
Inclusion Criteria :

* Age ≥ 18 years.
* Hospitalized patient suffering from a positive COVID 19 diagnosed by Reverse transcription polymerase chain reaction (RT-PCR) or chest computed tomography scan (CTscan) with specific lesions

Exclusion Criteria :

* History of neurological damage interfering with auditory evoked potentials (PEA) and Electromyography (EMG) reflexes of the brainstem (stroke of the brainstem, acoustic neuroma, amyotrophic lateral sclerosis, facial diplegia, damage to nerves V or VII, etc.)
* Impaired alertness
* Sedative treatments or treatments that disturb nerve conduction.
* Pregnancy or breastfeeding
* Individuals under legal protection or unable to express personally their consent
Comparison of Melatonin or Metformin and Dacarbazine Combination Versus Dacarbazine Alone in Disseminated Melanoma

Treatment of disseminated melanoma is still a difficult issue. Obvious achievements of recent years proves efficacy of immunologic approachees in this field. The ability of melatonin and metformin to decrease metabolic immunosuppression was shown in many experimental studies. Some literature data confirm the possibility of increasing efficacy of melatonin with dacarbazine (DTIC) and metformin with DTIC combinations. We hypothesized that this combinations could be more effective than DTIC monotherapy in terms of response rate and time to progression.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18.
* Obtained Inform Consent
* Morphologically confirmed disseminated Stage IV melanoma
* Eastern Collaborative Oncology Group Performance Status Scale 0 - 2.
* Expected survival \>3 month

Exclusion Criteria:

* Evidence of active brain lesions (brain lesions after stereotaxic ray therapy allowed)
* Evidence of liver and bone marrow clinically meaningful disfunction
* Severe uncontrolled concomitant conditions and diseases
* Pregnancy or lactation
* Systemic therapy for disseminated melanoma
* Second malignancy
* Diabetes mellitus requiring drug therapy
* Any condition preventing study participation by investigator opinion
Potential Impact (Benefit) of Preventative Treatment With Topamax on the Effectiveness of Axert in the Acute Treatment of Migraine

The purpose of this study is to evaluate the impact of topiramate (migraine prevention medicine) on the effectiveness of almotriptan malate (acute migraine medicine) when treating acute migraine headaches.

Migraine afflicts greater than 28 million adults in the United States. Acute treatments, such as almotriptan malate, target the symptoms of a migraine attack. Preventive treatments, such as topiramate, primarily target the generation of attacks and may decrease use of acute treatments. Preventive treatments, by a process of neurostabilization, may result in an additive effect on almotriptan malate to improve acute treatment intervention response during a migraine attack. This is a randomized, double blind, parallel group multicenter study that will enroll patients 18-65 years old with a history of 3-12 migraine headaches each month for the past 3 months. The total study duration will be approximately 32 weeks. The study is divided into 4 phases as follows: A Screening Phase that lasts one month; An Open Label Phase where all patients will be treated with topiramate gradually dosed to 100mg a day lasting 6 weeks; A Double Blind Phase lasting 19 weeks at which time patients will be randomized to stay on topiramate 100mg per day or switch to placebo topiramate (50:50 chance) and a Taper/Exit Phase lasting 2 weeks. Almotriptan malate will be used for all migraine headaches during the study as needed. The study hypothesis is that the combination of almotriptan malate and topiramate will have a better clinical response than the combination of almotriptan malate and placebo topiramate. Migraine pain information will be collected from each patient with the use of a Personal Digital Assistant (PDA or Palm Pilot) throughout the study for each migraine attack. Commercial Topiramate will be gradually increased to 100mg/day in approximately 4-6 weeks. You will then be randomized to either Topiramate or Placebo, dosed at 100mg a day, for the remainder of the study (18 weeks). AXERT 12.5mg may be taken to treat migraine headaches during the study.

Eligibility Criteria:
Inclusion Criteria:

* Have a history of migraine headaches for at least 6 months
* Experience 3-12 migraines per month
* Able to take oral medication
* Able to complete the electronic diary (Personal Digital Assistant-PDA).

Exclusion Criteria:

* You will not be able to participate in the study if you previously discontinued Topiramate or Almotriptan because it did not make you feel better or it made you feel different
* Have 15 or more headache days a month
* Experience migraine aura without a headache
* Already on a migraine preventative medicine.
A Pilot Study to Explore the Role of Gut Flora in Metastatic Mesothelioma

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Metastatic Mesothelioma

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

   a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome)
3. Diagnosis of metastatic mesothelioma through biopsy and/or advanced imaging

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials

Infectious endocarditis is a serious pathology with difficult diagnosis especially on prosthetic valves or cardiac device because of the plurality of clinical presentations and the low sensitivity value of echocardiography in these patients. Despite a well validated indication for the detection of septic emboli, the value of FDG-PET for the detection of prosthetic valves or cardiac implantable device is still unclear especially because of frequent non-septic inflammatory processes.

To improve the specificity value, the use of radio-labeled leukocytes scintigraphy is conventionally proposed. An alternative method is to label leukocytes in vivo with an anti-murin anti body fragment ( Sulesomab , Leukoscan®). This scintigraphy is regularly used in the investigation of osteomyelitis and has been proposed in infectious endocarditis. To knowledge of investigators, the value of Leukoscan® scintigraphy on prosthetic valve or cardiac device infection had not been studied.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged \> 21 years
* Patients presenting a suspicions of infectious endocarditis on surgical materials
* Written informed consent

Exclusion Criteria:

* Patient with a history of exposure to murine antigens, particularly a patient who has already received a 99mTc-Leukoscan® scintigraphy
* Patients whose clinical condition requires prompt care, not allowing them to wait for the examination
* Pregnant or nursing (including pumping for storage and feeding)
* Patients under adapted antibiotic therapy for more than 15 days
* Deprivation of civil rights (curatorship, guardianship, safeguard of justice)
Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery

We hypothesize that pregabalin will decrease postoperative pain, as measured by the surrogate markers postoperative pain rating scores and postoperative opioid consumption while improving the quality of recovery following breast cancer surgery compared to placebo. The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period. Do women undergoing breast cancer surgery with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower NRS and a greater QoR score in the first 24 hours after their surgery than those women who received placebo?


Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesia physical status class I \& II
2. Age ¬\< 65 years
3. English-speaking
4. Unilateral breast cancer surgery without axillary node dissection (i.e. simple mastectomies and lumpectomies +/- "sentinal" node biopsy)

Exclusion Criteria:

1. Known or suspected allergy, sensitivity, or contraindication to pregabalin
2. Known or suspected allergy to morphine, NSAIDs, acetaminophen or oxycodone
3. Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
4. History of a seizure disorder
5. Pregnancy
6. Current pre-operative therapy with pregabalin, gabapentin, or any opioid
7. Any other physical or psychiatric condition which may impair their ability to cooperate with postoperative study data collection
8. CrCl \< 60 ml/min \[CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))\]
TO-ChERIsH: Trajectory of Cardiovascular Ageing, Its Determinants and Impact on Health

Specific Aim 1: To determine longitudinal changes in CV ageing (changes in CV imaging) over time.

Hypothesis: There are differences in rates of CV ageing over time.

Specific Aim 2: To study determinants of CV ageing To assess how biological pathways affect CV ageing by studying the relationships between biological signatures measured in longitudinal biospecimens are associated with CV ageing.

Hypothesis: Antecedent biological markers are associated with progression of CV ageing.

Specific Aim 3: To determine the impact of CV ageing progression on the development of clinical CVD and the overall physical, cognitive and functional health of the elderly.

Hypothesis: Those with stable CV imaging phenotypes have lower incidence of clinical CVD and also better overall health in ageing, compared to those with rapid deterioration (unhealthy CV ageing).

In Singapore, elderly residents aged 65 years and above make up 10.5% of our population and this is expected to double in 2030 (Singapore Department of Statistics, Ministry of Manpower, Registry of Birth and Deaths, September 2014). Cardiovascular diseases account for the majority of disability-adjusted life years by broad cause group, accounting for 20% of 399,675 life years lost due to mortality and ill-health in 2010 (Source: Estimates from the Singapore Burden of Disease Study 2010).

While chronological ageing is inevitable, a clear understanding is needed as to how ageing becomes a critical risk component of CVD for some individuals, and the mechanisms through which ageing results in such a vulnerable phenotype that leads towards clinical CVD. Following that, clinical tools and clinical guidelines to reduce cardiovascular disease and other health burdens contributed by ageing may be formulated. Such strategies may potentially reduce burdens and cost of healthcare provision to the ageing population.

Our proposal will generate data that identifies functional and structural changes in the cardiovascular system that occur in during ageing. Using a longitudinal design, this research will provide high quality evidence that distinguishes healthy from unhealthy cardiovascular ageing, and reveal determinants and impact of CV ageing over time on CVD and associated health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* \>= 21 years old

Exclusion Criteria:

* Unable to provide written informed consent to participate in the study
Comparing of Different Biomarkers From Vena Rectalis Superior and Vena Cubiti in Patients Undergoing Low Anterior Resection for Rectum Cancer

The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF and others ability to predict time to recidive and progressions free survival.

Patients undergoing LAR for rectum cancer is subjected. Preoperative blood samples from vena rectalis superior and vena cubiti is collected, as well as biopsies from tumor. Preoperative and after 3 month peripheral blood samples is collected.

A total of 50 patients will be included in this study.

The study is approved by the local scientific ethical committee No. S-20100006

Eligibility Criteria:
Inclusion Criteria:

* Histological verified cancer
* The cancer must be located in rectum maximum of 15 cm.
* Age above 18

Exclusion Criteria:

* Disseminated cancer
* Perioperative radio-chemotherapy
* Laparoscopy surgery
Phase Ia Dose-Escalation Safety, Pharmacodynamic and Pharmacokinetic Study of Imprime PGG™ Injection

The purpose of this trial is to the assess the safety, pharmacodynamics, and pharmacokinetics of escalating doses of Imprime PGG™ Injection in healthy volunteers.

The primary objective of this study is to evaluate the safety and tolerability of a single intravenous dose of Imprime PGG versus placebo when administered to healthy adult subjects by assessing the frequency, type, and severity of treatment emergent adverse events.

The secondary objectives are:

1. to determine the pharmacodynamics of a single intravenous dose of Imprime PGG when administered to healthy adult subjects by assessing the number of subjects who experience a 15% or more increase from baseline in the percentage of neutrophils with primed CR3; and
2. to derive the pharmacokinetic profile of a single intravenous dose of Imprime PGG when administered to healthy adult subjects by assessing the plasma concentration of Imprime PGG versus time.

Eligibility Criteria:
Inclusion Criteria:

1. Be aged 18 to 45 years, inclusive
2. Have a body weight of 45 to 125 kg, inclusive, and a body mass index less than or equal to 30 kg/m2
3. If female, be nonpregnant and nonnursing, and if premenopausal, have a negative urine pregnancy test confirmed prior to enrollment and practicing at least two methods of birth control
4. Be healthy as determined by the investigator on the basis of medical history, the physical examination, electrocardiogram, and clinical laboratory test results
5. Have the ability to understand the requirements of the study, have provided written informed consent, and agree to abide by the study restrictions and to return for the required assessments
6. Have provided written authorization for use and disclosure of protected health information

Exclusion Criteria:

1. Have a known hypersensitivity to baker's yeast
2. Have a history of tobacco use within 3 months of the Screening Period
3. Be a known or suspected abuser of alcohol or other drugs of abuse
4. Have an active yeast infection
5. Have a positive hepatitis B, hepatitis C, or human immunodeficiency virus test during the Screening Period
6. Except as otherwise indicated, have taken any prescription medication within 14 days of study drug administration on Day 0 or over-the-counter medication, herbal preparation, or vitamins within 1 week of study drug administration on Day 0 (The following medications are exempted from this criterion: acetaminophen \[maximum 3 g/day\], female hormone replacement therapy, and oral contraceptives.)
7. Have participated in an investigational drug study within 30 days or five half-lives (whichever is longer) of the Screening Period
8. Have donated or lost more than a unit of blood within 30 days of the Screening Period
9. Have any clinical condition that, in the opinion of the principal investigator, warrants exclusion from the study for either a scientific, procedural, or safety perspective
Burn Injuries During COVID-19 Pandemic and Its Influence on Length of Stay

Burn injuries were thought to be difficult to treat during the new corona virus epidemic. Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic.

1. Introduction / History

The world is being attacked by the rapidly expanding severe acute respiratory syndrome coronavirus-2 (SARS-Cov-2) epidemic, which is exacerbating an economic crisis. SARS-Cov-2 is the cause of the coronavirus disease 2019 (COVID-19). Anaesthetists are at risk for contracting a virus while doing their regular duties because they frequently come into touch with respiratory droplets.

All nations have put protective and preventive measures in place, forcing people to spend more time at home. A Brazilian study discovered that during the COVID-19 pandemic period, spending more time at home increased exposure to sanitizing products, which include ethanol and hydrogen peroxides that can cause burn injuries.

Aim of our Study:

Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic.

Inclusion Criteria:

Patients who had the burn graft surgery at Al Wakrah Hospital; Hamad Medical Corporation between from 1st of April to end of November 2020. Planned number will include all COVID-19 positive and negative subjects in this period.

Data Source The electronic medical record (Cerner) used in order to identify patients who match study defined criteria. The investigators can Collect data directly from Cerner to excel sheet

Variable Abstraction Patient demographic and clinical data will be collected including age, morbidities, presenting symptoms, physical examination, laboratory investigations, intraoperative data, type of surgery, postoperative course, survival, and length of hospital stay and follow up.

In addition, the type of anesthesia is also included as factor for further complications ex general anesthesia, spinal or combined spinal epidural type.

Observation full reviewing of their medical illness and chart laboratory and investigations will be collected after getting approval of MRC and IRB committee.

Eligibility Criteria:
Inclusion Criteria:

* All burn injuries required surgery with COVID-19 positive or negative status

Exclusion Criteria:

* Other surgery during COVID-19 pandemic