cyrilzakka/clinical-trials huggingface dataset:
Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following Administration of Rotarix™

This study aims to evaluate the serologic response to PCV-1 in the serum samples previously collected during initiation of vaccination series of Human Rotavirus (HRV) vaccine studies (1-2 months post Dose 2 of HRV vaccine or placebo). Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.

Serum samples collected from 6 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.

Eligibility Criteria:
Inclusion Criteria:

Not applicable as no subjects will be actively enrolled in this study, only the sera samples of the subjects who were a part of previously conducted trials will be used for testing. However, the archived serum samples of only those subjects who satisfy the following criteria will be included in this study:

* Subjects who received two doses of HRV vaccine or Placebo and were included in the ATP cohort for immunogenicity in the primary studies listed.
* Subjects for whom their parents or Legally Acceptable Representatives (LARs) had agreed that their child or wards blood samples could be used for further research while giving consent for any of the primary studies listed.
* Subjects who have sufficient residual volume of serum samples at both pre- and post-vaccination time points.

Exclusion Criteria:

* Not Applicable
Risk Stratification for Abdominal Emergency Surgery: a Cohort Study

The goal of this retrospective observational study is to identify risk factors of unwanted outcomes (in-hospital morbidity and mortality) among patients undergoing emergency abdominal surgery.

Patients undergoing emergency abdominal surgery at a single tertiary care institution with a high volume of emergency abdominal surgeries, especially for high-acuity patients, between January 1, 2023, and June 1, 2024, will be included. Baseline demographics, indication for surgery, and preoperative status (respiratory support, cardiovascular stability, Glasgow score, SOFA score, preoperative lab results, and preoperative waiting time including Time to Theatre (TTT) and Time to Knife (TTK)) will be recorded.

Definitions:

Time to Theatre (TTT): The duration from when it is determined that the patient needs surgery to the time the patient arrives at the operating theatre.

Time to Knife (TTK): The duration from when the patient enters the operating theatre to the time the first incision is made.

These data will be retrieved from the electronic health record system.

Intraoperative factors, including ASA classification, anesthesia method, type of surgical intervention, intraoperative lab results, transfusions, input/output (I/O), inotropic/vasopressor usage, and discharge ward, will also be retrieved from the electronic health record system. Postoperative outcomes, including in-hospital mortality and morbidity (complications stratified by the Clavien-Dindo classification system), will be assessed by trained investigators. Secondary outcomes include postoperative length of hospital stay and health care costs.

A statistical model will be built to identify risk factors for morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing emergency abdominal surgery at a single tertiary care institution between January 1, 2023, and June 1, 2024

Exclusion Criteria:

Repeated surgery for the same patients
Natural History Study of ATP1A3-related Disease

An observational study aiming to study the natural history of a UK-wide patient cohort with ATP1A3-related disease.

Alternating hemiplegia of childhood (AHC) is a rare very disabling neurodevelopmental syndrome caused by mutations in the gene ATP1A3. AHC is characterized by paroxysmal events including attacks of hemiplegia (weakness), dystonia (painful stiffening), oculomotor abnormalities and epileptic seizures. As the condition progresses permanent neurological symptoms, including unsteadiness and learning problems, emerge. Mutations in ATP1A3 also cause other related syndromes: rapid-onset dystonia-parkinsonism (RDP), less severe and usually presenting in adulthood, as well as cerebellar ataxia, areflexia, pes cavus, optic atrophy, and sensorineural hearing loss (CAPOS) syndrome, a severe syndrome of early childhood.

Currently therapeutic options are very limited aiming at symptomatic relief with limited success. As ATP1A3-related syndromes are very rare diseases, with an estimated prevalence of about 1/1000000, randomised clinical trials of available therapies are not possible due to lack of a large enough patient cohort. However, the revolution in genetic diagnostics has made the identification of these patients and the correlation between their phenotypes possible. At the same time further novel technologies in neuromonitoring and neuroimaging, as well as videography and sleep monitoring have become available that could help us further examine and understand the underlying mechanisms especially of the paroxysmal episodes that characterise all ATP1A3-related syndromes. The investigators believe that based on these scientific advances they will be able to recruit a UK-wide patient cohort to conduct an in depth study of the progression of this disease.

This is particularly relevant at the moment as rapid progress in genetic therapies and other novel therapeutics makes the availability of new treatment options in the near future a realistic prospect and, even though we will most probably still not be able to identify a large enough cohort for randomised clinical trials, our natural history study will act as a much needed benchmark to which the success of novel treatments can be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Children and adults of any age carrying a mutation in the ATP1A3-gene.
* Children and adults of any age matching an ATP1A3-related disease phenotype without a mutation in the gene.
* Written informed consent given by patient and/or parent/guardian.

Exclusion Criteria:

• Patients with a phenotype not fitting ATP1A3-related disease and no mutation in the ATP1A3 gene.
Humoral and Cellular Immunity in First-cycle SARS-CoV-2 Vaccinated COVID-19 Patients

Infection by the recent Coronavirus (SARS-CoV-2) has generated at a pandemic level a new pathology, called COVID-19, characterized by "flu-like" symptoms up to severe acute respiratory failure. The pathogenesis of the disease involves both humoral and cellular immunological responses; cell-mediated immunity is the first and most effective immune response to viral infection. To date, despite the extensive scientific research aimed at curing COVID-19, there are few effective means to tackle SARS-CoV-2 infection and reduce its disease progression. Among these, a first complete anti-SARS-CoV-2 vaccination course has been shown to significantly reduce the development of the disease towards the more severe forms requiring hospital and intensive care. On the other hand, over time the antibody response induced by vaccines against SARS-CoV-2 decreases, so much so as to indicate the need for a third booster dose. This translates into the fact that some patients who have undergone a complete first vaccination course, with third dose booster indications, develop severe critical disease, with the need for hospitalization. On the other hand, other patients with the same vaccination status do not develop the disease, although they are also positive for SARS-CoV-2. The investigators therefore hypothesized that the humoral and cell-mediated response among groups of patients may be radically different. For these reasons, the investigators designed this observational pilot study in order to analyze humoral and cell-mediated responses in SARS-CoV-2 positive first complete vaccination patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a complete first-cycle vaccination against SARS-CoV-2 performed 4 to 7 months before.

Exclusion Criteria:

* Presence of malignancy under chemotherapy
* Patient with previous transplantation
* Patient receiving immuno-modulatory or immunosuppressive drugs
* Patient receiving corticosteroid therapy since more than 10 days
* Pregnancy
* Consent withdrawal
Investigating Stress-related Mechanisms in the Laboratory and Real World in Individuals With Cannabis Use Disorder

This research project proposes a novel approach to elucidate the biological adaptations associated with Cannabis Use Disorder and to assess whether such adaptations are predictive of higher drug craving in response to both drug cues and stressors in both the laboratory and real-world, and higher relapse risk and drug use in the real world.

The intent of this study is to recruit 25 treatment-seeking individuals with Cannabis Use Disorder (CUD) and 25 light users (\<1 joint/week) to complete three guided imagery conditions (stress, cannabis, neutral) in inpatient research units. During the guided imagery, repeated measurements of subjective (i.e., craving, negative affect), neuroendocrine (i.e., cortisol), and physiological variables (i.e., heart rate variability \[HRV\]) will be collected. Thereafter, individuals with CUD will begin one-month of drug counseling treatment coupled with surveys delivered via smartphones daily in the morning, evening, and at four random times during the day.

Eligibility Criteria:
Inclusion Criteria:

* Cannabis using men and women who:
* 1. Are fluent in English;
* 2. Are using cannabis at levels to match either of the two groups:

  a) Light Users: i. Cannabis using levels of \< 1 joint/week ii. Has never met DSM-5 criteria for CUD or other substance use disorders. b) Individuals with Cannabis Use Disorder: i. Meets criteria for CUD based on the SCID (≤ 2 symptoms in past year); ii. Has a past-year cannabis use pattern of ≤3 times per week; iii.Do not meet criteria for any other substance use disorders other than mild Alcohol Use Disorder.
* 3. Provide a negative breathalyzer for alcohol and only positive for cannabis use at all appointments;
* 4. Can provide written informed consent.

Exclusion Criteria:

* 1. Meets current or past DSM-5 criteria for Axis I for major psychiatric disorders, other than depression or anxiety disorder;
* 2. Meets criteria for a current Substance Use Disorder other than Cannabis or mild Alcohol Use Disorder;
* 3. Has any significant current medical conditions requiring medication, including neurological, renal, thyroid, cardiovascular, liver, endocrine, or immune conditions;
* 4. Reports current use of medications/drugs that interfere with HPA axis response,
* 5. Are women who are pregnant or lactating, are peri-/post-menopausal, or those with hysterectomies;
* 6. Report current use of psychotropic drugs other than antidepressants.
Study of Tipifarnib in Patients With High-Risk Myelodysplastic Syndrome (MDS)

The purpose of this study is to characterize the hematological response rate, as well as other parameters of efficacy and safety induced by tipifarnib in patients with high-risk myelodysplastic syndrome (MDS). Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make cancer cells grow.

Treatment with tipifarnib will be given during one or more periods of time called cycle(s). Each cycle will be 28 days long and patients will take tipifarnib for the first 21 days of each cycle. No medication will be taken during the last 7 days of each cycle. On day 1 and 15 of each cycle, patients will be asked about any side effects that have occurred since their last visit. Blood will drawn for routine testing to evaluate any possible effects of tipifarnib on white blood cells or on specific elements, that can be measured in the blood. The study doctor will decide if any bone marrow aspirates or biopsies should be taken. Tipifarnib will be given until the patient's disease worsens or they develop unacceptable side effects or until they withdraw consent to receive tipifarnib. When tipifarnib treatment is ended or if the patient leaves the study early, they will be asked to come in for a final visit. The study doctor will decide if any blood draws, bone marrow aspirates or biopsies need to be taken.

Tipifarnib is 300 mg administered orally as three 100 mg tablets twice daily for the first 21 days in each 28-day cycle. Tipifarnib will be administered until the patient discontinues treatment due to disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Pathological evidence of MDS
* Not more than 1 prior cytotoxic treatment for MDS
* Able to take oral study drug
* Able to understand and provide signed informed consent

Exclusion Criteria:

* Refractory anemia (RA) or RA with excess of blasts (RAEB) or patients with RAEB with \< or = 10% marrow blasts
* Treatment-related MDS, if treated with chemotherapy less than 3 years ago
* Not adequately recovered from any treatment-related non-hematological toxicity
* Refractory to platelet transfusion
* Candidates for hematopoietic stem cell transplantation
* Previous therapy with a farnesyl transferase inhibitor
* Prior extensive radiation therapy
Simultaneous Injection of Propofol and Rocuronium in Inducing General Anesthesia

This study is conducted to evaluate the efficacy of simultaneous injection of propofol and rocuronium in inducing general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective surgery requiring endotracheal intubation
* ASA I, II, and III
* above 20 years

Exclusion Criteria:

* refuse to enroll
* patients with risk of aspirating gastric contents
* patients in whom NMBs are contraindicated
* patients with predictors of difficult mask ventilation
Volume-outcome Relationship in Rectal Cancer Surgery

Hospital centralization effect is reported to lower complications and mortality especially for high risk and complex general surgery operations, including colorectal surgery. However, no linear relation between volume and outcome has been demonstrated. Aim of the study was to evaluate the increased surgical volume effect on early outcomes of patient undergoing restorative anterior rectal resection (ARR).


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of a cancer located in the rectum, defined according to the international definition by D'Souza et al.,
* elective setting
* anterior rectal resection with primary anastomosis (with or without diverting loop ileostomy).

Exclusion Criteria:

* age below age of 18,
* inflammatory bowel disease,
* acquired or congenital immunodeficiency,
* preoperative infection,
* pregnancy,
* ASA IV,
* presence of synchronous cancers,
* abdominoperineal resection (APR),
* failure to perform rectal resection and primary anastomosis,
* emergency setting.
Radial Artery Bypass Graft Study of Tromsø

The purpose of this study is to answer, among others, the following questions: 1) What are the outcomes when using the radial artery as a bypass graft in coronary artery bypass surgery (CABG)? 2) Can multidetector computed tomography (CT) be used to reliably evaluate coronary artery bypass graft patency?

Radial arteries have been used as aortocoronary conduits with varying results. The study is based on the first 119 patients operated with this graft at our institution, aiming to answer the following questions:

1. What is the short-term patency (2-3 years) of radial artery bypass grafts in CABG (comparisons are made with saphenous veins and internal thoracic artery grafts)?
2. What complications occur and what in what frequency?
3. What are the clinical outcomes and patient satisfaction after using radial arteries in CABG? (n=119 pt.)
4. Can multidetector CT be used to reliably evaluate coronary artery bypass graft patency? (n=45 pt.)

Methods: Questionnaires, record review, coronary angiography.

Eligibility Criteria:
Inclusion Criteria:

* Operated with radial artery coronary bypass at our department during April 2001 - October 2004
* Written informed consent

Exclusion Criteria:

* For the angiography procedures, standard contraindications are adhered to
Idebenone Treatment of Early Parkinson's Diseasesymptoms

On May 30,2018 ,Investigators intend to conduct a multicenter, randomized, double-blind, placebo-controlled study of idebenone in the treatment of early-stage Parkinson's disease with motor and non-motor symptoms which is to observe the therapeutic effect of idebenone on motor symptoms and non-motor symptoms in patients with early Parkinson's disease。

This clinical trail was a multicenter, parallel, randomized, double-blind, placebo-controlled study led by Professor Liu Chunfeng from the Second Affiliated Hospital of Suzhou University which consisted of 15 sub-centers with a total of 180 subjects.

This clinical study is divided into two phases:

The first stage: double-blind period, 24 weeks. Three queues containing idebenone 180 mg/d,360 mg/d and placebo.

The second stage: open label extension period, 24 weeks. All enrolled participants continued to take idebenone 180 mg/d to study the long-term effects of idebenone.

Eligibility Criteria:
Inclusion Criteria:

* (1) Male or female, age \> 30 years old, ≤ 80 years old;
* (2) Conforms to the "Diagnostic Criteria for Parkinson's Disease" developed by the 2015 International Association of Sports Disabilities (MDS);
* (3) Patients with early Parkinson's disease, duration \<3 years, Hoehn-Yahr classification:1-3, MMSE scale score ≥ 24 points;
* (4)Receiving a stable dose of dopamine agonist or monoamine oxidase type B inhibitor for treatment before the enrollment;
* (5) The subjects need to sign the Informed Consent Form（ICF）

Exclusion Criteria:

* (1)Patients with disturbance of consciousness, aphasia and mental illness; patients with major depression (HAD scale score ≥ 15 points)
* (2)Patients with Parkinson's superimposition syndrome and patients with secondary Parkinson's syndrome (hepatolenticular degeneration, hepatic encephalopathy, cerebellar disease, hydrocephalus, parathyroid disease, etc.)
* (3)Patients who have long-term use of dopamine blockers (such as potent neuroleptics, sibutramine, reserpine, metoclopramide, etc.);
* (4)Patients who have taken coenzyme Q10 or idebenone within three months;
* (5) Patients taking amantadine and levodopa need to stop taking the drug for more than one month before the enrollment;
* (6)Patients with severe cardiopulmonary dysfunction, liver and kidney dysfunction (more than 3 times normal);
* (7)Patients who cannot cooperate with the neuropsychological test;
* (8) Patients with poor compliance, not following the prescribed treatment regimen.
Brain GABA Levels and Treatment Response in Major Depressive Disorder

This study will evaluate changes in brain gamma-aminobutyric acid (GABA) levels due to treatment with escitalopram in people with major depressive disorder.

Major depressive disorder (MDD) is a severe form of depression. MDD can significantly interfere with an individual's thoughts, behavior, mood, and physical health. People who suffer from MDD often experience feelings of worthlessness; they may feel hopeless and may be unable to cope with problems in their life. In addition, they often experience sleep disruption, loss of appetite, and chronic pain.

The purpose of the study is to compare images taken of the brains of people who are depressed and the brains of healthy volunteers. Specifically, we want to see if symptoms of depression are related to a decrease in a brain chemical called GABA. We measure the concentration of GABA using a brain-scanning device called "magnetic resonance spectroscopy" (or "MRS"), which is a type of MRI.

The study lasts for 14 weeks and involves 8 visits to our MGH clinic in Boston. The first visit is the screening visit, which can last up to 3 hours. The rest of the visits are about a half hour long and take place every other week. In addition to these 8 visits, there are also 2 visits to McLean Hospital Brain Imaging Center for the MRS scans. The first scan takes place within a few days after the screening visit, and the second scan will be at the end of the 14 weeks. Each scan visit lasts between an hour and a half and two hours. Subjects are reimbursed $50 per MRS scan and $25 per visit to McLean to cover travel costs.

All subjects in this study will receive escitalopram (or Lexapro), which is an antidepressant medication approved by the Food and Drug Administration. Subjects start at 10 mg daily of the escitalopram, but may be increased up to 30 mg if the study doctor thinks it is appropriate.

Eligibility Criteria:
Inclusion Criteria:

* Meet diagnostic criteria for current Major Depressive Disorder
* Men or women aged 18-65
* Medication-free for one week prior to the start of the study
* Agrees to use an effective form of contraception throughout the study

Exclusion Criteria:

* Anyone who is suicidal
* Pregnant or breastfeeding women
* Anyone with a serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
* Anyone with a history of seizure disorder or hypothyroidism
* Anyone with a history of psychiatric disorders including bipolar disorder, schizophrenia, psychoses, or substance abuse (including alcohol abuse active within the last 12 months)
* Anyone with a history of intolerance or multiple adverse drug reactions or allergy to (es)citalopram.
* Patients who are currently taking medications active on GABA, including benzodiazepines.