cyrilzakka/clinical-trials huggingface dataset:
A Cohort of Patients Undergoing Percutaneous Coronary Intervention

To investigate the risk factors involved in the occurrence and prognosis of the patients with acute coronary syndrome, patients undergoing percutaneous coronary intervention will be recruited and followed up for at least 2 years.

Patients with acute coronary syndrome undergoing percutaneous coronary intervention will be recruited and prospectively followed up for the incidence of major adverse cardiovascular events (MACE events), including all-cause mortality, cardiovascular mortality, ischemic stroke. Blood and fecal samples will be collected for further analysis. The basic and clinical information will be collected such as diagnosis, medical history, laboratory test results, therapy methods, prognosis and follow-up information. The risk factors involved in the occurrence and prognosis of acute coronary syndrome will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as acute coronary syndrome and needed to undergo percutaneous coronary intervention.
* \>18 years old.

Exclusion Criteria:

* With malignant tumors, acute infectious diseases and advanced liver diseases.
* Won't sign an inform consent.
Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD

The purpose of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with PTSD.

The main question it aims to answer is: Do two open-label sessions of MDMA-assisted therapy reduce PTSD symptoms?

Participants will undergo three non-drug preparatory therapy sessions followed by two open-label MDMA-assisted therapy sessions. After, participants will undergo three non-drug integrative therapy sessions.

This Phase 2, open-label study will provide supportive data on the safety and effectiveness of MDMA-assisted therapy in participants with PTSD. This study will be conducted at a single study site in Vancouver, BC. There will be at least 2 co-therapy pairs. The study will enroll up to 20 participants.

The Preparatory Period will consist of three 90-minute non-drug preparatory therapy sessions. A flexible divided dose of MDMA will be administered during the Treatment Period with manualized therapy in up to two open-label experimental sessions. During the Treatment Period, each experimental session is followed by three 90-minute non-drug integrative therapy sessions. The experimental sessions are scheduled roughly 3 to 5 weeks apart.

Eligibility Criteria:
Inclusion Criteria:

* Are at least 18 years old.
* Are fluent in speaking and reading a recognized language of the study site.
* Are able to swallow pills.
* Agree to have study visits recorded, including Study Drug Sessions and non-drug therapy sessions.
* Must provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
* Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
* If of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session.
* Must not participate in any other interventional clinical trials during the duration of the study, and commit to medication dosing, therapy, and study procedures.
* At baseline, have moderate PTSD diagnosis.

Exclusion Criteria:

* Are not able to give adequate informed consent.
* Have uncontrolled hypertension.
* Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds \[ms\] in males and\>460 ms in females corrected by Friderica's formula).
* Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
* Have evidence or history of significant medical disorders.
* Have symptomatic liver disease.
* Have history of hyponatremia or hyperthermia.
* Weigh less than 48 kilograms (kg).
* Are pregnant or nursing, or are of childbearing potential and are not practicing an effective means of birth control.
* Have current alcohol or substance use disorders.
Optimization of Systemic Treatment Strategies in Elderly Patients With Advanced Solid Malignancies

The purpose of this study is to assess whether the presence of a Myelodysplastic Syndrome (MDS) , Idiopathic Cytopenia of Undetermined Significance (ICUS) or Idiopathic Dysplasia of Undetermined Significance (IDUS), correlates with treatment intensity and clinical outcome in older patients with advanced malignancies receiving palliative chemotherapy. We will study the relation between sarcopenia, comprehensive geriatric assessment en pharmacokinetics with treatment related toxicity as well. We hypothesize that a standardized flow cytometry test to determine bone marrow capacity, a Comprehensive Geriatric Assessment and/or measurement of human body composition with computerized tomography will provide an accurate tool to optimize treatment strategies in elderly patients with advanced malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 70 years
* Diagnosis of advanced cancer of colorectum, breast or prostate
* Standard first line palliative treatment with cytotoxic agents will be started (Folfox, Xelox, capecitabine, paclitaxel or docetaxel)
* Estimated life expectancy ≥ 3 months
* Able to give informed consent
* WHO performance status ≤ 2
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the treatment and follow-up schedule; those conditions should be assessed with the patient before registration in the trial
* No other severe medical or psychiatric conditions that in the judgment of the investigator renders the patient inappropriate for inclusion in this study.
* Before patient registration, written informed consent must be given and documented to ICH/EUCGCP, national/local regulatory requirements and the local rules followed in our institution

Exclusion Criteria:

* Presence of cytopenia due to iron-, vitamin B12 and folic acid deficiency or hemolysis, unless adequately supplemented.
* Creatinine clearance ≤ 30 ml/min
* Serum AST and ALT ≥ 2.5 x ULN, in case of liver metastases serum AST and ALT ≥ 5 x ULN
* In case of therapy with Docetaxel/Paclitaxel serum bilirubin ≥ 1.5 x ULN
Does ESPB Improve Postoperative Quality of Recovery After VATS

Video-Assisted Thoracoscopic Surgery (VATS) is a minimally invasive surgery. Despite reduced surgical trauma compared to the traditional thoracotomy approach, pain control after VATS remains challenging. Regional analgesia may be a crucial component of multimodal postoperative pain management. The use of nerve blocks, such as the recently described erector spinae plane block (ESPB) has been shown in case reports to reduce pain and thus has the potential to improve patient recovery. This study aims to test the hypothesis that ultrasound-guided SPB would improve the quality of recovery after VATS by reducing acute postsurgical pain.

VATS is a minimally invasive surgical technique to remove intrathoracic lesions. VATS has become increasingly popular and gradually becoming the standard of care for lung surgery. Although acute pain after VATS is less than the traditional thoracotomy, patients still experience moderate amount of pain within the first 24 hours. However, the optimal regional analgesic technique for VATS procedures has not been established.

Thoracic epidural analgesia (TEA) and paravertebral block (PVB) have been tried to improve postoperative analgesia after VATS. Although TEA and PVB provides superior analgesia, these technologies accompanied by the rare but serious complications involving epidural hematoma, pneumothorax and total spinal anesthesia.

Erector spinae plane block (ESPB) is a novel and simple ultrasound-guided regional anesthetic technique, providing analgesia for the ipsilateral hemithorax. Ultrasound guidance is believed to improve peripheral and regional nerve block success rates and safety. ESPB is a technically easy to perform. ESPB has only been reported in case series but so far, no adverse events such as hypotension, hematoma or infection has been reported.

Given its safety, ease of performance and efficacy, the study aims to verify the hypothesis that combines ESPB with general anesthesia would accelerate functional recovery after breast cancer surgery. Our secondary aims were to examine ESPB's effect on analgesic outcomes (e.g., postoperative pain intensity, cumulative opioid consumption, postoperative nausea and vomiting, dizziness, the postanesthesia care unit discharge time and patients' satisfaction) in patients undergoing VATS.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists' physical status class of I or II
* scheduled for elective VATS

Exclusion Criteria:

* a history of allergy to local anesthetics
* known coagulation disorders
* infection near the puncture site
* chronic opioid use
* inability to communicate,
* other reasons that not appropriate for this study.
The Acute Effects of Combined Caffeine and Sodium Bicarbonate Consumption on Isometric Mid-thigh Pull

The aim of this study was to investigate the effects of isolated and combined caffeine and sodium bicarbonate consumption on acute isometric mid-thigh pull (IMTP) strength, and verify whether they are cumulative, neutral or subtractive.

Method: Nineteen Sport Sciences Faculty students (Age 23.6±1.6 years, height 171±9.4 cm, weight 64.3±9.6 kg, fat percentage 20.5±7.3 %, BMI 21.7±2.4 kg/m2) participated and completed the intervention. This study was designed as crossover, double-blind and placebo-controlled. Subjects participated under 5 crossover conditions: control (without supplement) (Con), placebo (Pla), caffeine (Caf), sodium bicarbonate (NaHCO3) and caffeine+sodium bicarbonate (Caf+NaHCO3). For Caf conditions, participants consumed 6 mg/kg of caffeine, obtained from dosing the content of 200 mg capsules. As for NaHCO3 conditions, participants consumed 0.3 g/kg of sodium bicarbonate dissolved in water. For the combined condition, (Caf+NaHCO3), intake was set at 6 mg of caffeine and 0.3 g of sodium bicarbonate per kilogram of body weight. All supplements were consumed 60 min before the tests. Two submaximal trials of IMTP were performed at increasing intensities for 5 seconds (approximately %40-60 and %60-80 of their individually perceived 1RM, respectively, with 60-second rest intervals).

Eligibility Criteria:
Inclusion Criteria:

* Being physically active and healthy
* Did not use ergogenic supplements in the last 3 months
* Did not consume high doses of caffeine (≤120-170 mg/d) were included in this study

Exclusion Criteria:

* Actively using supplements
* Did not perform maximal effort during performance tests
* Not using the supplements in the correct dose or vomiting after use
Surgical Treatment of Hilar Cholangiocarcinoma: Minor or Major Liver Resection?

The investigators conducted a prospective study to determine the safety and efficacy of minor and major hepatectomy selected by predetermined criteria in 138 patients with hilar cholangiocarcinoma. In selected patients, minor liver resection was a good treatment.

Objective: To determine the safety and efficacy of minor and major hepatectomy selected by predetermined criteria in patients with hilar cholangiocarcinoma (HC).

Summary Background Data: For HC treated with hepatectomy, the extent of liver resection remains controversial despite extensive studies.

Methods: From January 2000 to December 2007, we prospectively studied patients who received surgical treatment for HC. Of the 187 patients who were surgically treated, 138 (73.8%) underwent resection with a curative intent. Minor hepatectomy was carried out in 93 patients who had Bismuth-Corlette types I, II and III HC without hepatic artery/portal vein invasion; and major hepatectomy in 45 patients who had type III HC with hepatic artery/portal vein invasion, or type IV HC.

Eligibility Criteria:
Inclusion Criteria:

* Criteria for resectability were absence of peritoneal or liver metastases, tumor extension to beyond secondary biliary branches bilaterally, tumor extension to secondary portal venous branches bilaterally

Exclusion Criteria:

* not in accordance with the above criteria
The Effect of TLR4 Inhibition in Obese and Type 2 Diabetic Subjects

To determine whether pharmacologic inhibition of Toll-like receptor 4 (TLR4) with eritoran for injection (E5564) will reduce inflammation and improve glucose metabolism in insulin resistant (obese and T2DM) subjects.

E5564 = Eritoran

Eligibility Criteria:
Inclusion Criteria:

* Subjects capable of giving informed consent.
* lean (BMI \<26 kg/m2) with normal glucose-tolerant subjects without a family history of type 2 DM
* obese (BMI 30-37 kg/m2) with normal glucose-tolerant subjects
* Type 2 DM subjects base on ADA criteria, who have HbA1c \<8.5% and control with diet or sulfonylureas.
* Both genders. (50% males)
* Age = 18-65 years. Older subjects are excluded because aging is a pro-inflammatory state.
* All ethnic groups
* Premenopausal women in the follicular phase, non-lactating, and with a negative pregnancy test. Postmenopausal women on stable dose of or not exposed to hormone replacement for \>=6 months.
* Lab: Hematocrit \>=34%, serum creatinine \<=1.4 mg/dL, normal electrolytes, urinalysis, and coagulation tests. Liver function tests up to 2x normal range.
* Stable body weight (+/-1%) for \>=3 months.
* One or less sessions of strenuous exercise/wk for last 6 months.

Exclusion Criteria:

* Current treatment with drugs known to affect glucose and lipid homeostasis. Subjects on a stable dose of statin (\>3 months) are eligible.
* Non-steroidal anti-inflammatory drugs or systemic steroid use for more than 1 week within 3 months.
* Current treatment with anticoagulants (warfarin). Aspirin (up to 325 mg) and clopidogrel will be permitted if these can be held for seven days prior to the biopsies.
* History of heart disease (New York Heart Classification greater than class II; more than non-specific ST-T wave changes on the ECG), peripheral vascular disease, pulmonary disease, smokers.
* Poorly controlled blood pressure (systolic BP\>160, diastolic BP\>90 mmHg).
* Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease.
A Study to Assess Infection Rate of Severe Acute Respiratory Syndrome - CoronaVirus 2 (SARS-CoV-2) and It's Affect on Quality of Life in Adult Volunteers in Lake County, Illinois

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to assess infection of SARS-CoV-2 and how quality of life is affected in adult volunteers in Lake County, Illinois.

Volunteers will be recruited through digital advertisements and participants will be required to fill an online questionnaire. Upon consent, participants will be required to provide nasal swab and blood sample. Approximately 1250 adult volunteers living or working in Lake County, IL will be enrolled.

Participants will be followed for approximately 9 months and will be required to provide nasal swab and blood samples every 3 months and complete questionnaires every 2 weeks.

There may be higher treatment burden for participants in this trial. Participants will be monitored by medical assessments, blood tests and questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Currently living or employed in Lake County, Illinois.
* Have regular access to computer, smartphone or tablet and sufficient internet access to connect to study platform.
* Willing and able to provide informed consent for collection of online data and of respiratory and blood specimens.
* Willing and able to follow the procedures of the study.
* Able to complete survey in English or Spanish.

Exclusion Criteria:

* Unable to provide informed consent.
* Unable to perform the requested study tasks and unable or unwilling to assign a proxy informant to complete the tasks.
* Hospitalized at the time of study enrollment.
Safety and Efficacy of AIN457 in Noninfectious Uveitis

This study was performed to evaluate the efficacy and safety of AIN457 for patients with active uveitis that requires systemic immunosuppression.


Eligibility Criteria:
Inclusion criteria:

* Active uveitis (i.e., uveitis that is not in remission).
* Intermediate uveitis, posterior uveitis, or panuveitis must be sufficiently severe that systemic immunosuppression is indicated.

Exclusion criteria:

* Active infection.
* Weight must not be greater that 120kg.

Other protocol-defined inclusion/exclusion criteria may apply
X-ray Guided Facet Block in Chronic Low Back Pain

Review outcome of injection of facet joint in chronic low back pain

Low back pain is a common problem that most people may experience. the incidence of low back pain is highest in the third decade and increases with age until the 60-65 year age group.

In the USA the prevalence of Low back pain is between 15 and 45%. Facet joint is the primary cause of pain in 10-15% of young adult patients with chronic low back pain.

Probable risk factors include genetic factors, age, smoking, heavy physical work, static work postures, lifting, vibration, obesity, and psychosocial factors.(2) Other Causes of low back pain include muscle and ligament strain, bulging or ruptured disc, arthritis, osteoporosis Treatment of chronic low back pain include pharmacological treatment, ,epidural steroid injection ,facet joint block and back surgery The facet joints are a set of plane types of synovial joints between the articular processes of two adjacent vertebrae, The lumbar facet joint is innervated by the medial branch from the posterior ramus of the lumbar spinal nerve.

Lumbar facet joint injections are performed by various techniques, including fluoroscopic-guided technique indications of diagnostic and therapeutic facet joint interventions

1. Average pain levels \> 5 on a scale of 0 to 10.
2. Contraindications or inability to undergo physical therapy or inability to tolerate oral medications.

Complications from facet joint injections in the lumbar spine are rare and mostly related to the needle placement and/or reactions to injected drugs.(3)

Eligibility Criteria:
Inclusion criteria:1-strong clinical suspicion of the facet syndrome,

2-Focal tenderness over the facet joints

3-Low back pain with normal radiological findings,

4-Post-laminectomy syndrome with no evidence of arachnoiditis or recurrent disc disease,

5-Persistent low back pain after lumbar spinal 6- Failed conservative treatment, including physical therapy with exercises, chiropractic management, and pharmacologic therapy

Exclusion Criteria:

- 1- Low back pain with abnormal radiological findings,

2-Post-laminectomy syndrome with evidence of arachnoiditis or recurrent disc disease,
Scandinavian Intensive Care Unit (ICU) Glutamine Study

This is a prospective double-blinded placebo-controlled block randomized study in intensive care patients comparing intravenous glutamine supplementation to placebo. The hypothesis is an improvement of clinical outcome. The primary endpoint is a reduction in the Sequential Organ Failure Assessment (SOFA) score on day 7 of treatment.

This is a prospective double-blinded placebo-controlled block randomised study in intensive care patients comparing intravenous glutamine supplementation (0.285 g/kg body weight/24 h) to placebo. Inclusion criteria are patients treated for more than 3 days. Primary endpoint is a reduction in SOFA-score on day 7 of treatments. Secondary endpoints are: ICU-mortality, 6-months mortality, length of ICU stay, organ failure free days as well as reduction in SOFA-score on day 10 of treatment. Nutrition will be standardised so that not less than 80% of the target which is basal energy expenditure according to Harris \& Benedict is given daily. Enteral nutrition is preferred, but a combination of enteral and parenteral nutrition is recommended to achieve the nutritional target. For statistical comparison non-parametric rank order statistics will be used. To detect a 0.75-point difference in the reduction of SOFA-score on day 7 of treatment, a total of 1,000 patients will be needed.

Eligibility Criteria:
Inclusion Criteria:

* admission to the ICU
* decision to give the patient full nutrition
* APACHE II score \> 10 at admission
* age 18-85 years

Exclusion Criteria:

* readmission to the ICU after a previous ICU-stay in which the patient has been included into the study
* subjects with any condition which in the opinion of the attending physician makes the subject unsuitable for inclusion
* no informed consent
A Study Of The Efficacy Of Gabapentin In Neuropathic Pain Patients As Measured By Quantitative Sensory Testing

The purpose of this study is to assess the reproducibility and the effect of gabapentin on quantitative sensory testing assessments in neuropathic pain subjects.


Eligibility Criteria:
Inclusion Criteria:

* Neuropathic pain of peripheral origin as a consequence of either post-herpetic neuralgia or post-traumatic neuropathic pain
* Well-defined skin area of mechanical allodynia to punctate (von Frey filament) stimuli
* Pain intensity score of ≥ 4/10 for von Frey filament-evoked allodynia at the skin area

Exclusion Criteria:

* Patients who have undergone neurolytic or neurosurgical therapy, including skin excisions, for neuropathic pain
* Patients who have trigeminal neuralgia, central pain, chronic radiculopathy, or peripheral neuropathy of non-mechanical or unknown origin
* Patients with any other co-existing pain which cannot be differentiated from the neuropathic pain of peripheral origin
A Phase 1 Study of RO6806127 in Healthy Male Volunteers

This two-part study will assess the safety and tolerability of single ascending oral doses of RO6806127 in a group of healthy male participants and investigate the effect of high fat and high caloric food on the relative bioavailability of a single oral dose of RO6806127 in a separate group of healthy male participants. The relationship between drug exposure and tolerability will be explored.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male participants aged 18 to 45 years, inclusive
* A BMI between 18 to 30 kg/m2, inclusive
* Agreement to use highly effective contraception

Exclusion Criteria:

* Clinically significant abnormalities in laboratory test results
* History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis
* Significant disorders of the central nervous system, including psychiatric disorders, behavioral disturbances, cerebrovascular events, depression, bipolar disorder, migraine, Parkinson, anxiety, any personal or familial history of seizures, epilepsy or other convulsive condition, previous significant head trauma, or other factors predisposing to seizures
* Use of any prohibited medications and food before study start and during the study
* Dietary restrictions that would prohibit the consumption of standardized meals