cyrilzakka/clinical-trials huggingface dataset:
Investigating the Effect of Dronabinol on Post-surgical Pain

This study is designed to investigate the effect of dronabinol on post operative pain in patients undergoing total knee replacement (for their own clinical care).

Total knee replacement is a common surgical procedure that restores function to the damaged joint. Recovery from this procedure takes weeks and requires opioids to manage post-surgical pain. The goal of this study is to investigate whether dronabinol (synthetic THC) can reduce pain and the need for opioid medication following this particular surgery.

Subjects will be recruited from the Department of Orthopedic Surgery. All subjects will undergo total knee replacement as part of their clinical care (the surgery itself is not part of this study). The study begins following discharge from the hospital. They will be asked to take dronabinol or placebo as they recover from surgery. During this time they will be given their usual pain medications at discharge which includes opioids for pain. The opioids are to be taken if the subject is experiencing pain. The investigator's hypothesis is that subjects taking dronabinol will need fewer doses of opioids to control pain.

Eligibility Criteria:
Inclusion Criteria:

* Participants undergoing total knee arthroplasty (TKA) at the CUIMC department of orthopedic surgery as part of their clinical care.
* Able to give informed consent and comply with study procedures in English

Exclusion Criteria:

* Meet DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, or psychosis. Subjects with a current substance use disorder will be excluded. Subjects with a past cannabis use disorder are excluded.
* Diagnosis of a major medical or neurological disorder, including orthostatic hypertension, cardiovascular disease (congestive heart failure, unstable angina, or a history of cardiac infarction), hypotension, or neurodegenerative disorders.
* Subjects taking medications that can lead to a drug interaction.
Safety and Efficacy Study of Bimatoprost/Timolol Fixed Combination in Patients Wtih Glaucoma or Ocular Hypertension

The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed Combination in the treatment of glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes
* Patient needs IOP-lowering drug in both eyes

Exclusion Criteria:

* Uncontrolled medical condition
* Contraindication to beta-adrenoceptor antagonist therapy
Effectiveness of Docusate in Preventing/Treating Constipation in Palliative Care Patients

The purpose of this study is to determine if docusate is effective in the treatment of constipation in palliative care patients.

Palliative patients frequently experience constipation due to multiple factors - structural abnormalities, medications, metabolic disturbances, neurological disorders, and other general conditions. Docusate is a stool softener that has been widely used, in combination with other stimulating laxatives, to prevent and treat constipation in palliative care patients. In the past decade there has been controversy about its effectiveness in these populations, but no controlled trials have been conducted on the use of docusate in palliative patients. The purpose of this study is to assess the effectiveness of docusate in preventing and treating constipation in palliative care patients. The study design is a randomized, double-blind, placebo-controlled trial to compare the current standard treatment (docusate in combination with a laxative, sennoside) to that of a sennoside laxative alone. A total of 70 patients (35 in each group) will be recruited from the Palliative Care Unit at St. Joseph's Auxiliary Care Hospital, the Mel Miller Hospice at the Edmonton General Continuing Care Hospital, and CapitalCare Norwood in Edmonton, Alberta, Canada. Patients must be ≥ 18 years of age, able to take oral medication, without difficulty swallowing, have a palliative performance ≥ 20%, and do not have a stoma. The duration of treatment will be for 10 days. The main outcome measures will include bowel frequency, stool consistency, other interventions (suppositories, enemas), difficulty defecating, and sense of inability to evacuate completely. This study will provide insight into the effectiveness of docusate in preventing and treating constipation in palliative patients who are cared for by family physicians and specialized palliative care providers. If docusate is found to have no added benefit,it has the potential to enhance the quality of life for palliative care patients by reducing the number of medications taken and reducing the palliative care team's (e.g. nursing) workload and cost.

Eligibility Criteria:
Inclusion Criteria:

* greater than or equal to 18 years of age
* new admissions
* able to take oral medications
* patient and/or personal directive agent (proxy) provides written consent
* does not have a stoma
* no difficulty swallowing
* no previous intolerance/contraindications to docusate
* palliative performance greater than or equal to 20%

Exclusion Criteria:

* less than 18 years of age
* failing to provide consent
* unable to take oral medication/difficulty swallowing
* previous intolerance/contraindications to docusate (Colace)
* patients who have a stoma
* palliative performance status \< 20%
Dexmedetomidine in Off Pump Coronary Artery Bypass Grafting

the study will assess the impact of intraoperative dexmedetomidine infusion on myocardial performance by investigating the left ventricular (LV) systolic and diastolic function and right ventricular (RV) fraction area change (which reflect RV systolic function) using two-dimensional trans-esophageal echocardiography (TEE) in patients undergoing elective first-time isolated off-pump coronary artery bypass (OPCAB) grafting. LV Systolic function will be measured by the TEE via the fractional area change, fraction shortening, and ejection fraction.

Off pump coronary revascularization is an old technique performed first in St Petersburg in 1964, Off pump coronary artery surgery has been developed following two different approaches. Minimally invasive direct-access coronary artery bypass (MIDCAB) that consists of anastomosing the left internal mammary artery to the left anterior descending coronary artery through small anterior left thoracotomy, The second approach is multi-vessel grafting without CPB performed through standard median sternotomy. Dexmedetomidine (Dex), a highly selective α2-adrenergic receptor agonist, is widely used for sedation and analgesia in the ICU or as an anesthetic adjuvant.

This study will be a prospective comparative controlled randomized double blinded clinical trial on 36 patients divided into control ,and dexmedetomidine group.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective first-time off-pump isolated coronary artery bypass graft (OPCAB) surgery
* Patients with good ventricular functions.
* Patients with normal levels of cardiac troponin I and myocardial enzymes
* Patients of Body Mass Index (BMI) more than 20 and less than 34.

Exclusion Criteria:

* Severe functional liver or kidney disease.
* Diagnosed HF (NYHA class \>3).
* Arrhythmia or received treatment with anti-arrhythmic drugs.
* Severe bradycardia (HR \< 45 bpm) and AV block.
* Pathologic esophageal lesion (esophageal stricture or varix )
* Pregnancy.
A Multicenter, Open-Label, Non-Inferiority Randomized Controlled Trial of Postoperative VTE Prevention in Chinese Patients After Colorectal Cancer Surgery

research objective

1. Optimize VTE prevention management after CRC surgery.
2. Improve the prevention and treatment level of VTE in current perioperative patients.
3. Reduce the social burden of VTE related diseases.

Participants will:

1. start low molecular weight heparin prophylaxis within 24 hours post-surgery.
2. The prophylactic regimen for the experimental group lasted 14 days, while the control group received it for 28 days. Low molecular weight heparin is given subcutaneously at a dose of 0.3ml once daily.
3. atients underwent lower limb color Doppler ultrasound on postoperative days 7 ± 2, 14 ± 3, and 28 ± 5, which included screening for thrombosis in the proximal deep veins (femoral, popliteal), distal deep veins (posterior tibial, fibular, and muscular veins), and their perforating branches.


Eligibility Criteria:
Inclusion Criteria:

* Age\&gt;18 years old; Diagnosed with colorectal cancer and undergoing curative, palliative, or other limited surgeries (laparoscopic or open surgery), with an estimated surgery time of\&gt;45 minutes; Expected postoperative survival\&gt;6 months; Expected Caprini score of ≥ 5 on the first day after surgery; The patient agrees to the research plan and signs an informed consent form.

Exclusion Criteria:

* Renal dysfunction (CrCl\&lt;30 mL/min) or liver dysfunction (ALT\&gt;3 times the upper limit of normal); Known allergies to LMWH, anesthetics, or contrast agents; There is a systemic bleeding disorder or bleeding tendency, such as active peptic ulcer, uncontrolled hypertension, cerebral thrombosis within 6 months, cerebral hemorrhage, or a history of neurosurgical surgery; Known brain metastases, endocarditis, or previous heparin induced thrombocytopenia; VTE occurred within 3 months before surgery; Use heparin or oral anticoagulant therapy within 5 days before surgery; Pregnant or lactating women; Pregnant or lactating women; Any conditions that researcher determines the subject not suitable for anticoagulant therapy.
Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence in Lung Cancers

A tumoral obstruction of the main stem bronchus is frequently observed in the follow-up of lung cancers with a high impact on survival and quality of life of these patients. The endoluminal resection of these tumors through interventional bronchoscopy can remove the tumor but fails to prevent the recurrence. A stent insertion could achieve this goal but this option was never proved in a prospective protocol.

The aim of this study is to analyze the impact of stent insertion on the survival without symptoms of bronchial obstruction in patients treated for their cancer with and without a first line treatment (chemo-radiotherapy or chemotherapy). The patients will be included after resection of the endoluminal symptomatic tumoral obstruction. We will test the effect of the silicone stent insertion ( from NovatechR ) by comparing a stent arm (170 patients with stent insertion) with a control arm (170 patients without stent). The inclusion period will last 3 years with one year of follow-up for each patient. The one-year survival without symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone) will be the main endpoint. All patients without symptomatic recurrence at one year will be controlled endoscopically. Survival and stent tolerance will be studied as secondary endpoints. All endoscopic events will be depicted on photographs or videos. Each endoscopical situation (before and after resection, recurrence or side effects of stents) will be analyzed and registered by an independent committee of 3 international experts.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* non-small cell lung cancer,
* inoperable and location : tracheal, carinal, main bronchus right or left, or intermediate trunk.
* TNM stage known and oncological treatment later determined
* central initial intrinsic bronchial obstruction \> 50%.
* resection of tumor with endoscopy, to obtain after therapeutic bronchoscopy a diameter \> 50% normal diameter of bronchial segment achieved.
* Tumoral segment fully recoverable by a stent
* Written consent, free and informed
* Patient affiliated or who is entitled to to a social security scheme.

Exclusion Criteria:

* against-indication for general anesthesia.
* Patient with one lung not working beyond the stenosis
* Patient under guardianship
* Pregnancy
* 12 months follow-up impossible
Hypertension Registry of "Hypertension Prevention and Control Initiative in China"

Hypertension is the leading preventable risk factor of cardiovascular disease globally and in China. Unparalleled to remarkable increase of hypertension burden in China, blood pressure(BP) control is inadequate. A political public health project, "Hypertension Prevention and Control Initiative in China(Chronic Disease Demonstration District Construction)", was initiated in October 2019 for explore a feasible and reproducible archetype for hypertension management and to improve the registration, management, treatment and control rates of hypertension in China. The project is designed to consecutively implement health service strategies in 40 pilot counties covering 31 provinces and around 200,000 hypertension patients in mainland China, via the National Medical Alliance for Hypertension(NMAH). The Hypertension Registry study aims to registry, follow up and observe the clinical features, treatment, blood pressure control and outcomes of all hypertension patients managed in the "Hypertension Prevention and Control Initiative in China" project.

Objective: The study aims to investigate the clinical features, treatment, blood pressure control and outcomes of hypertension patients managed in the "Hypertension Prevention and Control Initiative in China" project.

Study Type: A national, multicenter, observational, prospective cohort study.

Study Design: The cardinal contents of this registry study are as follows:

Introduce the Digital Information System and train in completing case report forms.

Collect sociodemographic information, lifestyle behaviors, self-reported personal medical history, BP, anthropometric measurements, medication at registration, laboratory investigations of hypertension patients managed in the "Hypertension Prevention and Control Initiative in China" project. Build a baseline database of hypertension patients.

Gather the follow up information including general, clinical, therapeutic, prognostic data of all recruits at 3-month intervals over 2 years and build up the follow-up database.

Data management, quality control and statistic analysis: Digital Information Platform for data capture, document and cloud computing has been built and the investigators will manage and analyze data in align with key indicators. The investigators have invited professional statistic analysts to assist analyzing data and a third party to supervise data quality.

Ethics: The Ethics Committee of Fuwai Hospital approved this study. Informed consents before patient enrollment are required.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Residing in the local administrative area for at least 6 months.
3. Hypertension：defined as systolic blood pressure (SBP) ≥140 mmHg and/or /diastolic blood pressure (DBP) ≥90 mmHg and/or use of antihypertensive medication within two weeks.
4. Informed consent.

Exclusion Criteria:

1. patients under pregnancy or lactation.
2. patients with severe liver or renal diseases.
3. patients with history of malignant tumor.
4. patients with mental illness that impair their consent.
SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy

This PAS is an observational, non-randomized, multi-center, single arm, clinical study to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve (15 AHPJ-505) as a replacement device for pediatric patients with a diseased, damaged, or malfunctioning aortic valve.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for prospectively enrolled subjects

  * Subject's legal guardian must provide written informed consent prior to any clinical study related procedure.
  * Subject requires aortic valve replacement and is intended to be implanted with a 15mm SJM15 AHPJ-505 MHV as determined by the implanting physician in accordance with the Instructions for Use.
  * The legal guardian and site agree to follow the subject per the assessment schedule and complete all required assessments per this protocol for the duration of the clinical study.
* Inclusion criteria for retrospectively enrolled subjects :

In an effort to ensure data on all real-world use conditions are consistently collected and reported on, a subject is eligible to participate in this post-approval study if he/she meets all of the following inclusion criteria and meets no exclusion criterion. For those subjects with a previous implant attempt to be eligible for study participation, the following inclusion criteria must be met:

* Echocardiography data at a time point greater than 90 days is available or may be acquired.
* An implant was attempted with the 15mm MHV, where implant attempt is defined as the device physically contacting the subject's cardiac anatomy.
* Either:
* For living subjects who already received the 15mm MHV, the legal guardian signs the study informed consent for this protocol allowing access to all relevant historical medical information, and complete all required assessments according to this protocol from the time of consent going forward (if applicable).

OR

* For subjects who are deceased or explanted, an implantation with 15mm MHV was attempted and the subject's legal guardian provides written informed consent for retrospective data collection of patient and study valve related information through death or explant of the study device.

Exclusion Criteria:

* Exclusion criteria for prospectively enrolled subjects:

Subject has a contraindication to anticoagulant/antiplatelet medication.

* Exclusion criteria of retrospectively enrolled subjects: None
Cheese Intake,CLA and Hypercholesterolemia

In this study the investigators aimed at verifying whether consumption of a sheep cheese, naturally enriched in ALA, CLA and VA, would modify the plasma lipid and endocannabinoid profiles in mild hypercholesterolemic subjects. This study was a 3-week, randomized, double blind, controlled, cross over clinical trial, conducted at the State Hospital Brotzu in Cagliari, Italy. The subjects were randomly assigned to eat 90g/d of the control or enriched cheese for 3 weeks, with a cross over after 3 weeks of washout.


Eligibility Criteria:
Inclusion Criteria:

* Adult volunteers with diagnosed mild hypercholesterolemia (total cholesterol 220-290 mg/dL)

Exclusion Criteria:

* Pregnant (or those planning to become pregnant during the study period) and lactating women
* Also individuals with a self-reported history of diabetes, inflammatory bowel disease, pancreatitis, gallbladder or biliary disease in the past 12 months, and lactose intolerance before the screening visit.
* Those with a history of cancer (except non-melanoma skin cancer) in the 2 years before screening, or of any major trauma or surgical event within 3 months before screening.
* Volunteers with the following characteristics were also excluded:

  * total cholesterol ≥300 mg/dL, serum triglycerides ≥250 mg/dL or ≤ 200 mg/dL, \*HDL ≥70mg/dL, BMI ≥ 30
  * uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at screening.
* Use of lipid-altering medications or supplements, and of anticoagulants, during the 2 weeks before screening and throughout the study was prohibited.
* Furthermore, we selected subjects with an Apo E aplotype 3/3, the most common in Sardinia, in order to avoid any variability in cholesterolemia due to a different dietary response.
MRI Screening for Auditory Pathway Malformations in Visually Impaired Children

This pilot study aims to assess the interest to add an auditory pathway morphological analysis during the MRI exploration of visual pathway in visually impaired children.


Eligibility Criteria:
Inclusion Criteria:

* age \< 18 years old
* visual impairment
* MRI scheduled to explore their visual impairment
* parents' informed consent for participation in the study

Exclusion Criteria:

* tumoral origin for the visual impairment
* no health insurance coverage
Operative vs. Conservative Treatment of Distal Radius Fractures

Even though broken wrists are of frequent occurrence, the investigators see a lack of extensive and well executed international studies to clarify which is the best treatment for elderly participants at 65+ years. The Danish Health and Medicines Authority recommend that broken wrists are treated with surgery by using plates and screws when certain radiological criteria are met. Recent studies show that, apparently, there are no advantages by operating rather than treating with plaster when comparing the functional results after one year. However, there is a 30 % risk of serious complications occurring after surgery. This study will examine the pros and cons that participants at 65+ years with broken wrists experience after, by lot, having been treated with either surgery (using plates and screws) or without surgery (using plaster for 5 weeks). The purpose of this study is to compare the complications and level of functioning between participants treated with surgery and without surgery.


Eligibility Criteria:
Inclusion Criteria:

* Danish National Guidelines for operative treatment of distal radius fractures

Exclusion Criteria:

* Patients treated with plaster in Arm1/control group who unexpectedly requires surgery
Broad Band Emission LED Phototherapy Source Versus Narrow Band

Phototherapy is the most frequently used treatment in neonatology when serum bilirubin levels exceed physiological limits. Light-emitting diodes (LEDs) are become routinely used for phototherapy in neonates with hyperbilirubinemia. Blue LED light with peak emission around 460 nm is regarded as the most suitable light sources for phototherapy and they recommended by most neonatal guidelines. However, the effectiveness of phototherapy with narrow-band LED light sources can be increased by expanding the spectral range of incident radiation within the absorption of bilirubin due to the strongly marked heterogeneity absorption properties of bilirubin in a different microenvironment. Longer wavelength light, such as green light, is expected to penetrate the infant's skin deeper. It is still controversial whether the use of green light has any advantage over blue light. The most effective and safest light source and the optimal method to evaluate phototherapy, however, remain unknown.The aim of this study was to compare, at equal light irradiance, the clinical efficacy of broad spectrum blue- green LED with blue narrow spectral band phototherapy device.


Eligibility Criteria:
Inclusion Criteria:

* non-haemolytic hyperbilirubinaemia, but otherwise healthy, indications for phototherapy based on NICE criteria, gestational age ≥33 weeks, birth weight ≥1800 g, postnatal age \>24 hrs and ≤14 days

Exclusion Criteria:

* hemolytic jaundice, major congenital animalities and history of phototherapy. Infants with indication of intensive treatment double phototherapy were not included.