cyrilzakka/clinical-trials huggingface dataset:
Molecular Profiling of Advanced Biliary Tract Cancers

This is a study where fresh tumor tissue and blood samples will be collected from patients with advanced biliary tract cancer who will be undergoing 1st line therapy with gemcitabine or fluorouracil (5-FU) regimens to see how useful it is to look for changes and characteristics in genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour to find characteristics that may be useful in choosing treatments for patients in the future.

Changes (mutations) in genes have been shown to be an important characteristic in cancers. Looking at differences in genes in patients with unresectable or metastatic biliary tract cancer and comparing this information with response to their initial chemotherapy treatment may help to learn which treatments may be better for certain patients after initial treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a histological or radiological diagnosis of inoperable or metastatic biliary tract cancer (BTC).
* Patient must have a tumor lesion that is amenable to a core needle biopsy as judged by a staff radiologist.
* Patients must have a measurable lesion by RECIST 1.1 in addition to the lesion that is going to be biopsied.
* Patients must be fit enough to safely undergo a tumor biopsy as judged by the investigator.
* Eastern Cooperative Group (ECOG) performance status ≤ 1 (Karnofsky ≥60%).
* Life expectancy of greater than 90 days, as judged by the investigator.
* Within 14 days of the proposed biopsy date, patients must have normal organ and marrow function.
* Patients must undergo systemic treatment with gemcitabine or 5-FU based regimens as first line standard systemic palliative treatment with or without other investigational agents within a clinical trial.
* Ability to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Patients with one or more contraindications to tumor biopsy.
* Patients who have had prior systemic treatment (chemotherapy or any other anti-cancer agent) in the advanced setting.
* Patients who are currently on anti-cancer treatment including chemotherapy.
* Patients with known brain metastases are excluded from participation in this clinical study.
* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
The Efficacy of Lopinavir Plus Ritonavir and Arbidol Against Novel Coronavirus Infection

The study explores the efficacy of lopinavir plus ritonavir and arbidol in treating with novel coronavirus infection. As a result this study would provide evidence for the clinical usage of these drugs in the future .

This is a phase IV, open-labelled, randomized controlled clinical trial. A total of 125 cases who are novel coronavirus positive are planned to be recruited. These cases are randomized into 3 groups: in group A（Standard treatment+lopinavir/ritonavir）, 50 cases are given ordinary treatment plus a regimen of lopinavir (200mg) and ritonavir (50mg) (oral, q12h, every time 2 tablets of each, taking for 7-14 days). In group B（Standard treatment+arbidol） , 50 cases are given ordinary treatment plus a regimen of arbidol (100mg) (oral, tid, 200mg each time, taking for 7-14 days). In group C（Standard treatment）, 25 cases are only given ordinary treatment. The observation duration is 21 days. Patients will be followed up at baseline (day 0) and day 2, 4, 7, 10,14, 21 after receiving indicated treatment. The primary observed indicators include viral nucleic in acid nose / throat swab, body temperature, respiratory rate, oxygen saturation of blood, chest imaging. The secondary observed indicators include but not limited to blood pressure, heart rate, blood routine test, liver and kidney function, myocardial enzyme, flow cytometry classification and counting, cytokines, other infection indicators, conditions and parameters of auxiliary respiration, the total days in hospital, exacerbation and mortality.

Eligibility Criteria:
Inclusion Criteria:

* In sputum, throat swab, lower respiratory tract secretion, blood and other samples, the nucleic acid of the novel coronavirus was positive, or the sequencing of the virus gene was highly homologous with the known novel coronavirus
* Age is between 18-80 years old, the weight is more than 30kg, and there is no limit for men and women
* The following conditions were met: creatinine ≤ 110 umol / L, creatinine clearance rate (EGFR) ≥ 60 ml / min / 1.73m2, AST and ALT ≤ 5 × ULN, TBIL ≤ 2 × ULN;
* The subjects should fully understand the purpose, nature, method and possible reaction of the study, voluntarily participate in the study and sign the informed consent.

Exclusion Criteria:

* Have a clear history of lopinavir or ritonavir or arbidol allergy
* Severe nausea, vomiting, diarrhea and other clinical manifestations affect the oral or absorption of the drugs
* At the same time, take drugs that may interact with lopinavir or ritonavir or arbidol
* Patients with serious underlying diseases, including but not limited to heart disease (including history of angina pectoris or coronary heart disease or myocardial infarction, atrioventricular block), lung, kidney, liver malfunction and mental diseases that cannot be treated together
* ancreatitis or hemophilia
* Pregnant and lactating women
* Suspected or confirmed history of alcohol and drug abuse
* Participated in other drug trials in the past month
* The researchers judged that patients were not suitable for the study
Intraoperative Monitoring (IOM) Patient Registry

The primary objective of this study is to evaluate the rate of new or worsening neurologic deficits and/or radiculopathy following lumbar or cervical surgery in light of IOM using neurological testing (motor and sensory) in the optimal management of the surgical patient.

Prospective reports will be collected on approximately 10,000 patients undergoing lumbar or cervical spinal surgery using intraoperative monitoring. Patients will be enrolled in registry after signing informed consent. Data will be collected prior to surgery, during surgery, immediately following surgery and 4 to 6 weeks post surgery. The registry will serve as a database for surgeries using IOM.

Specific outcome measures will be: neurological assessment, length of hospital stay, pain intensity, and complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lumbar or cervical surgery
* Utilization of IOM
* Understand and sign informed consent

Exclusion Criteria:

* There are no specific exclusion criteria
Effect of Breathing and Muscle Relaxation Technique in Individual With Essential Hypertension

Primary hypertension, also called essential hypertension, is a rise in blood pressure (BP) with no identifiable cause. The most prevalent form of hypertension is essential hypertension, which involves 95% of patients with hypertension.Progressive muscle relaxation (PMR) is learning to relax some groups of muscles while paying attention to the feelings connected with both the tense and relaxed states.It is generally established that regular slow (deep) breathing exercises enhance respiratory and cardiovascular function by enhancing parasympathetic tone and reducing sympathetic activity, thus reducing BP, heart rate, respiratory rate, and stress levels in hypertensive patients. This study aimed to investigate the combined effect of slow breathing and PMR technique on BP, heart rate, respiratory rate, and anxiety in patients diagnosed with essential hypertension.

From the previously published literature, it is obvious that both slow breathing and PMR and slow breathing is effective in patients with essential hypertension. However, no studies are available on the combined effect of these two techniques. So, the study aims to investigate the combined effect of slow breathing and PMR technique on BP, heart rate, respiratory rate, and anxiety in patients diagnosed with essential hypertension.

Sixty-four participants diagnosed with essential hypertension were randomly allocated into four groups (Slow breathing (SB), PMR, SB+PMR, Control) with 16 subjects in each. Baseline BP, HR, RR and perceived stress scale were taken. All three-intervention groups underwent 30 minutes of training three days before the day of the intervention. The intervention consisted of 30 minutes, pre, mid and post-intervention BP, HR, RR and Perceived Stress (PS) were measured. The control group rested for 30 minutes. Pre, mid and post-rest measurements of BP, HR, RR and PS were taken.

Eligibility Criteria:
Inclusion Criteria:

* Participants with essential hypertension, a diastolic BP between 90 to 109mm of Hg, a systolic BP of more than 140mm of Hg,
* Aged between 30 to 60 years, and
* Self co-operation.

Exclusion Criteria:

* Participants with secondary hypertension, any physical abnormalities that may disturb the exercise intervention,
* Participant who cannot perform any relaxation or breathing exercises, and
* Non-cooperation of participants.
Risk Stratifying COPD Exacerbations

To identify clinical characteristics on presentation which predict differential outcomes in patients with exacerbation of COPD.

Exacerbations of COPD (ECOPD) are heterogenous but are often considered as a single clinical entity. Clinical characteristics on presentation may predict outcome of patients with ECOPD.

DECAF score was previously proposed to predict in-hospital mortality but has not been validated in Asian subjects. ROME classification was recently proposed to better risk stratify ECOPD according to symptoms, physiological parameters and laboratory findings on admission, but no prospective validation study is available so far.

This study aims to identify clinical characteristics on presentation to predict outcome of patients with ECOPD.

Eligibility Criteria:
Inclusion Criteria:

* Background history of COPD, defined by the GOLD 2023 guidelines
* Presented with exacerbation of COPD, defined by the GOLD 2023 guidelines
* Age \>= 18 years old
* Informed consent available

Exclusion Criteria:

* Age \< 18 years old
* No informed consent
EPOCH Chemotherapy +/- IL-12 for Previously Untreated and EPOCH Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma

The prognosis of AIDS-related Non-Hodgkin's lymphoma is poor, especially in the relapsed setting. There is no standard treatment, and the few small studies that have been conducted have reported dismal outcomes. The purpose of this study is to pilot the use of EPOCH plus rituximab in previously treated AIDS-related lymphoma. Clinical endpoints of the study include toxicity and response. Progression-free and overall survival will be measured. Tumors will be evaluated for p53 mutations, p-16, bcl-2 expression, tumor proliferation, c-myc and EBV when possible.

The prognosis of AIDS-related Non-Hodgkin's lymphoma is poor, especially in the relapsed setting. There is no standard treatment, and the few small studies that have been conducted have reported dismal outcomes. The purpose of this study is to pilot the use of EPOCH plus rituximab in previously treated AIDS-related lymphoma. Clinical endpoints of the study include toxicity and response. Progression-free and overall survival will be measured. Tumors will be evaluated for p53 mutations, p-16, bcl-2 expression, tumor proliferation, c-myc and EBV when possible.

Eligibility Criteria:
* INCLUSION CRITERIA:

Aggressive CD20 + NHL confirmed by Pathology, DCS.

HIV + serology.

All stages (I-IV) of disease.

NHL previously treated with up to two chemotherapy regimens and evaluable disease.

Age greater than or equal to 18 years.

Laboratory test: (Abnormalities are allowed if due to organ involvement by lymphoma).

Creatinine less than or equal to 1.7.

Bilirubin must be less than 2.0 mg/dl, or total bilirubin less than or equal to 3.7 mg/dl with direct fraction less than or equal to 0.2 mg/dl and indirect fraction of less than or equal 3.5 mg/dl in patients for whom these abnormalities are felt to be due to protease inhibitor therapy.

AST and ALT less than or equal to 3 times ULN (AST and ALT less than or equal to 6 times ULN for patients on hyperalimentation for whom these abnormalities are felt to be due to the hyperalimentation).

ANC greater than or equal 1000/mm(3).

Platelets must be greater than or equal to 75,000/mm(3) (patients with ITP platelets greater than or equal to 30,000/mm(3).

Signed informed consent and Durable Power of Attorney.

EXCLUSION CRITERIA:

Pregnancy or nursing.

History of clinical heart failure or symptomatic ischemic heart disease.

Serious underlying medical condition or infection other than HIV that would contraindicate EPOCH.

Concurrent anti-retroviral therapy during EPOCH therapy.

Primary CNS lymphoma.
A Study of Mobility Outcomes in Post-Pulmonary Embolic Disease

The purpose of this study is to develop a unique structure and delivery of home-based exercise through multidisciplinary expertise of cardiovascular medicine specialists and cardiac physiologists using an Interactive Care Plan.


Eligibility Criteria:
Inclusion Criteria:

Acute intermediate-risk PE, defined as:

* Intraluminal filling defect in segmental or larger vessels on computed tomography pulmonary angiography or high-probability ventilation/perfusion scan AND
* Evidence of right ventricular enlargement by computed tomography (RV to LV ratio \>1) or echocardiography; and/or right ventricular dysfunction by transthoracic echocardiography. These imaging characteristics must be in the setting of acute PE rather than explained by a prior chronic condition.

Acute high-risk PE, defined as:

* Intraluminal filling defect in segmental or larger vessels on computed tomography pulmonary angiography or high-probability ventilation/perfusion scan AND
* Evidence of right ventricular enlargement by computed tomography (RV to LV ratio \>1) or echocardiography; and/or right ventricular dysfunction by transthoracic echocardiography. These imaging characteristics must be in the setting of acute PE rather than explained by a prior chronic condition; AND
* Hypotension (systolic blood pressure \< 90 mm Hg sustained for more than 15 minutes; or requiring vasopressors) or cardiogenic shock due to acute pulmonary embolism.

Exclusion Criteria:

* Inability to ambulate independently, which is necessary to perform 6MWD (may be self-reported or as deemed by physical therapy during inpatient evaluation).
* If patient requires supplemental oxygen during ambulation, this does not exclude patient from participation and will be noted during eCRF.
* Prior history of pulmonary embolism
* History of CTEPH or pulmonary arterial hypertension
* Unable to read a questionnaire in English
* Unable to return for baseline, 3- or 6-month follow-up visit
* Pregnancy-associated pulmonary embolism
* Life expectancy \<1 year based on comorbidities
* Unable/unwilling to provide informed written consent
Calibration and Validation of High Quality Low-Cost 3D Printed Pulse Oximeter

Pulse oximetry is a vital tool in the rapid and non-invasive assessment of emergency patients, providing a continuous estimate of hemoglobin saturation in arterial blood. Unfortunately, the costs of these devices are prohibitive and reduce availability in smaller centres and poor countries, putting millions of patients in danger of easily treatable and preventable conditions. With current rapid prototyping technologies such as 3D printing, it is possible to create a very inexpensive pulse oximeter that meets or exceeds the gold standard. The goal of this study is to develop, validate and certify a pulse oximeter that measures hemoglobin, carboxyhemoglobin and methemoglobin. This pulse oximeter will be certified with Health Canada, and then released under the Open Hardware License (OHL), such that hospitals and ministries of health in rural and impoverished communities in Canada and internationally would have easy access to these devices.


Eligibility Criteria:
Inclusion Criteria:

- This study has 2 Phases. In Phase 1, healthy, non-smoking adult volunteers greater than 18 years of age are invited to participate. In Phase 2, all adult (\>18) non-critical patients and healthy community volunteers visiting the ED at VH and UH are eligible to participate.

Exclusion Criteria:

Potential participants will be excluded based on the following criteria:

Phase 1:

* greater than 70 years of age,
* current smokers,
* previous history of cardiac disease (e.g., atrial fibrillation, myocardial infarction, congestive heart failure),
* history of moderate or severe asthma,
* history of seizures,
* history of stroke or transient ischemic attack
* pregnant women
* Patients with any active pulmonary disease such as pneumonia
* Individuals who are unwilling to participate or are less than 18 years old
* Those who are unable to consent

Phase 2

* Critical patients will be excluded from participating
* Individuals who are unwilling to participate or are less than 18 years old will be excluded
* Those who are unable to consent.
Transconjunctival vs Transcutaneous Anaesthesia in Oculoplastics

Eyelid surgery is commonly performed under local anaesthesia. For many such procedures, the local anaesthetic injection may be given either transcutaneously (through the skin) or transconjunctivally (through the conjunctiva, i.e. from the inner surface of the eyelid after administration of topical anaesthetic drops). Both methods are commonly used, sometimes in combination. Currently, the choice of route is largely determined by surgeon preference, but it is not known whether one method is better or more comfortable than the other. Our study will compare the two methods of local anaesthetic administration, in terms of patient comfort during anaesthetic administration, efficacy (i.e. whether any additional anaesthetic is needed during surgery), and adverse effects (e.g. bruising, postoperative double vision).

We will recruit adult patients who are due to undergo eyelid surgery on both sides under local anaesthesia, on Miss Siah's lists at Southampton General Hospital or Lymington Hospital. Patients will receive topical anaesthetic eye drops to both eyes, followed by an injection of local anaesthetic to each eyelid. One side will be administered transcutaneously, and the other side transconjunctivally. The order be randomised. After the injections, participants will be asked to rate their pain levels during each injection on a standardised numerical scale (1-10). A photograph will also be taken, so that an independent assessor can subsequently rate the extent of any bruising. The eyelid surgery will then be performed as normal, with any need for further anaesthetic during the surgery being recorded. Patients will attend for their normal follow-up appointment afterwards and any postoperative complications will be recorded, but the study will not require any extra hospital visits. The study is sponsored by University Hospitals NHS Foundation Trust, but does not have any external funding.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing bilateral oculoplastic procedures under local anaesthesia on selected lists at Southampton General Hospital or Lymington New Forest Hospital, UK
* able to give informed consent and adhere to the study protocol

Exclusion Criteria:

* patients undergoing substantially different procedures on each eye
* patients undergoing procedures not amenable to the administration of anaesthetic via the transconjunctival route (e.g. brow lift)
* patients undergoing a first procedure on one eye and a 'redo' procedure on the fellow eye (as the presence of scar tissue on the previously operated eye is likely to affect results)
* patients having their procedure under general anaesthesia, or receiving intravenous sedation prior to the administration of local anaesthetic
Vitamin E and C to Slow Progression of Common Carotid Artery Plaque Build-Up

This study will evaluate the effects of vitamin E supplementation in retarding the progression of common carotid artery intima-media thickening in African Americans.

BACKGROUND:

Evidence from epidemiologic studies, and from one unpublished study, suggests that greater intake of antioxidant vitamins is associated with reduced risk of coronary heart disease and stroke. Findings from an animal model indicate that increased intake of antioxidant vitamins prevents progression of aortic fatty streaks induced by an atherogenic diet, but not from more advanced injury-induced lesions. These observations suggest the hypothesis that increased antioxidant vitamin intake may prevent further progression of early atherosclerosis, possibly by means of reduced susceptibility of low density lipoprotein to oxidative modification and consequent cytotoxic, chemotactic, chemostatic, and unregulated uptake effects.

A new, automated, low-cost, portable ultrasound system for determining intima-media thickness of the common carotid artery makes it feasible to test the primary prevention impact of antioxidant vitamins on early atherosclerosis. Results of two studies at the University of Southern California suggest that the low-density lipoprotein effects on common carotid artery intima-media thickness can be detected by automated methods within 12 to 24 months in small patient samples. Retardation of intima-media thickness progression was achieved in both studies without significant changes in average vessel diameter, which suggests effects on early atherosclerotic lesions.

DESIGN NARRATIVE:

Patients will be screened for carotid intima-media thickness at home or at schools in mobile vans equipped with portable ultrasound equipment. After 12 months, those patients above the age and sex-adjusted 66th percentile at Screen I will be re-screened (Screen II), and those showing the greatest progression in intima-media thickness will be invited to participate in a trial run-in to assess vitamin E compliance. Patients will be randomized to the following four groups: 1) vitamin E (573 mg/day); 2) vitamin C; 3) Vitamin E and C combined; and 4) placebo. Common carotid artery intima-media thickness will be observed by ultrasound at 12- and 24-month follow-ups. The primary outcome is 24-month rate of change in average common carotid artery intima-media thickness.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Eligibility Criteria:
Inclusion Criteria:

* African American