cyrilzakka/clinical-trials huggingface dataset:
Shengyu Decoction and Lijin Manipulation for Knee OA: 3D Gait Analysis

Detailed Description Avoid duplicating information that will be entered or uploaded elsewhere in the record.

This study aims to explore the efficacy of the Shengyu Decoction combined with manual therapy for the treatment of knee osteoarthritis (OA) using a clinical randomized controlled trial design. Additionally, based on three-dimensional gait analysis technology, the investigators will delve into the biomechanical mechanisms underlying the onset of knee OA and elucidate the mechanism of action of the Shengyu Decoction combined with manual therapy. This will further validate the clinical superiority of the Shengyu Decoction combined with manual therapy in the treatment of knee OA, providing strong support for reducing pain and improving knee function in patients with knee OA.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic criteria of Western medicine: Knee pain for at least 1 month, X-ray showing osteophyte formation, age ≥50 years, morning stiffness ≤30 min, and bone fricative sound.
* TCM diagnostic criteria: Dull pain in the knee joint, flexion and extension limitations, pitching and side rotation unfavorability, slight activities slightly relieve pain, climate change aggravates symptoms, and repeated middle-aged and elderly patients, hidden onset, slow onset, slight local swelling of the knee joint, friction or clicking sound when moving, and severe cases may show muscle atrophy and joint deformity.
* Radiographs showing joint space narrowing, bone hyperplasia, subchondral osteosclerosis, and osteophyte formation.
* Patients who are between 45 and 85 years old.
* Patients who can understand and provide informed consent.
* Patients who are willing and able to undergo manual treatment for 1 course of treatment and cooperate with the doctor to complete the study.

Exclusion Criteria:

* Patients who do not meet the diagnostic criteria for knee osteoarthritis established by the rheumatology society.
* Severe knee pain with surgical indications (or X-ray grading standards reached level 4).
* Pregnant or planning to become pregnant.
* Patients who have participated in or are participating in other clinical trials within the last 3 months.
* Patients who have received or are receiving other treatment methods such as drugs that affect the evaluation of efficacy within the past 3 months.
* Patients with fractures, dislocation, skin damage, and severe infectious skin diseases within three weeks.
* Patients with severe primary diseases such as liver, kidney, hematopoietic system, endocrine system, cardiovascular and cerebrovascular, nervous system, tuberculosis, joint malformations, tumors, and psychiatric patients and postoperative patients.
* Patients who are unable to accurately evaluate the effectiveness and safety of treatment due to their medical condition.
A Study of RO4905417 in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery

This randomized double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 in the prevention of saphenous vein graft disease in patients undergoing elective or urgent coronary artery bypass (CABG) surgery. Patients will be randomized to receive either RO4905417 20 mg/kg by intravenous infusion or placebo every 4 weeks for 32 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \> 18 and \> 85 years of age
* Patients undergoing primary multi-vessel CABG with at least one saphenous vein graft. with or without cardiopulmonary bypass
* Body mass index (BMI) \</= 35 kg/m2

Exclusion Criteria:

* Participation in previous studies evaluating RO4905417
* Positive for HIV, receiving antiretroviral drugs, or immuno-suppressed
* Acute infection at screening or active chronic infection within 3 months prior to CABG surgery
* Patients undergoing emergency cardiac surgery for an immediately life-threatening condition
* Patients undergoing concomitant valve surgery
* History of CABG (only patients without prior CABG surgery will be admitted to the study)
* Left ventricular ejection fraction \< 20%
* History of transient ischemic attack or stroke within the 12 weeks prior to the CABG procedure
* Significant renal or liver impairment
* Malignancy diagnosed within the previous 5 years (except for successfully resected basal cell cancer)
Clinical Experimentation With Tenofovir Disoproxyl Fumarate and Emtricitabine for COVID-19

Clinical, control, double-blind, randomized trial with tenofovir disoproxyl fumarate and emtricitabine for Covid-19

Several therapeutic agents have been evaluated for the treatment of Covid-19, and only one using an antiviral drug called remdesivir administered intravenously has shown efficacy to reduce the duration of the disease in 26.7% in critically ill patients. This proposal has as its primary objective (a) Determine the effect of TDF and TDF + FTC on the duration of Covid-19 evaluated in the 14th. day of follow-up at the outpatient clinic in the hospital, duration of the disease observing clinical signs and symptoms, as well as evaluating the RT-PCR viral load tests on the 1st, 7th, 14th. and 28th. days of the study protocol. In addition, the proposal assesses several secondary objectives: (b) Assess the action of TDF and TDF + FTC on the immune response using the rapid ELISA test (IgM / IgG) to be performed on the 7th. and 28th. days of monitoring the experimental protocol; (c) Determine the effect of clinical interventions with the drugs TDF and TDF + FTC in the short and medium term on the viral load of SARS-CoV-2; and (d) Assess the effect of TDF and TDF + FTC on inflammation biomarkers cytokines and chemokines (IL-6, MCP-3, D-dimer, IL1-RA, IL-10, GCSF, TNF-α, MCP-1 , IL-2R, MIP-1 alpha, IP-10, IL-8, NT-proBNP, Troponin I, CRP and procalcitonin) in the blood of patients collected in the 1st, 14th. and 28th. study days. The study will be a prospective, double-blind, placebo control and randomized clinical trial of a total of 219 patients with mild to moderate disease, aged 18 years or over, with clinical signs and symptoms of Covid-19 and certified after the RT-PCR test for the detection of SARS-CoV-2 viral load. The study will be carried out at the outpatient clinic of Hospital São José, Fortaleza, CE. The random groups will be: (1) Group - Placebo control (Vitamin C - 500mg / day, for 10 days); (2) Group - tenofovir disoproxyl fumarate (TDF; 300 mg / day, for 10 days); and (3) Group - TDF + emtricitabine (FTC; 200 mg / day, for 10 days). The study aims to evaluate the efficacy of tenofovir alone or combined with emtricitabine in the duration of mild to moderate Covid-19 cases. The study will also assess the effect of drugs on viral load and immune-inflammatory response. In this sense, the study has the perspective of minimizing the evolution of the disease to severe cases, thus relieving the collapse of the health system and minimizing the social, economic and health disorders of the pandemic by SARS-CoV-2.

Eligibility Criteria:
Inclusion Criteria:

* Patient is \> 18 years old
* Patient diagnosed with COVID-19

Exclusion Criteria:

* Patient is already receiving some of the study drugs
* There is a hospitalization plan in the next 24h
* Some study treatment is contraindicated
* Patient has HIV infection
* Patient has VHB infection
* Patient lives in another city or state
* Female patient, pregnant
Does Aerobic Training Followed by Resistance Training Enhance Aerobic Capacity in Seniors

In healthy young subjects a single bout of strength training following endurance training has been shown to improve markers for aerobic capacity in muscle compared to a single bout of endurance training alone. The present project tests the hypothesis: 12 weeks of training with sessions of endurance training followed by strength training is superior to endurance training alone for health participants 50-65 years of age. The outcome measures are maximal oxygen uptake and knee-extension strength.


Eligibility Criteria:
Inclusion Criteria:

* healthy
* understanding Danish language

Exclusion Criteria:

* medical contraindication for training
* taking beta-blockers
* physical exercise training more than 2 hrs per week
Evaluation of Portal Vein Stenting in Patients with Portal Vein Stenosis and Gastrointestinal Cancers

This study collects information about the safety and effect of portal vein stenting in gastrointestinal cancer patients with portal vein stenosis. This study may help researchers learn how long the portal vein stays open and free from blockage and the effects of portal vein stenting on patients' overall well-being.

PRIMARY OBJECTIVE:

I. To evaluate the safety and efficacy of portal vein stenting in patients with portal vein (PV) stenosis and gastrointestinal malignancies, including quality of life measurements.

SECONDARY OBJECTIVES:

I. Stent patency and duration of clinical success related to the intervention. II. Compare the efficacy of portal vein stenting on liver volumes, nutritional status, and laboratory values relative to patients with portal vein stenosis/thrombosis who do not undergo portal vein stenting.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT A: Patients complete a quality of life (QoL) questionnaire at 2-4 weeks and then 6-8 weeks after portal vein stenting procedure. Patients' medical records are also reviewed.

COHORT B: Patients' medical records are reviewed retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* COHORT A: All patients will undergo initial staging and treatment as per the institution standard of care. Patients will be considered eligible for porto-mesenteric venous stenting (PVS) if:

  * There is \> 75% porto-mesenteric venous stenosis in either main portal vein (PV), left PV, right PV, or the superior mesenteric vein (SMV), even in absence of symptoms of portal hypertension
  * Patients presented with any degree of vascular narrowing of said vessels and symptomatic portal hypertension including variceal bleeding, refractory ascites, abdominal pain, intestinal edema, or diarrhea after exclusion of tumor-related causes as direct tumor invasion or peritoneal dissemination
* COHORT B: Patients who have thrombosis/stenosis of the main portal vein but who did not undergo stenting
BioMonitor 2 In-Office Setting Insertion Safety and Feasibility Evaluation With Device Functionality Assessment

The purpose of this study is to evaluate the safety and feasibility of performing the BioMonitor 2 insertion procedure in an office setting.


Eligibility Criteria:
Inclusion Criteria:

* Indicated for continuous monitoring with an insertable cardiac monitor
* Willing to be implanted in an office setting with only local anesthetic available
* Able to understand the nature of the study and provide informed consent
* Able and willing to complete all routine follow-up visits at the study site for the expected 90-day follow-up
* Able and willing to use a CardioMessenger® capable of communicating with the BioMonitor 2
* Age greater than or equal to 18 years

At the time of insertion, the following pre-procedure criteria must be met for the subject to undergo insertion:

* Most recent INR value (within 7 days) is less than 3.5 if currently taking warfarin
* Absence of infection with no history of infection within the last 30 days

Exclusion Criteria:

* Compromised immune system or at high risk of developing an infection
* Abnormal thoracic anatomy or scar tissue at the implant site that may adversely impact the insertion procedure
* Enrolled in any investigational cardiac device trial
* Currently indicated for or implanted with a pacemaker, ICD device, or hemodynamic monitoring system
* Currently implanted with an ICM or ILR
* Life expectancy less than 6 months
* Patients reporting pregnancy at the time of enrollment
A Study of Ixekizumab in Healthy Participants

The purpose of this study is to compare three different formulations of ixekizumab. One formulation (Reference) has been approved by the Food and Drug Administration (FDA) and two formulations (Test 1 and Test 2) have not been approved. This study will compare how much of each of the three formulations get into the blood stream. Information about any side effects that may occur will also be collected.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male participant or female participant who agree to not become pregnant
* Are male participant or female participants with chronic stable medical problems, that in the investigator's opinion will not place the subject at increased risk by participating in the study

Exclusion Criteria:

* Have a significant history of, or current, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of the investigator poses an unacceptable risk to the participant if participating in the study
* Are allergic or hypersensitive to the study medicine
* Had a vaccination with a live vaccine within 12 months prior to the first check-in or intend to get a vaccine for tuberculosis within 12 months of completing treatment on this study
* Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other serious infection
* Show evidence of active or latent tuberculosis (TB)
* Presence of significant neuropsychiatric disorder or a recent history of depression
* Have had any active or recent infection within 4 weeks of Day 1 that, in the opinion of the investigator would pose an unacceptable risk to the participant, if participating in the study
Impact of Computerized Physician Order Entry on Medication Prescription Errors in the Intensive Care Unit: a Controlled Cross-Sectional Trial.

Device: computerized physician order entry.

We wanted to investigate if the introduction of a computerized intensive care unit system reduced the incidence and severity of medication prescription errors (MPEs). A prospective trial was conducted during 5 weeks in a paper-based unit versus a computerized unit. The registration of different classes of MPEs was done by a clinical pharmacist. An independent panel evaluated the severity of MPEs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted to the Surgical Intensive Care Unit

Exclusion Criteria:

* Adult Patients admitted to other units
* Pediatric patients
NAC Sparing Mastectomy After Neo-adjuvant Chemotherapy

Nipple areolar-complex (NAC) sparing mastectomy, extending the concept of skin-sparing mastectomy, allows to leave the nipple-areola complex intact and to provide a better cosmetic result. Large operable T2-T3 breast cancer (BC), treated with neoadjuvant chemotherapy, may theoretically appear suitable for this surgical option, alternative to conventional mastectomy or breast conserving surgery in case of unfavorable size of the breast, when a good response to neoadjuvant chemotherapy has been achieved.

From January 2009 to May 2013, 422 BC patients were progressively accrued to NAC-sparing mastectomy, of which 361 invasive BC patients underwent NAC-sparing mastectomy as first treatment (NAC-group), whereas 61 T2-T3 invasive BC patients underwent surgery after primary chemotherapy (NAC-PC group). 151 BC patients underwent primary chemotherapy and conventional mastectomy (PC group) from 2004 to 2009, has been evaluated as comparative group respect to NAC-PC group.

Using propensity score matching, local disease-free survival (LDFS) in NAC-PC patients was first compared with that in PC patients.

The NAC-PC cohort was then compared to NAC patients in terms of LDFS using two different matching criteria, one with tumor size after neoadjuvant chemotherapy and one with tumor size before neoadjuvant chemotherapy as balancing covariates.

Eligibility Criteria:
Inclusion Criteria:

T2-T3 N0-N1 breast cancer (NAC-PC and PC groups). T1-T3 N0-1 M0 breast cancer (NAC-group) In our series of NAC-sparing mastectomy patients, with or without treatment with neo-adjuvant chemotherapy, the selection of patients for NAC-sparing mastectomy has been made on the basis of the following criterions: tumor nodule without adherence to the skin, no nipple retraction, retroareolar main duct free for neoplastic tissue inside at frozen section examination. Furthermore, patients were considered still eligible for NAC-sparing mastectomy even if the tumor lies in close proximity (\<1 cm) to the NAC at physical and radiological examination.

Exclusion Criteria:

(NAC-PC and PC groups). Exclusion criteria for the present study were all the other breast cancer patients, particularly T4 breast cancer with inflammatory or ulcerated breast cancer before chemotherapy and patients with synchronous distant metastases. Patients affected with other clinical diseases (i.e. cardiovascular diseases) conditioning the optimal therapeutic strategy were excluded.

For NAC-sparing mastectomy, exclusion criterions were nipple retraction, Paget's disease, inflammatory changes of the breast and bloody discharge from the nipple. The study did not exclude women with prior breast augmentation, heavy smokers, obese patients.

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Efficacy of Extra Virgin Olive Oil (EVOO) Supplementation on Hand-Foot Syndrome Incidence in Patients With Capecitabine

The study was aimed to evaluate the efficacy of extra virgin olive oil (EVOO) supplementation compared to placebo to prevent HFS by observing changes in serum COX 2, malondialdehyde (MDA), and TNF α levels in breast cancer and colorectal cancer patients undergoing capecitabine chemotherapy. Current study was designed as a single-center prospective randomized clinical trial. The patients were Stage III or Stage IV colorectal and breast cancer patients receiving capecitabine-based chemotherapy who enrolled in the trial voluntarily. All patients were divided randomly into three groups treated with EVOO, olive oil, or placebo. The incidence of hand foot syndrome was documented. The serum COX 2, malondialdehyde (MDA), and TNF α levels before and after chemotherapy was documented.


Eligibility Criteria:
Inclusion Criteria:

* Patients pathologically and clinically diagnosed with III or IV stadium of breast cancer or colorectal cancer.
* fully recovered after curative resection within 8 weeks
* receive adjuvant capecitabine based chemotherapy

Exclusion Criteria:

* did not meet the eligibility criteria for chemotherapy
* had previous allergy with capecitabine or olive oil
Medico-Economic Analysis of Management of Flail Chest Between Medical Treatment and Surgical Treatment With Stracos

Optimize the management of polytraumatises with flail chest: surgical treatment Stracos by decreasing the length of stay and the late complications: pain chronicles, quality of life, respiratory function


Eligibility Criteria:
Inclusion Criteria:

* Patients with flail chest including bifocal fracture of three or more consecutive ribs in at least two places with or without paradoxical movement
* The surgical procedure was performed in the first 48 hours after admission
* pathology with prognosis for survival 6-month-old inferior

Exclusion Criteria:

* Paraplegia or Tetraplegia
* Patients having the necessity of neurosurgical treatment or reanimation of neurosurgical
* Aorta hematoma or rupture
* ß-HCG positive in women
* titanium allergy
An Improvement Project Around Staffs' Influenza Vaccine Uptake

To reach seasonal vaccination against influenza targets, University Hospitals Birmingham (UHB) already invites staff to take up the vaccination, and every November reminds staff that have not yet vaccinated to do so. The current protocol describes a randomized controlled trial (RCT) in which staff will be sent different reminders, and the investigators will compare the proportion of staff that go on to vaccinate after receiving each reminder.

Seasonal vaccination against influenza is recommended for NHS staff. , To increase vaccination rates, NHS England put forth a Commissioning for Quality and Innovation goal for the 2018/2019 season of 75%. University Hospitals Birmingham NHS Foundation Trust (UHB) wants its vaccination rate to surpass this target. Since staff get infected outside of the hospital and from patients staff vaccination does not provide significant 'herd immunity'

To reach past targets, every September UHB already invites staff to take up the vaccination, and regularly reminds staff that have not yet vaccinated to do so. The current protocol describes a randomized controlled trial (RCT) in which staff will be sent a different letter when first invited to receive vaccination, and we will compare the proportion of staff that go on to vaccinate after receiving each type of letter..

To conduct the RCT the research team will design four letter styles. One factor will emphasize an authority figure inviting staff to vaccinate (the Chief Executive, who is also a doctor). The other factor will emphasize a competitive social norm describing vaccination rates in peer hospitals, including Addenbrooke's, Cambridge University Hospitals (which has exemplary rates) see appendix A and across American hospitals (which also have high rates). Letters will be sent to staff in the first week in October by UHB's communications team and they will be disseminated in a randomized fashion.

The UoW's role in this study is to advise the study's design and write-up the project for publication. UHB will approve the reminders, send the reminders, retrieve the data, and analyse the data. No individual-level data will be transferred across organizations. All individual-level data will be managed by authorized UHB employees, e.g., a UHB statistician will randomize staff to receive different reminders and analyze the data, and UHB's communication team to disseminate the reminders.

Eligibility Criteria:
Inclusion Criteria:

* All UHB staff eligible for the seasonal influenza vaccination are eligible for this study. (no patients are included)