cyrilzakka/clinical-trials huggingface dataset:
Different Kinds of Acupuncture Treatment for Knee Osteoarthritis

Knee osteoarthritis (KOA) a chronic disease with symptoms of persistent pain or rest pain , joint stiffness, numbness, limitation of activity and even disability, with significant associated costs and effects on individuals' life quality. Acupuncture as an approach for the management of chronic pain, is receiving increasing recognition from both the public and professionals. The aim of this study is to indicate the effects of three commonly used acupuncture treatments for KOA.

360 subjects with KOA recruited from six centers will be randomized to six groups ,and receive four-week acupuncture, Electro-acupuncture, Moxibustion ,Warm-needling ,sham-needle, celebrex treatment. The primary outcomes are Visual Analogue Scale (VAS) and WOMAC function score.The Secondary outcomes are WOMAC pain score, WOMAC stiffness score,the Physical Activity Scale of the Elderly (PASE),knee joint swelling measurement and WHO-BREF life quality scale.The follow-up period is six months. This study will be a rigorous,randomized, sham and drug controlled trial focusing on using different kinds of acupuncture treatment for treating KOA.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the Clinical Classification Criteria for Osteoarthritis of the Knee, diagnosed by specialist.
2. Aged 40-75 years old;
3. History of chronic knee pain for more than 3 months, and complain of knee pain on most days of the past month;
4. Kellgren and Lawrence Grades 1-3;
5. With related knee pain in one or both knees rated \> 4 cm on a 10 cm Visual Analog Scale(VAS) (VAS:0 to 10)
6. Who volunteer to participate and sign the consent form .

Exclusion Criteria:

1. Knee osteoarthritis patients with gout, infection, tumor, autoimmune diseases, trauma or other causes of knee pain or knee deformities;
2. Patients who have local skin damage, poor skin conditions or coagulant dysfunction and patients who are not suitable for acupuncture;
3. Patients who are accompanied with serious medical problems or mental disorders, cognitive dysfunction，disorders of shallow sensation or who cannot cooperate with the treatment;
4. Patients who have received acupuncture or needle knife in the past month;
5. Other patients who are not suitable for acupuncture treatment.
Lung Ultrasoung Guided Treatment in Chronic Heart Failure Patients: a Randomized Controlled Trial

Introduction: Despite the great advances in treatment, heart failure (HF) continues to be an important health problem because of its high prevalence, morbidity, mortality and associated costs. Research shows at least 40% of HF in-patients are going to be readmitted in the following year. Thus, new strategies to reduce HF decompensations are needed.

In recent studies, pulmonary congestion which is expressed in the form of B-lines detected by lung ultrasound (LUS) has proven to be a potent prognostic predictor of hospitalization and mortality in HF. Moreover, the use of LUS is becoming more common due to its availability (with pocket devices with sizes approaching those of smart phones); its simplicity (rapid learning curve and rapid examination, less than 5 minutes) and its safety (radiation free).

We hypothesize that a management guided by LUS in HF patients may improve outcomes.

Objective: The aim of our study is to evaluate if ambulatory LUS guided treatment of patients after a hospitalization for HF, decreases the combined end-point of mortality or re-hospitalization after a 6 months follow-up.

Study design: The design of our study is a randomized, simple blinded, clinical trial.

Eligible patients are patients older than 18 years of age who have been hospitalized for HF. The exclusion criteria are life expectancy of less than 6 months or uninterpretable lung ultrasound. Eligible patients are going to be randomized into either the "LUS group" or the "control group".

The follow-up consists of visits to the HF clinic at periods of 15 days, 1, 3 and 6 months after the initial hospitalization. LUS is going to be performed on all patients despite their respective group. Only in relation to the "LUS group", the treating physician will have the result of the examination and the subsequent treatment adjustment could be made in response to those findings.

This study complies with the Declaration of Helsinki and the study protocol is being evaluated by the Ethic Committee of our institution.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* Current hospitalization for heart failure decompensation

Exclusion Criteria:

* Not able to do the follow up
* Life expectancy of less than 6 months
* uninterpretable lung ultrasound
(Cost)-Effectiveness of Optical Coherence Tomography (OCT) in Basal Cell Carcinoma (BCC)

A multi-centre randomized non-inferiority trial investigating the (cost-)effectiveness of Optical Coherence Tomography (OCT) versus regular punch biopsy in the diagnosis and subtyping of Basal Cell Carcinoma (BCC).

Skin cancer incidence rises worldwide due to high sun exposure and ageing. Basal cell carcinoma (BCC) is the most prevalent form, with a lifetime risk of 16-20% in the Netherlands. Currently, the gold standard for diagnosing and subtyping BCC is a punch biopsy. Since this technique is invasive, new non-invasive diagnostic methods have been developed, including optical coherence tomography (OCT). In patients with clinical and dermoscopic suspicion of BCC, OCT makes it possible to confirm and subtype BCC with high confidence, thereby obviating the need for a punch biopsy in a substantial part of patients. Hence, BCC diagnosis and treatment can be accomplished in one day. As a result, patients experience less distress and costs can be saved. By discussing diagnosis and treatment with the patient directly, care can be provided more efficiently, preventing treatment delay and saving extra hospital visits. The investigators hypothesize that the use of OCT is a cost-effective strategy when compared to regular care (always punch biopsy). However, it is important to evaluate whether an alternative OCT guided diagnostic approach does not lead to an unacceptable increase in risk of recurrent BCC.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (\>18 years)
* Clinical and dermoscopic suspicion of BCC
* BCC is in the differential diagnosis and a biopsy would normally be obtained to confirm the diagnosis and subtype or exclude other skin lesions.

Exclusion Criteria:

* Patients with BCC in the high-risk zone of the face (ear, nose, eye region)
* Patients with a large BCC referred to our (tertiary care) head and neck tumour working group.
A Study of CM350 in Patients With Advanced Solid Tumors

This is an open label, dose escalation and expansion Phase I/II study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of CM350 in patients with advanced solid tumors.

The phase I study consists of a dose escalation part (Part A) and a dose extension part (Part B).

The safety and tolerability of CM350 and the maximum tolerated dose (MTD) will be evaluated in Part A.

The safety, tolerability and efficacy of CM350 at MTD and/or the dose of one level less than MTD (MTD-1), and the recommended dose level for the phase II study will be determined in Part B.


Eligibility Criteria:
Inclusion Criteria:

* Dose escalation part of Phase I study : Patient with histologically or cytologically confirmed advanced solid tumors for which standard treatment do not exist, are no longer effective, or are not acceptable to the patient.
* Dose expansion part of Phase I study : Patient with histologically or cytologically confirmed IHC GPC3-positive advanced solid tumors for which standard treatment do not exist, are no longer effective, or are not acceptable to the patient.

Exclusion Criteria:

* Patients who received any cytotoxic chemotherapy agent, radiotherapy, targeted therapy, biotherapy, antitumor traditional Chinese medicine, or any other investigational antitumor agent within 28 days prior to first dosing of CM350.
* Had major surgery within 28 days prior to first dosing of CM350.
* Received any antibodies/drugs/therapies targeting T-cell co-regulatory proteins (immune checkpoints) within 28 days or 5 half-lives (whichever is shorter) prior to first dosing of CM350, including but not limited to cytokine therapy, anti-programmed death receptor 1 (PD-1), anti-programmed death receptor ligand-1 (PD-L1), anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), chimeric antigen receptor T cell (CAR T) therapy, etc.
* Received therapies targeting GPC3, including but not limited to monoclonal antibodies, peptide vaccines, chimeric antigen receptor T cells (CAR-T), and bispecific antibodies.
Drug to Prevent Pneumonia in the Tube Fed

Background: Older people with neurological dysphagia are at risk of recurrent aspiration pneumonia. Angiotensin converting enzyme inhibitor (ACEI) has been shown to improve swallowing and cough reflexes which may protect dysphagic patients from aspiration pneumonia.

Hypotheses: ACEI reduces the risk of pneumonia in older patients who are nasogastric tube fed because of dysphagia from cerebrovascular diseases.

Design: Randomized placebo controlled trial

Method: 302 older patients who have been tube fed for more than two weeks because of dysphagia secondary to cerebrovascular diseases are randomized to take half of lisinopril 5 mg or placebo tablet once daily for 26 weeks. The subjects will be recruited from medical wards in Prince of Wales and Shatin Hospitals, and from outpatients of geriatric or speech therapy clinics, who have had hospital stay in previous three months. The subjects are followed up at week 12 and 26. The primary outcome is the incidence rate of pneumonia as determined by pneumonic change on X ray and clinical criteria. The secondary outcomes are mortality rate, total episodes of pneumonia over 26 weeks, and swallowing ability defined by the Royal Brisbane Hospital Outcome Measure at week 12. Cost effectiveness analysis of public health care and personal health care costs will be performed. Intention to treat and log rank will be used to analyzed the group differences in outcomes. 60 subjects (30 in each trial group) recruited from medical inpatients at Prince of Wales Hospital will undergo swallowing videofluoscopy at baseline and week 12 follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Tube fed for more than four weeks for reason of neurological dysphagia as recommended by a trained speech therapist;
* clinical diagnosis of cerebrovascular diseases, confirmed by CT head scan. The reason for restricting the subjects to those with cerebrovascular disease is that previous studies which showed beneficial effects of ACEI on dysphagia were mostly based on stroke patients.

Exclusion Criteria:

* life expectancy less than six months;
* live outside Shatin area;
* systolic blood pressure less than 100 mm Hg;
* known intolerance of ACEI;
* existing use of ACEI or angiotensin receptor blockers;
* symptomatic chronic lung disease or cardiac failure;
* frequent withdrawal of enteral tube by patients;
* serum creatinine \>100 µmol/L;
* serum potassium \> 5.1 mmol/L.
Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion

This trial is for patients with acute occlusion of one of the arteries supplying blood to the leg. The trial is designed to determine the safety and activity of a novel clot dissolving (thrombolytic) drug (alfimeprase).


Eligibility Criteria:
* Patients with acute peripheral arterial occlusion of the lower limb (onset of symptoms within 14 days)
* Rutherford Class I or IIa (minimal sensory loss, no muscle weakness, audible venous flow)
* Age 18 or above
* Able to consent
* Able to follow up
Investigation of Dysynchrony in Patients With Pulmonary Hypertension

The purpose of the study is to determine whether patients with pulmonary hypertension (PH) have dysynchrony, and if so whether it is electrical or mechanical. Once this has been determined, during a catheterization the investigators will test if pacing the heart improves blood circulation.

This is a two part study of ventricular dysynchrony in patients with pulmonary hypertension. The first part is an observational study, reviewing routinely obtained clinical information (such as echocardiograms) to assess whether patients with pulmonary hypertension have electrical or mechanical dysynchrony. If so, we will proceed to the second part of the study which will assess whether temporarily pacing the right ventricle, during a clinically indicated catheterization can acutely improve hemodynamics. We will also gather control data for phase 1 from clinically indicated echos and ECG's in patients with ASD's (RV volume load) and in patients who are evaluated for an innocent murmur ( Nl heart). We hope to learn whether patients with pulmonary hypertension, and compromised right ventricles have electrical and mechanical dysnchrony. If this is true, it is theoretically possible that resynchronization (pacing) of the right ventricle could improve hemodynamics, symptoms and long term outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Pulmonary artery mean pressure at rest of 25 mm Hg
* Controls (for phase 2) Patients undergoing transcatheter closure of secundum ASD Patients undergoing echocardiogram and ECG as part of work-up for functional murmur who have normal intracardiac anatomy

Exclusion Criteria:

* Reversible cause of pulmonary hypertension
* Age \< 5 yrs (for phase 2)
The Effects of Aromatherapy on the Stress Levels of Nurses Working in an Urban, Safety-Net Community Hospital

Parkland Hospital inpatient nursing staff will be the focus of this study. This project aims to investigate the use of lavender on the stress levels associated with the nursing role. Nurses will wear the Elequil aromatabs ® over a four-hour period and a post survey will be given to assess root cause of stress and changes related to intervention.

Nurses today are facing unprecedented patient acuities, burnout, fear, uncertainty, a continuously evolving workflow and nursing shortages, Therefore, workplace-related stress has become one of today's most serious occupational hazards. Aromatherapy can be a convenient, inexpensive, and non-invasive method of stress relief. There is little research regarding the efficacy of aromatherapy by means of inhaling essential oils in reducing workplace stress-related symptoms among nurses. Therefore, this study will examine the efficacy of lavender-scented aromatherapy tabs (Elequil ® aromatabs ®) in reducing job stress-related symptoms among nurses.

The study for the participants goes as follows:

1. Nurse identified by:

   * Leadership
   * Self-identified
   * SPARKS member
2. Process:

   * Identified nurse will be informed and consented regarding the study.
   * An aromatab will be given to the nurse.
   * They will place the aromatab on their uniform top to allow for continuous exposure to the scent.
   * Four (4) hours later - nurse completes survey as to the effects of the aromatab
   * Completed survey is placed in research file at charge nurse desk in opaque folder.

Data to be used within the research project will be obtained from the collected survey forms.

Recruitment will be completed face-to-face between the SPARKS team member, leadership, or self -identification of the potential subject. Considerable care will be taken so that the person contacted does not feel pressured to participate.

The research team will meet prior to enrolling the first participant, during and upon completion of data collection. Any safety concerns will be addressed at those times. At any time during data collection, the PI's or any study team members may request that the team meets to address a safety concern. Study participants will be assured of anonymity and confidentiality of the data and they will also be reminded that they can withdraw from the study at any time.

Eligibility Criteria:
Inclusion Criteria:

* Nurses volunteering to participate in the study and are experiencing stress while at work

Exclusion Criteria:

* Known allergies or sensitivities to aromatherapy products, a history of respiratory problems, asthma, allergies to fragrance, or lost sense of smell. Those nurses who have had serious disease complications will also be excluded from the study.
Construction of an Ultrasound Profile and a Mammographic Profile Corresponding to the Different Molecular Subtypes of Brest Cancer. A Retrospective Study

PROFILS is a retrospective, exploratory study on data collected in 203 breast cancer cases diagnosed during a national screening campaign from 2015 to 2018.

The aim of the study is to analyse histological, clinical and radiological data collected during the screening campaign to build an ultrasound profile and a mammographic profile corresponding to brest cancers' different molecular sub-types (Luminal A, Luminal B, HER2+, Triple negative) using the BI-RADS classification.

The study has the following objectives:

* To compare molecular profiles of breast cancers detected in a cohort of women diagnosed with tomosynthesis and ultrasound with molecular profiles of brest cancers detected in the cohort of women diagnosed with classical mammography and ultrasound
* To describe molecular profiles of cancers detected only with ultrasound,


Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with a breast cancer
* Detection of a breast cancer during the screening campaign organized between june 2015 and july 2018 in the following geographic zones : Cantal, Haute Loire and Puys de Dôme

Exclusion Criteria:

* Patients who expressed their opposition to the use of their personal data
A Phase 2, Multi-Center Study To Compare The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist With Ranibizumab In Adults With Diabetic Macular Edema

The study hypothesis under test is that administration of the CCR2/5 antagonist has the potential to be as effective as the current treatment options for subjects with diabetic macular edema. The current treatment option for these subjects is an injection directly into the eye, while this CCR2/5 antagonist would be an oral drug which has the potential to be just as effective. This CCR2/5 antagonist also has a broader anti-inflammatory potential and might be able to provide an alternative mechanism to treat Diabetic Macular Edema.

Study recruitment was stopped on April 9, 2015. This decision was taken for business reasons due to changes in the prioritization of the drug development portfolio. This decision was not as a result of any evolving safety, efficacy issue or changes in the risk:benefit assessment of this product or regulatory interactions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Diabetes Mellitus (Type 1 or Type 2) Showing Diabetic Macular Edema in the Eye
* Reduced visual acuity resulting from retinal thickening
* Female subjects of non-childbearing potential ≥18 years and male subjects greater than or equal to 18 years. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
* Female subjects who are not of childbearing potential must meet at least one of the following criteria:

  * Have undergone a documented hysterectomy and/or bilateral oophorectomy;
  * Have medically confirmed ovarian failure; or
  * Achieved post-menopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females.

Exclusion Criteria:

* Severe Impaired Renal Function
* Any intraocular condition or previous surgery in either eye that would likely require medical or surgical intervention during the study duration or if allowed to progress untreated for the 16 weeks of study duration, would likely contribute to a reduction in visual acuity.
Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms

Many breast cancer survivors report chronic pain that develops or worsens following chemotherapy. The impact of chemotherapy on the development of chronic pain is uncertain. In this proposal, we are studying the impact of chemotherapy on a patient's sensitivity to pain. We are also investigating whether a patient's sensitivity to pain is related to how many symptoms she experiences during treatment.


Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Histologically proven stage I-III invasive carcinoma of the breast who is planning to receive a standard dose of adjuvant chemotherapy.
* Surgical resection should be complete at the time of study enrollment.
* Eastern Cooperative Oncology Group performance status 0-2.

Exclusion Criteria:

* Average pain over the past 24 hours of 4 or greater on a 0-10 scale.
* Peripheral sensory neuropathy grade 2 or higher.
* Personal history of schizophrenia or major depressive disorder, or history of suicidal ideation or attempt within the past 2 years.
* Thumbnail abnormalities on either hand (such as artificial nails) that are likely to alter pain perception during testing.
* Pregnant or nursing.
* No prior chemotherapy for any reason
Triple Blockade of the Renin Angiotensin Aldosterone System in Diabetic (Type 1&2) Proteinuric Patients

Study Hypothesis:

Reduction in albuminuria has been shown to decrease progression of diabetic

nephropathy. In diabetic nephropathy patients treated with maximal

antihypertensive doses with dual RAAS blockade (total daily dose valsartan 320

mg and either enalapril 40 mg or benazepril 40 mg daily, or losartan 100mg), persistent

albuminuria reflects further additional RAAS activation. Microvascular renal

disease due to increased RAAS activation may be more effectively treated with

triple blockade by the addition of a direct renin inhibitor (DRI) Aliskiren.


Eligibility Criteria:
Inclusion Criteria:

* Macroalbuminuria \> 300mg/g
* Microalbuminuria 30-300mg/g
* Stable on max dose of an ACE-I or ARB (Can also be titrated to max dosage of ACE-I and ARB and stable on those doses for at least 2 weeks)
* Blood pressure \<130/80 mm Hg at time of enrollment
* Diabetic either Type 1 or 2

Exclusion Criteria:

* GFR \<60 m/min
* Potassium \> 5mg/dl at time of enrollment
* Pregnant
* History of Angioedema
* ACE-I cough
* Allergic to ARB, ACE-I, DRI
* A1C \> 9%
A Stylet Use May be Beneficial for Elective and Rescue Intubation of Prematurely Born Infants

Contrary to recent findings suggesting that stylets offer no advantage in general infant intubations, this study focuses on their potential benefits for premature infants undergoing elective or rescue intubation in the delivery room. The goal is to compare the safety and efficiency of intubations with or without a stylet.

Recent studies have found that using a stylet does not offer any benefits during intubation across a diverse infant population. The research, however, specifically targets extremely and very premature infants undergoing elective or rescue intubation in the delivery room. A single-center retrospective observational study was conducted to compare the number of intubation attempts, the duration of intubation until successful, and the rate of associated desaturations exceeding 20%. The outcomes were determined through video recordings and statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* intubation in the delivery room

Exclusion Criteria:

* both method used, video record not available