cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Topical Lidocaine/Prilocaine in Pain Management in Pleurocentesis

The research aims to compare the efficacy of topical Pridocaine cream (lidocaine 2.5% and prilocaine 2.5%) and the standardized local lidocaine infiltration in pain management before pleurocentesis.

Acute pain management is a core ethical concept in medical practice. During pleurocentesis, the standardized pain management is with 1% lidocaine with a 25 gauge needle for skin and a smaller gauge needle for deeper tissue. As the anesthetic injection is painful in and of itself, during these two procedures, pain management can sometimes fall short due to a lack of education and incorrect personal opinions. One example is "one needle insertion can cause less pain than two-needle insertions". Therefore, it is essential to find an alternative method that is painless and reduces procedural pain, which does not require expertise to administer. This is particularly important in centers with a high volume of patients and a lack of expert medical staff.

Another option for administering a local anesthesia is using a topical anesthetic. Generally, these are easily applied, tolerated better by patients, and have minimal systemic absorption resulting in fewer side effects6. A topical anesthetic can be a substitute for infiltrative lidocaine (IL) if it can be effective in reducing pain. Lidocaine-prilocaine cream (LPC) is an example of a topical anesthetic, which was introduced in 1980 for dermabrasion and minor surgery.

Previous research findings had noted the efficacy of LPC compared to IL in trans-radial catheterization, perineal tears following vaginal delivery, and some pediatric procedures like lumbar punctures and venipunctures. Additionally, LPC can be substituted for infiltrative prilocaine in pediatric femoral catheterization.

Hanieh Halili et al, found a significant difference between the LPC and IL groups in terms of patient pain or satisfaction levels, but their study was on a small sample size and they recommended further studies.

Eligibility Criteria:
Inclusion Criteria:

* All Patients will be prepared for pleurocentesis.

Exclusion Criteria:

1. Patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.
2. Patients treated with class III anti-arrhythmic drugs (e.g., amiodarone, bretylium, sotalol, dofetilide).
Capecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer

To compare the efficacy and safety of capecitabine and cyclophosphamide (XC) versus physician's choice as maintenance therapy for patients with advanced breast cancer who achieved disease control after salvage treatment.


Eligibility Criteria:
Inclusion Criteria:

* Female, age≥18 years old
* ECOG≤2
* Pathologically confirmed primary breast cancer, with pathologically or radiologically confirmed recurrent or metastatic lesions
* HR+/HER2+ or HR-/HER2+ or HR-/HER2-
* At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1
* Disease control (complete response + partial response + stable disease) after salvage treatment
* Expected survival ≥6 months
* Adequate organ function

Exclusion Criteria:

* during pregnancy and lactation
* Patients with central nervous system metastasis
Clinical Application of Personal Designed 3D Printing Implants in Bone Defect Restoration

Objective: Clinical application of 3D printing implant in bone defect treatment.

Study design: multicenter randomized controlled study . Methods:patients randomly grouped according to register number into internal fixation and bone graft group and 3D printing group. Reconstruct 3D models ,evaluate models preoperatively , simulate surgery in computer,design 3D implant, and 3D print implants,perform surgery with 3D implants to achieve the greatest degree of physiological reconstruction.Evaluate surgical efficacy .


Eligibility Criteria:
Inclusion Criteria:

* Open fracture with bone defect
* Burst fracture of spine with bone defect
* Bone tumor with bone defect
* Bone tuberculosis with bone defect
* Nonunion with bone defect

Exclusion Criteria:

* Patients who can not tolerate anesthesia and surgery due to severe impairment of heart and lung function
* Systemic or local infection
Evaluation of Remin Pro Forte Versus Remin Pro on Treatment of White Spot Lesions Post Orthodontic Treatment

randomized clinical trial to evaluate caries regression, the change in colour and mineral content of the demineralized enamel after treatment with Remin Pro Forte paste (fluoride, hydroxyapatite, xylitol, ginger, and curcuma) and Remin pro cream which contains (fluoride, hydroxyapatite, xylitol) remineralizing agents with the null hypothesis that Remin Pro forte will have the same clinical performance as Remin Pro in remineralizing white spot lesions post-orthodontic treatment.

Recently, a remineralizing water based cream containing Hydroxyapatite, Fluoride and Xylitol (Remin pro) has been introduced. It has been claimed that hydroxyapatite fills eroded enamel, fluoride seals dentinal tubules and xylitol acts as an antibacterial agents. This product has been assumed to be suitable for management of dentinal hypersensitivity, prevention of enamel demineralization and promoting remineralization of enamel subsurface lesions. There are few studies regarding the effect of calcium phosphate and hydroxyapatite-based agents on remineralization and optical appearance of White spot lesions following orthodontic therapy.

Recently a new formulation of Remin pro has been introduced called (Remin Pro Forte) with the same components of fluoride, hydroxyapatite, xylitol in addition to two natural products (Ginger, curcuma) with the rationale based behind that they have antibacterial effect against streptococcus mutans in addition to anti-cariogenic effect which is being confirmed in the scientific literature.

Follow up period is selected to be 3 months, which is enough for evaluation of the outcomes (caries regression, color change, mineral content) assessed in this study.

Eligibility Criteria:
Inclusion Criteria:

1. No systemic disease.
2. Has completed fixed orthodontic treatment, brackets debonded.
3. Has at least two teeth with white spot lesion.
4. Has received conventional periodontal therapy after orthodontic treatment.
5. Between the ages of 12 and 25 years of age.

Exclusion Criteria:

1. Presence of enamel hypoplasia or dental fluorosis.
2. Presence of tetracycline pigmentation.
3. Periodontal pocketing of 3mm or greater.
4. Taking antibiotics.
5. Presence of carious cavities.
6. Allergy to fluoride gel / varnish being used in study.
7. Subjects who had evidence of reduced salivary flow or significant tooth wear
ACT-Based Nursing Intervention for Ovarian Cancer Patients: A Pilot Study

The purpose of this study is to evaluate the feasiblity and effectiveness of an Acceptance and Commitment Therapy (ACT)-based nursing intervention aimed at managing psychological flexibility, distress, anxiety, depression, fear of cancer recurrence/progression, quality of life, and symptoms. Patients will participate in a single online session with a nurse, followed by a daily self-monitoring survey online for one week. Data will be collected at baseline (prior to the ACT session), on day 8 (after one week of self-monitoring), and at 5 weeks. Primary outcome is psychological flexibility.

This study is a preliminary single-group pre-post design aimed at developing and evaluating the feasibility of an ACT-based nursing intervention for distress management in patients with ovarian cancer. A total of 25 ovarian cancer patients who consent to participate will be enrolled in the study. Paticipants will receive a one-time ACT-based nursing intervention lasting approximately 60 minutes.

The researcher will coordinate schedules with participants to deliver the ACT-based nursing intervention using Zoom, a video conferencing platform which minimizes time and location constraints. Before the intervention, the research will ensure that the participants' video conferencing is working properly to minimize potential difficulties during the session.

Following the single-session intervention, the researcher will send a daily Google Form link to participants for seven consecutive days. Participants will be encouraged to access the link and complete self-monitoring surveys to reinforce the key components addressed in the program.

Eligibility Criteria:
Inclusion Criteria:

* adult (19 ≤ age ≤ 75).
* ovarian cancer patients with FIGO stage 2-3.
* Those who have completed first-line chemotherapy for ovarian cancer (excluding maintenance therapy) within the past 2 years.

Exclusion Criteria:

* Patients with cognitive problems such as dementia or psychiatric problems such as major depression or generalized anxiety, or who are actively receiving treatment for any of these conditions.
* Patients with history of cancer recurrence.
Pharmacokinetics And Tolerability Of Subcutaneous Administration Of PF 04236921 In Healthy Volunteers

This study will evaluate the safety, tolerability, and pharmacokinetics of PF-04236921 administered as a single subcutaneous dose in healthy volunteers.

Tolerability and Pharmacokinetics of subcutaneously administered dose of PF-04236921 in healthy volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy males between 18-55 years, inclusive.
* Healthy females of non-childbearing potential between 18 and 55 years, inclusive.

Exclusion Criteria:

* Evidence or history of clinically significant disease.
* Females of childbearing potential.
Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy

The scientific interest of this study is to improve post-operative comfort in patients after thyroid surgery using simple, inexpensive techniques. The investigator expects that local applications of ice or cortisone aerosols will reduce swallowing discomfort and control post-operative pain (POP). The investigator hopes that local cryotherapy will decrease post-operative oedema (vasoconstriction) and the volume of liquid drained (action on the serous fluid at the site of the thyroidectomy).


Eligibility Criteria:
Inclusion Criteria:

* Patients about to undergo total thyroidectomy by cervicotomy
* Single surgeon: Dr Osmak-Tizon Liliana
* Patients who have provided written consent to take part in the research
* Hospitalized in the endocrine surgery unit
* Whose mental and physical state allows them to participate in the quantification of a symptom using a Visual Analogue Scale(VAS)

Exclusion Criteria:

* Patients under 18 or adults under guardianship
* Patients about to undergo unilateral thyroid surgery (thyroid lobectomy)
* Patient who have had parathyroid surgery
* History of cervicotomy
* Intolerance to, contra-indication for or allergy to any of the treatments tested.
* Pregnant or breast-feeding women
* Patients without national health insurance cover
Efficacy Study of the Embryo Transfer Catheter

A prospective randomized trial comparing Cook K-SOFT-5100 and Frydman classical catheter 4.5 for embryo transfer in human IVF/ICSI was performed. Three experienced operators participated in the trial, using a fixed distance transfer protocol. Primary endpoint was clinical pregnancy rate, secondary endpoints were rates of difficult transfer and of catheter failure. Patients were randomized by a computer program immediately prior to embryo transfer.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing embryo transfer in our IVF program between 2000 and 2005

Exclusion Criteria:

* patients not giving consent were excluded
The Diabetic Retinopathy Screening, Prevention and Control Program

The greatest harm of diabetes is various acute and chronic complications, especially diabetic retinopathy(DR), leading to extremely high rates of disability and blindness. Early screening, early diagnosis, and early treatment are the keys to maintaining vision in patients with DR. However, compared with the high prevalence of diabetes in China, the DR screening ability is relatively inadequate. To change this situation, deep learning(DL), a form of artificial intelligence (AI), might be a potential effective method to solve this dilemma.

The greatest harm of diabetes is various acute and chronic complications, especially DR, leading to extremely high rates of disability and blindness. However, if the fundus examination is carried out regularly in the early stages of onset, the risk of blindness can be significantly reduced. Therefore, early screening, early diagnosis, and early treatment are the keys to maintaining vision in patients with DR. However, compared with the high prevalence of diabetes in China, the DR screening ability is relatively inadequate.

The Diabetic Retinopathy Screening and Prevention Program is a branch project of MMC. Its purpose is to carry out an efficient workflow for early detecting, timely managing of DR, and to establish a referral system for implementing treatment and the long-term follow-up of DR by means of DL. First, In order to improve its sensitivity and specificity, more participants are involved in other medical institutes besides MMCs, then we can effectively explore the prevalance of DR in China and helps to early screening, prevention, treatment and referal process of DR. Secend, we collect participants' serum, plasma,DNA, several medical stastistics and life styles to explore genetics, new biomarkers, risk factors of DR.

Objective:

1. To validate the methodology and feasibility of DR screening using a DL based automated DR grading system in clinical practice.
2. To explore the prevalence of DR and subgroup identification, and fundus images analysis, etc.
3. To explore the genetics, new biomarkers, risk factors of DR.
4. To explore the methods of early screening, prevention, treatment and referal process of DR.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for type 2 diabetes according to the World Health Organization (WHO) in 1999; Type 1 diabetes, single gene mutation diabetes, secondary diabetes caused by pancreatic damage, Cushing's syndrome, thyroid dysfunction, or acromegaly;
* Subjects from other medical institutes are diabetes, non-diabetic patients and healthy participants who are invited to participate in the study.

Exclusion Criteria:

* Those who have a history of drug abuse;
* Sexually transmitted diseases such as AIDS and syphilis, and infectious diseases such as viral hepatitis and tuberculosis which are at active phase;
* Any condition that the investigator think that the subject is not suitable for participating in the study.

For detailed In-/Ex-clusion criteria please see the study protocol.
Chemotherapy for Resectable Colorectal Liver Metastases

There is a degree of uncertainty regarding the role of perioperative chemotherapy (CTx) in the treatment of resectable colorectal liver metastases (CRLM). In the clinical practice, the combination of surgery and CTx is increasingly accepted as treatment for CRLM, especially in the context of patients with synchronous disease or metachronous disease with a high risk of recurrence. However, controversy exists whether all patients with resectable CRLM benefit from perioperative CTx.

There is paucity of good quality studies on this topic. A pooled analysis of two phase III randomized clinical trial, closed prematurely because of slow accrual, showed a marginal statistical significance in favor of adjuvant CTx. Nevertheless, long term results of the EPOC trial founded benefit in disease free survival (DFS) with no difference in overall survival (OS) when perioperative CTx with FOLFOX4 was compared with surgery alone for resectable CRLM. Furthermore, a retrospective series from Ayez et al showed that patients with a high CRS benefit from neo-adjuvant CTx while in patients with a low risk profile did not. On the other side, another retrospective series from the MSKCC showed the timing of additional CTx for resectable CRLM was not associated with improved outcomes. The ongoing CHARISMA trial is currently comparing the outcomes of neo-adjuvant CTx followed by surgery versus surgery alone in high-risk patients with resectable CRLM.

This uncertainty regarding CRLM management may partly be due to the fact that these studies are not well powered to detect minor differences in long term outcomes and they often involved a very heterogenous group of patients with both synchronous and metachronous CRLM, not stratified by clinical risk score (CRS) as described by Fong et al.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years with resectable liver metastases of histologically confirmed primary colorectal carcinoma.
* Minimum follow-up of five years.

Exclusion Criteria:

* Patients with extrahepatic disease
Study of NMB Drug Ejecting Balloon for Peripheral Arteries

The purpose of this study is to demonstrate the Safety and effectiveness of the use of NMB's drug ejecting balloon for the treatment of de novo and restenotic lesions in peripheral arterial disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old or older
* Patient with lifestyle limiting claudication or rest pain (Rutherford- Becker scale 2, 3 or 4).
* Patient with de novo lesion or restenotic lesion ≥70% in the iliac, femoral, popliteal or tibial artery.
* The target lesion can be successfully crossed with a guide wire and dilated.
* The target lesion is in a native artery of 2.5-10mm in diameter and less than 80 mm in length.
* Patient is willing to and able to sign a written informed consent and to comply with procedures (e.g., adherence to follow-up visits, including 6 months CT-angiography/MRA follow-up).

Exclusion Criteria:

* Women who are pregnant or breast-feeding and women of childbearing potential who do not use adequate contraception.
* Previous participation in another study with any investigational drug or device within the past 30 days.
* The patient is currently enrolled in another investigational device or drug trial.
* Severe reaction to contrast agents that cannot be adequately premedicated prior to procedure.
* Stenosis with corresponding thrombosis treated within 7 days before enrollment.
* Patient with known contraindications for aspirin or other anticoagulant/antiplatelet therapy.
* Patient that has co-morbid illness that may result in life expectancy of less than 12 months.
* History of haemorrhagic stroke or gastro-intestinal bleeding within 6 months.
* Patient with major surgery during the 30 days preceding the interventional procedure.
Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost

Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Study

Not provided

Eligibility Criteria:
Inclusion Criteria:

* IOP \>/= 15mmHg and \< 40 mmHg in each eye using Goldmann applanation tonometry at visit 2
* Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

* Patients with closed-angle, congenital glaucoma or secondary glaucoma caused by steroid drugs, etc.
* best-corrected visual acuity 20/80 or less
* Patients who have ongoing medical history of ocular inflammation
* central corneal thickness is not in between 470um and 591um.
* Patients who have received lacrimal duct procedure within the last 3 months or who have plans to have it.
* pregnant or nursing women
Evaluation of a Program for Routine Implementation of Symptom Distress Screening and Referral in Cancer Care

This study proposes to evaluate the process and outcome of an implementation program designed to implement nurse-led symptom distress screening and referral into routine cancer care clinics. Specifically, using a stepped-wedge cluster randomized controlled trial, This study aim to test if a systematic symptom distress screening program increases the proportion of eligible patients screened and referred compared to usual control. For process evaluation, this study will use qualitative methods to assess the experience and response to the implementation program.

This study proposes to evaluate the process and outcome of an implementation program designed to implement nurse-led symptom distress screening and referral into routine cancer care clinics. Specifically, using a stepped-wedge cluster randomized controlled trial, this study aim to test if a systematic symptom distress screening program (i.e. using the five implementation strategies including training, audit, feedback, facilitation and adaptable workflow) increases the proportion of eligible patients screened and referred compared to usual control under which no implementation strategies will be used to facilitate the adoption of the systematic symptom distress screening and referral. The investigator hypothesize that (1) the intervention will increase the proportion of eligible patients screened; (2) the intervention will increase the proportion of patients with moderate to severe symptom distress referred for psychosocial support.

For process evaluation, this study will use qualitative methods to assess the experience and response to the implementation program.

Eligibility Criteria:
Inclusion Criteria:

* All cancer patients within two years post-treatment attending the specialized outpatient clinics for surveillance will be eligible for symptom distress screening, with no exclusions by any demographic and clinical characteristics.

Exclusion Criteria:

* All cancer patients beyond two years post-treatment
A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients

In this study, a system will be developed to guide patients with chronic obstructive pulmonary disease (COPD) to complete a mindful breathing practice at home. COPD is the third leading cause of death in the United States and no cure exists. Shortness of breath is the most common disabling symptom. Pursed lips breathing is a type of breathing practice that has demonstrated effectiveness for patients with COPD. It requires practice to maintain and there is currently no home system to provide the needed feedback and support to maintain PLB. Additionally, syncing breathing and heart rate variation offers patients additional benefits. The proposed project explores the use of biofeedback to guide COPD patients in a breathing practice and to provide data for health coaching to monitor and support the practice.


Eligibility Criteria:
Patients eligible for Pulmonary Rehabilitation will be recruited for this study.
Italian Observational Study Assessing the Impact of Gout on Patients Disability and Quality of Life

The study aims to identify which characteristics are associated with disability and poor quality of life in patients suffering from gout. This is a multicentre prospective observational study carried out in a cohort of Italian patients with gout. Subjects are randomly selected from a list of patients referred to each participant rheumatology clinic in the previous 2 years. Clinical evaluations are performed at baseline, at 6 and 12 months; data are retrieved about sociodemographic variables, life-styles, history of gout, comorbidities and patterns of treatment. At each visit patients complete questionnaires assessing disability and health-related quality of life. Preplanned analyses will be performed to investigate predictors of disability and poor quality of life in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of gout
* Must be able to understand questionnaires

Exclusion Criteria:

* Diagnosis not validated by rheumatologist
* Not able to sign informed consent