cyrilzakka/clinical-trials huggingface dataset:
Development and Feasibility Testing of Digital Theory-based Pursed Lip Breathing in Stable Patients With COPD

The goal of this pre-post design clinical trial is to develop a digital, theory-based Pursed Lip Breathing intervention protocol software system installed on smartphones (DT-PLB) and to preliminarily evaluate its feasibility and effects in stable Chronic Obstructive Pulmonary Disease (COPD). The main objectives are:

1. To develop a digital, theory-based Pursed Lip Breathing intervention protocol software system installed on smartphones for managing breathing exercises in stable COPD patients.
2. To pilot the methodological procedures of the pre-post study.
3. To determine the recruitment rate, retention rate, attrition rate, and software usage compliance during the subject recruitment and follow-up process of the pre-post study.
4. To evaluate the perception and satisfaction of COPD patients using the DT-PLB.
5. To preliminarily examine the effects of using the DT-PLB intervention on COPD patients, including the six-minute walking test, FEV1% predicted, FEV1/FVC, mMRC scale, COPD assessment test scale, and health points.
6. To identify any potential adverse events associated with the implementation of DT-PLB.

Participants will perform the following tasks during the intervention:

1. Register a personal account on the DT-PLB software.
2. Acquire knowledge and skills related to Pursed Lip Breathing by watching instructional videos.
3. Practice Pursed Lip Breathing for 10 minutes per session, three times daily for eight weeks, as per reminders and guidance provided by the software.
4. Earn health points by completing specific actions as instructed.
5. Optionally post individual texts on the peer forum for peer support within the DT-PLB software.
6. Complete two outcome assessments as scheduled.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with COPD satisfying GOLD criteria (Agusti, 2022) ;
* Being Chinese;
* Able to understand, speak, and hear;
* Clinically stable for at least three months prior to enrollment (Soler-Cataluna et al., 2018) ;
* The classification of GOLD grades for patients is mild, moderate, and severe, which means: FEV1/FVC\<70%, FEV1\>30%pre (Agusti, 2022) ;
* Participants who were mindful about the IT technology and known how to use a smartphone.

Exclusion Criteria:

* Impaired hand function causing inability to use the application;
* Have disorders in pleural effusion, pulmonary malignancy, heart diseases, stroke with sequels;
* Patients who have oral or nasal diseases cannot complete the exercise.
Impact of Preoperative Chemotherapy on Complications and Regeneration After Resection of Colorectal Liver Metastases

The objective of this study is to evaluate for the first time not only the impact of neoadjuvant chemotherapy on clinical outcome, but also on liver regeneration after liver resection.


Eligibility Criteria:
Inclusion Criteria:

* Liver resection due to colorectal liver metastases between 2003 and 2007

Exclusion Criteria:

* Incomplete assessment of preoperative chemotherapy
Shanghai Pediatric Cataract Study

The purpose of this study is to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of pediatric cataract participants, including congenital and traumatic cataract. The investigators will further investigate into the various genetic and environmental factors that may contribute to the pathogenesis of pediatric cataract.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of pediatric cataract
* Must be able to cooperate with the ophthalmic examination

Exclusion Criteria:

* Clinical diagnosis of mental illness
* Mentally disabled
Oral and Systemic aMMP-8 in Periodontal Disease

Periodontal disease is an inflammatory process that can result in tooth loss and also is considered a modifying factor for systemic health. Matrix metalloproteinase (MMP)-8 is the major collagenase of periodontal tissue breakdown. The aim of the present study is to analyze active (aMMP-8) levels in gingival crevicular fluid (GCF), saliva and serum in the context of new criteria of gingivitis and stage 3 grade C periodontitis.


Eligibility Criteria:
Inclusion Criteria:

* systemically healthy and non-smoker individuals aged 25 to 50 years
* having ≥20 teeth present (except third molars)
* individuals with periodontally healthy, gingivitis and stage 3 periodontitis diagnoses

Exclusion Criteria:

* having any systemic disease
* smoking
* pregnancy or lactation
* using antibiotic or any anti-inflammatory drug or any periodontal treatment within the past 6 months.
Influence of Arm Retraction on the Supraclavicular Approach for Subclavian Vein Catheterization

The purpose of this study is to determine the effect of arm retraction on the supraclavicular approach for subclavian vein catheterization in adults and children.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing general anesthesia regardless of subclavian venous catheterization

Exclusion Criteria:

* patients with infection over the puncture site history of thoracic surgery or clavicular fracture vascular malformation anatomical abnormality of subclavian vein
ROSA Knee System vs Conventional Total Knee Arthroplasty

This is a randomized clinical study, in which 150 patients with end-stage osteoarthritis will be enrolled to ROSA®-assisted knee arthroplasty or conventional knee arthroplasty. Patients are recruited at Zuyderland Medical Center, enrolled pre-operatively and followed up for 12 months post-surgery. In- and exclusion criteria are stated below.

After recruitment, participants will be invited for a pre-operative visit. During this pre-operative visit Informed Consent is signed and completion of patient-reported outcome measures (PROMs) is checked. Additionally, measurements regarding body composition, strength and fitness and metabolic outcomes are performed. Participants will have a blood sample taken. Scans, adverse event and medication use will be confirmed. Participants will receive a ActiGraph for collecting data from physical activity. Of all patients, 72 will undergo additional measurements (gait, proprioception).

During surgery ROSA- and surgery-data will be collected. Post-operative participants will have a 6-weeks, 3-month and 12-month visit. During these visits pre-operative measurements are repeated.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for primary TKA
* age 40-90 years
* Body-Mass-Index 18.5-50.0 kg/m2
* American Society of Anaesthesiologists Class I-III
* Willingness and capability to understand and follow protocol

Exclusion Criteria:

- Rheuma-/trauma-indicated knee arthroplasty
Safety Study of Multiple Peptide Vaccine to Esophageal Cancer

This is a phase 1 study of multiple peptide vaccine therapy and GM-CSF in treating patients with esophageal cancer.

LY6K (lymphocyte antigen 6 complex, locus K) was identified as a new target of tumor associated antigen using cDNA microarray technologies combined with the expression profiles of normal and cancer tissues. On the other hand, anti-angiogenic therapy is now considered to be one of promising approaches to treat of cancer. In this clinical trial, we evaluate the safety and immune responses of multiple peptide cocktail including LY6K and vascular endothelial growth factor receptor 1 (VEGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2) together with IFA and GM-CSF as immunoadjuvants in patients who had LY6K expressed primary esophageal cancer. Toxicity profiles will be monitored, and antigen specific T cell responses will be described.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have metastatic disease of esophageal cancer, and treatment has failed, or in the situation where effective therapy is not available, or has been refused due to severe adverse effects of chemotherapy
2. WHO performance status of 0 to 2
3. Age ≥ 20 years, ≤75 years
4. Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry
5. Expected survival of at least 3 months
6. WBC≥ 2,000/mm³ Platelet count ≥ 100,000/mm³ Total bilirubin ≤ 1.5 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper limits
7. Patients must be HLA-A2402
8. Primary lesion of esophageal cancer must express LY6K
9. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
2. Breastfeeding
3. Serious infections requiring antibiotics
4. Patient with peptic ulcer disease
5. Previous history of intestinal perforation
6. bleeding disorders (INR ≥ 1.5)
7. Necessity of drug-mediated inhibition with platelet function
8. Taking antithrombogenic agents within 10 days
9. Serious hypertension
10. Previous history of arterial thrombosis or venous thrombosis
11. Other malignancy within 5 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ
12. Clinically significant heart disease or previous history of myocardial infarction within the past 12 months
13. Concomitant treatment with steroids or immunosuppressing agent
14. Disease to the central nervous system
15. Decision of unsuitableness by principal investigator or physician-in-charge
Dentoskeletal Effects of Two Different Fixed Functional Appliances for Correction of Class II Malocclusion: A Comparative Clinical Study

Fixed Functional Appliances comparisons in treatment of orthodontic class II malocclusion cases

Comparison between two types of fixed functional appliances, the first one is the Mandibular Protraction Appliances, while the second one was the PowerScope Appliance.

the treatment duration was 6 months the patients age was considered according to Baccetti et al, CVMI 3,4

Eligibility Criteria:
Inclusion Criteria:

1. Skeletal and dental class II malocclusion with mandibular retrognathia, SNB\>= 4.
2. Patients in cervical vertebral maturation index 3 -5.
3. Age ranged from 13-16 years.
4. Overjet ≥ 5 mm.
5. Minimum crowding in dental arches requiring no extraction of any permanent teeth (excluding third molars).
6. Good oral hygiene and general health.
7. No previous orthodontic treatment or jaw's surgery.

Exclusion Criteria:

* Class I skeletal malocclusion
* periodontally compromised patient
* patients have systemic diseases interfering with orthodontic treatment
JASPER Implementation in NFLD

This study will focus on examining the supports required to enable community Senior JASPER Trainers to support the training and development of junior interventionists throughout the province of Newfoundland and Labrador, Canada. The study will examine the training and supports delivered by Senior Trainers to help junior interventionists provide a targeted social communication intervention (JASPER: Joint Attention, Symbolic Play, Engagement, and Regulation) with children with autism spectrum disorder (ASD). Children's engagement, play, and social communication outcomes will be examined as well as the influence of junior interventionists' intervention implementation on children's outcomes. Further, the study will examine the supports required to help junior interventionists who demonstrate slower gains in implementation fidelity after the first three months of standard support. Interventionists who are slow to gain implementation fidelity will be randomized to either (a) enhanced feedback plus peer support or (b) enhanced feedback plus intensive refresher course.

The proposed study is an adaptive intervention trial that will focus on tailoring supports for new JASPER interventionists. Coaching and training supports will be provided by Local Senior JASPER Trainers will support the development of new interventionists. Based on the interventionist's individual response to the coaching/training supports, a change in support may be provided at a priori time points including end of month 1 (training case) if at least 70% fidelity is not reached, and at end of month 4 (midpoint of first child cohort), at least 90% fidelity is not reached.

Eligibility Criteria:
Inclusion Criteria:

* Children: Must be 2.0-8.11 years of age; must meet the scoring benchmark for "autism" or "autism spectrum disorder" on the ADOS-2; has not previously received JASPER intervention in the province
* Interventionists: Work as an interventionist for the Government of Newfoundland and Labrador; minimum educational requirement is a Bachelor's Degree or Master's Degree in Psychology or a related field
* Senior JASPER Trainers: - Have been trained previously in JASPER; Work as a Senior Trainer for the Government of Newfoundland and Labrador; Minimum educational requirement is a Master's degree in a related field (e.g., Speech and Language Pathology, Occupational Therapy, Developmental Psychology).

Exclusion Criteria:

* Children: Child is below 2.0 years of age or above 8.11 years of age; Child does not meet the benchmark for autism or autism spectrum disorder on the ADOS-2; Child has received JASPER intervention prior to this study
* Interventionists: Not employees of the Government of Newfoundland and Labrador; does not hold a Bachelor's degree in a related field
* Senior Trainers: No prior JASPER training; Not employees of the Government of Newfoundland and Labrador; does not hold a Master's Degree in a related field
Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice.

This is a multi-center, randomized, double blind, vehicle controlled, study designed to evaluate the pediculicidal activity of Summers 5% L.A. compared to a vehicle control.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females 6 months of age or older.
2. Have an active infestation with pediculus capitis, the human head louse, with at least three live lice at baseline.
3. Agree not to use any other pediculicides or medicated hair-grooming products during the duration of the study.
4. Be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period.
5. Subject or guardian is able to understand the new HIPAA regulations and sign the HIPAA form.
6. Subject or guardian has read, understood, and signed appropriate informed consent in English. If English is not the primary language, the information about the study must be explained in their language and a copy of the informed consent must be in that language.
7. Subject is willing to participate in the study, and abide by the protocol requirements.

   -

Exclusion Criteria:

1. Participation in any clinical study within the past 30 days.
2. Known hypersensitivity to any ingredient in the product formulation.
Efficacy and Safety of Photodynamic Therapy for Unresectable Cholangiocarcinoma

The aim of this study is to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time, decreasing cholestasis and improving health-related quality of life (HRQoL) by comparing PDT puls stents versus stents alone in patients with unresectable cholangiocarcinoma,and to assess the safety of PDT by observing the complications after the procedure.

Cholangiocarcinoma (CCA) is difficult to diagnose due to its anatomic location, clinical course, and lack of definitive diagnostic criteria. It is often clinically silent with symptoms developing only in advanced disease. Surgical resection is the recommended curative intervention with only a minority of patients (10-20%) having potentially resectable tumors at time of diagnosis.

Endoscopic palliative therapy in CCA entails the relief of obstructive jaundice through transpapillary or percutaneous insertion of plastic or metal biliary stents. Although biliary decompression provides relief of cholangitis and improvement in quality of life, it does not improve survival.

Photodynamic therapy (PDT) in conjunction with biliary stenting may improve bile duct patency by local obliteration of malignant tissue through the cytotoxic effects of reactive oxygen species. Several studies suggest PDT plus biliary stent placement may prolong survival (range of 360-630 days), reduce cholangitis, and improve the quality of life of patients with advanced disease. The aim of this study is to determine the effectiveness and safety of PDT with biliary stenting compared to biliary stenting alone in the palliative treatment of unresectable CCA in China.

Eligibility Criteria:
Inclusion Criteria:

* Obtention of a written informed consent.
* Patient over 18.
* Patient with histologically proved cholangiocarcinoma ; histologic diagnosis must be proved by biliary brushing, bile cytology, endobiliary biopsy under Spyglass, or by EUS-FNA.
* Patient with Karnofsky score ≥ 50 %
* Patient capable of fill in the quality of life questionnaire

Exclusion Criteria:

* No written informed consent.
* Patients under or already treated by radiotherapy or chemotherapy treatment for cholangiocarcinoma.
* Patients with porphyria or hypersensibility to porphyrins.
* Pregnant, parturient or breastfeeding women.
* Patient under 18.
Protocol To Evaluate Patient Measurements After Ultrasonic Treatment

The objective of this study is to observe body contour changes following treatment using the MC1 device.

The purpose of this research study is to observe body contour changes following treatment using the MC1 device. The MC1 System is FDA cleared for relief of minor muscle aches, pain and muscle spasm, temporary improvement in local blood circulation, and temporary reduction in the appearance of cellulite.

Eligibility Criteria:
Inclusion Criteria:

1. Is female.
2. Is between 20 and 50 years of age, inclusive, on the day of enrolment.
3. Has a BMI between 20 and 30 kg/m2.
4. Is to be treated in the infra-scapular area using the MC1.
5. Has never been treated with the MC1 before.

Exclusion Criteria:

1. Patient is lactating, has a positive pregnancy test within 7 days of planned study procedure (for female patients of child-bearing potential), or intends to become pregnant during the study or is not using effective methods to prevent pregnancy.
2. Currently enrolled in another device or drug study that has not completed the required follow-up period, or has completed all other study-required follow-up less than 30 days before enrolment in this study.
3. Keloid scars, hypertrophic scars or a history of abnormal healing.
4. Thrombophlebitis.
5. Bleeding or bruising disorders (e.g. idiopathic thrombocytopenic purpura, anticoagulated patients).
6. Tissue ischemia in the area to be treated.
7. Hypertension or abnormally high blood pressure.
8. High cholesterol.
9. Active collagen vascular disease (e.g. fibromyalgia, panniculitis, lupus etc.).
10. Diabetes.
11. Epilepsy.
12. Tuberculosis.
13. Auxiliary electric organs (such as pacemakers), metal or myoelectric prosthesis.
14. Endocrine syndromes or thyroid hyperfunction.
15. Any type of hemorrhagic (bleeding) status.
16. Active skin infection, any infection in the treated area within the last 30 days or skin disease in the area to be treated (e.g. eczema, psoriasis, urticaria, dermographism).
17. Hepatic or renal insufficiency.
18. Bone, muscle or joint disease, dysfunction or healing in the area to be treated.
19. Malignancy in the area to be treated.
20. Laminectomy in the area to be treated. 5.2. Withdrawal and Replacement of Subjects
Raltegravir One Thousand Two Hundred vs Darunavir-cb in Immnunosupressed Patients: ROTDIP Study

Multicenter, randomized, open label pilot clinical trial with two parallel arms aimed to compare the efficacy of Raltegravir (RAL) 1200mg QD vs Darunavir/Cobicistat (DRV-cb) 800-150mg QD both in combination with alafenamide/emtricitabine (TAF/FTC) in patients with Human Inmunodefficiency Virus (HIV) infection and CD4\<200 cells/microL

The trial consists of two parallel arms to study the therapeutic success of 48 weeks, tolerability, immunological recovery, persistence of treatment, safety and results reported by the subject in severely immunocompromised HIV infected patients (with an initial CD4 count \<200 cells/μl) naive to antiretroviral therapy.

Included subjects will be randomized two to one (2:1) to RAL 1200mg QD plus FTC/TAF or DRV/cb (800-150mg) plus FTC/TAF.

Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18 years of age.
* HIV-1 infection.
* Naive to antiretroviral treatment.
* CD4 count at the beginning of the study \<200 cells/μl.
* Estimated glomerular filtration ≥ 50 mL / min, according to the formula CKD-EPI.
* Grant Informed Consent in writing to participate in the study

Exclusion Criteria:

* Breastfeeding, pregnant or women in childbearing age who do not commit to maintain barrier contraceptive measures during the trial.
* Concomitant use of any drug with possible pharmacological interaction with the study drugs that it is advisable to "avoid" through the database for interactions at the University of Liverpool (www.hiv-druginteractions.org).
* Previous use of any antiretroviral for HIV infection.
* Resistance to the study drugs, or presence of any contraindication to use it. The inclusion in the study can be carried out before receiving the result of the resistance test. Once it is received, in case of presenting any mutation of resistance to drugs of the indicated regimen, the patient will be removed from the study and will be offered the best available treatment for their medical condition at that time.
* Therapies that include interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressants at the entrance to the study.
* Current consumption of alcohol or other substances that at the discretion of the investigator may interfere with subject's treatment compliance.
* Subjects who currently participate in any other clinical trial using a research product, with the exception of studies in which the treatment studied has been stopped for more than 12 weeks.
* AIDS event in diagnosis of HIV infection or in the 3 months prior to the inclusion of the study.
* Suspected severe hepatopathy (grades B or C of the Child-Pugh classification), of any origin, according to the clinician.
* Any other clinical condition or previous treatment that, in the investigator's judgment, makes the subject unsuitable for the study or unable to comply with the dosage requirements.
Prehospital Translation of Chest Pain Tools

Decision aids such as the HEART Pathway, Emergency Department Assessment of Chest Pain Score (EDACS), Revised Geneva Score and PERC Score have similar ability to accurately risk stratify Emergency Department (ED) patients with possible Acute Coronary Syndrome (ACS) and Pulmonary Embolism (PE) and have become standard practice in the ED setting. This study seeks to determine whether prehospital use of these decision aids is feasible and determine which are the most sensitive and specific for prediction of ACS and PE, respectively.

To accomplish our Specific Aims the study team proposes a prospective, observational pilot study of four rapid risk stratification tools, the HEART Pathway Score, EDACS score, revised Geneva score, and PERC score, among 250 chest pain patients within two large EMS systems. The proposed pilot study has broad-based support from local and state EMS agencies, including Cumberland and New Hanover County EMS agencies. Each tool will be pilot tested and compared in the prehospital setting for feasibility and accuracy. Paramedics will be trained in risk stratification tool use and then will prospectively collect the clinical data needed to calculate each risk stratification score when caring for adults with chest pain. Completed paramedic risk assessments will be used to determine feasibility. Patients will be followed for 30 days to determine occurrence of ACS and PE events and the sensitivity of each risk stratification decision aid will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 21
* Acute non-traumatic chest pain
* Transported by Cumberland or New Hanover County EMS to a local Emergency Department

Exclusion Criteria:

* Patients with evidence of ST elevation myocardial infarction (STEMI) on ECG
* Inter-facility transports (transfers)
* Patients with unstable vital signs
* Prisoners
* Non-english speakers