cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Kinesiology Tape Wrapping for Paronychia Induced by Epidermal Growth Factor Receptor Inhibitors

Epidermal growth factor receptor inhibitors(EGFRIs) have been applied in several common malignancies including advanced non-small cell lung cancer. Paronychia is one of the most common cutaneous side effects, characterized by inflamed granulation tissue around the nails leading to pain and reduced quality of life. Despite available conventional therapies such as topical beta-blockers or chemical cauterization, some patients still do not respond well. Our previous pilot study suggested that adding Kinesiology tape wrapping to the conventional treatment may effectively improve pain and granulomas in patients with treatment-resistant EGFRI-related paronychia, with good safety. This study aims to evaluate the clinical efficacy and safety of using Kinesiology tape wrapping as an adjunct to conventional therapy for patients with EGFRI-related paronychia.

In this study, eligible patients with paronychia affecting their big toes will be included and randomized to receive a combination of Kinesiology tape wrapping and conventional treatment, or conventional treatment alone for 3 months. Patients are evaluated at baseline, at 1, 2, 4, 8, and 12 weeks after the initiation of the treatment. These evaluations will occur at the outpatient department or through phone contact and photos taken by patients if they cannot visit in person. Efficacy endpoints include pain numerical rating scale (NRS) and scoring system for paronychia related to oncologic treatments (SPOT). Besides, any side effects will be recorded at each visit.

Eligibility Criteria:
Inclusion Criteria:

* EGFR inhibitors-induced paronychia
* Having at least one big toe involved with CTCAE(Common Terminology Criteria for Adverse Events) grade 2-3 paronychia

Exclusion Criteria:

* Younger than 20 years
* severe ingrown nails
* concomitant cutaneous infection
* severe nail destruction
* chronic paronychia with severe periungual fibrosis
Study to Assess the Efficacy and Safety of Endolex Forte VErsus Diosmin and Hesperidin in Reducing VeNous Insufficiency

The trial is designed as a randomized, multicenter, open label, comparative, 6 months, clinical study.

A randomized, multicentered, open label, comparative study to assess the efficacy and safety of Endolex Forte® versus a combination of micronized diosmin (450 mg) and micronized hesperidin (50 mg) in reducing the symptomatology of patients diagnosed with Chronic Venous Insufficiency which is rated between functional classes CEAP 1-4, during a period of 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients, male or females aged 18 to 75 years old
* BMI≤40
* Presence of chronic venous insufficiency which is rated between functional classes CEAP 1-4
* Patients diagnosed with superficial vein thrombophlebitis and have skin reaction by redness, swelling, fever and pain symptoms.or patients presenting a painful venous symptomatology in the lower limbs for at least 30 days.
* Willing and able to give written informed consent prior to participation in the trial
* Patients expected to be compliant with the study treatment

Exclusion Criteria:

* Known allergy to the product's ingredients
* Pregnancy or breastfeeding
* Patient is involved in any other clinical trial
* Deep vein thrombosis
* Stasis dermatitis
* The patient is taking non-steroids anti-inflammatory drugs include oral , topical creams or patch form)
* Open ulcers or lower extremity amputation
* Patient treated by venotonic treatments or vascular protectants or assimilated dietary supplements or homeopathic treatments or diuretics within 15 days prior inclusion
* Patient presenting permanent oedema,
* Patient with a history of lower limbs trauma responsible for sequel pains
* NYHA III and IV Heart Failure
* Renal Failure
* Untreated or uncontrolled Arterial Hypertension
* Hepatic Failure
* History of a known liver disease such as hepatitis A, hepatitis B, or C.
* Malignant neoplasms, from any etiology, or who are receiving any type of anticancer treatment, unless when properly treated and with no evidence of recurrence during the last five years
* Previous history of alcoholism, drug abuse, psychological or emotional problems in the last 5 years that can invalidate the Informed Consent Form or restrain participant's ability to comply with the requirements of the protocol.
* Immobility.
Evaluation of EverOn™ System in Medical / Surgical Ward

The EverOn™ system developed by EarlySense, Ltd., the sponsor of this study, is intended to assist hospitals to better address and improve recognition and response to changes in a patient's condition.

The system, monitors the patient while in bed consists of a contact-free sensor that is placed under the bed mattress and identifies respiratory and heart rates, degree of patient's movement or agitation while in bed as well as patient's actual exit out of the bed. The EverOn system does not require a physical contact with the patient, eliminating the need for any direct contact electrodes, leads, cuffs or nasal cannulae.


Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years.
2. Patients not monitored continuously by telemetry, vital sign monitor or oximetry.
3. Patients not requiring special mattresses (e.g. airflow).
4. The patient or a legal guardian is ready to sign the Informed Consent.

Exclusion Criteria:

1. Patients that at the judgment of the staff in the evaluating unit, are not able to communicate coherently and respond to nurses' questions.
2. Patients monitored continuously by telemetry, vital sign monitor or oximetry.
3. Patients requiring special mattresses.
Coaching Intervention in Women At-risk for Common Mental Disorders

This study aims to provide coaching intervention for prevention of developing common mental disorders to 60 at-risk women in Hong Kong.

Participants will be recruited through online screening tool. Eligible subjects with informed consent provided will be randomly assigned to coaching group or self-help tips plus telephone support group.

To test the effectiveness of the coaching intervention, data collection will be conducted on demographics, symptoms and psychosocial aspects at baseline, immediately, 3-month and 12-month post-intervention. A self-reported brief questionnaire will be administered at every intervention as well.

Eligibility Criteria:
Inclusion Criteria:

* Willing to provide written informed consent
* Able to understand Cantonese and read/write Chinese
* With subsyndromal or minor common mental disorders (CMD) indicated by 10 - 20 of Depression subscale of Depression, Anxiety and Stress Scale (DASS) or 8-14 of Anxiety subscale of DASS

Exclusion Criteria:

* Those mental conditions that require other treatment priorities (e.g., suicidal risk, substance abuse, current or past episodes of psychotic disorder, personality disorders)
* Those medical conditions that severely limit participation, comprehension, or adherence to treatment (e.g., epilepsy, dementia, terminal medical illness)
* Those who are receiving structured psychotherapy or counseling
Safety and Efficacy of HO/02/02 20µg vs. SoC (Aloe Vera) to Reduce Radiation Dermatitis

This is a single-center, open-label, randomized, prospective study evaluating the safety and efficacy of HO/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment fields vs. standard of care (SoC), Aloe Vera treatment

This is a single-center, open-label, randomized, prospective study evaluating the safety and efficacy of HO/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment fields vs. standard of care (SoC), Aloe Vera treatment in addition to sterile water for irrigation applied daily for 15 minutes (with gauze) on treatment fields to create the same cooling effect as in treatment arm 1. Both treatment arms 1\&2 treatments will be applied topically once daily for up to 8 weeks to reduce radiation dermatitis in up to 90 breast cancer patients undergoing adjuvant radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Female patients 18 years old and above.
* Histology confirmed unilateral breast cancer following lumpectomy
* Planned to receive 50 Gy, whole breast XRT and regional lymph nodes radiation.
* ECOG performance status 0-2
* Completed Chemotherapy 3 weeks prior to XRT (if applicable)
* Patient should be available for the entire study period, and be able and willing to adhere to protocol requirements;
* Patient must sign an informed consent form prior to undergoing any study-related procedures

Exclusion Criteria:

* Known uncontrolled diabetes
* Prior radiation to breast
* Known connective tissue disorder
* Known skin disease over the treated breast
* Prior burn over treated area
* Evidence of infection or inflammation of breast to be treated.
* Receiving biological therapy or hormone therapy (other than Herceptin) during radiation treatment/study duration and 4 weeks prior to study entry.
* Pre-existing skin breakdown within the planned radiotherapy field at the time of study entry.
* Pregnancy, planned pregnancy, lactation or inadequate contraception as judged by the Investigator.
* Participation in another investigational drug or vaccine trial concurrently or within 30 days.
* Use of any other topical or systemic treatments aimed at radiation dermatitis.
* Use of a prescription or over-the-counter medication that contains hydrocortisone or any other cortisone or corticosteroid containing preparation
Comparison of Subjective Experiences Between Patients Receiving Clear Aligners or Fixed Appliances

This study aimed to compare experiences between adult patients receiving clear aligners and fixed appliances during the initial stage of orthodontic treatments.

Patients receiving either clear aligner treatments were enrolled in this study. During the same time period, patients receiving fixed orthodontic treatments well-matched with clear-aligner patients by similar ages (difference \< 3 years), same gender and similar levels of severity of malocclusion \[similar Index of Complexity Outcome and Need (ICON) level\] were enrolled.The two groups were well-matched with ages, gender and levels of malocclusion severity. Pain perception, anxiety and quality of life were assessed through visual analogue scale (VAS), state-trait anxiety inventory (STAI) and oral health impact profile-14 (OHIP-14), respectively.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older;
* Must be in good general health;
* Upper and lower arches were both involved in two groups;
* The fixed appliances group must be treated with wires and brackets only with the initial arch wire of 0.012 NiTi ;
* Must be willing to sign and give written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

* Once been undergoing with orthodontic treatment;
* Experienced tooth ache recently;
* Been diagnosed with contagious and/or systematical diseases;
* Have taken any kind of painkillers three days before the initial treatment;
* When Trait Anxiety Inventory (T-AI) shows a score believed to define a psychological state of over anxiety (male over 53 points and female over 55 points).
Effectiveness of High Intensity Electromagnetic Therapy and Pelvic Floor Exercises in Women With Urinary Incontinence

The aim of this study is to evaluate the effect of pelvic floor exercises and high intensity electromagnetic therapy on pelvic floor muscle function, quality of life and urinary parameters in women with stress urinary incontinence. The individuals to be included in the study will be selected from women with stress urinary incontinence who receive follow-up from Medipol Acıbadem Hospital. Women who meet the inclusion criteria will be explained the details of the study by the responsible researcher and an informed consent form will be presented. The study is planned as two groups:

Group 1: Pelvic floor muscle training (PBST) group. Group 2: Pelvic floor muscle training and high intensity functional electromagnetic stimulation (HIFEM) treatment group.

Envelope opening method will be used for randomisation of the participants into two groups. They will be included in the first or second group according to the number in the envelope they choose.

Each participant will be given a baseline assessment. Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists. Participants in 2 groups will also receive HIFEM treatment for 6 weeks, 2 days a week for 28 minutes. The evaluations will be repeated at the end of the treatment.

Research Outcome Measures:

Demographic and Clinical Characteristics International Incontinence Consultation Questionnaire-Short Form Urogenital Distress Inventory (UDI-6) Quality of Life King Health Survey Muscle function Emg-Biofeedback


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as stress urinary incontinence by a physician,
* Between the ages of 20-65,
* Has not had recurrent vaginitis infection,
* Women with no active urinary tract infection or more than 3 urinary tract infections in the last 1 year will be included in the study.

Exclusion Criteria:

* History of cardiac implant or untreated cardiac arrhythmia,
* The presence of a metal implant,
* Vaginal and pelvic surgery within the last 6 months,
* Gave birth within the last 12 weeks and had a history of miscarriage within 6 weeks,
* A recent surgical procedure,
* Any concurrent UI treatment,
* With renal and hepatic insufficiency,
* Neurological or neuromuscular disease
* It will be excluded in case of any contraindication listed in the investigational device manual.
Observational Study in Localized Osteosarcoma

Observational prospective trial aimed to collect the collect demographic, clinical, surgical, pathological and molecular characteristics and treatment from patients affected by localized OsteoSarcoma (OS) treated according the AIEOP/Italian Sarcoma Group (ISG) OS 2021

Osteosarcoma is the most frequent primary malignant bone tumor in children and adolescents and is considered a rare disease.

The overall incidence of OS is 0.2-3 / 100,000 inhabitants per year with a bimodal distribution by age, with a first peak in adolescence.

Currently, the treatment strategy for localized OS includes courses of neo-adjuvant chemotherapy based on 3 agents: Adriamycin (ADM), cisplatin (CDP) and high dose methotrexate (HDMTX) followed by surgical removal of the primary tumor and subsequent adjuvant chemotherapy treatment.

The MAP (Methotrexate, Adriamycin, cisPlatin) regimen, with or without ifosfamide (IFO) and etoposide (ETO), is considered the "gold standard" for the treatment of localized osteosarcoma.

Given the rarity of the disease, it is considered appropriate to collect information prospectively on the diagnosis, chemotherapy and surgical treatment and outcomes on patients treated by the network of AIEOP and ISG Centers according to the recommendations on the treatment of localized OS AIEOP/ISG OS 2021.

This study will be active up to the next interventional prospective protocol aimed at the therapy of high-grade, non-metastatic OS.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of high grade OS of the extremities
* Age at diagnosis ≤ 40 years at the time of diagnosis
* Localized disease (skip metastases are allowed)
* Adequate organ function according the AIEOP/ISG OS 2021 recommendation
* Patients or parents oe guardians of minors who have given their written informed consent to participate in the study

Exclusion Criteria:

* Presence of metastases
* Diagnosis of periosteal OS, of parosteal OS or secondary OS
* Any medical condition which can not allowed the use of the treatments recommended by AIEOP/ISG OS 2021
Fibrin Sealant VH S/D 500 S-apr in Hepatic Resection

The purpose of the study is to compare safety and efficacy of Fibrin Sealant (FS) Vapor Heated (VH) S/D 500 s-apr with manual compression as a supportive treatment of local bleeding (i.e. oozing) in hepatic resection surgery when standard surgical techniques are insufficient.


Eligibility Criteria:
Pre-Operative Inclusion Criteria:

* Signed informed consent obtained from the subject before any study-related activities
* Subject's age is 18 years or above
* Subject will undergo planned, elective resection of at least 1 anatomical segment of the liver for any reason by laparotomy
* Subject is willing and able to comply with the requirements of the protocol
* Female subjects of childbearing potential must present with a negative serum or urine pregnancy test within 72 hours before the elective liver resection
* Female subjects of childbearing potential must agree to employ adequate birth control measures for the time of their participation in the study

Intra-Operative Inclusion Criteria (before randomization):

* Resection of at least 1 anatomical segment of the liver has been performed
* Oozing from the cut surface of the liver persists after conventional resection procedure and primary control of arterial and venous bleeding by sutures, ligations, clips, vascular stapler, point electrocautery or focal radiofrequency ablation
* Need for additional supportive hemostatic treatment to stop bleeding (i.e. diffuse oozing) of the liver resection area

Pre-Operative Exclusion Criteria:

* Subject needs emergency liver surgery
* Subject will undergo liver resection via laparoscopic procedure
* Subject has known congenital coagulation disorder (e.g. hemophilia)
* Subject has known hypersensitivity to any ingredient of the investigational medicinal product
* Suspected inability or unwillingness of the subject to comply with trial procedures
* If female, subject is pregnant or lactating at the time of study enrollment
* Subject has already participated in this study (each subject can only be enrolled once)
* Subject has participated in another clinical study involving an investigational product or investigational device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational product or investigational device during the course of this study

Intra-operative Exclusion Criteria (before randomization):

* Occurrence of any severe surgical complication that require resuscitation or deviation from the planned surgical procedure
* Disseminated intravascular coagulopathy (DIC)
* Application of any topical hemostatic material on the resection surface of the liver prior to application of the study treatment
* Radiofrequency precoagulation of the liver resection surface, except focal use of radiofrequency as primary hemostatic treatment
CEND-1 Injection (QLC12102) in Patients With Advanced Metastatic Pancreatic Ductal Adenocarcinoma

The purpose of this study was to evaluate the preliminary safety, efficacy and PK characteristics of cend-1 in patients with advanced metastatic pancreatic ductal adenocarcinoma (Chinese population).

This study is a multi-center, non-randomized, open-label phase Ib/II clinical study carried out in Chinese patients with advanced metastatic pancreatic ductal adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 80 years old, male or female.
* Patients with histologically confirmed metastatic pancreatic ductal adenocarcinoma;
* The Eastern Cooperative Oncology Group (ECOG) score is 0 to 1.
* The life expectancy is no less than 12 weeks.
* According to the RECIST v1.1 evaluation criteria, the patient has at least one measurable lesion (exclude if there is only a target lesion located at a site previously treated with radiation);
* The patient who is suitable for first-line treatment with a combined regimen of paclitaxel (albumin-bound type) and gemcitabine;

Exclusion Criteria:

* The patients who have been previously treated with chemotherapy or other drugs for pancreatic carcinoma, or who have been treated with other anti-cancer drugs, including chemotherapy, targeted therapy, immunotherapy, or biologics.
* The patients who are known to be allergic to the investigatinal drug (CEND-1 analogue) or its any excipient;
* The patients with the following conditions: myocardial infarction, severe/unstable angina, NYHA grade 2 or above cardiac dysfunction, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention within 6 months before signing the ICF;
* The patients with symptomatic CNS metastasis, leptomeningeal metastases, or spinal cord compression due to metastasis. However, the patients with symptomatic CNS metastasis before first administration of the investigational drug, who is treated and stable for no less than 4 weeks, and the systematic hormone (any dose) treatment has been stopped for over 2 weeks, can be enrolled;
* The patients with other active malignant tumors within 3 years before signing the ICF. The cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast ductal, and papillary thyroid cancer are excluded.
* The patients with human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis or co-infection with hepatitis B and C.
* The patients who participated in any other drug clinical trial and administrated the investigational drug within 4 weeks before first dose;
A Study Investigating the Change in Metabolism Phenotype in Paediatric, Adolescent & Young Adults With Hodgkin or Non-Hodgkin Lymphoma.

PEGASUS aims to test acceptability and feasibility of studying phenoconversion (the change in metabolism phenotype) using probe medications in a paediatric oncology patient population. The study will be conducted in patients (6-25 years of age) with Hodgkin lymphoma or non-Hodgkin lymphoma as exemplar cohort, but with the understanding that cancer-directed and supportive care medicines of the CYP3A4, CYP2C19, and CYP2D6 metabolic pathways are commonly utilised for the treatment of many paediatric, adolescent, young adult, and adult cancers.

The study involves administration of the probe medication at timepoints which align with pre-determined hospital visits for the treatment of lymphoma and subsequent blood draws to measure the metabolism of the probe medications.

The acceptability and feasibility of this study will inform future studies in phenoconversion within the paediatric cancer population to direct more personalised precision medicine.


Eligibility Criteria:
Inclusion Criteria:

* Age 6-25 years of age.
* New diagnosis of Hodgkin Lymphoma or Non-Hodgkin Lymphoma.
* Able to swallow and absorb oral or nasogastric tube (NGT) administration of probe drugs.
* Able to provide written informed consent.

Exclusion Criteria:

* Failure to comply with inclusion criteria.
* Has a known previous allergy to any of the probe medications (i.e., omeprazole or dextromethorphan).
* Common Terminology Criteria for Adverse Events (CTCAE) Grade IV end organ dysfunction (i.e., hepatic, renal, gastrointestinal).
* Had previous oncological treatment (not first cancer diagnosis).
* Is a clinically unstable patient requiring intensive care admission in high-risk circumstances will not be considered eligible for consent.
* Any patient requiring urgent initiation of anti-cancer treatment outside hours where a member of the study staff is unable to approach the parent/guardian or participant for consent prior to commencing anti-cancer therapy will be ineligible for consent.
* Unable to provide written informed consent.