cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of Laser Hair Depilation for Pilonidal Disease

Pilot study to assess tolerability and safety of laser hair depilation in adolescents and young adults with pilonidal disease.

This is a pilot study to measure safety and tolerance of laser hair depilation in adolescents and young adults with pilonidal disease as a potential treatment to intervene on future recurrence.

Up to a total of 10 patients will be enrolled.

Each patient will be involved in the study for one year. Patients will be brought into Surgery clinic for 1 laser treatment every 4-6 weeks to obtain a total of 5 treatments. Follow up will occur monthly from the time of initial treatment through 1 year after the last treatment as we evaluate for tolerance and efficacy.

Inclusion Criteria

* English and non-English speaking patients
* All Fitzpatrick skin types
* Age : 12-20 years
* Diagnosis of pilonidal disease

Exclusion Criteria

* History of photosensitivity
* Actively inflamed pilonidal sinus

Laser depilation treatment: Patients will be brought into Surgery clinic for 1 treatment every 4-6 weeks to obtain a total of 5 treatments. The treatment will consist of an 810 nm or Nd:YAG depending on Fitzpatrick skin type and tolerability. A cooling platform and application of topical lidocaine cream will be used to minimize any discomfort associated with the heat of the laser treatments.

Initial follow up for the laser depilation group will be performed to assess for tolerance of the laser treatment. Patients will report their pain every 6 hours for the first 48 hours after their laser hair depilation treatment. Once tolerance is established, patients will return to surgical clinic every month for their laser or placebo visit. After the 5th clinic visit, they will receive a telephone call monthly to assess for any evidence of resolution or recurrence of disease up to 1 year after the completion of the treatments.

Eligibility Criteria:
Inclusion Criteria:

* English and non-English speaking patients
* All Fitzpatrick skin types
* Age : 12-20 years
* Diagnosis of pilonidal disease

Exclusion Criteria:

* History of photosensitivity
* Actively inflamed pilonidal sinus
Chatbot Facilitated Education on Child and Adolescent Abuse

Background: Child and adolescent abuse and neglect (CAAN) cases are increasing both in Taiwan and worldwide. As the first healthcare professionals who come in contact with CAAN cases, nurses play a crucial role. Studies show that the lack of professional knowledge and ability of nursing staff on CAAN affects the effectiveness of timely identification and notification. Therefore, it is extremely important to improve the knowledge and ability of nursing staff to assess and report CAAN. With advancements in technology, continuing education for nurses is now more extensive than traditional lecture teaching. Online education, which breaks down the barriers of time and space in learning, has thrived after the COVID-19 pandemic. Chatbots are an option for individual learning and can increase accessibility and convenience for nurses learning how to recognize and report CAAN.

Objective: The aims of the study are to evaluate the effectiveness of using chatbots as teaching aids to assist nursing personnel in preventing child abuse. This evaluation will be the impact of learning on CAAN competency.

Method: The study utilizes an experimental design in which participants are purposively sampled and subsequently randomized into either the experimental or control group. The experimental group will use "chatbot" to facilitate teaching. The control group only receives lecture-based teaching. The course content is comprised of two main subjects: "CAAN" and "Nurses' Roles and Functions in CAAN," which was developed using the ADDIE model. The study employs the CAAN Knowledge and Competency Scale which retrieves from the Child abuse report intention scale (CARIS) by Feng and Wu (2005). Additionally, the learning effect is assessed at three different time points: before the course, one week after, and four weeks after.

Expected Results: The study predicts that the learning effects of the experimental group, which used chatbots, will be better than those of the control group. It is expected that these results will be able to implement in various educational fields, including CAAN and interdisciplinary teams.


Eligibility Criteria:
Inclusion Criteria:

Nurses who

1. work in Hualien Tzu Chi Hospital
2. finish the probationary period, directly do the practical care
3. want to participate and sign the consent

Exclusion Criteria:

The nurses will be excluded if they are in an administrative position or withdraw the protocol for any reason.
Leptin, IGF1 and the Refeeding Index

Background and study hypothesis:

Refeeding syndrome is a dangerous condition which could arise if patients who have had little or no food for many days, are started on any form of feeding. The metabolic consequences of this condition could affect the heart, lungs and nervous system of the patient and cause serious imbalance in the level of salts in the body.

The available guidelines for predicting that refeeding syndrome may occur are very subjective since they depend mainly on a history which is sometimes difficult to obtain from the patient.

The main biochemical landmark that refeeding syndrome has occurred is a fall in the phosphate levels once feeding has been started. There are currently no biochemical markers that can identify patients at risk of developing refeeding syndrome.

Leptin and IGF1 are hormones which have been observed to go down if someone has had little or no food for a while. The investigators therefore hypothesized that using a combination of leptin and IGF1 values in a 'Refeeding Index' would make the latter a useful biochemical marker to predict that refeeding may occur, hence take the precautionary measures to avoid its occurrence before starting feeding.

Design: Thirty five consecutive patients referred for commencement of parenteral nutrition (PN) were included. Serum leptin and IGF1 were measured prior to starting PN. Electrolytes, liver and renal function tests were measured before and daily for one week after initiating PN. The primary outcome was a decrease in phosphate on day two or three after initiating PN. A 'Refeeding Index' (RI) was defined as leptin x IGF1 divided by 2800 to produce a ratio of 1.0 in patients who are well nourished.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients referred for parenteral nutrition at King's College Hospital between January and April 2009.

Exclusion Criteria:

* Non adult patients (less than 18 years of age).
Vaginal Infection Study 2

This study will evaluate the efficacy and safety of a vaginal product compared with that of another vaginal product in the treatment of vaginal infections.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a clinical diagnosis of vaginal infection.
* Patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control.

Exclusion Criteria:

* Patients must not have any other infections
* May not be pregnant or nursing
* May not be receiving any other antimicrobial therapies or any medications that would interfere with the outcome of the study.
Portable Monitoring Device for the Diagnosis of Sleep Apnea in Patients With Chronic Obstructive Pulmonary Disease

Introduction:

The prevalence of overlap between Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea Syndrome (OSAS) is around 10%. This overlap syndrome is an important issue because is related to nocturnal desaturation and its complications. The use of portable monitoring devices (PM) for the diagnosis of OSAS was recently accepted as an alternative to full-night polysomnography (PSG). However, there are not studies evaluating the PM recording in COPD patients to detect or exclude OSAS.

Objective:

To evaluate if a PM (Stardust®, Respironics, Inc, USA) could accurately measure the apnea-hypopnea index (AHI) in COPD patients with a suspicion of OSAS.

Patients will be recruited from the Pneumology outpatient clinic of UNIFESP, Patients had been diagnosed with COPD in GOLD's stages II and III, were stable (no COPD exacerbation in the last three months), were using bronchodilators without a dose change during that period, and had symptoms suggestive of OSAS (loud snoring, reported breathing pauses during sleep and excessive sleepiness). We excluded patients with other sleep-related disorders, a diagnosis and/or previous treatment for OSAS, severe cardiovascular disorders or neuromuscular disease and those using oxygen, psychotropic drugs, alcohol or other drugs of abuse.

Patients will undergo two assessments of sleep, randomly determined: 1) PM at home for one night, 2) PM in the sleep laboratory simultaneously to the PSG. Three apnea-hypopnea index (AHI) values will be obtained and analyzed: a) AHI from PM at home, b) AHI from PM in the laboratory, and c) AHI from the PSG. Analyses of all evaluations will be performed by two trained technicians, blinded to study details.

Eligibility Criteria:
Inclusion Criteria:

* Presence of Chronic Obstructive Pulmonary Disease stage II and III of Global Initiative for Chronic Obstructive Lung Disease, stable for three months, and with symptoms suggestive of Obstructive Sleep Apnea Syndrome.

Exclusion Criteria:

* Presence of Chronic Obstructive Pulmonary Disease stage II and III
An Observational Study on the Safety Profile of MabThera/Rituxan (Rituximab) in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (MABERYC)

This prospective observational study will evaluate the safety of MabThera/Rituxan (rituximab) in combination with chemotherapy in patients with previously untreated or relapsed/refractory B cell-lineage chronic lymphocytic leukaemia. Data will be collected from each patient for 6-12 months, depending on the prescribed chemotherapy regimen.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* B cell-lineage chronic lymphocytic leukaemia (B-CLL)
* Prescribed with MabThera/Rituxan in combination with chemotherapy according to the approved SMPC
* Informed consent to data collection

Exclusion Criteria:

* Treatment with any marketed or non-marketed drug substance or experimental therapy within 4 weeks prior to first dose of study drug or participation in a clinical trial within 30 days prior to entering this study
* Any other tumour disease
Molecular Study and Precision Medicine for Colorectal Cancer

Researchers collect specimens from advanced or recurrent colorectal cancer (CRC) patients to conduct molecular profiling and establish tumor organoids (PDOs)/ patient-derived xenografts (PDXs). The aim of this study is to identify clinical actionable targets and predict in vivo response of the tumor to targeted drugs by using PDOs/ PDXs. And the above-mentioned studies will provide the patients with potential personalized cancer treatment options.

Patient-derived organoid is a model that can recapitulate the histology and behavior of the cancer from which it is derived, and is increasingly used as a tool for drug development in pre-clinical settings. Clinical treatment option of colorectal cancer now is quite limited. By molecular profiling, clinical actionable alterations may be identified. And according to the genomic investigation results, we can find the matched targeted drugs, following further testing in the organoids and PDXs. This will provide an opportunity to guide the precision medicine.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, age 18 to 75 years old
* Patients with a documented (histologically- or cytologically-proven) advanced or recurrent colorectal cancer
* Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 and a life expectancy of at least 3 months
* Patients, both male and female, who are either not of childbearing potential or who agree to use a medically effective method of contraception during the study and for 3 months after the last dose of study drug.
* Patients with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.

Exclusion Criteria:

* Patients with any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluation of the safety of the study drug
* Patients with abnormal coagulation function, bleeding tendency, or receiving thrombolytic or anticoagulant therapy
* Patients with any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever \> 38ºC within 2 weeks prior to first study drug administration.
* Patients with a history of human immunodeficiency virus (HIV) or any other immunodeficiency disease.
* Patients who are currently using certain drugs that are not permitted
* Patients with a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies
* Patients with the inability, in the opinion of the Investigator, to comply with the protocol requirements
Clinical Presentations Before AMI Onset and Coronary Atherosclerosis

This study aimed to evaluate the incidence of preinfarction angina in AMI patients and test the hypothesis that different clinical presentations before AMI onset can affect coronary plaque morphologies in AMI patients .

Patients with AMI who underwent primary percutaneous coronary intervention（PCI） and optical coherence tomography (OCT) examination is expected to be included in this study.Data about history were prospectively collected by a standard questionaire ,especially regarding the detail information about preinfarction angina.The basic clinical characteristics,angiographic and OCT findings are compared between patients with and without preinfarction angina.

Eligibility Criteria:
Inclusion Criteria：

1. Men or non-pregnant women \>18 years of age and \< 85 years of age;
2. Patients undergo cardiac catheterization for AMI;
3. Patients able to provide written informed consent.

Exclusion Criteria:

1. Patients cant afford medical history;
2. Cardiac shock；
3. Severe left ventricular dysfunction;
4. Left main disease;
5. Hepatic or kidney dysfunction;
6. OCT was performed after predilation;
7. Poor OCT image or massive thrombus.
Nurse-led Smoking Cessation Program With Follow-up in Healthy Life Centres: a Randomized Clinical Trial

A better understanding of how to incorporate effective smoking cessation measures into clinical practice is requested. In this is prospective, multi-center, randomized, open, blinded end-point (PROBE) trial, we assigned daily smokers hospitalized with an acute cardiac event 1:1 to an in-hospital nurse-led smoking cessation intervention with direct referral to further follow-up in the municipal healthy life-centres (intensive intervention) or to written information about smoking cessation and the municipal program (low-threshold intervention) . The primary outcome will be the smoking cessation rates between the groups at 6 months follow-up. Key secondary outcomes include a cost-effectiveness analysis of the intensive intervention and cessation rates at 3- and 12-months follow-up, the proportion who used nicotine replacement therapy and the proportion who attended the healthy-life center program between the two groups. We also assess effects of recurrent cardiovascular events and mortality after 12 months, two and five years follow-up. Exploratory analyses include new knowledge about the patient and system factors of importance for participation to healthy life-centers and for changes in smoking behaviour.


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years and smokes at least 1 cigarette daily
* Hospitalized with an acute cardiovascular event (i.e. myocardial infarction, unstable or stable angina, arrythmias, stroke, transitory ischemic attac, carotid stenosis or claudication with need for revascularization)
* established atheroscledrotic cardiovascular disease
* Sign informed consent and is expected to participate according to ICH /GCP

Exclusion Criteria:

* Does not usually live or work in the Vestre Viken catchment area
* Any condition (e.g. psychosis, alcohol abuse, dementia) or situation that may pose a significant risk to the participant, confuse the results or make participation unethical
* Lack of Norwegian and English knowledge
* Short life expectancy (\<12 months)
Pharmacotherapy Prescribing Pattern and the Adherence Level to Iron Chelation Therapy in Thalassemia

Thalassemias are a heterogeneous grouping of genetic disorders that result in dysfunctional Hb, reduced RBC life span leading to chronic anemia . Thalassemia is endemic in the Middle East. Iron chelation therapy (ICT) is one of treatment used however ICT is associated with patients adherence problem thus impacting its effectiveness .

Thalassemias are a heterogeneous grouping of genetic disorders that result from a decreased synthesis of alpha or beta chains of hemoglobin resulting in dysfunctional Hb, reduced RBC life span and hemolytic anemia as well as ineffective erythropoiesis leading to chronic anemia. Thalassemia is endemic in the Middle East, the Mediterranean region, and Southeast Asia, its prevalence in these region range from 7%-10%. There are 3 iron chelators licensed for clinical use, namely, deferoxamine (DFO), deferiprone (DFP), and deferasirox (DFX). Advancement in blood transfusions and ICT transforms this disease from fatal childhood disease to adult chronic disease . From other side, thalassemic patients on ICT suffering from therapy related challenge such as nonadherence, Nonadherence to ICT remains a long-standing and serious issue in thalassemia with ranges from 30% to 80% World widely. Issue of nonadherence and suboptimal responsiveness to ICT is complex and multifactorial such as side effects and administrations on top of inadequate knowledge and practice lead to reduced adherence to ICT thus increasing morbidity and mortality

Eligibility Criteria:
Inclusion Criteria:

* male and female patients with age above 3 years old diagnosed with thalassemia,
* having iron overload
* taken Iron chelation therapy
* having the acceptance to participate in the study.

Exclusion Criteria:

* renal and hepatic impairment,
* Allergic to any drug of the study
* history of viral hepatitis or HIV
* Gastrointestinal disorder affecting drug absorption.
* psychiatric disorder affecting consent agreement and unable to comply with study.
Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2)

To evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of the anti-FGFR2 antibody drug conjugate BAY1187982 in subjects with advanced solid tumors known to express fibroblast growth factor receptor 2 (FGFR2)


Eligibility Criteria:
Inclusion Criteria:

* All subjects must be \>/= 18 years at the first screening examination / visit
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Subjects with advanced, histologically or cytologically confirmed solid tumors described to express fibroblast growth factor receptor 2 (FGFR2) that are refractory to any standard therapy
* For maximum tolerated dose (MTD) Dose Expansion: Subjects with advanced, histologically or cytologically confirmed triple-negative breast cancer who had undergone within 4 lines of systemic anti-cancer treatment and not eligible for standard therapy anymore.
* Subjects need to have evaluable disease (measurable or not measurable).
* Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of treatment

Exclusion Criteria:

* History of allergic reactions to monoclonal antibody therapy (or excipients in the formulation)
* Anti-cancer chemotherapy, experimental cancer therapy including clinical trial, or cancer immunotherapy within 4 weeks prior to the first dose of the investigational drug.
* Toxic effects of previous anti-cancer chemotherapy, experimental cancer therapy, or cancer immunotherapy have not normalized.
* History of symptomatic metastatic brain or meningeal tumors unless the subject is longer than 3 months from the end of definitive therapy before the first dose of the investigational drug and has clinically or radiologically no evidence of tumor growth.
* History of clinically significant cardiac disease
* Congenital coagulation abnormalities
* Subjects who are pregnant or are breast-feeding
Comparative Study Between Liberal and Conservative Oxygen Therapy in Mechanically Ventilated Intensive Care Patients

To assess the benefits and drawbacks of high versus low oxygen therapy on mortality and myocardial function in mechanically ventilated patients


Eligibility Criteria:
Inclusion Criteria:

* adults aged 18 years or older admitted to ICU and expected to receive mechanical ventilation beyond next calendar day

Exclusion Criteria:

* inclusion in other trial
* severe acute respiratory distress syndrome at time of admission
* acute Chronic obstructive airway disease exacerbation
* pregnancy
* Carbon monoxide poisoning
* Guillain Barre syndrome
The Study of Gut Associated Lymphocytes in HIV and HCV/HIV Co-infected Patients

The purpose of this research study is to explore what role immune cells within the gut (the sigmoid colon) have locally and on the immune system of patients infected with HCV, HIV or HCV/ HIV co-infection.

Objective 1: Characterization of the Gut Associated Lymphocytes (GALT) in HIV, HCV and coinfected patients regarding the role of Th17 and cytokine profiles.

Hypothesis 1a: HIV and HCV/HIV coinfection is associated with changes in Th17 numbers and functions in GALT.

Hypothesis 1b: HIV and HCV/HIV coinfection is associated with changes in cytokine profiles in intestinal mucosa.

Objective 2: Identify the relationship between changes in Gut Associated Lymphocytes (GALT) in HIV, HCV and coinfected patients and markers of microbial translocation.

Hypothesis 2a: Changes in GALT are associated with increase in microbial translocation in HIV, HCV and coinfected patients.

Eligibility Criteria:
Inclusion Criteria:

* are at least age 18, but not older than 70 years old
* have HIV, HCV or both
* do not have HIV, HCV or both, and are having a screening colonoscopy or flexible sigmoidoscopy for abdominal pain or colon cancer screening (control subject)

Exclusion Criteria:

* have a history of inflammatory bowel diseases (IBD) or suspected IBD
* have a history of autoimmune diseases including rheumatoid arthritis
* are taking systemic immunomodulators
* are pregnant