cyrilzakka/clinical-trials huggingface dataset:
Laparoscopic Single Incision -Vs- Multiple Incision Gastric Band Surgery

A double blinded randomised control trial comparing the differences between laparoscopic single incision versus multiple port bariatric surgery in morbidly obese patients (BMI\>35). Single incision surgery is a new minimally invasive surgical technique requiring the surgeon to operate through one small single incision and is virtually scarless. The traditional laparoscopic approach to abdominal surgery is through multiple small incisions (4-7 ports) across the whole abdomen. This study seeks to identify the risks, benefits and costs of the adjustable gastric band insertion via single incision and multiple incision within the morbidly obese patient group.


Eligibility Criteria:
Inclusion Criteria:

* Morbidly obese patients, BMI ≥35 kg/m2
* Undergoing gastric band surgery
* Undergone a pre-weight loss surgery risk assessment
* Fit for anaesthesia and surgery
* Fulfil day surgery criteria
* Full understanding of bariatric procedure, with informed consent of the risks and benefits of laparoscopic single incision and multiple incision surgery

Exclusion Criteria:

* Pregnancy
* History of portal hypertension
* Previous gastric surgery or large hiatus hernia
* Previous laparotomy or bariatric surgery
* Weight \>150kg (day surgery limit)
* Unwilling to consider surgical treatment
Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty

A structured consent process, in combination with one or a number of the aforementioned modalities (nursing education, handout, video, etc), may reasonably be expected to improve surgical informed consent. The investigators hypothesized that overall patient knowledge/retention would be influenced by the type of consent process and that more intensive training and review would result in better patient retention and recall. The investigators further hypothesized that the knowledge retention would decline following the consent process and surgery, but in a stratified manner based on the nature of preoperative teaching.

please see details above

Eligibility Criteria:
Inclusion Criteria:

1. recommended total knee arthroplasty

Exclusion Criteria:

1. Unwilling to participate
2. Unable to complete questionnaire in English
Skin Barrier Assessment in Pregnancy and at Birth

This is a prospective birth cohort study assessing the role of maternal and environmental factors on the development of allergic diseases in children. Pregnant mothers will be enrolled and we will examine her skin barrier with skin tape strips (STS) and transepidermal water loss (TEWL), along with blood work. We will then follow her offspring and perform similar testing, along with detailed questionnaires inquiring about exposures such as use of detergents and soaps, sunlight exposure, and pollution exposure. When the infant is around 12 months old, we will contact the family via telephone to see if the child developed any allergic conditions within their first year of life, such as eczema, food allergy, or wheezing. A final questionnaire will be performed.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria of the pregnant women:

• Pregnant women at any stage of a singleton pregnancy.

Inclusion criteria of the infant:

• Infant is the offspring of a woman enrolled in the study.

Exclusion Criteria:

Exclusion criteria of all subjects:

* Use of systemic immunosuppressive drugs including oral steroids within 30 days of skin barrier assessment
* Has received total body phototherapy (e.g., ultraviolet light B \[UVB\], psoralen plus ultraviolet light A \[PUVA\], tanning beds \[\>1 visit per week\]) within 30 days of skin barrier assessment
* Use of topical corticosteroids, topical immunomodulatory agents, or topical antibiotics on the extremity being evaluated within 7 days of skin barrier assessment
* Use of systemic antibiotics, antiparasitics, antivirals, or antifungals within 7 days, or antihistamines within 5 days of skin barrier assessment
* Has taken a bleach bath within 7 days of skin barrier assessment
* Use of emollients on the extremity being evaluated within 24 hours of skin barrier assessment
* Has taken a bath or shower on the day of the skin barrier assessment

Exclusion criteria of the pregnant women:

* Pregnant women with high risk pregnancies.
* Pregnancy is from an egg donation.
* Pregnant women pregnant with more than one fetus.
* Pregnant women with psychiatric and developmental co-morbidities that would render them unable to provide informed consent or perform study-related procedures.
* AIDS and HIV infection.
* A fetus with chromosomal or congenital abnormalities, a heritable hematological disorder like thalassemia or sickle cell disease in the mother.

Exclusion criteria of the infant:

* Infant is delivered earlier than 34 weeks gestation.
* Infant is born with a significant birth defect or medical condition where enrollment in this study is not in the infant's best interest.
Systemic Corticosteroids in Treatment of Post-COVID-19 Interstitial Lung Disease

Aim: To investigate the efficacy of systemic corticosteroids in treatment for Post-COVID-19 Interstitial Lung Disease.

Method: Method: In this multi-centre, prospective, randomised controlled open label clinical trial, patients are divided into two arms: standard treatment arm and standard plus systemic corticosteroid arm. After twelve weeks; clinical, functional, and radiological improvement will being assessed as primary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Post-COVID-19 Interstitial Lung Disease (ILD) patients who had completed the treatment of acute phase and have recovered, but despite after 90 days from recovery diagnosed as post-COVID ILD based upon the persistent respiratory symptoms with functional impairment and radiological sequela.

  * At least 90 days required after discharge for hospitalized patients or termination of isolation for outpatients
* Confirmation of the diagnosis of COVID-19 via real time polymerase chain reaction assay (rt-PCR) or antigen or antibody test in the acute phase of COVID-19.
* Presence of sequelae interstitial changes in follow-up (pre-enrollment) thorax high-resolution computed tomography (HRCT)/CT.
* Presence of persistent respiratory symptoms in the post-COVID-19 period or hypoxemia at rest and/or desaturation with exercise.

Exclusion Criteria:

* Patients who had a normal lung imaging examination (radiography, tomography, etc.) at discharge or enrollment phase
* Pre-existing diffuse parenchymal lung disease before pandemic
* Cystic bronchiectasis
* Presence of contraindications for systemic corticosteroids (uncontrolled Diabetes, uncontrolled Hypertension, unstable angina pectoris, history of acute coronary syndrome at last month, presence of active infection, active peptic ulcer, presence of uncontrolled psychiatric disease, etc.)
* Decompensated heart failure
* Contraindications for pulmonary function tests and those who cannot cooperate with the test
* Younger than 18 years old
* Pregnant women
* Breastfeeding women
* Those who do not give written consent
Chronic Otitis Media With Effusion in Chronic Sinusitis With Polyps

The relationship between otitis media with effusion (OME) and chronic rhinosinusitis with nasal polyposis (CRSwNP) remains unclear. A cross-sectional study of 80 consecutively presenting patients who were diagnosed with CRSwNP was conducted. The aim was to ascertain the prevalence of OME in CRSwNP patients, to determine whether the severity of CRSwNP affected OME, and to identify risk factors for OME in CRSwNP patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 15 years of age
* Presence of chronic rhinosinusitis with nasal polyposis (CRSwNP) previously diagnosed or diagnosed at study's onset by endoscopic nasal examination

Exclusion Criteria:

* Presence of a mucopurulent discharge or granuloma during endoscopic nasal examination
Asthma Patient Survey Study to Assess Asthma Effect and Medication in Finland

This study was aimed at clarifying how the asthma medication is used in practice and how asthma affects everyday life. Total of 106 GPs were asked to recruit patients using inhaled steroid as maintenance treatment for asthma to take part in a telephone survey. Altogether 142 patients were interviewed.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed persistent asthma
* regular use of inhaled steroids and concomitant medication

Exclusion Criteria:

* never been diagnosed COPD
* seasonal asthma
Diaphragmatic Breathing Exercises in Total Knee Arthroplasty Patients

Rationale: While total knee replacements (TKA) are one of the most commonly performed surgical procedures in the United States, this procedure can also be very painful. Postoperative mobilization and rehabilitation is vital to a patient's recovery, but inadequate pain control can impede patients' progress. Diaphragmatic breathing is an additional non-pharmacological and non-invasive tool with no adverse effects that could aid in recovery. This will serve as a pilot study for a possible larger controlled trials.

Study population: Patients (participants) undergoing total knee arthroplasty at Keck USC Hospital at HC3

Study methodology: Patients (participants) will be taught with the aide of a handout and instructional videos preoperatively and in the recovery room on how to perform diaphragmatic breathing exercises for post-operative pain control. Patient (participant) pain levels will be assessed using the visual analog scale (VAS). The investigators will then be comparing VAS scores and daily opioid doses (morphine equivalents) between the study group and a control group. The control group will include prior patients (participants) over the past year who underwent TKA at Keck Hospital and also had pain scores and opioid usage measured, but did not receive the breathing treatment.

Study endpoints: Endpoints will include: pain levels via VAS scale, anxiety levels via VAS scale, and opioid usage (morphine equivalents).

Eligibility Criteria:
Inclusion Criteria:

* Patients (participants) undergoing total knee arthroplasty with a continuous peripheral nerve block catheter

Exclusion Criteria:

* Inability to perform or learn diaphragmatic breathing exercises or do not wish to participate in diaphragmatic breathing or study protocol
* Pregnant patients
* Patients without continuous peripheral nerve block catheter
Investigating Clinical Trial Participation for Acne Patients

Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This trial will scrutinize the experiences of patients diagnosed with acne as they take part in a separate medical intervention clinical trial. The focus will be on tracking the rates of completion and withdrawal among these individuals.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future acne patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with acne
* Patient is able to read, understand and provide written Informed Consent
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Inability to perform regular electronic reporting
* Pregnant or lactating women
* Has significant intercurrent illness, psychiatric disposition or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study
The Outcomes of Laparoscopic Hybrid Surgery Versus Totally Open Surgery

Simultaneous colorectal cancer liver metastasis (SCRLM) is one of the risk factors for poor prognosis in colorectal cancer. Surgical resection of primary and metastatic lesions is the first choice of treatment for patients with resectable SCRLM. Simultaneous resection of colorectal cancer liver metastases by totally open surgery (TOS) has been widely used. However, we propose that laparoscopic hybrid surgery (LHS) may have better short and long-term outcomes. This study aimed to compare the safety, short-term, and long-term efficacy of LHS versus TOS for patients with resectable SCRLMs.


Eligibility Criteria:
Inclusion Criteria:

* Liver metastasis was detected while the colorectal cancer was diagnosed.
* Both the primary lesions and liver metastases were confirmed by postoperative pathological examination.
* Clinical data is complete.

Exclusion Criteria:

* Patients with unresectable extrahepatic metastases.
* Patients with other malignant tumor diseases that have not been cured.
* Clinical and pathological data were missed or incomplete follow-up data.
Feasibility and Metabolic Effects of a 5:2 Fasting Intervention in Women With Breast Cancer During Radiotherapy

The intervention consists of the adoption of a 5:2 intermittent fasting diet during radiotherapy of breast cancer patients. The aim of the study was to assess the feasibility of this intervention and its impact on body composition and selected metabolic blood parameters.

The 5:2 intermittent fasting (FAST) intervention consisted of two nonconsecutive days of fasting per week that could be chosen freely according to the patient's weekly schedule. The minimum amount of time to count as a fasting day was 24 hours, but patients were advised to aim for a complete fasting day including the nights before and after that day. On a fasting day, only water and unsweetened tea or coffee was allowed. However, given that fat is the macronutrient interfering the least with the metabolic adaptions to fasting, while carbohydrates disturb the most \[26\], patients were allowed to consume small amounts of bone broth/meat broth, coconut oil, butter/ghee or heavy cream as an "emergency plan", i.e., in case that they felt they needed some energy-containing foods to complete an initiated fasting day.

The primary study outcome was the feasibility of the FAST intervention and its effects on longitudinal body composition changes from baseline until the final week of radiotherapy (body mass, fat mass, fat-free mass, muscle mass, extracellular and total body water). Secondary endpoints were absolute changes in metabolic parameters, hormones, and overall quality of life scores in the FAST group. As a surrogate marker for insulin resistance, the triglyceride-glucose index (TyG) was calculated according to TyG=ln⁡(fasting triglycerides \[mg/dl\]×fasting glucose \[mg/dl\]/ 2).

Eligibility Criteria:
Inclusion Criteria:

* Non-metastasized breast cancer
* Indication for curative radiotherapy

Exclusion Criteria:

* metallic body parts that would interfere with electric bioimpedance (BIA) measurements
* difficulties with understanding the aims of the study
The Blood Glucose Control in Patients With Type 2 Diabetes Treated With Glargine

Glargine is commonly used in insulin supplemental therapy in patients with type 2 diabetes(T2D) at present. This study aims to investigate the current status of blood glucose control in patients with T2D treated with glargine. Glycated hemoglobin(HbA1c) will be tested in these patients to assess the blood glucose control and Continuous Glucose Monitoring System (CGMS) will be used to investigate the glucose variability. Islet function, duration of diabetes, complications, exercise, insulin dose, oral medication regimen and insulin antibodies will be recorded in detail. This study will analysis the association between these clinical characteristics and blood glucose control.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999;
2. Patients were using glargine with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 2 month would be recruited into this study;
3. Patients had relatively constant diet and exercise in 2 month before the study;
4. Fasting blood glucose was between 6.1 and 16mmolL, and postprandial (or random) blood glucose \<22.2mmol/L.

Exclusion Criteria:

1. Patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure;
2. Patients with severe infectious diseases;
3. Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis;
4. Patients with history of psychiatric disorders and were unsuitable to use CGMS;
5. Any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.
Effect of Add-on Montelukast to Inhaled Corticosteroids on Airway Responsiveness

Leukotriene receptor antagonists appear to posses additive anti-inflammatory effects to the effect of inhaled corticosteroids.

Hypothesis: Treatment with oral montelukast will lower the dose-response plateau to inhaled methacholine in patients with mild to moderate persistent asthma treated with a stable dose of inhaled corticosteroids.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking adults with mild to moderate persistent asthma:

  * FEV1 \> 70 % pred
  * PD20 methacholine \< 3.9 mmol
  * treated for at least 3 months with a stable dose of inhaled corticosteroids
* Documented dose-response plateau to inhaled methacholine on two occasions
* Males and non-pregnant females

Exclusion Criteria:

* Asthma medication other than inhaled corticosteroids and inhaled b2-agonists
* Viral respiratory tract infections within the 3 weeks prior to enrollment
Helium Neon Laser Versus Gallium Arsenide Laser

There will be different effects for different laser wavelengths in treatment of venous ulcer.

The cost of treating venous ulcer can vary within wide limits and depends on the technology used. In the countries of the European community, the closure of one ulcer as an outpatient procedure costs 800-1500 euros, and supporting anti-relapse treatment makes 100-150 euros per month. In the United States, for closure of venous ulcer within 3 months, direct medical costs reach US$1500- 2000. Prolongation of the treatment for a longer time results in increased cost up to US$30 000 or more.

Poor efficiency of the known methods of treating patients with venous ulcer necessitates the search for new ways and modes of laser therapy (LT) based on a comprehensive approach. Application of physical therapy, primarily with the use of LLLT, capable of influencing various stages in the pathogenesis of the disease, allows a high therapeutic effect in many cases, while ensuring systemic response of the patient's body with the proper exposure procedure.

So, the current study will be conducted to compare the effect of different laser wavelengths on venous ulcers and provide an effective treatment method for patients with venous ulcers with low cost and in short duration.

Eligibility Criteria:
Inclusion Criteria:

* All patients approximately the same age (50-60).
* All patients had venous leg ulcers just above medial malleolus. The common cause of ulcers for all cases was venous insufficiency.
* All patients with conscious.

Exclusion Criteria:

* All patients had no diabetes or blood problems.
* any immunity disorder affect wound heaing.
Exemestane in Advanced and Recurrent Endometrial Carcinoma

A phase II study of Exemestane in Advanced or recurrent endometrial carcinoma

Hypothesis: Treatment With Exemestane can give a response rate of at least 30%

Patients With Advanced or recurrent endometrial cancer of endometrioid type were treated With Exemestane tablets 25 mg daily.

Patients were grouped according to estrogen receptor status.

Eligibility Criteria:
Inclusion Criteria:

* Advanced or recurrent endometrial cancer not considered for treatment modalities apart from hormonal treatment
* Endometrioid histology
* Age above 18 years
* Post menopausal status
* Performance status 0-2
* Informed consent

Exclusion Criteria:

* Congestive heart disease grade III.IV
* History of thromboembolic signs
* Other primary hormonal therapy
* Patients With symptomatic brain metastasis
* Severe hepatic or renal impairment
* Pregnancy, lactation or child bearing potential without adequate contraception
Jigsaw Learning Model and Urinary Catheter Care

This study was planned to evaluate the effect of the reversed Jigsaw learning model on urinary catheter care in nursing students. It is anticipated that the relevant method will increase the knowledge level of students.

In this research, it is aimed to use the flipped learning model and the Jigsaw learning model together. The group in which the intervention will be carried out will continue their education outside the classroom with videos and lecture notes, and will carry out group work during class time as required by the Jigsaw strategy. In a study in which these two teaching methods were applied to nursing students within the scope of an ethics course, an increase in the students; ethical sensitivity and familiarity with ethical dilemmas was noted. Therefore, in this study focusing on urinary catheter care, the academic success of the students will make a difference in patient safety. It is anticipated that this study is original in its field and will guide instructors within the scope of teaching techniques.

Eligibility Criteria:
Inclusion Criteria:

* Getting information about urinary catheter care for the first time
* Volunteering to participate in the study

Exclusion Criteria:

* Having received previous training on urinary catheter care
* Not volunteering to participate in the study
* Not participating in the posttest and follow-up test
Assessing Innovative Wireless and Wearable Sensors for Continuous Blood Pressure Measurement in Obese Pregnant Women

This study is a prospective study targeting at least 20 obese and super-obese patients admitted to Labor \& Delivery (L\&D) for delivery at UNC Medical Center. Patients with clinical indicated radial A-lines either planned or already in-situ will be offered participation. The study will evaluate the accuracy of noninvasive blood pressure measurements with the ANNE One system to blood pressure readings with the radial A-line.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years old
* Ability and willingness to provide written informed consent
* Admitted for delivery at UNC Medical Center
* BMI of \>= 40 kg/m2
* Clinically indicated radial A-lines either planned or already in-situ prior to delivery

Exclusion Criteria:

* Skin sensitivity or allergy that precludes placement of ANNE One
* Any condition (social or medical) which, in the opinion of the study staff would make any study participation unsafe or complicate data interpretation
* Expected delivery within \<= 1 hour of arrival to L\&D