cyrilzakka/clinical-trials huggingface dataset:
Coreg CR, Blood Vessel Stiffness and Blood Vessel Function

We are comparing the blood pressure-lowering effects of two marketed medications, Coreg CR and Toprol XL. Although both drugs reduce blood pressure by blocking the action of noradrenaline on beta-receptors in the blood vessels, Coreg CR also blocks alpha-receptors, which may provide added blood pressure-lowering. In addition, Coreg CR may have anti-oxidant actions. Cells which line blood vessels (termed "endothelial cells") make nitric oxide (NO), which relaxes the muscle cells encircling the blood vessels, causing a reduction in blood pressure. When body cells use oxygen, they normally produce "free radicals", which can destroy NO,leading to high blood pressure, heart damage and worsenimg of diabetes. Antioxidants remove free radicals and prevent or repair this damage. In this study we will measure endothelial cell function, blood vessel wall stiffness, NO in exhaled breath, and blood levels of substances which reflect NO production and destruction to determine if a pure beta-blocker (Toprol XL) differs from an alpha/beta blocker (Coreg CR) in these effects. We will also examine the mechanism by which such differences might occur.

The following techniques will be used:

Endothelial function will be measured non-invasively by flow-mediated changes in pulsatile blood volume in the finger-tips.

Vascular compliance (stiffness) will be assessed by tonometry of the radial pulse wave ("augmentation index") and diastolic puse wave analysis.

Plasma nitrate/nitrite levels mirror NO production and will be measured spectrophotometrically by the Griess reaction.

Plasma nitrotyrosine, an in vivo marker of NO-dependent damage induced by reactive nitrogen intermediates derived from NO, will be measured by ELISA.

Exhaled NO may provide an real-time measure of endothelial cell NO production and can be measured by a hand-held device which contains an electrochemical detector sensitive to 5 ppb.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes mellitus,
2. Stable antidiabetic regimen for 3 months
3. Hemoglobin A1c \<8.6%
4. Stable antihypertensive medication regimen for 3 months or more, including either an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker

Exclusion Criteria:

1. Any clinically significant abnormality on history, physical examination, or laboratory testing which could preclude safe completion of the study
2. Significant cardiac conditions
3. Lung disease
4. Cigarette smoking
5. Chronic kidney disease (Stage 3 or greater)
6. Type 1 diabetes
7. Known contraindication to alpha- or beta-blocker therapy
Effect of PEEP on Lung Regional Ventilation and Perfusion

Investigate effects of PEEP on pulmonary regional ventilation and perfusion assessed by EIT

1. When the research team was available, adult patients within 7days who were sequentially admitted to the Department of Critical Care Medicine and required central venous catheters and mechanically ventilation were eligible for the study.
2. Written informed consent was obtained from all patients or next of kin before data were included in the study.
3. Information collected at enrollment included demographic characteristics, such as age, sex.
4. The blood pressure（BP）,heart rate（HR）, pulse O2（SpO2）,tidal volume and lung regional ventilation and perfusion were collected at PEEP 0 centimeter H2O column and PEEP 12-15 centimeter H2O column.
5. Indicator-based EIT method: rapidly inject 10ml 10% Sodium chloride（NaCL） through central venous catheter during a 8s respiratory hold, and the curve of impedence change was collected by EIT machine

Eligibility Criteria:
Inclusion Criteria:

1. have been placed central venous catheter based on patient's condition
2. Under mechanically ventilation
3. Under sedation and control ventilation mode
4. Year\>18

Exclusion Criteria:

1. Pneumothorax
2. pregnancy
3. Severe chest wall wound
4. Severe hypernatremia
Efficacy of the Yoga and Aromatherapy on Salivary Hormone and Immune Function in Pregnant Women.

This study's aims are to examine the effects of yoga and aromatherapy on women's stress and immune function during pregnancy.

This longitudinal, prospective, randomized controlled trial recruited 75 healthy pregnant women from a prenatal clinic in Taipei using convenience sampling. The participants were randomly assigned to the aromatherapy group (n=25), yoga group (n=25) or control (n=25) group using Clinstat block randomization.

The aromatherapy group received 70 minutes of aromatherapy massage once biweekly for 20 weeks; the yoga group participated in two weekly 70-minute yoga sessions led by a midwife certified as a yoga instructor for 20 weeks; the control group received only routine prenatal care. All participants' salivary cortisol and immunoglobulin A levels were collected before and after yoga or aromatherapy every 4 weeks from 16 to 36 weeks' gestation.

To collect a sufficient quantity of saliva, we used Salivette® cotton swabs (Salimetrics, State College, PA, USA), which were stored in double-layer plastic tubes with a lid. When participants chew a swab for about 2 to 3 minutes, saliva flow is stimulated to a sufficient amount (1 mL) for collection. After the tube was centrifuged at 1000 x g for 2 minutes, saliva was stored at -80°C until assay for salivary cortisol and IgA concentrations.

Cortisol was measured using a competitive enzyme-linked immunoassay (ELISA) kit (Cayman Chemical Company, USA), and salivary IgA was measured using double-antibody sandwich ELISA method per the manufacturer's instruction (ICL, Inc., USA).

Eligibility Criteria:
Inclusion Criteria:

* Normal pregnancy
* Age 20-45 years
* Agreed to follow-up collections of saliva samples
* Could read and write Chinese

Exclusion Criteria:

* Oral steroid use
* History of severe illness (e.g., heart disease, systemic lupus erythaematosus, metabolic disorders) or depression.
* Drug use (prescribed or illicit).
* High-risk pregnancy (i.e., first-trimester vaginal bleeding, artificially insemination, multiple gestations, foetal growth restriction or other abnormalities).
Psychological Assessment of Patients With Chest Wall Deformities

The study aims to investigate the most frequent psychological outcomes associated to chest wall deformities and patients' quality of life.

The study aims at providing psychological assessment (body image, self-esteem, overall mental health) and quality of life investigation of adolescents affected by chest wall deformities, in relation to the severity and type of deformity, and patients' age; identifying risk factors for psychological disorders.

The following hypotheses were tested: differences between patients with different chest wall deformities regarding body image and mental health were expected; no hypothesis on the possible results concerning the effect of the severity of deformity on each studied variable was formulated, since previous findings are unclear. Concerning age, some differences according to different age ranges were expected. Regarding risk factors for mental health problems, older age and greater body image dissatisfaction were expected to be significant risk factors for psychological problems; regarding the severity and type of deformity, results of previous studies are unclear or lacking, so no hypothesis was tested; quality of life and self-esteem variables were also tested, as previous studies showed they are significantly related to general well being and mental health in adolescents.

Adolescents coming at the outpatient clinics for the first evaluation of their chest wall and one of their parents/caregivers were enrolled. After the medical examination, patients meeting inclusion criteria are invited to participate in the study and to be assessed by a trained psychologist who administered them all questionnaires after they expressed their informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of pectus excavatum or pectus carinatum;
* Age from 12 to 18 years old;
* High level of fluency in Italian.

Exclusion Criteria:

* Clinical diagnosis of chronic or acute disease, or presence of other conditions which could significantly influence adolescents' quality of life, mental health, body image and self-esteem;
* Diagnosis of intellectual disability or other conditions (e.g. low level of fluency in Italian) which could hinder questionnaires understanding.
Definition for Biliary Atresia Associated Cholangitis After Surgery

Cholangitis is the most common postoperative complication of biliary atresia, with a reported incidence of 40-90%, which seriously affects the surgical effect, survival rate and the quality of life and prognosis of patients. Without of direct evidence, the diagnosis of cholangitis sometimes is difficult to make, thus most of them are diagnosed based on the symptoms of children. According to literature reports, different centers and regions have different diagnostic criteria for postoperative cholangitis after hepatic portoenterostomy, which has a great influence on the accuracy of the incidence rate and appropriate treatment of cholangitis, and also brings differences in the analysis of the causes and prognostic factors of cholangitis.

Based on the above reasons, we used the Delphi method，in which worldwidely 48 experts participated in, to establish the diagnostic scoring system for postoperative cholangitis after biliary atresia.

Now we aimed to verify the specificity and sensitivity of the new scoring system through clinical cases, in order to unify and standardize the diagnostic criteria and provide help for the diagnosis and treatment of cholangitis after biliary atresia.


Eligibility Criteria:
Inclusion Criteria:

① Admission time: 2019.01.01-2021.12.31;

② The first diagnosis after discharge was cholangitis

Exclusion Criteria:

① Cholangitis after non-Kasai procedure;

* Postoperative cholangitis of biliary atresia not operated in the unit; ③ Patient has been treated in other hospitals during this episode; ④ The treatment period for cholangitis is not completed or the patient is discharged automatically.
Mycotoxin Exposure and Dietary Habits in Colorectal Cancer Prevention and Development Among Polish Population

The aim of the study is the determination of the zearalenone and its metabolites (α and β) level in the blood plasma and faeces of patients at increased risk of cancer, in relation to the nutrition data (FFQ) and information on the quality of life dependent on health (WHOQOL-BREF).

The study is performer within the framework of the Polish Colonoscopy Screening Program. Within the study 100 volunteers between 50 and 65 years of age. while, the colonoscopies will be performed in Provincial Specialist Hospital in Olsztyn. Patients with positive test result, who have been diagnosed with polyps or cancer, will be assigned to risk group. The study has been approved by a local bioethics committee.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged from 50 to 65 years residing in Poland.

Exclusion Criteria:

* subjects requiring long-term care due to somatic, mental retardation or other mental illness.
* history of colorectal resection.
Eat Well Produce Benefit for Diabetes and Food Insecurity

The goal of this clinical trial is to assess the impact of participation in Eat Well for diabetes patients who are at risk of food insecurity. The main questions it aims to answer are:

* whether there is a difference in Haemoglobin (Hb) A1c measurements and emergency department (ED) utilization between the Eat Well and control groups up to 18 months post-program completion.
* whether there are differences in cardiometabolic health-related outcomes for Eat Well participants.

Participants in the program will receive gift/debit cards for fruits and vegetables and educational nutrition materials. Researchers will compare Eat Well participants with those only receiving educational materials to see if there are differences in cardiometabolic health outcomes.

This pragmatic trial aims to assess the impact of Eat Well participation for diabetes patients at risk of food insecurity. Eligible patients will receive gift/debit cards for the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)-approved fruits and vegetables and be assigned to either receive the card for up to 12 months or not. Random assignment will occur using a 2 to 1 treatment to control allocation ratio. Both treatment and control groups will receive curated diabetes educational materials. The study will assess the impact of the intervention on clinical factors such as glycemic control, weight, BMI, lipids, medication adherence, medication number, blood pressure, and utilization up to 18 months pre, during, and post program enrollment using data from clinical visits. The primary analysis of interest will be differences in HbA1c measurements and ED visits between the Eat Well and control groups at 12 months of program participation, with further evaluation of differences at 12 months post-program completion.

Eligibility Criteria:
Inclusion Criteria:

* Be active in the Duke Diabetes Registry in the past 12 months AND
* have had at least one outpatient A1c measurement AND
* are at risk for food insecurity as defined by one of the following:

  1. answered often true or sometimes true on one or both of the food insecurity questions as part of the electronic health record social history section (Maestro Care/ Epic of Verona WI) OR
  2. answered hard or very hard to the financial stress question as part of the electronic health record social history section (Maestro Care/ Epic of Verona WI) OR
  3. has Medicaid as insurance payer OR
  4. lives in Area Deprivation Index (ADI) zip code of 7th decile or harder

Exclusion Criteria:

* none
Healthy ReStart Intervention to Improve Health and Functioning

This study tests an intervention that uses health coaching, motivational interviewing, positive psychology, and online wellness tools to help adults with mental illness return to active lives after major disruptions such as the COVID-19 pandemic.

This study is testing the efficacy of a brief intervention delivered to adults with mental illness by trained health coaches, designed to help recipients engage in health and mental health self-management, while setting goals to return to an active life after major disruptions such as a pandemic. Adult clients of collaborating community mental health agencies are randomly assigned to the intervention plus services as usual, versus services as usual alone. They are assessed at baseline and 6 months later. Analysis of covariance (ANCOVA) models are used to assess the primary outcome of changes in mental and physical health, functioning, perceived competence for life self-management, and mental health recovery. Also examined are study condition differences in self-advocacy skills, access to services, and disruptions from COVID-19.

Hypothesis 1: Compared to services as usual (SAU), intervention recipients will report better health, well-being, and service use.

Hypothesis 2: Compared to SAU, intervention recipients will have more perceived competence and self-advocacy.

Hypothesis 3: Healthy ReStart recipients will report high levels of satisfaction with the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Diagnosis of serious mental illness defined as a DSM 5 psychiatric disorder and moderate to severe functional impairment
* Membership in a collaborating community mental health agency
* Access to the Internet for online meetings
* Able to provide informed consent

Exclusion Criteria:

* A cognitive impairment preventing informed consent
* Unable to communicate in English
THP Hip Fracture Plating System Study

The objective of this study is to systematically document the clinical outcomes of THP Hip Fracture Plating System when used to treat intracapsular and intertrochanteric fractures.

Primary Endpoint:

• Revision rate due to device related complication(s) or non-union of the femur.

Secondary Endpoints:

• Radiographic and clinical fracture healing of the proximal femur using standard scoring methods.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years of age or older.
* Patient must be eligible for an open reduction and internal fixation of the proximal femur.
* Patient must have an intracapsular or intertrochanteric fracture.
* Patient must have need for alignment, stabilization, and reduction of bone fractures.
* Patient must have ability and willingness to follow postoperative care instructions until healing is complete.
* Patient must be in good nutritional state.
* Patient must be able and willing to sign the IRB/EC approved informed consent.

Exclusion Criteria:

* Patient is a prisoner.
* Patient is a current alcohol or drug abuser.
* Patient is known to be pregnant or breastfeeding.
* Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent.
* Infection.
* Patient conditions including bloody supply limitations, obesity or insufficient quantity or quality of bone.
* Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
* Patient has foreign body sensitivity. Where material sensitivity is suspected or unknown, testing is to be completed prior to implantation of the device.
* Patient is expected to be non-compliant with recommended post-operative weight-bearing instructions.
Breastmilk Alone or in Combination With Paracetamol for Reducing Pain

Efficacy of Expressed Breast Milk Alone or in Combination with Paracetamol in Reducing Pain during ROP Screening.

Retinopathy of prematurity (ROP) has been widely acknowledged to be the primary cause of preventable childhood blindness in developing countries. However, the procedure for screening is extremely painful. In this study, we will attempt to relieve the pain experienced by these babies using breast milk alone or in combination with oral paracetamol. This randomized control trial study will be conducted with the aim to assess the efficacy of Expressed Breast Milk Alone or in Combination with Paracetamol in Reducing Pain during ROP Screening. All preterm neonate who undergone ROP screening will be the study population. A total of 60 preterm neonates will be randomized into three groups: (Group A - control group = 20, Group B - breast milk group = 20, and Group C - oral paracetamol + breast milk = 20). Group A will get current care as per institutional protocol, Group B received 2 ml expressed breast milk (EBM) through a sterile syringe orally 2 min prior to procedure, Group C received syrup paracetamol, 15 mg/kg 30 min prior to procedure and EBM as in Group B. Pain experienced was measured by the premature infant pain profile (PIPP) score 20 s prior, during and 2 min after procedure. All procedures were video recorded. The Ophthalmologist and analyzer both will be blinded to the intervention. Results will be incorporated after enrollment

Eligibility Criteria:
Inclusion Criteria:

* 1. Gestational age \<35 weeks, and birth weight \<2000 gm

Exclusion Criteria:

* 1. Parents of neonate who refused to participate in the study 2. Newborns with multiple congenital anomalies 3. Patient who is on mechanical ventilator during ROP examination 4. Neonate receiving narcotic or sedative drugs 5. Neonate not receiving oral feed.
UCMSC Transplantation in the Treatment of Cartilage Damage

The purpose of this study is to investigate the efficacy and safety of transplantation of umbilical cord mesenchymal stem cells（UCMSCs） in patient with Knee cartilage damage.

Human cartilage only has limited regenerative potential. Transplantation of umbilical cord mesenchymal stem cells (UCMSCs) is a promising strategy given the high proliferative capacity of MSCs and their potential to differentiate into cartilage-producing cells - chondrocytes. The acquisition of ucMSCs does not require invasive surgical intervention or cartilage extraction from other sites as required by other cell-based strategies. The investigators inject allogeneic human mesenchymal stem cells to the cartilage lesions in patients via intra-articular injection method, and to investigate the efficacy and safety。

Eligibility Criteria:
Inclusion Criteria:

* Patients whose lesion (single joint) should be in the range of 2 cm\^2-8 cm\^2.
* Patients with pain in affected joint of 60 mm- 100 mm VAS (visual analogue scale)
* Patients with articular swelling, tenderness and active range of motion of Grade 2 or below
* Patients with knee joint cartilage defect or injury of ICRS (International Cartilage Repair Society) Grade 4 confirmed by arthroscopy (At screening, patients diagnosed as such with an MRI may be included)
* Patients who needs invasive interventions of arthroplasty due to no response from existing pain medication
* Patients voluntarily agreed to participate in the study and signed informed consent

Exclusion Criteria:

* Patients with autoimmune diseases or medical history
* Patients with infections requiring injection of antibiotics
* Patients with severe internal diseases
* Patients who are currently pregnant or lactation
* Patients who had participated in any other clinical trials within the past four weeks
* Patients who had been administered with immunosuppressants within the past four weeks
* Patients whom the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above
Proactive Health Intervention for Tobacco Users (Get PHIT)

The goal of this study is to understand how information about smokers' health risks affects their attitudes, mood, and behavior.

The current study will test a community-based, tobacco intervention. The project will compare the effects of a proactive, personally-tailored, biologically-based motivational intervention to those of a proactive, generic motivational intervention for smoking cessation. The biologically-based motivational treatment will include feedback on participants' carbon monoxide (CO) exposure (expired CO and estimated carboxyhemoglobin levels), pulmonary functioning assessed via spirometry, and self-reported smoking-related symptoms. All participants will be given equal access to action-oriented treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old,
* smoke greater than or equal to 15 cigarettes a day,
* have an expired CO level greater than or equal to 10 ppm,
* are not currently being treated for smoking cessation,
* can read and write in English,
* provide contact information,
* agree to the study requirements,
* have no medical contraindications for spirometry assessment,
* and no an obvious cognitive or physical impairment that would preclude their ability to comprehend or fully participate in the study.

Exclusion Criteria:

-