cyrilzakka/clinical-trials huggingface dataset:
Electrical Impedance Tomography for Identification of Optimal Positive End-expiratory Pressure in Newborn Infants

Electrical impedance tomography (EIT) enables assessment of regional lung ventilation at the bedside. EIT has been safely used in newborn infants to image intrathoracic lung volume patterns as early as from the first minute of life. This prospective single-centre observational study is to identify optimal PEEP in infants on respiratory support by measurements of EIT, FOT and SOPI.

Evidence-based guidelines on the optimal level of positive end-expiratory pressure (PEEP) in newborn infants on respiratory support do not exist. Furthermore, there is a lack of simple bed-side parameters to guide clinicians towards the optimal PEEP level. Nevertheless, PEEP requires individual adjustment to minimize ventilator induced lung injury (VILI), shorten the duration of mechanical ventilation and reduce respiratory long-term morbidity.

Potential techniques to assess optimal PEEP level in infants on respiratory support include electrical impedance tomography (EIT), the forced oscillation technique (FOT) and the saturation oxygenation pressure index (SOPI). EIT is a promising non-invasive technique that provides information on regional changes in lung aeration and ventilation inhomogeneity. FOT is used in mechanically ventilated or spontaneously breathing infants and provides information on reactance (Xrs) and resistance (Rrs) of the respiratory system. SOPI is a score calculated from the PEEP level, the amount of administered oxygen (FiO2) and the infant's peripheral oxyhaemoglobin saturation (SpO2). SOPI provides information on the ventilation to perfusion ratio dependent on the PEEP level. EIT, FOT and SOPI seem promising tools for identification of optimal PEEP in newborn infants on respiratory support. In particular, a combination of information on regional ventilation (by EIT), global lung mechanics (by FOT) and ventilation to perfusion ratio (by SOPI) will improve the understanding of optimal PEEP and may reduce long-term respiratory sequelae.

This prospective single-centre observational study is to identify optimal PEEP in infants on respiratory support by measurements of EIT, FOT and SOPI. Measurements are performed once daily during the first three days on respiratory support and are repeated in weekly intervals if the infant remains mechanically ventilated. An additional measurement is planned after extubation.

Eligibility Criteria:
Inclusion Criteria:

* 22+0 to 41+6 weeks' gestational age
* Requiring mechanical ventilation
* Written informed parental consent

Exclusion Criteria:

* Major congenital malformations including lung and cardiac malformations
* Infants on high frequency oscillatory ventilation
* Lack of written informed parental consent
The Effect of Coffee on Energy Expenditure and Caffeine Metabolism

Obesity is a risk factor for chronic diseases, and improving energy expenditure is a way to prevent and treat obesity. The purpose of this project is to explore the relationship between the effect of coffee on energy expenditure and caffeine metabolism, which has important significance in the rational application of caffeine.

The investigators will study the relationship between the effect of coffee on energy expenditure and caffeine metabolism. The investigators will recruit healthy participants. Participants will be forbidden to consume stimulant drinks such as coffee for 24 hours before the experiment. When the participants arrive at the lab on the day of the experiment, they will sign an informed consent form, a health history questionnaire and a daily coffee consumption questionnaire. The changes of drinking water/coffee on total energy expenditure (TEE), body temperature, heart rate, blood pressure, electrocardiogram, memory，cognition, sleep time and so on will be observed. The concentration of caffeine and its metabolites in the blood and urine will be measured by liquid chromatography-mass spectrometry (LC-MS) and gas chromatography-mass spectrometry (GC-MS).

Eligibility Criteria:
Inclusion Criteria：

* Healthy adults.
* Must be able to drink coffee.

Exclusion Criteria:

* Diabetes.
* Hypoglycemia.
* Gout.
* Osteoporosis.
* Gastric ulcer.
* Pancreatitis.
* Intestinal obstruction.
* Blood phobia.
* Pathological hypo or hyper tension.
* Impaired glucose tolerance.
* Claustrophobia.
* HIV,etc.
App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy

Patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy can take part in the study. The aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition.

Patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy can take part in the study. The aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition.

Patients in the experimental arm receive the daily reminder message via app (Emento) that they should pay attention to adequate caloric intake. In addition, these patients receive 3 screening questions about their current health and nutritional status twice a week.

In case of relevant deterioration (any negative value in the screening questions is explained under study procedure), additional further questions are asked, which are specifically aimed at the side effects of the tumor therapy (mainly dysphagia, pain). The answers will be transmitted to the radiation clinic.

If a question is answered positively, this is reported to the radiotherapy clinic on the one hand and on the other hand, the patient is asked to consult the doctor in the clinic as soon as possible.

Eligibility Criteria:
Inclusion Criteria:

* Patients with squamous cell carcinoma in the head and neck region, who receive a postsurgical or definitive radio(chemo)therapy
* Patients who have a smartphone on which the Emento app can be installed
* Minimum age 18 years

Exclusion Criteria:

* Patients who are represented by a legal guardian
* Patients who are not suitable for participation in the study due to a language barrier
An RCT to Evaluate the Effect of a New Skin Care Regimen on SBF in Those With Podoconiosis

An RCT (n=193) in two podoconiosis clinics in Ethiopia to evaluate the effectiveness of a research based skin management regimen compared to the current regimen. The experimental group added 2% glycerine to the current skin care regimen and used 1 litre of water in the water soak compared to the 6 litres used in the current regimen.

Background. Podoconiosis (non-filarial elephantiasis) affects some of the poorest people in 20 countries in the world. In Ethiopia least 3 million people are affected with 17 million at risk. Irritant minerals (smectite, mica and quartz) from volcanic soil and pathogens enter skin breaches in the feet causing inflammation, lymphoedema and hyperkeratosis. Podoconiosis is preventable and treatable but is not curable. Current treatment consists of educating those with disease on its causes, prevention and treatment. Treatment taught in the Action on Podoconiosis (APA) Clinics consists of a daily hygiene regimen of washing the feet/legs with soap, soaking the feet and legs in water with sodium hypochlorite (NaOCI) (0.0125%) added as a disinfectant, air drying and the application of a thin layer of petrolatum jelly. Whitfields ointment (benzoic acid and salicylic acid) is applied to any fungal infections. Wearing shoes is encouraged but this does not offer complete protection against the alkaline soil.

Although the current treatment skin care regimen is effective there is no robust evidence on optimal skin care regimens to improve skin barrier function in this disease.

Objective. To evaluate the effectiveness of a new, low-cost, evidence-based skin care intervention to improve SBF in the lower limbs of those with podoconiosis.

Method. A randomized control trial (RCT) was conducted over 3 months in two APA Clinics (n=193). Intervention was 2% glycerine (v/v) added to a reduced amount of soaking water (1 litre versus 6 litres). The control group received the current skin care regimen. The primary outcome measure was skin barrier function (SBF). This was determined by measures of trans-epidermal water loss (TEWL) and stratum corneum hydration (SCH) at four specific sites on the lower limbs.

Eligibility Criteria:
Inclusion Criteria:

* Patients in Ethiopia with a diagnosis of podoconiosis. That is those living above 1000 feet sea level with high rainfall, above 1,00mm annually with foot or lower leg oedema which had started in the feet, with sensation present in the feet and no hand involvement. The diagnosis was determined by the nurses at the outreach clinics.
* Patients who were able to understand instructions and give informed consent as determined by the nurses at the outreach clinics.
* Patients over 18 years of age.

Exclusion Criteria:

* Patients not diagnosed with podoconiosis as determined by nurses at the outreach clinics.
* Patients who were unable to understand instructions or give informed consent as determined by nurses at the outreach clinics.
* Patients under 18 years of age.
Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH

The purpose of this study is to evaluate the safety and efficacy of a single treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥50 years
* Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months
* IPSS ≥15
* Maximum urine flow (Qmax) of 5 - 15 mL/sec
* Prostate volume of 30 - 100 mL as determined by TRUS
* Serum prostate-specific antigen (PSA) values \<10 ng/mL
* Post-void residual (PVR) \<= 200 mL

Exclusion Criteria:

* Inability to void ≥125 mL urine
* Prior surgery/MIST for BPH
* Presence of or history of certain conditions that could interfere with study results or endanger subject
* Use of certain prescribed medications that could interfere with study results
Web-based Follow-up to Former ICU Patients

This study evaluates if a web-based 1-year programme is a useful method for follow-up intensive care survivors with short ICU-stay. Half of the participants are randomized into receiving the web-based follow-up while the other half will receive no follow-up.

It is not uncommon for Intensive care survivors to have persisting, psychiatric, cognitive and physical impairments long time after the critical illness occurred. Today, nurse-led follow-up is used but the main focus is on patients with a ICU-stay for at least three days. This study evaluates ICU-survivors with a maximum ICU-stay for 72 hours.

Participants are randomized to the web-based one year follow-up programme and no follow-up. Both group receive questionnaire 2, 6 and 12 month after the end of their intensive care stay.

The web-based follow-up programme includes, short lectures that describes the intensive care e.g. hallucinations, memory loss and delirium. The programme also include short films that shows the medical equipment and how and why it´s used. Regular contact with ICU-nurse to discuss any upcoming problems.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age.
* Treated at the ICU under the time of the study.
* Have a Bank-id (which is needed to log in to the website.)

Exclusion Criteria:

* Institutionalized due to severe cognitive deficit.
* Does not communicate in the Swedish language.
* Patient is moved from other ICU to ICU where study is being held.
* Patient is sent to another ICU from ICU where study is being held.
* No home address.
* Patient decline to participate in study.
* Patient is receiving psychiatric specialist care post-icu e.g. high suicide risk.
* Patient is receiving ICU-treatment due to violence and is under on-going police-investigation.
* Palliative care.
* Patient receiving in-hospital care for more than 4 weeks in a row (except patient who is cared for in physical rehab-clinic at the hospital).
Effectiveness and Cost-effectiveness of the Diabetes Integrated Care Breakthrough Collaborative

The study tests whether implementing professional evidence-based guidelines and best practices for diabetes care -through participation of multidisciplinary teams in a Breakthrough collaborative- results in an improvement of diabetes care, its health outcomes and economic costs. Determinants of success are studied. Data on diabetes will also be used to better understand Breakthrough as an implementation or improvement method.

Diabetes mellitus as a chronic disease is a major and growing health care problem. Studies on the prevention of severe complications provide evidence for the necessity of tight control. Different interventions and models to achieve strict control and reduce diabetes related risks of complications are available. These are, however, not implemented in daily practice. Our study focuses on this implementation problem: it tests whether implementing professional evidence-based guidelines and best practices -through participation of multidisciplinary teams in the Breakthrough collaborative- results in an improvement of diabetes care, its health outcomes and economic costs.

Data on diabetes will also be used to explore and better understand the Breakthrough model as an implementation method. Only uncontrolled observational studies have, so far, described the outcomes of Breakthrough collaboratives. They also describe significant differences between teams in specific improvements made in patient care and organisational performance, resulting in different implementation and medical costs. There is hardly any information regarding these costs and the cost-effectiveness of collaboratives, and little knowledge about how they could be made more effective. Insight is also needed into the factors that influence the success of individual teams. There are no data regarding the sustainability of improvements.

Eligibility Criteria:
Inclusion Criteria:

* each patient, male or female, visiting the hospital outpatient clinic or general practice with type II diabetes mellitus during a specified period. Patients should be able to read and write the Dutch language.

Exclusion Criteria:

* pregnancy
* patients with a life expectancy \< 1 year
Trial for Surgical Treatment of Reducible Atlantoaxial Dislocation

The management of reducible atlantoaxial dislocation associated is challenging. Direct posterior distraction technique we proposed in 2010 could achieve satisfactory reduction. In 2020, we modified this technique and proposed a posterior intra-articular distraction technique. The intra-articular distraction technique could theoretically achieve satisfactory reduction and fusion. However, its superiority has not been proven. Therefore, we design a RCT study to compare the reduction rate and fusion rate of different strategies.


Eligibility Criteria:
Inclusion Criteria:

* CT indicated atlantoaxial dislocation Agree with the operation plan Agree to be followed up

Exclusion Criteria:

* The pathology is traumatic or RA Underwent operations in occipital-cervical region before With mortal diseases Without ability to sign papers
Efficacy of Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas

The purpose of this study is to evaluate the efficacy of aspiration and sclerotherapy during laparoscopy using 95% ethanol for the treatment of endometriomas, compared to the standard cystectomy treatment - a prospective case control study.

Women who are candidates for elective laparoscopy for the treatment of ovarian ensometriomas will be assigned to one of two groups - a) standard cystectomy treatment, b) aspiration and sclerotherapy using 95% ethanol. The women will be introduced with both operative options and they will choose which one they prefer. After an elaborate explanation about the study they will sign an informed consent form. the following data will be collected prior the operation: age, gravity \& parity, operative history, general medical history, the cyst size, AMH (Anti Mullerian Hormone), AFC (Antral Follicle Count), symptoms related to endometriosis (through a questionnaire), fertility history including any fertility treatment in the past and planned pregnancy after the operation.

The laparoscopy will take place in Meir Medical Center. in the study group the cyst content will be aspirated and flushed with normal saline. 95% sterile ethanol will be instilled into the cyst through a foley catheter. Ethanol will be left in the cyst for a maximum of 15 min then aspirated as completely as possible following normal saline flushing. In the control group we will follow the standard treatment which is cystectomy.

The women will be followed 4 and 6 months after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* women with endometrial cyst ≥ 4 cm.
* candidates for elective laparoscopy due to endometriosis.
* age 18-45 years

Exclusion Criteria:

* endometrial cyst \< 4 cm.
* an emergency surgery.
* age \<18 or \>45
* women with a history of tubal ovarian abscess (TOA).
* high index of suspision for ovarian malignancy.
* ethanol sensitivity.
Epidural and Cardiac Surgery

In the present study the investigators test the hypothesis that the epidural anesthesia added on the general anesthesia is able to improve patient's outcome.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing cardiac surgery
* adult (\>18y)
* sternotomy

Exclusion Criteria:

* abnormal coagulation profile
* antiplatelet medications (other than aspirin)
* ongoing anticoagulation
Rates of Pertussis Disease Among Persons Receiving Pentacel® or Other Pertussis Vaccines

The purpose of this cohort study is to determine vaccine-specific rates of pertussis disease during the period of the study, among Wisconsin residents younger than 60 months of age (the Surveillance Population), and to descriptively compare the proportion of such persons vaccinated with Pentacel® vaccine who acquire pertussis disease to the proportion of such persons vaccinated with any other Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) vaccine who acquire pertussis disease.

Primary Objective:

To determine the rates and relative risk of pertussis disease among Surveillance Population members who have received Pentacel vaccine or another pertussis vaccine.

The study will be conducted by the University of Wisconsin School of Medicine and Public Health, in collaboration with the Wisconsin Division of Public Health (WDPH).

Epidemiological and laboratory surveillance for pertussis disease among Wisconsin residents is routinely conducted by the WDPH. During the period of the study, de-identified data regarding all incident pertussis cases will be obtained from WDPH and vaccination coverage rates, by vaccine regimen, age group, and period of time, will be obtained from ongoing marketplace surveillance conducted on behalf of the Sponsor by a national sample-survey organization. Using these data, rates of pertussis disease will be determined.

No vaccine will be administered as part of this study.

Eligibility Criteria:
Inclusion Criteria :

* Persons will be under surveillance for this study whenever the following three conditions are true: the individual resides in Wisconsin, is age birth through 59 months, and is within the surveillance period of 01 October 2009 through 30 September 2014 (or as extended in order to accrue 61,761 person years of Pentacel vaccine exposure).

Exclusion Criteria :

* Not applicable
Trapeziectomy and Suture Suspensionplasty for Thumb Carpometacarpal Arthritis - Is In-Clinic Therapy Needed?

The study is a randomized, controlled trial to evaluate the efficacy of formal occupational therapy on outcomes following CMC arthroplasty

While hand surgeons agree that strength and flexibility exercises are crucial after surgery, there is currently no consensus on whether the benefits of participating in formal hand therapy outweigh the investment required. The financial and time investments required to participate in formal hand therapy can be particularly large in patients living in rural locations, as access to certified hand therapists are often limited. Therefore, a prospective, randomized trial of hand therapy utilization is warranted to explore this phenomenon. The purpose of this clinical trial is to assess the outcomes for post-operative therapy from in-clinic or at-home exercise therapies and analyze costs associated with the different therapies. For this clinical trial patients will be randomized to either in-clinic occupational therapy where patients come into clinic and undergo about 30-60 minutes of occupational therapy 1-2 a week with a physician or at-home exercise therapy where patients are provided instructions in clinic prior to HEP-therapy and have check-ins with physicians at their normal follow-up appointments; each consisting of about 5-10 minutes of exercise at home everyday of the week.

This study is a prospective, randomized, controlled trial to asses and analyze:

1. The outcomes after trapeziectomy and suture suspensionplasty with in-clinic occupational therapy (OT) and without in-clinic occupational therapy: home exercise program (HEP).
2. The cost difference between the OT and HEP groups as well as historical control patients that have undergone LRTI for thumb carpometacarpal joint arthritis (Including preoperative, intra-operative, and postoperative costs).

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 years
* Patients undergoing CMC Arthroplasty
* Ability to read and write in English
* Ability to provide informed consent

Exclusion Criteria:

* Patients undergoing revision CMC arthroplasty
* Acute traumatic dislocation of the CMC joint as indication for surgery
* Concomitant treatment of MCP hyperextension
Hoat Huyet Nhat Nhat Versus Tanakan for Treatment of Symptoms Related to the Insufficient Blood Supply to the Brain

The purpose of this study is to evaluate the effectiveness of Hoat Huyet Nhat Nhat on the reduction of common symptoms related to the insufficient blood supply to the brain such as headache, vertigo, dizziness, sleep disorders and forgetfulness; compared with Gingko Biloba Egb761 (Tanakan) after 45 days of treatment


Eligibility Criteria:
Inclusion Criteria:

* Male and Female more than 18 year old.
* With at least one of the symptoms related to the insufficient blood supply to the brain scored more than 5 out 10, on the Visual Analog Scale.
* Patients who will be using either Hoat Huyet Nhat Nhat or Tanakan following doctor's prescription or by patients own decision.
* Sign the informed consent form

Exclusion Criteria:

* Use of any medications for treatment of the insufficient blood supply to the brain in the last 3 months
Improving Students' Self-esteem With an Online Intervention

The aim of this study is to measure the impact of an online intervention on students' self-esteem, using the model outlined by Melanie Fennell.

The purpose of this study is to test the level of students' self-esteem (explicit and implicit) before and after an online intervention. All selected participants will enjoy one of the online working groups led by a psychologist for five weeks. In these group sessions, students will be trained to identify how their low self-esteem was developed, what are those factors that maintain their low self-esteem and what can they do for improving their low self-esteem, using Fennell model.

Eligibility Criteria:
Inclusion Criteria:

* Low Self-Esteem (Cut-off=35 at Rosenberg self-esteem scale)
* Being first year student in West University of Timisoara

Exclusion Criteria:

* Severe clinical depression symptoms (Cut-off=15 at PHQ9)
* Severe clinical anxiety symptoms (Cut-off=15 at GAD7)