cyrilzakka/clinical-trials huggingface dataset:
Bariatric Surgery and Fatty Liver Disease

The study is based on data from morbidly obese patients who fulfilled the criteria for bariatric surgery during 2016-2018 at the Department of Surgery, University Hospital Ostrava, Czech Republic.

The study is based on data from morbidly obese patients who fulfilled the criteria for bariatric surgery during 2016-2018 at the Department of Surgery, University Hospital Ostrava, Czech Republic. Patients with age above 18 years, BMI \> 35-40 kg/m2, and associated with at least one of the complications including hypertension, diabetes, and failure of the current therapies to relieve the symptoms were included in the study. Patients included in the current study do not have a history of excessive alcohol consumption, use of hepatotoxic drugs, infectious liver diseases (i.e. hepatitis A, B, C), and genetic hemochromatosis. A total of 72 patients including n = 26 during 2016, n = 26 during 2017, and n = 20 during 2018 who qualified for bariatric surgeries were included in this observational study. Data related to patients' gender, age (years), weight (kg), height (cm), and associated co-morbidities like diabetes and hypertension were recorded before surgery. BMI (kg/m2), biochemical parameters including triglycerides profile (mmol/L), platelet count (number/L), Gamma glutamyl-transferase (international units - IU/L), albumin concentration (g/L), Alanine amino-transferases (units/L), Aspartate aminotransferases (international units - IU/L), were evaluated following standard procedures. Platelet count, triglycerides, and enzymes were determined using standard procedures.

The biochemical results were compared to the corresponding paired values before surgery and after surgery. The current study was designed to prospectively investigate the effect of bariatric surgeries among non-alcoholic obese individuals from 2016-2018 and one year follow up on liver biochemistry, BMI, non-alcoholic fatty liver disease (NAFLD) fibrosis score, Fibrosis 4 (FIB 4) Index, and Fatty Liver Index (FLI).

The continuous variables were expressed as mean ± standard deviation and median (interquartile range) in case of normal and non-normal distribution, respectively. The Shapiro-Wilk test was used to test for normal distribution. The within-patient changes in clinical parameters (continuous or ordinal variables) from baseline to 1-year after bariatric surgery were compared using the Wilcoxon matched-pairs signed-rank tests for ordinal variables and continuous variables when the change was not normal or using the paired Student's t-test otherwise. The statistical testing was done at the two-tailed α level of 0.05. The data were analyzed using GraphPad Prism Version 8.0.2 (GraphPad Software, Inc., USA).

Eligibility Criteria:
Inclusion Criteria:

* age 18 years and above
* BMI \> 35-40 kg/m2
* hypertension or diabetes or failure of the current therapies to relive the symptoms

Exclusion Criteria:

* history of excessive alcohol consumption
* use of hepatotoxic drugs
* infectious liver diseases (i.e. hepatitis A, B, C)
* genetic hemochromatosis
Evaluation of Serum Chemokines for Patients Undergoing Treatment With Boceprevir.

The purpose of the study is to determine differences in levels of serum chemokines from patients undergoing treatment with Boceprevir. The aim is to determine if non-responders have significantly different levels of chemokines than responders.

Patients undergoing standard of care at the UNC Liver Center are consented for collection of an additional serum sample under the UNC Liver Center serum and tissue bank study. These samples will be used to analyze differences in serum chemokines across responders and non-responders.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (age 18 or older) treated with an antiviral Hepatitis C treatment regimen that includes Boceprevir.

Exclusion Criteria:

* Inability to provide informed consent for a serum sample enrolled in the University of North Carolina Liver Center serum bank.
* No pre and post serum sample available within 6 months of the treatment period.
Endobronchial Ultrasound- Transbronchial Needle Aspiration (EBUS-TBNA) Versus Mediastinoscopy for Mediastinal Lymph Node Staging of Non-small Cell Lung Cancer (NSCLC)

Accurate staging of the mediastinum is essential to evaluate prognosis in non-small cell lung cancer and to devise an appropriate treatment plan. Mediastinal staging by surgical techniques (mainly cervical mediastinoscopy) is considered to be the gold standard, although surgical staging is invasive, requires general anesthesia, and is subject to potential serious complications. Endobronchial ultrasound (EBUS)-transbronchial needle aspiration (TBNA) is a new modality for the evaluation of mediastinal and hilar lymph node metastasis from lung cancer. Compared to other diagnostic methods, EBUS-TBNA is a real-time procedure that enables multiple biopsies with high-quality histologic cores under local anesthesia. However, there have been few data on the head-to-head comparisons of mediastinoscopy and EBUS-TBNA. The aim of this prospective study is to determine the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of EBUS-TBNA and mediastinoscopy in identifying N2 and N3 lymph node for patients with non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histology-proven non-small cell lung cancer
* N2 or N3 lymph node invasion is suspected based on chest CT or PET/CT scans (at least one of three criteria) : 1) enlarged (1cm or more in short axis diameter) mediastinal lymph node(s), 2) FDG uptake in the mediastinal lymph node(s), or 3) FDG uptake in N1 node(s)
* The patient is otherwise considered a candidate for a surgical treatment with the intention to cure

Exclusion Criteria:

* Distant metastasis
* Inoperable T4 disease
* Confirmed supraclavicular lymph node metastasis
* Former therapy (chemotherapy or radiotherapy or surgery) for lung cancer
* Contraindications for bronchoscopy
* Uncorrected coagulopathy
* Concurrent other malignancies
* Suspicious mediastinal lymph node metastasis which are not accessible by EBUS-TBNA or mediastinoscopy (i.e. paraaortic, aortopulmonary window, or paraesophageal lymph nodes)
Breast Edema Compression Vest

A common complication of breast conserving therapy is breast edema, which may lead to chronic pain, but also reduced quality of life (QoL) and poor cosmetic outcome. When pain is present most patients are currently treated with physical therapy, but evidence of its effectiveness is still low and a gold standard does not yet exist. A downside of physical therapy is that patients have to undergo the therapy regularly and treatment might even has to continue for years after symptoms and treatment started. Another treatment option is a compression vest with the potential, apart from reducing symptoms, to improve self-efficacy in patients because they decide when to wear it without the need to visit therapists. However effectiveness of the compression vest has not yet been objectified in studies.

The aim of this pilot study is to study if there is an effect on pain, QoL and the amount of breast edema of wearing a compression vest, in order to determine whether a large randomized study is feasible.

In this pilot study, a maximum of 40 patients with symptomatic breast edema after surgery and/or radiotherapy for breast cancer are offered treatment with a compression vest. These patients will be followed for 6 months. Recruitment will continue until 20 active vest users are participating.

Primary endpoint is the course of patient reported pain over a 6 month period. Secondary endpoints are the course of degree of breast edema and quality of life over a 6 month period.

Patients who are wearing the vest may experience relief of breast edema related symptoms. In terms of burden, they might experience a tight feeling on the skin while wearing the vest, which could also be the case when treated with compression therapy and taping by a physical therapist. This tight feeling can be overcome by changing the vest to a larger size. All patients will fill out questionnaires upon inclusion, at 2 weeks, and 1, 3 and 6 months. This will take approximately 10-15 minutes per follow-up moment. Patients will have to visit the hospital at baseline and 1, 3 and 6 months after they started wearing the vest (i.e. 25 minute consult with physical examination, photo documentation of the breast and short basic follow-up questions), and it is expected that additional measurements for fitting a new compression vest will need to be taken 2-5 times during participation in the study. Those fitting measurements will be performed at a location as desired by the patient (e.g. UMC Utrecht or at patients' home).

Eligibility Criteria:
Inclusion Criteria:

* Females, aged 18 years and older.
* Patient treated with surgery and/or radiotherapy for breast cancer, with symptomatic breast edema (e.g. pain).
* Visual Analog Scale (VAS) pain score of 3 or more.

Exclusion Criteria:

* Inability to understand the Dutch language.
* Indicated to undergo radiation treatment of the breast/chestwall within the next 6 months.
* Cardiac complaints.
* Pacemaker.
* Port-a-cath.
* Thrombosis of the arm.
* Pulmonary embolism.
* Pulmonary disease.
* Pregnancy.
* Non-breast cancer related lymph edema.
* Clinical depression or anxiety disorder.
Effectiveness of 5-week Digital Respiratory Practice in Children With Duchenne and Becker Muscular Dystrophies.

The purpose of this study is to analyze the effectiveness of a 5-weeks respiratory digital intervention program in patients with Duchenne muscular dystrophy and Becker muscular dystrophy.

It will be done 4 times a week for a period of 5 weeks, for a duration of 55-60 minutes (20 sessions), with an intensity adapted to the characteristics of each participant. An intervention program will be used based on respiratory muscle training exercises, upper limb strength work, yoga, diaphragmatic awareness exercises, always trying to do them through the use of games, and even try to include exercises that use motor imagery.

It is advisable during intervention program to have a playful environment stimulated for the children, and that the intervention program is carried out and stimulated through videos and therapeutic teaching to the caregivers in the first evaluation session, as well as with a weekly follow-up using WhatsApp as forms of communication, or a telephone call to ensure correct follow-up of the intervention program.

It is essential that to carry out the intervention, videos obtained from YouTube, own videos prepared to explain the exercises in a playful way applied to children, and even other applications such as Spotify to work with music, will be used, being offered in case of Zoom calls may be necessary to help optimally resolve doubts that arise when carrying out the program by video call.

At the end of the respiratory digital physiotherapy program, variables will be evaluated by the principal examiner.

Eligibility Criteria:
Inclusion Criteria:

* Participants with Duchenne muscular dystrophy and patients with Becker muscular dystrophy will be chosen.
* Aged between 5 and 20 years.
* Child who could walk and follow the intervention program, and were diagnosed according to the International Classification of Diseases, 10 Revision. code (G71-01); and who had an NSSA score greater than 20.

Exclusion Criteria:

* Patients who present associated heart disease.
* Patients who presentor fractures, a heart rate greater than 120 beats per minute, or an oxygen saturation less than 89% will be excluded.
* Participants who do not have the capacity to have internet at home to perform the intervention, as well as all patients whose caregivers did not agree to sign the informed consent.
Minimally Invasive Reduction and Fixation of Thoracolumbar Fractures

Spinal injuries, such as vertebral fractures, often result in a significant instability of the spine and lead to acute or delayed neurological deficits. Depending on the type of injury there are various methods available to stabilize the spine. The proposed study should clarify whether the combined reduction and fixation with a minimally invasive approach can actually be done with the same precision as in a conventional approach. The primary endpoint of this investigation is the monosegmental anterior wedge angle (AWA), and its maintenance over the first 6 postoperative weeks. It is the aim of the study to gather key radiological, clinical and subjective patient outcome parameters for its patient population that will allow to compare the results to a historical group of patients. The study design is non-interventional, prospective, open,and multicentric.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of the patients of 18 years
* Indication for operative treatment of fractures of the thoracic or lumbar spine
* Singular A3.1-3 fractures according to the AO classification system
* Declaration of consent in participation in this study and willingness to the treatment according to the study protocol
* Physical and mental ability to meet the clinical and radiological follow-up plan

Exclusion Criteria:

* Additional severe trauma, that makes survey of the patient difficult or impossible influence the results of the fracture treatment significantly
* Additional trauma or fractures of the spine
* Other serious conditions complicating participation in the study
* Systemic or local infections
* Pregnancy or planned pregnancy
* Neurological deficits
* Severe blood coagulation disorders diagnosed preoperatively
* Intake of preoperatively anticoagulants
* Osteoporosis
* Bone metabolism disorders
* Laminectomy necessary during surgery results in exclusion of the patient either
Evaluation of the Quality of the NovoSeven (rFVIIa) Tratment Practice at Rigshospitalet, Copenhagen University Hospital

The purpose is to evaluate and improve NovoSeven treatment practice done according to our guidelines


Eligibility Criteria:
Inclusion Criteria:

* Indication for NovoSeven treatment according to our guideline

Exclusion Criteria:

-
To Assess the Feasibility of Same Day Discharge Following a POEM Procedure

This is a study of an investigational surgical procedure for the treatment of achalasia the inability of smooth muscle to move food down the esophagus. A new procedure, called the POEM procedure (per oral endoscopic myotomy) has been developed for achalasia. This study is being performed to determine if patients can go home on the same day as their procedure.

This is a study of an investigational surgical procedure for the treatment of achalasia the inability of smooth muscle to move food down the esophagus.

Standard care for participants includes Heller Myotomy, a laparoscopic procedure that includes cutting the muscle layers in the lower esophageal sphincter (LES) the valve at the bottom of your esophagus. A second procedure is then required to prevent reflux (acid entering the esophagus from the stomach) called fundoplication. Patients with the Heller myotomy will typically stay overnight in hospital. A new procedure, called the POEM procedure (per oral endoscopic myotomy) has been developed for achalasia. This procedure uses endoscopy and no incisions to cut one muscle layer. A fundoplication is not required with this method. This study treatment works by entering the surgical area through the mouth and then making an incision (cut) through the esophagus and placing flexible instruments along the outside of the esophagus and down to the LES through a tunnel. The instruments used in this procedure are standard endoscopic instruments that will be provided by one of the leading endoscopic instrument manufacturers, Olympus. The investigators have recently completed a small study showing this procedure is safe and feasible. One observation from this pilot study was that most patients had no pain and didn't need any pain medications. Due to this reason, the investigators think patient's may go home on the same day as their procedure.

Eligibility Criteria:
Inclusion Criteria:

Participants must meet ALL of the following inclusion criteria:

* Candidate for a Heller myotomy
* Their age is ≥18 years and ≤80 years
* Able to give written consent

Exclusion Criteria:

Participants who meet any of the following criteria at the time of the baseline visit are NOT eligible to be enrolled in this study:

* Previous Heller myotomy or POEM procedure
* contra-indication to general anesthesia
* Previous mediastinal surgery hiatal hernia greater than 2 cm
* Any anatomical esophageal anomaly that in the opinion of the investigator may render the intervention more difficult, such as sigmoid esophagus on the pre-operative barium swallow or hiatal hernia \> 2cm.
* Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
* Pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)
Evaluating the Performance of Precision1 Daily Disposable Contact Lens in a Group of Heavy Digital Device Users

The purpose of this study is to evaluate the performance of Precision1 DD CLs with regard to subjective symptoms (dryness, comfort, vision), lens fit and time to haze in CL wearers who identify themselves as heavy digital devices users (at least 6 hours of digital device use per day).


Eligibility Criteria:
Inclusion Criteria:

1. Is between 18 and 40 years of age (inclusive) and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Is a heavy digital device user (at least 6 hours on a typical day using any combination of digital devices such as PC, laptop, smartphone, or tablet);
5. Is a habitual wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision, not a current wearer of Precision1 lenses) for at least 5 days/week and at least 10 hours/day during the month prior to enrollment;
6. Has a vertex corrected spherical equivalent distance refraction that ranges between -0.50D to -6.00D in each eye;
7. Has a vertex corrected refractive cylinder of no more than -1.00D cylindrical correction in each eye after vertexing to the corneal plane;
8. Demonstrates an acceptable fit and achieves best corrected visual acuity of at least 0.20 log MAR in each eye with Precision1 contact lenses;
9. Is willing to wear Precision1 CLs at least 5 days per week and 10 hours per day throughout the study;

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active\* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Is aphakic;
8. Has undergone refractive error surgery;

   * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Hyperbaric Oxygen in Lower Leg Trauma

Study hypothesis :Hyperbaric Oxygen may prevent complications and improve outcomes in severe lower limb trauma. We propose to investigate this hypothesis by conducting an International multi centre randomised control trial of standard trauma/orthopaedic care with or without a concurrent course of hyperbaric oxygen treatments.

A randomised controlled trial was undertaken on using hyperbaric oxygen in addition to standard orthopaedic trauma care in severe lower leg injury, defined as an open tibial fracture with severe soft tissue injury. The control arm subjects received standard hospital trauma care whilst the intervention group received standard trauma care with the addition of hyperbaric oxygen therapy with the aim of providing 12 HBOT sessions over the first 9 days of hospital care. The primary outcome measure was the incidence of wound necrosis AND/OR wound infection as assessed at Day 14, with secondary outcomes of wound closure, wound complications, infections and delayed bone union at 12 months plus quality of life and functional questionnaire outcomes at 12 months and 2 years.

The detailed study protocol was published in in June 2015 and the results were published in September 2022. Both publications are Open Access (See References section for publication details)

Eligibility Criteria:
Inclusion Criteria:

* Acute fracture of the tibia with significant soft tissue injury of Gustilo Grade 3
* Enrolment within 48 hours of injury with expectation of commencement of HBO therapy within 48 hours of injury
* Valid consent

Exclusion Criteria:

* Significant head injury
* Injuries incompatible with HBO
* resuscitation requirements incompatible with HBO
* follow up not possible
* hyperbaric contra indications
Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #1

The purpose of this study is to set an optimal measurement time for assessing driving ability in a driving simulator in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥18.5 and \<25.0 kg/m2 at screening inspection
* No visual impairment (enable to correct the vision with eyeglasses or contact lens)
* Receive a prior explanation on the study, able to accept its content, and capable to provide voluntary written consent for participation in this study

Exclusion Criteria:

* History of drug and food allergy
* Routinely drink alcohol before bedtime
* Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator
Omega-3 Fatty Acids in Tourette's Disorder

This study examines the safety and efficacy of omega-3 fatty acids (fish oil) for the treatment of Tourette's Disorder.

This is a 20-week, double-blind, placebo (olive oil) controlled study examining supplemental fish oil in the treatment of tic and OCD symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Ages 6 through 18 inclusive
* Meet full DSM-IV diagnostic criteria for TD or chronic motor tic disorder
* Normal laboratory results, including serum chemistries, hematology, and urinalysis
* Must be able to swallow capsules.
* Must be of normal intelligence in the judgment of the investigator.
* Subjects and parents must possess an educational level, degree of understanding and command of the English language to enable them to communicate suitably with the investigator and study coordinator and to understand the nature of the study.
* Subjects and their legal representatives must be considered reliable.

Exclusion Criteria:

* Organic brain disease, for example, traumatic brain injury residua
* Meeting criteria for mental retardation as defined by the DSM-IV.
* A history of seizure disorder (other than febrile seizure).
* A Subjects with history of Sydenham's Chorea.
* Autism, schizophrenia or other psychotic disorders.
* A primary diagnosis of a major mood disorder that requires ongoing psychiatric treatment.
* A neurological disorder other than a tic disorder.
* A documented auto-immune disorder.
* A major medical illness.
* A history of ongoing or previously undisclosed child abuse (risk of removal from home would not allow for consistent caretaker ratings).
* Subjects who, in the opinion of the investigator, are unsuitable in any other way to participate in this study.