cyrilzakka/clinical-trials huggingface dataset:
Impact of TENS on Postoperative Pain and Quality of Life After Inguinal Hernia Repair

Lichtenstein herniorrhaphy still remains one of the most often performed inguinal hernia repair techniques. It is frequently associated with acute postoperative and chronic pain. Due to insufficient effect of non-steroidal anti-inflammatory drugs, they are often overdosed. However opioids have many side effects. Interventional treatment, such as transversus abdominis plain (TAP) block requires an additional intervention and has relatively short effect, also could not be applied in outpatient conditions. The hypoalgesic effect of transcutaneous electric nerve stimulation (TENS) is well known for many years, but effectiveness during postoperative period is still controversial and maybe therefore didn't come to daily practice. However it could be a promising part of multi-modal pain treatment for hernia patients. This study analyse the hypoalgesic effect of TENS and its impact on hernia specific quality of life (QoL) after Lichtenstein hernia repair.

Aim#1 To determine whether use of TENS is effective for acute postoperative pain relief.

Aim#2 To determine whether use of TENS have impact on hernia specific QoL in early and late postoperative period.

Aim#3 To identify factors associated with effectiveness/ineffectiveness of TENS procedures.

Aim#4 To determine whether a psychological condition (depression, anxiety and pain catastrophisation) is somehow associated with TENS effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Elective Lichtenstein repair for primary hernia
* Male gender
* No TENS procedures in the past
* American Society of Anesthesiologists physical status I or II
* No cognitive, speaking, hearing or visual disturbances
* No movement disorders

Exclusion Criteria:

* Non Lithuanian speaker
* Known allergy to a patch glue
* Chronic use of non-steroidal anti inflammatory drugs or opioids
* Neuropathic diseases
* General contraindication for TENS procedures (such as skin disorders in site of electrodes application or pacemaker)
* Not able to complete the questionnaires
Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Helmet

Non invasive ventilation has been proposed to reduce the incidence of ventilatory dysfunction following abdominal aortic surgery. However, the nasogastric tube reduces the airtightness of the facial mask used to perform non invasive ventilation and induces air leaks. The use of a helmet reduces air leaks, thus seems adequate to ensure patient-ventilator interface. However, the high dead space related to helmet volume is responsible for asynchrony between patient demand and ventilatory support delivery. The investigators hypothesized driving the ventilator based on a neural signal (diaphragm electrical activity) would reduce patient-ventilator asynchronies.


Eligibility Criteria:
Inclusion Criteria:

* Patients with increased risk of postoperative ventilatory dysfunction following abdominal aortic surgery

Exclusion Criteria:

* Contra-indication to non-invasive ventilation pregnancy.
Comparison of Two Blades of Videolaryngoscope in Simulated Difficult Airway in Children

Airway management and tracheal intubation are routinely performed in paediatric anaesthesia and yet are associated with preventable adverse events. The D-blade of videolaryngoscope is preferred in difficult intubation with a more curved blade then the Macintosh videolaryngoscope blade, which may be more useful in difficult intubation. The aim of the study is to compare the D-blade of videolaryngoscope with Macintosh videolaryngoscope blade.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients
* Undergoing elective surgeries
* Age between 1-5 years

Exclusion Criteria:

* Anticipated difficult intubation
* Pulmonery diseases
* \>III ASA scores
Glucocorticoid Induced Whole Body Catabolisme

The main purpose of the trial is to advance our knowledge on the possible mechanism underlying the catabolic effects of long-term treatment with glucocorticoid.

Long-term treatment with glucocorticoid induces a general state of catabolism and increases insulin resistance. The underlying mechanisms are insufficiently characterized, however glucocorticoid induced changes of Growth Hormone (GH) and the Insulin-like growth factor I (IGF-I) appear to be of outmost importance.

We wish to investigate the mechanism behind glucocorticoid induced catabolism and insulin resistance.

More specific we wish to investigate:

* Whether glucocorticoid induces IGF-I inhibiting substances in serum or interstitial fluid that block the ability of IGF-I to phosphorylate its receptor in vitro
* Whether glucocorticoid inhibits intracellular IGF-I and insulin signaling in vitro and in vivo
* The mechanisms by which growth hormone counteracts the CG-mediated inhibition of IGF-I action

Eligibility Criteria:
Inclusion Criteria:

* signed and dated informed consent
* healthy subjects
* sex: male
* age 20-30 years
* BMI 19-26 kg/m2
* normal HbA1c

Exclusion Criteria:

* suspected og known allergy to the trial drug or similar medications.
* known current illness including diabetes mellitus, ischemic heart disease or cardiac arrhythmia.
* Daily drug intake (excluding Over-the-Counter medicines).
* Known or previous mental illness
* Current participation or previous participation in experiments using ionizing radiation for a year prior to inclusion in this study.
* Participation in a larger X-ray examinations in trial period.
Bialystok Exercise Study in Diabetes

The "Bialystok Exercise Study in Diabetes" (BESD), is an exercise intervention study, conducted by the Department of Endocrinology, Diabetology and Internal Medicine and Clinical Research Centre of the Medical University of Bialystok. In the project, sedentary males at different stages of dysglycemia living in the city of Bialystok participate in three months of an exercise intervention consisting of supervised training sessions at a local fitness centre. The aim of the study is to assess the effectiveness of the exercise intervention in patients at different stages of dysglycemia progression, including type 2 diabetes and prediabetes and compare the response between groups.


Eligibility Criteria:
Inclusion Criteria:

* Age: 35-65 years old
* BMI: 25-35 kg/m2
* Male gender
* Ability of performing exercise trainings
* Sedentary lifestyle

Exclusion Criteria:

* Smoking
* Drug or alcohol addiction
* Any chronic disease (exceptions: hypertension, obesity with BMI ≤ 35 kg/m2, type 2 diabetes)
* Any chronic medications (exceptions: angiotensin-converting-enzyme inhibitors for hypertension and metformin in type 2 diabetics)
* Highly active lifestyle
* Medical contraindications to participate in planned exercise sessions
Randomized Trial Comparing Carbonated Drink With Water as a Solvent for Colonoscopy Solution

This prospective randomized trial will be conducted in all patients undergoing elective colonoscopies from February 2020 to August 2020 in Dowites Operation Theater Endoscopy suite by surgical unit III, Civil Hospital Karachi. Patient will be select randomly based on inclusion criteria. Patients will be advised to take 90ml of sodium phosphate in 800ml solvent ( zero calorie soft drink and water). Patients will be nil per oral from midnight aside from clear liquids. Serum electrolytes, urea, creatinine will be measured after and before bowel preparation. Bowel preparation will be assessed by consultant during endoscopy. Questionnaire will be filled by PI for palatability, tolerance of solution, adverse effects, and willingness to repeat the preparation.

This prospective randomized trial will be conducted in all patients undergoing elective colonoscopies from February 2020 to August 2020 in Dowites Operation Theater Endoscopy suite by surgical unit III, Civil Hospital Karachi. Patient will be select randomly based on inclusion criteria. Patients will be advised to take 90ml of sodium phosphate in 800ml solvent ( zero calorie soft drink and water). Patients will be nil per oral from midnight aside from clear liquids. Serum electrolytes, urea, creatinine will be measured after and before bowel preparation. Bowel preparation will be assessed by consultant during endoscopy. Questionnaire will be filled by PI for palatability, tolerance of solution, adverse effects, and willingness to repeat the preparation.

90ml of sodium phosphate will be added to 800ml of solvent and taken in divided doses one day prior to procedure. Whole solution will be finished 3 -4 hours before colonoscopy. The instructions about how to take the solution will be clearly explained at the time of booking. Complete Blood Count and hepatitis B and C screening as routine shall be done. All procedure will be carried out under monitored sedation by trained colorectal surgeon from the faculty

Eligibility Criteria:
Inclusion Criteria:

* • Age \> 18 years

  * Non-emergency / non urgent colorectal diseases (IBD, suspected colonic polyps, colorectal cancer)
  * Screening Colonoscopy

Exclusion Criteria:

* Age \<18 years Pregnancy Intestinal obstruction Unfit patient Acute or serious illness Coagulopathy Unwilling patients
Transperineal Laser Ablation vs Transurethral Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial

The primary objective of the study is to compare Trans-Perineal Laser Ablation of Prostate versus Trans-Urethral Resection of Prostate in the immediate impact on post-operative pain; in terms of relief in benign prostatic obstruction and preservation of the ejaculatory function in the short term (at 1, 3 and 6 months).

The secondary objective of the study is the evaluation of the long-term deobstructive effectiveness (12 months).

Consecutive patients coming to our institution affected by benign prostatic obstruction (BPO) with indication to surgery and strong need of ejaculatory preservation will be enrolled in the present randomised controlled trial study after counseling. After an informed consent is obtained, uroflowmetry with calculation of the post-voiding residual volume (PVR), a transrectal ultrasonography to estimate prostate volume (PVol), the international prostate symptoms score (IPSS) questionnaire with quality of life (QoL) assessment, and the evaluation of the ejaculatory sexual function will be performed in all patients.

Trans-Perineal Laser Ablation of Prostate (TPLA) will be performed using the EchoLaser combined system (Elesta, Italy).

During the procedure, two 21G spinal needles are inserted transperineally in the peri-urethral area under ultrasound-guidance. By optical fibers, a maximum energy of 1800 J at a power of 3 Watts is delivered. If necessary, the fibers are eventually pulled-back. Immediately after the procedure, the patients will be asked to fill in the Visual Analogue Scale (VAS) for the assessment of the pain perceived. Perioperative data and postoperative data including assessment of ejaculatory function will be analyzed at different time points.

Eligibility Criteria:
Inclusion Criteria:

* signed written informed consent
* patient able to complete the Whole protocol
* IPSS score ≥ 10
* Maximum urinary flow rate \< 15 ml/sec
* Prostate volume at preop. ultrasonography \< 100 mL
* normal urinalysis (all of the above)

Exclusion Criteria:

* former prostate surgery
* prostate cancer (history)
* urethral stricture (history)
* Marion's disease (history)
* bladder stones
* median obstructive lobe, as defined by a \> 1 cm of prostate abutting in the bladder lumen at ultrasonography
* neurological conditions potentially impacting on the bladder voiding (at least one of the above)
Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis

To investigate the immunologic effects and safety of 60-day treatment of the Standardized Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.


Eligibility Criteria:
Inclusion Criteria:

* clinical history consistent with grass pollen-induced allergic rhinoconjunctivitis.
* Use of symptomatic treatment of grass pollen-induced allergic rhinoconjunctivitis.
* Positive skin prick test response (wheal diameter ≥3 mm) to Phleum pratense.
* If asthma, daily use of Inhaled corticosteroid (ICS) should be ≤400 microgram budesonide or equivalent
* Moderate or higher level of Phleum pratense specific IgE (Immunoglobulin E) (defined as ≥IgE Class 2; or ≥0.70 Kilo Units/liter (kU/L))

Exclusion Criteria:

* Reduced lung function (defined as FEV1 \< 70% (FEV1=Forced Expiratory Volume in 1 second) of predicted value after adequate pharmacologic treatment) measured at Visit 1 and Visit 2
* Clinical history of uncontrolled asthma within 3 months prior to the screening visit
Effect of Transcranial Direct Current Stimulation (tDCS) on Tobacco Consumption

The primary purpose of the protocol is to evaluate the effect of repeated application for 5 consecutive days of a real tDCS compared to the application of a placebo tDCS (sham procedure) on the evolution of tobacco consumption in the short term between Day 1 and Day 5.

The study hypothesis is that a repeated application for 5 consecutive days of a real tDCS on the left dorsolateral prefrontal cortex region will reduce the craving induced causing a decreased of daily tobacco consumption between Day 1 and Day 5 which can persist at the final visit between Day 15 and Day 20.

Smoking is a major public health problem and it is the leading cause of preventable death in the world. Care should include education, psychotherapy and treatments, but despite these therapeutics, the smoking cessation process is often characterized by relapses. The main risk factor for relapse is craving. Neurophysiological studies have provided evidence in the understanding of craving. This craving involves surface structures including the dorsolateral prefrontal cortex, accessible by neurostimulation. Repetitive neurostimulation applies on this structures involved in craving could therefore modulate it. Two non-invasive stimulation techniques exist: repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS). The choice of tDCS is based on its ease of use, excellent tolerance, its better quality of placebo and low cost.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 60 years old
* Smoking ≥ 5 years
* Smoking ≥ 15 manufactured cigarettes per day or ≥ 10 rolled cigarettes per day
* Fagerström test ≥ 5
* Smokers who have at least an attempt to stop of minimum 7 days
* Written informed consent signed by the patient
* Affiliated to medical insurance

Exclusion Criteria:

* Co-addiction (cannabis, alcohol, other drugs)
* HAD test: D ≥ 8; A + D ≥ 19
* Treatment by nicotine replacement therapy, bupropion or varenicline within 30 days prior inclusion
* Neuropsychiatric disease, considered serious by the investigator
* Psychotropic treatment (antidepressant, anxiolytic, antipsychotic)
* Skin scalp dermatosis
* Pregnancy or breastfeeding. Positive pregnancy test.
* Patient under guardianship, trusteeship or judicial protection
* Patient in inclusion period for another clinical research protocol
A Prospective Study for the Early Diagnosis of Lung Cancer in Korean Females

This is a single-arm prospective pilot study in a single institution. The target accrual is 200 participants of Korean, female sex, never smoker status, and family history of lung cancer. The study will aim to enroll 200 participants in two years.

Interested individuals will contact a research coordinator who will help to assess for study eligibility. Individuals who are eligible and able to sign informed consent will then proceed to have a LDCT screening exam with a result reported by a radiologist approved to read lung cancer screening scans. Results of this screening test will be discussed with the subject and further recommendations will be given. Negative results will proceed to have repeat LDCT exams for two additional years. Positive results will be recommended to have further diagnostic work-up, and possible treatment. Those with positive findings may be recommended to repeat a LDCT at varied intervals (e.g. at 3 months, at 6 months, etc.) per Lung-RADS recommendations which can be conducted as a research LDCT or as standard-of-care.

In addition, blood draw collection for a plasma-based assay will be collected at baseline, first year and second year for all patients along with the repeated LDCT scans.

A medical history questionnaire containing questions regarding ethnicity, family history of lung cancer, environmental exposures including secondhand smoke exposure, and a residential district to estimate the exposure of PM2.5 or PM10 will be given to the patient at the initial visit after informed consent has been obtained (Appendix A). Questionnaire can be collected within 1 month from the baseline consent.

Eligibility Criteria:
Inclusion Criteria:

1. Age 45-74 years old
2. Korean female
3. Never smoker defined as a lifetime exposure of less than 100 cigarettes
4. Family history of lung cancer at first degree relatives (parents, siblings, or children)

Exclusion Criteria:

1. Prior history of lung cancer.
2. Diagnosis of any cancer within the past five years
3. Participation in a cancer prevention trial.
4. Present symptoms suggestive of current lung cancer, including: unexplained weight loss of over 5 kilograms within the last 12 months or unexplained hemoptysis.
5. Medical or psychiatric condition precluding informed medical consent.
6. History of LDCT screening, chest CT, PET or PET/CT scan within 10 years
Tobacco Tactics Website for Operating Engineers

This is a clustered randomized control trial to test the Tobacco Tactics intervention among Operating Engineers (heavy equipment workers). The intervention group will be directed to the Tobacco Tactics website, and the control group will be directed to the state supported 1-800 quit-now telephone hotline during routine annual safety training that all Operating Engineers are required to attend. The web-based quitting intervention includes provision of over-the-counter nicotine replacement therapy and will be followed by nurse email and/or telephone counseling. It is expected that Operating Engineers who are randomized to the Tobacco Tactics website intervention will have at least equal or greater decreases in smoking at 30-day and 6-month follow-up compared to those randomized to the 1-800-QUIT-NOW quit line. In addition, the investigators expect to find that Operating Engineers randomized to the Tobacco Tactics website intervention will: a) be able to accomplish tasks; b) be able to accomplish goals with skill and speed; c) be able to operate the system; d) be satisfied with the website; e) access the site repeatedly; and f) spend time on the site during the intervention period.


Eligibility Criteria:
Inclusion Criteria:

* attending a training session provided by the Operating Engineers Local 324 Education Center
* greater than 18 years of age
* smoked cigarettes in the past month
* interested in participating in a program to quit smoking
MDD(Mild Cognitive Impairment Delirium Dementia) Cohort

* Identify the degree of delirium in subjects with mild cognitive impairment and find the risk factors of delirium. Mortality, hospital stay, and medical expenses are analyzed as clinical consequences related to delirium incidence.
* Dementia conversion rate and conversion period of subjects with mild cognitive impairment with delirium and it identifies the effect of delirium on dementia conversion.
* Develop an AI(Artificial intelligence) algorithm for predicting dementia transition in subjects with mild cognitive impairment based on the research results of the 1st, 2nd, and 3rd years.


Eligibility Criteria:
Inclusion Criteria:

* Patients 65 years of age or older who are admitted to a LTC
* Patients diagnosed with mild cognitive impairment by doctors
* Patients with a score of 18 or more and 23 or less on the Mini-Mental State Examination

Exclusion Criteria:

* Patients unable to measure the delirium assessment tool, The Short Confusion Assessment Methods (S-CAM) (Inouye, 2014) due to severe vision and hearing problems
* Patients with serious psychiatric or neurological diagnosis,Patients who expire or were transferred on the day of admission -
* Patients receiving emergency treatment at the time of the delirium assessment or unable to measure or intervene with S-CAM due to hospital circumstances
Study Comparing ABX-CBL (Monoclonal Antibody) Versus Atgam in Patients With Steroid Resistant Acute Graft Versus Host Disease

Trial evaluating the improvement in survival at 180 days of two therapies (Atgam versus ABX-CBL, a monoclonal antibody) in patients with acute graft versus host disease that does not respond to steroid therapy.


Eligibility Criteria:
Inclusion Criteria:

* Recipient of single allogeneic stem cell transplant from any donor type
* Time post transplant less than 100 days
* Received no treatment for GVHD other than steroids

Exclusion Criteria:

* Recipient of second allogeneic stem cell transplant or subsequent lymphocyte product from the donor post transplant
* IBMTR index less than A
* Received any murine product in the past
* Diagnosed with chronic GVHD
* Received Atgam later than day 10 post transplant
* Change to prophylactic regimen for acute GVHD within 72 hours of randomization
A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer

To establish the progression free survival in patients with extensive stage small cell lung cancer treated with cisplatin and etoposide plus or not apatinib

Assess progression free survival, overall survival and toxicity of standard EP regimen combined or not with VEGF tyrosine kinase inhibitor-apatinib. Response measured by RECIST response criteria. Toxicity via physical exam, adverse event review, assessing signs and symptoms, quality of life assessment and blood testing.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically verified SCLC, extensive stages
2. WHO performance status 0, 1, 2
3. Age 18 years or older
4. Treatment naive
5. Anticipated survival more than 3 months
6. HB \>90g/L, ANC\>1.5 x 109/L, Platelets \>80 x109 /L
7. No prognancy
8. Signed informed consent

Exclusion Criteria:

1. Limited stage disease
2. Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm
3. Uncontrolled hypertension
4. Uncontrolled heart failure
5. Coagulation problem
6. Surgery, trauma, uncontrolled ulcer in 4 weeks.
7. Required by physician