cyrilzakka/clinical-trials huggingface dataset:
Pain Outcomes During Rigid Cystoscopy in Females With and Without Cystoscopic Sheath Obturator

Rigid cystoscopy is a common procedure to evaluate lower urinary tract symptoms in females. This procedure can be done with or without an instrument called a sheath obturator. Both techniques are used by surgeons and are considered safe, but have never been studied to see if one technique leads to less discomfort with the patient's first void after the procedure. The obturator's use may potentially reduce urethral irritation and bothersome postprocedural symptoms, primarily dysuria. The investigators aim to determine whether there is a difference in dysuria outcomes postoperatively when cystoscopy is performed with or without an obturator.

Rigid cystoscopy is a common procedure to evaluate lower urinary tract symptoms in females. This procedure can be done with or without an instrument called a sheath obturator (or obturator for short). There are two acceptable insertion techniques for performing cystoscopy in women. Surgeons can perform cystoscope without the use of the obturator by using a "visual" technique where a telescope with a sheath is inserted for entry into the bladder (referred to as cystoscopy without the obturator). Surgeons can also perform cystoscopy by using an obturator with a sheath allowing for smooth entry without needing the telescope (referred to as cystoscopy with the obturator). Both techniques are used by surgeons and are considered safe, but have never been studied to see if one technique leads to less discomfort with the patient's first void after the procedure. The obturator's use may potentially reduce urethral irritation and bothersome postprocedural symptoms, primarily dysuria. The investigators aim to determine whether there is a difference in dysuria outcomes postoperatively when cystoscopy is performed with or without an obturator.

Eligibility Criteria:
Inclusion Criteria:

* Female patients scheduled for gynecological procedures where cystoscopy is indicated
* Ability to comprehend and participate in the study

Exclusion Criteria:

* \< 18 years
* Pregnancy
* Current pelvic mesh erosion
* Exposure or pain complications from mesh
* Genitourinary malignancy;
* History of recurrent urinary tract infection (e.g., 2 in 6 months)
Significance of MAIT Cells in Inflammatory Bowel Disease

To examine the level and function of MAIT cells in IBD patients, and to compare it with disease activity.

Inflammatory bowel diseases (IBDs), including ulcerative colitis (UC) and Crohn's disease (CD), are chronic inflammatory diseases of unknown origin. IBD has become a global disease with increasing incidence in newly industrialized and westernized countries. Genetic and environmental factors with inadequate host immune response to gut flora appear to play important roles in the pathogenesis of IBD. Adaptive immune response has been classically considered to play a major role in IBD pathogenesis .

Infiltrating lymphocytes including T helper (Th) 1 cells and Th17 cells can lead to the development of intestinal lesions . However, recent evidences suggest that innate immune response is equally important in inducing gut inflammation . Altered epithelial barrier function and aberrant innate immune responses contribute to intestinal inflammation in IBD patients.

Mucosal-associated invariant T (MAIT) cells are innate lymphocytes that express a conserved invariant Tcell receptor (TCR) Vα7.2-Jα33 chain paired with a limited set of Vβ chains. Using distinct pairs of TCR chains, MAIT cells can recognize bacteria-derived riboflavin (vitamin B2) metabolites presented by MHC(major histocompatibility complex) class 1b-like related protein (MR1).

Upon MR1-dependent recognition of antigens, MAIT cells are activated to rapidly release Th1/Th17 proinflammatory cytokines (i.e., interferon \[IFN\]-γ, tumor necrosis factor \[TNF\]-α, and interleukin \[IL\]-17 and cytotoxic molecules (i.e.,granzyme and perforin) to kill infected host cells.

MAIT cells are abundant in peripheral blood where they where they express gut-homing chemokine receptors such as CCR6(chemokine receptor type 6) and CCR9(chemokine receptor type9). They are also abundant in intestinal mucosa where they likely confront normal flora or pathogenic bacteria producing bacterial ligands.

Given tissue- homing properties and rapid production of proinflammatory cytokines, MAIT cells may play an important role in infectious diseases and autoimmune disorders.

Results from experiment with transfer of MAIT cells to TNBS(trinitrobenzene sulfonic acid)-induced IBD murine models suggest that MAIT cells might play a protective role in TNBS-induced intestinal inflammation . In addition, previous studies have reported MAIT cell dysfunction in IBD patients. However, the role of MAIT cells in IBD patients remains unclear.

Eligibility Criteria:
Inclusion Criteria:

* Patients with active IBD according to clinical scores with the following:

  1. Recently discovered.
  2. Average age (15-50).

Exclusion Criteria:

* Patient with history of any of the following ;

  1. History of respiratory disorders such as chronic obstructive diseases, pulmonary disease or pulmonary embolism.
  2. Other Autoimmune diseases, infectious diseases.
  3. Recent surgery, malignancies, left ventricular dysfunction, use of immunosuppressive drugs.
  4. Chronic liver, renal, and endocrine diseases.
Feasibility of Measuring Exercise's Effects on Molecular Mechanisms of Disease Progression in Prostate Cancer

The investigators aim to evaluate the feasibility of a larger clinical trial assessing an exercise program during the "teachable moment" in patients with prostate cancer and measuring its effect on tumor apoptosis signaling, lipogenesis and steroidogenesis. Participants will be randomized between a 4-12 week exercise program or to standard of care only. Participants will be assessed at screening, baseline (day 0), throughout the trial intervention (days 1-84), post-intervention visit (prior to radical prostatectomy) and final study visit 6-months post-radical prostatectomy. At each assessment, physical, biological samples and psychosocial assessments will take place.


Eligibility Criteria:
Inclusion criteria:

* Completed Pre-Screening Consent Form
* Men with CaP, who are deemed suitable by a urologist for RP
* Engaging in \<90 minutes/week of moderate-to-vigorous exercise
* BMI \<40
* Age \>19
* Able to speak and read English (to be able to complete questionnaires)
* Willing to comply with all study procedures (including committing to twice-weekly visits to the study exercise facility and exercise at home) and be available for the duration of the study
* Provide signed and dated informed consent form

Exclusion Criteria:

• Men with a medical, musculoskeletal condition or use of mobility aid that prevents participation in the exercise intervention.
HEAD-Study Optimizing the Treatment of Children With BECTS

The investigators hypothesize that Levetiracetam is as effective as Sulthiame in the treatment of children with BECTS. Patients entering the HEAD-Studie are either treated with Leveitracetam or Sulthiame over a 6 months period. Patients are equally randomised to one of the two treatment regimens. Administration of medication as blinded capsules.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 6 and 12 years
2. Weight between 15 kg and 60 kg
3. At least two preceding seizures within the last six months before study start
4. Typical electroencephalogram (EEG) with Rolando focus (centrotemporal spike or sharp-wave-focus)
5. Diagnosis of BECTS
6. Written informed consent from parents and child

Exclusion Criteria:

1. Other forms of epilepsy (e.g. continuous spikes and waves during slow sleep \[CSWS\], Landau-Kleffner-syndrome)
2. Preceding treatment with antiepileptic drugs
3. Mental Retardation (intelligence quotient \[IQ\] \<85)
4. Focal neurological deficit
5. Relevant major internistic disease (e.g. hepatopathy, nephropathy, endocrinopathy)
6. Participation in another clinical trial within the last 30 days
Effects of High and Low Frequency TENS on Sympathetic Skin Response and Skin Temperature

The aim of this study was to determine the effects of 4 Hz and 110 Hz transcutaneous electrical nerve stimulation on the sympathetic nervous system via measuring the sympathetic skin response (SSR) and skin temperature.

15 healthy subjects (8 females, 7 males) with a mean age of 22.6 ± 3.7 years participated in this study.

All subjects participated, randomly, in a 4 Hz TENS session, a 110 Hz TENS session, and a control (off-TENS) session. Each session consisted of a 20- minute stimulation period and a 10-minute follow up period.

Outcome measures: Sympathetic skin response from the simulated (Right) hand and skin temperature of both stimulated (Right) and none stimulated (Left) hand was measured 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 30 years

Exclusion Criteria:

* History of cardiovascular, neurologic or musculoskeletal disease
* Taking medication at the time of the study
Exercise Program for Colorectal Older Patients

The Exercise for COlorectal OLder patients (ECOOL program) is randomized controlled trial to assess the effects of an exercise program on physical function and health-related quality of life of patients 75 years and older with colorectal cancer undergoing surgery. ECOOL is a multicomponent home-based exercise intervention focused on the development of strength, balance, gait ability and inspiratory muscle function of older patients who receive weekly telephone follow-up from cancer diagnosis to 3 months after surgery. The investigators expect that ECOOL program will improve physical function and health-related quality of life of older patients 3 months after surgery and to maintain these benefits up to 6 months after surgery compared with the control group receiving usual care.

Colorectal cancer (CRC) is the second most common cancer and the second cause of cancer-related death in Europe. Thirty-one percent of new cases are older than 74 years. The decrease in reserve capacity (i.e., frailty), comorbidity and the surgical treatment imply that the elderly patient is at greater risk of functional decline (reported between 15% and 18% three months after surgery).Up to 50% of those who have experienced functional decline do not recover previous levels of functional independence. The aim of this research is to investigate the effects of a multicomponent physical exercise program on physical function and health-related quality of life (HRQoL) of patients 75 years and older with CRC undergoing surgery. The exercise program focuses on the development of strength, balance, gait ability and inspiratory muscle function of older patients who receive weekly telephone follow-up from cancer diagnosis to 3 months after surgery. Weekly telephone follow-up is provided by an exercise specialist who monitors adherence to the exercise program and insists on its compliance, clarifies any doubt and prescribes exercise progression. Moreover, patients complete a supervised exercise session at baseline, during hospitalization and one month after surgery to ensure correct exercise execution and provide feedback. The investigators expect that ECOOL program will improve physical function and HRQoL of older patients 3 months after surgery and to maintain these benefits up to 6 months after surgery compared with the control group receiving usual care.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 75 years or older diagnosed with colorectal cancer.
* Patients included in colorectal surgery waiting list of the Hospital General Universitario Gregorio Marañon (Madrid, Spain)
* Patients able to communicate, understand and sign the informed consent.

Exclusion Criteria:

* Patients finally excluded for colorectal surgery.
* Patients with absolute contraindications to exercise
* Walk disability (FAC \<2)
* Severe cognitive impairment (MMSE \<18)
* Terminal illness
Escitalopram to Placebo in Patients With Localized Pancreatic Cancer

Use of antidepressants for participants with localized pancreatic and periampullary cancer receiving neoadjuvant therapy.

Anti-depressants have been shown to be beneficial in cancer participants. They reduce depressive symptoms and improve quality of life. Randomized trials have shown that antidepressants can reduce the development of depression in non-depressed participants with breast, melanoma, and head and neck cancers. It has been shown that treating depression can impact survival in cancer participants. Additionally, depressed pancreatic cancer participants have worse survival. Therefore, anti-depressants may also have implications for cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have histologically or cytologically confirmed localized or locally advanced pancreatic ductal adenocarcinoma or other periampullary adenocarcinoma (bile duct, duodenal, ampullary)
2. Subjects must not currently be on an antidepressant, anti-anxiety, anti-bipolar, or anti-psychotic medicine
3. Aged 18-80 years.
4. ECOG PS (Eastern Cooperative Oncology Group Performance Status) score of 0-2
5. Planned to have at least 12 weeks of neoadjuvant chemotherapy as standard of care cancer treatment
6. No diagnosis of bipolar disease
7. Willing to comply with all study procedures and be available for the duration of the study
8. Subjects must be mentally competent and must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients under the age of 18 or over 80
2. Metastatic pancreatic or other periampullary cancer
3. Resection of pancreatic cancer within the past year prior to study enrollment or planned surgery within the next 12 weeks.
4. Currently on an antidepressant, anti-anxiety, anti-bipolar or anti-psychotic medicine. Patients who have taken MAOIs (Monoamine Oxidase Inhibitors) within the past 6 months are excluded.
5. Patients with a history of seizure disorder
6. Patients with a recent medical history of myocardial infarction or unstable heart disease
7. Patients with a history of QTc prolongation or torsade de points, a baseline QTc

   1. interval of \> 500ms, a history of drug-induced QTc prolongation or congenital long QT
   2. syndrome
8. Patients with Child-Pugh score of B or C
9. Patients with moderate to severe renal disease with a GFR (glomerular filtration rate) \< 45.
10. Patients who cannot ingest oral medication
11. Patients with any history of mania
12. Known allergy to escitalopram
13. Pregnancy or lactation
Remifentanil and Glycemic Response in Cardiac Surgery

This study evaluates the effect of using remifentanil during cardiopulmonary bypass surgery to supress the hyperglycemic response in perioperative period. Half of the participants will receive continuous intravenous remifentanil during surgery, while the other half will receive intermittent intravenous fentanyl during surgery. Intermittent intravenous fentanyl administration is this institution's standard of care.

Stress-induced hyperglycemia is a well-known phenomena that occurs during cardiopulmonary bypass surgery. Hyperglycemia increases the incidence of major adverse events and mortality in patients undergoing cardiac surgery.

Remifentanil, an ultra-short acting opioid analgesic, has been shown to reduce the stress response to cardiopulmonary bypass when compared to intermittent fentanyl and inhalation anesthesia. This in turn, will reduce the occurence of perioperative hyperglycemia, glycemic variability and insulin requirements in patients undergoing cardiac surgery.

NOTE;

Primary Outcome changed on 06/15/2015-Change Approved by University of Pittsburgh IRB on 06/22/2015- First patient enrolled January 2016.

Primary outcome measure; Percentage of patients with two or more than two intraoperative blood glucose levels more than 180 mg% in both groups will be estimated and the difference in this parameter between the two groups will form the primary outcome measure of this study.

Eligibility Criteria:
Inclusion Criteria:

* Open cardiac surgery through sternotomy approach (coronary artery bypass, valve surgery, and any other open heart surgeries)
* Surgery with use of cardiopulmonary bypass
* Patients over 18 years of age
* Both female and male genders
* All races

Exclusion Criteria:

* Minimally invasive heart surgery through thoracotomy approach
* Patients receiving regional analgesia such as intrathecal morphine
* Patients undergoing procedures under deep hypothermic circulatory arrest
* Patients with active infections such as acute infective endocarditis
* Emergency surgery
* Patients undergoing transplantations and ventricular assist device insertion
* Patients on any mechanical circulatory support preoperatively
* Patient's refusal
* Allergy to remifentanil
* Positive pregnancy test
* Morbid obesity
* End stage liver and kidney disease
Discovering New Treatments for Asthma and COPD. A New Human Rhinvovirus for Human Challenge

A GMP rhinovirus was manufactured according to GMP and then characterised in human volunteers in the human viral challenge model.

Human Rhinovirus infection is an important precursor to asthma and chronic obstructive pulmonary disease exacerbations and the Human Viral Challenge model may provide a powerful tool in studying these and other chronic respiratory diseases. In this study we have reported the production and human characterisation of a new HRV-16 challenge virus produced specifically for this purpose.

An HRV-16 isolate from an 18 year old experimentally infected healthy female volunteer (University of Virginia Children's Hospital, USA) was obtained with appropriate medical history and consent. We manufactured a new HRV-16 stock by minimal passage in a WI-38 cell line under Good Manufacturing Practice conditions. Having first subjected the stock to rigorous adventitious agent testing and determining the virus suitability for human use, we conducted an initial safety and pathogenicity clinical study in adult volunteers in our dedicated clinical quarantine facility in London.

Eligibility Criteria:
Inclusion Criteria:

* Young healthy adults as determined by medical history, physical examination, serology (HIV and Hepatitis B and C) and clinical laboratory tests.
* Female subjects were required to provide of a history of reliable contraceptive practice.

Exclusion Criteria:included;

* asthma,
* hypersensitivity to mercurials or chicken eggs,
* anatomic or neurologic abnormality impairing the gag reflex or contributing to aspiration, chronic nasopharyngeal complaints,
* abnormal electrocardiogram (ECG),
* febrile illness or significant symptoms of upper respiratory infection on the day of
* Subjects using medication or other products for rhinitis or nasal congestion,
* Subject who had received systemic glucocorticoids within 1 month, or cytotoxic or immunosuppressive drugs within 6 months of the study start.
* Subjects agreed not to smoke during the quarantine phase.
The Effects of a Wrist Extensors Exercise With Blood Flow Restriction (BFR) in Lateral Elbow Tendinopathy.

A randomized cross-over trial comparing the immediate effects of a wrist extensor exercise with and without blood flow restriction (BFR) on pain perception in patients with lateral elbow tendinopathy (LET).

Patients with LET will participate in the study performing an exercise with and without blood flow restriction (BFR) in a randomized order (two occasions). A target of 20 patients for enrollment has been set for 80% power, p\<0.05 (Effect size= 1). Two interventions will be used lasting 40 minutes each.

Intervention: A wrist extension exercise (concentric-eccentric) with Blood Flow Restriction (30-15-15-15 reps). Exercises will be performed using dumbbells according to a pain monitoring approach (\<2/10 in numerical pain rating scale).

Control Group: A wrist extension exercise (concentric-eccentric) without Blood Flow Restriction (30-15-15-15 reps). Exercises will be performed using dumbbells according to a pain monitoring approach (\<2/10 in numerical pain rating scale).

Primary outcomes: pressure pain thresholds lateral epicondyle, cervical spine and tibialis anterior (bilateral).

Secondary outcome: pain free grip strength

Eligibility Criteria:
Inclusion Criteria:

* Men and women diagnosed with Lateral Elbow Tendinopathy (LET)
* Symptoms for over 2 weeks
* Pain provoked by palpation on the lateral epicondyle
* Positive: Cohen's test, Maudsley test, Mill's test
* decrease in pain grip strength \>5% in elbow extension compared to flexion

Exclusion Criteria:

* Shoulder tendinopathy
* Cervical radiculopathy
* Rheumatoid arthritis
* Neurological deficit
* Radial nerve entrapment
* Past treatment for the elbow before entering the study
* Professional athletes
* Lateral elbow tendinopathy of the same side in the last 3 years
* Serious cardiovascular diseases
* Venous deficiency
* History of heart surgery
* Cancer history
* Breast surgery
* Orthopaedic surgeries during the last 6 months
* Thrombosis
* Body mass Index ≥ 30
* Crohn syndrome
* Family or personal history of pulmonary embolism
A Placebo-Controlled Study of a Combination of Metyrapone and Oxazepam in Cocaine Addiction

Subjects will be randomly assigned to receive either one of the two potential dose combinations of the study medications or placebo over 6 weeks. The study will include twice weekly visits to the research clinic for laboratory studies, safety assessments and urine drug screens. Subjects will also be questioned regarding drug craving and mood symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 - 50 years of age
* Requests treatment for cocaine addiction
* Meets the DSM-IV criteria for cocaine dependency
* Able to provide written informed consent and comply with the study
* Females of childbearing potential must have a negative pregnancy test and must be using adequate birth control during the study
* Test positive for cocaine on a urinary drug screen
* Healthy and medically stable in the opinion of the Principal Investigator

Exclusion Criteria:

* Liver enzymes greater than two times normal
* Any history of hepatitis
* History of disorders requiring chronic treatment with steroids
* Significantly abnormal ECG
* Any prominent DSM-IV axis I disorders other than cocaine dependence
* Any subject who presents as a danger to self or others in the opinion of the Principal Investigator
* Concomitant use of methamphetamine as determined by self-reporting and verified by measurement of methamphetamine in urinary drug screen
* Alcohol consumption greater than 4 drinks per day (1 Drink = 12 oz beer; 5 oz wine; 1.5 oz shot of liquor)
* Any clinically significant laboratory test abnormalities
* Use of any concomitant medication during the study that would interfere with study medications
* Serum cortisol less than 3 µg/dl at any time before or during study
* Treatment with an investigational product within 30 days prior to study enrollment
* Currently seeking other forms of professional addiction treatment
* Known allergic reaction to oxazepam or metyrapone
* Lactose intolerance