cyrilzakka/clinical-trials huggingface dataset:
Preemptive Analgesia in Total Knee Arthroplasty

Acute Pain is the most common early complication after total knee arthroplasty that caused delayed mobilization, demands of morphine, and higher operative cost. There were many researches that had been done in analgesia method to find the most effective analgesia, lowest side effect, and easy to apply. Preemptive analgesia of combined celecoxib and pregabalin were reported to give a promising outcome.

In a randomized, double blind controlled clinical trial, 30 subjects underwent surgery for total knee arthroplasty using 15-20mg bupivacaine 5% epidural anesthesia. All subjects were divided into three groups. First group was given celecoxib 400mg and pregabaline 150mg 1 hour before operation, second group was given celecoxib 200mg and pregabaline 75mg twice daily started from 3 days before operation, and the last group was given placebo. The outcome was measured with VAS, knee ROM, and post-operative mobilization


Eligibility Criteria:
Inclusion Criteria:

* 55-80 years old patients who come to orthopaedic polyclinic
* underwent TKA procedure
* have osteoarthritis
* consumed pain killer and anti inflamatory drugs routinely

Exclusion Criteria:

* psychiatric disorder
* have history of renal disease
* histroy of chronic neurophatic
* have genu arthritis that caused by rheumatid arthritis and infection
* diabetic and obesity
* coagulopathy
* patients with severe pain that needed immediate analgesia regimen
Biomarkers in Predicting Response to Treatment in Patients Who Have Undergone Surgery for Pancreatic Cancer

RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is looking at biomarkers in predicting response to treatment in patients who have undergone surgery for pancreatic cancer.

OBJECTIVES:

* To determine if a method of extracting and identifying biomarkers (i.e., secreted cytokines and growth factors) from tissues of the quantity obtained from typical biopsy can now be applied in the setting of pancreatic cancer
* To correlate pre-treatment biomarkers with recurrence, overall survival, and tumor response to radiotherapy and chemotherapy in patients with pancreatic cancer.

OUTLINE: Tumor tissue specimens are obtained from the Vanderbilt Ingram Cancer Center Human Tissue Acquisition Core and analyzed for biomarkers (e.g., integrity of DNA repair pathways as analyzed by Rad51 and phosphorylated DNA-PK foci formation). The biomarkers are correlated with clinical outcomes (recurrence, overall survival, and tumor response to treatment).

Patients are followed for recurrence, relapse, and death from disease.

Eligibility Criteria:
Inclusion criteria

* Diagnosis of pancreatic cancer
* Excess tissue collected at the time of routine surgery for pancreatic cancer must be available for analysis

Exclusion criteria

* None known
Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin C

A clinical trial to establish the long term response of using intraoperative 5-fluorouracil (5-FU) versus mitomycin C (MMC) in trabeculectomy glaucoma surgery. Antiproliferative agents such as 5-fluorouracil and Mitomycin C have been used extensively in trabeculectomy surgery to improve the success of the surgery and prevent further visual loss and blindness in glaucoma patients.

Glaucoma is a life-long progressive disease, and patients are living longer. Therefore, a long term full evaluation of the efficacy of intraoperative 5-FU and MMC needs to be performed to assess the true efficacy of MMC compared to 5-FU. We, therefore propose, a long-term prospective study of patients previously enrolled in the prospective study involving the evaluation of single intraoperative application of mitomycin C versus 5-fluorouracil in low to moderate risk glaucoma patients.

Eligibility Criteria:
Inclusion Criteria:

* Only patients deemed successful as 36 months will be included. These patients will have participated in the randomized prospective study trial comparing intraoperative 5-FU and mitomycin C in primary trabeculectomy.

Exclusion Criteria:

* Only patients deemed successful as 36 months will be included. These patients will have participated in the randomized prospective study trial comparing intraoperative 5-FU and mitomycin C in primary trabeculectomy.
Safety, Tolerability and Pharmacokinetics of Genz-682452 in Healthy Men

The objectives of this study are to assess the tolerability, safety and pharmacokinetic parameters of Genz-682452 in healthy adult males, in two parts.

Part 1 (GZFD00111TDU12766): double-blind, randomized, placebo-controlled, sequential ascending single dose study;

Part 2 (GZFD00211FED12767): open-label, randomized, 2-sequence, 2-period, 2-treatment crossover study with a minimum wash-out period; to obtain preliminary information on the pharmacokinetics, tolerability and safety of Genz-682452 after single oral doses in fed and fasted conditions.

Subjects are not allowed to participate in more than 1 part of the study.


Eligibility Criteria:
Inclusion Criteria:

* Body weight between 50.0 and 100.0 kg, inclusive, body mass index between 18.0 and 32.0 kg/m\^2, inclusive.
* Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).

Exclusion Criteria:

* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
* Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
* Blood donation, greater than 100 mL, within 2 months before inclusion.
* Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
* History or presence of drug or alcohol abuse.
* Unable to stop smoking cigarettes during the study.
* Excessive consumption of beverages containing xanthine bases.
Treatment of Postmastectomy Pain Syndrome With Fat Grafting

This study evaluates the possible beneficial effect of fat grafting for post mastectomy pain syndrome. Half of patients will receive fat grafting and the other half of patients will receive sham.

Several studies have suggested that fat grafting can alleviate pain in post mastectomy pain syndrome. These studies however have either been in the form of case series or unblinded studies with great risk of bias.

It is believed that fat grafting with its content of adipose-derived stem cells can modulate the scar tissue upon grafting and hereby decrease pain.

In this study patients will be randomized to either fat grafting or a sham procedure where they undergo the same liposuction but no fat grafting, only injection of saline instead of fat.

Eligibility Criteria:
Inclusion Criteria:

* Treated for breast cancer
* Pain in the breast cancer treated area on the breast or axilla.
* Pain present at least 4 days a week with an intensity above 3 on VAS.
* Duration longer than 3 months
* Recurrence free for minimum 6 months
* Understand the nature of the study and can give informed consent

Exclusion Criteria:

* Psychiatric condition that can affect participation.
* Recurrence of breast cancer at any time.
* Other indication for fat grafting other than pain treatment.
* Breast reconstruction with flap
Minimal Clinically Significant Difference (MCID) of Multidimensional Dyspnea Profile (MDP) in COPD Patients Undergoing Respiratory Rehabilitation

This study is designed to determine the individual threshold of minimal clinical change (MCID) for each component of the Multidimensional Dyspnea Profile (MDP) questionnaire in COPD patients undergoing pulmonary rehabilitation.

The aim of the research is to determine the minimal clinically significant difference (MCID) in MDP scores in COPD patients after a respiratory rehabilitation course using the anchoring method :

* The A1 score will be compared with the Borg Affective Dyspnea (BorgA) scale.
* The sensory score will be compared with the Borg Sensory Dyspnea Scale (BorgS).
* The 5 sensory items will be compared with the Borg Sensory Dyspnea scale.
* The emotional score will be compared with the Borg Emotional Dyspnea Scale.
* The 5 emotional items will be compared with the Borg affective dyspnea scale. The various questionnaires will be administered to patients at inclusion, after a constant work-rate cycling exercise test, and at isotime during the same cycling exercise test at the end of the pulmonary rehabilitation course.

The sensitivity study will be conducted using the visual analog dyspnea scale instead of the Borg score. Finally, we will also determine the MCID using the distribution method. The MCID score will be correlated with various quality of life and physical performance scores.

Eligibility Criteria:
Inclusion Criteria:

* Gold B or D COPD patient
* Moderate to severe obstructive ventilatory disorder (FEV1\<80%)
* Admitted for a pulmonary rehabilitation
* Having given free, informed and written consent

Exclusion Criteria:

* Lack of French language skills, preventing completion of questionnaires
* Cognitive impairment preventing completion of questionnaires
* Patient under guardianship
* Patient not affiliated to the social security system
* Chronic ethylism
Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke

The purpose of this study is to estimate the clinical relevance of monitoring patients with acute ischemic stroke with 48 hours' inpatient cardiac telemetry in relation to evaluate the presence of brief runs of premature atrial complexes and new diagnosed atrial fibrillation. Furthermore to evaluate the prognostic significance of brief runs of premature atrial complexes in relation to develop atrial fibrillation, recurrent stroke/transient ischemic attack and death.

Stroke is the second leading cause of death worldwide and it is well known that atrial fibrillation(AF) is a major risk factor for ischemic stroke. Paroxysmal AF can be difficult to detect because many cases are asymptomatic. In recent years prolonged cardiac rhythm monitoring of patients with ischemic stroke has showed an underestimated prevalence of AF. However, no optimal monitoring strategy is implemented in the clinic yet. This is the reason why research currently is focused on finding predictive risk markers of AF. Cohort studies of healthy individuals and stroke patients have shown that excessive premature atrial complexes (PACs) and brief runs of PACs are an emerging risk marker in helping to identifying patients in risk of having or developing AF. Despite this brief runs of PACs less than 30 s are today in everyday clinical practice perceived to be of no clinical significance.

The study population of ischemic stroke patients have all without known AF underwent ECG and 48 hours' inpatient cardiac telemetry as a clinical routine. In the medical record it is registered if patients had runs of PACs or new diagnosed AF.

All patients are registered in the Danish Stroke Registry, and all the baseline data on patients will be obtained from the registry.

The follow-up end August 2015 and information on AF, recurrent stroke and death will be obtained from medical records and the Funen Patient Administrative System, which is linked to the national Civil Registration System.

The purpose of this study is to estimate the clinical relevance of monitoring patients with acute ischemic stroke with 48 hours' inpatient cardiac telemetry in relation to evaluate the presence of brief runs of PACs and new diagnosed AF. Furthermore to evaluate the prognostic significance of brief runs of PACs in relation to develop AF and the prognostic significance of brief runs of PACs and AF in relation to recurrent stroke and death.

Eligibility Criteria:
Inclusion Criteria:

* admitted with ischemic stroke from August 2008-April 2011
* Registered in the Danish Stroke Registry

Exclusion Criteria:

* Hemorrhagic stroke
* No Danish civil registration
* no permanent address in Denmark during follow-up.
* patients with lack of telemetry data
The Impact of Glycemic Index on Sleep and Memory Consolidation

The study will test whether the consumption of a low versus a high glycemic index pre-bed drink influences sleep architecture, memory consolidation, nocturnal glucose metabolism, and mood.

Few studies have examined the impact of meal composition on sleep. Most research has focused on carbohydrate intake, although reports are sporadic and confounded by the manipulation of other macronutrients. Nonetheless, the pattern of results appears to depend on the nature of the sleep variable under investigation e.g., latency, duration, or efficiency. The study will determine whether manipulating the glycemic index of a pre-bed drink influences sleep architecture, procedural and declarative memory consolidation, nocturnal glucose metabolism, and mood.

Participants will stay in the sleep laboratory for three nights, each night separated by one week (visit 1, 2, and 3). The first night is an acclimatisation night. The same procedure will be followed on all three nights, as described below.

On the morning of each visit, a continuous glucose monitor will be set up and worn until 8pm the following evening. Participants will be asked to return to the sleep laboratory at 7pm, having fasted for five hours, and asked to consume a standardised evening meal. Several mood questionnaires will be completed throughout the evening and a polysomnography will be set up. Two memory tasks will be administered at approximately 10pm. Immediately after this, participants will consume either water (night 1), or a low glycemic index or high glycemic index drink (night 2 or 3). Participants will retire to bed at approximately 11pm and woken up between 6.30am - 8am, depending on personal preference.

In the morning, the memory tasks will be administered again, as well as two mood questionnaires. Participants will be asked to wear a Pro-Diary watch throughout the day, which measures mood and hunger. At 8pm, both the continuous glucose monitor and Pro-diary watch will be collected from the participant.

Eligibility Criteria:
Inclusion Criteria:

* Male (given that the menstrual cycle may influence sleep polysomnography)
* Good health
* Not taking any medication known to effect sleep or metabolism
* Normal sleep duration (i.e. between 6.5 - 9 hours of sleep per night)
* A sleep efficiency score above 80% (Pittsburg Sleep Quality Index)
* Normal sleep schedule (i.e. fall asleep between 10pm and 12pm)
* No difficulty sleeping in new places

Exclusion Criteria:

* Diagnosis of any physical or mental disorder e.g. diabetes, cardiovascular disorders, gastrointestinal disorders, sleep problems, epilepsy, or mood disorders
* Unhealthy weight (BMI over 30)
* Drink more than 300mg of caffeine per day (3 - 4 standard sized 8-oz cups)
* Work nights or shifts
* Smoke/vape
* Regularly drink alcohol (\>3 glasses per day)
* Used recreational drugs within the last 6 months
* Take part in \>3 hours of vigorous exercise per week
* Any known food allergies or intolerances
* Nocturnal eating or regular consumption of alcohol before bed (assessed by the Meal Pattern Questionnaire)
Effect of Fetal Aortic Valvuloplasty on Outcomes

In one of the most severe congenital heart defects, hypoplastic left heart syndrome (HLHS), the left ventricle is underdeveloped and the prognosis is worse than in most other heart defects. The underdevelopment can occur gradually during fetal growth caused by a narrowing of the aortic valve. At some international centers, such fetuses are treated with a balloon dilation of the narrowed valve, but there is no scientifically sound evidence that this treatment is effective.

The aim of this study is: 1/ to evaluate whether balloon dilation during the fetal period of a narrowed aortic valve can reduce the risk of the left ventricle becoming underdeveloped and the baby being born with a so-called univentricular heart (HLHS); 2/ to investigate whether such treatment improves the prognosis for this group of children with a very complex and severe heart defect and 3/ to also describe side effects and risks in fetuses and mothers of the fetal procedure.

Routinely collected pre- and postnatal clinical data will be entered into a digital database and echocardiographic examinations will be uploaded to a server. A core lab will measure and analyze all echocardiographic examinations according to protocol. The growth of the left heart structures and the postnatal outcome will be compared between the intervention and non-intervention groups.

The decision whether a fetal balloon dilatation shall be attempted is not part of the study protocol. The number of examinations of mother/fetus/infant in this study is not different from the number of examinations that will be recommended for someone choosing not to be part of this study. Participation in the study does not affect the care and treatment mothers and fetuses are receiving during pregnancy, nor how the infant is examined and treated after birth.

Eligibility Criteria:
Inclusion Criteria:

A. All of the following echocardiographic criteria need to be satisfied between 23+0 and 31+6 weeks (z-scores according to Schneider et al):

1. Aortic valve stenosis with antegrade flow through the valve
2. Predominantly left-to-right shunt at the atrial level
3. Predominantly retrograde flow in the aortic arch between the first two brachiocephalic vessels
4. Qualitatively depressed left ventricular function
5. Left ventricular end-diastolic diameter Z-score \> ±0
6. Left ventricular inlet length in diastole :

   1. Gestational age ≤ 24+6: Z-score \> ±0
   2. Gestational age 25+0 to 27+6: Z-score \> -0.75
   3. Gestational age ≥ 28+0: Z-score \> -1.50
7. Mitral valve diameter in diastole Z-score \> -2.0

B. All of the following postnatal treatment options need to be available: 1. Surgical or catheter based aortic valvotomy 2. Ross-Konno surgery 3. Norwood or hybrid stage-one surgery

Exclusion Criteria:

1. Any associated cardiac defect except persistent left superior vena cava and coarctation of the aorta
2. Any significant (i.e. that might influence outcome) extracardiac anomaly and/or known chromosomal aberration. Also, if such a condition is present at inclusion but diagnosed only after birth the case will be retrospectively excluded.
Relative Bioavailability and Activity of Different Formulations of Insulin Glargine and Lixisenatide in Patients With Diabetes Mellitus Type 1

Primary Objective:

* to assess the relative bioavailability of a single dose of insulin glargine (Lantus) and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug

Secondary Objectives:

* to compare the activity of a single dose of insulin glargine and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug
* to assess the safety and tolerability of insulin glargine and lixisenatide given subcutaneously as on-site mix

The study period for one patient is one month in average and it can last up to 7 months (+ 2 weeks) with post-study and follow-up visits

Eligibility Criteria:
Inclusion criteria:

* Subjects with type 1 diabetes mellitus for more than one year with total insulin dose of \<1.2 U.kg/day, but otherwise healthy with glycohemoglobin (HbA1c) ≤ 9.0%, stable insulin regimen for at least 2 months prior to study, normal finding in medical history and physical examination.

Exclusion criteria:

* any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type I), hematological, neurological, psychiatric, systemic (affecting the body as a whole), ocular, gynecologic (if female), or infectious disease; any acute infectious disease or signs of acute illness
* More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months
* Frequent severe headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month)
* Symptomatic hypotension, or asymptomatic postural hypotension defined by a decrease in systolic blood pressure (SBP) equal to or greater than 20 mmHg within three minutes when changing from the supine to the standing position
* Presence or history of a drug allergy to clinically significant allergic disease
* Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
* Pregnant or breast feeding women
* Any medication within 14 days before inclusion, or within 5 times the elimination half-life of that drug, whichever the longest and regular use of any medication other than insulins in the last month before study start with the exception of thyroid hormones, lipid-lowering and antihypertensive drugs, and, if female, with the exception of hormonal contraception or menopausal hormone replacement therapy, any vaccination within the last 28 days.
* Positive reaction to any of the following tests: hepatitis B surface (HBs Ag) antigen, antihepatitis B core antibodies (anti-HBc Ab) if compound having possible immune activities, anti-hepatitis C virus (anti-HCV2) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab)
* History of unexplained pancreatitis, chronic pancreatitis and/or pancreatectomy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Efficacy of Double Wire Technique in Difficult Cases of Common Bile Duct Cannulation in ERCP (UDOGUIA-04)

The purpose of this study is to determine if the double guide wire technique is more effective than the conventional method in those cases of difficult selective biliary cannulation in the ERCP procedures.

Complications associated with ERCP have been related with certain characteristics of the procedure. One is the number of attempts of selective biliary cannulation. Our hypothesis is that double guide wire placement could be a useful technique for selective biliary cannulation in those cases of difficult ERCP procedures, reducing the number of cannulation attempts and the complication associated with the procedure.

We are conducting a controlled prospective multicentre randomized study to compare the double guide wire technique with the conventional method in two groups previously randomized after presenting a difficult selective biliary cannulation under the conventional method. The study is carried out in six public Hospitals from Spain. Assignation is concealed to both groups, and the expected study period is 18 months for a number of randomized patients equal or over 262 (statistical power of 90% with an α-error of 0.05, to detect a success rate of 74% in the group undergoing double guide wire technique against a success rate of 60% in the control group). The main outcome variables are successful selective biliary cannulation (primary outcome variable), number of attempts and morbimortality associated in both groups (secondary outcome variables).

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Clinical and/or radiological suspicion of Bile Duct Diseases which require ERCP procedure with intention of selective biliary cannulation
* Patients must be admitted in the participant hospitals of the investigators units
* Written informed consent of the patient, relative or legal tutor

Exclusion Criteria:

* Previous biliary or pancreatic sphincterotomy
* Previous pneumatic dilatation of duodenal papilla
* Presence of biliary-digestive derivation
* Previous diagnosis or suspected pancreas divisum
* Use of any biliary or pancreatic stent in the last 6 months
* Use of any drug aimed to reduce post-ERCP pancreatitis
* Pregnancy or maternal feeding
* Previous inclusion in the study