cyrilzakka/clinical-trials huggingface dataset:
Stopping Aminosalicylate Therapy in Inactive Crohn's Disease

The purpose of this study is to assess whether withdrawal of aminosalicylate (5-ASA) is non-inferior to continuation of 5-ASA therapy in Crohn's disease (CD) subjects in remission.

Aminosalicylate (5-ASA) agents have proven effective for inducing and maintaining remission in mild to moderate ulcerative colitis (UC) and thus are commonly used as first-line agents for patients with Crohn's disease (CD) in remission. However, there is uncertainty regarding their effectiveness for CD.

In this open-label, randomized study, participants with CD in remission will be allocated to either continue their 5-ASA therapy or withdraw their 5-ASA. The purpose is to investigate if withdrawal of 5-ASA therapy is not unacceptably less effective than continuing on 5-ASA in maintaining CD remission over a 24 month period.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of CD at least 3 months prior to enrollment
* Taking any brand or dosage of an oral aminosalicylate for at least 6 months
* Subject-confirmed compliance with current aminosalicylate therapy (taking at least 75% of prescribed doses)
* CD currently in clinical remission
* Able to participate fully in all aspects of the clinical trial
* Written informed consent obtained and documented

Exclusion Criteria:

* A current diagnosis of UC, indeterminate colitis, microscopic colitis, or diverticular disease-associated colitis
* A diagnosis of short-bowel syndrome
* Active perianal disease
* Active fistulizing disease
* A flare of CD within 3 months prior to enrollment requiring initiation/escalation of medical therapy or surgery
* Use of systemic corticosteroids for CD (2 continuous weeks or more) within 3 months prior to enrollment
* Any major resective bowel surgery for CD (ileal resection, ileocecal resection, proctocolectomy, colectomy, enterectomy, ostomy formation and repair, anastomosis/reanastomosis) within 6 months prior to enrollment
* Unwillingness to stop taking aminosalicylates for the duration of the trial
* Untreated bile salt malabsorption that, in the opinion of the investigator, may interfere with accurate study HBI assessment
* Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study
* History of active alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures
* Currently participating in another interventional trial, or previous participation within the last 3 months
Adequate Duration of Antibiotic Treatment in Community-acquired Pneumonia With High Risk Class and Adequate Initial Clinical Response

Non-inferiority, multicenter, prospective double-blind, randomized clinical trial of two parallel groups. The randomization between the 2 study groups will be carried out according to a scheme generated by a computer program, in blocks of 6 and stratified by centers. The antibiotic treatment will be evaluated during 5 days compared to the usual antibiotic treatment for more than 7 days in patients with community-acquired pneumonia with a Pneumonia Severity Index IV-V severity score who present an adequate response in the first 4 days of hospital antibiotic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes older than 18 years
* Hospitalized patients diagnosed with CAP: appearance of a new radiological infiltrate plus the presence of at least two of the following signs or symptoms: fever (\> 38 ° C), cough, expectoration, chest pain, dyspnea or tachypnea, and signs of occupation of the alveolar space.
* That they present a PSI score class IV or V.
* Patients who have received adequate antibiotic treatment according to clinical guidelines (SEPAR, ATS) ((1,8,19)) from the first hour of admission to the emergency room.
* Patients who reach clinical stability: temperature ≤37.2 ºC, heart rate ≤100 beats / min, respiratory rate ≤24 breaths / min, systolic blood pressure\> 90 mmHg; oxygen saturation\> 90%; or oxygen blood pressure\> 60 mmHg (15) before the fourth day.
* Signature of informed consent.

Exclusion Criteria:

* Immunosuppression: Co infection with HIV and presence of AIDS, treatment with neutropenic effect or have received immunosuppressive treatment for any reason. Patients that are in chronic use of corticosteroids as prednisone or its equivalent with \> 10 mg / day for 14 days.
* Patients hospitalized in the previous 14 days.
* Patients with pleural effusion
* Suspected multiresistant germs of any cause.
* Hypersensitivity or alterations in the tendons associated with the fuoroquinolones.
* Pregnancy or lactation.
The Use of Ultrasound for Botulinum Toxin Subscapularis Muscle Injection Guidance in Spastic Hemiplegic Shoulder Pain

The aim of the study is to describe the efficacy of a new approach to the subscapularis muscle under US guidance for the injection of botulinum toxin in patients that underwent a stroke suffering from hemiplegic shoulder pain.

Pain and spastic shoulder are common findings in hemiplegic patients following a stroke.

The pain interferes with rehabilitation prolonging hospitalization and is related with decreased quality of life.

There is a close relationship between spasticity of the subscapularis muscle and pain The patients show a clinical picture of adduction and internal rotation of the shoulder, elbow and wrist and fingers flexion with a limited external rotation of the shoulder.

The investigators suggest that paralyzing the subscapularis muscle with botulinum toxin may alleviate pain in the hemiplegic shoulder. Best produced when injected in a specific area of the muscle where a higher concentration of motor points exists.

Treatment using injection of botulinum toxin to the subscapularis spastic muscle has been described in the literature and is a common practice in hemiplegic shoulder. The Injection technic in this pathology is described by using anatomical landmarks of the shoulder region without using medical imaging.

On the other hand, injections to the subscapularis muscle has also been described using ultrasound guidance but not for this specific pathology.

There are no evidence-based guidelines describing us guided spastic subscapularis muscle injection. Injecting this muscle while in its spastic state requires a modulated approach Harrison et.al described cadaveric dissections of the subscapularis muscle and proposed a technique to reach the motor point zone of this muscle In our study the investigators follow the injection description published by Dong Wook Rha on cadavers based on Harrison's lateral approach description. The Ultrasound enables a correct identification of the target muscle avoiding possible complication of vessel or pulmonary puncture In our study the investigators will try to prove the efficacy of the lateral approach to the subscapularis muscle using ultrasound and nerve stimulator

Eligibility Criteria:
Inclusion Criteria:

Post stroke patients

* Complaints of pain in hemiplegic shoulder
* Spasticity of subscapularis muscle
* Coherent
* Hebrew speakers

Exclusion Criteria:

* Aphasia
* Allergy to botulinum toxin
* Pregnant women
Visceral Obesity and Colorectal Surgery

While perirenal fat measurement is an easy reproducible surrogate of visceral fat, its value as independent parameter in predicting postoperative complications after colorectal resection remains poorly investigated.

The investigators want to test the value of perirenal fat as surrogate of visceral obesity as risk factor for morbidity in colorectal surgery and to compare it to the effect of Body mass index (BMI) and Waist- Hip ratio (WHR).


Eligibility Criteria:
Inclusion Criteria:

* elective colorectal resection

Exclusion Criteria:

* age under 18
* emergency condition
* immunosuppression
Developing and Testing an Implementation Strategy to Improve Perioperative Diabetes Care

Optimising glycaemic control during hospital stay reduces the rate of infections, length of stay and mortality, in particular in surgical patients. In this study, we test a strategy to implement optimal perioperative diabetes care in a controlled before and after design in 6 Dutch hospitals.

OBJECTIVE/RESEARCH QUESTION Optimising glycaemic control during hospital stay reduces rate of infections, length of stay and mortality,in particular in surgical patients. In guidelines and literature recommendations on optimal perioperative diabetes care are described. Nevertheless, in daily practice, perioperative glycaemic control is very often not achieved. This study aims at developing an implementation strategy that is tested on feasibility to improve perioperative diabetes care in terms of effectiveness, experiences and costs.

DESIGN/OUTCOME MEASURES/IMPLEMENTATION STRATEGY A step-wise implementation model is applied: 1) recommendations on optimal perioperative diabetes care (e.g. the administration of intravenous insulin, encouragement of diabetes self-management) are systematically translated into quality indicators; 2a) using these quality indicators, current care is measured by performing a medical record search among 400 patients in 6 hospitals; 2b) barriers and facilitators for optimal care are measured by performing interviews with professionals and, e.g. regarding self-management, with patients; 3) based on this information an implementation strategy is developed;4) implementation activities are enacted and 5) evaluated in a controlled before-after design in 6 hospitals providing before and after intervention 400 patients.

DATA ANALYSIS To obtain an indication of the effectiveness of the strategy, baseline and post intervention outcomes of intervention hospitals are compared with outcomes in control hospitals, using the quality indicators. Experiences of participants in the intervention hospitals will be measured to, if necessary, adapt the strategy to make it more effective and acceptable.

ECONOMIC EVALUATION A cost analysis of the implementation strategy will take place. Implementation costs will be related to the difference in percentage of patients treated as described in the quality indicators before and after implementation. Information on the costs and effects at the patient level will also be compared before and after the implementation of the recommendations on optimal care.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus AND
* Cardiac surgery OR
* Abdominal surgery OR
* Large joint orthopedic surgery And
* Duration of surgery minimum one hour

Exclusion Criteria:

* Rejection to participation
BEnefit of Arterial Preparation by LONGitudinal Scoring

The purpose of the artery preparation concept is to perform regular longitudinal micro-incisions on the inner side of the artery ("scoring") and therefore promote a regular expansion of atheroma by balloon inflation.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18-year-old, with symptomatic lower extremity occlusive arterial disease
* Rutherford class of symptom 2 to 5
* Atheromatous ≥ 70 % stenosis or occlusion of SFA and/or PA
* Absence of \> 50% residual stenosis of the run-in vessels at the end of procedure
* Presence of at least one patent (no ≥ 50 % stenosis) run-off tibial or fibular vessel to the foot at the end of procedure
* De novo or restenotic lesions, including in-stent restenosis
* Willingness to participate in the study and signature of informed consent

Exclusion Criteria:

* Renal failure with glomerular filtration rate (GFR) 30 ml/min or below, estimated by the Cockroft-Gault equation.
* Women who are pregnant, lactating, or planning to become pregnant during the duration of the study
* Recent artery thrombosis, at risk of distal embolization during percutaneous procedure
* Previous use of a PCB in the lesion during last 15 months
* Extremely calcified lesions, defined by calcification involving ³ 270° of the artery circumference over ³ 15 cm.
* Sub-intimal recanalization
* Tortuous contra-lateral femoral access with difficult cross-over
* Previous or planned surgery of the target lesion
* High risk of bleeding
* Contra-indication to dual antiplatelet therapy for one month, and/or to single antiplatelet therapy for 1 year
* Allergy to aspirin, clopidogrel or heparin
* Life expectancy less than one year
Exploring Prolonged AMR in ACL Reconstructed Patients

The goal of this observational study is to explore the significance of subject-reported outcomes and clinical parameters in relation to the occurence of prolonged presence of arthrogenic muscle responses (AMR) in anterior cruciate ligament (ACL) reconstructed patients. The main questions it aims to answer are:

1. Is there a link between the long-term occurence of AMR in ACL reconstructed patients and the level of kinesiophobia experienced before or after their ACL surgery? We hypothesize that ACL patients with higher levels of kinesiophobia are more likely to exhibit prolonged AMR as an unconscious reaction to protect their affected knee joint.

2. Is the long-term presence of AMR in ACL reconstructed patients linked to their subjective knee function and stability (at certain time points throughout their recovery)? Our hypothesis is that poorer subjective knee function and stability might be associated with the presence of prolonged arthrogenic muscle responses in ACL reconstructed patients.

3. Is the prolonged presence of AMR in ACL reconstructed patients linked to their pain levels (at certain time points throughout their recovery)? Our hypothesis is that ACL patients with higher pre- and/or postsurgical pain levels may exhibit a higher degree of long-lasting AMR.

4. Is the long-term presence of AMR in ACL reconstructed patients linked to clinical parameters such as swelling, isometric quadriceps and hamstrings strength and knee range of motion (at certain time points throughout their recovery)? Our hypothesis is that ACL patients with poorer outcomes in terms of these clinical parameters may be more likely to exhibit prolonged AMR.

Participants will:

* Fill in the following questionnaires 1 week before surgery and at 1 and 3 months after surgery:

  * Demopgraphical information
  * Knee Injury and Osteoarthritis Outcome Score (KOOS)
  * Lysholm Score (only question 1)
  * Tegner Activity Scale (current activity level, pre-injury activity level and desired activity level after recovery)
  * Numeric Rating Score (NRS) for pain levels during the day \& during the night
  * ACL-Return to Sport after Injury Scale (ACL-RSI)
* Complete a testing protocol 5 months after their surgery, which includes bilateral electromyographical measurements of the hamstrings and quadriceps during jumping tasks and a quadriceps inhibition measurement using the interpolated twitch method to evaluate the presence of prolonged AMR.


Eligibility Criteria:
Inclusion Criteria:

* 18-40 years old.
* Having suffered an ACL rupture.
* Undergoing a surgical ACL reconstruction in the AZ Delta hospital in Roeselare (Campus Brugsesteenweg).

Exclusion Criteria:

* Revision ACL reconstruction.
* Other severe injuries to the lower limbs within the past year.
* Muscular or neurological disorders affecting lower limb functioning.
* Fibromyalgia or chronic fatigue syndrome.
A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis

The purpose of this study is to learn about an investigational drug known as oral lipoic acid (LA) that may help treat multiple sclerosis. This study will measure how a person's body absorbs and breaks down the drug (pharmacokinetics) and will compare four different forms of the drug from four different manufacturers as well as LA in conjunction with fish oil.

Multiple sclerosis (MS) is a common, often disabling inflammatory disease of the central nervous system (CNS). Present treatments for MS are only partially effective, available only in injectable forms, have significant side effects and are very costly. Developing more effective and better-tolerated treatments of MS thus remains an important goal for the improvement of the care of MS. Lipoic acid (LA) is an antioxidant that is widely available as a dietary supplement.

The primary outcome of this study is to determine the pharmacokinetics of oral LA 1200 mg to see if we can identify factors affecting the bioavailability of LA. We will also study the salivary concentrations of oral LA and its correlation with the serum LA concentrations. We will also study the effects of LA on the immunological markers after four hours of administration.

Eligibility Criteria:
Inclusion Criteria:

* Definite MS by McDonald's or Poser's criteria
* EDSS ≤ 7.5
* Age 18 to 80

Exclusion Criteria:

* No clinically significant MS exacerbation within 30 days of the screening
* No systemically administered corticosteroids within 30 days of study entry
* Patient not pregnant or breast feeding
* No LA in previous 2 weeks
* Not on anti-coagulants such as heparin, coumadin, or aspirin during study
* No other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase risk of patient experiencing adverse events
* Inability to give informed consent
* Any condition which would make the patient, in the opinion of the investigator, unsuitable for the study
RFA+Highly-purified CTL vs. RFA Alone for Recurrent HCC

Hepatocellular carcinoma (HCC) is the fifth most common and the third leading cause of cancer-related death worldwide. Recurrence of tumor within the liver remnant is common, with a reported 5-year recurrence rate of 70%. Repeat hepatectomy is an effective treatment for intrahepatic HCC but with a small proportion of resection rate because of the poor functional liver reserve and postoperative complications. Radiofrequency ablation(RFA) is becoming the main effective treatment for small HCC (≤5.0cm). The efficacy of RFA for recurrent HCC has been reported to be comparable to those achieved by surgery with minimal, but higher local recurrence rate after RFA. It has been reported that immunotherapy in patients who underwent curative treatment for HCC, adjuvant immunotherapy with activated CIK cells increased recurrence-free and overall survival. But there is little evidence for adjuvant immunotherapy of recurrence HCC. Cytotoxic T lymphocytes(CTL), a kind of effective T cells that specific recognizing and killing antigen targeted cells through cloning amplification after receiving antigen information from antigen presented cell and playing key role to clear cancerous cells. So our hypothesis is that RFA combined with immunotherapy (Highly-purified CTL) is superior to RFA for recurrent HCC. The aim of this prospective study is to compare the outcome of RFA combined with immunotherapy (Highly-purified CTL) with RFA for small recurrent HCC after partial hepatectomy.


Eligibility Criteria:
Inclusion Criteria:

1. age 18-75 years;
2. recurrence of HCC 12 months after initial hepatectomy;
3. no other treatment received except for the initial hepatectomy;
4. single tumor≤5.0cm in diameter; or 2-3 lesions each≤3.0cm;
5. lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound;
6. no severe coagulation disorders (prothrombin activity\<40% or a platelet count\<40,000/mm3);
7. Eastern Co-operative Oncology Group performance(ECOG) status 0-1.

Exclusion Criteria:

1. Pregnant women, breastfeeding women or plan pregnancy for the future 2 years;
2. The presence of vascular invasion or extrahepatic spread onimaging;
3. Usage of strong immunosuppressive agents such as corticosteroids, cyclosporine A within six months or longer;
4. HIV antibody or HCV antibody positive;
5. Immunodeficiency diseases or autoimmune diseases (such as rheumatoid arthritis, Buerger's disease, multiple sclerosis and type 1 diabetes);
6. Suffering with cancers (except skin cancer, prostate cancer or cervical carcinoma in situ) at the enrolling time or 5 years before;
7. Suffering with other organ failure;
8. Suffering with severe mental illness;
9. Drug addiction (including alcohol) for 1 year before the enrolling time;
10. Participate in other Clinical trials within three months prior to 3 months before the enrolling time;
11. Other researchers believe that the patient is not fit for inclusion.
Long-term Follow-up After Laparoscopic Inguinal Hernia Repair Using Tisseel for Mesh Fixation

In hernia repair a mesh is used to close the defect in the abdominal wall. This mesh is either secured with tissue penetrating devices (ex. staples,tacks or sutures) or fibrin glue (Tisseel/Tissucol) or left unfixated.

The investigators believe, and previous studies indicate, that the use of fibrin glue greatly reduces the amount of postoperative complications (ex. chronic pain, impaired ejaculation in men or recurrence of the hernia)when compared with the use of tacks or staples.

The aim of this study is to compare the recurrence rates and amount of postoperative complications in patients who have had inguinal hernia repair with fibrin glue and in patients who have had inguinal hernia repair with tacks, staples or sutures.

The study will use prospectively collected data from the Danish Hernia Database to find the patients. The patients will be contacted using a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

inguinal hernia repair from January 2009-September 2012

Exclusion Criteria:

Patients lost to follow-up
Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness

Multicentre, prospective, non-randomised, single-arm, open label, mechanistic study to investigate the mechanism of action of BGF 160 on ventilation pattern complexity and variability


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed informed consent prior to any study specific procedure
* Female or male subjects aged 40-75 years inclusive at the time of enrolment (Visit 1)
* Documented history of COPD with a post-bronchodilator FEV1/FVC \<0.70 and a post-bronchodilator 30 % \< FEV1 \<70% of predicted normal value (according to ERS 1993 reference values for spirometry ) at screening
* Smoking history \> 10 pack-years
* Baseline significant dyspnea with a mMRC ≥ 2

Exclusion Criteria:

* History or current diagnosis of asthma or ACOS (asthma-COPD overlap syndrome)
* Respiratory infection or COPD exacerbation within 6 weeks (2 months if it resulted in hospitalization) prior to screening
* Clinically significant or relevant cardiovascular conditions, laboratory tests, electrocardiogram (ECG) parameters:

  * Unstable angina/acute coronary syndrome, or Coronary Artery Bypass Grafting (CABG), Percutaneous Coronary Intervention (PCI) or myocardial infarction within the past 6 months.
  * Congestive heart failure New York Heart Association (NYHA) class III/IV.
  * Structural heart disease (hypertrophic cardiomyopathy, significant valvular disease).
  * Paroxysmal (within the past 6 months) or symptomatic chronic cardiac tachyarrhythmia.
  * Left bundle branch or high-degree AV block (second degree AV block type 2 and third degree AV block) unless the patient has a pacemaker.
  * Sinus node dysfunction with pauses.
  * Ventricular pre-excitation and/or Wolff-Parkinson-White syndrome.
  * QTcF interval \>470 msec (QT interval corrected using Fridericia's formula; QTcF=QT/\[RR1/3\]).
  * Any other ECG abnormality deemed clinically significant by the Investigator.
  * Bradycardia with ventricular rate \< 45 bpm.
  * Uncontrolled hypertension (\> 165/95 mmHg).
* Clinically relevant respiratory conditions (other than COPD)
* Severe renal impairment eGFR \< 30
* Hepatic impairment
* Narrow-angle glaucoma that, in the opinion of the Investigator, has not been adequately treated.
* Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that is clinically significant
* Patients not able to perform IOS, spirometry, plethysmography, or VT acquisition (10 min)
* Any contraindication to LABA or LAMA drugs or to Inhaled corticosteroids
* Pregnancy or breastfeeding
* Woman of childbearing age without effective contraception
* Any type of cancer within 5 years
* Patients under guardianship
* Refuse or incapacity to give an informed consent
* Absence of social insurance