cyrilzakka/clinical-trials huggingface dataset:
Supplementation of Glutamine and Fish Oil Versus Placebo in Patients With Heart Failure

The aim of this study is to determine whether supplementation of glutamine and fish oil can improve peripheral skeletal muscle function and metabolism in patients with heart failure. The investigators propose a randomized, double-blind, placebo controlled study comparing the combined supplementation of fish oil and glutamine with placebo in patients with stable heart failure. 30 patients with heart failure will be randomized to either receiving 6.5 g fish oil/d and 8 g glutamine/d (n=15) or placebo (n=15) for 90 days. The primary outcome in this study is the change in muscle functional capacity measured as changes in maximum muscle strength and fatigability, peak VO2 and exercise time after supplementation. A secondary outcome is the measurement of systemic and local markers of inflammation.


Eligibility Criteria:
Inclusion Criteria:

* age greater than 18 years,
* left ventricular ejection fraction less than or equal to 35%,
* stable on standard HF medications, and
* optimal medical therapy.

Exclusion Criteria:

* major cardiovascular events,
* procedures in the last 6 months,
* dementia,
* presence of cardiovascular diseases that may lead to harm if the patient took part in the study (congenital heart disease, long QT syndrome, hypertrophic cardiomyopathy, active myocarditis).
The Clinical Efficacy of Different Durations of Suprascapular Nerve Pulsed Radiofrequency

Chronic shoulder pain due to impingement syndrome and supraspinatus tendinosis is a debilitating condition. Suprascapular nerve innervates most part of shoulder joint. Supraspinatus nerve block can be used as a part of pain therapy. However, its efficacy is short-lasting. To prolong analgesia, short bursts of electrical stimulation to suprascapular nerve may be applied. To the date there is no consensus about duration of these type of stimulation. Investigators' aim is to investigate efficacy of two different duration of stimulation (pulsed radiofrequency) on chronic shoulder pain.

Pulsed radiofrequency (pRF) treatment of suprascapular nerve can be used successfully to alleviate pain due to shoulder impingement syndrome and supraspinatus tendinosis. Radiofrequency waves produced by radiofrequency (RF) generator through pRF modality are applied to suprascapular nerve and create magnetic field. This field leads to pain modulation by changing neuronal activity and resulting in long term depression of pain transmitting nerve fibers. Temperature around nerve never exceeds 42 degree and by this way the nerve can be protected from coagulation necrosis and demiyelinisation. pRF can be used in the treatment of mixed type nerves such as suprascapular nerve. There are preclinical and clinical studies which report that with longer pRF duration, more favorable analgesia. Suprascapular pRF is performed with 22G, 10 cm, 5 mm active lead RF needle via USG guided posterior approach as institution procotol. Howeveri clinicians can choose any duration of pRF. Instution's pain medicine practitioners HAU and GEO choose 4 and 9 minutes of pRF duration, respectively. Investigators' aim is to investigate the efficacy of two different pRF duration, 4 and 9 minutes, on Shoulder Pain and Disability Index (SPADI) and Numeric Rating Scale-11(NRS-11) at 3 month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80 years
* Shoulder pain caused by impingement syndrome
* Shoulder pain due to supraspinatus tendinosis
* Diagnosis of impingement syndrome and supraspinatus tendinosis confirmed through physical examination and radiological imaging (MRI)
* Pain persisting for 3 months or longer
* Numeric Pain Rating Scale (NRS) score of 4 or higher despite conservative treatment

Exclusion Criteria:

* Patients unwilling to participate in the study
* Presence of chronic pain due to other conditions
* Presence of cervical radiculopathy
* History of opioid use
* Uncontrolled diabetes (HbA1c \> 8)
* History of shoulder surgery on the affected side
* Uncontrolled psychiatric disorders despite medical treatment
* History of cancer
* History of stroke
CT-angiographic Follow up of Patients That Underwent Coronary Bypass Surgery Between 1993-1997

Coronary artery surgery (CABG) is necessary to improve blood circulation in many patients with coronary artery disease. This is done by using alternative blood vessels (grafts) to bypass the stenosed coronary arteries. In CABG, vein grafts are traditionally used where surrounding tissue is removed, this may damage the vessel and influence its patency.

The "no-touch" technique was developed by Professor Domingos Souza at the Department of Cardiovascular and Thoracic Surgery, Örebro University Hospital. This technique includes taking out the vein with its surrounding tissue and by this way the vessel is less damaged. The first two follow ups have shown that no-touch grafts had better patency than conventionally extracted graft at 18 months and 8.5 years.

This long term follow up is a continuation of the randomized trial started in 1993 where the patency and incidence of stenoses in the no touch and conventional vein grafts has been studied.


Eligibility Criteria:
Inclusion Criteria:

1. First time coronary artery bypass grafting with either conventional or no touch vein grafts performed by Dr.Souza between 1993-1997.
2. Included in the previous follow up studies
3. Signed and dated consent.

Exclusion Criteria:

1. Allergy to contrast
2. Renal failure
3. Uncontrolled diabetes
4. Unable to implement the study according to protocol -
Probiotic in Treatment of Adult Patients With Drug-resistant Epilepsy

This study is a randomized, double-blind parallel group placebo-controlled clinical trial with the aim of investigating the effect of probiotic versus placebo on drug-resistant adult patients with epilepsy.


Eligibility Criteria:
Inclusion Criteria:

Drug resistant epilepsy

Exclusion Criteria:

* Hypersensitivity to probiotic
* Acute pancreatitis
* Pregnancy
* Breastfeeding
* Being under treatment with corticosteroids
* Being under treatment with antibiotics during 2 months before enrollment
* Need for antibiotic therapy during the study
* Change in anti-seizure medication within the month before enrollment
Catheterization During Second Elective Caesarean Delivery

Use versus non use of urinary catheterization during Second Elective caesarean delivery:

Evaluation OF use versus non use of urinary catheterization during Second Elective caesarean delivery:by urine analysis 24 hours postoperative to exclude urinary tract infection.

Eligibility Criteria:
inclusion criteria

* pregnant females who will undergo second elective caesarean section at full term pregnancy (38:41 weeks gestational age).

Exclusion Criteria:

* Women with history of more than one previous caesarean Section.
* Women with history of a tonic postpartum hemorrhage.
* Women with Urinary tract infection in present pregnancy.
* Women with diabetes mellitus in present pregnancy.
* Women with medical disorder in present pregnancy that obligate monitoring of urine output during and after caesarean section, such as severe pre-eclampsia or renal disease with pregnancy.
* Emergency caesarean section
Specific Cognitive Remediation for Schizophrenia

Rationale:

Cognitive deficits are a core feature in schizophrenia. Conventional treatments (antipsychotic medication and psychological treatments) have limited effects so cognitive remediation programs were designed to alleviate the problems. Interventions typically involve a variety of exercises in a paper and pencil or a computerized format with a growing number of specialized computer programs now being developed. However, many of these programs lack specificity which does not allow an individual's specific needs to be addressed. More targeted interventions might increase the effects of therapy so RECOS - COgnitive REmediation for Schizophrenia - was developed to fit this gap.

Methods: This is a multicenter, randomized, controlled study comparing patients aged 18 to 45 years suffering from schizophrenia according to DSM-IV-TR. RECOS will be compared to an already validated program (CRT).

220 patients will be randomized as follows :

* Arm 1 : RECOS (42 h)
* Arm 2 : CRT (42 h) The recruitment is performed by psychiatrists in Lyon, Paris, Clermont-de-l'Oise, Niort, Bordeaux, Ville-Evrard and Lausanne.


Eligibility Criteria:
Inclusion Criteria:

* men and women aged 18 to 45 years
* French speaker or French schooling since 7 years
* clinical stability
* diagnosis of schizophrenia

Exclusion Criteria:

* visual or auditory disorder
* history of neurological illness or trauma
* alcohol or drug dependence
* mental retardation
Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients

In assisted reproductive treatment (ART), it is necessary to follow closely the stimulation cycles of patients undergoing these treatments in order to monitor the number and size of developing follicles. Oestradiol (E2) and progesterone (P) are products of steroidogenesis and the concentrations of both hormones increase with the diameter of the growing follicle and accurate and reliable methods to measure E2 and P are essential to assess treatment response and support clinical decision. Measurement of both hormones, as well as monitoring of follicle growth through ultrasound measurements, is an important part of ovarian stimulation, requiring patients to undergo multiple blood draws. It is often a physically and emotionally painful process and the most convenient solution to this problem is the measurement of hormone concentration in other biological fluids. Salivary diagnostic tests are a less invasive, inexpensive and stress-free alternative to measurements of hormone concentration in other biological fluids. The current study pretends to evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients. In addition, secondary objectives include the measurement of diurnal variability of salivary hormone levels and patient experience with saliva collection as users.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing IVF/ICSI treatment
* Patients planned to embryo transfer (ET) undergoing hormonal replacement therapy
* Aged from18-45 years old.
* BMI 19-30 kg/m2
* Signed written informed consent

Exclusion Criteria:

• Patients suffering for any systemic disease or endocrine disorder will be excluded foe the study
Relative Bioavailability BI 10773 and Metformin in Healthy Male Volunteers

The objective was to investigate a possible drug-drug interaction between BI 10773 and metformin when co-administered as multiple oral doses. Therefore, the relative bioavailabilities of BI 10773 and metformin were determined when both drugs were given in combination compared with BI 10773 or metformin given alone.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP (Blood Pressure), PR (Pulse Rate)), 12-lead ECG (Electrocardiogram), clinical laboratory tests
* Age 18 to 50 years (incl.)
* BMI (Body Mass Index) 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

Exclusion Criteria:

* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 30 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of trial site
Effects of Intraoperative Dexamethasone and Ondansetron on Postoperative Nausea and Vomiting in Microvascular Decompression Surgery

Postoperative nausea and vomiting (PONV) is a common problem and may lead to catastrophic complications, especially in neurosurgical cases. The aim of this study was to evaluate the effects of dexamethasone and ondansetron for preventing PONV in patients who underwent microvascular decompression surgery (MVD).

A prospective, double-blinded randomized control trial was conducted with 54 patients who underwent MVD. Patients were allocated into two groups. The study group (Gr. D) received intraoperative dexamethasone 4 mg iv and ondansetron 4 mg iv, whereas the control group (Gr. N) received placebo (0.9% normal saline 1 ml iv and 0.9% normal saline 2 ml iv). The incidence and severity of PONV were observed at 1, 2, 4 and 24 hr post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were scheduled for MVD of trigeminal nerve root
* Patients who had a physical status classification of I to III according to the American Society of Anesthesiologists, and those who had a body mass index of 18 to 35 kg/m2

Exclusion Criteria:

* Patients on long-term administration of dexamethasone or ondansetron, those with a history of allergic reactions to dexamethasone or ondansetron, those who had undergone antiemetic therapy within 24 hr before surgery, those with underlying liver or renal failure, those who were pregnant, or those who had undergone emergency surgery.
A Comparison of an Ultra-thin and Standard Colonoscope in Achieving Caecal Intubation

The aim of the study is to study the caecal intubation rate of a prototype ultra-thin colonoscope compared to a standard colonoscope and to study usefulness of this new colonoscope as a rescue instrument for failed initial colonoscopy with a standard colonoscope and to study the patient satisfaction scores using a validated endoscopy GHAA-9 for a new prototype colonoscope as compared to a standard colonoscope.

Colonoscopy is a common endoscopic procedure, widely used for the investigation of lower gastrointestinal tract diseases manifesting as altered bowel habit, per rectal bleeding and abdominal pain. It is used to diagnose colonic polyps, colorectal cancer and inflammatory bowel disease to name a few examples.

Colorectal cancer screening has been shown to decrease colorectal cancer. Despite this the uptake by the general population is suboptimal.

A new prototype colonoscope from Olympus with an additional distal bending section was designed. The investigators hypothesize that its performance characteristics will be similar to a standard colonoscope with patient tolerability.

This randomised control trial aims to invite patients attending their first outpatient colonoscopy and who are able to provide informed consent.(so they have had no prior experience) to assess the completion rate, patient and endoscopist satisfaction.

Patients with prior colorectal surgery or previous colonoscopy were excluded.

Eligibility Criteria:
Inclusion Criteria:

* First outpatient colonoscopy
* Able to provide informed consent

Exclusion Criteria:

* Unable to provide consent
* Prior colon surgery (except appendectomy)
Safety Study of a Liposomal Vaccine to Treat Malignant Melanoma

The purpose of this study is to determine whether Lipovaxin-MM, a new anti-cancer vaccine, is safe and effective in improving the body's ability to destroy cancer cells in patients with metastatic melanoma.


Eligibility Criteria:
Key Inclusion Criteria:

* Patients with incurable stage IV malignant melanoma for which no standard or curative therapy exist OR patients locoregionally recurrent melanoma (including local metastases, in transit metastases and satellitosis) where surgery is not the best therapeutic option.
* Must be able and willing to provide written informed consent.
* Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Life expectancy of ≥12 weeks.
* Female subjects must be of non-child-bearing potential or using appropriate contraception.
* Positive test for cell mediated immunity.

Key Exclusion Criteria:

* Brain metastases or spinal cord compression, unless treatment was completed at least 4 weeks before entry and stable without steroid treatment for at least 4 weeks.
* Previous immunotherapy (except IL-2 or interferon-based therapy) for melanoma.
* Inadequate bone marrow reserve.
* Serum bilirubin ≥1.2 times the upper limit of normal.
* In absence of metastases, liver transaminase levels greater than 1.5 times the upper limit of normal.
* If metastases are evident, liver transaminase levels 2.5 times the upper limit of normal will be acceptable.
* Inadequate renal function.
* Evidence of severe or uncontrolled systemic diseases.
* Unresolved toxicity ≥CTC Grade 2 from previous anti-cancer therapy except alopecia (if applicable) unless agreed that the patient can be entered after discussion with the Medical Monitor.
* Participation in a trial of an investigational agent within the prior 30 days.
* HIV infection.
* Immunosuppressive therapy including corticosteroids within 4 weeks of screening.
* Pregnant or breast-feeding females.
Choosing Wisely: De-implementing Fall Prevention Alarms in Hospitals

This is a Hybrid II de-implementation study to reduce use of fall prevention alarms in hospitals. The intervention consists of tailored, site-specific approaches for three core implementation strategies: education, audit/feedback and opinion leaders. Hospital units will be randomized to low-intensity or high-intensity coaching for the implementation of the tailored strategies.

Inpatient falls result in significant physical and economic burdens to patients (increased injury and mortality rates and decreased quality of life) as well as to medical organizations (increased lengths of stay, medical care costs, and litigation). The Centers for Medicare \& Medicaid Services (CMS) considers falls with injury a "never event"- an error in medical care that indicates a real problem in the safety and credibility of a health care institution. Hospitals are no longer reimbursed for extra costs incurred in the diagnosis and management of inpatient fall-related injuries. Thus, because patient falls are common, costly and interpreted as poor care quality, hospitals are highly incentivized to prevent them.

Alarm systems are designed to reduce falls by alerting staff when patients attempt to leave a bed or chair without assistance. There is now strong evidence that alarms are ineffective as a fall prevention maneuver in hospitals. Despite this, more than one-third of hospital patients are undergoing fall prevention alarm monitoring. In nursing homes, CMS regulates the use of fall prevention alarms as it does physical restraints. Instructions to nursing home surveyors state these devices should be used only when medically necessary and continuously reevaluated.

Guided by the Choosing Wisely De-implementation Framework, this project will generate a generalizable approach using coaching and tailored de-implementation strategies to reduce use of fall prevention alarms in hospitals. The investigators will conduct a hybrid II implementation study in 30 medical or medical-surgical units from US non-federal hospitals participating in the National Database of Nursing Quality Indicators. Findings from this study could also support future trials aimed at de-implementing low-quality alarm use in other care settings with known high fall rates (e.g., stroke care, cancer care). Evaluation of high versus low intensity coaching addresses an urgent need to evaluate use of tailored strategies and to establish effective thresholds for coaching within health service settings that have varying resources to support de-implementation efforts

Eligibility Criteria:
Inclusion Criteria:

* Stakeholders in fall prevention at up to 30 participating NDNQI hospitals

Exclusion Criteria:

-
Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness

This open-label extension study will evaluate the long-term safety of glatiramer acetate and its effect on the neurologic course of participants with relapsing-remitting multiple sclerosis (RRMS). Participants have scheduled visits every 3 months to assess glatiramer acetate safety and their Multiple Sclerosis (MS) status.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have participated (been randomized) in the Copaxone double-blind placebo-controlled study 01-9001 and/or the double-placebo-controlled extension study 01-9001E.
* Participants could be male or female. Women of childbearing potential must have practiced an acceptable method of birth control.
* Participants must have completed the scheduled termination visit for Amendment 12 (Month 264).
* Participants must have signed an approved informed consent form (ICF) prior to continuing in the study extension or at the first visit in the extension (Month 264 which corresponds to the termination visit of Amendment 12).
* Participants must have been psychologically and physically stable to participate in the trial as judged by the investigator.
* All participants enrolled in this extension study were required to have the following study-specific baseline characteristics prior to entry to Study 01-9001: a diagnosis of RRMS as defined by Poser et al 1983, at least 2 clearly identified relapses and remissions in the 2-year period prior to study entry, ambulatory with a Kurtzke EDSS score of 0 to 5.0 inclusive, and a stable neurologic state for at least 30 days prior to study entry.

Exclusion Criteria:

* Pregnancy or lactation.
* Medical or psychiatric conditions that affect the participant's ability to give informed consent or complete the study.
* Inability to self-administer subcutaneous medication or lack of another responsible individual to administer the study preparation daily.
* Use of approved MS therapies including interferons, experimental MS therapies, or previous immunosuppressive therapy with cytotoxic chemotherapy (azathioprine, cyclophosphamide, or cyclosporine).