cyrilzakka/clinical-trials huggingface dataset:
IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103)

This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in the United States) compared with Simvastatin 40 mg. As per the original protocol, if low-density lipoprotein cholesterol (LDL-C) response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped). Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of cardiovascular (CV) death, major coronary events, and stroke.


Eligibility Criteria:
Inclusion Criteria:

* Clinically stable participants may be eligible to enroll within 10 days following hospital admission with high-risk acute coronary syndrome (either ST-elevation myocardial infarction \[STEMI\] or Non-STEMI or unstable angina)
* Participants not taking a statin must have an LDL-C of 125 mg/dl or less. Participants taking a statin must have an LDL-C of 100 mg/dl or less.

Exclusion Criteria:

* Pregnant or lactating woman, or intending to become pregnant
* Participant with active liver disease or persistent unexplained serum transaminase elevation
* History of alcohol or drug abuse
* History of sensitivity to statin or ezetimibe
* A participant for whom discontinuation of existing lipid lowering regimen poses an unacceptable risk.
Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective Craniotomy

This is a prospective study to evaluate the performance and safety of a new medical device used in case of cerebrospinal fluid (CSF) leakage after an elective cranial surgery.

Patients who consented to participate in the trial and fulfilled the preoperative inclusion and exclusion criteria underwent screening prior to surgical treatment. After dural suturing, if patients met the intra operative inclusion and exclusion criteria, they received I-020805. If necessary, autologous grafts were to be used to augment dural closure.

I-020805 was delivered from a double syringe applicator that creates a fine layer over the dura. This layer quickly sets within seconds to form a watertight seal.

Eligibility Criteria:
Inclusion Criteria:

Pre-operative

* Male or female of 18 years old or over
* Elective cranial procedure entailing a dural incision of at least 2 cm in length
* Requires a procedure involving surgical wound classification Class I/Clean
* Signed informed consent form
* Negative pregnancy test at screening for women of childbearing potential and agreeing to use an acceptable birth control method or abstinence until 90 days post-surgery

Intra-operative

* Surgical wound classification Class I/Clean
* Dural margin from bony edges of at least 3 mm throughout
* Spontaneous expression of CSF assessed visually or a CSF leakage upon Valsalva maneuver

Exclusion Criteria:

Pre-operative

* Cranial procedure requiring translabyrinthine, transoral and/or any procedure penetrating the air sinus or mastoid air cells
* Presence of symptomatic hydrocephalus
* Pre-existing external ventricular drainage or lumbar CSF drain
* Radiotherapy in the planned surgical region which ended within 3 months prior to planned surgery
* Presence of systemic infection
* Known history of hemophilia or other clinically significant coagulopathy
* Known oral anticoagulant use
* Pregnancy or breast feeding
* Known allergy to any components of I-020805
* Previous participation in this trial or any investigational drug or device study within 30 day of screening
* Known clinically significant organ or systemic diseases
* Known or suspected non-compliance with trial procedures

Intra-operative

* Patient not meeting the pre-operative eligibility criteria
* Not able to tolerate a Valsalva maneuver
* Gap of more than 2 mm remaining after primary closure of dura
* Use of synthetic or non-autologous duraplasty material
CanCope: Digital Intervention for Coping With Cannabis Craving

The CanCope Study is a micro-randomized trial conducted to gather evidence about and compare the effectiveness of a momentary intervention to help young adults cope with cannabis cravings as they attempt to reduce their use.

The CanCope Study is designed to test the effectiveness of two distinct strategies (mindfulness and distraction) to cope with cannabis cravings in young adults (19 - 25 years) who are attempting to reduce their cannabis use. Cannabis use is determined using a single-item question about the number of days out of the past 30 days the individual used cannabis. Young adults who reported using cannabis \>10 out of the past 30 days, who were not pregnant or breastfeeding, and who were not currently in treatment for problems related to substance use were eligible to enroll in this four-week study.

The CanCope intervention was delivered to participants through the MetricWire app, which was available for download on the participants' personal smartphones. Participants were asked to complete five ecological momentary assessments (EMA) per day, which asked questions related to cannabis use including one question about current level of craving on a scale of 0 - 10. If a participant reported a craving level \>4, a message was sent via the app encouraging the participant to try a mindfulness or distraction coping strategy, or the participant received a thank-you for completing the EMA which served as an attention control.

Eligibility Criteria:
Inclusion Criteria:

* Used cannabis at least 10 out of the past 30 days

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Currently in treatment for problems related to substance use
Art in Improving Outcomes in Participants Undergo Surgery

This trial studies how well art works in improving outcomes in participants who are undergoing surgery. Exposure to art may help to improve clinical and psychological outcomes.

PRIMARY OBJECTIVES:

I. Investigate through evidence-based randomized controlled trial the effect of exposure to art during the perioperative period on the outcome of surgical outcomes II. Assess patient response to artwork and investigate the correlation of patient response with the clinical outcomes of the patients.

III. Measure cognitive changes that may occur for patients based on art exposure.

OUTLINE: Participants are randomized into 1 of 2 arms.

ARM I: Participants attend at least 2 sessions of viewing art pieces over 15 minutes every day for 2 years.

ARM II: Participants receive standard of care for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Ambulant inpatients that will stay for at least 2 days postoperatively and do not require continuous monitoring
* All races and ethnic groups are eligible for this study

Exclusion Criteria:

* Patients with altered mental status, psychiatric illness, debilitating pain, blind patients, or those who require continuous monitoring postoperatively will be excluded from the study
* Adult unable to consent, individuals who are not yet adults, pregnant women or prisoners
Effectiveness of a Group Intervention for the Treatment of Shoulder Pathologies

The investigators determined the effectiveness of a group intervention for the treatment of shoulder pathologies.

The investigators performed a two-armed prospective clinical trial study, analyzing a sample formed by 76 patients with shoulder pain. The patients were allocated to one group randomly (intervention or control group). The data was obtained in the San Juan de Alicante Hospital between November 2014 and July 2015.

Eligibility Criteria:
Inclusion Criteria:

-Patients who came to the Rehabilitation Service of the San Juan de Alicante Hospital between November 2014 and July 2015 with one of the diagnosed diseases indicated in the 726.10 ICD-9-CM code (nontraumatic rotator cuff tear, bursitis, tendinitis, and medical diagnostics impingement syndrome of any severity depending stadiums Neer (1990) unilateral or bilateral joint balance with free or minimally limited internal rotation).

Exclusion Criteria:

* Patients who cannot perform the exercises correctly (example: psychiatry disorders)
* Patients with Shoulder surgery
* Patients whose shoulder pain is above 7 according VAS pain.
Omega Tots Long Term Follow-up

This is a continuation study to the Omega Tots trial (NCT01576783). The purpose of this study is to follow-up with participants of the original study to determine the long-term effect a daily fatty acid dietary supplement taken during toddlerhood might have on children born preterm now that they are 8.5-10.5 years old.

The overall objective with the present study is to determine the long-term effects of docosahexaenoic acid (DHA) plus arachidonic acid (AA) supplementation on general cognitive ability, language, and executive function, and to examine genetic explanations for treatment effects, through one comprehensive study visit with children and parents from the Omega Tots trial cohort (NCT01576783).

Eligibility Criteria:
Inclusion Criteria:

* Previous participation in Omega Tots (NCT01576783).
* Current age of 8 years, 180 days to 10 years, 180 days.

Exclusion Criteria:

* Child in custody of children's services for their window of eligibility
Free Fatty Acids: Threshold Repeatability Study

This study seeks to determine if non-esterified fatty acid (NEFA) taste detection thresholds change with repeated testing. Threshold testing for NEFA taste has been reported by a number of laboratories, including our own; however, these studies have reported data for only one testing occasion. The investigators seek to conduct repeated testing to measure the test-retest reliability of these methods. The investigators believe that with repeated exposure to NEFA, a person's sensitivity increases. The investigators are also testing the efficiency of testing by two methods (forced-choice ascending trial versus staircase). Additionally, the association between taste responses, diet and BMI will be explored.


Eligibility Criteria:
Inclusion Criteria:

* 18-55 years old
* in good health
* available for three months

Exclusion Criteria:
Walking Impairment Questionnaire in PAD

Purpose is to test and validate a new questionnaire (the WELCH questionnaire) to estimate walking capacity in patients with claudication

Questionnaires (WELCH and WIQ) submitted to patients referred for treadmill walking test Comparison of sore to MWD on treadmill. Comparison with WIQ will be performed

Eligibility Criteria:
Inclusion Criteria:

* informed consent signed, french language fluent patients

Exclusion Criteria:

* rejection of the questionnaire
The Effects of Varenicline on Cognitive Function in Patients With Schizophrenia

The primary objective of this project is to examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. The secondary objective is to evaluate the effect of this combination therapy on smoking in people with schizophrenia. This study will be a randomized, double blind, parallel group, placebo controlled 8 weeks trial.

Cognitive deficits have been considered as a core symptom domain of schizophrenia. Amelioration of or improvement in cognitive impairments is becoming an important focus of clinical treatment development. Varenicline is a potent and selective alpha 4 beta 2 nicotinic acetylcholine receptor partial agonist that has been developed for smoking cessation. In animal studies, alpha 4 beta 2 receptor agonists significantly improve working memory and attention function. Subjects will be assigned in 1:1 ratio to receive varenicline or placebo respectively. Assessments will be done using several neuropsychologic tests, clinical rating scale including assessment of nicotine withdrawal scales.Varenicline has been found to be efficacious for smoking cessation in the general population and animal studies have demonstrated the cognitive benefits of this agent. However, no published work is available evaluating the cognitive effects in humans. Thus, patients may experience improvements in cognitive function and in people who are smokers, these people may be able to achieve abstinence in smoking. This will in turn improve long-term functional outcomes and health outcomes in people with schizophrenia. This is an exciting opportunity for discovery if indeed cognitive abilities could be improved with this adjunctive treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinically stable patients with schizophrenia

Exclusion Criteria:

* Refractory schizophrenia
* Mental Retardation
* Serious Medical illness
Improvement of Left Ventricular Ejection Fraction in ICD Patients Undergoing Therapy With Sacubitril/Valsartan

The study is aimed to evaluate the improvement of the left ventricular volumes and of the left ventricular ejection fraction in a population of ICD patients with heart failure and left ventricle systolic dysfunction undergoing therapy with Sacubitril/Valsartan (according to current Guidelines), during a 6-month follow-up.

Consecutive, unselected patients with heart failure and left ventricle systolic dysfunction, carrying a single-chamber or a bicameral implantable cardioverter defibrillator (ICD) for primary prevention of sudden death, undergoing therapy with Sacubitril/Valsartan (according to current Guidelines) will be enrolled in the study. A two-dimensional echocardiogram with evaluation of left ventricular end-diastolic volume, left ventricular end-systolic volume, and left ventricular ejection fraction will be performed, according to standard clinical practice, at the beginning of the observation, and at a 6-month follow-up. The improvement of the left ventricle volumes and of the left ventricular ejection fraction will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* heart failure
* left ventricular systolic dysfunction
* carrying a single-chamber or a bicameral implantable cardioverter defibrillator implanted for primary prevention of sudden death
* undergoing therapy with Sacubitril/Valsartan according to current Guidelines

Exclusion Criteria:

* age \<18 years
Bioequivalence of Telmisartan / HCTZ Fixed Dose Combination Compared to Its Monocomponents in Healthy Male Volunteers

To establish the bioequivalence of 80 mg telmisartan/12.5 mg HCTZ fixed dose combination vs. its monocomponents


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males according to the following criteria:

   Based upon a complete medical history, physical finding, physical examination (measurements of height and body weight), vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), clinical laboratory tests 1) No finding of clinical relevance 2) No evidence of a clinically relevant concomitant disease
2. Age ≥ 20 years and age ≤ 35 years
3. Body Mass Index (BMI) ≥ 17.6 kg/m2 and BMI ≤ 25.0 kg/m2
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) (MHW Ordinance No. 28, as of Mar. 27, 1997) and the local legislation

Exclusion Criteria:

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
2. Surgery of gastrointestinal tract (except appendectomy)
3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
4. History of relevant orthostatic hypotension, fainting spells or blackouts
5. Chronic or relevant acute infections
6. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
7. Positive result for Hepatitis B virus surface antigen (HBsAg), anti HCV (Hepatitis C virus), syphilitic test or Human immunodeficiency virus (HIV) antigen-antibody test
8. Intake of drugs with a long half-life (≥ 24 hours) within at least 1 month prior to administration or within a period of 10 or less half-lives of the respective drugs during the trial
9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial.
10. Participation in another trial with an investigational drug within 4 months prior to administration or during the trial
11. Smoker (20 or more cigarettes/day)
12. Inability to refrain from smoking during hospitalisation
13. Alcohol abuse (60 g or more ethanol/day: ex. 3 middle-sized bottles of beer, 3 gous (equivalent to 540 mL) of sake)
14. Drug abuse
15. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
16. Excessive physical activities (within one week prior to administration or during the trial)
17. Any laboratory value outside the reference range that is of clinical relevance
18. Inability to comply with dietary regimen of study centre
19. Any other volunteers whom, the investigator or sub investigator would not allow to participate in this study
Different Surgical Approaches for Treatment of UPJ Obstruction in Children: Prospective Randomized Clinical Trial

This study aimed to evaluate the clinical efficacy of laparoscopic pyeloplasty (LP) for ureteropelvic junction obstruction (UPJO) via retroperitoneal and transperitoneal approaches.

Ureteropelvic junction obstruction (UPJO) is the most common congenital abnormality of the kidney and is responsible for flank pain, recurrent urinary infections, hydronephrosis and the loss of renal function. Until recently, open pyeloplasty (OP) was the standard surgical treatment modality for UPJO.However, with the development of laparoscopic devices and surgical technology, laparoscopic pyeloplasty (LP) has become a more beneficial choice for the patients with UPJO than open surgery because of the advantages of excellent visualization, minimal trauma, rapid postoperative recovery, good cosmetic result, and a nearly successful rate compared with open pyeloplasty. The first LP in children was performed in 1995. It has gained popularity for older children. LP can be performed though retroperitoneal and transperitoneal approaches. Which surgical method is better is still controversial.

Eligibility Criteria:
Inclusion Criteria:

* Age above two years.
* Unilateral UPJO.

Exclusion Criteria:

* Age below two years.
* Bilateral UPJO.
* Recurrent UPJO.
* Malrotated kidneys and renal fusion anomalies.
Bicarbonate Given During Dystocic Labor

Dystocic deliveries and the use of bicarbonate

A randomized controlled trial of 200 primiparous women in active labour.If cervical dilation crossed the action line in the partogram or if labour progress was arrested for two hours or more the delivery was considered to be dystocic, and Oxytocin was suggested for stimulation. Inclusion criteria were: primiparity, singleton pregnancy, with an arrested labour progress with a need for oxytocin. Gestational age was between 37-42 weeks, and no maternal /fetal chronic and/or pregnancy-related conditions. Excluded were multiparous women, deliveries with non-cephalic presentation, multiples, deliveries with fetal chronic and/or pregnancy-related conditions, IUFD (Intra Uterine Fetal Death) or premature \< 37 weeks of gestation. A randomization into two groups was performed. One group was treated with two bags of Samarin® (=Samarin® group, 5g bicarbonate) one hour before stimulation with oxytocin started. The other group (=nonSamarin® group) received no bicarbonate and started oxytocin immediately, according to local clinical guidelines. Maternal and fetal data was collected from medical files after delivery and analysed according to group.

Eligibility Criteria:
Inclusion Criteria:

* primiparity, singleton pregnancy
* with an arrested labour progress according to the partogram with a need for oxytocin
* Gestational age was between 37-42 weeks
* and no maternal /fetal chronic and/or pregnancy-related conditions.

Exclusion Criteria:

* multiparous women
* deliveries with non-cephalic presentation
* multiples
* deliveries with fetal chronic and/or pregnancy-related conditions
* IUFD (Intra Uterine Fetal Death) or premature \< 37 weeks of gestation
Decolonization of Carbapenem-resistant Enterobacterales (CRE) in Patients With Faecal Carriage of CRE With Neomycin

Rates of antimicrobial resistance are increasing worldwide. There is increasing evidence that physiological gut microbiota is a large reservoir of antibiotic-resistance genes. Healthy gut microbiota is known to prevent the colonization of the gastrointestinal tract by pathogens, the so-called mechanism of colonization resistance, but this protective mechanism can be altered by therapies that impair gut microbiota, including antibiotics with consequent colonization of gut pathogens, including carbapenem-resistant Enterobacterales (CRE). CRE carriers represent an epidemiological threat to other hospitalized patients and to the whole community, but are also at risk of developing clinical consequences of this colonization, including bloodstream infections from these pathogens. Neomycin has shown high efficacy in the eradication of CRE invitro. Neomycin has also been approved to treat hepatic coma by eradicating bacterial in gastrointestinal tract. Therefore, this evidence suggests that this procedure could be useful in eradicating CRE.

However, current evidence is mostly limited.

The aim of this study is to investigate the efficacy of Neomycin, compared with no intervention in eradicating gut colonization from CRE.

The investigators will randomize patients colonized by CRE (diagnosed by rectal swab) to Neomycin by stratified randomization according to type of CRE species (E.coli or non-E.coli). Then, patients will be followed up, rectal swabs will be repeated, and stool samples for culture and will be collected, up to 14 days after Neomycin.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged \>18 years
* Hospitalized in medical wards
* Presence of CRE in stool/rectal swab without symptom from active surveillance of CRE
* Sign informed consent to participate the study

Exclusion Criteria:

* CRE infected patients
* Receiving anti-CRE antibiotics
* Known allergy to neomycin or other aminoglycosides
* Receiving Cidofovir, Colistin methate sodium, foscarnet , furosemide, digoxin
* eGFR (estimated Glomerular Filtration Rate) \< 30 ml/min/1.73 m2
* Had gastro-intestinal tract diseases
* Pregnancy or breast-feeding
DMT310-003 Topical in the Treatment of Acne Vulgaris

The objective is to evaluate the tolerability, safety, and efficacy of DMT310 topical powder mixed with diluent in male and female patients with moderate to severe facial acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:
* Patient is male or non-pregnant female at least 12 years of age.
* Clinical diagnosis of moderate to severe acne vulgaris as determined by:

Investigator's Global Assessment (IGA) at Randomization Patient has at least 20 inflammatory lesions on the face Patient has at least 20 noninflammatory lesions on the face

* Patient is willing to apply the Investigational Product as directed
* Patient is willing and able to comply with the protocol

Exclusion Criteria:

* Patient is pregnant or planning to become pregnant
* Patient is taking a topical therapy on the face which may affect the patient's acne