cyrilzakka/clinical-trials huggingface dataset:
Cognitive Remediation for First Episode of Psychosis Patients

This study aims to look at the effectiveness of a combination of cognitive remediation and social cognition training to improve cognition and functioning when compared to cognitive remediation alone. The target population will be those who are experiencing their first episode of psychosis.

A first episode of psychosis is defined as the first experience of positive symptoms, such as hallucinations and delusions, and the behaviour that accompanies it. This is associated with problems in many areas of cognition; the ability to acquire knowledge and understanding. These cognitive symptoms have been found to have a large impact on daily functioning (e.g. accessing education or employment and maintaining relationships) and cannot effectively be treated with medication. Cognitive remediation (CR) is a therapy that aims to improve cognition and, through generalisation of this, improve daily functioning and quality of life. Although it is an area of deficit, social cognition, the ability to perceive and understand emotional states, is often not targeted in cognitive remediation. However, interventions which have focused on providing social cognition training (SCT) alongside CR have shown large improvements in daily functioning.

This study aims to look at the effectiveness of a combination of CR and SCT to improve cognition and functioning when compared to CR alone. The target population will be those who are experiencing their first episode of psychosis. Participants will be recruited from an Early Intervention in Psychosis service which is an NHS service set up to provide rapid treatment for those experiencing psychosis.

Participants will take part in a ten week CR or CR+SCT intervention which will consist of spending 90 minutes a week in a small group setting working through a series of computer games which aim to improve cognition. Interviews and questionnaires regarding daily functioning, cognition, quality of life and symptoms will be used before and after the intervention. Participants will be asked to attend follow-up interviews 6 months after the intervention has ended to complete the measures again to see if any beneficial effects have lasted.

Eligibility Criteria:
Inclusion Criteria:

* Non-affective psychosis
* Premorbid IQ of over 70
* A service user of the early intervention service
* Aged 18 or over (up to the age of 35 which is the limit for the early intervention service)
* Psychiatrically stable enough to attend to completion (no hospitalisations or medication changes in last 4 weeks)

Exclusion Criteria:

* Active substance dependency
* History of severe head injury
Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone

The overall purpose of this study is to examine the effect of pregnenolone (PREG) on the acute psychosis-like and cognitive effects of Delta-9-tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with PREG and then assessing their responses to THC.


Eligibility Criteria:
Inclusion Criteria:

* Exposed to cannabis at least once in lifetime.

Exclusion Criteria:

* Cannabis naive
* Individuals with a documented reaction/allergy to Pregnenolone
Prevention of Musculoskeletal Injuries in Musicians

Musicians are a group with a high prevalence of musculoskeletal injuries. In particular, wind musicians, due to their playing requirements, are prone to suffer from cervical and mandibular alterations.

For this reason, a specific exercise programme has been designed with the aim of analysing its effectiveness in improving these regions.

This study is a clinical trial with a control group whose participants are university music students specialising in wind instrument performance.

The intervention of the participants in the Experimental Group consists of the individual performance of a specific programme of warm-up exercises prior to instrumental practice aimed at improving the mobility and strength of the cervical and mandibular regions, as well as a series of cool-down exercises after instrumental practice based on stretching the main muscles of both regions.

Participants in the Control Group will continue their normal life without performing any specific exercise previously taught by the researchers.

For the evaluation of the programme, an initial evaluation and a re-evaluation after 12 weeks will be carried out. In both, cervical and jaw mobility as well as body posture will be assessed. In addition, at the muscular level, the activity of the upper trapezius and masseter muscles will be assessed, and the pain threshold at trigger points will also be measured.

The hypotheses are that by carrying out the exercise programme designed for wind musicians, an improvement in body posture, in the range of cervical and jaw mobility and in muscle activation will be achieved, as well as a decrease in the pain threshold.

For the study of the results, an inferential statistical analysis of the data will be carried out using the Wilcoxon test for paired data or Student's t-test for repeated measures according to the sample characteristics in order to determine the effect of the exercise programme on the different variables of the experimental process. Correlation statistics will be used to establish the association between certain quantitative explanatory variables and ANOVA for categorical variables. The level of significance will be kept at p\<.05 and all calculations will be carried out using the SPSS 22.0 statistical programme.

Eligibility Criteria:
Inclusion Criteria:

* Woodwind or metal musicians
* University students of music performance

Exclusion Criteria:

* Any surgical intervention in cervical spine, orofacial region or temporomandibular joint.
* Analgesics or physiotherapeutic treatment in the last 24h.
* Pregnancy
Evaluation of the Safety and Precursors of Efficacy

The purpose of this study is to evaluate and compare the safety and pre-cursors of efficacy of a non-invasive 1064nm laser and 940nm diode, for the disruption of subcutaneous adipose tissue and skin tightening.

The purpose of the biopsies is to assess if the device causes an inflammatory response in the abdominoplasty tissue that will be excised.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoking subjects between ages of 20-55 years of age presenting excess abdominal tissue (fat and skin), are candidates for an abdominoplasty procedure and are willing to allow the use of this device on their skin
* Subjects (Group 2 and 3) who will allow the excess skin removed as part of the abdominoplasty to be sent for laboratory analysis
* Understand and accept the obligation associated with the procedure
* Subjects with Fitzpatrick skin types I to VI.
* Subjects (Group 2 and 3) who are willing to consent to participate in the study will be asked to undergo treatment, elasticity and ultrasound measurements, as outlined for each group and defined in section 6.0.
* Subjects must agree to maintain the same diet and exercise regime throughout the study

Exclusion Criteria:

* Any previous liposuction/lipo-sculpture or any type of procedure in the abdominal area in the past 6 months
* A history of allergic reactions to medications or anesthesia required for the procedure
* A history of thrombophlebitis
* A history of acute infections
* A history of heart failure
* Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti-inflammatories within 2 weeks pre treatment
* Intolerance to anesthesia or medications to be prescribed before or after the procedure.
* Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study
* Taking medications that are photosensitive
* A history of keloid formation
* A study subject must not be pregnant or have been pregnant in the last 3 months
* The physician has the right to make determination of eligibility as he/she determines based on the standard of care
Study of the Effect of omega3 on Biomarkers of Cardiac Necrosis (CKMB and Troponin I) and Inflammation Marker (CRP) After Elective Percutaneous Coronary Intervention (PCI)

The purpose of this study is to investigate the effect of omega 3 on biomarkers of cardiac necrosis(CKMB and troponin I) and inflammation marker CRP.

Percutaneous coronary intervention (PCI) has become the most common form of coronary revascularization worldwide. Although PCI is a safe procedure, it may have multiple risks including bleeding, coronary dissection, abrupt vessel closure, and myocardial necrosis. It is estimated that approximately 25% of patients undergoing PCI have significant postprocedural creatinine kinase (CK)/creatinine kinase myocardial band (CK-MB) elevations and approximately 50% of patients have significant post-procedural troponin elevations. Initially, it was felt these elevations were simple enzyme leaks with no long-term implications.

Now, several studies have demonstrated that periprocedural infarction is associated with short-, intermediate-, and long-term adverse outcomes, most notably mortality. Pretreatment with antiplatelets such as aspirin and clopidogrel play an important role in reducing cardiovascular events (CV events) following PCI.

Omega -3 polyunsaturated fatty acids (PUFAs) have antiplatelet effect. It may also improve response to aspirin and clopidogrel in low-response patients.

This study is a randomized clinical trial (RCT) evaluating the effect of omega 3 supplement \[with 400mg Eicosapentaenoic acid (EPA) and 200mg docosahexanoic acid (DHA)\] on biomarkers of cardiac necrosis (CKMB and troponin I) in patients undergoing elective PCI. Eighty patients planed to do elective PCI will be categorized into two groups. The first group will be received standard regimen for PCI (aspirin, clopidogrel, and heparin) and the second group will be treated with standard regimen in addition to 3 gram omega 3 (12 hours before PCI). Blood samples will be drawn in all patients before and 8 and 24 h after intervention for cardiac biomarkers assessment (CK-MB, troponin I)and inflammation marker C-reactive protein (CRP). Major adverse cardiac events (MACE) will be evaluated as a second endpoint.

Eligibility Criteria:
Inclusion Criteria:

* candidate of elective PCI
* treatment with aspirin at least 5 days before PCI

Exclusion Criteria:

* high CKMB and troponin I level
* cardiac bypass in recent 3 months
* platelet count \< 70×10 9/L
* sever chronic renal failure
* active bleeding
* treatment with glycoprotein IIb/IIIa inhibitors during PCI
* treatment with bivalirudin during PCI
* sensitivity to aspirin and clopidogrel
Bioequivalence of Two Tacrolimus 0.1% Topical Ointment Formulations in Patients With Atopic Dermatitis

The primary objectives are to establish the therapeutic equivalence of tacrolimus ointment 0.1%, manufactured by Taro Pharmaceuticals Inc. and Protopic® (tacrolimus), 0.1% topical ointment (Astellas Pharma US, Inc.) and to show superiority over vehicle in the treatment of moderate to severe atopic dermatitis.

The secondary objectives are to compare the adverse event (AE) profiles of the two ointments and to investigate their systemic absorption at steady state.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating female, 18 years of age or older.
* Patient has documented evidence that they have been unresponsive to alternative more traditional therapies such as topical corticosteroids, or in the investigators opinion, such first line therapy would be deemed inadvisable because of potential risks to the patient.
* If female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, IUD, oral, transdermal, injected or implanted hormonal contraceptives).
* Have confirmed diagnosis of atopic dermatitis using the diagnostic features as described by Hanifin and Rajka.
* Have an IGSA score of 3 (moderate) or 4 (severe)
* Have an affected Body Surface Area (BSA) of at least 20%
* Have a minimum Eczema Area and Severity Index (EASI) score of at least 15

Exclusion Criteria:

* Mild atopic dermatitis as defined by IGSA score of 0 (clear), 1 (almost clear), or 2 (mild) OR %BSA affected less than 20% OR EASI Score of less than 15.
* Clinically infected atopic dermatitis at the baseline visit. Tacrolimus is not indicated for the treatment of clinically infected atopic dermatitis
* Any dermatological condition other than atopic dermatitis that in the Investigator's opinion may interfere with the evaluation of the patient's atopic dermatitis
* Females who are pregnant, lactating or likely to become pregnant during the study.
* History of allergy or sensitivity to tacrolimus, pimecrolimus, any macrolides such as clindamycin erythromycin
* Current diagnosis or history or any disease, which in the Investigators opinion would contraindicate the use of immunosuppressants, including but not limited to human immunodeficiency virus (HIV) and cancer.
* Use of any nonsteroidal immunosuppressants
* Regular use of intranasal or inhaled corticosteroids, greater than the equivalent of 2 mg of prednisone/day, within 14 days of the first dosing day.
* Use of non-sedating histamines are not allowed for at least 7 days prior to the first dosing day or throughout the study.
Sleep-Disordered Breathing in Patients With Severe Valvular Regurgitation Undergoing Clip Procedure

In a prospective observational study, the investigators investigate the prevalence of sleep disordered breathing in patients with severe valvular regurgitation and the effect of using the minimal invasive Clip technique on sleep disordered breathing.

The purpose of this study is to analyze the prevalance of sleep disordered breathing in patients with severe valvular regurgitation and the impact of a therapy with the minimal-invasive Clip technique.

Therefore, the investigators want to include consecutive patients with unknown sleep-associated respiratory distress syndrome and, in addition, as a study-specific achievement, the investigators want to obtain the quality of life and specific symptoms of the patients by using established questionnaires. After three month of post-interventional care, the patients will get a post-interventional check-up in our cardiological outpatient clinic, where the course of sleep-associated respiratory distress syndrome and the actual quality of life and specific symptoms will be documented by using a cardiorespiratory polygraphy and the same questionnaires.

The entire hospital stay, including possible post-interventional complications, will be documented for this study from the patients' medical records. The routine examinations (laboratory values, ECG, 6-minute walk test, pulmonary function examinations, spiroergometry, transthoracic / -oesophageal echocardiography, etc.) shall also be recorded in the database of this study.

The plan is to include 100 evaluable patients with complete follow-up and the associated test results. For this purpose, a screening of 150 patients is expected to be required.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe valvular regurgitation and currently unknown sleep disorder breathing who will be treated with a minimal invasive Clip technique

Exclusion Criteria:

* Patients with more then one valvular disease which requires Treatment
* Patients with complex congenital heart disease
* Pregnant women
Treatment of Microscopic Colitis

The study compares the effect of Budesonide, Bismuth and fiber in patients with microscopic colitis

This randomized, controlled, open study compares the effects of 8 weeks' treatment with Budesonide, Bismuth and fiber on symptoms and histological findings in patients with microscopic colitis (both collagenous colitis and lymphocytic colitis).

Eligibility Criteria:
Inclusion Criteria:

* Microscopic colitis verified with biopsies from the colon
* Symptoms to such an extent that treatment is indicated
* Age \> 17 years
* Informed consent

Exclusion Criteria:

* Previous treatment with any of the investigational drugs
* Patients treated with ketoconazole
* Pregnant and breast-feeding females
Comparison of Two Formulations of Bio-K

Main research Question: The investigators would like to find out if both the Bio-K (lactobacillus acidophilus and lactobacillus casei) drink and capsule are equally effective in the prevention of diarrhea associated with antibiotic use.

Why is this research project important? About 25% of patients who use antibiotics may develop diarrhea as a side effect. Symptoms are mild and consist of watery diarrhea and abdominal pain. Some patients may develop a more severe form of diarrhea, called clostridium difficile-associated diarrhea. Clostridium difficile-associated diarrhea may lead to more serious consequences like inflammation of the large bowel and in some cases, death. There are some studies that suggest Bio-K drink, a probiotic preparation containing lactobacillus acidophilus and lactobacillus casei, decreases the risk of diarrhea from antibiotic use. As a result, St. Joseph's Healthcare has recently to use Bio-K routinely to try to reduce risk of patients developing diarrhea. No other Hamilton hospitals use Bio-K routinely as there is not strong evidence about the effectiveness of Bio-K for the prevention of diarrhea. This study will provide more information about Bio-K's effectiveness in the prevention of diarrhea associated with antibiotic use as both a capsule and a drink.


Eligibility Criteria:
Inclusion Criteria:

* speak English
* capable of providing consent
* reachable by telephone within the next three months
* willing to comply with study protocols
* age over 65 years
* prescribed clindamycin, fluoroquinolones or cephalosporin for more than one dose

Exclusion Criteria:

* ICU patients
* transplant patients
* patients on immunosuppressant medications (prednisone greater than 50 mg/day for 7 days, azathioprine, cyclosporine, cyclophosphamide, tacrolimus, sirolimus, methotrexate, mycophenolate, anti-TNF agents, interleukin-2 chemotherapy)
* HIV patients with CD4+ count less than 250 cells/mm3
* neutropenic patients with total neutrophil count less than 500
* patients with prosthetic heart valves
A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients

PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients.


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female subjects between the ages of 18 and 60 years;
* Body Mass Index (BMI) of \>25.0 kg/m2 and \<40 kg/m2;
* Subjects must have a historical diagnosis of T2DM in accordance with the ADA guidelines;
* Subjects who have been on well-tolerated and stable doses of metformin

Exclusion Criteria:

* Recent evidence (6 months prior to screening) or history of unstable major organ disease;
* Diagnosis of Type 1 diabetes mellitus;
* Current medical history of myocardial infarction, unstable angina, or history of stroke (including TIA) within 6 months prior to Screening;
* Treatment with thiazolidinediones (TZDs), or subcutaneously administered antidiabetic agents;
Sublingual Buprenorphine for Chronic Pain

The purpose of this study is to develop and pilot test clinical guidelines for the use of buprenorphine for the treatment chronic pain among patients with substance abuse histories. Buprenorphine, an opioid medication, holds promise as a treatment of chronic pain because, compared to most other opioid analgesics, it has a high safety profile, a low level of physical dependence, and mild withdrawal symptoms on cessation. Moreover there are promising reports from Europe of its use as a skin patch to treat chronic pain as well as clinical reports in the U.S. that it may be effective when used sublingually (placed under the tongue). This study will test the sublingual formulation.


Eligibility Criteria:
Inclusion Criteria:

Undergoing treatment for moderate-severe chronic pain for at least six months at either an ambulatory practice of the Department of Pain and Palliative Medicine Beth Israel Medical Center in New York City or the the Peter Kruger Clinic at the same institution.

Either

1. On opioid therapy (any dose) and observed to have had at least four of the aberrant drug-related behaviors described in (Passik et al. Clin J Pain; 22(2):173-81 2006) during the past six months, or
2. Considered a candidate for long-term therapy by the pain specialist and a history of a substance use disorder, as determined by DSM-IV criteria, but no longer meeting criteria for at least one year.

Age 18-70

Exclusion Criteria:

* Meets DSM-IV criteria for current opioid dependence or other substance use disorder including alcohol abuse.
* Currently being treated for opioid dependence with methadone.
* Currently maintained on naltrexone (e.g., for alcohol dependence).
* Taking benzodiazepines on a daily basis.
* A history of moderate-severe cardiopulmonary disease or symptoms or signs consistent with moderate-severe cardiopulmonary disease.
* Elevated liver function test (LFT) results (\> 2.5 above normal).
Fast Track Hip Fracture - an Optimized Pathway for Hip Fracture Patients

The study examines if the introduction of a fast track pathway for hip fracture patients had an influence on mortality and quality of life by comparing these outcomes between all hip fracture patients operated at Akershus University Hospital two years before and two years after this change in standard care.

The Norwegian hip fracture register prospectively collects data on all hip fracture patients including, among others, time to surgery, type of fracture, type of surgery and American Society of Anesthesiologists (ASA) score. The register also collects quality of life data 4 and 12 months after surgery. Using the unique Norwegian personal identification number the data from the Norwegian hip fracture register will be connected with data from the electronic patient record at Akershus University hospital (AHUS). Fast track surgery for hip fracture patients was introduced at the end of 2013. Mortality and quality of life data will be compared for all hip fracture patients operated at AHUS two years before and two years after this change in standard care. The combined data from the register and the electronic patient records will be used for regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* Operated at Akershus university hospital for a hip fracture (neck of femur, trochanteric, subtrochanteric) in 2012, 2013, 2014 or 2015
* 18 years or older

Exclusion Criteria:

* stress fracture
Infectivity of Norovirus in Groundwater-Human Challenge Study

Norwalk virus and related "Norwalk-like viruses" are the most common cause of outbreaks of stomach sickness (nausea, vomiting, diarrhea) in older children and adults in the United States. These viruses are sometimes found in drinking water, ice, shellfish and in other foods. They can be spread easily from contact with water, food, objects or hands that have even small amounts of feces from someone who was sick.

The purpose of this research study is to see how long Norwalk virus can survive in water and still be able to cause sickness. When this is determined the researchers will be able to recommend risk levels for norovirus contaminated waters. Another purpose for this study is to see how a person's body's immune cells respond to Norwalk virus in the body. During this study volunteers will receive a dose of Norwalk virus in water that may make them sick.


Eligibility Criteria:
Inclusion Criteria:

* Normal healthy volunteer
* Must be within 33% of normal body mass index

Exclusion Criteria:

* Have a job in which they handle food
* Work in a child care, elderly care center or if they live with young children or anyone who has a weak immune system
* Are not willing or able to wash their hands every time after they go to the bathroom, or before and after they prepare or handle food for up to eight days after they take the virus
* Are over the age of 50
* Are pregnant
* Have tested positive for the HIV virus