cyrilzakka/clinical-trials huggingface dataset:
Real World Outcomes Study of Hepatic Encephalopathy Patients' Experience on Rifaximin (PROSPER)

This study evaluates hepatic encephalopathy (HE) and liver-related hospitalization rates and duration of stay in patients with HE treated with rifaximin-α 550mg compared to patients receiving other therapies.

This registry study aims to comprehensively and rigorously characterize the impact of rifaximin-α 550 mg on hospitalization, clinical safety and effectiveness outcomes, and quality of life in patients with HE in Europe and Australasia.

Whilst clinical trial data and a few small observational studies have demonstrated the potential of rifaximin-α 550 mg to reduce overt HE episodes and hospitalizations, there is a need by physicians, commissioners and other healthcare professionals caring for patients with HE to understand the impact of management with rifaximin-α 550 mg on healthcare resource use in real world clinical practice. Currently available data are from evaluations undertaken in single UK centres. In addition, the overall burden of HE has not been well characterized, including the impact on patient quality of life, or impaired productivity incurred by patients' caregivers. This multinational, multicentre disease registry study aims to comprehensively and rigorously characterize the impact of rifaximin-α 550 mg on hospitalization, clinical safety and effectiveness outcomes, and quality of life in patients with HE in Europe and Australasia. The study will expand upon previous work in the following ways:

* Provide characterization of the burden of HE and the impact of rifaximin-α 550 mg in a real world setting, to complement RCT evidence;
* Allow for more rigorous characterization of the impact of rifaximin-α 550 mg on patient outcomes for individuals with HE over time. This will be achieved by prospectively enrolling patients not taking rifaximin-α 550 mg to characterize outcomes over time in the absence of treatment, and by assessing the quality of life and workplace productivity implications of HE.

There will be no change to the management of patients for the purposes of this study beyond normal clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cirrhosis;
* Patient is ≥18 years of age;
* Patient is enrolled within 12 weeks of resolution of an episode of overt HE associated with a hospital visit;
* Patient is able to provide informed consent to participate in the study (individually or via caregiver);
* Patient meets clinical eligibility to receive rifaximin-α 550 mg in the opinion of the participating physician, regardless of HE treatment actually received.

Exclusion Criteria:

* West Haven Conn score of ≥2 at time of study entry (i.e. at provision of informed consent);
* Mental health disorder such as dementia or psychosis which makes diagnoses of HE questionable;
* Prior treatment with rifaximin in the 12 months before qualifying episode of overt HE associated with a hospital visit;
* Contraindications to the use of rifaximin-α as per local summary of product characteristics
The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients

The aim of this study is to investigate the effect of Gliatamin (chonline alphoscerate) on depressive mood in type 2 diabetes patients and demonstrate the impact of improved depressive mood could be influence the patient's quality of life and glycemic control.

The prevalence of depressive disorder is higher in individuals with chronic diseases, and the screening and management of depression is emphasized. Diabetes mellitus (DM) is a class of chronic disease and the incidence of DM has been increasing. According to previous study, 31.1% of patients with DM accompanied with depressive disorders which was higher than that of subjects without DM. Furthermore, DM as well as depression is known for risk factor for dementia.

The choline metabolism involves in neuropathology of depressive disorders and individuals with depressive disorders showed the lower level of choline concentration. Choline alphoscerate is cholinergic precursor and showed the favorable clinical results in dementia management.

As pseudodementia can be presented as depressive disorder and choline alphoscerate would be an option for these cases. Therefore, the aim of this study is to investigate the effect of Gliatamin (chonline alphoscerate) on depressive mood in type 2 diabetes patients and demonstrate the impact of improved depressive mood could be influence the patient's quality of life and glycemic control.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients
* Age ≥ 50
* Glycemic control: HbA1c ≤ 10.0%
* 10 ≤ Beck Depression Inventory (BDI) \<30 points
* Participants who can undergo contraception in case of being in childbearing period
* Understands the study procedure, alternatives, and risks and voluntarily agrees to participate by giving written informed concent

Exclusion Criteria:

* Type 1 diabetes, Secondary diabetes, gestational diabetes
* Ongoing dementia treatment or anti-depressive disorder medication
* Uncontrolled psychiatric disorder
* BDI ≥ 30 points
* Heavy alcoholics
* Underlying chronic liver disease (hemochromatosis, liver cell carcinoma, autoimmune liver disease, liver cirrhosis, chronic viral hepatitis)
* Allergy or hypersensitivity to target medication or any of its components
* Renal failure, moderate or severe renal impairment (estimated glomerular filtration rate \< 30 mL/min/1.73 m2), or ongoing dialysis
* Abnormal liver function (AST/ALT \> x3 upper normal limit)
* History of alcohol or drug abuse in the previous 3 months
* Premenopausal women who are nursing or pregnant
* Human immunodeficiency virus (HIV) or human immunodeficiency virus (AIDS)
* chronic pancreatitis or pancreatic cancer
Stroke in North of Norway and Denmark. A Prospective Cohort Study.

The study is a comparative effectiveness study with comparision of two cohorts of patients with stroke in North of Norway and in Denmark. At baseline information is collected from the stroke registries in both countries. Time points for follow up are at 3 and 12 months post-stroke. Data are collected from medical charts and with use of telephone interview in addition to self-report questionnaires. The study will provide information about functional status, health related quality of life and rehabilitation needs. Information about rehabilitation services in both countries are collected and compared, and analysed in relation to patients outcome.


Eligibility Criteria:
Inclusion Criteria:

* Verified stroke. Admitted to stroke unit.

Exclusion Criteria:

* Patients outside the regions excluded.
Effect of a Specific Aquaporin-1 Inhibitor on Vascular Oxidative Stress in Healthy Volunteers

Bacoxy_II study aims to evaluate the efficacy of a standardized Bacopa monnieri extract, KeenMind®, on vascular oxidative stress.

The food supplement Bacopa monnieri is a plant used in Ayuverda medicine, especially in the treatment of chronic neurological disease with cognitive impairment and memory disorders and for stress management.

Bacopa monnieri contains several Bacosides including Bacopaside II, a specific inhibitor of aquaporin 1 (AQP1), the main water chanel found in mammalian cardiovacular tissues.

AQP1, more than a water chanel, is a peroxiporin able to facilitate the passage of H2O2.

AQP1 is present in myocyte, endothelial and red blood cells. Concerning the endothelial function, analyses in the FATH laboratory (IREC - UCLouvain), confirm the attenuation of H2O2 transport by AQP1 through Bacopaside II in red blood cells but also in endothelial cells.

As H2O2 is involved in oxidative stress mechanisms and endothelial dysfunction, the investigators hypothezised that the oral intake of Bacopa monnieri containing the Bacopaside II could induce an inhibition of AQP1 and attenuate the passage of H2O2 leading to an attenuation of vascular oxidative stress and endothelial function.

In order to answer to this question, the investigators set up the Bacoxy_II clinical study, that is a double-blind, prospective, interventional and controlled study. The study will last 4 months, including 3 months of treatment and 1 month of post-treatment follow-up. This study will include 2 groups of 20 volunteers: one group will receive a dose of 320 mg/d of Bacopa monnieri and the other group will receive the placebo treatment.

Eligibility Criteria:
Inclusion Criteria:

- healthy volunteers

Exclusion Criteria:

* any chronic disease
* use of chronic drugs or food supplements
* smoking
Monitoring Antioxidant/Redox Status at Concordia (MARS-C)

The European Space Agency (ESA) runs a research centre in Antarctica as an earth-based model for long duration deep-space missions. Just like astronauts travelling into space, crew-members overwintering at this Concordia base are exposed to a number of extreme environmental stressors; including high altitude (approximately 3800m); extreme cold; long periods of 24 hour darkness or daylight; and complete isolation. The investigators will recruit up to 30 over-wintering crew members working at this station for ESA over a 2 year period and observe how their bodies adapt and respond to the stress of living and working in this environment. The investigators will collect blood, saliva and urine samples, together with ultrasound images of muscle mass and grip strength measurements at regular intervals throughout their deployment to Antarctica. These samples will be transported back to Southampton to be analysed for biochemical levels of stress. During the final month of their stay, all participants will be randomised to receive a daily nutritional drink which is either high or low in targeted dietary supplements. Following similar studies that the investigators has successfully performed over shorter durations at high altitudes previously, they hypothesise that levels of stress experienced in extreme environments such as Antarctica or deep space can be reduced with targeted nutritional supplementation. These findings may become important to members of the general public as commercial aviation moves increasingly towards using low space-orbital vehicles to drastically reduce international travel times over the coming decade.


Eligibility Criteria:
Inclusion Criteria:

* Adult
* Member of Concordia station over-wintering crew
* Able to give written informed consent
* Fluent in either English, French or Italian

Exclusion Criteria:

* Participating in another interventional research study during the deployment to Concordia
Garcinia Mangostana L.Pericarp Gel as a Local Drug Delivery in Treatment of Chronic Periodontitis

A single-center, randomized controlled clinical trial was done to assess the periodontal status of the individuals and the presence of red complex microorganisms (RCM) such as Treponema denticola, Porphyromonas.gingivalis and Tannerella.forsythia in the subgingival tissues of periodontal pockets at baseline followed by the application of mangostana gel as an adjunct to scaling and root planing. The periodontal parameters and RCM were again assessed at 3rd month and compared with the placebo group.

Background: The study aim to assess the periodontal status of individuals and the presence of red complex microorganisms (RCM) such as Treponema denticola (T.d), Porphyromonas gingivalis (P.g) and Tannerella forsythia (T.f) in the subgingival tissues of periodontitis subjects before and after the application of 4% mangostana gel (MGA) as an adjunct to scaling and root planing.

Methods: 25 sextants (MGA group) were treated with scaling and root planing (SRP) and subgingival application of mangostana gel used as local drug delivery (LDD). 25 sextants (Placebo group) were treated with SRP and placebo gel. Clinical parameters were recorded and the presence of RCM were assessed at baseline and at 3rd month.

Statistical Analysis: The mean probing pocket depth, clinical attachment level, bleeding index, plaque index were assessed at 0th day and 3rd month and compared between the groups using one way analysis of co-variance (ANCOVA). Intra-group comparison (MGA) for the presence of T.d, from baseline to 3rd month and inter-group comparison (MGA \& Placebo) at 3rd month was done using Fischer exact test. In both MGA and placebo group, the presence of T.d in subgingival tissues was compared with the clinical parameters at 3rd month using student's t-test. The p ≤ 0.05 was chosen as a level of significance.

Eligibility Criteria:
Inclusion Criteria:

* Age: 30 to 65 years
* Systemically healthy subjects with chronic periodontitis

Exclusion Criteria:

* aggressive periodontitis,
* systemic disorders,
* known or suspected allergy to the MGA/placebo group,
* pregnant and lactating females,
* long term steroid medication,
* smokers,
* alcoholics,
* immunocompromised individuals and
* those with history of antibiotic or periodontal therapy in preceding 6 months
Improving Perioperative Antimicrobial Prophylaxis by the Use of a Computerized Decision Support System

To evaluate the impact of using a computerized decision program on the adequacy of the perioperative antimicrobial prophylaxis

Adequacy rate of surgical antimicrobial prophylaxis, helped by a computerized decision support system, according to the internal guidelines considering the aspects: drug choice, dosing, timing, and re-dosing

Eligibility Criteria:
Inclusion Criteria:

* All elective \& emergency surgeries done by neurosurgery, orthopaedics, cardiovascular and digestive specialties made at University Hospitals of Geneva

Exclusion Criteria:

* Patients \< 40 kgs
Effect of Visual Retraining After Stroke

This project is intended to collect data using standard clinical tests and psychophysics to quantify the effect of visual cortical damage on the structure of the residual visual system, visual perception, spatial awareness, and brain function. The investigators will also assess the effect of intensive visual retraining on the residual visual system, processing of visual information and the use of such information in real-world situations following damage. This research is intended to improve our understanding of the consequences of permanent visual system damage in humans, of methods that can be used to reverse visual loss, and of brain mechanisms by which visual recovery is achieved.


Eligibility Criteria:
Cortically Blind Subjects

Inclusion:

* Between 21 and 80 years of age
* Residents of the United States or Canada
* Unilateral stroke or stroke-like damage to primary visual cortex or its immediate afferent white matter sustained within the specified age range (21-75 years)
* Reliable visual field defects in both eyes as measured by Humphrey, MAIA, Goldmann, and/or equivalent perimetry, large enough to enclose a 5-deg diameter visual stimulus.
* Able to fixate on visual targets reliably for 1000ms
* Must have a home computer (desktop or laptop) and reliable internet access
* Willing, able, and competent to provide informed consent
* Normal cognitive abilities, able to understand written and oral instructions in English, and competent and responsible adults in order to complete the visual training at home, independently, as instructed, for several months.

Exclusion:

* Past or present eye disease interfering with visual acuity
* BCVA worse than 20/40 in either eye
* Damage to the dorsal Lateral Geniculate Nucleus
* Diffuse whole brain degenerative processes
* History of traumatic brain injury
* Any other brain damage deemed by study staff to potentially interfere with training ability or outcome measures
* Documented history of drug/alcohol abuse
* Currently taking neuroactive medications which would impact training, as determined by PI
* Presence of cognitive or seizure disorders
* One-sided attentional neglect
* Subjects who lack the competence or are otherwise unable to perform the visual training exercises as directed.

Control Subjects (n = 50)

Inclusion:

* Between 21 and 80 years of age
* Report no history of neurological disorder.
* Competent and responsible, as determined by the Principal Investigator.

Exclusion:

* Presence of damage to the visual system
* Presence of an active disease process involving their nervous system.
* Cognitive or seizure disorders
* Best corrected visual acuity worse than 20/40 in either eye
* Presence of vision field loss from ocular disease or disorder
Urdu Translation And Cross-Cultural Validation of the Foot And Ankle Disability Index

The goal of this Cross-cultural validation study is to Urdu translate and cross-cultural validation of Foot and Ankle Disability Index for the Patients with Chronic Ankle Instability. The main question it aims to answer was:

• To Translate Foot and Ankle Disability Index in Urdu and to find out the Validity and Reliability for Patients with Chronic Ankle Instability.

Data collection procedure would be, FADI Urdu version was introduced and the patients were asked to fill FADI Urdu version. The questionnaire was filled again by the same participants after one week to assess the test retest reliability. Questionnaire was conducted to have the best result. After the ethical approval, participants who meet the inclusion criteria and who were free from exclusion criteria were explained about the objectives of this study. Only those who gave consent were included in the study.

The foot and ankle are common sources of pain and disability, with approximately 2 million people in the United States per year affected by foot pain. As many as 25% of sports injuries have been attributed to the foot or ankle, with ankle sprains accounting for up to 45% of all injuries in some sports. The Foot and Ankle Disability Index (FADI) were designed to assess functional limitations related to foot and ankle conditions. Therefore, it is used to assess the patients with chronic ankle instability. The FADI was originally developed in English. It has been translated and validated in Italian languages and showed excellent reliability and responsiveness. To cross culturally validate the FADI in Urdu, the FADI will be translated in Urdu to assess the chronic ankle instability patients to check the instability. Convenience sampling technique will be used in this study. A study will be conducted at Pakistan Sports Board Lahore including 10 athletes for 1st stage and 50 Athelets in 2nd stage. The aim of this study was to translate FADI in Urdu and to find out the validity and reliability of Urdu version of FADI in patients with chronic ankle instability. Reliability and validity of FADI in Urdu version was evaluated by calculating Cronbach's alpha, intra-class correlation co-efficient and Pearson/ spearman rank correlation co-efficient. SPSS 25 was used for data analysis.

Eligibility Criteria:
Inclusion Criteria:

* A history of ankle sprain with pain and/or limping for more than 1 day,
* Chronic weakness, pain, or instability that they attributed to the initial injury
* Giving way in the last 6 months.
* Able to read Urdu Language

Exclusion Criteria:

* Bilateral ankle instability
* History of ankle fracture
* Ankle injury within 3 months of participation
* History of anterior cruciate ligament injury
* History of balance disorder
* Current participation in supervised physical rehabilitation.
Cognitive Behavioral Social Skills Training for Improving Social Functioning in People With Schizophrenia

This study evaluated the effectiveness of Cognitive Behavioral Social Skills Training versus goal-focused supportive contact in improving social functioning in people with schizophrenia.

Schizophrenia is a chronic, severe, and disabling brain disorder. People with schizophrenia sometimes hear voices others don't hear, believe that others are broadcasting their thoughts to the world, or become convinced that others are plotting to harm them. These symptoms make it difficult for people with schizophrenia to interact normally and establish healthy social relationships with others. Cognitive Behavioral Social Skills Training (CBSST) is a group behavioral therapy intervention that focuses on improving cognitive and metacognitive impairments and social skills deficits that interfere with normal functioning in people with schizophrenia. Goal-focused supportive contact (GFSC) is a group therapy intervention that focuses on helping people with schizophrenia to verbalize their problems or worries and to seek advice from fellow group members. This study evaluated the effectiveness of CBSST versus GFSC in improving social functioning in people with schizophrenia. The study will assessed changes in cognition, psychotic symptoms, and use of psychiatric healthcare services.

Participants in this open label study were randomly assigned to one of the following treatment groups: treatment as usual (TAU) plus CBSST or TAU plus GFSC. Both interventions consist of 2-hour therapy sessions weekly for 36 weeks. Groups receiving each intervention do not exceed ten people. CBSST integrates cognitive therapy, social skills training, and neurocognitive compensatory aids. Cognitive therapy helps participants challenge unhelpful thoughts and build communication and problem-solving skills. Participants receive workbooks that describe the skills and contain homework assignments. GFSC focuses on empowering participants to share problems, worries, or concerns with others who face similar issues. Participants share advice with each other, but therapists do not teach skills. Outcomes were be assessed at Months 4.5, 9, 15, and 21 for all participants.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia or schizoaffective disorder at any stage of illness

Exclusion Criteria:

* Level of care required at baseline interferes with outpatient group therapy participation (e.g., partial or inpatient hospitalization for psychiatric illness, substance use, or physical illness)
* No case manager or care coordinator
* Medically or psychiatrically unstable for outpatient therapy
* Exposure to social skills training (SST), cognitive behavioral therapy (CBT), or dialectical behavioral therapy (DBT) within 5 years prior to study entry
Electronic Prescription Data to Improve Primary Care Prescribing

This is a randomised controlled study to evaluate the effect of providing prescribing feedback that includes individual patient data to General Practitioners (GP) in Scotland on high risk or low quality prescribing.

This study makes use of data held in the Prescription Information System (PIS), the national database available to national health service (NHS) health boards in Scotland, on all prescriptions dispensed by community pharmacists which include the unique patient identifier for Scotland (CHI).

The design is a two parallel arm cluster randomised trial with general practices as the unit of randomisation to whom the feedback intervention is directed, and outcomes measured at patient level. Both arms receive the same active interventions but focused on different topics, with each acting as control to the other.

The primary outcome in the asthma arm is a composite of measure of potentially high-risk asthma prescribing (multiple short acting beta-agonists or single agent long acting beta-agonists both in the absence of inhaled corticosteroid therapy).

The primary outcome in the urinary tract infection antibiotic arm is a measure of repeated use of single (likely long-term prevention) or multiple (repeated treatment courses) urinary tract infection antibiotics.

Within the feedback, alongside the patient-level analysis, there will be action-orientated messages to guide the GP practice.

GP practices will get the reports three times at six-monthly intervals.

Eligibility Criteria:
Inclusion Criteria:

* GP practices in the participating Health Board area (NHS Greater Glasgow and Clyde)

Exclusion Criteria:

* GP practices with registered list sizes \<250 patients (all of these are unusual practices in various ways, for example serving the homeless or people with challenging behaviour).
* GP practices with \<80% of prescriptions for inhaled bronchodilators and UTI antibiotics in the prescription database with a recorded patient identifier for each month from January 2014 to December 2014.
* GP practices which were created after 1 January 2015.