cyrilzakka/clinical-trials huggingface dataset:
Fructose: Substrate, Stimulus, or Both?

This objective of this study is to use sensitive methodology under controlled conditions to investigate the mechanisms by which fructose consumption contributes to excess fatty acid synthesis and elevations in blood glucose levels following consumption of meals containing fructose.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index 22 to 35 kg/m2
* Prediabetic (HbA1c 5.7% to 6.5%) or hyperinsulinemic (fasting insulin ≥12 µIU/mL) but non-diabetic (fasting glucose \<126mg/dL and HbA1c \< 6.5%) ; or normal control (fasting insulin \<10 µIU/mL, fasting glucose \<100 mg/dL, and HbA1c \< 5.7%)

Exclusion Criteria:

* Pregnancy or lactation within the past six months
* Type 1 or 2 diabetes mellitus
* History of liver disease or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2x the upper limit of normal (ULN);
* Fasting triglyceride or total cholesterol levels above 95th percentile for age and sex;
* Hemoglobin or hematocrit below the lower limit of normal for sex;
* Report of hepatitis or HIV infection;
* History of cancer, use of any anti-diabetic medications or hypolipidemic agents in the past six months;
* History of surgical procedure for obesity;
* Self-reported change in body weight \>5% in the past six months;
* History of other conditions known to affect insulin sensitivity and lipid metabolism;
* Known intolerance to acetaminophen or components of the liquid test meals.
Pharmacoeconomic Evaluation of the Cost/effectiveness Ratio of Physical Exercise on Non-alcoholic Fatty Liver Disease

Physical inactivity and poor dietary habits are associated with an increased risk of obesity and chronic disease (World Health Organization, 2019; Glanz and Bishop, 2010). Conversely, higher levels of total physical activity result in a reduced risk of cardiovascular disease, breast and colon cancer, and diabetes (Kyu et al., 2016). Similarly, consumption of the minimum recommended level (600 g per day) of fruit and vegetables is associated with a lower risk of cardiovascular disease and cancer (Ezzati et al., 2004). However, despite these recognized benefits, unhealthy diet and physical inactivity are still major contributors to poor health and rising health care costs. Worldwide, physical inactivity accounted for 13.4 million disability-adjusted life years (DALYs) in 2013 and cost $53.8 billion to health systems and an additional $13.7 billion in productivity due to deaths attributable to physical inactivity (Ding et al., 2016).

Pharmacoeconomics, or the economic evaluation of treatments aimed at maintaining the health of the population, is a set of evaluation models used to identify the value (convenience) and the overall economic impact of a possible treatment.

The results of economic evaluations help decision makers inform their choice. Their advantage is that the result is obtained by applying known and validated models, and everyone can know the basis of the decision (evidence-based decision making). The clinical-economic value and the overall financial impact must be compared with the willingness to pay the related costs.

Economic evaluations are a tool for defining the value of a medicine in terms of cost-opportunity, from the point of view of the patient, the NHS and society as a whole.

The definition of "value" is very broad, multidimensional and includes concepts from many disciplines, beyond economics. Specifically, economic evaluations that take into consideration new medicines, innovative or not, the value is given by the marginal utility that the patient, the NHS and/or society can obtain from its acquisition. In this regard, the measurement of years of life gained in full quality of life (QALY - quality-adjusted life years) is widely applied to medicines in various regulatory contexts, albeit with the awareness that it is not able to capture all the elements that contribute to value (Carletto, A et al.; Drummond, M. F)


Eligibility Criteria:
Inclusion Criteria:

* Being affected by NAFLD in the observation period (2018-2020)
* Participating in health promotion activities by performing physical exercise under the supervision of the institution's kinesiologists

Exclusion Criteria:

* Patient deceased
* Patient who does not agree to participate in the study
Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study

This study is being carried out to see if adding ZD1839 to other standard supportive care is more effective than standard supportive care alone for the treatment of patients with NSCLC whose disease has recurred after previous chemotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* · Life expectancy of at least 8 weeks.

  * Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma
  * Not suitable for chemotherapy
  * WHO Performance status 0,1, 2 or 3

Exclusion Criteria:

* Newly diagnosed CNS mets
* Less than 1 week since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
* ALT/AST greater than 5 x upper limit of normal
* ANC less than 1.0 x 109/L or platelets less than 100 x 109/L
Safety of Continuing CHemotherapy in Overt Left Ventricular Dysfunction Using Antibodies to HER-2

Trastuzumab is an important treatment for HER 2 positive breast cancer. But trastuzumab can cause injury to the heart, and this is one of the main reasons it cannot be administered as planned. Heart injury can often be successfully treated using cardiac medications. The aim of SCHOLAR is to evaluate whether it is safe to continue trastuzumab in individuals with mild or moderate cardiac injury, while treating them with appropriate cardiac medications. In this way the investigators hope to be able to optimise the delivery of a treatment to patients with breast cancer that has proven survival benefits, especially when administered for a full 12-month course.

The SCHOLAR study design will be a modified phase I, non-randomized clinical study.

Initially a cohort of 5 participants will be enrolled. They will continue to receive trastuzumab. All participants in SCHOLAR will also be prescribed standard-of-care treatment for patients with LV systolic dysfunction, including the beta-blocker, carvedilol, and the ACE-I, ramipril, as tolerated, at the maximum doses tolerated, up to carvedilol 25mg BID and ramipril 10mg once daily. If at any time 1 or more of the first 5 participants develop cDLT, de-escalation will occur. De-escalation will involve a change in the eligibility criteria to exclude patients with LVEF \<45% and patients with NYHA class II, III, or IV heart failure. A further 5 patients will then be recruited. If 2 or more of the second 5 participants develop cDLT after de-escalation, the intervention will be considered unsafe, and the study will be closed. If the intervention is considered safe either using the initial eligibility criteria or the de-escalated eligibility criteria, the study will be closed after 20 participants have been recruited. If at any time during the study \>20% of participants develop cDLT, the intervention will be considered unsafe, and the study will be closed.

Patients will be seen by a cardiologist at the following time points (referenced from the baseline visit): baseline, 3 weeks ± 1 week, 6 weeks ± 1 week, 3 months ± 1 week, 6 months ± 1 week, 9 months ± 1 week, 12 month ± 1 week

Eligibility Criteria:
Inclusion Criteria:

* Stage I-III HER-2 positive breast cancer
* Receiving adjuvant therapy with trastuzumab
* Provide informed consent
* Exhibit LV dysfunction as evidenced by either

  * LVEF between 40% and the lower limit for normal (i.e. \<54% in women or \< 52% in men18), or
  * LVEF within normal limits (i.e. ≥54% in women or ≥52% in men) and NYHA class II heart failure symptoms within the past year, or
  * A fall in LVEF of ≥15% from baseline

Exclusion Criteria:

Patients will not be eligible for SCHOLAR if they have any of the following:

* NYHA class III or IV heart failure
* Systolic blood pressure \<90mmHg
* Current use of both ACE-I/angiotensin receptor blocker and beta-blocker
* Contra-indication to both ACE-I/angiotensin receptor blocker and beta-blocker
Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease

The project is a placebo-controlled study that aims to use closed-loop transcranial alternating current stimulation (tACS) to study patients with symptoms of mild cognitive impairment which is likely due to Alzheimer's disease or another form of dementia (AD-MCI). Patients will undergo an EEG and complete some questionnaires and computer tasks during each study visit. The project has the following aims and hypotheses: 1.) To determine the impact of closed-loop 40 Hz tACS on the entrainment of natural gamma rhythms in patients with AD-MCI, 2.) To determine the impact of closed-loop 40 Hz tACS on cognitive performance in patients with AD-MCI, and 3.) To assess the relationship between baseline neurodegenerative burden and impact of tACS. \[exploratory\]


Eligibility Criteria:
Inclusion Criteria:

* Overall cognitive functional status consistent with amnesic MCI (CDR 0.5) likely due to AD (AD biomarker supported)
* 50-80 years of age
* English native speakers

Exclusion Criteria:

* Known presence of a structural brain lesion (e.g., tumor, cortical infarct)
* Acute or decompensated active medical conditions, including cancer, cardiovascular disease, stroke, congestive heart failure
* Active hematological, renal, pulmonary, endocrine or hepatic disorders
* Longstanding premorbid history (i.e., longer than 10 years) of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed
* tACS contraindications (lesions in the scalp, history of seizures)
Virtual Reality Versus Conventional Exercise Intradialysis

All participants exercised during 16 weeks following a conventional intradialysis exercise program. The last 4 weeks of the study participants were randomized into two different exercise programs intradialysis. One group exercised through a virtual reality exercise adapted specially for patients while receiving hemodialysis treatment. The other group exercised with a conventional exercise program, combining aerobic cycling and strengthening exercises.

The first 16 weeks all participants followed an intradialysis exercise program. The exercise program consisted of strengthening exercises for lower limbs and for the upper limb free of fistula. The exercise program included isotonic exercises for quadriceps, triceps surae, psoas, glutei, and brachial biceps; and isometric exercises for hip adductors and hamstrings. Elastic bands were used to apply resistance. Progression was achieved from increasing from 1 set of 10 repetitions until 3 sets of 15 repetitions. This first part lasted no more than 30 minutes. The program also included aerobic exercise (cycling) for up to 30 minutes. Intensity was adapted through the duration of the study so that the participant felt the exercise from hard to somewhat hard (13 to 15 at the rate of perceived exertion 6 to 20). Time and resistance were adapted progressively.

The last four weeks of the program participants were randomized into virtual reality exercise or conventional exercise group. The virtual reality exercise group undertook 30 minutes of exercise. After warming up, participants had to play to an adapted 'treasure hunt' game. Their legs movements were the players projected into an individual tv that gave them feedback regarding their achievements. The aim of the game was to achieve the higher possible score.They moved to pick up coins and to avoid bombs. An adapted Kinect technology was used for the game development.

Eligibility Criteria:
Inclusion Criteria:

- Patients in HD therapy at least 3 months

Exclusion Criteria:

* recent myocardial infarction (within 6 weeks)
* unstable angina
* malignant arrhythmias
* above the knee amputation without replacement
* cerebral vascular disease (ictus, transient ischemia)
* musculoskeletal and respiratory disorders that can get worse with exercise
* impossibility to achieve functional testing
Clinical Study of Fecal Microbiota Transplantation in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)

Small intestinal bacterial overgrowth (SIBO) is defined as the presence of excessive numbers of bacteria in the small bowel causing gastrointestinal (GI) symptoms. These bacteria are usually coliforms, which are typically found in the colon and include predominantly Gram-negative aerobic and anaerobic species that ferment carbohydrates producing gas .Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. To explore the overall efficacy and safety of FMT in the treatment of SIBO.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a positive breath test result upon initial admission.
* Patients presenting with abdominal symptoms.
* Patients who have stool and small intestinal fluid samples available before and after FMT.

Exclusion Criteria:

* Patients with gastrointestinal malignancies.
* Patients with a history of gastrointestinal surgery.
* Patients on long-term probiotic use.
* Patients with a history of extensive antibiotic use.
Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients

The aim of this study was assesment of splanchnic and systemic hemodynamic effects of chronic administration (2 month) of spironolactone or propranolol, alone or in association in alcoholic cirrhotic patients. The patients were randomized in 4 groups (aldactone 150 mg/day, propranolol 160 mg/day, aldactone 150 mg/day + propranolol 160 mg/day, placebo). Systemic and splanchnic hemodynamic effect were evaluated by hepatic venous pressure gradient measurements before and after 2 month of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Indication of transjugular hepatic biopsy
* alcoholic cirrhosis
* presence of oesophageal varices ≤ stade 2

Exclusion Criteria:

* renal insufficiency
* natremia ≤ 135 mmol/l
* vasoactive treatment in the last month before inclusion
* hepatocellular carcinoma
* positive HIV and HCV patients
* paracentesis in the last week before inclusion
* digestive bleeding in one last week
* oesophageal varices stade 3 or 2 with red signs
Dynamic Monitoring and Characterization of Pelvic by 3D Ultrafast MRI

Pelvic floor disorders affect a large population of women and are responsible for a significant impairment in their quality of life, but the pathophysiology of these disorders is still poorly understood.

The project proposes to define new ultra-fast 3D MRI sequences to capture the movements of the main pelvic organs. Visualization of 3D volumes is of great importance to clinicians, but data size hinders clinical use.

This study is the first to propose a dynamic 3D representation of pelvic organs, together with quantitative estimates of the deformations undergone.

The method is based on four steps: dynamic acquisition, organ segmentation, temporal reconstruction, quantification and visualization of deformations.

The D3-Pelvis project responds to the challenge of "technologies for health" with dynamic 3D MRI acquisition and 3D modeling, offering prospects for diagnostic aids and simulators.


Eligibility Criteria:
Inclusion Criteria:

* Adult women, +/- of childbearing age, with or without effective contraception.
* Informed consent signed prior to any procedure described in the study.

Exclusion Criteria:

* Contraindication to MRI,
* Impossibility of performing the examination during thrust,
* Minor patients
* Pregnant or breast-feeding women,
* Women of legal age under guardianship
* Persons staying in a health or social institution,
* People in emergency situations,
* Persons not covered by a social security scheme,
* Persons deprived of their liberty.
* Specifically, women with IUDs will be excluded if they cannot remove them before the examination.
* For healthy volunteers: history of colorectal surgery.
An Epidemiological Cohort Study of Acute Coronary Syndromes in The Greek Population. The PHAETHON Study

A nationwide registry of patients with acute coronary disease to evaluate epidemiological patient characteristics, medical management, implementation of invasive strategy, patient outcome and impact on quality of life in Greece.

A nationwide registry of patients with acute coronary disease to evaluate epidemiological patient characteristics, medical management, implementation of invasive strategy, patient outcome and impact on quality of life in Greece.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* \> 25 years
* Admission in hospital within 24 hours from beginning of symptoms of transfer from antother hospital within 24 hours from beginning of symptoms.
* Acute Coronary Syndrom

Exclusion Criteria:

-
Relationship of Realize Mysuccess Usage to Outcomes of Bariatric Surgery

The goal of this observational study is to assess the efficacy of Realize My Success (RMS),a website that allows patients and providers to maintain contact via the website. We will compare RMS users on a number of different variables with the goal of identifying which variables are associated with optimal outcomes (larger weight losses) at one year (and potentially beyond). The study has two primary objectives. The first is to assess changes in body weight at postoperative year 1 in frequent v. infrequent RMS users. We predict that frequent users will achieve significantly greater reductions in weight at 6 and 12 months (and beyond) than infrequent users. The second objective is to assess changes in body weight at postoperative year 1 in persons who use different features of the RMS site. We hypothesize that persons who, on a regular basis, record their food intake, track their physical activity and make specific behavioral goals will experience significantly greater reductions in weight beginning 6 months after surgery as compared to those who do not use these features of the RMS site.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* BMI between 40-70 kg/m2 (or 35-70 kg/m2 in the presence of co-morbidities)
* Have registered in the Realize Mysuccess Systema and have logged into the system at least once postoperatively.

Exclusion Criteria:

* We will be receiving/analyzing a data set based on the inclusion criteria, therefore there is no set exclusion criteria for our research.
Autologous Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal

a hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) versus transobturator tension free vaginal tape(TVT-O)

a surgeon tailored hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) is used for treatment of urinary stree incontinence and its efficacy is compared to transobturator tension free vaginal tape (TVT-O) conventional mid urethral sling

Eligibility Criteria:
Inclusion Criteria:

* stress urinary incontinence

Exclusion Criteria:

* previous surgery for stress incontinence
Correlation Between COMT Val158Met Polymorphism and Dopaminergic Transporter Density (DAT) in Obese Women

The present study aims to evaluate the correlation between the presence of COMT Val158Met polymorphism and the density of dopaminergic transporters (DAT) in young obese women.

The prevalence of obesity remains increasingly alarming in Brazil and worldwide. The most widely recommended therapy for obesity is lifestyle modification, however, implementing these changes that can lead to weight loss is difficult and maintaining a long-term weight loss is even more challenging. Consequently, an academic effort is required to understand the pathophysiology and treat obesity for the establishment of new approaches to reducing food intake.

Recent evidence in the field of obesity and brain-based integration indicates a potential for designing new therapeutic interventions. Noninvasive neuromodulation of brain activity has been shown to be a technique that can help reduce food cravings and food intake and, more recently, body weight, offering a new way to treat obesity. However, recent studies have shown that this biomedical intervention could have a paradoxical effect related to COMT Val158Met polymorphism, which impacts dopamine levels in the prefrontal cortex. The potential mechanisms underlying this effect are unclear and future studies are needed to promote this clarification.

This study aims to verify the influence of the COMT Val158Met polymorphism on the density of dopaminergic transporters in the presynaptic membrane of dopaminergic neurons, exploring the 3 dopaminergic pathways: via nigroestrital, mesolimbic and mesocortical. This investigation will be carried out through the cerebral SPECT using the radiopharmaceutical 99mTecnécio-TRODAT-1 in young obese women with and without COMT Val158Met polymorphism. In baseline conditions, the investigators will compare the SPECT 99mTc-TRODAT-1 of obese women with and without the COMT Val158Met polymorphism with a database of non-obese volunteers.

Our hypothesis is that the study will facilitate understanding of the variability of the individual response of carriers and non-carriers of the Met allele of the COMT Val158Met polymorphism, affecting dopamine levels in the brain and to design, in the future, for the treatment of obesity based on the individuals' genotypic differences.

Eligibility Criteria:
Inclusion Criteria:

* Women with obesity (BMI 30-35kg/m2), with and without COMT Val158Met polymorphism.

Exclusion Criteria:

* pregnancy
* any active psychiatric or neurological condition at the time of joining the study
* any other significant medical condition
Prevention of Venous Thrombosis After Permanent Transvenous Leads Implantation

The aim of this study was to compare the safety and efficacy of warfarin versus placebo, administered for 6 months, in the prevention of thromboembolic complications after transvenous cardiac devices implantation in high-risk patients.

Venous lesions following cardiac devices implantation are a common complication of transvenous access that may cause disease manifestations and difficulties during reoperations. These lesions tend to develop early, and their incidence decreases gradually within 6 months after device implantation. Ventricular dysfunction and previous transvenous temporary leads ipsilateral to the permanent implant are risk factors identified in a previous study performed at our institution and other risk factors have been reported recently.The usefulness of prophylactic therapeutic strategies to prevent these complications, however,remains unknown. This randomized trial examined the effects of warfarin in the prevention of these complications in high-risk patients. After device implantation, patients were randomly assigned to receive either placebo or warfarin. Periodical clinical and laboratorial evaluations were performed to anticoagulant management. Following the six-month period, every patient was submitted to a digital subtraction venography.

Eligibility Criteria:
Inclusion Criteria:

* adults patients submitted to first transvenous implant of pacemakers, implantable cardioverter-defibrillator, or cardiac resynchronization therapy devices
* left ventricular ejection fraction ≤0.40 and/or
* previous transvenous temporary leads ipsilateral to the permanent device implant

Exclusion Criteria:

* history of venous thromboembolism
* atrial fibrillation
* coagulopathy or platelet disorder
* malignancy
* gastro-intestinal hemorrhage or active gastro-duodenal ulcer in the past 6 months
* abnormal prothrombin time (PT)or an international normalized ratio (INR) \>40%, or treated with oral anticoagulants