cyrilzakka/clinical-trials huggingface dataset:
Effect of Nutrition Bars on Satiety in Women

This study investigates nutrition bar consumption and possible impact on self-reported ratings of hunger and fullness compared to a control.

Participant eligibility will be screened at visit 1. Test days will commence at 8 to 10 a.m. and visits two to four will be spaced four days apart. On visit days participants consume a nutrition bar; satiety and hunger ratings, blood samples are collected simultaneously over a three hour period. After completion, participants will complete gastrointestinal (GI) tolerability as well as Palatability and Adverse Events questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women
* Body mass index (BMI) 20.00-29.99 kg/m2
* Maintenance of habitual diet, physical activity patterns, and body weight throughout the trial
* In general good health on the basis of medical history; and taking no medication other than birth control, hormone replacement therapy, statins or blood pressure medication
* Participant understands the study procedures, provides signed informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
* Participant can consume a nutrition bar in the allotted time frame

Exclusion Criteria:

* Use of over-the-counter weight-loss drugs and herbal remedies or supplements and dieting programs/behavior (within two months of visit 1)
* Variation in body weight \>8.8 lbs. (4 kg) within the previous three month before screening
* Any history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating) diagnosed by a health professional
* Subject scores ≥14 on restraint factor of the Three-Factor Eating Questionnaire
* History or presence of clinically important renal or gastrointestinal disorders, or diabetes mellitus
* Extreme dietary habits (e.g. vegan, Atkins diet, exclusion of major food groups, etc.)
* History of allergy, sensitivity, or strong dislike towards any of the components of the study products
* Females who are pregnant, or planning to be pregnant during the study period or lactating
* Use of an investigational drug product within the last 30 days
* Individual has a condition the Investigator believes would interfere with her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
* Subject does not understand English.
Prospective Randomised Study Comparing Laparoscopic Versus Open Surgery in Patients With Rectal Cancer

The aim of this study is to compare laparoscopic versus open approach on the surgical treatment of mid and low-lying rectal cancer, both performed by the same surgical team with experience in open colorectal surgery and advanced laparoscopic surgery, assessing preoperative and anatomopathological results and long-term outcome.


Eligibility Criteria:
Inclusion Criteria:

* Mid- and low-lying rectal cancer (between 0 and 11 cm from the anal margin)
* Histology of adenocarcinoma

Exclusion Criteria:

* Locally advanced disease (T4)
* Emergency surgery
* Rectal cancer over familial colic polyposis
Comparisons of the Therapeutic Effects of Dienogest and Danazol on Endometriosis

The aim of this study is to evaluate the efficacy between dienogest and danazol.

Objective: Women with adenomyosis or endometripsis are often suffered from dysmenorrhea or menorrhagia. Dienogest and danazol are frequently used for the treatment of endometriosis. However, there was no literature mentioned about which medication is better for the treatment of endometriosis. Thus, the aim of this study is to evaluate the efficacy between dienogest and danazol.

Methods: All consecutive women, who have endometriosis, will be randomized to receive dienogest or danazol treatment, and will assess symptoms severity, receive CA125 examination, sonographic examination at baseline, 4 weeks and 16 weeks after treatment.

Eligibility Criteria:
Inclusion Criteria:

* \> 20 years old
* Have an endometriosis-related condition (including adenomyosis, adenomyoma, ovarian endometrioma, or pelvic endometriosis).

Exclusion Criteria:

* Minors.
* Have a history of breast cancer or other cancers.
* Patients with vascular obstruction such as stroke.
The Use of Teledermatology in the Treatment of Patients With Severe Acne on Isotretinoin

This is a non-blinded randomized controlled non-inferiority trial designed to assess the efficacy and role of teledermatology visits in the treatment of patients with severe acne starting isotretinoin. Males and females 16 years or older will be randomized to either the control arm (monthly office visits during treatment weeks 8-20) or treatment arm (teledermatology visits during treatment weeks 8-20). The primary outcome is the change in total inflammatory lesion count. Secondary outcomes include changes in acne severity based on the Leeds scale, patient satisfaction, acne severity as perceived by the patient, cost and time-lost to patients and families, need for interim and unexpected urgent appointments, adverse medication effects. The investigators are hypothesizing that patients randomized to the treatment arm will have no statistically significant difference in total inflammatory lesion count or acne severity than the control arm. The investigators also hypothesize that adverse events will be equivalent in both groups and the treatment arm will report less cost associated with visits.

The role of telemedicine in dermatology is ever-expanding. Currently, teledermatology has been shown to be advantageous in disease processes that require frequent office follow-up visits such as psoriasis. In 2010, Watkins et al. demonstrated that teledermatology was effective in treating patients 16 years and older with moderate acne and demonstrated equivocal clinical outcomes as traditional office visits along with equivocal patient and provider satisfaction scores. More recently, Fruhauf et al. conducted a small study examining patients with severe acne on isotretinoin and found similar results in terms of safety and efficacy. Patients with severe acne on isotretinoin therapy currently are scheduled for monthly office visits in the dermatology clinic for at least six consecutive months during which time the severity of their acne is assessed by a dermatologist and dose adjustments are made accordingly. Patients are also required to get monthly laboratory studies immediately before, during, or after their visit, and this must be reviewed by the provider prior to prescription renewal according to iPledge guidelines. Given the fact that this medication is typically prescribed to teenagers or young adults, the high frequency of office visits put a significant burden on both patients and their families and results in unnecessary time missed from work or school.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of severe acne by a dermatologist with a plan of initiating treatment with isotretinoin
* Patients must first be enrolled in iPledge prior to eligibility

Exclusion Criteria:

* Patients who have baseline hepatic dysfunction or hypertriglyceridemia
* Patients with a history of depression, suicide attempts or suicidal ideation
* Patients without access to internet or a camera (including portable camera and/or smart phone) at home
* Patients who are pregnant - absolute contraindication
Burden of Hepatitis D Virus (HDV) Infection in Italy

The circulation of the Hepatitis D Virus (HDV) has considerably diminished in Italy, secondary to the control of the Hepatitis B Virus (HBV) with vaccination; this has led to the perception that HDV is vanishing and has reduced attention to the diagnosis of Hepatitis D. However, migratory fluxes from HDV endemic areas, fostered by labour-forces globalization, are increasingly reconstituting the reservoir of HDV in the country and hepatitis D has not yet vanished in native Italians but will remain an important medical issue for several years to come. As the epidemiologic and clinical features of HDV infection in migrant communities are largely unknown and the features of native Italians with long standing HDV infections have not been updated, this project intends to establish the contemporary epidemiological and medical context of HDV in immigrants in Italy and to determine the clinical characteristics and needs of the residual cohort of native HDV Italians, through the analysis of all HDV cases recruited in 12 months in a coordinated network of 35 Italian medical centers. The data will provide an appraisal of the burden of hepatitis D in the country and of its impact on the National Health System. They will present the paradigm of the current trend of HDV infection in high-income countries in the world.


Eligibility Criteria:
Inclusion Criteria:

* HBsAg-positive subjects
* 18 years or older
* anti-HD-positive
Venlafaxine Augmentation in Treatment Resistant Depression

This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic quetiapine in treatment resistant depression.

We examine the efficacy of Venlafaxine-HCL augmentation with the neuroleptic Quetiapine in treatment resistant depression in a double-blind randomized clinical trial. Secondary objective is the evaluation of pharmacogenetic factors contributing to drug efficacy in treatment resistant depression.

Eligibility Criteria:
Inclusion Criteria:

* Female and male inpatients with a major depressive disorder without psychotic features or with a depressive episode within a bipolar I or II disorder without psychotic features
* Ages between 20 and 70 years
* Total score greater than 18 on the Hamilton Depression Rating Scale
* Documentation of at least one ineffective antidepressant drug trial under adequate dosage for at least 6 weeks in the current episode

Exclusion Criteria:

* Other psychiatric axis I disorders than those mentioned as Inclusion criteria
* Acute suicidality (Item 3 of the Hamilton Depression Rating Scale greater than 2)
* Drug or alcohol addiction
* Patients with severe hepatic, cardiovascular, neurologic, metabolic or malignant disorders
* Documentation or report of a previous ineffective treatment trial with venlafaxine, lamotrigine or quetiapine
* Functional kidney disorders
* Untreated hypertension
* Acute treatment with thyroid hormone (less than 3 months)
* Pregnant or nursing patients
* Women of childbearing age without effective contraception
Spironolactone in Atrial Fibrillation

This study aims to assess whether treatment with a drug called spironolactone, which is an aldosterone inhibitor, can improve ability to cope with exertion, quality of life and ability of the heart to relax better in symptomatic patients with atrial fibrillation with preserved pumping capacity.

IMPRESS-AF study is a double-blinded randomised placebo-controlled trial of 2-year treatment with an aldosterone antagonist, spironolactone (25mg once daily) vs placebo in 250 patients with symptomatic chronic atrial fibrillation and preserved left ventricular contractility (both added to the current optimised care). The trial will establish impact of spironolactone on the primary outcome of exercise tolerance (peak oxygen consumption on cardiopulmonary exercise testing) and secondary outcomes: (i) health-related quality of life (assessed using the validated Minnesota Living with Heart Failure and EuroQol EQ-5D questionnaires self-completed by patients), and (ii) left ventricular diastolic function (E/e' ratio on echocardiography) - all assessed at baseline and at 2 years; (iii) rates of all-cause hospitalisations during 2-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Permanent AF
* Left ventricular ejection fraction \>= 55% as established by echocardiography
* Able to perform cardio-pulmonary exercise testing using a cycling ergometer and complete quality of life questionnaires in English or in their native language.

Exclusion Criteria:

* Severe systemic illness (life expectancy \<2 years)
* Severe chronic obstructive pulmonary disease (e.g., requiring home oxygen or chronic oral steroid therapy)
* Severe mitral/aortal valve stenosis/regurgitation
* Significant renal dysfunction (serum creatinine 220 µmol/L or above), anuria, active renal insufficiency, rapidly progressing or severe impairment of renal function, confirmed or suspected renal insufficiency in diabetic patients/ diabetic nephropathy
* Increase in potassium level to \>5mmol/L
* Recent coronary artery bypass graft surgery (within 3 months)
* Use of aldosterone antagonist within 14 days before randomisation
* Use of or potassium sparing diuretic within 14 days before randomisation
* Systolic blood pressure \>160 mm Hg
* Addison's disease
* Hypersensitivity to spironolactone or any of the ingredients in the product
* Any participant characteristic that may interfere with adherence to the trial protocol
The Influence of SISCOM on Intracranial Electrode Implantation in Epilepsy Surgical Candidates

The aim of this study is to determine the role of SISCOM (see below) in aiding clinicians to manage epilepsy surgery candidates. SISCOM is already a routine component of pre-surgical epilepsy evaluation at Mayo Clinic. In particular, we are interested in assessing whether use of SISCOM can minimize the need for prolonged (\>24 hours) invasive monitoring with electrodes placed on the surface of the brain prior to surgical resection.

Note: this study has recruited the required number of patients and is closed to further enrolment.

Successful epilepsy surgery depends on accurate identification of the area of brain from which seizures originate (the epileptogenic zone). There are many non-invasive tests (including EEG and MRI) to indicate this area. Some patients require implantation of intracranial electrodes in order to determine the epileptogenic zone. A test known as SISCOM (subtraction ictal-interictal SPECT co-registered with MRI) has been validated as a non-invasive means of indicating the epileptogenic zone. However, this test is not widely available in the US, and it is not known how often the additional information provided by SISCOM makes a difference to clinical decision-making.

In order to determine the contribution of SISCOM towards clinical decision-making in epilepsy surgery candidates, we will ask epileptologists at Mayo Clinic to consider case presentations given all clinical information except for SISCOM results, and then to reconsider those same cases in conjunction with SISCOM data. This will indicate the degree to which SISCOM influences decision making.

50 patients at Mayo Clinic (38 adults, 12 children) will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of localization-related epilepsy
* Evaluated by clinical epileptologist at Mayo Clinic
* SISCOM ordered by treating physician
* Case presented at weekly Epilepsy Surgery Conference
* Patient consent
Motivational Interviewing Compared to Psychoeducation for Smoking Precontemplators With SMI

The investigators primary hypothesis was that recipients of the Motivational Interviewing intervention would be significantly more likely than those assigned to the Psychoeducation intervention to demonstrate increased readiness to quit smoking at the end of the intervention and to seek smoking cessation treatment in the one month period following the intervention. We also predicted that the Psychoeducation intervention would result in greater improvements in smoking knowledge.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Had a diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or chronic major depressive disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria
* Smoked at least 10 cigarettes per day
* At baseline, reported not being ready to quit smoking within the next 30 days (i.e., in precontemplation or contemplation stages).

Exclusion Criteria:

-
Diabetic Under 70 (Diabetics Below 70)

A screening project of diabetics with a very high cardiovascular risk (e.g. diabetes plus coronary heart disease) who already receive cholesterol-lowering therapy. Lipid profile and rate of patients who are treated to target (which is \<70mg/dl for such patients with very high risk) are screened. The doctors therapy decisions after the screening will be documented and 8-10 weeks later the lipid profile of each patient will be evaluated again. Our aim is to evaluate dosing habits, to evaluate how many patients are treated to their LDL-C target and to underline the importance of treating patients to their cholesterol targets.


Eligibility Criteria:
Inclusion Criteria:

* Diabetics with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PAVK, etc.) who already receive cholesterol-lowering therapy

Exclusion Criteria:

* Diabetics w/o CVD; diabetics who do not receive cholesterol-lowering therapy
Effectiveness of Levonorgestrel-intrauterine System (LNG-IUS) Versus Depot Medroxyprogesterone Acetate (DMPA) in Treatment of Pelvic Pain in Clinically Diagnosed Endometriotic Patients

randomized controlled trial

Eligiblility criteria Provisional diagnosis Clinical presentation Progressive dysmenorrhea Chronic pelvic pain Deep dyspareunia Evidences of endometriosis Endometriotic nodule Cul-de-sac nodularity Endometrioma detected by ultrasonography size \< 4 cm

Inclusion criteria Female age 18-45 yr Moderate to severe pelvic pain categorized by VAS \>50 Previous sexual intercourse

Exclusion criteria Co-existing other genital tract disease associated pain Previous hormonal use within 3 months History of DMPA treatment failure WHO eligibility criteria 2009 for DMPA and LNG-IUS Category 3,4 Fertility desire in upcoming 1 year

Primary objective To compare efficacy of pain control in endometriosis associated pelvic pain between LNG-IUS and DMPA

Secondary objective To compare side effect, continuation rate, satisfaction and quality of life between LNG-IUS and DMPA in treatment of endometriosis associated pelvic pain

Primary outcome Severity of pelvic pain Measured by VAS score 0 mean no pain 100 mean most pain

Secondary outcomes Vaginal bleeding pattern Side effects of systemic progestogen Lipid profiles Weight gain Quality of life Measured by quesionaire SF36 Satisfaction Measrured by linket scale 0-4 0 mean very dissatisfied 1 dissatisfied 2 not satisfied and dissatiffied 3 satisfied 4 very satisfied Continuation rate Endometrioma size reduction


Eligibility Criteria:
Inclusion Criteria:

* Female age 18-45 yr
* Moderate to severe pelvic pain categorized by VAS \>50
* Previous sexual intercourse

Exclusion Criteria:

* Co-existing other genital tract disease associated pain
* Previous hormonal use within 3 months
* History of DMPA treatment failure
* WHO eligibility criteria 2009 for DMPA and LNG-IUS Category 3,4
* Fertility desire in upcoming 1 year
Strategy Training for People With Aphasia After Stroke

One-third to one-half of acute strokes result in newly acquired cognitive impairments. Approximately 30 to 40% of people in the acute phase of stroke also sustain communication impairments. Stroke-related cognitive impairments are associated with significant functional disability, as indicated by the inability to regain independence in daily activities. The overall aim of this study is to examine the feasibility of an adapted form of strategy training for people with communication impairments who are admitted to inpatient rehabilitation. These analyses will address a critical gap in current rehabilitation research, namely the exclusion of people with communication impairments in acute stroke rehabilitation clinical trials, and provide pilot data to inform the design of future inclusive clinical trials seeking to reduce disability after stroke.

This pilot study will use a descriptive case series design with repeated measures to assess the feasibility of an adapted form of strategy training for people with communication impairments after acute stroke. The investigators will recruit people with aphasia due to stroke admitted to the inpatient rehabilitation units and administer the adapted form of strategy training one session per day 5 days per week for 10-15 sessions. The investigators will assess the feasibility of the intervention based on feedback from participants and therapists. These data will serve as pilot data to inform the design of a future clinical trials for people with cognitive impairments after stroke, including people with communication impairments. These efforts will allow the investigators to test new models to support optimal interventions for individuals with stroke-related cognitive impairments, including people with communication impairments who are among those most vulnerable for long-term disability.

Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis of acute stroke
* admission to acute rehabilitation
* mild to moderate aphasia but able to understand and express communication with verbal, written, and/or augmentative communication (score of 1 or 2 on the National Institutes of Health Stroke Scale item 9, or score 1 to 5 on the Boston Diagnostic Aphasia Examination Severity Scale)

Exclusion Criteria:

* pre-stroke diagnosis of dementia
* severe global aphasia (Boston Diagnostic Aphasia Examination Severity Scale score of 0)
* dysarthria as the only communication impairment (score of 1 or 2 two on the National Institutes of Health Stroke Scale item 10, but score of 0 on item 9)
* current major depressive disorder (unless treated and in partial remission), bipolar disorder, or any other psychotic disorder (indicated by PRIME-MD)severe global aphasia (Boston Diagnostic Aphasia Examination Severity Scale score of 0)
Energy Expenditure and Substrate Oxidation in a Whole Room Calorimeter

The investigators aim to establish a protocol for metabolic rate measurements obtained using continuous monitoring of oxygen consumption and carbon dioxide production in a whole room calorimeter setting.

The purpose of this study is to determine the duration and time course of the thermic effect of single meals consumed by subjects who have been previously fasting for 12 hours overnight. Capturing the full thermic effect of a meal may take up to 8 hours, depending on the calorie load, nutrient composition of the meal, and rate of digestion. The investigators will test meals consisting of conventional foods that are low (20% of energy), moderate (40% of energy) or high (60% of energy) in fat calories, as fat is thought to slow the digestive process. The investigators will test a liquid meal, that is high (60% of energy) in fat calories, as liquid foods are thought to move more quickly through the digestive process. Another purpose of this study is to determine the test-retest reproducibility for the meals described above. To accomplish reproducibility, a volunteer will be permitted to repeat a test day two times using the same test meal.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index 18.5 - 39.9 kg/m2

Exclusion Criteria:

* BMI \< 18.5 or \> 40 kg/m2
* Presence of untreated or uncontrolled metabolic diseases
* Presence of gastrointestinal distress or disorders that prevent consumption of a study meal (in particular, the high fat meals)
* Presence of Crohn's disease, irritable bowel syndrome, or colitis
* Previous gallbladder removal
* Presence of cancer or other serious chronic disease
* Implanted medical device that is battery operated, such as a pacemaker, defibrillator, electrocardiograph, or nerve simulator
* Presence of a large amount of metal in the body such as a hip implant
* Current use of tobacco in any form
* Claustrophobia
* Dietary restrictions that would interfere with consuming study meals
* Pregnant or nursing within the last 6 months, or plan to become pregnant