cyrilzakka/clinical-trials huggingface dataset:
Pathophysiological Implications of the Incretin Hormones in Patients With Liver Disease With and Without Diabetes

The main objective of this study is to analyze the pathophysiological implications of glucagon and the incretin hormones in patients with liver disease (Non alcoholic fatty liver disease (NAFLD) or cirrhosis) with and without diabetes compared with healthy controls. The present study will contribute significantly to the understanding of the pathophysiology of liver disease and glucose metabolism. The final goal is that the results could pave the way for new treatment modalities for patients with liver disease.

Comparison of of insulin secretion (Area Under the Curve (AUC)) during the experimental days. Furthermore a comparison of GIP, GLP1 and glucagon responses as well as plasma glucose levels.

Eligibility Criteria:
I) Group 1: NAFLD patients with normal glucose tolerance Inclusion criteria

* NAFLD verified by a liver biopsy
* Caucasian \>18 years of age
* Negative islet cell (ICA) and glutamic acid decarboxylase 65 (GAD65) autoantibodies
* Normal 75-g OGTT as specified in the WHO Criteria
* Normal haemoglobin and blood pressure (BP)
* Written informed consent

II) Group 2: NAFLD patients with type 2 diabetes Inclusion criteria

* NAFLD verified by liver biopsy
* T2DM according to the WHO Criteria
* Caucasian \>18 years of age
* Negative ICA and GAD65, normal haemoglobin, normal BP
* Written informed consent

III) Group 3: NAFLD patients without type 2 diabetes Inclusion criteria

* NAFLD verified by liver biopsy
* Caucasian \>18 years of age
* Normal 75-g OGTT
* Negative ICA and GAD65-autoantibodies
* Normal haemoglobin and BP
* Written informed consent

IV) Group 4: Cirrhosis with or without type 2 diabetes Inclusion criteria

* Liver cirrhosis verified by liver biopsy
* Caucasian \> 18 years of age
* Negative ICA and GAD65-autoantibodies
* Normal haemoglobin and BP
* Written informed consent

V) Group 5: Healthy controls Inclusion criteria

* Caucasian \>18 years of age
* Normal 75-g OGTT according to the WHO Criteria
* Negative ICA and GAD65-autoantibodies
* Normal haemoglobin and BP
* Written informed consent

Exclusion criteria (all groups)

* Other known liver disease - viral hepatitis, hereditary haemochromatosis, autoimmune liver disease, alpha-1 trypsin deficiency, Wilson disease, drug induced liver Injury (DILI)
* Treatment with medications that cannot be discontinued for 12 hours
* Unwillingness to participate in protocols
* Pregnancy or lactation
Stories for Change: Early Detection Can Save Lives

The purpose of this study is to evaluate the Stories for Change (S4C) Cancer Prevention digital storytelling intervention for acceptability and socio-behavioral constructs to increase cancer screening among Hispanic or Latino individuals.


Eligibility Criteria:
Inclusion Criteria:

* Self-identify as Hispanic, Latino/a/x/e, or Chicano/a/x;
* For breast cancer screening: age 40-74 years; for cervical cancer screening: age 21-65 years; for colorectal cancer screening: age 45-75 year
* Receive primary care at either Hennepin Healthcare (HH) or Mountain Park Health Center (MPHC), or Mayo Clinic.
* At least one office visit within the previous 12 months to the primary care site.
* Eligibility for breast, cervical, or colorectal cancer screening documented in the electronic medical record (EMR).
* Intention to continue to receive medical care at HH, MPHC or Mayo Clinic for the next three months.

If a potential participant is eligible for more than one screening, they will be given the option of participating in multiple versions of the intervention.

Exclusion Criteria:

* Individuals with previous breast, cervical, or colorectal cancer diagnoses.
* For the participants in the colorectal cancer screening intervention, those under surveillance (i.e., did not have a cancer diagnosis but did have polyps) will also be excluded.
A Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent Implantation in Non-diabetic Patients

The purpose of the study is to look at the biomarkers of inflammation and platelet activation in patients with drug eluting stents implanted approximately 12 months ago on aspirin and statin, for a 4-week period after the routine discontinuation of clopidogrel


Eligibility Criteria:
Inclusion Criteria:

* Subjects with one or more drug-eluting stents of any type who are coming to the end of their 12 months of clopidogrel (75 mg daily) treatment
* Subjects receiving low dose ASA
* Subjects receiving a statin
* Current medication regimen (including ASA and statins) must have been stable for three (3) months. i.e. no initiation of new prescription medication or change in dosage of any previously initiated medication within three (3) months of entering this study
* Subjects with no clinical history of diabetes mellitis
* Men and women, ages 18 years or older
Probiotics for Irritable Bowel Syndrome

This randomised, double blind, cross-over study compares the effect (symptoms, fecal bacterial growth, gas production) of three weeks' treatment with lactobacillus plantarum MF 1298 with placebo in patients with irritable bowel syndrome. The results are related to dietary habits, food intolerance and food allergy.


Eligibility Criteria:
Inclusion Criteria:

* Irritable bowel syndrome according to the Rome II criteria
* regular symptoms

Exclusion Criteria:

* Use of probiotics last three weeks
* pregnancy
* lactation
* co-existing other gastrointestinal disorders
* use of laxatives and antibiotics within last 5 weeks.
Investigation of Conservative Treatment on Adolescent Idiopathic Scoliosis Patients.

Aim: It was aimed to investigate the effectiveness of three-dimensional scoliosis exercises and balance-coordination exercises in patients with adolescent idiopathic scoliosis.

Method: Thirty patients who were diagnosed with adolescent idiopathic scoliosis were randomly divided into three groups. The first group was treated with 3-dimensional scoliosis exercise program according to Schroth method, second group was treated with Schroth exercises and balance-coordination exercises in addition to brace. Exercises were performed for a total of 6 weeks (18 sessions). The third group was treated only with brace and the control group consisted of healthy individuals. Patients were assessed for their curve angle (Cobb method), rotation angle (scoliometer), spinal flexibility (anterior and lateral bending tests), quality of life (Scoliosis Research Society-22), cosmetic effects (Walter Reed Visual Rating Scale), balance parameters (Balance Master System NeuroCom International Inc. Clackamas, OR, USA ver 8.1), vertical perception (Subjective Vertical Detection test) and brain responses (electroencephalography) were assessed before and after treatment. SPSS 20.0 statistical program was used for data analysis of the study.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with adolescent idiopathic scoliosis between the ages of 10-16 and being deemed appropriate for brace use,
* Cobb angle between 20º -50º,
* To be able to continue the program to be applied,
* Not having a chronic disease that requires the use of any neurological or psychiatric medication, Hearing test results are within normal values,
* Parents allow the child to participate in the study

Exclusion Criteria:

* The patient has any contraindications to exercise,
* Previous spine surgery,
* Having a curvature of thoracic apex 6 or more,
* Having any mental problems,
* Scoliosis is not idiopathic but has occurred for different reasons (neurological, congenital, etc.),
* Presence of neurological, psychiatric, muscular, rheumatic or orthopedic diseases.
Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis

This study will assess the efficacy, safety and tolerability of BYM338 in patients with sporadic Inclusion Body Myositis


Eligibility Criteria:
Inclusion Criteria:

- Males and Females aged 40-80 with a confirmed diagnosis of sporadic Inclusion Body Myositis

Exclusion Criteria:

* Unable to walk at least 3 meters without assistance from another person
* Use of oral beta agonists, oral corticosteroids, androgens or androgen inhibitors, or intravenous gamma globulin in the last 6 months
* patients with a history or presence of renal impairment and/or liver disease

Other protocol-defined inclusion/exclusion criteria may apply
Effect of Early Prosthetic Fitting in Patients With Below-knee Amputation

A randomized control trial of 50 patients to identify the effect of early prosthetic fitting and physical rehabilitation. Previous studies show a significant impact of early induction of prosthetic rehabilitation of amputation. Delayed rehabilitation may cause severe physical complications like joint contracture, and muscle strength loss.

Along with physical complications delays in rehabilitation may also significantly affect psychological, economic, and quality of daily life. Pakistan is a low-income developed country and the major cause of amputation here is traumatic amputation, which affects mostly younger age people. After missing a precious body part if the amputee comes along with such kind of physical and Psychological complications, his/her whole daily life will be affected. There is a keen need for the implementation of global rules for physical rehabilitation of amputees and disabled including the duration of induction of prosthetics as well as overall physical rehabilitation after surgical and traumatic removal of limbs.

Eligibility Criteria:
Inclusion Criteria:

* Male and female below-knee amputees due to trauma and diabetes were included

Exclusion Criteria:

* patients with comorbidities and old users of prostheses were excluded
Italian Multicenter Observational Registry on Takostubo Syndrome

Takotsubo syndrome (TTS) has recently been described as an acquired form of cardiomyopathy whose pathophysiology is not yet well understood and mainly affects postmenopausal women. TTS or "broken heart" syndrome was first described in Japan in 1991. The Japanese term "tako-tsubo" means "polyp vessel" and describes the morphology of the left ventricular apex during systole in patients with this condition. The onset usually follows physical or emotional stress and mimics that of acute coronary syndrome (ACS) with a parade of symptoms, including chest pain, dyspnea, syncope, and nausea. Objective examination is often normal or otherwise nonspecific. ECG may document ST-T changes while echocardiogram shows areas of altered ventricular kinetics. Serum cardiac biomarkers may be increased. Currently, the gold standard method for the diagnosis of TTS is coronarography, which documents epicardial coronary arteries that are normal or free of critical lesions.

It is estimated that more than 2.5% of patients with a suspected diagnosis of ACS have TTS, and this number is probably underestimated. Although the prognosis of TTS is generally considered favorable, during the acute phase these patients can develop potentially fatal complications such as ventricular arrhythmias, cardiogenic shock, and heart rupture. Moreover, emerging scientific evidence sheds light on the need to adopt a dedicated diagnostic-therapeutic pathway for this type of patients.

The exact pathophysiology of TTS is still unknown and no large population studies or registries are currently available. Therefore, the purpose of the study is to better characterize the profile of this disease through the creation of a large registry.


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with TTS in accordance with the InterTAK Diagnostic Criteria.

Exclusion Criteria:

* Age less than 18 years
* Myocarditis
* Acute coronary syndrome
* Myocardial infarction with non obstructive coronary arteries (MINOCA)
Deep Brain Stimulation for Traumatic Brain Injury

The study will evaluate the benefit of Deep Brain Stimulation for subjects with severe disability due to Traumatic Brain Injury.

The study will evaluate the benefit of Deep Brain Stimulation for subjects with severe disability due to Traumatic Brain Injury. DBS has been proven safe and efficacious for remediation of multiple neurological conditions. It is the hope of the study team that the protocol will provide further insight into the potential of DBS to improve the quality of life and functioning of persons with severe disability due to TBI and at the same time can provide new clinical insights that will improve treatment for the entire spectrum of injury severity.

Eligibility Criteria:
Inclusion Criteria:

* 24 months post traumatic brain injury Scores in Severe range of the Glasgow Outcome Scale-Extended Evidence of impaired cognitive functioning Medically and neurologically stable

Exclusion Criteria:

* Medical contraindications for surgery Evidence of substance abuse in the last 12 months Current Diagnosis of major depressive disorder current participation in rehabilitation services Co-morbid conditions that would interfere with study activities
Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability

Investigation of the prevalence etiology and therapy of micturition disorders of children with a mental and/or motoric disability

Overview of the problem by a questionnaire, diary of micturition and drinking behaviour, filled out by the parents or by the staff of the institution.

Investigation of the etiology by clinical and functional examination (uroflowmetry, bladder scan, video-urodynamic examination).

Frequency:

* Uroflowmetry: two periods of two weeks, with 6 weeks break between both periods. During the follow-up period every 3 months during 12 months
* Bladder scan: once during the periods of the uroflowmetry
* Video-urodynamic examination: once in selected participants, after consent of the parents
* Adaptation of the drinking behaviour: start after two weeks of observation, after uroflowmetry and bladder scan. Continuous proces.
* Therapeutic measures (medication, miction clock): start after 10 weeks of observation or after video-urodynamic examination.

Development of a therapeutic plan: adaptation of the micturition and drinking behaviour, anticholinergic therapy.

Eligibility Criteria:
Inclusion Criteria:

* Children with a motoric and/or mental disability
* 4-14 years

Exclusion Criteria:

* Known neurogenic bladder disorder
68Ga-PSMA PET/CT Imaging in Assessment of Prostate Cancer

Dual-time point 68Ga-PSMA PET/CT could increase the lesion detection in PCa patients, it remains difficult to perform in clinical practice. The possibility of one-time point 68Ga-PSMA PET/CT imaging could be achieved using a total-body PET/CT.


Eligibility Criteria:
Inclusion Criteria:

* primary staging of pathology-confirmed PCa or evidence of BCR with PSA value \> 0.2 ng/ml
* positive 68Ga-PSMA findings
* both standard and delayed scans were performed on the total-body PET/CT

Exclusion Criteria:

* only one scan was performed
* negative PSMA results
Managing Non-acute Low Back Symptoms in Occupational Health: Two Trials

The purpose of this study is:

* Epidemiological part: characteristics of low back pain patients from a forestry company in Finland. Data is collected from occupational health databases and self administered questionnaires.
* Intervention: To determine the effectiveness and cost-effectiveness of several different interventions in subacute low back pain (LBP) patients in occupational health (OH).

Eligible subjects were divided into two randomised controlled trials with the name of "mild" or "moderate" low back pain trials (interventions) and also mild vs natural course (NC) and moderate vs. NC interventions.

Pain, disability and quality of life were collected up to 2 years by self-administered questionnaires and sickness absences were gathered from electronical records for at least 4 year's follow up time.

Eligibility Criteria:
Inclusion Criteria:

* age 18-56 years
* present employment at the company
* at least one criteria out the following qualified for the study:

  * nonspecific LBP with the duration of 2 weeks or more
  * radiating, present low back pain
  * recurrent LBP (2 or more episodes per year)
  * work absence because of LBP
* included subjects also responded having low back pain during preceding week prior to the questionnaire (VAS ≥ 10 mm, Visual Analogue Scale 0-100 mm)

According to pain level, patients were later divided into two separate RCT's, "mild": VAS 10mm - 34mm, "moderate": VAS 35mm or more.

Exclusion Criteria:

* retirement
* acute nerve root compression symptoms
* malignant tumor
* recent fracture
* severe osteoporosis
* other specific disease preventing participation in the follow-up
PFx Closure System in Subjects With Cryptogenic Stroke,Transient Ischemic Attack,Migraine or Decompression Illness(PFO)

The primary objective of this study is to demonstrate the safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.

Patent Foramen Ovale has been implicated in the etiology of paradoxical embolism, cryptogenic stroke, transient ischemic attack, and right to left gas embolism in severe decompression illness. An association between patent foramen ovale and severe migraine headaches has also been reported. Several implantable devices are being used for percutaneous closure of patent foramen ovale; this study uses a non-implantable system to safely effect closure with the application of radiofrequency energy.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years old
* Documented PFO
* Subjects with one or more of the following:cryptogenic stroke, transient ischemic attack, embolism, migraine headaches, decompression illness

Exclusion Criteria:

• Inappropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.
Effectiveness and Implementation of a Mental Health Intervention for ASD

The purpose of this study is to test the effectiveness of training community mental health therapists to deliver a mental health intervention for ASD ("AIM HI") and study the process of implementing AIM HI in community mental health programs.

This study is a randomized controlled effectiveness trial of AIM HI ("An Individualized Mental Health Intervention for ASD"), an intervention designed specifically for implementation in community mental health clinics, to reduce problem behavior among school-age children with autism spectrum disorders (ASD). Although the individual components of AIM HI are well-established evidence-based practice strategies and pilot study data indicate that child behavior problems decrease when their community mental health therapists deliver AIM HI, the effectiveness of the protocol has not been established. Therefore, the primary aims are to test the impact of training community therapists in AIM HI on child and family outcomes and determine how child/ family characteristics and level of therapist fidelity moderate treatment effects. The secondary aim is to collect initial data on implementation outcomes and conduct exploratory analyses to identify barriers and facilitators of AIM HI implementation (e.g., intervention, organization, provider characteristics). This study has the potential to make a significant impact by building local capacity to serve school-age children with ASD in routine service settings, and advancing the science on the effectiveness of packaging evidence-based practices (EBPs) for specific services settings. It will also produce generalizable knowledge about implementation that can be applied for this population/ setting.

Eligibility Criteria:
Inclusion Criteria for Therapists

1. Employed as staff or a trainee at participating clinic (publicly-funded mental health program)
2. Employed for at least the next 7 months (i.e., practicum or internship not ending in next 7 months).
3. Has an eligible client on current caseload (see below).

Inclusion Criteria for Child/ Parent Participants

1. Child age 5-13 years.
2. Has a current ASD diagnosis on record.
3. Meets criteria for ASD on the Autism Diagnostic Observation Schedule (ADOS) or exhibits other clinical indicators of ASD
4. English or Spanish speaking.

Exclusion Criteria for Child/ Parent Participants

1. Child does not present with challenging behaviors.
2. Child does not meet criteria for ASD on the ADOS or exhibit other clinical indicators of ASD
Progressive Resistance Exercise in Rheumatoid Arthritis

A randomized controlled trial with rheumatoid arthritis patients will be realized. Patients will be randomized into two groups. Experimental group will do a 12 weeks training of progressive resistance exercise for global muscles and remain with the clinical treatment and the control only remain with the clinical treatment. Patients will be evaluated at baseline, after 6, 12 and 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis according to American College of Rheumatology 2010
* Both genders
* Age between 18 and 65 years
* Functional class I, II and III
* Stable medication within the three months preceding the study
* Haven't done any kind of regular exercise (two or more times per Week) for at least three months before study start
* Have agreed to participate in the study and signed an informed consent form.

Exclusion Criteria:

* Participating in another type of study
* Have difficulty understanding the evaluation tools with fibromyalgia
* Joint deformities that make impossible do the exercises
* Other musculoskeletal diseases
* Other diseases that contraindicate exercises.
Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke

The purpose of the study is to explore the feasibility of using a wearable device, called a myoelectric-computer interface (MCI), to improve arm movement in people who have had a stroke.

Impaired arm movement after stroke is caused not just by weakness, but also by impaired coordination between joints due to abnormal co-activation of muscles. These abnormal co-activation patterns are thought to be due to abnormal movement planning.The MCI aims to reduce abnormal co-activation by providing feedback about individual muscle activations.

This randomized, controlled, blinded study will test the home use of an MCI in chronic and acute stroke survivors.


Eligibility Criteria:
Inclusion Criteria:

Chronic stroke participants

* Hemiparesis from first ever stroke at least 6 months prior to screening
* Severe motor impairment (FMA of 7-30)
* At least some voluntary shoulder and elbow muscle activation.

Acute stroke participants

* Hemiparesis from first ever stroke within the past 21 days
* Severe motor impairment (FMA of 3-20), or total Manual Motor Score of 1-8 combined in Shoulder Abduction and Finger Extensors

Exclusion Criteria:

* Cognitive impairment with at least moderately impaired attention, or unable to follow instructions of the MCI task
* Visual impairment (such as hemianopia) preventing full view of the screen
* Anesthesia or neglect in the affected arm, or visual hemineglect (score of 2 on the NIH Stroke Scale Extinction and Inattention subtest).
* Participation in another study on the affected arm within 6 weeks of enrollment or any pharmacological study
* Inability to understand or follow commands in English due to aphasia or other reason
* Diffuse or multifocal infarcts
* Substantial arm pain preventing participation for 90 minutes a day
* New spasticity treatment (pharmacological or Botox)