cyrilzakka/clinical-trials huggingface dataset:
THE GIRAFFE Study: Genomic Risk Markers for Atrial Fibrillation Following Extended Cardiac Rhythm Monitoring

Our primary hypothesis is that a risk score comprised of approximately 10 single nucleotide polymorphisms (SNPs) that are associated with atrial fibrillation at the Genome Wide Association Study (GWAS) level is associated with the development of atrial fibrillation among previously undiagnosed patients at high risk for atrial fibrillation. A current example of these SNPs is shown in Table 1. As a secondary hypothesis, we will test the association between atrial fibrillation diagnosed in this study with a subset of SNPs reported to be associated with atrial fibrillation and with fine-mapping SNPs. We will also test the association between atrial fibrillation of less than and greater than 30 seconds and a panel of approximately 10 SNPs.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of high clinical suspicion for atrial fibrillation prompting referral for ambulatory cardiac rhythm monitoring for potential atrial fibrillation.

AND

* At high risk for atrial fibrillation, defined as any one of the following: ischemic stroke with no defined etiology (In prior 6 months) \[3, 4, 6, 7\], hypertension \[33\], increased body mass index (BMI \>30kg/m2) \[33\], heart failure \[33\], clinically significant murmur \[33\], prolonged PR interval on resting ECG \[33\], chronic kidney disease \[34\], hypertrophic cardiomyopathy \[35\], congenital heart disease \[36\], chronic obstructive pulmonary disease \[37, 38\], sleep apnea \[39-41\], thyroid disease \[42, 43\], family history of atrial fibrillation \[44\], diabetes \[45\] or excess alcohol consumption (Male \> 14 drinks/week, Female \>7 drinks/week)\[46\].
* Age 40 years or older
* Capable of providing informed consent
* Capable of wearing a Zio Patch for up to 14 days
* Capable of providing a blood sample

Exclusion Criteria:

* Previously documented atrial fibrillation or atrial flutter.
* Prior cardiac surgery (coronary artery bypass grafting, valve replacement or repair, pericardial stripping, etc) within the past 30 days.
* Hyperthyroidism.
* Have known skin allergies, conditions, or sensitivities (e.g. allergy to adhesives, psoriasis) as the Zio Patch should not be used on patients with known skin allergies, conditions, or sensitivities.
* Are receiving pacing therapy.
* Are anticipated to receive or require external cardiac defibrillation during the monitoring period.
* Are anticipated to have exposure to high frequency surgical equipment during the monitoring period.
Preventive Anti-inflammatory Diet to Reduce Gastro-intestinal Inflammation in FAP Patients: a Prospective Pilot Study

Preventive anti-inflammatory diet to reduce gastro-intestinal inflammation in FAP patients: a prospective pilot study

a prospective pilot study

Eligibility Criteria:
Inclusion Criteria:

- FAP patients carrying mutations in APC gene, submitted to prophylactic total colectomy/IRA (with rectum preservation) and that participate to the regular endoscopic surveillance program at IRCCS-INT.

Exclusion Criteria:

* FAP patients taking NSAIDs and/or Omega 3
* Patients who carried MUTYH germline mutations or had no APC mutation found.
TRANSPARK_LONG: The Diagnostic Value of Early Transcranial Ultrasound in Patients With Extrapyramidal Diseases in a Swedish Population

Popular science summary of the project The purpose of the study is to investigate in a Swedish population how well the investigators' previous ultrasound findings match the final diagnosis (PD, APS or ET) after a particularly long follow-up time, which greatly increases the certainty that the diagnosis does not change more and is thus correct. Furthermore, the investigators want to study whether the initial ultrasound findings have changed during the control interval and whether measurement results regarding the diameter in one of the fluid-filled rooms in the brain (third ventricle) can be correlated with the development of cognitive impairment or dementia later in the course of the disease. For this, this study have got ethical permission to go into the patients' medical records and to call a subgroup back to the clinic to be able to do a new examination and a memory test.


Eligibility Criteria:
Inclusion Criteria:

* Patients with parkinsonism or essential tremor who came into contact with our clinic before 2017
* Satisfactory transcranial bone window
* Previous TU (clinical indication)

Exclusion Criteria:

* No transcranial bone window
Guided Self-Help Treatment for Binge Eating Disorder

This study will determine the effectiveness of guided self-help treatment in treating individuals with binge eating disorder (BED).

Binge eating disorder (BED) is a serious condition characterized by compulsive overeating and feelings of powerlessness. The condition often has a negative impact on both physical and emotional health. This study will examine ways to help people determine whether they have BED and will test whether guided self-help (GSH) treatment is effective in treating BED.

Participants will be randomly assigned to receive either GSH treatment or usual clinical care (which may include general support and talk therapy) for 3 months. The GSH treatment is a cognitive behavioral therapy-based program that will be administered over 8 sessions. Participants receiving GSH will be given a book that focuses on dealing with BED; they will also meet with a therapist regularly to have their progress monitored. The Eating Disorders Examination (EDE), self-reports, questionnaires, and surveys will be used to assess participants. Assessments will be conducted at study entry, at Weeks 2 and 4 of the treatment, at the end of the treatment, and at 6 and 12 months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of binge eating disorder (BED) bulimia nervosa (BN), or spectrum BN, defined as recurrent binge eating at least once a week for 3 months
* Body mass index (BMI) between 18 and 45
* Continuous membership in the Kaiser Permanente Northwest Division for at least 12 months prior to study entry

Exclusion Criteria:

* Diagnosis of anorexia nervosa or psychotic disorder
* Significant organic brain syndromes, retardation, pervasive developmental disorder, or autism
* At risk for suicide
* Pregnancy
Clinical Efficacy and Safety Evaluation of HCP1904-3 in Essential Hypertension Patients

The purpose of this study is to evaluate of efficacy and safety of HCP1904-3 and RLD2001-1 alone in patients with essential hypertension inadequately controlled on RLD2001-1 monotherapy.

A Multi-center, Randomized, Double-blinded, Active-Controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of HCP1904-3 in Essential Hypertension patients

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 19 years of age
2. Patients who understands the process of clinical study and voluntarily signs a peer letter
3. Visit1: A person whose blood pressure measured in visit1 corresponds to the following conditions

   * Blood pressure medication taken patients: 130mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg
   * Blood pressure medication free patients: 140mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg
4. Visit2: 140mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg or if patients are in high risk group: 130mmHg ≤ sitSBP \<180mmHg, sit DBP \< 110mmHg

Exclusion Criteria:

1. Difference in mean value of blood pressure measured in both arms of more than 20mmHg in sitSBP or more than 10mmHg in sitDBP
2. Orthostatic hypotension with symptoms within 3months of visit 1
3. Secondary hypertensive patient or suspected to be
4. Uncontrolled diabetes mellitus(HbA1c \> 9%) or type I diabetes mellitus
5. Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
6. Severe heart disease or severe neurovascular disease
7. Severe or malignant retinopathy
8. Clinically significant hematological finding
9. Severe renal diseases (eGFR\<30mL/min/1.73m2)
10. Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
11. Hypokalemia or Hyperkalemia(K\<3.5mmol/L or K ≥ 5.5mmol/L)
12. Hyponatremia or Hypernatremia(Na\<135mmol/L or Na ≥ 155mmol/L)
13. Hypercalcemia
14. History of malignancy tumor
15. History of autoimmune disease
16. History of alcohol or drug abuse
17. Positive to pregnancy test, nursing mother, intention on pregnancy
18. Considered by investigator as not appropriate to participate in the clinical study with othe reason
Forearm Immobilization in T2D

The aim of the present study is to assess the impact of short-term forearm immobilization on forearm muscle glucose uptake and amino acid net balance and kinetics in individuals with T2D compared with a control group with normoglycaemia.

Participants with and without T2D will undergo 2 days of forearm immobilization as a model of local physical inactivity. Before, throughout, and after immobilization arteriovenous forearm balance measurements will be combined with a stable isotope tracer infusion to measure muscle glucose uptake and amino acid balance, uptake, and efflux.

Eligibility Criteria:
Inclusion Criteria:

* Males and females with or without diagnosed type 2 diabetes (diagnosed at least one year prior)
* Apply lifestyle changes and/or use metformin as oral glucose-lowering medication as treatment for T2D
* Aged 18-65 years at the time of signing informed consent
* 18.5 \< BMI \< 30 kg·m2

Exclusion Criteria:

Type 1 or a genetic form of diabetes

* Any diagnosed cardiovascular (heart) disease or high blood pressure (≥140 mmHg systolic and/or

  ≥90 mmHg diastolic)
* Chronic use of any prescribed or over-the-counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
* Do not consume three regular meals a day (breakfast, lunch, and dinner) and or follows a low carbohydrate diet
* Smoking or chewing tobacco
* Known anaemia
* Regular use of dietary protein and/or amino acid supplements (\>3 times per week)
* Currently involved in a structured progressive resistance training program (\>3 times per week)
* A personal or family history of thrombosis (clots), epilepsy, seizures, or schizophrenia
* Any previous motor disorders or disorders in muscle and/or lipid metabolism
* History of kidney disease
* History of liver disease
* Pregnant or breastfeeding
* History of any drug or alcohol abuse in the past two years
* Any musculoskeletal injury of the arms in the 12 months before starting the study
* Claustrophobia
* Unable to give consent
Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment

Behavioral weight loss, the current treatment of choice for moderate obesity, achieves impressive short term results, however, weight regain following treatment is a major problem. Over 50% of participants in behavioral weight loss programs report difficulty with internal antecedents to unhealthy weight control behaviors and this difficulty is associated with weight regain following treatment. Current treatment approaches do not adequately address these antecedents. The aim of this series of studies is to develop, implement, and evaluate a behavioral weight loss program modified to provide participants with skills to deal effectively with affective and cognitive difficulties. The study targets men and women with BMI of 27-40 who self-report difficulty with emotional and/or cognitive antecedents to unhealthy weight control behaviors. The study is an uncontrolled pilot study in 20 participants to initially assess acceptability and efficacy of the innovative treatment. The long-term goal of this research is to improve the weight loss maintenance outcomes of behavioral weight loss programs by addressing affective and cognitive antecedents to unhealthy weight control behaviors.


Eligibility Criteria:
Inclusion Criteria:

* Age between 21 and 70 years
* Body mass index between 27 and 40
* Score 5 or above on the internal disinhibition scale of the Eating Inventory

Exclusion Criteria:

* Are currently participating in a weight loss program and/or are taking a weight loss medication or lost greater than or equal to 5% of body weight during the past six months
* Are pregnant, lactating, less than 6 months postpartum or plan to become pregnant during the time frame of the investigation
* Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction

Rupture of a coronary artery plaque leads to thrombotic occlusion of the coronary artery and would present as ST segment elevation myocardial infarction. Early treatment with aspirin and early primary percutaneous coronary intervention are indicated. Anticoagulation therapy, usually with unfractionated heparin, is required during percutaneous coronary intervention.

Investigators hypothesis is that pretreatment with unfractionated heparin in addition to aspirin at first medical contact may facilitate spontaneous reperfusion of culprit artery and procedural thrombotic complication in patients with ST elevation myocardial infarction without significant risk of bleeding complications.

Randomization of patients with STEMI at first medical contact in a 1:1 ratio into an intervention group receiving 100 IU of unfractionated heparin (UFH) per kilogram of body weight IV and later additionally UFH after diagnostic coronary angiography according to the activated clotting time (ACT) and a control group receiving only UFH after diagnostic coronary angiography at the dose of 100 IU per kilogram of body weight.

The primary end point of the study is TIMI flow at coronary angiography. Secondary endpoints are: Bleeding complications (defined by BARC score), occurrence of cardiogenic shock, and 30-day mortality.

Investigators plan to randomize 600 patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with STEMI referred for primary PCI
* Duration of symptoms less than 6 hours before presentation

Exclusion Criteria:

* Pregnancy
* Cardiogenic shock at presentation (hemodynamic instability)
* Cardiac arrest before randomization
* Duration of symptoms for more than 6 hours before presentation
Personal Patient Profile - Prostate (P3P) II: Effectiveness-Implementation Trial in Diverse Health Care Networks

The purpose of this study is to determine whether using the P3P website can increase decisional preparation and satisfaction, and decrease decisional conflict, in men deciding how to manage early stage prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven diagnosis of prostate cancer, T1 or T2 of any risk level
* Biopsy done at enrolling site
* Upcoming appointment with consulting specialist at enrolling study site
* Able to read, write, understand English

Exclusion Criteria:

* Two or more post-biopsy specialist consults
* Begun treatment (or active surveillance)
Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers

The purpose of this study is to find out if an investigational combination drug called Lovaza (made with fish oils)+Curcumin C3 Complex (made from a root called curcumin) can help reduce the size of lung nodules. Researchers also want to find out if the combination of Lovaza+Curcumin C3 Complex is safe and tolerable.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 55 years of age or older
* Former smokers and current enrolled in LDCT lung cancer screening or those who are detected using a regular CT, and have Lung-RADS 3 category lesion(s), that would get a 6 month f/u LDCT or regular CT based on Lung-RADS recommendations or former and current smokers enrolled in LDCT lung cancer screening, or regular CT and have Lung-RADS 2 category lesions with part-solid or non-solid lung nodule ≥4mm mean diameter detected during screening LDCT or regular CT scans
* History of cigarette smoking with ≥ 20 pack years
* All current smokers should accept to receive smoking cessation
* Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 1
* Able to swallow study pills
* Able to undergo CT
* Not allergic to components of study agents
* Willing to discontinue current vitamin/mineral supplement use containing components of study agents. A standard multivitamin supplement provided for the study
* Willing to comply with proposed visit and treatment schedule
* Able to understand and willing to sign a written informed consent document
* Participants must have normal organ and marrow function
* Willing to use contraception during the intervention period of 6 months (males and females)
* Not pregnant or lactating nor planning to become pregnant or lactate during the 6 month study intervention period..

Exclusion Criteria:

* Invasive cancer diagnosis (excluding basal cell carcinoma or skin squamous cell carcinoma) diagnosed within the last 2 years
* Inability to undergo CT
* Newly diagnosed nodule meeting Lung-RADS 4 criteria
* Have taken doxycycline or tetracycline less than or equal to 2 weeks
* Females- pregnant or lactating (throughout the duration of intervention of 6 months)
* Unwilling to use effective form of birth control (Males and females) (throughout the duration of intervention of 6 months).
Repetitive Transcranial Magnetic Stimulation (rTMS) in Fibromyalgia

This study aims to evaluate the effectiveness of 10 Hz neuronavigated repetitive transcranial magnetic stimulation (rTMS) to the left dorsolateral prefrontal cortex (DLPFC) on pain, stiffness, fatigue, depression/anxiety, quality of life and cognitive functions in fibromyalgia syndrome (FMS).

This is a single-center, prospective, randomized, double-blind, sham-controlled study in two-arm parallel-group design. Twenty participants will be randomized into 2 groups. Randomization will be performed using computer-generated block randomization with 1:1 allocation between the active rTMS group (Group 1) and the sham-control group (Group 2). Group 1 will receive high frequency repetitive transcranial magnetic stimulation (10hz-HF-rTMS)-A total 14 sessions of HF-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks). Group 2 will receive sham stimulation-A total 14 sessions of sham-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks).All patients will be evaluated with pain severity (VAS-10mm),stiffness severity (VAS-10mm), Fibromyalgia Impact Questionnaire (FIQ), Fatigue Severity Scale (FSS), Hospital Depression Anxiety Scale (HADS), Addenbrook Cognitive Examination-revised version (ACE-R).Patients will be questioned for the safety of treatment. Available drug therapies will be continued in both groups. Patients and clinical raters will be blinded to treatment. All patients will be reviewed by the investigator in terms of rTMS treatment safety and motor threshold determination before each treatment session and observed for possible side effects after treatment. All side effects will be recorded. Magnetic stimulation will be applied using Neurosoft-Neuro MS/D with a figure-of-eight-shaped coil. rTMS therapy will be applied under the guide of neuronavigation with the following parameters: target-left DLPFC, with the %90 of the RMT, 10 Hz stimulation for 5 seconds intervals (on) with 25 seconds inter-train intervals (off), 15 minutes, 1500 pulses.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age between 18-65 years)
* Diagnosis of fibromyalgia syndrome according to 2016 Fibromyalgia diagnostic criteria
* The mean pain intensity is VAS ≥ 4/10
* Stable treatment for at least last 3 months
* Patients accepting participation by signing an informed consent form

Exclusion Criteria:

* To have a clinical condition to be contraindicated for TMS (metallic implant, cardiac pace, pregnancy, lactation, epilepsy, head trauma, history of cranial operation...)
* The presence of malignancy
* Systemic rheumatic diseases
* Major orthopedic / neurological problems that limit daily life activities
* Alcohol or drug addiction
* Major depression / personality disorder history
* Have received TMS treatment before
* Pregnancy or breastfeeding
A Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors

To evaluate safety and tolerability of PF-00299804 in Japanese patients with advanced malignant solid tumors at doses up to the clinically recommended phase 2 dose in non-Japanese studies.


Eligibility Criteria:
Inclusion Criteria:

* Malignant solid tumor with no currently approved treatment
* Adequate functions Bone Marrow, Renal, Liver and Cardiac

Exclusion Criteria:

* Any surgery, radiotherapy within 4 weeks of baseline disease assessments
* Clinically significant abnormalities of the cornea
* Patients with symptomatic brain/central nerve system metastases
* Any clinically significant gastrointestinal abnormalities
* Uncontrolled or significant cardiovascular disease
* Patients with significant interstitial pneumonia or pulmonary fibrosis
Observational Study of Pergolide Mesylate and Cardiac Valvulopathy

The primary objective of this study is to estimate the incidence of new-onset valvulopathy, determined by baseline and follow-up echocardiograms, in patients with Parkinson's Disease who are receiving pergolide as second-line therapy.

The secondary objective of the study is to estimate the prevalence of valvulopathy, as determined by baseline echocardiograms, among all patients who have Parkinson's Disease and are being considered for pergolide as second-line therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 and older with a diagnosis of Parkinson's Disease
* Receiving pergolide as second-line therapy as prescribed by Summary of Product Characteristics
* Willing to participate and sign a consent to release medical information
* Have had an echocardiogram within 3 months of initiation of pergolide therapy with no evidence of cardiac valvulopathy

Exclusion Criteria:

* There are no exclusion criteria for this study