cyrilzakka/clinical-trials huggingface dataset:
Personalized Education and Genetic Counseling to Increase Genetic Testing in Patients With a Known Family History of Pancreatic Cancer

This clinical trial studies whether personalized education and genetic counseling increases genetic testing in patients with a known family history of pancreatic cancer. Approximately 10% of pancreatic cancer cases are genetically linked and therefore, if a gene is found that could put a patient at risk, it could guide the patient to obtain more frequent screening for pancreatic cancer and possibly detect it earlier when it is more treatable. The current National Comprehensive Cancer Network (NCCN) guidelines suggest patients with a first-degree relative (parent, sibling, child) with pancreatic cancer be referred for a genetics consultation to discuss genetic testing if the affected family member cannot be tested. Personalized education is based on the patient's family history of pancreatic cancer and offers information regarding the current NCCN guidelines. This may be an effective method to increase patients' understanding of their pancreatic cancer risk and the NCCN guidelines. Genetic counseling is provided by an expert in hereditary disorders. The patient's family and personal medical history may be discussed, and counseling may lead to genetic testing. Personalized education and genetic counseling may increase genetic testing in patients with a known family history of pancreatic cancer.

PRIMARY OBJECTIVES:

I. Perform Housing-Based Socioeconomic Status (HOUSES) index analysis on 500 patients with a first-degree relative diagnosed with pancreatic cancer to see if there is a correlation with the National Comprehensive Cancer Network (NCCN) criteria.

II. Offer 40 patients who did not have appropriate NCCN intervention the opportunity to have a genetic consultation (to consider genetic testing).

III. Survey patients on their knowledge and experiences of genetic testing based on family history and their decision-making when offered genetic counseling and testing.

OUTLINE:

Patients receive a personalized message through the Mayo portal (EPIC) with education on the NCCN guidelines for genetic counseling and an offer for standard of care (SOC) genetic counseling. Patients then receive pre-genetic test counseling on study. Patients may then optionally undergo SOC genetic testing and collection of blood or saliva samples as well as receive post-genetic test counseling on study.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-75 years of age
* First-degree relative with pancreatic cancer listed in the EPIC family history tool
* Active patient at Mayo Clinic Florida (MCF) (visits within 1/1/2023-12/31/2023 to Family Medicine and/or Gastroenterology and Hepatology)

Exclusion Criteria:

* Patients not meeting the inclusion criteria as defined above
* Patients with an active or past history of pancreatic cancer
* Patients who are pregnant or breastfeeding
A Placebo Controlled, Double Blind, Randomised, 8-week Phase IIa Proof of Concept Study to Assess the Efficacy and Safety of AKR 202 in Patients With Osteoarthritis Pain

This proof of concept study will be a placebo controlled, randomised, double blind, parallel study. The purpose of the study is to determine efficacy for AKR 202 in the treatment of osteoarthritis (OA) pain in the knee.


Eligibility Criteria:
Inclusion Criteria:

Patient is between 40 and 75 years of age with a clinical diagnosis of OA of the knee for more than 6 months prior to Visit 1 based on clinical and radiographic criteria, and being of American Rheumatism Association (ARA) functional Class I, II, or III. Patients should have an average pain level of between 4 and 8 on a Numeric Rating Scale (NRS) for at least 5 of 7 days before the randomisation, when answering the question: Please, rate the average pain in your index knee during the last 24 hours. Prior to the study, patients should have been using pharmacological treatments, such as Non-Steroidal Anti-Inflammatory Drug (NSAIDs), acetaminophen or weak opioids for their OA pain on a regular basis (defined as having used NSAIDs, acetaminophen or weak opioids at least 10 days out of 30 days during the last month prior to the screening visit).

Exclusion Criteria:

Patient has a concurrent medical/arthritic disease that could confound or interfere with evaluation of efficacy.

Patients with impaired renal function, defined as an estimated creatinine clearance less than or equal to 50 ml/min, or patients taking medications that might impair renal function.

Patient has New York Heart Association (NYHA) Class III-IV congestive heart failure.

The patient has a history of uncontrolled hypertension or a current blood pressure that in the opinion of the Investigator makes the patient unsuitable for the study.

Patients with a trauma or surgery at the index knee within 3 months prior to screening.
Cluster Headache Treatment Survey

The objective of this study is to survey patients with cluster headache about treatment effectiveness and their views on treatments. Participants will complete one brief questionnaire online.


Eligibility Criteria:
Inclusion Criteria:

* Patients with episodic or chronic cluster headache that has been diagnosed by a health care professional (no documentation is needed, participant must simply state that he or she has been diagnosed)

Exclusion Criteria:

* Unable to speak English (the survey is only in English)
* Unable to use a computer to take the online survey
* Unable to provide consent
Vitamin B12 and Dextrose for Median Nerve Hydrodissection

Carpal tunnel syndrome is the most common peripheral entrapment neuropathy of the upper limb. Previous experiments found that ultrasound-guided median nerve hydrodissection with 5% dextrose water could ameliorate the condition of carpal tunnel syndrome. Oral administration of vitamin B 12 had been reported to reduce the discomfort from peripheral neuropathy although the level of evidence is not strong. This prospective, double-blind randomized control trial aims to compare the effects of different kinds of the injection agents on carpal tunnel syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20-80 year-old.
* Diagnosis (carpal tunnel syndrome) was confirmed using an electrophysiological study.

Exclusion Criteria:

* Previously undergone wrist surgery or steroid injection for CTS
* Thrombocytopenia
* Coagulopathy
* Inflammation status
* Polyneuropathy
* Brachial plexopathy
* Cervical radiculopathy
* Autoimmune disease
* Malignancy
* Pregnancy

Thoracic outlet syndrome
Drug Interaction Between Paracetamol and Warfarin

The objective of this study is to investigate whether paracetamol, given at therapeutic doses (2g/day and 3 g/day), may potentiate the anticoagulant effect of warfarin.

Paracetamol is recommended as a first-line analgesic and antipyretic therapy in patients receiving short- and long-term oral anticoagulation, especially elderly patient.However,Increased INR was previously observed in patients treated with warfarin and paracetamol given at the maximum recommended dose (4g/day).

To date, the mechanism of this interaction has not been determined.A recent in vitro study suggested that the toxic metabolite N-acetyl-para-benzoquinoneimine (NAPQI) appeared to interfere with vitamin K-dependent γ-carboxylase (VKD-carb) and vitamin K epoxide reductase (VKOR) activites12. The question remaining to be dealt with is whether this in vitro observation can explain the in vivo paracetamol-warfarin interaction. We aim to evaluate the effect of paracetamol at the most widely used doses 2 and 3g/day on INR in stable patients treated with warfarin in a double blind randomized placebo-controlled trial and to identify the mechanism involved in this interaction in vivo.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with warfarin (target INR 2 to 3) stable anticoagulation at 2 to 9 mg for more than 30 days
* Aged 18 years or older
* Laboratory values (hemoglobin, blood cell counts, albumin, blood ionogram, complementary hemostasis parameters and aspartate, alanine transaminases (AST and ALT))remained within normal limits

Exclusion Criteria:

* Any treatment change within 7 days before enrollment
* Any paracetamol intake within the last 14 days
* Drug allergy Concomitant drug ( 5-fluorouracile, acetylsalicylic acid, non steroidal anti-inflammatory drugs, chloramphenicol, diflunisal, miconazole)
* St John's wort treatment
* Pregnancy
A Study to Investigate the Food Effect on the Pharmacokinetics of CM082 Tablet in Chinese Healthy Volunteers

The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of CM082 tablet.

The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of CM082 tablet in Chinese Healthy Volunteers. In addition, the safety of CM082 tablet in Chinese Healthy Volunteers who with High-fat meal or fasting state will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* age: 18 - 45 years;
* sex: male and female;
* body weight: Male ≥ 50 kg,female ≥ 45 kg, body mass index BMI (weight (kg)/height 2 (m2)) between 19-26 kg/m2 (including border);
* Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and all lab tests;
* Abstinence or physical contraception approved by researchers must be approved during and within three months after the trial is completed; and no sperm and egg donation plan is available；
* Written informed consent;

Exclusion Criteria:

* Received any investigational drugs within 14 days before the screening test;
* Donated 200 mL of whole blood within 30 days before the screening test,or donated 200 mL of whole blood during the study or within 30 days after completion of the study;
* Females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period;
* History of drug or food allergies;
* Abnormal blood pressure or pulse，Abnormal laboratory tests;
* Participated in other clinical trials within 3 months before screening;
* Smoking and drinking within 3 months before screening or test results of smoke, alcohol, and drug abuse are positive;
* Positive for HBsAg, Hepatitis C virus (HCV) antibody, HIV antibody or syphilis antibody;
* Clinically apparent disease/infection within 1 month before screening;
* The researchers determined that there were other conditions that were not suitable for the trial;
Prevention of Oral Mucositis in Head and Neck Cancer.

Oral Mucositis (OM) consists in the painful inflammation and ulceration of the mucous membranes lining the digestive tract, lasting between 7 and 98 days; and starts as an acute inflammation of oral mucosa, tongue, and pharynx after RT exposure.

Gel X spray is a product based on zinc gluconate. It could be helpful to achieve the prevention of Oral Mucositis and, in case of OM manifestation, the reduction of oral pain symptoms and to accelerate the healing process of oral mucositis ulcerations.

The aim of this study is to demonstrate the efficacy of the treatment with Gel X to reduce the incidence of oral mucositis, in comparison with Sodium Bicarbonate.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of the following HNC: oral cavity, pharynx, unknown primary, salivary glands, undergoing local radiotherapy for curative purpose
* Patients with diagnosis of HNC: oral cavity, pharynx, unknown primary, salivary glands, undergoing local radiotherapy as an adjuvant to surgical resection
* Patients able self-apply the product.

Exclusion Criteria:

* Patients with documented contraindication to any of the components of "Gel X" (there included eccipients): water, saccharin sodium, PVP, Taurine, Zinc Gluconate, PEG-40, Hydrogenated castor oil, Pullulan, Flavors
* Patients with any neurological and psychiatric condition having an influence on the ability to self-apply the treatment
* Patients participating to other clinical studies
SurgiQuest AirSeal in Robotic Partial Nephrectomy - (TARPAN Study)

A MULTI-CENTER, PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY TO EVALUATE PHYSICIAN PREFERENCE RELATED TO THE USE OF THE SURGIQUEST AIRSEAL INSUFFLATION SYSTEM (AIS) VS. CONVENTIONAL INSUFFLATION SYSTEMS (CIS) FOR THE MANAGEMENT OF PNEUMOPERITONEUM DURING ROBOTIC PARTIAL NEPHRECTOMY

A prospective, randomized, controlled multi-center clinical Study designed to evaluate Physician Preference related to the use of the SurgiQuest AirSealTM Insufflation System (AIS) vs. Conventional Insufflation Systems (CIS) for the Management of pneumoperitoneum during Robotic Partial Nephrectomy. Subjects will be randomized in a 1:1:1 treatment device to control ratio into one of three (3) different study arms: 1) AIS @ 12mmHg pressure, 2) AIS @ 15mmHg pressure, and 3) CIS @ 15mmHg pressure. 189 randomized subjects distributed in three arms of 63 patients. The three study sites are targeted to enroll 63 patients each, 21 patients in each of the three (3) study arms. It is expected that this will take up to 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. 18 to 80 years of age;
2. Capable and willing to give informed consent;
3. Acceptable candidate for an elective, non-emergent robotic partial nephrectomy;

Exclusion Criteria:

Subjects will be excluded from participating in this Study if they meet any of the following criteria prior to initiation of the endoscopic procedure 1.Advanced refusal of blood transfusion, if necessary; 2.Active systemic or cutaneous infection or inflammation; 3 Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids; 4.Uncontrolled diabetes mellitus 5.Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count \< 100,000 cells/mm3, baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours); 6.Severe co-existing morbidities having a life expectancy of less than 30 days; 7.Currently involved in any other investigational clinical Studies; 8.Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%; 9.Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating; 10.Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2); 11. Patients presenting with Ascites

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Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic Hepatitis C Virus (HCV) Genotype 3 (GT3) Infection (MK-5172-083)

This is a randomized, multi-site, open-label trial of the co-administration of a fixed-dose combination (FDC) of EBR 50 mg + GZR (100 mg) (EBR/GZR) and SOF 400 mg, with and without RBV, in treatment-naïve (TN) and treatment-experienced (TE) participants with chronic HCV GT3 infection with compensated cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* has HCV RNA (\>= 10,000 IU/mL in peripheral blood) at screening
* has documented HCV GT3 (with no evidence of non-typeable or mixed GT infection)
* has compensated cirrhosis of the liver
* has liver imaging within 6 months of Day 1 with no evidence of hepatocellular carcinoma (HCC)
* is either HCV TN or TE (i.e., has documented prior virologic failure or intolerance to peg-interferon/ribavirin)
* is otherwise healthy as determined by medical history, physical examination, electrocardiogram (ECG), and clinical laboratory measurements
* has compensated cirrhosis of the liver
* is TN or TE (i.e., documented prior virologic failure or intolerance to peg-interferon/ribavirin)
* is not of reproductive potential, or agrees to not impregnate a partner or become pregnant for at least 2 weeks prior to the first dose of study drug, and for 7 months after the final dose of study drug (or longer if dictated by local regulations)

Exclusion Criteria:

* has previously received one or more doses of a direct-acting antiviral (DAA)
* has evidence of decompensated liver disease
* is coinfected with hepatitis B (hepatitis B surface antigen \[HBsAg\] positive)
* has a recent (within 5 years) history of malignancy or is under evaluation for HCC or other suspected malignancy
* is currently or has participated (within past 30 days) in a study with an investigational compound
* has clinically-relevant drug or alcohol abuse within the past 12 months of screening
* is a female and is pregnant or breast-feeding
* is a male whose female partner is/are pregnant
* has any of the following:
* organ transplants
* poor venous access
* history of gastric surgery or malabsorption disorder
* current or history of clinically significant cardiac abnormalities or dysfunction
* chronic pulmonary disease
* hemoglobinopathy
* history of hospitalization within 3 months prior to enrollment
* medical or surgical condition that may result in need for hospitalization during the course of the study
* any condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or other immunosuppresant drugs during the course of the study
* any condition, prestudy laboratory or ECG abnormality, or history of any illness, which could confound results of the study or pose additional risks in administering study drugs in the opinion of the investigator
* has a life-threatening serious AE (SAE) during the screening period
* has evidence of history of chronic hepatitis not caused by HCV
Inofolic NRT and the Metabolic Syndrome

A prospective, randomized, controlled, open-label study will be carried out on 80 post-menopausal women affected by the metabolic syndrome (criteria are described in NIH ATP III). After a written informed consent, women will be randomly treated for 6 months with hypocaloric diet (control group) or with diet and a supplementation of myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg. will be given randomly Eighty post-menopausal women, affected by metabolic syndrome will be randomized into two groups: 40 treated with myo-inositol 2 g twice per day and forty treated with placebo for six months. The investigators hypothesize that the administration of myo-inositol would improve the insulin-receptor activity in these women, reducing insulin resistance.

Inclusion Criteria: post-menopausal women (12 months after last menstruation) affected by metabolic syndrome according to ATP III, 2001.

At least 3 of following 5 criteria must be present:

1. waist circumference \> 88 cm
2. Triglycerides \> 150 mg/dl
3. HDL-cholesterol \< 50 mg/dl
4. Fast glycemia \> 110 mg/dl
5. Systolic blood pressure \> 135 mmHg. diastolic \> 85 mmHg -

Exclusion Criteria:1) post-menopausal women with less than 12 months from the last menstruation 2) less than 3 criteria according with ATP III 3) TSH \> 3.5 4) in treatment with drugs lowering glycemia or cholesterol 5) allergy to cocoa

Eligibility Criteria:
Inclusion Criteria: post-menopausal women (12 months after last menstruation) affected by metabolic syndrome according to ATP III, 2001.

At least 3 of following 5 criteria must be present:

1. waist circumference \> 88 cm
2. Triglycerides \> 150 mg/dl
3. HDL-cholesterol \< 50 mg/dl
4. Fast glycemia \> 110 mg/dl
5. Systolic blood pressure \> 135 mmHg. diastolic \> 85 mmHg -

Exclusion Criteria:

1. post-menopausal women with less than 12 months from the last menstruation
2. less than 3 criteria according with ATP III
3. TSH \> 3.5
4. in treatment with drugs lowering glycemia or cholesterol
5. allergy to cocoa
XP13512 (GSK1838262) Versus Placebo in Patients With Restless Legs Syndrome.

The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary RLS, based on the International RLS Study Group Diagnostic Criteria.
* History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started;
* Documented RLS symptoms for at least 4 of the 7 consecutive evenings/nights during the Baseline study period;
* Total RLS severity score of 15 or greater on the International Restless Legs Syndrome Study Group Rating Scale (IRLS rating scale) at Visit 1 and at Visit 2;
* Discontinuation of dopamine agonists and/or gabapentin at least 2 weeks prior to Baseline;
* Discontinuation of other treatments for RLS (e.g., opioids, benzodiazepines) at least 2 weeks prior to Baseline;
* If female of child-bearing potential, the subject must agree to use clinically accepted birth control through completion of the study;
* Body Mass Index of 34 or below;
* Estimated creatinine clearance of at least 60 mL/min;

Exclusion Criteria:

* A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS;
* Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias, and dystonias);
* Abnormal laboratory results, electrocardiogram (ECG) or physical findings;
* Pregnant or lactating women;
* Women of childbearing potential who are not practicing an acceptable method of birth control.
Non-invasive Preoperative Tissue Evaluation in Head and Neck Tumor Patients Using Multispectral Optoacoustic Tomography (MSOT)

Multispectral Optoacoustic Tomography (MSOT) is a promising imaging technology that utilizes pulsed laser light. One of the key capabilities of this technology is measuring oxygenation within human tissue. This proposed study aims to investigate possible limitations of human tissue used for reconstructive surgery due to flawed tissue perfusion.

Healthy volunteers as well as patients with a diagnosed head and neck cancer entity will be recruited. Both cohorts will then be scanned on different body areas (most common tissue sites used for reconstructive surgery on the back, arms and legs) to assess differences in muscle oxygenation between the healthy and tumor patient cohort using MSOT.

The hypothesis of the study is, that patients with diagnosed head and neck cancer entities are prone to compromised tissue perfusion due to a high prevalence of smoking within the head neck tumor patient cohort and therefore perfusion restirciting diseases e.g. peripheral arterial occlusive disease (PAOD).


Eligibility Criteria:
Inclusion Criteria:

* Cohort 1: Histopathological diagnosed head and neck tumor patients.
* Cohort 2: Healthy adults.

Exclusion Criteria:

* Pregnancy / breastfeeding
* ink / tattoo in the areas of interest (upper back, distal forearm, upper and lower leg)
* missing consent form
* Cohort 2: Chronical abuse of alcohol and nicotine.
Interdental Guided Creeping Technique

The aim of this randomized clinical trial is to treat interdental papillary deficiency with minimally invasive interdental guided creeping technique (IGCT) comparing collagen membrane versus connective tissue graft.


Eligibility Criteria:
Inclusion Criteria:

* Healthy patients having interdental papilla deficiency.
* Good Oral Hygiene.
* Age range: 18 - 50 years.

Exclusion Criteria:

* Pregnancy or lactation.
* Smokers.
* Alcoholic patients and drug abusers.
* Handicapped and prisoners.