cyrilzakka/clinical-trials huggingface dataset:
Continuous Glucose Monitor for Mayo Clinic Advanced Care at Home Patients

The purpose of this study is to measure differences in diabetes control with the use of continuous glucose monitor (CGM) and diabetes education compared with standard of care for glucose monitoring (glucometer checks) and diabetes education in participants with diabetes mellitus receiving therapy with insulin and being admitted to Mayo Clinic Advanced Care at Home Program (ACH).


Eligibility Criteria:
Inclusion Criteria:

* Patients who are admitted to Advanced Care at Home (ACH) Program and supposed to remain in ACH for at least 72 hours.
* Patients with previous diagnosis of DM type 1 or type 2.
* Patients taking subcutaneous (SQ) insulin either via multidose injections or SQ insulin pump.
* Capable of giving signed informed consent

Exclusion Criteria:

* Actively treated for diabetes ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS).
* Participants taking acetaminophen more than 4g per day or more than 1gm every 6 hours.
* Participants with altered mental status.
* Participants diagnosed with dementia.
* Patients with suicidal ideations or experiencing suicidal behavior.
* Patients with liver cirrhosis.
* Patients with End Stage Renal Disease on dialysis bot hemodialysis or peritoneal dialysis.
* Participants with allergy to medical grade adhesive or medical tape.
* Participants taking hydroxyurea.
* Participants who are pregnant, wanting to become pregnant, or nursing during study period.
* Patients with a planned MRI within the following 10 days after admission to ACH.
* Participants currently using continuous glucose monitor (CGM) to dose insulin or check glucose level.
* Participants with diabetes mellitus (DM) treated with diet alone.
* Participants with DM treated with oral hypoglycemic medications.
* Participants with DM treated with one SQ insulin injection daily.
* Participants enrolled in other studies addressing CGM use.
* Participants physically or emotionally incapable of handling a cell phone with a smart display.
* Participants with hearing impaired to a degree that they are not able to hear a smart phone alert or alarm.
* Patients lacking WIFI or Cellular coverage needed to connect the monitoring cell phone to Internet network.
The Effects of Low Carbohydrate Diet on Liver Fat Content and Mitochondrial Fluxes

The purpose of this study is to examine whether a low carbohydrate diet as compared to simple calorie restriction decreases hepatic lipid content and changes hepatic mitochondrial flux in humans.

In this study, the investigators will examine whether a low carbohydrate diet as compared to simple calorie restriction will change hepatic lipid content and mitochondrial flux in humans. Before and after a low carbohydrate diet and a simple calorie restriction intervention, rates of hepatic mitochondrial flux will be assessed using positional isotopomer analysis of 3-13C-lactate during a 3 hour basal period. Rates of whole body ketogenesis will be determined using \[13C4\]β-hydroxybutyrate, and whole body glucose metabolism will be measured using \[2H7\]glucose. Body composition will be determined with bioelectrical impedance; hepatic lipid content will be measured with MRS. Whole-body oxidation of lipids, carbohydrates and protein will be determined using indirect calorimetry.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70
* Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent

Exclusion Criteria:

* chronic liver disease other than NAFLD
* chronic disease associated with hepatic steatosis such as diabetes mellitus
* use of drugs known to affect hepatic steatosis
* contraindications for MRI
* pregnancy or nursing at the time of the study
Mental Health Outcomes of Earthquake Survivors in Türkiye

The primary aim of this open trial pilot study will be to test feasibility, acceptability, and potential impact of Problem Management Plus (PM+), brief, scalable psychological intervention developed by WHO, for earthquake survivors in Türkiye. Secondly, this study aims to assess trial procedures in preparation for a future studies evaluating the effectiveness of PM+ intervention with earthquake survivors.

Considering the fact that around 16% of Turkey's population is affected by the February 6 earthquakes, reaching a higher number of people on time can be achieved through the implementation of brief, scalable interventions addressing common mental health problems. This will be the first study that investigate the individual PM+ among earthquake survivors in Türkiye. Testing these interventions will provide evidence for further use in future disasters.

The study will assess changes in depression, anxiety, posttraumatic stress symptoms, psychological distress, and psychosocial functioning scores before and after the intervention. The hypothesis to be examined posits that participants will have significantly lower depression, anxiety, posttraumatic stress, psychological distress and psychosocial functioning scores at the post assessment compared to pre-assessment.

This study will be designed as a single group pre-and post-test research. The sample will be adult earthquake survivors in Türkiye. A partnership has been formed with Travma ve Afet Ruh Sağlığı Çalışmaları Derneği (TARDE), a non-governmental organization working in the earthquake-stricken regions. 30 psychologists of TARDE have been trained for PM+ for their work with people who experienced the earthquake. The outcome measures will be assessed two times: once before and once after PM+ will be conducted. After the baseline assessment, all participants will receive the consecutive 5-session on individual PM+. The PM+ intervention consists of five weekly sessions incorporating evidence-based behavioral strategies.

Eligibility Criteria:
Inclusion Criteria:

* being 18 years or above
* being experienced the earthquake
* reported elevated level of psychological distress indicated by a score of \>15 on Kessler Psychological Distress Scale
* reported impaired daily functioning indicated by a score of \>16 on World Health Organization Disability Assessment Scale

Exclusion Criteria:

* imminent suicide risk (assessed with the PM+ manual suicidal thoughts interview)
* severe mental disorders (e.g., psychotic disorders) or cognitive impairment (e.g., severe intellectual disability (assessed by the PM+ manual observation checklist)
Study Evaluating the Potential of DVS SR to Inhibit the CYP2D6 Pathway

To evaluate the effects of multiple oral doses of desvenlafaxine sustained release (DVS SR) and paroxetine on the biotransformation of codeine to morphine in healthy subjects. To assess the safety and tolerability of DVS SR and paroxetine when coadministered with codeine to healthy subjects.

This is a randomized, open-label, inpatient/outpatient, 3-period crossover study in healthy subjects.The study will consist of 3 treatment periods. In treatment period 1, subjects will be randomly assigned on study day 1. A single 60-mg dose of codeine will be administered to all subjects. In periods 2 and 3, subjects will receive either DVS SR 100 mg/day or paroxetine 20 mg/day until the steady state is reached. At steady state, subjects will receive codeine 60 mg concomitantly with either DVS SR 100 mg or paroxetine 20 mg, depending on the treatment sequence to which they are assigned. DVS SR 100 mg or paroxetine 20 mg administration will continue for an additional 2 days. In treatment period 3, subjects will receive the alternative treatment sequence.

Eligibility Criteria:
Inclusion criteria:

* Healthy men and nonlactating and nonpregnant women of nonchildbearing potential aged from 18 to 45 years.
* Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.
* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion criteria:

* History of bronchial asthma, of seizure disorder (other than a single childhood febrile seizure)and of any clinically important drug allergy and any known allergy to desvenlafaxine, venlafaxine, paroxetine, codeine, or any of the non-active excipients in the dosage forms.
* Use of any CYP2D6 inhibitors or inducers within 30 days before test article administration.
* Demonstration of a positive orthostatic test at screening.
SAFEty and Efficacy of HOME-based Hospitalization Versus Inpatient Care for Patients With Acute Heart Failure in Chronic Heart Failure.

Evaluation of the efficacy, safety and and cost of home care versus conventional hospitalization care at 3-months in patients with worsening chronic heart failure.

Chronic heart failure (CHF) has an important socio-economic impact due to frequent hospital readmissions.

Hypothesis: Home care treatment (HC) will improve quality of live and decrease cost.

Methodology: Pilot, prospective, open, randomized controlled trial with 1-year follow-up for CHF patients admitted to 10 French hospital from March 2017 through February 2018, for acute decompensation of CHF. Patients will be randomly assigned to conventional hospital care or to the HC and treated with intravenous diuretics. Following discharge within 48 hours from the hospital, patients in the HC group will be treated at home. Follow-up will be conducted for both groups at discharge, 3 and 12 months after inclusion in the study.

Eligibility Criteria:
Inclusion Criteria:

* Acute heart failure (with history of Chronic Heart Failure)
* Identified in the first 48 hours
* Eligible for home-care with "Hospitalisation à Domicile" within 4 days after hospitalization.
* Patient affiliated to social security and to complementary health insurance

Exclusion Criteria:

* Under 18 years old
* Predominantly left-sided heart failure, dependent on oxygen because of the congestion
* Unexplored heart failure, indication of specific techniques (angiography) of device implantations (ICD, CRT).
* Severe cognitive disorders. Behavior disorders.
* Severe renal dysfunction with eGFR (MDRD) \< 15 mL/min/1.73m2
* Patient leaving alone
The Effect of Nebivolol on Insulin Sensitivity

The purpose of this study is to conduct a randomised trial to compare the insulin sensitivity, 24 hour blood pressure profile, and tolerability of nebivolol plus a thiazide-like diuretic versus atenolol plus a thiazide-like diuretic.

Retrospective studies of treated hypertensive cohorts have strongly implicated beta blocker therapy as increasing the risk of developing new-onset diabetes. This has led to the latest British Hypertension Society guidelines advising caution when using beta blockers particularly in combination with thiazide-like diuretics. However the National Institute of Clinical Excellence recommends beta-blocker + thiazide combinations as the treatment of choice in patients who are not at increased risk of developing diabetes. Nebivolol is a newer class of beta blocker. Some studies in diabetic hypertensive patients have suggested that nebivolol does not impair insulin sensitivity. The aim of this study is to compare the effect on insulin sensitivity of nebivolol versus atenolol, both in combination with a thiazide-like diuretic, in a group of non-diabetic hypertensive patients.

Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 or above
* Blood pressure that meets any of the three following criteria:
* BP should be \<140/85 mmHg on a maximum of two anti-hypertensive drugs

Exclusion Criteria:

* contraindications to beta-blockade
* contraindications to thiazide use
* if there was a history of asthma, diabetes, heart failure, bradycardia, atrial fibrillation, AV conduction disturbances
* concurrent treatment with verapamil \& dilitiazem
* childbearing women
* compelling indication for treatment with a beta blocker
* any condition that will interfere with the treatment or the patient's ability to complete the study
Safety and Efficacy of Different Antiviral Regimens for Hepatitis C Virus Relapse

The primary goal of hepatitis C virus (HCV) Direct Acting Antivirals (DAAs) is to achieve undetectable HCV RNA in the blood. A response that should be maintained for at least 12 weeks from completion of therapy. This is called sustained virological response (SVR) which corresponds to cure of HCV infection as risk of later relapse is very small. SVR is important to achieve improvement in liver necroinflammation and fibrosis and to decrease complications of cirrhosis.

Failing to achieve SVR after treatment requires another regimen for these experienced patients.

Real-world data are always needed to evaluate and improve our practices. Here investigators aim to assess tolerability and efficacy of different regimens used for management of genotype 4 HCV relapse.


Eligibility Criteria:
Inclusion Criteria:

* all patients with HCV relapse after sofosbuvir plus either Non-structural protein 5 A (NS5A) or protease inhibitor.

Exclusion Criteria:

* No exclusion criteria
An Investigational Drug Study in Adults With Type 2 Diabetes on Basal Insulin (MK-0941-006)

A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type 2 diabetics being treated with basal insulin.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (of non-childbearing potential) between 18 to 70 years of age
* Diagnosed with Type 2 Diabetes and currently being treated with basal insulin
* Smokers may participate, but they are limited to 10 cigarettes per day while at the clinic and must follow clinic smoking rules

Exclusion Criteria:

* History of Type 1 diabetes
* Treated with peroxisome proliferator-activated receptor (PPAR) agonists within 12 weeks prior to study start
* History of severe hypoglycemia
* Allergic to insulin
Iodine Supplementation in Obesity

The study hypothesis is that iodine supplementation will lower serum TSH and leptin concentrations and thereby improve the lipid and glucose profile.

The study will be a double blind, placebo controlled intervention study in obese women living in the Atlas foot mountains in Morocco, an iodine deficient area. Eligible subjects will be randomized into intervention and control group and will receive the respective supplement for 6 months. At baseline, midpoint and endpoint anthropometric as well as metabolic profile will be assessed. A health questionnaire will further be administered monthly when the tablets for the following month are distributed. Urine samples to determine iodine status will also be collected monthly.

Eligibility Criteria:
Inclusion Criteria:

* Women of reproductive age (20 to 50 years)
* Body mass index 27 to 40 kg/m2
* Having received oral and written information about the aims and procedures of the study
* Willing to comply with the study procedure
* Having provided oral and written informed consent

Exclusion Criteria:

* Chronic disease or gastrointestinal disorders
* Nodular goiter
* Regular use of medication (except oral contraceptives)
* Pregnancy or lactation
* Subject who cannot be expected to comply with study protocol
Noise-Induced Hearing Loss-Acute Exposure Treatment (UA)

The purpose of this study is to assess the safety and efficacy of zonisamide (ZNS) for the treatment of noise-induced hearing loss in adults.

This is a randomized, double-blind, and placebo-controlled study is to test whether zonisamide (ZNS) can treat noise-induced hearing loss in police officers on the range following training and certifications sessions. Participants who meet the eligibility requirements will be randomized to receive either ZNS 100 milligrams (mg) or placebo.

Study participants will be recruited from the Akron Police Department, Summit County Police Department, and other local surrounding police departments. Police officers will be offered participation if they are training for firearm certification as part of their standard occupational requirements. These are officers that would be recommended and/or required to complete these trainings/certifications despite this investigation and this investigation will have no influence on audiologic recommendations.

After being informed about the study expectations and potential risks, all individuals providing written informed consent will undergo screening to determine eligibility for study entry.

Eligibility Criteria:
Screening Inclusion Criteria:

* Police officers who are scheduled for firearm training and/or certification on the range.
* At least 18 years of age.
* Air conduction thresholds are to be no worse than 25 dB HL from 0.5 kHz to 3 kHz, no worse than 30 dB HL at 4 kHz, and no worse than 45 dB HL at 6 and 8 kHz prior to shooting range exposure.
* Ability to understand and willingness to sign an IRB approved written informed consent document.

Enrollment Inclusion Criteria:

* Observed audiometric TTS ≥ 10 dB HL at 2, 3, 4 and/or 6 kHz
* Observed air-bone gap \< 10 dB HL at .5, 1, 2 and 4 kHz, with normal tympanometry

Exclusion Criteria:

* History of known sulfa allergy or hypersensitivity to carbonic anhydrase inhibitors.
* History of moderate-to-severe kidney or liver disease.
* Acute viral, bacterial, fungal or parasitic infection.
* History of seizures.
* Currently pregnant or breast-feeding.
* Any current or history of otologic disorder.
* History of ototoxic drug use.
* Current use of strong/moderate 3A4 inhibitor/inducer and grapefruit juice.
* For secondary outcomes, exclusion criteria is as follows:

  1. DPOAE data will be used as a secondary outcome measure of TTS, and participants will be excluded if their DPOAE is absent at more than 3/7 frequencies. Criteria for a present response is any response that is \> 5 dB SPL above the noise floor and replicable within ±5 dB SPL.
  2. ECochG: Participants will be excluded if the ECochG/ABR wave I response is absent.
  3. WIN test: Participants with WIN scores greater than moderate difficulty or 14.9 dB SNR will be excluded.
Spot-Check Noninvasive Pulse CO-Oximeter Validation

In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age: Greater than one month
* Weight: Greater than or equal to 3kg
* Any racial or ethnic group
* The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study
* If an ICU patient, total hemoglobin of \< 9 g/dL at time of screening.

Exclusion Criteria:

* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
* Subjects deemed not suitable for the study at the discretion of the investigator
* Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
Patient's Knowledge on Their Anticoagulating and Anti Platelet Treatment St Joseph's Hospital)

Oral antigoagulant are used more than 60 years in thrombotic diseases. Even they are indispensable, the haemorragic risk is high.That's why it's the main reason of hospitalization for iatrogeny.The complication's reasons are mainly linked to errors of drug intake, drugs interaction and the lack of understanding the treatment.Moreover, the antiplatelet agglutening treatment is frequently added to anticoagulant treatment.This increases the haemorragic risk.Different means were used to minimize the risk , like INR follow up.

The purpose of the study is to evaluate smartphone use to follow the patients'treatment.

Two questionnaire via smartphone with 15 days gap.

Eligibility Criteria:
Inclusion Criteria:

* patient under ant-thrombotic treatment
* hospitalized in vascular medecine service

Exclusion Criteria:

* refusing the participation
A Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Adjuvanted Influenza Vaccine Compared to a Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of Age

This Phase 3 study is a randomized, observer-blind study of MF59-adjuvanted influenza vaccine (aQIV or aTIV) compared with a non-adjuvanted influenza vaccine (QIV or TIV) in adults ≥65 years of age. The aim of the study is to evaluate MF59-adjuvanted influenza vaccine compared with non-adjuvanted influenza vaccine in the prevention of reverse transcription-polymerase chain reaction (RT-PCR)-confirmed influenza A and/or B in subjects ≥65 years of age.


Eligibility Criteria:
Inclusion Criteria:

In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.

1. Adults of ≥65 years of age on the day of vaccination.
2. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
3. Individuals who have the ability to comply with study procedures including follow-up.

Exclusion Criteria:

In order to participate in this study, all subjects must not meet any of the exclusion criteria described below:

1. Bedridden subjects (i.e. confined to bed by sickness or old age).
2. Subjects that are incapacitated and because of that in need of a Legally Authorized Representative.
3. Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study.
4. Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study, or severe allergic reaction (e.g. anaphylaxis) to previous influenza vaccination.
5. Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
6. Clinical conditions representing a contra-indication to intramuscular administration of vaccines or blood draw.
7. Abnormal function of the immune system resulting from:

   1. Clinical conditions;
   2. Systemic administration of corticosteroids (PO/IV/IM) at a dose ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent; Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted;
   3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
8. Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
9. Receipt of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the study vaccination, or planned use during the entire study period.
10. Acute (severe) febrile illness.
11. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
12. Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.
Proton Therapy in Reducing Toxicity in Anal Cancer

The purpose of this research study is to determine whether the amount of radiation given to the normal areas around the anal cancer can be reduced by using Proton Therapy while reducing the side effects that are seen with standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* Karnofsky Performance Status \>70%
* Histologically documented squamous or basaloid carcinoma of the anal canal
* Stage T2-4 disease with any N category

Exclusion Criteria:

• Patients with a life expectancy of \< 3 months.