cyrilzakka/clinical-trials huggingface dataset:
Impact of a Sexology Consultation on Disease Control of Type 2 Male Diabetics With Erectile Dysfunction

Erection disorders constitute the first sign of vascular injury in type 2 diabetes patients. The important frequency of these disorders and their consequences in term of quality of life have a strong contrast with the actual interest showed for them by the medical community.

Natural evolution of the disease and its management make that these disorders often occur little time after a therapeutic change. As a consequence, patients often accuse their medication to be responsible for the appearance of these disorders. This confusion, associated to false believes that may have the patients on their disease or their treatment, often leads to treatment discontinuation which has a deleterious effect on the disease evolution.

Educational therapy programs showed a positive impact on therapeutic adherence. Increasing patients' knowledge on their disease and treatments increases their therapeutic adherence and makes it easier to balance diabetes and therefore limits complications appearance.

Educational therapy programs concern today the disease, its process, its evolution, its treatments, their efficacy, their adverse effects but erection disorders are not specifically addressed.

This study aims to evaluate the impact of a sexology consultation on diabetes balance measured via HbA1c rate. This consultation aims at precising this particular symptom of erection disorders, without any medicine prescription. The aim is to explain to patients the different links between their symptoms, diabetes, medicines and themselves.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetic male medically treated
* aged from 18 to 65 years old included
* having issue obtaining or maintaining an erection allowing a satisfying sexual intercourse
* hospitalised or followed in consultation in one of the 2 participating sites

Exclusion Criteria:

* treated by a medicine which could be responsible for the erectile disorders (beta-blockers, central anti-hypertensive drugs, antialdosterones)
* presenting another disease which could be responsible for the erectile disorders (neurological, hormonal, vascular, psychiatric diseases)
* treated by an insulin pump
Effectiveness of Percutaneous Electrolysis in the Treatment of Lateral Epicondylalgia. A Single-Blind Randomized Controlled Trial.

The concept of epicondylitis refers to the manifestation of pain ni the area of insertation of the epicondile muscles, and that it is accompained by limitation funcional.A tendinopathy is characterized as a process of degenaration, with fibroblast proliferation and disorganization of the fibers of collagen. This tendon pathology especially affects the epicondyle extensors and especially the first and second radial and short extensor carpal.

Eccentric exercises of the epicondyle muscles were performed in 3 sets of 10 repetitions. Participants were asked to perform the exercise program on an individual basis twice every day for 4 weeks. The eccentric program consisted of 3 exercises, focusing on the epicondyle muscles. Participants were asked to do a normal flexion extension (concentric phase) and a slow return to the initial position (eccentric phase) included first the concentric phase, and the eccentric phase was slowly conducted. The exercise program was taught by a physiotherapist in the first session and monitored in the subsequent sessions.

Eligibility Criteria:
Inclusion criteria:

- Patients of both sexes, aged between 18 and 60 years, in an active state of pain and with a diagnosis of one month of evolution.

Exclusion Criteria:

- Patients who are pregnant, have pacemakers and those surgically operated patients who have been treated with Epte a month earlier
Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)

The purpose of this study is to assess efficacy, as determined by the proportion of subjects with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) \< Limit of quantitation (LOQ) at post-treatment Week 12.

* ASV = Asunaprevir (BMS-650032)
* DCV = Daclatasvir (BMS-790052)
* Peg = Peg-interferon Alfa-2a (PegIFN)
* Rib = Ribavirin (RBV)

Eligibility Criteria:
Inclusion Criteria:

* Males and females, ≥ 18 years of age
* HCV Genotype 1 or 4 who previously failed treatment with Peginterferon alfa-2a or peginterferon alfa-2b and Ribavirin (P/R), classified as previous null and partial responders based on previous therapy
* HCV RNA ≥ 10,000 IU/mL
* Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg)
* Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)

Exclusion Criteria:

* Prior treatment of HCV with HCV direct acting antiviral (DAA)
* Evidence of a medical condition contributing to chronic liver disease other than HCV
* Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
* Diagnosed or suspected hepatocellular carcinoma or other malignancies
* Uncontrolled diabetes or hypertension
* Total bilirubin ≥ 34 μmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert's disease
* Alanine aminotransferase (ALT) ≥ 5x Upper limit of normal (ULN)
* Albumin \< 3.5 g/dL (35 g/L)
* Alpha Fetoprotein (AFP) \> 100 ng/mL (\>82.6 IU/mL) or ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of Hepatocellular carcinoma (HCC) are excluded
* Absolute neutrophil count (ANC) \< 1.5 x 1000,000,000 cells/L (\< 1.2 x 1000,000,000 cells/L for Black/African-Americans)
* Platelets \< 90 x 1000,000,000 cells/L
* Hemoglobin \< 12 g/dL for females or \< 13 g/dL for males
* Any criteria that would exclude the subject from receiving P/R
An Evaluation of the Talk Test for Exercise Prescription for Home-Based Cardiac Rehabilitation

The objectives of this pilot RCT are to examine if the Talk Test is an effective and safe tool as compared with CPET for exercise prescription in patients who have undergone CABG or PCI and enrolled in a home-based CR program with virtual exercise training monitoring.

The Talk Test has been shown to be a valid, practical and inexpensive tool for guiding exercise training in patients with CAD. The general premise of the Talk Test is that exercising at or above the ventilatory threshold or lactate threshold does not allow comfortable, conversational speech and thus serves as a means of estimating the cut point between moderate and vigorous intensity exercise. The Talk Test can be used to produce exercise intensities (64 to 95% HR peak i.e. moderate-to-vigorous intensity exercise) within accepted Canadian Association of Cardiovascular Prevention and Rehabilitation (CACPR) guidelines for exercise training, to avoid exertional ischemia, and has been shown to be consistent across various modes of exercise (i.e. walking, jogging, cycling, elliptical trainer and stair stepper).

There is a critical need to evaluate the effectiveness and safety of using the Talk Test as the principal method of exercise prescription in patients with CAD who have undergone CABG or PCI when compared to standard care CPET. Such a trial has wide-scale appeal for CR programs across Canada and beyond. It will directly and positively impact patient care by reducing the need for in-person interactions for CPET, of paramount importance during COVID-19 outbreaks, between patients and CR staff, thus reducing COVID-19 infection risk and concerns of contracting the virus.

Eligibility Criteria:
Inclusion Criteria:

* recently underwent PCI or CABG (at least 4 weeks but less than 12 weeks post-event or procedure);
* able to perform a CPET;
* at least 40 years of age;
* access to MyChart; and,
* access to email and the internet
* access to a cellphone with broadband internet (4G, LTE, 5G).

Exclusion Criteria:

* currently participating in a virtual or on-site CR program;
* ventricular ejection fraction ≤45%;
* unstable angina or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy;
* unable to return for 12-week follow-up visits.
Exercise Training in Colorectal Cancer Patients

Neoadjuvant chemoradiotherapy (NACRT) prior to surgery for lower gastrointestinal (colon and rectal) cancer is associated with improved survival, but also adversely affects physical fitness, potentially rendering patients unfit for major surgery or increasing the risk of adverse outcome (death and serious complications) after major surgery. The investigators have pilot data using an upper gastrointestinal cancer patient cohort showing that neoadjuvant chemotherapy (NAC)reduces objectively measured exercise capacity (fitness). The investigators therefore propose a blinded, single centre, prospective interventional trial of patients undergoing NACRT prior to elective colorectal cancer resection in an NHS teaching hospital.

The investigators wish to explore various hypotheses:

1. Is exercise intervention feasible and tolerable in this cohort of patients?
2. Can fitness be improved using a structured, responsive exercise training programme (SRETP)?
3. Can SRETP improve quality of life?
4. Can SRETP improve physical activity?
5. Can SRETP improve surgical outcome?
6. Can physiological fitness and oncological outcome be matched to identify an optimal time for physiological recovery following NACRT prior to major surgery.

The investigators aim to recruit 5 patients for a feasibility and tolerably study and 30 patients for an interventional study over 24 months from Aintree University Teaching Hospitals NHS Foundation Trust. Consenting patients will undergo a series of tests designed to evaluate the ability of the muscle to take up and utilise oxygen, namely a cardiopulmonary exercise test (CPET) and VO2 Kinetics tests, all done pre-CRT and at 3,6,9 and 14 weeks post-CRT (pre-surgery). All patients will have their CPET, as well as standard restaging scans at 9 and 14 weeks post NACRT. Outcome, activity and quality of life data will also be collected.


Eligibility Criteria:
Inclusion Criteria:

* All patients listed to undergo elective colorectal cancer resection and longcourse neoadjuvant chemoradiotherapy at Aintree University Hospitals NHS Foundation Trust

Exclusion Criteria:

* Unable to consent
* Under 18 years of age
* Unable to perform exercise
* Meet any contraindications on the ATS CPET safety guidelines
Observational Study of LUMRYZ in Narcolepsy

This is an observational study of LUMRYZ prescribed in clinical practice. Patients are asked if they would be willing to complete questionnaires over a 4-month period after starting LUMRYZ. The questionnaires ask about narcolepsy symptoms, experience with LUMRYZ, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Adults with narcolepsy
* Oxybate naive or prior treatment with twice-nightly oxybate
* Access to smart phone, tablet or laptop with reliable internet connection
* Able to read/understand English
* Written informed consent and ability to comply with schedule

Exclusion Criteria:

* Already using LUMRYZ
* Clinical or mental health condition excluded by LUMRYZ label
* Any other condition/situation that would adversely impact participation
Personalized Versus Standard Hydration for Prevention of CI-AKI: a Randomized Trial With Bioimpedance Analysis

The aim of this study was to evaluate, in patients with "lower fluid status" defined by bioimpedance analysis, whether two different protocol of IV isotonic saline infusion are associated with different volume expansion and differing risks for CI-AKI in patients undergoing coronary angiographic procedures.

Iodinated contrast media are a well-recognized cause of iatrogenic acute kidney injury in patients undergoing imaging diagnostic or therapeutic procedures (contrast-induced acute kidney injury, CI-AKI).

Several protocols have been tested for the prevention of CI-AKI, including periprocedural hydration with isotonic saline or sodium bicarbonate, antioxidant compounds, use of low- or iso-osmolar contrast agents, and hemofiltration or dialysis. The results of these interventions and strategies have been often disappointing or inconclusive and intravenous volume expansion remains the only therapy of undisputed efficacy.

Bioimpedance analysis is an inexpensive, rapid, and accurate tool for evaluating a patient's hydration status, and can be performed at the bedside within minutes \[Maioli, JACC 1014;63:1387-94\]. In this study we defined patients with "lower fluid status" with high risk of CI-AKI (Male with resistance/height ratio \> 315 Ohm/meter and Female \> 380 Ohm/meter). BIVA may represent the optimal tool to monitor the adequacy of volume expansion and protective strategy delivery.

However, most hydration protocols rely on a "one size fits all" approach with a fixed volume and time of infusion without an assessment of whether adequate hydration was achieved. This practice risks either under-hydration without true amelioration of CI-AKI risk or over-hydration with risk of adverse outcomes.

Thus, on the basis of results of BIVA testing a randomized fluid infusion plan is prescribed.

Eligibility Criteria:
Inclusion Criteria:

* consecutive patients admitted in Cardiology Unit for coronary or peripheral angiography with "lower fluid status" defined on the basis bio-impedance analysis (Male with resistance/height ratio \> 315 Ohm/meter and Female \> 380 Ohm/meter).

Exclusion Criteria:

* contrast medium administration within the 10 days
* end stage renal failure requiring dialysis
* refused to give informed consent
Block and Periarticular Injection Study

The purpose of the study is to compare two types of perioperative analgesic modalities, adductor canal block plus interspace between popliteal artery and capsule of the knee (IPACK) block and periarticular injection versus periarticular injection alone, to determine their relative efficacies with regard to pain relief and functional outcomes in the early postoperative period following primary total knee arthroplasty.

The widespread adoption of multimodal analgesia in contemporary total knee arthroplasty (TKA) has led to improvements in perioperative pain control, expedited recovery times, and shorter hospital stays1-3. Periarticular injections (PAIs), adductor canal blocks (ACBs), and interspace between popliteal artery and capsule of the knee (IPACK) blocks are commonly utilized as part of contemporary multimodal analgesia protocols, but their relative efficacies in improving early recovery after TKA has yet to be definitively elucidated4. There are a few known potential drawbacks of ACBs and IPACKs including surgical delay due to administration timing, increased costs, and small risks associated with a regional block. Both regional anesthesia and PAI have been found to be effective alone in improving pain and opioid consumption, but there is limited data on whether there is an additive benefit of providing both treatments for patients undergoing primary TKA. Therefore, the purpose of our study is to compare the efficacy of regional anesthesia and PAI vs. PAI alone for pain management and functional recovery in the early postoperative period following TKA.

Design Prospective randomized trial

Treatment Groups All ACBs will be administered as a single shot preoperatively in the holding area on the day of surgery by the regional anesthesia team and PAIs will be administered intraoperatively by the treating orthopaedic surgeon.

Group 1: regional anesthesia (ACB + IPACK) and PAI Group 2: PAI alone

Eligibility Criteria:
Inclusion Criteria:

* Planning to undergo Unilateral primary total knee arthroplasty.
* 18 and up
* Willing to sign informed consent
* Willing to return for all follow-up visits
* Smartphone or tablet device capable of running the FocusMotion platform

Exclusion Criteria:

* BMI \> 45
* Preexisting functionally limiting neurologic disorders
* Hepatic or renal insufficiency
* History of unprovoked venous thromboembolism
* Inability to complete baseline functional testing
* Chronic opioid or gabapentin and pregabalin use (chronic defined as use \>5 days per week prior to the surgical procedure)
* Allergy or intolerance to trial medications
* Planned admission to a postoperative rehabilitation facility
* Planned general anesthesia
* Receiving workers compensation or disability payments
Online WIC Nutrition Education to Promote Farmers' Market Fruit and Vegetable Purchases and Consumption

This study is evaluating the WIC Fresh Start program, a theory-driven, web-based nutrition education lesson to promote farmers' market fruit and vegetable purchases and consumption among women enrolled in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC).

This study is evaluating the WIC Fresh Start program, a theory-driven, web-based nutrition education lesson to promote fruit and vegetable (FV) consumption among women enrolled in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). Designed to leverage vouchers provided to WIC participants for FV purchases through the Farmers' Market Nutrition Program (FMNP) and monthly cash value vouchers (CVVs) redeemable at farmers' markets, the lesson is conceptually grounded in formative research on knowledge, attitudes and skills influencing farmers' market FV purchases and consumption and theoretical understanding of approaches for modifying them. Lesson content delivery is primarily through short video segments and audio output to increase accessibility for low-literate learners. Informed by a community-based participatory research approach, WIC participants are engaged as full partners in the development of the lesson and the delivery of content (videos feature WIC participants). The setting is a large WIC agency serving three New Jersey counties. Separate samples of women were recruited to participate in 1) focus groups for guiding lesson content development (N = 56 participants) and pretesting the resulting content (N = 52 participants), 2) cognitive testing to assess the clarity and interpretability of items and response formats in measures of knowledge, attitudes and skills developed for the study (N = 15), 3) one-on-one sessions to assess reactions to initial versions of video segments developed for the lesson (N = 20), and 4) the outcome evaluation (N = 744). Stratified based on FMNP voucher receipt, participants are randomized to receive the lesson or existing online health education. Outcome measures (administered orally to reduce literacy demands of the response task) are completed at pretest (immediately before the lesson), posttest (two weeks after the lesson), and 3 and 6 months after posttesting. Short- and long-term lesson effects on FV intake, FMNP voucher redemption and the redemption of CVVs at farmers' markets will be evaluated. Evidence for mediation by knowledge, attitudes, and skills of lesson effects on FV intake and voucher redemption, dose-response relationships, and user satisfaction with the lesson also will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant or postpartum WIC participant
* Female caregiver of infant/child WIC participant

Exclusion Criteria:

* Restrictions on food intake
* Classified by WIC as high risk/requiring an individualized nutrition care plan
Epigenorm Antivir Combined With Acupuncture for the Treatment of Osteoarthritis Patients Who Are Overweight or Obese

The study evaluates analgesic, antiinflammatory and metabolic effects of a supplement Epigenome-Antivir (extracts of glycyrrhiza roots, hippophae rhamnoides leaves, curcumin, green tea, and vitamin C) combined with acupuncture in patients with knee osteoarthritis (OA) and metabolic syndrome.

Epigenome-Antivir components have long been used in traditional medicine and have been shown to exert anti-inflammatory properties both in vitro and in vivo. It has also been shown that acupuncture can provide a moderate analgesic effect in osteoarthritis. It is anticipated that the combination of Epigenome-Antivir and acupuncture will reduce pain, inflammatory and metabolic markers in patients with OA and metabolic syndrome.

Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis of the knee fulfilling American College of Rheumatology (ACR) criteria
* BMI of 25 or more

Exclusion Criteria:

* use of NSAIDs one month prior to study entry (paracetamol is allowed)
* pregnancy and lactation
* increased sensitivity to the study drug
* clinically significant renal function impairment
* use of antidepressants
* diagnosis of bipolar disorder
* use of symptomatic slow acting drugs of OA (SYSADOA) one month prior to study entry
* any condition which may lead to difficulties to participation in the study from the viewpoint of Investigator
Veneclax, Chidaniline Combined With Azacitidine Followed by Decitabine + MAG Regimen in the Treatment of Elderly Untreated AML

A multicenter, prospective, single-arm clinical study of veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) in the treatment of elderly untreated acute myeloid leukemia (AML)

A multicenter, prospective, single-arm clinical study of veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) in the treatment of elderly untreated acute myeloid leukemia (AML)

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed acute myeloid leukemia (non-M3). Have not received treatment before and cannot accept standard cytarabine and anthracycline induction regimen treatment due to age or comorbidity or patient preference;
2. Age \>= 60 years old, male or female, expected survival time greater than 3 months;
3. Estimated creatinine clearance \>= 30 mL/min;
4. AST and ALT \<= 3.0 x ULN (unless considered due to leukemic organ involvement). Bilirubin \<= 1.5 x ULN (unless considered due to leukemic organ involvement);
5. ECOG \<= 2;
6. Able to understand and voluntarily provide informed consent.

Exclusion Criteria:

1. Acute promyelocytic leukemia (APL) and low-risk cytogenetics, such as t(8;21), inv(16), or t(16;16);
2. Active central nervous system leukemia;
3. A history of myeloproliferative neoplasms (MPN), including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myelogenous leukemia (CML) with or without BCR-ABL1 translocation and AML with BCR- ABL1 translocation;
4. HIV-positive patients and/or HBV or HCV active infection (documented by HBV-DNA and HCV-RNA positive tests);
5. Suffering from chronic respiratory diseases requiring continuous oxygen inhalation, or having an obvious history of kidney, nervous system, psychiatric, endocrine, metabolic, immune, liver, and cardiovascular diseases;
6. Suffering from malabsorption syndrome or other diseases that exclude the enteral route of administration;
7. Clinically significant QTc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular tachycardia and atrial fibrillation, second-degree heart block, myocardial infarction, and congestive heart failure within one year before enrollment patients, and patients with coronary heart disease who have clinical symptoms and need drug treatment;
8. Active, uncontrolled severe infection;
9. There is a history of other malignant tumors within 2 years, except for the following cases: adequately treated carcinoma in situ of the cervix or carcinoma in situ of the breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
10. White blood cell count \> 25 x 10\^9/L (hydroxyurea or leukapheresis can meet this standard);
11. Mental disorders that will hinder research participation;
12. Participants have received the following treatments: hypomethylation agents, venetoclax and/or chemotherapy for myelodysplastic syndrome (MDS), solid organ transplantation;
13. Any other circumstances that the investigator believes that the patient is not suitable to participate in this trial.