cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction

The goal of this clinical trial is to assess if a new device is safe to use as a potential treatment for erectile dysfunction following radical prostatectomy.

The main questions it aims to answer are:

* Is the device safe?
* Does the device works well? Are the participants satisfied with the device?

Participants will be implanted with the device during the ongoing prostatectomy surgery and will be asked to complete the following tasks during 6 months follow-up:

* Come to the hospital for follow-up visits,
* Complete questionnaires,
* Activate the device every day,
* Measure erection hardness.

Researchers will compare an implanted group (participants having the device) with a control group (participants not having the device) to see if the device works well.


Eligibility Criteria:
Inclusion Criteria:

* Men of ages between 30-70 years;
* Men with indication for nerve-sparing prostatectomy surgery;
* Localised prostate cancer considered suitable for bilateral nerve sparing prostatectomy according to clinical criteria
* International Index of Erectile Function (IIEF-15) erectile function domain score equal to or greater than 26 prior prostatectomy;
* Men interested in minimizing the effect of radical prostatectomy on erectile function;
* Ability to read and understand patient information materials and willingness to sign a written informed consent.

Exclusion Criteria:

* Men with neurological disease, including a history of spinal cord injury or trauma;
* IIEF-15 erectile function domain score less than 26 prior prostatectomy;
* Failure to demonstrate adequate nocturnal erectile function prior prostatectomy;
* History of erectile dysfunction, priapism and Peyronie disease;
* History of previous pelvic surgery, trauma or irradiation therapy;
* Currently have an active implantable device;
* Patient diagnosed with neurologic degenerative diseases that may negatively impact erectile functions;
* Identification of technical or clinical limitation to properly apply the use of nerve-sparing techniques during operation;
* Inability to understand and demonstrate device use instructions;
* Patients with insulin-dependent diabetes who suffer peripheral neuropathy or other diabetes associated complications;
* Patient unwillingness to engage in sexual activity;
* Patient is currently participating in another clinical investigation that would serve as a contraindication to implant a neurostimulator device to augment erectile function;
* Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other drug or device study during the next 24 months;
* Possess any other characteristics that, per the investigator's judgment, may increase the risk or impair data collection for the procedure/study;
* Patient is a member of a vulnerable population (Vulnerable participants include those who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, and employee volunteers).
Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668 Administered Subcutaneously to Healthy Volunteers

This is a study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668 Administered Subcutaneously to Healthy Volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects 18 to 55 years of age.
2. Body weight between 60 kg and 80 kg, body mass index between 20 and 30 kg/m2 inclusive.
3. NHV as evidenced by comprehensive clinical assessment (detailed medical history and complete physical examination).
4. Normal resting blood pressure and heart rate
5. Willingness to refrain from the consumption of alcohol for 24 hours prior to each study visit.

Exclusion Criteria:

1. History or presence of currently relevant medical conditions, including any cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, musculoskeletal, psychiatric, systemic, ocular, infectious or parasitic disease, or signs of acute illness.
2. Administration of any medications within 1 week before randomization, other than vitamins, nutritional supplements, or low doses of aspirin taken prophylactically.
3. Onset of a new exercise routine or major change to a previous exercise routine within 2 weeks prior to randomization. Subjects must be willing to maintain a relatively constant level of exercise during the study and refrain from unusually strenuous physical activities
4. Known history of human immunodeficiency virus (HIV) antibody; and/or positive hepatitis B surface antigen (HBsAg), and/or positive hepatitis C antibody (HCV) at the screening visit.
5. History of substance (eg. drug or alcohol) abuse or regular (daily) smoking within a year prior to randomization or positive results on urine drug screen.
6. Excessive consumption of beverages with xanthine derivates (caffeine, theophylline, theobromine), such as coffee, tea, cola, or yerba mate (more than 4 cups or glasses per day).
7. Hospitalization for any reason within 60 days of randomization.
8. Participation in any clinical research study evaluating another investigational drug or therapy within 30 days of the investigational drug, whichever is longer, prior to the randomization visit.
9. Live/attenuated vaccinations within 12 weeks of randomization or during the study.
10. Tuberculosis vaccination within the last year.
11. Previous exposure to any other biological agent within 12 months of randomization.
12. History of a hypersensitivity reaction to doxycycline or other tetracyclines.
13. Recent travel (within 12 months of randomization) to areas endemic for parasitic helminthes, such as developing countries, particularly in Africa and the tropical and subtropical regions of Asia.
14. Pregnant or breast-feeding women.
15. Unwilling to use adequate birth control if of reproductive potential and sexually active
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy

To determine whether use of detemir compared to neutral protamine hagedorn (NPH) decreases rates of composite neonatal outcome and maternal hypoglycemia events in women with Type 2 Diabetes Mellitus (T2DM).


Eligibility Criteria:
Inclusion Criteria:

* Preexisting type 2 diabetes mellitus requiring medical treatment or
* overt diabetes diagnosed prior to 20 weeks of gestation using either Hemoglobin A1c (HBA1C) ≥ 6.5 or fasting glucose ≥126 mg/dl or random blood glucose ≥ 200 mg/dl or two step method ( 50g glucose challenge test (GCT) \>135 mg/dl followed by 100 GCT with at least 2 values above thresholds: Fasting Blood Glucose (FBG) \>90, 1 hr \>180, 2 hr \> 155, 3 hr \> 140 mg/dl).
* Gestational age ≤20 weeks
* Willing to start insulin therapy or to continue insulin treatment during pregnancy
* Singleton or twin pregnancy

Exclusion Criteria:

* Known allergy/prior adverse reaction to NPH/detemir
* Patients \<18y
* Known major fetal anomalies
* Diabetic nephropathy (Creatinine (Cr)≥1.5)
* Diabetic proliferative retinopathy
* Patients with Type 1 diabetes or gestational diabetes
Diagnosis of Septicaemia by Detection of Microbial DNA in Blood in Severe Infections

The primary purpose is to improve and quicken the microbial diagnosis in severe infections, since only one third of the cases are documented by blood cultures and adequate anti-infective therapy in the 48 hours reduced mortality and morbidity.

Our hypothesis is that detection of microbial DNA in blood by real time PCR may increase the number of cases diagnosed for bacteraemia or fungemia and shorten the time to positive results, which will provide information for an adequate anti-infectious therapy.

We will evaluate the advantage of adding the molecular test to the microbial investigations usually done (blood cultures and others) in cases of febrile neutropenia, suspicion of infective endocarditis and severe sepsis in intensive care units.

This is a prospective study conducted in 18 sites (7 in the Paris area and 11 all over France) which will enrolled about 2000 patients over 18 years. Sites are randomized for starting with a 6-month period performing the test or 6-month period without the test (control time with the standard of care).

Primary outcome are the number of patients with documented bacteraemia or fungemia. Secondary outcome are (1) the number of patients with an adequate anti-infective therapy and how long it happens after the diagnosis, (2) mortality, (3) new complicated infection, (4) number of investigations (microbial and non microbial) done for the etiological diagnosis, and global hospitalization costs.

The advantage of the new test will be evaluated per protocol and with an intend to treat analyses. We hypothesized that the new test will bring 15% more microbial diagnosis than the standard of care. Consequently, and according to the number of sites interested in the study, 166 to 2500 patients will be enrolled with 480 to 750 patients with febrile neutropenia, 1000 to 1500 patients with severe sepsis in Intensive Care Units (ICU). Patients with suspicion of infective endocarditis will be evaluated for the number of diagnosis of true endocarditis according to Duke Criteria, and the time to diagnosis.

Health economic evaluation will compare the costs of hospitalization, microbial investigations including the new test, other non clinical investigations and consequences on the organization.

Eligibility Criteria:
Inclusion Criteria:

* Age≥ 18 years
* Written signed and dated inform consent
* First time with fever observed in a neutropenic patient
* Severe sepsis in a patient hospitalized in ICU
* Suspicion of infective endocarditis
* Microbial investigation from Monday to Friday

Exclusion Criteria:

* Not affiliated to Health Insurance (social security)
* Included in another interventional trial testing microbial DNA detection during the time "without Septifast®"
* Included in another clinical trial for which the clinician assumes that it will not be possible to prescribe an anti-infectious therapy adequately to microbial detection in the blood
* Patient previously included in the protocol
* Sepsis with a microbial diagnosis
Effect of Physician Attire on Patients' Preference of Physician

The goal of this research study is to learn about the effects of a doctor's characteristics on participant's preference for a doctor. Researchers also want to learn about how a doctor's characteristics affect participant's options about professionalism and compassion.

If participant agrees to take part in this study, participant will be asked to complete 7 questionnaires. These questionnaires ask about participant's gender, date of birth, ethnicity, marital status, level of education, religion, and information about the disease and treatments participant received. Participant will also be asked about any symptoms participant may be having, how much trust participant has in the medical profession in general, how participant feels about the disease, any depression or anxiety participant may have, and participant's level of hopefulness. These questionnaires should take about 6 minutes to complete.

Participant will be shown 2 videos (each 3 minutes long) and then participant will complete questions about each video. Participant will be asked to rate the doctors participant saw on their professionalism and their compassion.

Caregivers will be required to leave the room or stay silent while the participant is watching the videos.

The total time to watch the videos and complete the second set of questionnaires should be about 7 minutes.

Finally, participant will be asked to complete 3 questionnaires about participant's overall preference for a doctor. These questionnaires will take about 5 minutes to complete.

Length of Study Participation:

Participation in this study is complete after participant answers the final questionnaires.

Overall, this study should take about 30 minutes to complete.

This is an investigational study.

Up to 108 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Advanced cancer diagnosis (locally advanced, recurrent or metastatic disease).
2. Patients presenting as follow-ups only at the outpatient Supportive Care Center.
3. Age \>/= 18 years-old
4. English speaking

Exclusion Criteria:

1. Altered cognition (as assessed routinely in the Supportive Care Clinic using the Memorial Delirium Assessment Scale (MDAS), with a score of \>/= 7/30).
2. Patients suffering from a severe psychiatric disorder or condition that would significantly interfere with study participation.
3. Patients with hearing and/or visual impairments.
Virtual Trial to Compare Two Digital Therapeutics as Interventions for Physical and Mental Health in People With Cancer

This is a 2-arm randomized controlled study comparing how effective two therapeutic digital software devices are at improving anxiety and other indicators of psychological and physical health in patients with cancer. The study will be completely virtual, meaning participants can take part completely from home without visiting a clinic or study site.

The digital software devices, called called attune™ and cerena™, are designed to be used for approximately 12 weeks alongside oncology usual care regimens (medical, psychosocial). The study will enroll at least 352 stage I-III cancer patients with elevated anxiety symptoms who are currently receiving systemic treatment (radiation, chemotherapy, immunotherapy), have received systemic treatment within the last 6 months, or who have an established treatment plan that includes systemic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Stage I-III cancer diagnosis
* Currently in active systemic treatment of chemotherapy, radiation or immunotherapy, have completed systemic treatment within the past 6 months, or have a treatment plan including planned systemic treatment.
* Are experiencing at least moderate anxiety
* 18 years of age or older
* Are fluent in English
* Have access to a smartphone (a mobile phone that performs many of the functions of a computer, typically having a touchscreen interface, internet access, and an operating system capable of running downloaded applications) or tablet that runs iOS or Android software, with cellular data service or wifi access.
* Willing to download software onto smartphone or tablet from Apple store or Android store

Exclusion Criteria:

* Systemic treatment plan includes only endocrine therapy.
* Treatment plan includes stem cell/bone marrow transplant.
* Currently participating in any other investigative CBT trial for treatment of anxiety or depression.
* Participant is unable to complete training, has cognitive deficits, more severe psychiatric conditions, lack of access to internet accessible device or psycho-social conditions (e.g., other social conditions, that would interfere with adherence to self-directed care), such that in investigator's opinion the participant would be unable to complete the study
* Recently completed use of Blue Note Therapeutics Covid Cancer Care Program or other Blue Note Therapeutics device or Blue Note Therapeutics-sponsored study
* Are experiencing severe levels of depression OR indicate suicidal risk (measured by surveys during screening for the study)
* Are experiencing anxiety below the required level (measured by a survey during screening for the study)
* Cancer diagnosis is melanoma, multiple myeloma, unstaged cancer.
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148

The purpose of this study is to evaluate the long-term safety and tolerability of brexpiprazole in children and adolescent participants, aged 5 to 17, with irritability associated with autism spectrum disorder.


Eligibility Criteria:
Inclusion Criteria:

* 5 to 17 year of age or turned 18 while enrolled in the 331-201-00148 study
* Autism Spectrum Disorder
* Completion of 331-201-00148 trial
* Investigator assessment

Exclusion Criteria:

* Did not complete treatment period or incurred significant protocol deviations during 331-201-00148 study
* Sexually active males or female of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose
* Female with positive pregnancy test
Safety and Efficacy of Mobic Inj. (Meloxicam) for the Patients With OA or RA: Observational Study

The main objective of this PMS study was to monitor and assess the safety of Mobic® intramuscular injection (7.5mg \~ 15mg, q.d.) up to 3 days (in case of need for prolonged treatment, switch to Mobic® capsule therapy was possible) in Korean patients with osteoarthritis and rheumatoid arthritis.


Eligibility Criteria:
INCLUSION CRITERIA:

diagnosed as osteoarthritis and rheumatoid arthritis

EXCLUSION CRITERIA:

1. Known hypersensitivity to meloxicam
2. Cross hypersensitivity to aspirin and other non-steroidal anti-inflammatory drugs
3. Symptoms of asthma, rhinitis, angioneurotic edema, or urticaria following the administration of aspirin or other NSAIDs
4. Active peptic ulceration
5. Severe hepatic failure.
6. Non-dialysed severe renal insufficiency
7. Children and adolescents aged 15 years or less
8. Pregnancy or breastfeeding
Severe Hypoglycemia in Pregnant Women With Type 1 Diabetes

Background:

The risk of stillbirth and preterm delivery is three times increased among pregnant women with type 1 diabetes compared with healthy pregnant women. Normal blood glucose levels are mandatory in order to prevent these complications. Severe hypoglycemia (requiring assistance from another person) is the decisive limiting factor for obtaining near-normal blood glucose regulation in pregnant women with type 1 diabetes. Severe hypoglycemia occurs in about one third of pregnancies complicated with type 1 diabetes and can result in unconsciousness, traffic accidents and deaths.

Aim: To test the following hypotheses:

1. Severe hypoglycemia is frequent in pregnancy complicated by type 1 diabetes with the highest incidence in gestational weeks 8-16 and the lowest incidence in gestational weeks 28-34
2. Predictors for severe hypoglycemia during pregnancy complicated with type 1 diabetes can be identified at the first pregnancy visit
3. Possible pathophysiological mechanisms include changes in the growth hormone system and in the renin-angiotensin-system during pregnancy

Methodology:

One hundred and eight pregnant women with type 1 diabetes are consecutively and prospectively included. In connection with the clinical control at the first pregnancy visit at week 9 and in gestational weeks 14, 22, 28, 34 and one day postpartum the following tests are carried out:

The patients are asked to answer a validated questionnaire about mild and severe hypoglycemia and hypoglycemia-associated factors such as blood glucose level during hypoglycemia, the degree of awareness, pregnancy-associated nausea and vomiting, insulin type and dose etc. Other medication, exercise habits, coffee- and alcohol intake, smoking and social status will be recorded. In case of severe hypoglycemia a structured interview concerning the episode will be performed within 24 hours. Blood glucose, HbA1c, the degree of insulin resistance and the levels of IGF1, placenta growth hormone and of the renin-angiotensin-system will be monitored.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Pregnancy before gestational week 14

Exclusion Criteria:

* Other diseases that might influence the risk of severe hypoglycemia
AV-node Stimulation Clinical Download Study to Reduce Ventricular Rate During AF

The aim of this multi-center research study is to evaluate the performance (primary purpose) and safety of a new algorithm aimed at controlling ventricular rate (VR) during rapidly conducted atrial fibrillation (AF) by delivering AV node stimulation (AVNS) from the atrial lead placed at a septal position, and designed with the purpose of reducing inappropriate shocks. Additional purposes include the assessment of a possible application of AVNS aimed at allowing prolonged control of VR during AF and reducing AF symptoms, and evaluation of implantation data on selective placement of the atrial lead in postero-septal right atrium. About 37 patients will be followed for half a year.

The aim of this multi-center research study is to evaluate the performance (primary purpose) and safety of a new algorithm aimed at controlling VR during rapidly conducted AF by delivering AVNS from the atrial lead placed at a septal position, and designed with the purpose of reducing inappropriate shocks. Additional purposes include the assessment of a possible application of AVNS aimed at allowing prolonged control of VR during AF and reducing AF symptoms, and evaluation of implantation data on selective placement of the atrial lead in postero-septal right atrium. About 37 patients will be followed for half a year.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a documented history of paroxysmal or persistent AF are eligible to be enrolled in the study if one of the following criteria is met:
* Indication for CRT implant according to current Guidelines (Heart Failure, NYHA III-IV class, symptomatic despite optimal stable medical therapy, left ventricular (LV) ejection fraction ≤35% and QRS≥120ms); OR
* Indication for upgrading to CRT-D from a single chamber device; OR
* Indication for upgrading to CRT-D from a dual chamber device with septal atrial lead or a dislodged atrial lead; OR
* Indication for device replacement or surgical revision in patients already implanted with a CRT-D device and an atrial lead in the septal position or a dislodged atrial lead; OR
* Patients already implanted with a ConsultaTM device and an atrial lead in the septal position, requiring electrical cardioversion.

Exclusion Criteria:

* If any of the following criteria are met, patient cannot be enrolled in the study:
* Permanent atrial fibrillation;
* Patients who are not on anti-coagulant therapy;
* Advanced AV block (II-III degree AV block);
* Patients previously submitted to valvular surgery;
* Patients previously submitted to AV or AF ablative procedures;
* Age \< 18 years;
* Patient not disposed to sign the Informed Consent;
* Participation in other studies which could potentially conflict with this study;
Effects of Purple Vegetables on Cardiovascular Disease (CVD) Risk Factors

The hypothesis is that richly coloured purple vegetables, rich in polyphenolic compounds including anthocyanins will have higher antioxidant and other biological activities, than more lightly coloured versions of these foods. Diets of human subjects will be modified to allow consumption of 200-300 g of raw carrots or cooked potatoes. Participants will be randomized to consume either orange or purple carrots, or white or purple potatoes. They will consume these diets for 12 weeks and bioavailability of polyphenolics will be examined as well as anthropometry and blood biochemistry for changes in risk factors associated with cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* adult men and women 18-65 years of age
* must have a least one of the following risk factors associated with increased risk of type II diabetes and/or cardiovascular disease:

  * borderline high or hypertension or undergoing treatment for such
  * abnormal fasting blood glucose or undergoing treatment for such
  * overweight or obese
  * borderline high or high LDL-cholesterol or undergoing treatment for such
  * borderline low or low HDL-cholesterol
  * borderline high or high triglycerides or undergoing treatment for such

Exclusion Criteria:

* smokers, pregnant or nursing women