cyrilzakka/clinical-trials huggingface dataset:
The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy

This trial is conducted in Europe, Oceania and the United States of America (USA).

The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes mellitus
* Glycosylated haemoglobin (HbA1c) 7.0-9.0% (53-75 mmol/mol) (both inclusive)
* Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg once daily (OD) Victoza® (liraglutide) or 10 microgram twice daily (BID) Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza® (liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated dose) for 90 days or more prior to screening visit (Visit 1)
* BMI (body mass index) equal to or below 40 kg/m\^2

Exclusion Criteria:

* Any use of oral anti-diabetic drugs (OADs) (except for metformin, pioglitazone and sulphonylurea) for 90 days or less prior to screening visit (Visit 1)
* Use of any drug (except metformin,pioglitazone, sulphonylurea and GLP-1 receptor agonist) which in the Investigator's opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
* Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)
* Screening calcitonin equal to or above 50 ng/l
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
* Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary, carotid or peripheral artery revascularisation procedures
* Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator's opinion
* Subjects with a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes mellitus), neurological, genitourinary or haematological system that in the opinion of the Investigator may confound the results of the trial or pose additional risk in administering trial products
* History of chronic pancreatitis or idiopathic acute pancreatitis
A Study in Healthy Men to Test Whether BI 474121 Can Reverse the Memory Problems Caused by Ketamine

To investigate the effect of BI 474121 compared to placebo on ketamine-induced cognitive deficits to predict efficacy in patients with cognitive disorders.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 32 kg/m2 (inclusive)
* Signed and dated written informed consent(s) prior to admission to the study, in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
* If men who are able to father a child, are willing to participate, they have to use an adequate form of effective contraception for the duration of study participation and for at least 30 days after treatment has ended

Exclusion Criteria:

* Any finding in the medical examination (including ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm evaluated as clinically significant by Investigators
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* History of diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Evaluating Combined Electromagnetic Stimulation for Enhanced Physical and Psychological Recovery in Athletes with DOMS

This randomized controlled trial explores the impact of a combined transcranial and peripheral electromagnetic stimulation over the potential correlation between psychological well-being and recovery outcomes of young athletes experiencing Delayed Onset Muscle Soreness.

This randomized controlled trial explores the impact of a combined transcranial and peripheral electromagnetic stimulation (TMS and PES) over the potential correlation between psychological well-being and recovery outcomes of young athletes experiencing Delayed Onset Muscle Soreness. Grounded in the emerging theory of DOMS as an axonopathy affecting muscle spindles, this study examines whether paired-associative stimulation can show link over physical and psychological recovery processes. Forty-eight male athletes, aged 18 to 35 years, regularly engaged in exercise, will be randomly assigned to one of four groups: Control (placebo), PES, TMS, and Combined Stimulation (TMS + PES). All participants will perform a muscle-damaging exercise protocol to induce DOMS, followed by the assigned electromagnetic intervention. Assessments will include dynamometry, Counter Movement Jump (CMJ), Visual Analog Scale for Fatigue (VAS-F), Pain Pressure Threshold (PPT), sprint performance, and various psychological measures, such as the State-Trait Anxiety Inventory (STAI), Acceptance and Action Questionnaire-II (AAQ-II), and the Spanish versions of the Big Five Personality Traits, Perceived Stress Scale (PSS), and the Zung Self-Rating Depression Scale. These assessments will be conducted at baseline and at multiple intervals post-exercise (1 hour, 24 hours, 48 hours, and 72 hours).

Eligibility Criteria:
Inclusion Criteria:

1. be male,
2. aged between 18 and 35 years
3. engage in regular exercise at least three times per week for a minimum of one year
4. have no hypersensitivity to the areas designated for peripheral stimulation
5. be free from chronic conditions incompatible with exercise performance
6. have no recent musculoskeletal injuries to the lower limbs within the past six months,
7. be non-smokers
8. possess the cognitive capacity to understand the study's objectives and procedures.

Exclusion Criteria:

-
Relaxation With Virtual Reality on Fatigue and Comfort in Hemodialysis Patients

Based on the task of providing the comfort of the patient, which is an indispensable part of the nursing profession, which many nurse theorists emphasize, there has been no study in the literature on the determination of the effect of virtual relaxation, which can be effective on the fatigue and comfort levels of patients receiving hemodialysis treatment. Therefore, the aim of this study is to examine the effect of virtual reality and relaxation on fatigue and comfort in hemodialysis patients.

The patient will be prepared for relaxation with virtual reality and will be given a comfortable sitting position.

The patient will watch the relaxation practice with virtual reality once during the hemodialysis treatment.

The application will be terminated with the expiration of the virtual reality relaxation video.

Fatigue and comfort score will be measured after the application.

Eligibility Criteria:
Inclusion Criteria:

* Receiving hemodialysis treatment for the last 6 months
* Receiving four-hour hemodialysis treatment three times a week
* 18 years or older
* Deaf and visually impaired
* Without cognitive and psychiatric diagnosis
* Open to communication and cooperation
* Patients who agreed to participate in the study

Exclusion Criteria:

* Kidney transplant
* Discomfort due to virtual reality glasses
* Suspected/diagnosed COVID-19
* Patients who want to leave the study voluntarily
* Death
Can A Nutrition Education Immersion Program Foster Sustainable Improvements in Clinical Parameters Over Time?

Nutrition and Education Immersion program sponsored by WholeFoods, Inc. for their employees.

An ongoing Nutrition and Education Immersion program is currently ongoing that is supported by Whole Foods, Inc. for their employees. Eighty employees have previously agreed to attend a one week nutrition education and immersion program October 14-21, 2017. This program will involve nutrition education seminars, exercise and support classes that they are scheduled to attend. All meals are provided. They will all be 100% plant based with low oil. All employees will complete a dietary survey at the beginning of the study. Clinical parameters will be tested at start and end of the program. The majority of the lectures are CME certified by Rush University.

All participants will be approached for participation on day one to allow for the collection of the data being obtained as part of the existing project. In addition to the data from the program, this project will include a lab draw for nutritional markers at baseline and at the end of the immersion program, a dietary survey, SF-36, and DASI at baseline. Participants will be contacted by phone at months 3 and 6 and will be asked to complete the dietary survey, SF-36, and DASI. In addition, self-reported weight will be collected, and occurrence of health events (hospitalizations, new diagnoses). This will end their participation.

Eligibility Criteria:
Inclusion Criteria:

* 18yrs or older
* all comers with and without cardiovascular disease risk factors
* are attending the one week lifestyle immersion program sponsored by Whole Foods

Exclusion Criteria:

-unwilling to provide consent
Reduced Radiation Dose and IR-impact on Coronary Calcium Quantification

Evaluation of reduced radiation dose iterative reconstruction reconstructions for calcium scoring compared to full dose filtered back projection reconstructions


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing routine calcium scoring CT at facilities at the University of Pennsylvania

Exclusion Criteria:

* Patients found to have no coronary calcium on full dose FBP reconstructions
Shockwave Therapy and Platelet Rich Plasma for the Treatment of Erectile Dysfunction

The purpose of this research study is to evaluate whether the combination of Shock Wave Therapy (SWT) with Platelet Rich Plasma (PRP) is synergistic and can reverse the pathology of microvascular Erectile Dysfunction (ED) and enhance erectile function by improving vasodilation, and endothelial function


Eligibility Criteria:
Inclusion Criteria:

1. Be Male
2. Be 30 to 80 years of age (inclusive).
3. Be able to provide written informed consent.
4. Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
5. Sexually active in a stable, heterosexual relationship of more than three months duration.
6. IIEF-EF score 12-25 at screening
7. Agree to attempt sexual intercourse at least 4 times per month for the duration of the study without being under the influence of alcohol or recreational drugs.
8. Agree to comply with all study related tests/procedures.

Exclusion Criteria:

1. Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
2. Previous history of priapism or penile fracture
3. Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%) (indicative of untreated hypogonadism), or greater than 1197 ng/dL (±5%).
4. Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. (Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded.
5. Psychogenic ED as determined by study investigator.
6. Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area.
7. Patients using Intracavernosal Injection (ICI) for management of ED
8. Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease.
9. Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
10. History of consistent treatment failure with Phosphodiesterase Type 5 (PDE5) inhibitors for therapy of ED.
11. Any history of significant psychiatric disease, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity. Patients who are currently using Selective Serotonin Reuptake Inhibitors (SSRI) or psychotropic medications.
12. Hemoglobin a1c \>9%.
Evaluation of Dermafill Dressing for Donor Sites

The purpose of the study is to compare one type of dressing against the current standard dressing that is used to cover the unburned area of the skin where a piece of skin is removed to cover another part of the body that was burned.

Hypothesis: The mean healing time for wounds treated with the Dermafill dressing will be less than the mean healing time for wounds treated with Xeroform dressing.

At the time of the procedure, donor sites that are symmetrical in size and shape will be selected. The donor sites will be harvested. Once the grafts have been harvested, the wounds will be randomized for treatment using either the Dermafill dressing or Xeroform. The wound dressings will then be observed at least once a day beginning post op day 2/48hours after surgery until healed, which is defined as 90% or more of the wound surface is confluently re-epithelized.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older; male or female.
* Burn wounds less than 30% of total body surface area (TBSA) with no systemic abnormalities
* Burns do not involve the harvesting area
* Burn wounds require excision and grafting of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surface areas
* Scheduled excision and grafting procedure is the first such operation for subject during this hospitalization
* Subject agrees to participate in follow-up evaluations

Exclusion Criteria:

* Critical illnesses requiring ventilator support, systemic infection or hemodynamic instability
* Major acute or chronic illnesses affecting wound healing (e.g. peripheral vascular disease, insulin dependent diabetes, blood clotting disorder)
* Subject receiving medications that inhibit/compromise wound healing (e.g. anticoagulants, antiplatelet drugs, oral steroids). The use of anticoagulants does not include deep venous thrombosis (DVT) prophylaxis.
* Cellulitis or other infection of potential donor site
* Previously harvested donor site
* Subjects with greater than 30% TBSA burns
* Pregnancy
Feasibility of Ambulatory Surgery for Early Breast Cancer

The aim was to assess the patient compliance and medical and psychosocial effects of same day hospital discharge after breast conserving surgery and sentinel node biopsy only.

The patients with small breast tumours (\<2 cm)and clinically node negative disease, were randomized to receive breast conserving surgery and sentinel node biopsy as ambulatory surgery or inpatient-surgery.Complication rate, patient satisfaction and psychosocial outcomes were compared. The psychosocial effects of the treatment mode on their spouses were recorded as well.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer \< 2cm
* Clinically node negative
* ASA I-II

Exclusion Criteria:

* Axillary clearance performed
* ASA III-IV
* No adult companion at home
Bimatoprost 0.03% Versus Travoprost 0.004% in Patients Currently on Latanoprost 0.005%

Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering, will be randomized to receive either bimatoprost 0.03% or travoprost 0.004% in place of latanoprost 0.005%


Eligibility Criteria:
Inclusion Criteria:

* Glaucoma or ocular hypertension in both eyes
* Currently being treated with latanoprost 0.005% daily and in need of additional IOP-lowering
* Best-corrected visual acuity of 20/100 or better in each eye
* Visual field within 6 months of study entry

Exclusion Criteria:

* Secondary glaucoma
* Active intraocular inflammation or macular edema
* Intraocular surgery or laser surgery within the past 3 months
Dressing Wear Time After Breast Augmentation With Prosthesis

This study was designed to determine whether the duration of dressing wear following augmentation mammaplasty influence skin colonization and eventually surgical site infections rates.

Augmentation mammaplasty is currently one of the most performed plastic surgery procedures. It is a clean operation, and surgical site infection (SSI) rates are low. However, a SSI, since a minor one, leads to the failure of the procedure. Thus, minimizing SSI risks is imperative.

The Centers for Disease Control and Prevention (CDC) provides recommendations concerning prevention of SSI.No recommendation is offered for some practices, either because there is a lack of consensus regarding their efficacy or because of the available scientific evidence is insufficient to support their adoption.

CDC´s "Guideline for Prevention of Surgical Site Infection" recommends protecting with a sterile dressing for 24 to 48 hours an incision that has been closed primarily. There is no recommendation to cover the incision beyond 48 hours. One major risk factor for SSI is the presence of bacteria at surgical site.Thus, this trial was designed to verify the influence of dressing wear time on skin colonization.

Eligibility Criteria:
Inclusion Criteria:

* candidate to breast prosthesis implantation
* body mass index under 30Kg/m2

Exclusion Criteria:

* pregnancy, delivery or breast feeding during the last 12 months
* body mass index over 30Kg/m2
* breast cancer history
* previous breast surgery
* hard smoking
Acceptability, Feasibility, and Development of an AI Driven, Multi-sensor, Non-invasive Digital Mental Health Platform in Children With ADHD and Emotional Symptoms

This is an observational study collecting data using a wearable to measure the biometric features in youth with Attention deficit hyperactivity disorder(ADHD) and Autism.

Participants in therapeutic school for disruptive behavior with Attention deficit hyperactivity disorder( ADHD), Autism with age 4-7 year old. Participant will wear watch during their school days for 5 days in presence of investigator and raters taking behavioral observation. The data collected from the raters and wearable will be analyzed to correlate emotional dysregulation.

Eligibility Criteria:
Inclusion Criteria:

* Children in the therapeutic school, diagnosed with ADHD

Exclusion Criteria:

* Unable to tolerate wearing the watch
An Investigational Drug Co-Administered With Insulin in Patients With Type 2 Diabetes (0478-065)

This is a study to evaluate the effectiveness and tolerability of an investigational drug in patients with type 2 diabetes (a specific type of diabetes) who are not currently treated with insulin.

The duration of treatment is 30 weeks.

Eligibility Criteria:
Inclusion Criteria:

* People between the ages of 18 and 70 who have a specific type of diabetes called type 2 diabetes which is currently being treated only with oral medication(s). (Patients currently taking insulin would not be allowed to participate.)

Exclusion Criteria:

* People who have specific diseases (such as liver disease, gallbladder disease, pancreatitis, severe blood disorders or history of neoplastic diseases) which will be discussed by the study doctor and for which study participation would not be allowed.
Study of Quetiapine Treatment for Cannabis Dependence

Marijuana is the most commonly used illicit drug in the United States. However, the treatment options for cannabis dependence are limited; notably, no effective pharmacotherapy has been developed. Conceptually, the ideal medication treatment for cannabis dependence would:

1. be safe when administered to patients actively using cannabis
2. reduce cannabis intake and promote abstinence
3. treat the symptoms of cannabis withdrawal
4. reduce craving and relapse risk
5. have a low abuse liability.

Conceptually, the pharmacodynamic and clinical actions of quetiapine suggest that it may be useful for cannabis dependence. By antagonizing dopamine, quetiapine may interfere with the reinforcing effects of cannabis, while serotonin type 2A, histamine type 1, and adrenergic receptor antagonism may reduce cannabis withdrawal symptoms, primarily by sedating and anxiolytic effects. The proposed research project is an open-label pilot study to evaluate the tolerability and ideal target dosing range for quetiapine treatment of cannabis dependence over an eight-week period. The purpose of this pilot study is to obtain preliminary data regarding the potential efficacy, tolerability and safety of quetiapine treatment of cannabis dependence before conducting a larger double-blind trial.

Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 18-65
2. Meets DSM-IV criteria for current cannabis dependence
3. Seeking treatment for cannabis dependence
4. Reports using cannabis an average of five days per week over the past 28 days
5. Capable of giving informed consent and complying with study procedures

Exclusion Criteria:

1. Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
2. Current DSM-IV criteria for any other psychiatric disorder that may, according to the investigator's judgment, require either pharmacological or non-pharmacological intervention over the course of the study
3. Receiving prescribed psychotropic medication
4. Known history of allergy, intolerance, or hypersensitivity to quetiapine
5. Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients who are currently engaging in sexual activity with men
6. Unstable medical conditions, such as poorly controlled diabetes or hypertension, which might make participation hazardous
7. Current DSM-IV diagnosis of substance dependence other than cannabis or nicotine dependence
8. Are legally mandated to participate in a substance use disorder treatment program
9. Increased risk for suicide
10. Diabetes (whether controlled or not), hyperglycemia (fasting glucose \> 100 mg/dl), obesity (BMI \> 30) and elevated lipids (cholesterol \> 200 mg/dl; triglycerides \> 150 mg/dl).