cyrilzakka/clinical-trials huggingface dataset:
A Study Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab 600mg in Healthy Adult Male Subjects

This study is Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab 600mg in Healthy Adult Male Subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male is between 20 and 45
* Weight is between 50 and 90kg, and in 20% of ideal weight. Ideal weight(kg)=(height(cm)-100)\*0.9
* Medical history, physical examination, ECG and laboratory test are suitable to the study if judged by an investigator.
* Patient is willing to use an effective method of contraception during the study and for up to 1 months after the use of study drug ceases. (Effective method=spermicide with condom)
* Subject is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

* Patient received drug affected to the study within 14 days from the study initiation.
* Patient received drug-metbolizing enzyme inducer or inhibitor such as Barbiturates within 1 month from the study initiation.
* Subject is hypersensitive investigational drug(Thioctic acid).
* Patient with gastrointestinal history affected absorbing investigational drug or inhibiting normal gastrointestinal motility, gastrointestinal operation or gastrointestinal wound.
* Patient with renal, hepatic, bronchopulmonary, cardiovascular, gastrointestinal, metabolic, neurological, psychotic, oncologic, allergic disease, myocardial infarction, cardiac crisis, hepatitis or pancreatitis history.
* ECG is abnormal.
* Patient abused drug.
* Patient joined other clinical study within 3 months from the study initiation.
* Patient doanted whole blood within 2 months or plasma blood within 1 month from the first medication.
* HBsAg, HCV Ab or HIV Ab are positive.
* Patient who was not suitable to the study if judged by an investigator.
Bio-electrical Impedance Analysis Derived Parameters for Evaluating Fluid Accumulation

The purpose of this study is to assess fluid accumulation (FA) in the body using BIA (Bioelectrical Impedance Analysis) in critically ill patients treated in the ICU. This study is an observational cohort with an initial phase that analyzes prospective individual patient data

This research will begin by identifying subjects through the collection of initial data. The identification of subjects will involve using BIA (Bioelectrical Impedance Analysis) equipment. Subsequently, the subjects will be divided into two groups based on the initial BIA test results of body fluid balance. The first group will comprise patients with a body fluid balance exceeding 500cc, while the second group will consist of patients with a body fluid balance of 500cc or less. Throughout the study, various BIA-derived parameters will be closely monitored for both groups, starting from the initial BIA test until the patients are discharged from the ICU or for a maximum of 7 days of ICU care from the time of the first test.

Eligibility Criteria:
Inclusion Criteria:

* New patients admitted to Intensive Care Unit Cipto Mangunkusumo Hospital and Indonesia University University
* Willing to be included in this research and signed the consent form

Exclusion Criteria:

* Obesity(BMI\>35kg/m²) OR underweight (BMI \< 18,5 kg/m²)
* Pregnant or Breastfeeding
Effect of Insulin on Endothelin-Dependent Vascular Tone in the Forearm Circulation

Previous studies have shown that insulin may stimulate the release of endothelin (ET) from endothelial cells. This mechanism may contribute to the adverse vascular effects determined by chronic hyperinsulinemia. The aim of this study will be to evaluate the effect of local hyperinsulinemia on ET activity in the forearm circulation. To this purpose, we will assess the forearm blood flow response to ET receptor antagonism in control conditions and during intraarterial infusion of insulin. We will also measure changes in plasma ET-1 levels in response to the different pharmacological stimuli.

Previous studies have shown that insulin may stimulate the release of endothelin (ET) from endothelial cells. This mechanism may contribute to the adverse vascular effects determined by chronic hyperinsulinemia. The aim of this study will be to evaluate the effect of local hyperinsulinemia on ET activity in the forearm circulation. To this purpose, we will assess the forearm blood flow response to ET receptor antagonism in control conditions and during intraarterial infusion of insulin. We will also measure changes in plasma ET-1 levels in response to the different pharmacological stimuli.

Eligibility Criteria:
Between 40-65 years old.

No medications.

No medical problems.

No serum cholesterol levels below 200 mg/dl.

No contraceptives.
Transbronchial Needle Forceps for Endobronchial Ultrasound

Prove the feasibility of a needle forceps in patients with enlarged mediastinal lymph nodes

Patients with enlarged mediastinal lymph nodes must be staged. The EBUS TBNA technique is an established technique. Unfortunately the size of the needle is limited to 21 gauge. With tne new designed needle forceps it should be possible to obtain more material and establish the diagnosis more often

Eligibility Criteria:
Inclusion Criteria:

* enlarged mediastinal lymph nodes

Exclusion Criteria:

* comorbidities
Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine

This is a randomized, double-blind, placebo controlled, multicenter study in male and female participants who are seeking treatment for opioid use disorder.

After completing an up to 2-week screening period, subjects entered an open-label run-in induction phase with SUBOXONE (buprenorphine/naloxone) sublingual film for 3 days followed by a 4- to 11-day SUBOXONE sublingual film open-label run-in dose-adjustment period to achieve buprenorphine dosages ranging from 8 to 24 mg according to the SUBOXONE sublingual film prescribing information.

This is a 24-week non-residential study with participants being randomized after meeting randomization criteria. On Day 1 and Day 29 (± 2 days) participants will receive subcutaneous injections of 300 mg RBP-6000 or placebo. Thereafter, participants will receive 4 injections (once every 28 days ± 2 days) of either 300 mg or 100 mg RBP-6000 doses or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Currently meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for moderate or severe opioid use disorder
* By medical history has met DSM-5 criteria for moderate or severe opioid use disorder for the 3 months immediately prior to signing the informed consent form
* Is seeking medication-assisted treatment for opioid use disorder
* Is an appropriate candidate for opioid partial-agonist medication-assisted treatment in the opinion of the investigator or medically responsible physician
* Body mass index (BMI) of ≥ 18.0 to ≤ 35.0 kg/m\^2

Exclusion Criteria:

* Current diagnosis other than opioid use disorder requiring chronic opioid treatment
* Current substance use disorder as defined by DSM-5 criteria with regard to any substances other than opioids, cocaine, cannabis, tobacco, or alcohol.
* Positive urine drug screen (UDS) result at screening for cocaine or cannabis AND meets DSM-5 criteria for either moderate or severe cocaine or cannabis use disorder, respectively
* Meets DSM-5 criteria for moderate or severe alcohol use disorder
* Received medication-assisted treatment for opioid use disorder (e.g., methadone, buprenorphine) in the 90 days prior to providing written informed consent
Effects of Mindfulness, Mobilization of Resources, or Biofeedback on Stress Before OSCE

Stress generated during the curriculum might have deleterious effects on the wellbeing and the health of medical students. Objective and Structured Clinical Examinations (OSCEs) will be incorporated soon in the certification process as a final national undergraduate ranking examination. This exam will be an additional major stressor for medical students.

Stress coping strategies could be implemented to help them better prepare for this examination. The aim of this study was to compare the efficiency on stress reduction of three different 6-minutes coping interventions in medical student, few minutes prior to the OSCE.

This randomized, controlled and monocentric study will be conducted during the OSCE tests contributing towards the final exam grades for 4th year medicine students at the Claude Bernard Lyon 1 university.All the students will receive information for the study and sign consent before being randomized into four interventions groups. All the interventions will last six minutes long.

The randomisation groups are:

* Mindfulness through watching/listening video tape
* Mobilization of inner resources through watching/listening video tape
* Cardiac biofeedback guided standardized timing for respiratory rate and with immediate feedback on cardiac variability score
* Unemotional video tape as controlled group

Psychological stress will be measured using short questionnaires and self-rated Visual Analogue Scale (from 0 to 100mm) regarding perceived stress, answered by students before and after intervention. For measuring physiological stress, all the student will be equipped with emWAve® devices that allows us to record heart rate variability during the time of intervention. Students will also answer a questionnaire of personality.

Main objective is to show that interventions are better than control to reduce stress level before OSCE.

The main outcome is to compare the effect of the interventions on physiological stress, using HRV as physiological stress marker.

Secondary outcomes are to compare the effects of the interventions on psychological stress and to compare the specified aspect of the intervention. Finally, our project will permit to assess if the personality modulates the effectiveness of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adult person
* Registered as medical student at the university
* Participating at OSCE examination
* Have signed an informed consent form.

Exclusion Criteria:

* None
Brain Function and Perfusion in Patients With Heart Failure

The investigators will evaluate the determinants of cerebral impairment in patients with non-ischemic heart failure compared to controls, and its relation to cognitive function. They hypothesize that patients with heart failure have impaired brain perfusion and hemodynamic factors are associated with cognitive dysfunction.


Eligibility Criteria:
Inclusion Criteria Control Group:

* Healthy subject, as assessed by clinician
* Age matched with patient group

Exclusion Criteria Control Group:

* Age \< 18 years
* Carotid artery or intracranial disease, as assessed by echo-doppler (significant stenosis \> 50%)
* Unable or unwilling to undergo MRI
* The presence of ferromagnetic material in or on the body, for example tattoos with ferrous ink or pacemakers or cardiac defibrillators. Also the presence of pregnancy and claustrophobia.
* History of cognitive impairment
* Unable to understand procedures
* Unable or unwilling to provide informed consent

Inclusion Criteria DCM-group:

* Heart failure due to DCM
* 15 patients with NYHA class II
* 15 patients with NYHA class III/IV

Exclusion Criteria DCM-Group:

* Age \< 18 years
* History of myocardial infarction
* History of peripheral artery disease
* History of cerebrovascular disease or
* Carotid artery or intracranial disease, as assessed by echo-doppler (significant stenosis \> 50%)
* History of cognitive impairment
* Unable to undergo MRI (eg pacemaker)
* Unable to understand procedures
* Unable or unwilling to provide informed consent
Effect of Urinary Indwelling Time on Early Continence After Robot-assisted Radical Cystectomy With Orthotopic Ileal Neobladder.

The clinical trial assesses the effect of urinary indwelling time on early continence after robot- assisted radical cystectomy with orthotopic ileal neobladder.

Radical cystectomy is the gold standard for muscle-invasive bladder. Orthotopic ileal neobladder, as one of the urinary diversion methods, is preferred whenever possible to achieve a better postoperative quality of life. After surgery, the patient usually indwells a catheter until the anastomotic site heals. And the urinary indwelling time may have an effect on early continence. This is a prospective study including patients undergoing RARC with orthotopic ileal neobladder. Urinary continence recovery and perioperative complication will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with pathologically confirmed bladder cancer
2. Undergoing robot-assisted radical cystectomy with orthotopic ileal neobladder
3. Complete perioperative clinical data

Exclusion Criteria:

1. Patients diagnosed with distant metastasis
2. Patients who had urinary incontinence before surgery
3. Patients with unavailable follow-up data
Aesthetic Outcome of Electrodesiccation and Curettage vs Excision With Complex Linear Closure

The purpose of this study is to determine whether electrodesiccation and curettage (ED\&C) versus excision with complex linear closure affects esthetic outcomes (primary outcome). As secondary outcome, we plan to look at patient quality of life measures and complications. This will be a prospective, 2-arm, randomized, evaluator-blinded clinical trial. One half of the patients will receive ED\&C and the other half will receive excision with repair by complex linear closure. Three-months post-surgery, the scar will be evaluated via the patient observer scar assessment scale (POSAS), a validated scar instrument, as well as the trace-to-tape method, an objective outcome measure for linear postoperative scars. In addition, patients will be provided a validated quality of life survey to complete. Any adverse events will also be recorded.

Low risk lesions on the trunk and extremities can be treated via various modalities including topical therapies, ED\&C, and excision. The purpose of this study is to compare ED\&C versus excision with repair by complex linear closure. The wound following ED\&C will heal by second intention, meaning that there will not be any sutures placed. Complex linear closures following an excision will require two layers of sutures: a deep (subcutaneous) layer and a top (cutaneous) layer.

This study aims to investigate whether ED\&C versus excision with repair by complex linear closure for low risk lesions on trunk and extremities affects cosmesis. In other words, the research team would like to determine which of the following yields a more cosmetically appealing scar: ED\&C or excision with linear closure. As secondary outcomes, the research team plans to look at quality of life measures via a validated survey and complications.

There has been a prospective cohort study measuring quality of life following ED\&C vs excision vs Mohs surgery1 and another prospective cohort study measuring patient reported outcomes following ED\&C2. However, randomized control trials comparing the cosmesis and quality of life of these two methods appear to be lacking in current literature. The research team hopes that this study will provide new insight in cutaneous surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Able to give informed consent themselves
* Patient scheduled for treatment of low risk cutaneous neoplasms on the trunk or extremities (superficial or nodular basal cell carcinoma and squamous cell carcinoma in-situ).
* Willing to return for follow up visit

Exclusion Criteria:

* Incarceration
* Under 18 years of age
* Pregnant Women
* Lesion size equal to or greater than 2 cm.
* Aggressive tumor subtypes(invasive squamous cell carcinoma (any subtype), infiltrative(sclerosing) basal cell carcinoma, micronodular basal cell carcinoma.
* Recurrent tumors
Motivating Individuals With Lupus to Exercise

Physical activity and exercise are helpful for managing symptoms like fatigue in people living with systemic lupus erythematosus (lupus; SLE). Despite research supporting physical activity participation, people with lupus are often inactive and report being afraid to exercise. To that end, this project is a pilot randomized controlled trial for examining the efficacy of a home-based behavioral intervention based on social cognitive theory and motivational interviewing for increasing physical activity and decreasing fatigue.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Lupus
* be able to speak and read English
* being non-active defined as not engaging in regular activity (150 minutes or more of moderate physical activity per week)
* being impacted by fatigue defined as a score of 36 or higher on the fatigue severity scale

Exclusion Criteria:

* moderate or high risk for undertaking physical activity
Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds

The purpose of this study is to evaluate a novel topical negative pressure (TNP) wound therapy device called the SNaP® (Smart Negative Pressure) Wound Care System for the treatment of lower extremity diabetic, venous and mixed aetiology leg wounds.


Eligibility Criteria:
Inclusion Criteria:

* Patient has diabetic foot ulceration, venous ulcer, or mixed aetiology ulcer with a surface area \<100 cm2 and \<10 cm in widest diameter on lower extremity, but larger than 1 cm2 (venous and mixed aetiology ulcers will be defined by clinical exam of treating physician. Diabetic foot ulcers will be defined by clinical exam of the treating physician and as lower extremity ulcers in patients with a diagnosis of diabetes, but without venous stasis disease).
* Wound present for \>30 days.
* Patient has wound in location amenable to creation of airtight seal around wound using TNP dressings.
* Patient is able to comply with study protocol requirements.
* Patient is able to understand and provide written consent.

Exclusion Criteria:

* Patient has evidence of wound infection in the opinion of the physician.
* Patient has a thick eschar that persists after wound debridement.
* Patient has an HbA1C \>12%.
* Patient has ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinaemia, necrobiosis lipoidica, panniculitis, lupus erythematosus, scleroderma, or calcinosis.
* Patient has untreated osteomyelitis.
* Patient has any other condition that, in the opinion of the investigator, makes the patient inappropriate to take part in this study.
* Patient is allergic to the wound care device or occlusive dressing.
* Patient has exposed blood vessels.
* Patient is pregnant or pregnancy is suspected.
* Patient is actively participating in other clinical trials that may interfere with their participation in this study.
Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion SNAP Trial

This study randomizes degenerative spondylolisthesis and/or degenerative disc patients into two groups: one to receive a new ceramic implant and a control group with a more traditional PEEK plastic implant. The procedure uses a single oblique cage in each group. The study will measure and compare pain and disability improvement with the two implanted devices over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age 18-75 years
* Chronic low back pain unresponsive to at least six months of conservative care
* MRI and standing x-ray evidence of Pfirrmann Grade III or greater disc degeneration and/or degenerative or isthmic spondylolisthesis of Grade I or II

Exclusion Criteria:

* Osteoporosis
* Patients with prior failed fusion at the same level
* Degenerative scoliosis
* Degenerative spondylolisthesis greater than Grade II
* Pregnancy
* Psychiatric or mental disease
* Alcoholism (drinking more than 5 units per day)
* Active infection or prior infection at the surgical site
* Active cancer
* Insufficient language skills to complete questionnaires
* Participation in another study
* More than two symptomatic levels that need fusion
Feasibility Study to Evaluate Safety of Nutriseal™ Nutriplace™ System

This is a single center, non-randomized feasibility clinical evaluation that is designed to affirm the safety of the Nutriplace™ System guidance during the placement of the Nutriseal™ enteral feeding tubes.

Enteral nutrition is the preferred route for the provision of nutritional support in most critical ill patients with functional gastrointestinal tract. Achieving early enteral nutrition (EN) in critically ill patients is associated with fewer major complications, reduced mortality and length of hospital stay, and significant cost savings.

It is estimated that approximately 1.2 million feeding tubes are placed blindly each year in the United States alone. Despite the obvious advantages of the enteral tube feeding, inadvertent placement of enteral feeding tube (EFT) into the airway is relatively common and can result in significant pulmonary injury including pneumothorax and pneumonia. Airway misplacement occurs in 1.2-4 % of blind EFT insertions, with 0.2 to 1.2% of all the feeding tube placements cause pulmonary complications to patients.

The gold standard for detecting inadvertent placement of a feeding tube in the lungs is radiography. However, because of its cost, possible delay of feedings while waiting for radiography, and risk for radiation exposure, clinicians continue to seek for alternative methods to confirm correct placement.

All the above mentioned, emphasizes the fact that safe and effective delivery of nasoenteral tube feedings requires assurance that the feeding tube tip is in a proper position.

The Nutriplace™ System is an electromagnetic tracking system which tracks the path of the feeding tube during placement.

The benefit of the system when EFT is misdirected into the pulmonary system is a real-time visual tracing, which may prompt users to withdraw the tube and reinsert it.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be \>21 years of age
2. Patients must require placement of a nasoenteral feeding tube
3. Patients have an endotracheal tube, OR Do not have an endotracheal tube but are sedated (RASS score of -2 or less) and/or obtunded (Glasgow Coma scale of 9-12)
4. Patients or legal authorized representative must be able to understand and adhere to all protocol procedures and be willing and able to provide written informed consent

Exclusion Criteria:

1. Patients must not have a history of:

   * Esophageal varices or ulcers
   * Upper airway obstruction
   * Upper GI stenosis or obstruction
   * Trauma involving sinuses, nares face or neck that would prevent Nasogastriv (NG) tube insertion
   * Deformities of the sinus cavities and/or skull base
   * Esophageal cancer or neoplasm
2. Patients must not have a significant concomitant illness that would adversely affect their participation in the study
3. Female patients who are pregnant or lactating