cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care

This study will evaluate a new dressing to be used for post-incision care for abdominoplasty patients. The hypothesis is that this dressing will minimize scar formation.

This study will evaluate a new dressing in up to 30 patients who have undergone an abdominoplasty procedure. They will wear the dressing through 8 weeks post surgery and the scar will be evaluated at 3 months post surgery.

Eligibility Criteria:
Inclusion Criteria:

* subjects who have undergone an abdominoplasty 1 week prior to study participation

Exclusion Criteria:

* subjects with a history of collagen vascular disease or scleroderma
* subjects with known adverse reactions to steri-strips, medical tapes or adhesives
Long-Term Study of MP-214 in Patients With Schizophrenia

The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from the patient before the completion of Study A002-A4
* Patients who have completed the A002-A4 study

Exclusion Criteria:

* Patients who are experiencing ongoing, uncontrolled, clinically significant adverse events (AEs), as judged by the investigator (or subinvestigator)

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Local CO2 Increases Core and Wound Temperature

Eighty adult patients undergoing open colon surgery will be randomized to either:standard warming measures or to additional insufflation of humidified carbon dioxide in the open wound cavity during major abdominal surgery.

PRIMARY AIM is to test if core and local temperature can be increased.

Eighty adult patients undergoing open colon surgery will be randomized to either:

standard warming measures including heating sheets, warming of fluids, and insulation of limbs and head, or to additional insufflation of humidified carbon dioxide (approx. 30ºC, approx. 80-100% relative humidity) via a simple humidifier (sterile warmed water) connected to a gas diffuser (Cardia Innovation AB) that is able to create a local atmosphere of 100% carbon dioxide (humidified ) in the open wound cavity.

PRIMARY AIM The primary aim of this study is to evaluate if humidified carbon dioxide insufflated into an open surgical wound can be used to warm the core, open wound cavity, and the wound edges during major abdominal surgery.

SECONDARY AIMS Secondary aims are to evaluate possible differences between the groups regarding complications and clinical differences including histological signs.

Eligibility Criteria:
Inclusion Criteria:

* major open abdominal surgery (colon surgery) in adults patient signed informed consent

Exclusion Criteria:

* acute surgery
Perinatal Research on Improving Sleep and Mental Health

The goal of this clinical trial is to compare two sleep programs in pregnant people with insomnia. The main questions it aims to answer are:

1. What is the efficacy of digital cognitive behavioral therapy for insomnia (CBT-I) versus digital sleep hygiene education (SHE) for preventing perinatal depression?
2. Is the effect of digital CBT-I on perinatal depression mediated through prenatal insomnia symptom improvement?
3. Is the effect of digital CBT-I on perinatal depression moderated by baseline depressive symptom severity?

Participants will receive one of two sleep programs - SHE or CBT-I. Both involve six weekly online sessions. Participants will complete surveys and interviews until 1 year postpartum.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant 14-28 weeks gestation
* 18 years or older
* Daily access to a web-enabled computer, smart phone, or tablet
* Current elevated insomnia symptom severity and insomnia disorder
* English speaking

Exclusion Criteria:

* Current major depression
* Taking or planning to take antidepressant medication (ADM)
* Other diagnosed or suspected sleep disorder
* Other psychiatric or medical issues (e.g., bipolar disorder, active suicidality, bed rest)
* Night shift worker
Self-System Therapy for Older Adults With Lung Cancer

The purpose of this study to use Self-system therapy (SST), to treat depression and lung-cancer-related distress in older adults (65 years and older).

The investigator will examine whether delivering the SST intervention will be both feasible and acceptable to study participants. The investigator will also examine whether participation in SST can help alleviate symptoms of depression and distress while helping improve overall functioning in older adults with advanced lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* English-speaking
* The patient has a diagnosis of late-stage (III-IV) lung cancer and is living at her/his home.

Exclusion Criteria:

* Unable to provide informed consent
* Visual or hearing impairments that preclude participation
* Serious mental illness
A Mass Balance Study of LCB01-0371 After a Single Oral LCB01-0371 Dose With a [14C]LCB01-0371-microtrace

The primary objectives of the study are:

• To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a \[14C\]-LCB01-0371-tracer dose to healthy subjects

This is a single-center, open-label, non-randomized, one-sequence, one-period, single arm study in healthy male subjects. A total of 6 subjects will be enrolled in the study, and a minimum of 4 evaluable subjects are considered sufficient. An evaluable subject is defined as a subject who has provided whole blood, plasma, exhalation and excreta samples sufficient for evaluation of the primary objectives. Study subjects will be screened for eligibility to participate in the study within 28 days before dosing.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male adults aged 19 to 45 (inclusive) years
2. Body weight at least 55 kg and calculated Body Mass Index (BMI) ranging from 18.0 to 25.0 kg/m2
3. Subjects who agreed to voluntarily participate in this study and comply with all the protocol requirements by signing informed consent form
4. Subjects who were deemed as eligible subjects by investigators on their physical examination, laboratory findings, and medical examination by interview.
5. Subject who were not to have a history of drug hypersensitivity or allergic reactions related to antibiotics, etc

Exclusion Criteria:

1. Subjects who had a clinically significant disease or a past history of disease
2. Subjects who had a past history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or surgery (excluding simple appendectomy or hernia surgery) that may have affected to absorption for the study drug.
3. Subjects who had the following laboratory test results at screening; AST, ALT, and total bilirubin ≥ 1.5 times upper limit of normal or CK (Creatine Kinase) \> 2.5 times upper limit of normal
4. Subjects who had history of drug abuse or showed a positive result on a drug screening urine test.
5. Subjects who showed a positive result for a serology test (HBsAg, Anti-HCV , HIV Ab, or VDRL), etc.
Epidemiology and Outcome of Anaphylactic Shocks Admitted to Intensive Care Unit

Anaphylaxis is a severe life-threatening reaction following exposure to an antigen. Its incidence is progressively increasing in the general population over years, accompanied with an increased number of hospitalizations. Although rare, this condition is often associated with a significant morbidity and mortality. The mortality rate has been recently estimated at 0.84 (95% CI, 0.79 to 0.88) per million per year in the French adult population. Age, chronic medication and cardiac or pulmonary comorbidities have been reported to increase the risk of a severe reaction. Obesity, age and cardiovascular comorbidities have been identified as risk factors for fatal anaphylaxis. However, the risk factors for death after ICU admission have not been elucidated yet.


Eligibility Criteria:
Inclusion Criteria:

* Being \> 18 years old
* suffered an anaphylactic reaction, regardless of the location or causative allergen
* transferred alive in an ICU

Exclusion Criteria:

* dead within less than one hour after admission
Family-Centered Diabetes Project

The purpose of this project is to determine whether a diabetes lifestyle program will improve the lives of Native American people living with diabetes. We recruited Native American people living in 8 Pueblo communities served by 3 Indian Health Service clinics. Forty percent of people living with diabetes in those communities participated in an interview and had height, weight, blood pressure and hemoglobin A1c measured at the beginning. Then they received a lifestyle program in either groups or one-on-one, or another group which got the intervention after one year (comparison group). The program was developed using input from community members, tribal leaders, and clinic staff, and was taught by community members in or near the participating communities. After each session, participants were asked for feedback about the curriculum. After the program ended, the interview and clinical measures were repeated. Feedback to tribal leaders and clinical staff is ongoing.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years or older with diabetes living in a participating Native American community served by one of three participating Indian Health Service clinics.

Exclusion Criteria:

* Unable to complete a yearly interviewer administered questionnaire and clinical measures of height, weight, blood pressure, and fingerstick hemoglobin A1c.
* Unable to participate in 5 lifestyle intervention meetings occurring over a one year period.
UroLift System TOlerability and ReCovery When Administering Local Anesthesia

The purpose of the study is to evaluate procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit.

The randomized portion of the study is a prospective, multicenter, non-blinded, single arm trial evaluating procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia. All subjects undergo UroLift system treatment and will be followed through 5 years after receiving the investigational device.

Eligibility Criteria:
Inclusion Criteria:

* Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)

Exclusion Criteria:

* Size, volume,length of prostate
The Effect of Left Ventricular Filling Pressure on Pulmonary Clearance of Free Radical Loaded White Blood Cells and Platelets in Congestive Heart Failure Patients Before and After Biventricular Pacing

1. To assess whether a correlation exist between the degree of pulmonary clearance of free radical positive white bloodcells and platelets and the degree of pulmonary congestion in congestive heart failure (CHF) patients
2. To asses whether cardiac resynchronization therapy improves pulmonary clearance of free radical positive white blood cells and platelets in CHF patients by alleviating pulmonary congestion
3. Interaction of oxidative stress with circulating endothelial progenitor cells (EPCs) and presence of apoptotic endothelial (progenitor) cells

Evidence exists that oxidative stress is enhanced in congestive heart failure patients resulting in damage to cellular lipids, proteins and DNA. Because of free radical-induced apoptosis of skeletal muscle fibers, oxidative stress is an important contributor to skeletal muscle fatigue and low exercise tolerance of congestive heart failure patients. Enhanced oxidative stress in congestive heart failure can exert negative inotropic effects and can have important effects on the structure and function of the myocardium, and may be implicated in the progression of congestive heart failure. Free radical stress could also impair recruitment and differentiation of circulating endothelial progenitor cells resulting in increased all cause mortality.

Reduced pulmonary clearance of free radical loaded white blood cells and platelets is an important contributor to enhanced oxidative stress in congestive heart failure patients. Failure of pulmonary clearance of free radical loaded white blood cells and platelets probably results from pulmonary congestion which has led to the rationale of the current study. Biventricular pacing for resynchronization therapy in congestive heart failure patients reduces left ventricular filling pressure and pulmonary congestion. Biventricular pacing may therefore augment pulmonary clearance of free radical loaded white blood cells and platelets in congestive heart failure patients.

We conduct a prospective, observational clinical study to investigate the correlation of left ventricular filling pressure, pulmonary clearance of FR loaded circulating white blood cells and platelets and number of endothelial progenitor cells in congestive heart failure (CHF) patients before and after implantation of a biventricular pacemaker for resynchronization therapy.

Eligibility Criteria:
Patient selection

Informed consented participants are recruited among all patients admitted to the OLVG hospital.

Inclusion criteria:

* Chronic congestive heart failure patients of all ages selected for biventricular pacemaker implantation for resynchronization therapy
* Dyspnoe NYHA class III and IV
* Optimal and constant heart failure treatment according to the ESC guidelines

Exclusion criteria:

* Renal failure (creatinine \> 1.70 mg/dl)
* Signs of infection or inflammation
Cu-64-PSMA-I&T Positron Emission Tomography (PET) Imaging of Metastatic PSMA Positive Lesions in Men With Prostate Cancer

This is a prospective, open-label Phase 2 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with recurrent metastatic prostate cancer after radical prostatectomy or radiation therapy.

The study will include a group of 26 patients with metastatic prostate cancer. Each patient will be administered a 7-9 mCi intravenous dose of copper Cu 64 PSMA I\&T injection. PET/CT images will be acquired for all patients at 1 hour ± 15 minutes and 4 hours ± 30 minutes post copper Cu 64 PSMA I\&T injection.

The PET/CT images will be interpreted independently by three readers blinded to all patient information. Each patient study will be assessed and scored for the detection of prostate cancer. Specifically, each reader will categorize images as "Disease" or "No Disease" based only on tumor uptake of copper Cu 64 PSMA-I\&T in each of the four regions: 1) prostate bed or prostate gland, 2) lymph nodes (pelvic and extra pelvic), 3) bone, and 4) viscera/soft tissue. Analysis of the reads will be used for determination of the CLR and CDR for 1 hour and 4-hour post-injection imaging of copper Cu 64 PSMA I\&T PET/CT by comparison to the Composite Reference Standard.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically proven prostate adenocarcinoma.
2. Prior radical prostatectomy or radiation therapy with curative intent.
3. Recurrence of disease defined as:

   1. Prior Radical Prostatectomy: PSA \> 0.2 ng/mL, or
   2. Prior Radiation Therapy: 2 ng/mL rise in PSA over post-treatment nadir
4. Patients with at least one extraprostatic site of disease suspected based on prior imaging or diagnosed by biopsy.
5. Age greater than or equal to 18 years.
6. Able to understand and provide signed written informed consent.

Exclusion Criteria:

1. Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway, unless subject has a rising PSA level.
2. Body weight greater than 350 lb (158 kg).
3. Investigational therapy within the past 30 days.
4. Creatinine clearance (ClCr) less than 30 mL/min.
5. Participants who are capable of fathering a child and who are unwilling to take precautions to prevent pregnancy.
Development and Application of Portable Multisensory Stimulation Device

This is a study to develop the vibroacustic devices, and to compare the effects between vibroacustic device therapy and music therapy in adults with dementia or with neck pain. The immediate effect and long-term training effect would be assessed.

The outcome measures included functional assessment ( such as: range of motion, balance etc.) and neurolphysiological assessment (such as: electroencephalographic activity or electromyographic activity).

Eligibility Criteria:
Inclusion Criteria:

* mild to moderate Dementia
* age-matched healthy subjects

Exclusion Criteria:

* can not follow order
Minimizing Ventricular Pacing

The aim of this study is to evaluate the effect of minimizing right ventricular pacing in dual-chamber pacemaker patients with sinus node disease (SND) and first degree atrioventricular block (AVIB)on exercise capacity, quality of life and other heart failure measures.


Eligibility Criteria:
Inclusion Criteria:

* prolonged PQ interval \> 200 ms,
* percentage of right ventricular pacing with standard AV delay \> 90.

Exclusion Criteria:

* second or third degree atrioventricular block,
* permanent atrial fibrillation.
Treatment of Myotonia - Lamotrigine Versus Namuscla

In this clinical study, the aim is to investigate whether there is a difference in treatment of myotonia using two drugs. A difference there can justify the significantly higher cost when treated by Namuscla versus Lamotrigine.

According to the current corona pandemic, the investigators designed an app to use for data collection in the study. The app also ensures that patients who live far from the clinic more easily can participate.

On 18 May 2020, the National Board of Health in Denmark approved Namuscla for the treatment of myotonia. Myotonia is a congenital muscle disease that delays muscle relaxation after a muscle contraction. Myotonia can be disabling, but with treatment, most are able to work. Namuscla is the first registered drug to treat myotonia, however, the active part mexiletine is not new. It has been used off-label to treat myotonia for decades. The price for the new preparation is high with a daily cost (approx. 70 EU/dollar). In 2017, the investigators found evidence that treatment with lamotrigine is efficacious against myotonia. Treatment with lamotrigine can reduce the price to 150 EU/dollar per year.

Therefore, the aim of the study is to investigate whether there is a difference in the effects om myotonia and side effects of the two drugs, which can justify the significantly higher cost when treated with Namuscla in a double blinded, inferiority, cross-over study lasting 4 months.

According to the current corona pandemic, the study is designed without need of physical attendance so that inclusion and collection of experimental data can take place, by phone conversations, video-guided testing, and diary registration via a study-App. It also ensures that patients who live far away more easily can participate. Blood tests and ECGs can be performed locally.

Eligibility Criteria:
Inclusion Criteria:

1. Capable adult women and men (age ≥ 18 years).
2. Diagnosed with Myotonia Congenita (Becker and Thomsen type), Paramyotonia Congenita, or Hyperkalemic periodic paralysis.
3. Myotonia under treatment or which significantly limits the daily activities (MBS\> 2).

Exclusion Criteria:

1. Allergy to lamotrigine, mexiletine, or the inactive ingredients in trial medication.
2. Disease, which is affected by trial medication such as heart disease (ischemia and arrhythmia), epilepsy, and significant renal or hepatic failure.
3. Treatment that, in the opinion of the project manager, can affect the study result - medication with significant interactions with trial medication.
4. In case of smoking, start or cessation during the study.
5. Pregnant or breastfeeding during the study period. Fertile women with a positive pregnancy test at the time of entry into the trial, or who do not use safe contraception during the project period.
Testing the Causal Effects of a Civic Engagement Intervention on Health and Wellbeing Among Youth (I-ACTED)

The purpose of this research is to understand how participating or not participating in an action civics curriculum may affect the health and wellbeing of young people. Participants will be chosen from students who attend certain schools that choose to participate in the action civics curriculum. Participation in this research involves completing surveys during class time in the Spring and Fall 2021-2022 semesters and then completing online surveys outside of class in the future.

Equal access to civic resources, such as opportunities for civic engagement and connections to one's community, are an important part of a culture of health. Meaningful experiences in civic engagement and community connectedness are transformative for young people - especially for youth from marginalized backgrounds, who often feel voiceless and excluded from decision-making in civic and social institutions. Theories and correlational evidence point to positive associations between civic engagement (e.g., volunteering, voting, and feelings of civic empowerment) and better mental, physical, and behavioral health and wellbeing. Meaningful civic engagement experiences may have an especially powerful effect on health and wellbeing for those from traditionally marginalized backgrounds. However, causal pathways between civic interventions, civic outcomes, and health and wellbeing outcomes among are not firmly established. Further, how civic engagement and sense of community affect health and wellbeing outcomes are unknown, and questions remain about for whom these effects may be especially beneficial. In this study, we ask whether an established civic intervention called Action Civics affects civic engagement and sense of community, and subsequently affects health and wellbeing among youth. To build on these observational findings, the study team will: (a) examine the causal links between youth civic engagement and sense of community and health, and (b) test whether an established school-based, civic engagement intervention can affect individual health and wellbeing and equity outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled Middle or High School student
* Enrolled in a course with a teacher from a school participating in the study
MRA/fMRI Study of Spontaneous Migraine

The purpose of this study is to examine migraineurs during spontaneous migraine attacks without aura, using high resolution magnetic resonance imaging (MRI), to study following:

* Changes in resting state blood-oxygenation-level-dependent-signal (BOLD-signal) using functional MRI (fMRI).
* Changes in circumferences of intra- and extracranial arteries using MR-angiography (MRA).
* Changes in regional and global cerebral blood flow (CBF) using the arterial spin labeling (ASL) method.

Moreover to perform diffusion tensor imaging (DTI) scans during spontaneous migraine attacks.

The migraine specific drug sumatriptan will be given to relieve pain and the effect will be registered using MRA and fMRI if possible.


Eligibility Criteria:
Inclusion Criteria:

* Migraine without aura according to IHS criteria.

Exclusion Criteria:

* Other primary headaches.
* Tension-type headache more than 5 days/month.
* Use of anti-pain medication before the scanning on the examination day.
* Pregnant or nursing women.
* Contraindication for MR scan.
* Anamnestic or clinical signs of cardiovascular or cerebrovascular disease, unregulated psychiatric disease or drug misuse.
* Other clinical conditions assessed by the examining doctor.