cyrilzakka/clinical-trials huggingface dataset:
Ketamine for Acute Pain Management After Trauma

The purpose of this study is to compare the effectiveness of Ketamine drip along with usual care and usual care alone on trauma patients and to longitudinally quantify the pain experience of patients during hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Adult trauma patients
* Admission to Shock Trauma ICU (STICU) or Surgical Intermediate Unit (SIMU)
* Randomization within 6 hours of arrival

Exclusion Criteria:

* Patient not expected to survive
* Contraindications to ketamine Allergy, Poorly controlled hypertension, Cardiac arrhythmia disorders (including atrial fibrillation), congestive heart failure, unstable coronary artery disease or recent myocardial infarction( MI)(within 6 months), cirrhosis, seizure disorder, and for those patients with unknown medical history - median sternotomy scar, mechanism of injury is fall from standing, 65 years of age or older, any arrhythmia on EKD)
* pregnancy
* in police custody
* history of dementia or movement disorder (i.e. Parkinson's)
Transpulmonary Pressure in Right Ventricle Protection of ARDS

To compare the effect between mechanical ventilation strategy guided by transpulmonary pressure and tranditional lung protective ventilation strategy in acute respiratory distress syndrome for right ventricle protection.


Eligibility Criteria:
Inclusion Criteria:

* duration of invasive mechanical ventilation less than 72 hours;
* meet the diagnostic criteria of Berlin definition for ARDS;
* age older than 18

Exclusion Criteria:

* esophageal surgery or damage;
* cardiac surgery;
* severe bronchopleural fistula;
* serious arrhythmia; pneumothorax;
* tricuspid stenosis;
* heparin allergy;
* chronic pulmonary heart disease
Coping Skills for Patients With Chronic Obstructive Pulmonary Disease (COPD) and Their Caregivers

This study is an NIH-funded clinical trial conducted at Duke University Medical Center and Ohio State University. The purpose of this study is to examine the effects of a telephone-based, care-giver assisted, coping skills training (CST) program in patients with Chronic Obstructive Pulmonary Disease (COPD) and their caregivers. This may help COPD patients and their caregivers to deal better with the stress of lung disease. This study will test 3 primary hypotheses: 1) That enhanced CST will be more effective in improving quality of life compared to a Usual Medical Care plus COPD education and symptom management control group; 2) That enhanced CST will be associated with better medical outcomes (i.e., greater survival and fewer COPD-related physician visits or hospitalizations) compared to Controls over a follow-up period of up to 4 years; and 3) That improvements in quality of life and survival will be mediated by increased functional capacity and better coping.

This proposed study builds upon our prior research by: a) adapting and refining our CST protocol, which was effective in improving psychosocial adjustment in patients awaiting lung transplantation, to a broader population of patients with COPD who are not immediate candidates for lung transplantation; b) enhancing our intervention to improve functional capacity, reduce somatic symptoms, and improve survival; c) examining the impact of CST on medical expenditures; and d) including caregivers in an enhanced CST intervention.

Overall, 746 participants (patients and caregivers) were consented for participation into this study from both Duke University Medical Center and Ohio State University. Of these, 326 patients were randomized and participated in the study intervention along with 252 consented participants who acted as a caregiver; in total 578 participants (patients and caregivers) were involved with the study intervention.

Eligibility Criteria:
Inclusion Criteria:

* male or female outpatients 21 years of age or older
* a diagnosis of COPD
* FEV1 25%-80% of predicted value
* FEV1/FVC \<70%
* capacity to give informed consent and follow study procedures

Exclusion Criteria:

* dementia
* psychotic features including delusions or hallucinations
* acute suicide or homicide risk
* other illness (e.g., cancer) that is likely to cause death within 3 years
* unstable angina
* congestive heart failure stage III - IV by NYHA classification
* active involvement in pulmonary rehabilitation or a formal exercise program
Small Versus Large Bite Closure of Emergency Midline Laparotomy

In daily practice, midline laparotomy is an incision frequently performed by surgeons to achieve a rapid and wide access to the abdomen. However, incisional hernia stands as the most common complication following this type of incision, with an incidence reaching up to 20% and even higher in the case of emergency laparotomy.

A recent randomized controlled trial compared small bite sutures and large bite closure of elective midline laparotomy and reported a significant decrease of incisional hernia rate from 18% to 5.6% in favor of small-bite technique. These promising results were subsequently confirmed in a wide-scale multicenter double-blinded randomized trial, the STITCH study.

The investigators will conduct this randomized controlled trial to compare the small tissue bite (SB) technique and the large bite (LB) technique for closure of emergency midline laparotomy. The main outcome of the study will be the incidence of incisional hernia within one year after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of both sexes aging less than 70 years old

Exclusion Criteria:

* All procedures which will be performed on elective basis will be excluded
* patients who are pregnant.
* Patients on systemic steroid or chemotherapy
* patients with incisional hernia or fascial defect; and/or relaparotomy within 30-days of another surgical intervention.
Pain Medication After Ambulatory Surgery

In Finland, there are no guidelines concerning post-operative pain medication of ambulatory surgery patients. There is a wide variety in drug prescription and medication practices of various doctors and clinics. To treat patients' pain safely, type of surgery, unique patient needs, risks, adverse effects and patient's capacity to follow instructions should be assessed during the few hour visit at the clinic. In many clinics, pain is treated after hospital discharge with strong opioid oxycodone, but the amount and dose of prescribed oxycodone varies. In Helsinki Universitys Hospital, Peijas Hospital, investigators have over 2000 ambulatory surgery procedures annually. Investigators have strict policy in oxycodone use after patient discharge compared to some other Finnish ambulatory surgery clinics. The aim of this study is to evaluate, whether the prescribed pain medication is sufficient and whether patients' suffer from adverse effects after discharge from ambulatory surgery (letter interview). The study proceeds in three phases: 1) observation of current medication practice, 2) observation after optimization and standardization of hospitals drug prescription protocol, 3) evaluation of mobile phone app in pain medication follow up.

After informed consent, all patients operated as ambulatory surgery patients during the study period are given a letter interview for pain, pain medication and symptom follow up. They are also given a return envelope (with paid postal fee) to return the interview.

Based on the results of the first interview phase, our pain medication practice is reconsidered by anesthetists and surgeons to create a standard operating protocol for pain medication. The standard operating protocol is informed to personnel. Then, patient interview phase is repeated for another 3 months.

Then, investigators continue with a pilot study on using a mobile phone app in evaluating patients pain, sufficient pain medication and adverse effects. All patient with informed consent, suitable mobile phone, and willing to use it for reporting pain for hospital personnel are contacted via the mobile app. Other patients operated during that study period are interviewed by either letter interview or phone interview. Investigators try to estimate whether mobile apps are suitable for pain and medication follow-up.

Eligibility Criteria:
Inclusion Criteria:

All plenipotentiary patients, operated as ambulatory surgery patients in our clinic during the study period, with informed consent

Exclusion Criteria:

We do not accept patients, who are not plenipotentiary (minor, incompetent, prisoners, conscript in military service) or do not understand finnish or swedish written information
Clinical Trial for Oral Formula of Vanillin and Wheat Germ Oil for Treatment of Mild and Moderate COVID-19 Viral Disease

* The study is a randomized clinical trial to assess a natural formula of vanillin \& wheat germ oil to treat and stop the clinical progression of COVID-19.
* The study aims to treat people with mild-to-moderate COVID-19 before their cases become severe.
* The study duration is a 5-day experimental intervention and an extended 4 weeks follow up.


Eligibility Criteria:
Inclusion Criteria:

1. PCR confirmed diagnosis for COVID-19.
2. Age ≥18 years.
3. Both genders
4. The disease started within 7 days (ideally 72 hours) of diagnosis or clinical deterioration.
5. Patients diagnosed as mild or moderate

Exclusion Criteria:

1. Patients diagnosed with severe Illness: Individuals who have SpO2 \<92% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) \<300 mm Hg, respiratory frequency \>30 breaths/min, or lung infiltrates \>50%.
2. General: advanced kidney disease; advanced liver disease; pregnancy (known or potential) or lactation, and advanced cardiovascular diseases.
3. Allergy to Vanilla flavor, vanillin, or wheat germ oil
4. Active cancer
The Effect of rTMS Treatment on Alzheimer's and Sleep Quality

This research is being conducted to study whether rTMS (repetitive Transcranial Magnetic Stimulation) could be potentially used as a treatment for Alzheimer's disease. rTMS is a technique that stimulates the brain by rapidly switching a magnetic field in a coil placed over your head. Prior to rTMS, single pulse TMS will be used to localize the specific brain region that we are interested in.

Upon meeting the inclusion criteria and providing informed consent, each participant will complete a series of cognitive assessments and rTMS treatments at the TMS Lab at Riverview Health Center. Each treatment session will involve implementing rTMS, while the patient is involved in a cognitive exercise such as naming object or action. The study sessions will be scheduled as follows: Block 1: 5 days/week for two weeks followed by 2 days a week for 1 week, followed by once a week for 1 week (total of 13 treatments); Pause: 4 weeks of no treatment; and Block 2: another 13 sessions of treatment with the same pattern as Block 1. One of these two sets of treatment (Block 1 or Block 2) will be sham and one will be real. Sham treatment sessions are identical to real treatment sessions, except that there is no magnetic stimulation. Patients will be randomly assigned to receive either sham or real treatment first. The purpose of sham treatment is to have a control group data that the plausible improvement as a result of rTMS can be compared to. By designing two sets of sham-real or real-sham treatment sessions, every participant will receive a real treatment, while we will also have control data.

The cognitive assessments will be done at the baseline, and then on weekly basis. A subgroup of the study population will be recruited for investigating the second objective: effect of rTMS on sleep quality. Those patients will be required to sign a second consent; then, the patients will go through full-night sleep study at Misericordia Health Center at the same time intervals as their cognitive assessments.

Eligibility Criteria:
Inclusion Criteria:

* Individuals must have a MoCA score between 5 and 26, indicating mild cognitive impairment or dementia.
* Participants must have probable early or moderate Alzheimer's disease as confirmed by their treating neurologist or psychiatrist, and/or by the co-investigators.

Exclusion Criteria:

* A recent (the last 3 months) history of stroke, recent (the last 3 months) head injury and loss of consciousness, any history of epilepsy, seizures, multiple sclerosis (MS), Amyotrophic Lateral Sclerosis (ALS), or Autism.
* Recent changes in medication (i.e. patients should be in a relatively stable phase of disease).
* The presence of metallic objects in the body; dental implants are fine but people with pacemakers are to be excluded; basically anything that is unsafe under MRI would be considered unsafe for TMS application.
To Evaluate Pharmacokinetics and Pharmacodynamics of Z-215 in Healthy Male Subjects

The purpose of this study is to evaluate pharmacokinetics and pharmacodynamics of Z-215 (10 mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium (10 mg, 20 mg ) in Healthy Male Subjects. And to evaluate food-effect in Healthy Male Subjects administrated Z-215 20 mg.


Eligibility Criteria:
Inclusion Criteria:

* Has negative results for H. pylori IgG antibody at screening.
* A body mass index 18.5≦BMI\<25.0 kg/m\^2 at screening.
* Able to understand the consent of the study and comply with the study. Able to give informed consent in writing before participating in the study.

Exclusion Criteria:

* Has a history of PPI allergy.
* Has a history of drug or food serious allergy.
* Presently has or has a history of diseases that may affect evaluation of the study results such as gastrointestinal, hepatic, renal, respiratory, endocrine, blood, cardiovascular, mental or congenial metabolic disease.
* Has a history of surgery (such as resection of the liver, kidney, or digestive tract) that may affect the pharmacokinetics of the study drug.
* History of previous and current acid-related diseases.
* Received H. pylori eradication treatment within 6 months before screening.
* Has 450msec\<QTC by Fridericia test at screening ECG .
* Has hypoacidity or anacidity. Or be determined that low gastric acid or no stomach acid by the gastric pH monitoring at baseline period.
* History or suspicion of drug, opioid, alcohol abuse or positive screening results.
* Use of any prescription drugs within 4 weeks prior to baseline period.
* Use of any over-the-counter drugs within 2 weeks prior to baseline period.
* Received blood transfusions within 12 weeks or donated ≥400mL of whole blood within 12 weeks or ≥200mL of whole blood within 4 weeks prior to baseline period. Donated platelet or plasma within 2 weeks prior to baseline period.
Optical Coherence Tomography in Patients With Radiotherapy for Head and Neck Cancer

The purpose of this study is to determine whether any eventual skin damage caused by radiation therapy can be detected and monitored at a subclinical level via optical coherence tomography (OCT). Another key question is whether subclinical OCT detected skin damage correlates with acute and late clinical toxicity.

Head and neck cancer patients that meet the eligibility criteria and singned the informed consent will undergo OCT-measurements before, during and after the course of radiation therapy. At the same time-points the skin areas are evaluated with dermatoscopy and patients are asked to self-assess their quality of life (EORTC QLQ C30 and respective head and neck module H\&N 43). Before the onset of radiation therapy radiation sensitivity analysis will be performed with in-vitro irradion of peripheral blood lymphocytes (FISH).

Eligibility Criteria:
Inclusion Criteria:

* Patients with cancer located at: nasopharynx, oropharynx, hypopharynx, larynx, oral cavity and definitive or adjuvant radiation- or radio-chemotherapy

Exclusion Criteria:

* reduced mental capacity
* treatment with C225 Cetuximab
* bearded patients
* overt skin disease
* vast tattoos in the neck region
Removal of Protein Bound Uremic Toxins by Modified Plasma Separation and Adsorption Combined With Hemodialysis

The aim of this study is to examine removal of protein bound uremic substances by mFPSA in chronic hemodialysis patients. mFPSA is an extracorporal blood purification system developed for detoxification in acute liver failure by removal of protein bound as well as water soluble substances.

Measurements of uremic protein bound substances before and after mFPSA and a preceding routine hemodialysis session.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* Anuria
* Chronic hemodialysis dependence

Exclusion Criteria:

* No present history of bleeding episodes
* Cardiac diseases
Therapy for People With Opioid Use Disorder

The goal of this pilot clinical trial is to test the feasibility of a 12-week manualized cognitive-behavioral therapy treatment for opioid use disorder in reducing or stopping illicit opioid use in a community setting. Participants will complete 12 weeks of therapy with a behavioral health counselor and will complete assessments at baseline and 12 weeks. Other outcomes include changes in mood and perceptions of recovery-related support after 12 weeks of therapy.

Cognitive-Behavioral Therapy (CBT) is one of the most well-supported and widely used psychosocial treatments for substance use disorders (SUDs); however, few studies have evaluated the efficacy of CBT for opioid use disorder (OUD). This prospective, longitudinal pilot study (pre-post design) will assess the feasibility of the first manualized CBT treatment for OUD in adults (N = 20) in a community-based setting (Prevention Point Philadelphia). This study will utilize clinical (urinalysis), patient-reported, and provider-reported outcomes (mood, support, feasibility, satisfaction with treatment) over 12 weeks of a manualized cognitive-behavioral treatment for OUD. This prospective, longitudinal pilot study will evaluate the feasibility of a novel psychotherapy for OUD. This study will utilize both clinical (urinalysis) and patient or provider-reported (mood, support, feasibility) outcomes to assess the feasibility of 12 weeks of manualized cognitive-behavioral treatment for OUD. All study recruitment, consent and intervention delivery will occur at Prevention Point (2913-15 Kensington Ave, Philadelphia, PA). Outcomes will include participant-reported treatment satisfaction, as well as EMR-extracted clinical data (session attendance, urinalysis, mood, demographics, medical information, and recovery-related support).

We hypothesize that individuals with OUD will demonstrate a reduction illicit opioid use from baseline to week 12 as assessed by urinalysis (% change, positive/negative). As a secondary outcome, use of other substances will also be assessed from baseline to week 12 (e.g., alcohol, cocaine). Use of medication for OUD (MOUD; e.g., buprenorphine. methadone) will be accounted for in analyses.

We hypothesize that mood and perceptions of recovery-related resources will improve from baseline to week 12.

As an exploratory aim, we will evaluate intervention feasibility through electronic medical record (EMR) data of number of sessions attended over 12 weeks, treatment fidelity checklists, and a participant survey of treatment satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Patient at Prevention Point Philadelphia
* 18 years or older
* Living with opioid use disorder
* Has a goal to reduce or eliminate illicit opioid use
* Able to provide informed consent

Exclusion Criteria:

* Not comfortable receiving psychotherapy in English
* Under custodial supervision through the legal justice system (e.g., halfway house following incarceration, involuntary detention or confinement, status as a "prisoner")
Accuracy of a Newly Developed Mobile Application Versus the Conventional Method of Cephalometric Analysis in the Diagnosis of Dental and Skeletal Deformities Among Pre-adolescent Patients

This study aims to evaluate the accuracy of a newly developed mobile application versus the conventional method of cephalometric analysis in the diagnosis of dental and skeletal deformities among pre-adolescent patients.

A mobile application will be developed to help pedodontists in orthodontic diagnosis, and treatment of dentoalveolar, or skeletal deformations ,The mobile application will provide quick cephalometric analysis and therefore, offers rapid and accurate case diagnosis, reduces errors in tracing, measurement, and identification of the landmark.

Reference test: Cephalometric analysis by the conventional method

-Trial design: Diagnostic accuracy study

Eligibility Criteria:
Inclusion Criteria:

1. Digital Lateral cephalometric radiographs of pre-adolescent patients (8-13) years old.
2. Cephalogram of good quality with all landmarks clearly visible
3. Presence of central incisors and first molars on cephalogram
4. Cephalogram with teeth in maximum intercuspation

Exclusion Criteria:

-
Ultrasound to Assess Sarcopenia in Prader Willi Syndrome

The aim of the study is to examine the clinical applicability of ultrasound as a diagnostic tool for sarcopenia in individuals with PWS by investigating the association between ultrasound-derived measurements, DXA-derived measurements, and sarcopenia-related outcomes.

Sarcopenia is an age-related loss of muscle mass plus low muscle strength, and/or low physical performance, that may affect over 25% of individuals over the age of 60, resulting in an increased likelihood of developing disability. Abnormal body composition with an increased in body fat mass and a decreased in skeletal muscle mass were noted in individuals with Prader Willi syndrome (PWS), thought to be related to hormonal deficiencies due to hypothalamic dysfunction, presenting as a unique congenital model of sarcopenia.

Muscle mass can be measured by dual-energy X-ray absorptiometry (DXA) scan device, but it is expensive, increased radiation exposure, and not easily accessible in all clinical practice. Ultrasound (USD) is a non-invasive, without ionising radiation, low-cost, and easily accessible tool for the assessment of soft tissue. There were increasing evidence for the use of USD in the measurement of muscle thickness (MT), cross-sectional area (CSA) and pennate anle (PA) of different muscle groups in different populations. However, the use of USD as a routine diagnostic tool in individuals with PWS has not been reported yet.

The aim of the study is to examine the clinical applicability of ultrasound as a diagnostic tool for sarcopenia in individuals with PWS by investigating the association between ultrasound-derived measurements, DXA-derived measurements, and sarcopenia-related outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Genetically diagnosed individuals with PWS who can cooperate with the examinations

Exclusion Criteria:

* Individuals with PWS who have arthritis, fractures, or severe musculoskeletal deformities that could interfere with the examinations.
* Individuals with PWS who have severe cognitive impairment and are unable to read or sign the written consent.