cyrilzakka/clinical-trials huggingface dataset:
Effects of Perioperative Patient Education Regarding Compartment Syndrome on Post-operative Opioid Consumption

This study is a prospective, randomized trial. Our study aims to study the effects of perioperative patient education about compartment syndrome on patients' perception of their own pain, amount of opioid medication utilization, and rate of diagnosis of compartment syndrome.


Eligibility Criteria:
Inclusion Criteria:

Patients with lower extremity trauma at risk for developing compartment syndrome specifically tibial plateau fractures, tibial/fibular shaft fractures, pilon fractures, and crush injuries.

Exclusion Criteria:

Patients with an extensive history of narcotic medication or drug use, polytrauma patients, and non-primary English speaking patients
Antiarrythmic Drugs - Long-term Follow-up in the Modern Era

Antiarrhythmic drugs are associated with significant side effect profiles. Amiodarone has primarily class III action and whilst it has unrivalled efficacy in management of certain arrhythmias, it has a formidable side effect profile. Complications of continued therapy include, thyroiditis, hepatitis, cholestasis, increased skin sensitivity and pulmonary fibrosis. Current prescribing guidelines recommend frequent blood tests to monitor kidney, liver and thyroid function, in addition to frequent pulmonary function tests. Sotalol is a betablocker which possesses class III action in high doses and may predispose to QT prolongation Other class I agents such as flecainide and propafenone can be associated with sudden cardiac death in certain populations, and may predispose to other arrhythmias.

This study will examine the incidence of discontinuation of AAD therapy and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* At least one prescription for antiarrythmic drug
Development and Application of a Thrombosis Risk Prediction Model in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors

The purpose of this observational study is to explore the incidence, risk factors, and relationship with therapeutic outcomes of VTE (venous thromboembolism) and ATE (arterial thromboembolism) associated with immune checkpoint inhibitors (ICIs) therapy. The primary questions it aims to address are:

1. What is the real-world incidence of VTE/ATE in lung cancer patients receiving immune checkpoint inhibitors?
2. What are the risk factors for VTE/ATE in lung cancer patients receiving immune checkpoint inhibitors?
3. What is the impact of VTE/ATE on the prognosis of lung cancer patients receiving immune checkpoint inhibitors?

Researchers will compare the characteristics and biomarkers of patients with and without ICI-associated VTE/ATE to identify novel specific biomarkers for thrombotic events. Furthermore, they will construct a risk assessment model for thrombotic events to provide guidance for precision prevention and treatment in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Histopathologically confirmed lung cancer diagnosis at enrollment
* Received at least one dose of a China-approved lung cancer immune checkpoint inhibitor
* Signed informed consent form

Exclusion Criteria:

* Excluded based on inclusion criteria
* Cannot comply with follow-up requirements
Telerehabilitation Dual-Task Training for Parkinson's: a Multidimensional Evaluation

In this clinical study, the aim is to assess the effectiveness of telerehabilitation-based dual-task training in improving balance and gait function among individuals diagnosed with Parkinson's Disease. Parkinson's Disease is characterized by motor symptoms such as tremors and slowness of movement, as well as cognitive impairments. While medical treatments help manage symptoms, exercise programs are vital for enhancing physical and cognitive functions.

Dual-task training involves combining motor and cognitive activities to enhance gait and balance control, and recent studies have shown its effectiveness in Parkinson's Disease rehabilitation. However, there's limited research on delivering dual-task training through telerehabilitation and determining the optimal content for maximum benefits.

This project involves 30 Parkinson's Disease patients who will be randomly assigned to three groups receiving different dual-task exercise programs via telerehabilitation. Each program focuses on combining balance and functional exercises with either cognitive or motor secondary activities. The exercises will be performed three times a week for four weeks under the guidance of a physiotherapist via Zoom.

Before and after the intervention, participants will be evaluated for feasibility, gait, balance, cognition, and activity levels. Researchers of this study hypothesize that telerehabilitation-based dual-task training will significantly improve balance and gait function in Parkinson's Disease patients, offering a convenient and effective treatment option to enhance their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with idiopathic Parkinson's Disease
* Stage 1-3 on the Hoehn-Yahr scale
* A minimum score of 21 on the Montreal Cognitive Assessment Scale test
* Stable drug treatment within the last 1 month
* Patients are in the "On" period
* Ability to walk independently on level ground (3 and above according to Functional Ambulation Classification)

Exclusion Criteria:

* Serious hearing or vision problems
* Having other neurological, cardiovascular or orthopaedic disorders that may prevent walking
* Any other neurological disorder (e.g. dementia, cerebrovascular disease)
* less than 5 years of education
* To have vascular lower extremity pathologies
* Not having internet access via smartphone or computer
Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab

The primary objective of this study is to evaluate pharmacokinetics (PK) of ravulizumab administered subcutaneously via an on-body delivery system (OBDS) compared with intravenously administered ravulizumab in adult participants with PNH who are clinically stable on eculizumab for at least 3 months prior to study entry.

The study will consist of up to a 30-day Screening Period, a 10-week Randomized Treatment Period, and an Extension Period of up to 172 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years of age
* Treated with eculizumab for PNH for at least 3 months prior to Day 1
* LDH level ≤1.5 × upper limit of normal (ULN) at screening
* PNH diagnosis confirmed by documented high-sensitivity flow cytometry.
* Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
* Body weight ≥40 to \<100 kilogram (kg)
* Female participants of childbearing potential must use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab.
* Willing and able to give written informed consent and comply with study visit schedule.

Exclusion Criteria:

* More than 1 LDH value \> 2 × ULN within the 3 months prior to study entry
* History of bone marrow transplantation.
* History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the Investigator or Sponsor, would preclude participation.
* Unstable medical conditions (for example, myocardial ischemia, active gastrointestinal bleed, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, coexisting chronic anemia unrelated to PNH).
* Females who are pregnant, breastfeeding or who have a positive pregnancy test at screening or Day 1.
* Participation in another interventional clinical study or use of any experimental therapy within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.
To Assess the Safety and Tolerability of 7.5, 15 and 30 mg of Sublingual Lobeline. - 1

To assess the safety and tolerability of 7.5, 15 and 30 mg of sublingual lobeline.

The primary objective of this study is to characterize the pharmacokinetics of three ascending doses of lobeline in normal volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals with a body mass index between 18 and 30.
* Willing and able to give written consent.
* Must have a negative drug test
* Females must have a negative pregnancy test prior to study drug administration
* Must have no medical contraindications as determined by routine testing

Exclusion Criteria:

* Please contact the site for more information
Mindfulness-Based Cognitive Therapy Effect on Depression and C-Reactive Protein Levels After 8 Weeks of Treatment

This study will investigate the efficacy of an 8-week course in Mindfulness-Based Cognitive Therapy (MBCT) for adults with major depressive disorder (MDD) by ;measuring change from baseline to completion of treatment at 8 weeks in terms of depression severity using the Hamilton Depression Ratings Scale. We will measure change in C-Reactive Protein, a measure of inflammation, over the same time period.

This study will investigate the effectiveness of MBCT as a primary treatment for MDD. Twelve unmedicated subjects with MDD were enrolled in the study. All subjects with MDD underwent depression severity assessment at baseline and after the 8-week intervention was complete to measure change. In addition, the subjects underwent blood sampling at the same time points to measure C-Reactive Protein change over the 8 weeks.

The primary goal of this pilot study is to determine the efficacy of MBCT as a primary treatment for adults with MDD. We will also measure change in the inflammatory biomarker C-Reactive Protein for an examination of the effects of depression treatment on this measure.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Able to give informed consent
* DSM-IV (SCID) Diagnosis of Major Depression
* HAM-D17 score ≥ 17
* Good general medical health; no active significant uncontrolled medical illness
* Free of antidepressant medication for a minimum of 6 weeks before study entry
* Not "needle phobic" by self report

Exclusion Criteria:

* Axis I and II disorders including: Bipolar, Obsessive Compulsive Disorder, Psychosis, or Antisocial or Borderline Personality Disorder with suicidal risk
* Major Depression with Psychotic Features
* Actively suicidal
* Recent (6 month) history of substance or alcohol dependence (DSM-IV criteria)
* Meditation practice once or more per week
* Yoga practice more than twice per week at study entry
* Mini Mental Status Exam score \< 25or history of neurologic illness
Cognitive Functioning Related to Job Tenure Among Patients With Schizophrenia

The aim of this research is to explore which cognitive function would affect the job tenure among people with schizophrenia. The investigators plan to recruit 60 people diagnosed with schizophrenia and divide into two groups, employment and unemployment. The investigators will use several cognitive function tests to collect their cognitive functions and PANSS to evaluate their psychotic symptoms. And then the investigators will compare and analysis the data through statistic software. Finally, the investigators will have the answer about if cognitive functions would affect the job tenure among people with schizophrenia. And the investigators hope that we could get the predict factor of cognitive function to predict the successful employment in future.


Eligibility Criteria:
Inclusion Criteria:

* schizophrenia, 18\~44y/o

Exclusion Criteria:

* substance abuse
Glucose Kinetics After Wheat and Rye Breads

Certain functional properties of cereal products, e.g. their postprandial glucose and insulin responses, have been characterized as steps towards obtaining a greater understanding of their beneficial health effects. A low-glycemic index diet results in decreased postprandial insulin and glucose responses, which is thought to be beneficial for insulin and glucose metabolism.

In healthy subjects, it has been shown that rye breads (RBs) produce a lower postprandial insulin response compared with refined wheat breads (RWB) despite similar glucose responses. Juntunen et al. (2003) suggested that the difference in the structural characteristics between rye and wheat breads is a possible explanatory mechanism. However, the underlying mechanism of this discrepancy between insulin and glucose responses to rye bread, the so-called "rye factor" (RF), is still largely unknown. Faster starch digestibility and higher postprandial insulin responses for RWB compared with RBs may indicate faster intestinal glucose absorption and faster glucose disappearance respectively.

Therefore our hypothesis is that despite having similar glucose responses, RWB has faster turn over (kinetics) compared with RBs. The present study is aiming to apply an experimental set up which can comprehend the hypothetical differences in RWB and RBs kinetics.

The human subjects after an overnight fasting 10-12 hours are coming to the clinic. On arrival, catheters are inserted into a forearm vein of each arm for blood sampling and isotope infusion, respectively. A primed followed by a constant-rate infusion of \[6,6-2H2\] glucose are administered. The enrichment of \[6,6-2H2\] glucose in the blood is then measured at different time points after the breakfast. The glucose kinetics can be calculated from this.

Eligibility Criteria:
Inclusion Criteria:

* Males 18-40 years with BMI 22-25.5 kg/m2

Exclusion Criteria:

* A family history of diabetes mellitus, regular use of nicotine, recurrent extensive exercise, regular intake of medication or food intolerances. The subjects had to be free from illnesses for one month prior to the study.
Sleeve Gastrectomy Versus One-anastomosis Gastric Bypass: Randomized Trial

Hormonal changes after SG and OAGB involve alterations in the levels of many enteric hormones, among these hormones are ghrelin and glucagon-like peptide-1 (GLP-1). Ghrelin is an orexigenic hormone that stimulates food intake and has a documented role in the development of obesity. While ghrelin levels decrease significantly after SG as the fundus, which is the main source of that hormone, is completely removed, they tend to increase after OAGB GLP-1 plays an important role in glucose homeostasis via affecting food intake and satiety. It enhances insulin secretion, stimulates the proliferation and growth of pancreatic beta cells, inhibits food and water intake, and promotes satiety. Some studies reported that both OAGB and SG are followed by increased GLP-1 levels. We conducted this randomized study to compare SG and OAGB with regards to weight loss, comorbidity resolution, changes in ghrelin and GLP-1 hormones, and complications.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of both genders with morbid obesity (defined as BMI \> 40 kg/m2 or \> 35 Kg/m2 with at least one associated comorbidity) were included. Patients who underwent previous surgery for morbid obesity were also included.

Exclusion Criteria:

* patients ageing more than 60 years
* patients with endocrine disorders
* patients with psychiatric disorders that influence perception of the study protocol
* patients unfit for general anesthesia.
Magnetic Resonance Imaging (MRI) Sequences Optimization in Healthy Subjects

Magnetic resonance imaging (MRI) is a noninvasive and non-ionizing (no use of X-rays) imaging modality. Today it is considered an anatomical and functional exploration reference technique. Since its inception around 1985, this technology is constantly evolving.

Many advances in MRI require constant adaptations of radiological practices. The morphological image is now associated with functional and parametric information (infusion, diffusion spectroscopy, etc ...). In parallel, work combining acquisition and post-processing of data also open new applications (tractography, functional MRI, etc ....). Thus, more and more procedures are necessary to "integrate" these techniques for the diagnosis and adapt to new demands of clinicians.

The type of sequence and its associated parameters allow to directly influence the contrast of images, to characterize tissue compared to another and, ultimately, to highlight morphological or functional abnormality. Image quality can be optimized on each MRI, depending on the time available for the acquisition on the one hand, and on the desired resolution and contrast, on the other hand. For each sequence, it is therefore necessary to find a compromise that will optimize the diagnostic quality of the examination.

This optimization requires a phase focusing on healthy volunteers. It is therefore important that researchers and physicists could design on healthy volunteers, the best settings of all parameters for an image or spectrum. Indeed, it is always necessary to properly optimize every parameter choices before beginning a study of a cohort of patients.

In this context, the main objective of this study is to optimize sequences and imaging protocols to evaluate and validate the choice of parameters in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged over 18 years
* Written informed consent given

Exclusion Criteria:

* contraindication to MRI :

  * Claustrophobia
  * morphotype not allowing access to MRI
  * Wear a metallic implant, such as:
  * Pacemaker (pacemaker)
  * Ferromagnetic surgical clips
  * Intra orbital metallic foreign bodies or encephalic
* Pregnancy
* Breastfeeding
* Adults under guardianship, trusteeship or safeguard justice
* No social Insurance
Predictors of Postoperative Complications and Readmissions in Laparoscopic Pancreas Resection

Laparoscopic resection of the pancreas has become widely accepted in the treatment of lesions which are benign or of low-grade malignancy. The objective of this study is to analyze the factors that predict postoperative complications and hospital readmission in a series of laparoscopic pancreatectomies.

The investigators conducted a retrospective study using a prospective database of laparoscopic resections performed between 2000 and 2020. Data were collected on age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, type of surgery, histologic type, operative time, hospital stay, postoperative complications, degree of severity and hospital readmission

Eligibility Criteria:
Inclusion Criteria:

* A retrospective study was carried out using data from a prospective database of all consecutive patients undergoing laparoscopic resection of the pancreas between 2000 and 2020 in the Clínica Universidad de Navarra

Exclusion Criteria:

* n/a
US Inhaled Insulin Dose Titration Study

This study will examine how to dose Exubera (inhaled insulin) in patients who are not well controlled on two or more diabetes pills. This study should show that a large number of patients enrolled in the study can reach the target Hemoglobin A1C levels (7% or less) that have been set by the American Diabetes Association (ADA). Target goals should be achieved by adjusting the Exubera dose either weekly or twice weekly. Patients will also receive nutritional counseling and diabetes education as part of the study.


Eligibility Criteria:
Inclusion Criteria:

* Male and female, age \>= 18 years and \<= 80 years, with a diagnosis of type 2 diabetes made at least 6 months prior to study entry, with hemoglobin A1C 7.5-10%
* Currently treated with 2 or more oral antidiabetic agents (sulfonylureas, metformin, and/or thiazolidinediones)

Exclusion Criteria:

* Type 1 diabetes
* Smoking within the past 6 months or significant pulmonary diseases
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy

This study is of an investigational drug called SUVN-G3031 (Samelisant) as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy. The main purpose of this study is to learn how well the study drug works and how safe the study drug is compared to placebo.

This is a Phase 2, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SUVN-G3031 compared to placebo in participants with narcolepsy with and without cataplexy. Participants will be randomized at a ratio of 1:1:1 to 2 mg SUVN-G3031, 4 mg SUVN-G3031, or placebo. Each participant will receive study drug once daily, in a tablet formulation, for 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Ages of 18 to 65 years (adult), inclusive.
* Have narcolepsy with or without cataplexy (Na-1 or Na-2) based on the International Classification of Sleep Disorders (3rd edition) criteria (new or previously diagnosed).
* Have undergone a multiple sleep latency test (MSLT) study showing an MSLT of ≤ 8 minutes.
* An Epworth Sleepiness Scale (ESS) score of ≥ 12; and mean Maintenance of Wakefulness Test (MWT) time of \< 12 min.
* Body mass index ranging from 18 to \< 45 kg/m2
* Negative urine drug screen.
* A woman must be either not of childbearing potential or of childbearing potential practicing highly effective methods of birth control.
* Willingness to complete the study protocol with full compliance with procedures and sign an informed consent form (ICF).

Exclusion Criteria:

* Habitual wake-up time after 8 AM as assessed by sleep diary, habitual sleep time of \< 6 hours, and habitual bedtime past 1 AM as determined by sleep diary entries.
* Use of any investigational therapy within the 30-day period prior to enrollment.
* Excessive caffeine (defined as \> 600 mg/per day) use at least 1 week prior to baseline assessments and during the course of the trial.
* Nicotine dependence that has an effect on sleep (eg, a patient who routinely awakens at night to smoke).
* Use of concurrent medications prescribed to treat narcolepsy as specified including stimulants, antidepressants and sodium oxybate.
* Current diagnosis of or past treatment for syndromes known to cause sleep disruption or any other cause of daytime sleepiness.
* Clinically significant ECG abnormalities.
* An occupation requiring variable shift work, night shifts, or frequent overnight travel which disrupts sleep patterns.
A Relative Bioavailability Study of Nicotine Delivery From Selected Oral Nicotine Products

This will be a randomised, cross-over, single-blind, confinement study conducted in 27 male or female snus or nicotine pouch users. The study will investigate 4 different nicotine containing products in a cross-over design, incorporating pharmacokinetic (PK) evaluation, nicotine extraction evaluation, subjective questionnaire assessments as well as safety and tolerability evaluation.

During the study participation, subjects will come for 2 visits to the clinic, including a screening visit and a 4-day confinement period. A final follow up end-of-study telephone call will be performed within a week of last product use.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 18.0 and ≤ 30.0 kg/m2
* Clinically normal medical history
* User of snus or nicotine pouches for ≥1 year, with a minimum weekly use of 2 or more snus or nicotine pouch cans and who is willing and considered able to use brands with nicotine content in the range of 14 to 20 mg nicotine/pouch

Exclusion Criteria:

* History of any clinically significant disease or disorder
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first use of IP.
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and HIV
* Female subjects who are pregnant or breastfeeding
* Presence or history of drug or alcohol abuse
* Excessive caffeine consumption defined by a daily intake of \>5 cups of caffeine containing beverages
* Intend to change nicotine-use habit or make a quit attempt within the next 3 months from the screening visit.