cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of BioFoam® Surgical Matrix to Improve Hemostasis During Liver Resection

The present randomized controlled trial evaluates the efficacy and safety of BioFoam® Surgical Matrix in patients undergoing elective liver resection. In contrast to other topical agents, the surgical adhesive BioFoam® Surgical Matrix may not only accelerate hemostasis but also facilitate sealing of bile ducts and thus has the potential to reduce the incidence of postoperative complications.

The primary objective of this trial is to show that time-to-complete hemostasis can be reduced using BioFoam® Surgical Matrix as compared to the conventional approach.

Hepatic resection is the primary therapy for various hepatobiliary disorders. Advances in preoperative imaging, surgical technique, and perioperative management have markedly improved outcomes and extended the indications for hepatic resection within the past three decades. However, liver resection remains associated with substantial morbidity and mortality of up to 60% and 10%, respectively. The outcome of patients undergoing hepatic resection is closely linked to the amount of intraoperative blood loss. Hemorrhage from the resection surface contributes significantly to the amount of blood loss. In addition, bile leakage from the resection surface presents a persistent clinical challenge. In fact, bile leakage remains the most frequent complication after hepatic resection with an incidence of 5 - 25%. Various topical agents have so far been suggested to facilitate hemostasis with the ultimate aim to improve perioperative outcome. However, none of these agents has so far gained wide acceptance, possibly due to their impractical method of application. Furthermore, these 'hemostatic agents' have been primarily designed to improve hemostasis and showed no effect on perioperative complications and in particular the incidence of bile leakage.

The present randomized controlled trial evaluates the efficacy and safety of BioFoam® Surgical Matrix in patients undergoing elective liver resection. In contrast to other topical agents, the surgical adhesive BioFoam® Surgical Matrix may not only accelerate hemostasis but also facilitate sealing of bile ducts and thus has the potential to reduce the incidence of postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective hepatic resection
* Age equal or greater than 18 years
* Informed consent

Exclusion Criteria:

* Previous treatment with BioFoam® Surgical Matrix
* Known sensitivity to materials of bovine origin
* Known sensitivity to glutaraldehyde
* Abnormal calcium metabolism (e.g. chronic renal failure, hyperparathyreoidism)
* Minimally invasive procedure planned
* Impaired mental state or language problems
* Expected lack of compliance
Treatment of Hypertrophic Scars With Intradermal Botox

This is a prospective, open label, single center, self-controlled clinical study to demonstrate the safety and efficacy of intradermal botulinum toxin in treating hypertrophic scarring.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy female and male subjects between the ages 18-75.
2. Non-Smoker.
3. Fitzpatrick skin type I-VI.
4. Desire to improve hypertrophic scarring.
5. Able and willing to comply with all visit, treatment and evaluation schedules and requirements.
6. Able to understand and provide written Informed Consent.

Exclusion Criteria:

1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
2. Presence of any active systemic or local infections.
3. Presence of active local skin disease that may alter wound healing.
4. Known allergy to botulinum toxin.
5. History of smoking in past 10 years.
6. History of chronic drug or alcohol abuse.
7. Inability to understand the protocol or to give informed consent.
8. History of cosmetic treatments in the area to be treated, including injectable filler of any type within the past year; Botox in the treatment area within the past 6 months; ablative or non-ablative resurfacing/rejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep peels within the past 6 months; surgery to the area within the past 6 months.
9. History of intralesional corticosteroids or any other injectable medication to the area within the last 3 months.
10. History of topical corticosteroids to the area within the past 4 weeks.
11. History of any musculoskeletal disease or any weakness in the area to be treated.
12. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
The Impact of Diaphragm Training on Dysphagia in Elderly Nursing Home Residents

The goal of this clinical trial is to explore the Diaphragm Training on swallowing function in Elderly Nursing Home Residents (≥60 year old) with swallowing disorders. It primarily aims to address: the effects of Diaphragm Training on swallowing function and quality of life in Elderly Nursing Home Residents. All participants are divided into 2 groups. The intervention group is required to undergo a continuous three-week (21 days) Diaphragm Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

Diaphragm training for dysphagia in elderly nursing home residents involves exercises and techniques aimed at strengthening the diaphragm muscle to improve swallowing function. Dysphagia, or difficulty swallowing, is common among older adults and can lead to complications such as malnutrition, dehydration, and aspiration pneumonia. Diaphragm training may include breathing exercises, postural adjustments, and swallowing maneuvers designed to enhance coordination and strength in the muscles involved in the swallowing process. By targeting the diaphragm, which plays a crucial role in breathing and swallowing coordination, this training approach aims to alleviate dysphagia symptoms and improve overall swallowing function in elderly nursing home residents, thus enhancing their quality of life and reducing the risk of associated health complications.

The goal of this clinical trial is to explore the Diaphragm Training on swallowing function in Elderly Nursing Home Residents (≥60 year old) with swallowing disorders. It primarily aims to address: the effects of Diaphragm Training on swallowing function and quality of life in Elderly Nursing Home Residents. All participants are divided into 2 groups. The intervention group is required to undergo a continuous three-week (21 days) Diaphragm Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

Eligibility Criteria:
Inclusion Criteria:

* Age over 60 years old.
* No hospitalization within the past six months.
* With clear consciousness and able to cooperate with questionnaires and training.
* The elderly people who voluntarily participate and agree to adhere until the end of the study.
* early dysphagia caused by sarcopenia.

Exclusion Criteria:

* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Physical disability.
* Difficulty in mobility.
* Simultaneously receiving other therapies that might influence this study.
* Individuals with a gastrostomy.
* Abnormalities of the oral, pharyngeal, or esophageal structures.
Pharmacological Aids for Interactive Smoking Cessation

There is an important need for effective smoking cessation programs that both (a) promote the effective use of pharmacological aids, such as nicotine replacement products and bupropion, and (b) provide cognitive-behavioral support for stopping smoking.The Internet is an increasingly attractive intervention medium for delivering behavior change interventions, including smoking cessation.This study examined smoking cessation rates among adults participating in a randomized controlled trial of the Smokefree Partners: 21 Days to Freedom ™ program, a theoretically based, online smoking cessation program that included message tailoring and interactivity combined with the live personal support of a smoking cessation coach. Coaching support was provided almost entirely asynchronously via prescripted but individually tailored emails.

The Smokefree Partners: 21 Days to Freedom combined online video, text, and interactive tools to promote the effective use of pharmacological aids (PA) - nicotine replacement products and bupropion (Zyban®) - and provide cognitive-behavioral support for users as they attempted to stop smoking. Smoking cessation content was based on the U.S. Surgeon General's Clinical Guidelines, Treating Tobacco Use and Dependence, 2008 update. Presentation of some of the content (e.g., gender of the narrator, PA recommendations) was tailored to the user on demographic and smoking history information provided during registration and within the introductory session.

Two critical features provided social support and accountability. First, each user was assigned a "live" smoking cessation coach to provide support via individually tailored phone or email contacts (contact preference specified by the user). Users also received automated email reminders and prompts from the program. Second, a bulletin board/forum feature was added to promote social support among users.

The Smokefree Partners intervention was a multi-session intervention in which users experienced a controlled and scheduled exposure to 21 discrete web site sessions. The program required users to wait at least 10 hours between sessions (i.e., login was "locked" until 10 hours had passed after a user's previous Web site session). Carefully timed and tailored coaching messages provided cessation tips and prompted users to return to the web site to view the next session.

The program was evaluated online in a randomized clinical trial of smokers recruited through major worksites across the United States. The aim of the evaluation was to determine if a theoretically based, online smoking cessation program that included message tailoring and interactivity combined with the live personal support of a coach would result in improved quit rates when compared to a wait-list control condition.

Eligibility Criteria:
Inclusion Criteria:

* large worksites with internet connection
* thinking of quitting smoking
* 18 years of age or older

Exclusion Criteria:

* not thinking of quitting smoking
* 17 years of age or younger
Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma

Cholangiocarcinoma (CCA) is a heterogeneous group of cancers arising from the epithelial cells of bile ducts. Because of highly aggressive malignancy, most of the patients are diagnosed at an advanced stage and lose the chance to undergo surgery.

As more effective and novel chemotherapy, targeted therapies, and immunotherapy become available, multiple treatments can be chosen for the patients with advanced CCA. Cytotoxic cell death during tumor chemotherapy triggers antigen release and induces strong anti-tumor effects of T cells. Tyrosine kinase inhibitors (TKI) can reduce the expression of PD-L1 and inhibit Treg cell infiltration, and together with immune checkpoint inhibitors, they can relieve tumor immunosuppressive microenvironment.

Therefore, the study aims to investigate the safety and efficacy of Lenvatinib, Tislelizumab combined with Gemcitabine plus Cisplatin (GPLET) in the treatment of advanced cholangiocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients.
* Expected survival period \> 12 weeks.
* The World Health Organization (WHO) / ECOG physical status (PS) was 0 or 1.
* There was at least one target lesion that matched the RECIST 1.1 criteria at baseline.
* Not previously received immunotherapy, including but not limited to CTLA 4, PD-L1 or/and PD-1 inhibitors.
* Adequate organ and bone marrow function, defined as follows: Hemoglobin (Hb)≥9.0g/dL; Neutrophils (ANC) ≥ 1.5\* 10\^9/L; Platelet (Pt) ≥ 50\*10\^9/L; ALT≤2.5×ULN（Normal upper limit); AST≤2.5×ULN.
* Voluntary participation and signing of informed consent.

Exclusion Criteria:

* Active or previously documented autoimmune disease or inflammatory disease.
* Uncontrolled complications.
* History of other primary malignancies.
* Active infection.
* Women who are pregnant or breastfeeding.
* Patients with severe allergic history or specific constitution.
* Researchers consider it inappropriate to participate in the test.
InSpace™ System Implantation in a Procedure Under Local Anesthesia

The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected shoulder.

A single arm, open-label, prospective, study to assess the feasibility, efficacy and safety of InSpace™ device implantation in a procedure under local anesthesia for a treatment of subjects with massive, irreparable rotator cuff tear.

Subjects with radiological confirmed massive RCT who are eligible per inclusion/exclusion criteria, will be enrolled for the study treatment.

Subjects will undergo surgical intervention under local anesthesia , fluoroscopic and/ or arthroscopic visualization of InSpace™ implantation.

Subjects will then be followed for safety and efficacy for a 24 months following the implantation.

The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected shoulder.

The efficacy will be assess by using Constant and ASES outcome score The Constant and the ASES will be completed by the investigator at each study visit .The patient will complete the patient self-evaluation part of the ASES at each study visit.

The Safety assessment will be conducted by collecting all device related AEs/SAEs throughout the entire study period.

Eligibility Criteria:
Inclusion Criteria:

1. Age 50 or older.
2. Positive diagnostic MRI of the affected shoulder indicating full thickness massive irreparable RCT of at least 5cm in diameter (according to Cofield classification) including fatty infiltration grade III or IV (according to classification of Goutallier).
3. Persistent pain and failure of non-operative treatment of the affected shoulder for at least 3 months.

Exclusion Criteria:

1. Known allergy to the balloon material
2. Evidence of significant osteoarthritis or cartilage damage in the shoulder
3. Evidence of gleno-humeral instability
4. Evidence of major joint trauma, infection, or necrosis in the shoulder
5. Major medical condition or known drug or alcohol abuses that could affect quality of life and influence the results of the study.
6. Concurrent participation in any other invasive clinical study one month prior to enrollment to the study and during the entire study period.
7. Subjects with worker's compensation claims or other litigation claims related to the shoulder being treated in the study.
Vaping Prevention and Vaping in Youth (Vapechat)

Many youth are addicted to nicotine due to increased nicotine vaping (e.g., e-cigarettes). Unfortunately, there are no effective interventions to help teens quit vaping. In addition, existing vaping prevention programs have limited effectiveness because teens have reported that existing available interventions are out of touch with teen's culture and are not appealing to the intended audience. Therefore, to be effective, a vaping intervention must be acceptable, appealing, and engaging to teens, and most importantly, it should be designed to be channeled into an existing infrastructure such as the school setting.

The investigators' research group has designed a vaping prevention and cessation intervention that is implemented as a VR game for high school teens. The overall objective of this research is to assess the acceptability, feasibility, and preliminary efficacy of the VR experience among high school students in two high schools in Boston.

The investigators will conduct a randomized trial of high school students (freshman to seniors) in the Boston area to determine feasibility, satisfaction, and preliminary efficacy of the VR-based vaping cessation and prevention game. Students will be randomized by class to either receive the Virtual Reality (VR) program (experimental condition) or control condition (questionnaire assessment only). There will be three VR sessions played at school during a health class. Participants in the VR condition will also engage in a gamified home-based component on their smartphone, in order to reinforce skills learned in the school-based VR experience.

Seven high school classes across two high schools will be randomized to VR intervention or assessment only. Health classes in each high school will be randomly assigned using a 1:3 threshold probability using a random digit generator. Participants will be enrolled in the study for approximately 6 weeks. In the first 3 weeks, participants will engage in the VR game experience once per week during their classes. In the fourth and fifth week, participants may make up any VR game session that they missed because of absence (e.g., illness). At week 6, participants will complete the follow-up questionnaire assessments.

Eligibility Criteria:
Inclusion Criteria:

* Students enrolled at Everett and Quincy High Schools (freshmen, sophomores, juniors, and seniors).
* Students in Health class
* Child assents

Exclusion Criteria:

* Teacher indicates that participation is not appropriate for the student (e.g., severe mental illness; visual or auditory disability; medical issue)
* Parent(s)/guardian(s) opt student out of the study.
* Prone to motion sickness or seizures.
* Visual impairments that would preclude playing VR or otherwise unable to use VR device.
Effects of Hand MOtor Rehabilitation Using a sEMG-biofeedback

Stroke is the first cause of disability worldwide. The motor impairment of the hand is one of the most common sequelae in patients after stroke. Indeed, approximately 60% of patients with diagnosis of stroke suffers from hand sensorimotor impairment. In the last years, new approaches in neurorehabilitation field has been permitted to enhance hand motor recovery. Wearable devices permit to apply sensors to the patient's body for monitoring the kinematic and dynamic characteristics of patient's motion. Moreover, wearable sensors combined with electrodes detecting muscle activation (i.e. surface electromyography - sEMG) permit to provide biofeedback to the patient to improve motor recovery.

The aim of the study is to investigate the effect of using REMO® (Morecognition srl, Turin, Italy) device in hand motor rehabilitation.

The device REMO® is an armband composed by 8 bipolar electrodes able to record and process the electromyography of forearm muscles. The patterns of muscle activations are classified and used to perform sEMG-biofeedback exercises in stroke rehabilitation training. The device is developed by clinicians of IRCCS San Camillo Hospital and Morecognition Srl.

A total of 20 patients with first diagnosis of stroke and with no other neurological diagnosis or severe cognitive impairment has been enrolled. The patients are tested with REMO® and if they are able to control at least one movements, they are enrolled in the longitudinal pilot study. The treatment consists in 15 sessions, 1hour/day, for 5 days/week, for 3 weeks. The patients are clinically evaluated before and after the REMO® treatment to define clinical effect of the sEMG-biofeedback training.

Eligibility Criteria:
Inclusion Criteria:

* Single ischemic or haemorrhagic stroke
* able to control at least 1 movement with REMO (i.e. able to cross the pre-defined empirical threshold (10%) of the ratio between the maximum voluntary contraction (MVC) of the movement and the EMG recording during baseline (i.e. rest position)

Exclusion Criteria:

* Untreated epilepsy;
* Major depressive disorder;
* Fractures;
* Traumatic Brain Injury;
* Severe Ideomotor Apraxia;
* Severe Neglect;
* Severe impairment of verbal comprehension.
Effect of Levodopa on Human Multifocal Electroretinogram

It is known that dopamine is a functional neuromodulator at several levels of the visual system. Dopamine seems to be involved in the organization of the ganglion cell and the bipolar cell receptive fields and modulation of physiological activity of photoreceptors. There is evidence for the functional significance of dopaminergic modulation of visual sensitivity in humans which confirms the hypothesis that dopamine plays an important role in retinal light adaptation as well as in motion and contrast sensitivity function. The electrophysiological effects of dopamine, various dopamine antagonist and levodopa in animals and humans have been investigated by means of visual evoked potentials and electroretinograms. The multifocal ERG technique, developed by Sutter et al. allows a rapid, simultaneous recording of focal ERGs from multiple retinal locations. Although this technique is relatively new, it has already provided insights into the mechanisms of retinal diseases (e.g. involvement of visual system in Parkinson disease), but until now there is no data on influence of dopaminergic substances on mERG.


Eligibility Criteria:
Inclusion Criteria:

* Men aged between 19 and 35 years, nonsmokers
* Body mass index between 15th and 85th percentile
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 3 Dpt

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent

The aim of this project is to verify the effect of the global postural reeducation (GPR) intervention used in physiotherapy on scoliosis progression (scoliosis angle), back pain, quality of life, respiratory function, trunk posture and trunk muscle functioning and walking endurance. To do so, we will recruit 144 participants at three scoliosis specialized Centers. Participants will be randomly allocated to the standard of care (SC) group (observation or brace plus home video of exercises for 12 months) or to the GPR group (SC plus individual sessions once a week for 6 months and individual sessions alternating with telerehabilitation sessions once per two weeks between 6 and 12 months). At initial, 6, 12- and 24-months evaluation, participants will have x-ray, complete self-report questionnaires to document back pain and quality of life. Thereafter, measurement of trunk posture, electromyography activity of the back muscles, excursion of the diaphragm muscle using echography and respiratory function as well as distance covered using the 6-minute walk test for walking endurance will be done. We believe that GPR intervention may prevent scoliosis progression and improve physical health and quality of life in adolescence.


Eligibility Criteria:
Inclusion Criteria:

* aged between 10 and 16 years old,
* Cobb angle between 15º and 45º,
* Risser sign ≤3 (skeletal growth incomplete),
* with a risk of progression index \> 1.3,
* having recent x-rays (4-6 weeks),
* ability to travel weekly to attend GPR intervention

Exclusion Criteria:

* patients with diagnosis other than AIS,
* patients who are planned for surgery,
* have had surgery,
* worn a brace for at least three months prior to GPR intervention