cyrilzakka/clinical-trials huggingface dataset:
Use of Prineo in Breast Reduction Surgery

This is a prospective, randomized, controlled, single-blinded study to compare Prineo™ with subcuticular sutures in 20 women undergoing bilateral breast reduction. For each patient, the final skin layer of one breast will be closed with subcuticular suture while the other breast will be closed with Prineo™. The treatment will be randomized to left or right breast. Therefore, the investigators will have 20 breasts in the suture group and 20 in the Prineo™ group, with each patient serving as her own control. For this study, the resident will close one side with suture and Dr. Rohde will apply the Prineo. The investigators will perform this study of incision closure under conditions as similar to normal conditions of closure.

Wound closure with dermal sutures is time consuming and may increase risk of infection and inflammation. Moreover, appearance of the resulting scar depends largely on surgeon technique. Use of the Prineo™ wound closure system may decrease operative time, decrease incidence of infection and inflammation, and improve aesthetics of the resulting scar. Prineo™ has been shown to hold as well as sutures for the first 12-25 days and may reduce closure time of the final skin layer up to 75% in abdominoplasty and breast procedures. The system provides excellent coverage of the wound edge, protecting the incision with a microbial barrier. Cosmetic results in abdominoplasty and breast procedures appear to be equivalent to sutures.

The main endpoints will be operative time to closure of the final skin layer and patient-rated and blinded observer-rated scar quality. The investigators hypothesize that operative time to closure of the final skin layer using Prineo™ will be faster than operative time to closure using subcuticular suture. The investigators also hypothesize that subjective and objective scar quality of incisions closed with Prineo™ will be better than those closed with subcuticular suture.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing Wise pattern breast reductions for symptomatic macromastia.

Exclusion Criteria:

* Subjects who have an allergy to cyanoacrylate, formaldehyde, surgical tape, or any other known component of the Prineo system will be excluded.
* Subjects who refuse to be photographed or refuse to have their scars assessed by a blinded plastic surgeon will be excluded.
A Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis

This trial is conducted in Europe. The aim of the trial is to investigate the effect of recombinant factor XIII (rFXIII) administered to subjects with mild to moderate active ulcerative colitis (UC).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ulcerative colitis for at least 3 months from the time of initial diagnosis. The diagnosis must have been confirmed by historical endoscopy and histology. The severity of disease must have been confirmed by endoscopy at screening
* Currently receiving oral aminosalicylates at approved doses of at least 2g/day for at least 6 weeks. Doses of oral aminosalicylates should be stable for at least two weeks prior to dosing (Visit 2)

Exclusion Criteria:

* Diagnosis of UC limited to the rectum (ulcerative proctitis only, defined as less than 15 cm from the anal verge)
* Requiring hospitalisation for current episode of severe UC
* Use of biologic therapies for the treatment of UC within 12 weeks prior to dosing (Visit 2)
* Treatment failures to anti-tumour necrosis factor-alfa (anti-TNF-a) agents (e.g. infliximab, adalimumab)
* Use of immunosuppressant agents (e.g. azathioprine) within 4 weeks prior to dosing (Visit 2)
* Use of corticosteroids (oral, intravenous (i.v.), intramuscular (i.m.), or rectal ) within 14 days prior to dosing (Visit 2)
* Use of enemas (corticosteroid or aminosalicylate) within 14 days prior to screening (Visit 1)
* Use of cyclosporine, tacrolimus, D-penicillamine, leflunomide, methotrexate, mycophenolate mofetil, or thalidomide within 4 weeks prior to dosing (Visit 2)
* Currently receiving total parenteral nutrition
Triclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds

Comparing the incidence of SSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery

Comparing the incidence of surgical site infection (SSI) in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery. Also, comparing the post hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* age: 18-75
* clean-contaminated wound surgery

Exclusion Criteria:

* Patient has immunodeficiency disorder.
* Patient receiving anti-cancer / immunosuppressive therapy.
* Patients with established pre-operative infection whether community acquired or hospital acquired either at / remote from the operative site.
An Integrative Intervention for Preventing Children's Emotional Disorders

The general objective of the study is to test an online platform for the prevention of emotional disorders in children aged 8-12 without any clinical symptoms.

The general objective of the study is to test an online platform for the prevention of emotional disorders in children aged 8-12 without any clinical symptoms. The game will be used by children and adolescents for a period of four weeks. Pre-test and post-test measurements will be taken.

Eligibility Criteria:
Inclusion Criteria:

* children aged 8 to 12 years
* parental consent provided
* al least one answer different than never true on the Childhood Trauma Questionnaire - Short Form (CTQ-SF; Bernstein \&amp; Fink, 1998; Bernstein et al., 2003), measuring dichotomically the presence of Emotional Neglect, Physical Neglect, Emotional Abuse, Physical Abuse

Exclusion Criteria:

* intellectual disability or physical limitations precluding the use of the online platform presence of a mental health disorder in the children or their enrolled parent
Outcome-related Performance Evaluation Through Revision and Analysis of inTraoperative Events

The goal of this prospective, multicentric, observational, cohort study is to evaluate intraoperative adverse events (iAEs) through video-based assessment (VBA) across minimal invasive procedures performed in general surgery departments. The main questions it aims to answer are:

* The prevalence, type, and severity of iAEs
* Correlation between iAE and clinical outcomes
* Correlation between iAE and surgical performance
* Qualitative analysis of root cause analysis and mitigation strategies

The OPERATE study is a prospective, multicenter observational cohort study focused on evaluating the prevalence and impact of intraoperative adverse events (iAEs) during minimally invasive surgeries. The study aims to systematically collect and analyze surgical videos and clinical outcomes from multiple centers. By using advanced video-based assessment (VBA) tools, such as the Objective Clinical Human Reliability Analysis (OCHRA) and the Severity of Intraoperative Events and Rectification (SEVERE) index, the study will examine how surgical performance correlates with post-operative outcomes.

The study will initially focus on colorectal surgery, with the possibility of expanding to other types of minimally invasive procedures. Videos of the surgeries will be recorded, de-identified, and uploaded to a centralized platform for analysis. The study also seeks to identify root causes of iAEs and develop strategies to prevent them. Data collection will include not only video-based assessments but also patient demographic details, surgical history, and post-operative recovery data.

By understanding the frequency and nature of iAEs, this study aims to improve surgical safety, reduce complications, and ultimately enhance the quality of patient care in a broad range of general surgical procedures. The findings may contribute to developing new training protocols, artificial intelligence instruments to model errors and increase procedural safety, and guidelines to optimize surgical performance and patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective minimally-invasive surgery in participating centers
* Patients with no contraindication to anesthesia and laparoscopic procedures
* Capable of providing informed consent

Exclusion Criteria:

* Surgery performed with palliative intent or under unplanned/emergency setting
* Pregnant or breastfeeding patient
* Patient under legal custody or guardianship
Diabetes Complications and Hearing Loss

Observation study, shows the relation between diabetes, its neurological and optical complication and hearing loss, by asking participants questions about there age,BMI,job,the history of any cataract,diabetes retinopathy or heart attack,hypertension,swollen or tingling legs and take there consent to measure the hearing impairment.


Eligibility Criteria:
Inclusion Criteria:

* Diabetics who signed consent for the study.
* Diabetics who have filled out the form completely.
* Diabetics who have undergone a pure tone hearing screening test .

Exclusion Criteria:

* Patients with glandular disease causing hearing loss.
* Patients with traumatic ear injury.
* Patients who have recently had a middle or inner ear infection.
* History of acoustic neuroma.
* Patients are under active treatment with medications that have a toxic effect on the auditory cells.
* Patients with diabetic foot.
* The patient's occupation or residence is within a noisy environment.
Efficacy of Selegiline in Negative Symptoms of Schizophrenia

Antipsychotic drugs are effective in treating the positive symptoms of schizophrenia; however their efficacy in treating negative symptoms is limited. This study wants to evaluate efficacy of selegiline augmentation of antipsychotic medication to treat negative symptoms in inpatients with chronic schizophrenia. With randomized clinical trial two groups of patients will select to receive selegiline or placebo.

Primary end point is decreasing in negative symptoms in case group. Inclusion criteria : 1- Patients with moderate to severe negative symptoms 2- Patients with at least one year antipsychotic drug therapy, at the current dose \>= 1 month. 3- No other psychotropic drugs during past month. Exclusion criteria: 1- Severe major depressive disorder, substance abuse, severe positive symptoms of schizophrenia, Treatment of MDD with antidepressant drugs during past month.


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe negative symptoms
* Patients with at least one year antipsychotic drug therapy, at the current dose \>= 1 month.
* No other psychotropic drugs during past month

Exclusion Criteria:

* Severe major depressive disorder
* Substance abuse
* Severe positive symptoms of schizophrenia
* Treatment of MDD with antidepressant drugs during past month.
rTMS in Alleviating Pain and Co-Morbid Symptoms in Gulf War Veterans Illness (GWVI)

This study aims to look at the effectiveness of using repetitive transcranial magnetic stimulation (rTMS) in relieving pain and other co-morbid symptoms of Gulf War Illness.

Headaches (HA), muscle and joint pain, are some of the most common debilitating symptoms in military personnel served in the 1990-1991 Persian Gulf War (GW1). Migraine like HA and diffuse body pain were detected in 64% of Gulf War Veteran (GWV) diagnosed with Gulf War Illness (GWI). Likewise, depression carries a very high co-morbid rate (50%) in patients with chronic pain, and in GWV with GWI related chronic HA and body muscle and joint pain conditions (GWI-HAP). Unfortunately, conventional pharmacological treatments for GWI-related pain has not been shown to be effective and drugs such as narcotics contain many long term untoward psychosomatic and abusive side effects. This study is assessing the effectiveness of repetitive transcranial magnetic stimulation (rTMS), non-invasive treatment option, in alleviating pain and other co-morbid symptoms of GWI.

Eligibility Criteria:
Inclusion Criteria:

* Male or female under 65 years of age who served in the military for at least 30 consecutive days between August 1, 1990, and July 31, 1991 in the Persian Gulf War region
* CDC Criteria for GWVI (GWI)
* Kansas Criteria for GWVI (GWI)
* International Headache Society Criteria for Migraine Headache without aura
* Average Overall Daily Muscle Pain Intensity \>3 on 0-10 a NPS
* Average Overall Daily Extremities Joint Pain Intensity \>3 on 0-10 a NPS
* Headache Exacerbation/attack once a week with the average intensity \>3 on a 0-10 NPS, lasting \> 1 hour in the past three months
* Hamilton Rating Scale of Depression (HRSD) greater than or equal to 14 based on the sum of scores for the first 17 items

Exclusion Criteria:

* Pregnancy
* History of pacemaker implant
* Any ferromagnetic (e.g. bullet fragment, shrapnel, device implant) in the brain or body that will prohibit the patients from having a brain MRI
* History of dementia, major psychiatric diseases, or life-threatening diseases
* Presence of any other chronic neuropathic pain states such as Complex Regional Pain Syndrome or Painful Peripheral Neuropathy
* History of seizure
* Pending litigation
* Low back pain with mechanical origins such as lumbar radiculopathy or radiculitis or lumbar facet arthropathy
* Lack of ability to understand the experimental protocol and to adequately communicate in English
* History of Traumatic Brain injury
* Chronic Tension or Cluster Headache
* Ongoing Cognitive Rehabilitation or Treatment of PTSD
A Trial of a Positive Psychology Intervention for Older Adults (RESET) During the COVID-19 Pandemic

The heightened vulnerability to COVID-19 of African American older adults in Detroit, Michigan and other marginalized communities is linked to systemic racism experienced over the life course. Structural inequities also magnify the pandemic's impact on older adults' physical and psychosocial functioning. Many older adults in Detroit, burdened by poor health even before the pandemic, face a downward spiral of increased distress, reduced physical and social activity, and physical deconditioning. RESET (Re-Engaging in Self-care, Enjoying Today) is a self-management and resilience-building intervention led by community health workers (CHWs) at the Detroit Health Department (DHD). The central hypothesis of this study is that RESET, with components that include group telephone calls, a podcast series, and activity trackers, will improve psychosocial and physical functioning at 2 and 8 months. Specific aims are: 1) With input from a Community Advisory Board, modify RESET for group delivery and refine content after testing in a mini-pilot (n=10). 2) Conduct a randomized, controlled trial to assess the impact of RESET (compared to a one-time /telephone wellness check) on PROMIS-29 Psychosocial Score (a weighted combination of distress, fatigue, pain, social participation and sleep) among 456 primarily African American older adults age 50 and over who are at elevated risk of poor functioning. 3) Collect qualitative (interview) data from participants and other stakeholders, and use this data to better understand trial results, as well as to assess community impact and inform a dissemination toolkit.


Eligibility Criteria:
Inclusion Criteria:

* Any elevated physical or psychosocial symptoms as follows:

Depression: Score ≥3 on the Patient Health Questionnaire-2 (PHQ-2); Anxiety: Score \> 3 on the GAD-2 anxiety screening scale; Fatigue: Rating \>=4 on a 0 to 10 scale (0 = fatigued at all and 10 = extremely fatigued); Loneliness, as indicated by a score \>=6 on 3-item UCLA Loneliness Scale; Perceived stress, as indicated by a mean score \>3 on the Perceived Stress Scale-4; Chronic pain: Self-reported pain in muscles or joints for \>3 months, \>4 (0-10 scale) mean pain intensity over last month, and \>=1 day in past month when pain made it difficult to do usual activities.

* Have a cell or landline phone.
* Able to converse comfortably in English.

Exclusion Criteria:

* Serious acute illness or hospitalization in last month.
* Planned major surgery in next three months that would interfere with program participation (e.g., knee or hip replacement).
* Severe cognitive impairment or dementia.
* Any other diseases or conditions that would impair cooperation with the study team or ability to complete study procedures, as determined by the clinicians on the investigative team. This would include but not be limited to severe psychiatric disorders, active suicidal ideations or history of suicide attempts, and an uncontrolled drug and/or alcohol addiction).
Evaluation of the Safety and Efficacy of Bilateral Subthalamic Nucleus (SNT) Radiosurgery in Idiopathic Severe Parkinson's Disease Fulfilling Inclusion Criteria for STN Deep Brain Stimulation and Presenting With a Contraindication to Intracerebral Electrode Implantation.

The goal of our trial is to evaluate the tolerance and efficacy of the STN radiosurgery in Parkinsonian patients presenting with the inclusion criteria for the STN stimulation but presenting also with clear contraindications to the implantation of the deep brain electrodes.

Subthalamic nucleus (SNT) deep brain stimulation (DBS) is the reference treatment for severe drug resistant Parkinson's disease, responsible to dopaminergic therapy, to the state of complication. The efficacy of this therapeutic approach has transformed the functional prognosis of these patients. Unfortunately, those of the patients presenting with contraindications for anaesthesia or electrode implantation are excluded of these therapeutic hope.

Gamma Knife radiosurgery is a neurosurgical procedure going to operate in the brain of the patients without opening the skull without infection or bleeding risk.

Gamma Knife radiosurgical treatment will be done in two separate times (GK1 and GK2). Treatment of the second side (GK2) will be done at least 12 months after the treatment of the first side (GK1), in the same methodology as the first treatment. The major risk of onset of acute ballism although low is planned to be managed by the standard protocol by the recruiting team involved in the trial.

Eligibility Criteria:
Inclusion Criteria:

* patients presenting with contraindications for anaesthesia or electrode implantation

Exclusion Criteria:

* contraindications for a surgical treatment
* Pregnant or breast-feeding women
An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness

A randomized, double-blind, placebo controlled, multicenter Phase 3 trial to evaluate the efficacy, safety, tolerability, quality of life and impact on normal daily activities of ARGX-113 in patients with gMG.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
2. Male or female patients aged ≥ 18 years.
3. Diagnosis of MG with generalized muscle weakness meeting the clinical criteria for diagnosis of MG as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, IVa and IVb.

Other, more specific inclusion criteria are defined in the protocol

Exclusion Criteria:

1. Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing.
2. Male patients who are sexually active and do not intend to use effective methods of contraception during the trial or within 90 days after the last dosing or male patients who plan to donate sperm during the trial or within 90 days after the last dosing.
3. MGFA Class I and V patients.
4. Patients with worsening muscle weakness secondary to concurrent infections or medications.
5. Patients with known seropositivity or who test positive for an active viral infection at Screening with:

   * Hepatitis B Virus (HBV) (except patients who are seropositive because of HBV vaccination)
   * Hepatitis C Virus (HCV)
   * Human Immunodeficiency Virus (HIV)

Other, more specific exclusion criteria are further defined in the protocol.
Special Survey for Paediatric Subjects

This study is conducted in Japan. The aim of this study is to collect safety and efficacy data when using NovoRapid® (insulin aspart) in children with type 1 and type 2 diabetes under normal clinical practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* Requiring insulin therapy
* No treatment history of NovoRapid® (insulin aspart)
Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background

The purpose of this clinical research study is to learn if it is safe for rheumatoid arthritis patients to take BMS-582949 along with methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* Diagnosis of RA for ≥6 months
* Swollen or tender joint or ESR \>ULN. Subject must be on stable doses of MTX
* Women of Childbearing Potential

Exclusion Criteria:

* Serum transaminase levels \>ULN
* CK\>ULN
* Cannot have taken Orencia or Remicade within 8 weeks of baseline, Humira or Enbrel within 4 weeks of baseline
* Use of H2 blockers or Proton Pump inhibitors while on study