cyrilzakka/clinical-trials huggingface dataset:
Novel Senhance Robotic System in Urologic Surgery: Its Clinical Application and Implication

An observational study to collect data from the participants who received urologic surgeries using the Senhance Robotic system.

This is an observational study and investigators will collect peri-operative demographic data, and short-term outcomes (3-6 months) from the participants who received minimal invasive surgeries using Senhance robotic system in the National Taiwan University Hospital Yunlin Branch, Urology Department. The investigators want to demonstrate if the robotic system is safe and feasible in urologic laparoscopic surgeries.

The operation included TEP, radical prostatectomy, radical nephrectomy (nephroureterectomy) , adrenalectomy, radical cystectomy, and ureter surgery et al.

up to 2022/12, we had recruited 127 TEP, 83 radical prostatectomies, 17 adrenalectomies, 40 nephrectomies, 29 partial nephrectomies, 13 radical cystectomies and 18 other surgeries, such as ureter surgery

Eligibility Criteria:
Patients undergo laparoscopic urologic surgeries
A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea and Vomiting in the Bariatric Surgery Population

To assess the effectiveness of Amisulpride to treat Post Operative Nausea and Vomiting (PONV) and to assess the effectiveness of Amisulpride to prevent PONV following bariatric surgery.

This is a phase III/IV, randomized, placebo-controlled, patient-blinded cross-over pilot study to evaluate the effectiveness of Amisulpride in the treatment and prevention of Post Operative Nausea and Vomiting (PONV) in adult patients, 18-65 years of age, at a single surgery site in the pacific northwest who are undergoing bariatric surgery. Approximately 100 patients will be randomized in a 1:1 ratio to receive a single intravenous dose of Amisulpride (5mg IV single dose) or a placebo (saline control, 1mL IV single dose) at the induction of anesthesia. Those who initially receive placebo will undergo an additional randomization in the post-anesthesia care unit (PACU) to receive a dose of Amisulpride (10mg IV single dose) or placebo (saline control, 2mL IV single dose) in a 1:1 ratio as first line treatment for PONV.

Eligibility Criteria:
Inclusion Criteria:

* The study will recruit adult patients (Age 18-65) scheduled for bariatric surgery. Additional inclusion criteria include ASA class I-III and patients who plan to be inpatient for at least 24 hours.

Included Surgeries:

Robotic, Laparoscopic or Open Roux-en-Y Robotic, Laparoscopic or Open Gastric Sleeve Robotic, Laparoscopic or Open Gastrectomy Robotic, Laparoscopic or Open Revision Gastric Bypass

Exclusion Criteria:

* Pregnant or breastfeeding
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* Congenital QTc abnormalities
* Current use of droperidol
* Parkinson's disease
* Allergy to Barhemsys
* GFR \&lt; 30 mL/min/1.73m2
* Emergency surgery or add-on cases
Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD

This trial investigates the behavioural effects of Internet-based Cognitive behaviour therapy for insomnia (CBT-I) in adolescents with autism spectrum disorder with sleep problems. This is a randomised controlled trial.

Sleep problems are common in adolescents with autism spectrum disorder (ASD)1. Internet-based Cognitive behaviour therapy for insomnia (iCBT-I) is considered as an evidence-based treatment for insomnia 2. To date, no Internet-based CBT-I delivered treatment for sleep problems in adolescents with ASD has been undertaken. The objective of the study is to investigate the efficacy and effectiveness of the Internet-based CBT-I for sleep problems in adolescents with ASD.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents with a clinical ASD diagnosis based on the Diagnostic and Statistical Manual-fifth edition (DSM-5). Participants have been investigated with the Autism Diagnostic Observation Schedule (ADOS).
* Insomnia diagnosis or sleep problems according to DSM-5
* Intelligence quotient (IQ) \> 70 according to Wechsler Intelligence Scale for Children - fourth edition
* Psychiatric comorbidities according to DSM-5: anxiety disorders or depression.

Exclusion Criteria:

* The presence of clinically assessed self-injury
* High risk of suicidal behaviour
* borderline personality disorder or any form of schizophrenia or related disorders;
* substance abuse as well as physical illness or condition that was largely influence sleep condition.
The Impact of Prehabilitation Bundle on Perioperative Outcome for Frail Elderly Patients Undergoing Major Abdominal Surgery

This study aims to study the efficacy of a preoperative "bundle" of interventions, which consists of preoperative physiotherapy, nutritional support and cognitive exercises on elderly frail patients undergoing major abdominal surgery, and evaluating their outcomes. There will be two arms, intervention and control.

Frailty is a geriatric syndrome, defined as an increased vulnerability to stressors leading to a state of decreased physiological resistance. It is characterised by a "constellation of symptoms and signs that describe the heterogeneous response of older adults to physiological and metabolic challenges." While frailty is not necessarily synonymous with chronological age, it is more prevalent among the older adult population and is associated with up to a threefold increased risk of mortality or major morbidity postsurgery. Thus, it has become critically important for healthcare systems to develop strategies designed to improve clinical outcomes in this high-risk population when undergoing surgeries.

Currently there is no clear intervention that has been proven to modify the syndrome of frailty or its impact on postoperative outcomes. This study investigates a novel multidisciplinary approach that can be implemented within a short time frame prior to surgery.

We plan to study the efficacy of a preoperative "bundle" of interventions, which consists of preoperative physiotherapy, nutritional support and cognitive exercises on elderly frail patients undergoing major abdominal surgery, and evaluating their outcomes based 1) length of hospital stay 2) Functional recovery from surgery 3) post-operative complications.

Eligibility Criteria:
Inclusion Criteria:

1. Patients attending the Preoperative Evaluation Clinic, SGH at least 11 days prior to his/her elective major abdominal surgery. Major abdominal surgery is defined as an intraperitoneal surgery with expected length of stay beyond 2 days. For patients who attended the clinic more than 11 days prior to surgery date, they will be informed to start their prehabilitation bundle 10 days prior to surgery.
2. Aged 65 and above
3. Diagnosed as frail based on Fried criteria score 3and above
4. Able to understand and follow the prescribed cognitive and physical exercise

Exclusion Criteria:

1. Patients with Parkinson disease, previous stroke, neuromuscular disorders and those taking carbidopa/levodopa, donepezil hydrochloride or antidepressants as previous studies have found that these medications may cause symptoms that are similar with domains of frailty.
2. Patients who are not able to communicate
Safety, Tolerability and Pharmacokinetic Study of MT-3995 in Subjects With Diabetic Nephropathy

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Type 2 diabetes mellitus and diabetic nephropathy, who have been treated with a stable dose of angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB)
* Glycosylated haemoglobin (HbA1c) ≤10.5%
* Subject with albuminuria

Exclusion Criteria:

* History of Type 1 diabetes, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
* Serum potassium level \<3.5 or \>5.0 mmol/L
* Subjects who had acute kidney injury within 3 months prior to baseline or have undergone hemodialysis at any time prior to randomisation
* Subjects with clinically significant hypotension
Intra-articular Allocetra in Osteoarthritis of the of the Temporomandibular Joint (TMJ)

This study is a single center trial to assess the safety and initial efficacy of intra-articular administration of Allocetra to patients with Temporomandibular Joint Osteoarthritis (TMJ-OA)

The temporomandibular joint (TMJ) is a critical synovial joint enabling jaw movement. TMJ osteoarthritis results from factors such as disc dislocation, trauma, overuse, or developmental anomalies, affecting all joint structures, including cartilage, synovium, bone, and ligaments. Key pathological features include chondrocyte loss, extracellular matrix degradation, and subchondral bone remodeling. TMJ-OA progresses gradually through phases of activity and remission, ultimately leading to a burnout phase.

Allocetra is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.

This study is a single center, open lable safety and initial efficacy trial to assess intra-articular administration of Allocetra in patients with TMJ-OA who have not responded sufficiently to conventional therapies.

The study is comprised of two stages, during which a single treatment of Allocetra, will be administered via intra-articular injection into the target temporomandibular joint.

Patients will be followed for up to a year following treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with temporomandibular OA in the target TMJ.
2. Inflammatory findings by Magnetic Resonance Imaging (MRI).
3. Acceptable blood workup results (CBC, electrolytes, kidney and liver function).

Exclusion Criteria:

1. Prior intra-articular injection to the target TMJ within 3 months prior to treatment.
2. Any significant injury or surgery to the target TMJ.
3. Evidence of active local infection in the vicinity of the target TMJ or clinically significant active infection anywhere in the body.
4. Patients with a known neurological disease or rheumatic condition, a major medical condition that would affect quality of life and influence the results of the study, or other pain of unknown etiology.
Incidence of Venous Thromboembolic Disease and Portal Vein Thrombosis After Hepatectomy. A Cohort Study.

Observational. Retrospective cohort.

Venous thromboembolism (VTE) is a disease that includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). It is a common, potentially lethal disorder that can occur among postoperative patients. Liver surgery implies a prothrombotic state, as a result of an alteration of the equilibrium between synthesis and use of pro and anti coagulant factors after a parenquimal resection. The use of antithrombotic prophylaxis following surgery is not standarized, and current practices vary depending on the attendant surgeon's particular experience or hospital's customs and habits.

In published research, postoperative patients have been studied as a whole so far. There is little evidence regarding patients undergoing hepatectomy. Furthermore, the use and need of extended prophylaxis remains unexplored in this group of patients.

The objetives of the following study are:

* To estimate the incidence of symptomatic venous thromboembolism (VTE) \[deep vein thrombosis (DVT), pulmonary embolism (PE) and fatal PE\] in a third level center in patients undergoing any hepatectomy within 90 days after surgery.
* To estimate the incidence of portal thrombosis (PT) in a third level center in patients undergoing any hepatectomy within 90 days after surgery.
* To identify and describe factors associated to the development of VTE in patients following hepatectomy.
* To identify and describe factors associated to the development of PT in patients following hepatectomy.
* To describe major bleedings or minor but clinically relevant bleedings during the period in which those patients received chemical thromboprophylaxis.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old.
* Following hepatic surgery.

Exclusion Criteria:

* Living donor
* Venous thromboembolism within 6 months previous to surgery.
Autologous Intraovarian Platelet Rich Plasma Treatment in Women With Poor Ovarian Response

Reproductive age women diagnosed with poor ovarian response (POR) based on Bologna criteria with a history of at least two prior failed ICSI cycle will be recruited for the study. Antral follicle count (AFC), serum anti-mullerian hormone (AMH), and early follicular phase serum follicle stimulating hormone (FSH) levels will determined at baseline. Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols and will be injected to both ovaries. Ovarian reserve parameters and ICSI outcomes will be determined.

Reproductive age women diagnosed with POR based on Bologna criteria with a history of at least two prior failed intracytoplasmic sperm injection (ICSI) cycle will recruited for the study. Antral follicle count (AFC), serum anti-mullerian hormone (AMH), and early follicular phase serum follicle stimulating hormone (FSH) levels will be determined at baseline. Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols. PRP injection will be performed under sedation anesthesia, using a 11.8 inch (30 cm) single lumen 21G needles under transvaginal ultrasound guidance. On the 2 to 4th days of the first three menstrual cycles following the procedure, AFC, AMH, and FSH levels will be re-assessed. Patients with at least one antral follicle will be started on ovarian stimulation for ICSI, followed by embryo transfer. Biomarkers of ovarian reserve (AFC, FSH, AMH), and ICSI outcome parameters (number of metaphase II (MII) oocytes, blastocyst embryos, fertilization rate, oocyte and embryo quality) will be followed.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with POR based on Bologna criteria and with a history of at least two prior failed ICSI cycles
* A previous assisted reproductive technology cycle with less than 3 oocytes (conventional stimulation protocol) and AFC \< 7
* The same ovarian stimulation protocol before and after the PRP treatment

Exclusion Criteria:

* Age over 46 years,
* Body mass index (BMI) ≥ 30 kg/m2,
* Presence of pregnancy
* Uncontrolled endocrine disorders (polycystic ovary syndrome and others)
* Parental genetic and chromosomal disorders,
* Immunological disorders
* Cancer diagnostics
Special Drug Use Investigation for LAMICTAL® (Long Term)

The objectives of this post-marketing surveillance (PMS) are to grasp the actual use of lamotrigine tablets to collect safety information in the long-term use according to seizure type and concomitant antiepileptic drug (AED), and to confirm its efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome
* Subjects who are treated with lamotrigine tablets

Exclusion Criteria:

* None
Dose-response Curves Between Propofol and Intraoperative Electroencephalographic Patterns

In the world, 230 million surgeries are performed per year and a significant part is performed in patients over 65 years of age. These patients are more labile, especially from the neurocognitive point of view with a high risk to develop neurocognitive complications, such as postoperative delirium. Recent studies have linked this type of complication with an overdose of general anesthetics during surgery. For this reason, in recent years, the use of brain function monitors during the intraoperative period has been recommended to adapt the dosage of the drugs to each patient and thus to avoid overdosing of general anesthetics. However, to date, the available monitors that process the electroencephalographic signal are not able to adequately discriminate gradual changes in anesthetic depth. Also, no systematic studies have been performed that analyze changes that occur in the electroencephalogram (EEG) signal secondary to increases in complications from general anesthetics. Thus, the investigators design this study with the main aim to determine the changes in electroencephalographic patterns induced by a stepped increase of propofol until the burst suppression is reached.

The investigators will carry out a prospective analytical observational clinical study at the Clinical Hospital of the University of Chile. In total 15 patients will be recruited, in who a frontal electroencephalographic signal will be recorded using a SedLine® monitor, and propofol concentration will be estimated using the Marsh model. First, the concentration of propofol at the loss of consciousness (LOS) will be recorded in the presence of remifentanil (7.5 ng/mL). Then, patients will be intubated and remifentanil will be decreased to 4 ng/mL. After that, the concentration of propofol that caused the LOS will be maintained for 20 minutes. Finally, propofol will be increased in steps of 0.3 mcg/mL for 7 min, until an episode of burst suppression will be observed. In the complete protocol, EEG activity will be acquired using a SedLine® monitor.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Physical Status 1 or 2
* Low-risk surgery

Exclusion Criteria:

* BMI \> 35 kg/m2
* Benzodiazepines use
* Epilepsy
* Psychiatric disorder
* Kidney disease
* Liver disease
* Brain damage
Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw

Zynex's blood volume monitor (BVM) is a non-invasive monitoring device to monitor blood volume and blood loss of a patient during surgery, post operatively and/or in recovery. This monitoring device will identify baseline blood volume and relative changes in blood volume using a specific algorithm to compare and review data already monitored during surgery, displaying blood volume and blood loss in real-time.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Male, 18-65 years of age
* Subject is suitable for a blood draw of a pint of blood
* Weighs at least 110 pounds

Exclusion Criteria:

* Subject has a heart condition that may interfere with the Zynex CM-1500
* Subject has unstable or untreated heart disease
* Subject has been diagnosed with chronic fatigue syndrome
* Subject is taking coumadin (warfarin), heparin, or other prescription blood thinners for at least 7 days prior to blood draw
* Subject donated blood within 8 weeks prior to blood draw
* Subject has high or low blood pressure on the day of blood draw
* Subject hemoglobin \< 12.5 g/dL
Stress Management for College Students

The goal of this clinical trial is to learn if a virtual task can reduce distress in college students. The main questions it aims to answer are:

1. Will those who complete the virtual task have less distress?
2. Will men and women both benefit equally from the virtual task?

Researchers will compare the virtual task to a control task (another virtual task that we expect will not impact distress) to see if distress differs.

Participants will spend 20 minutes engaging in the virtual task (or the control task) on 3 different days all within one week. They will complete a survey about their well-being before starting the first virtual task and again \~6 weeks afterward.

Easily accessible and cost effective strategies for reducing emotional distress and improving stress tolerance in college students and the population generally are desired. The scalability and feasibility of virtual interventions hold promise for reaching segments of the population that find one-on-one psychotherapy aversive. Males in particular have higher perceived treatment stigma relative to women and find may typical traditional therapeutic processes incongruent with their masculine identity and values. The research team has designed an innovative, self-directed, virtual intervention to reduce distress and stress intolerance. The intervention consists of a set of virtual tasks which reflect the Sequential Model of Emotional Processing presented with language, imagery and content that engages men.

Using a randomized clinical trials design, this pilot project will compare the effects of the virtual intervention with a virtual control task on emotional well-being outcomes in college students.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* college student

Exclusion Criteria:

* Younger than 18 years of age
Ultralong-segment Barrett's Esophagus: Towards a Capsule-sponge Surveillance Strategy

The purpose of this study is to evaluate the Endosign capsule sponge test as a novel surveillance method in patients with an ultralong-segment Barrett's esophagus.

In this study we will investigate the concordance between the Endosign capsule sponge test and esophagogastroduodenoscopy (EGD) by an expert endoscopist to detect dysplasia and/or esophageal adenocarcinoma (EAC) in patients with an ultralong-segment Barrett's esophagus. Patients will receive both the Endosign test and an EGD, after which we will compare both outcomes. To detect dysplasia and/or EAC on the cells collected by the Endosign test, we will look at cellular atypia and use p53 immunohistochemistry and novel biomarkers. In the future the Endosign test could perhaps replace EGD in the surveillance of Barrett's esophagus patients.

Eligibility Criteria:
Inclusion Criteria:

* Any participant 18 years and above, with ultralong-segment Barrett's esophagus and clinically fit for an endoscopy
* Ability to provide informed consent

Exclusion Criteria:

* Individuals with a diagnosis of an oro-pharynx, esophageal or gastro-esophageal tumor (T2 staging and above), or symptoms of dysphagia
* Esophageal varices or stricture requiring dilatation of the esophagus
* Individuals who have had a cerebrovascular event \< 6 months prior where their swallowing has been affected
* Patients who have had previous treatments such as Photodynamic therapy (PDT), Radiofrequency ablation (RFA) or Argon Plasma Coagulation (APC) for dysplastic Barrett's esophagus
* Participants who are unable to provide informed consent
* Participants under age 18 years
Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)

Patients with a desire for nipple reconstruction following breast cancer and breast reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK Biodesign® Nipple Reconstruction Cylinder.


Eligibility Criteria:
Inclusion Criteria:

* Patient presents with a history of breast cancer, having previously completed either uni- or bi-lateral breast removal and reconstruction.
* Patient presents with a desire to obtain nipple reconstruction
* Patient is at least 18 years of age
* And other inclusion criteria

Exclusion Criteria:

* Patient is not medically fit enough for surgery under local anesthesia
* Patient is currently smoking, using tobacco products, or nicotine products (i.e. patch, gum, or nasal spray)
* Patient is pregnant, breastfeeding or planning further pregnancy during the study period
* Patient has physical allergies or cultural objections to the receipt of porcine products
* And other exclusion criteria