cyrilzakka/clinical-trials huggingface dataset:
Feasibility and Safety of Robotic Bariatric Surgery Using the SenhanceTM Surgical System

Evaluating feasibility and safety of the Senhance Surgical System with digital laparoscopy in bariatric surgery.

The introduction of laparoscopy in bariatric surgery is considered a milestone to improve postoperative outcomes in terms of less complications and shorter hospital stay. Furthermore, conversion into open surgery is associated with higher postoperative morbidity and mortality in bariatric surgery. Nevertheless, the laparoscopic technique has several drawbacks as lack of tactile feedback, limited degrees of freedom of the laparoscopic instruments, bad depth perception and limited field of view and therefore a flat learning curve.

Senhance Surgical System from Asensus Surgical is an innovative robotic technique which presents haptic feedback, an eyetracker system, microinvasive surgery (with 3mm instruments), reusable instruments and a lower docking time when compared to usual robotic systems.

The use of this new technology has not been systematically analysed in bariatric surgery. Nevertheless, its use is expected to be safe and efficient and may also present some advantages over conventional laparoscopic surgery.

The primary endpoint of the study is the safety of this new robotic platform in bariatric surgery (intraoperative complications, postoperative morbidity, and postoperative mortality). Secondary outcome is the feasibility of this new technology in bariatric surgery (docking time, operation time, conversion rate, length of hospital stay, and rehospitalisation rate).

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* ≥ 18 years old
* Capable of judgment
* Patient eligible for laparoscopic bariatric surgery according to the SMOB (Swiss Study Group for Morbid Obesity) -Criteria and having a bariatric operation (including Sleeve gastrectomy, Y-Roux gastric bypass, Omega-loop gastric bypass) using SenhanceTM Surgical System

Exclusion Criteria:

* \< 18 years of age
* Participants incapable of judgment or participants under tutelage
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* No informed consent signed
* Women who are pregnant
* High risk patients (immunosuppression, myopathy, liver cirrhosis, severe heart or lung disease, renal failure)
* Contra-indication for laparoscopic surgery
* Prior upper gastro intestinal tract operations (such as hepatobiliary, pancreatic, gastrooesophageal, anti-reflux, bariatric surgery or splenectomy except cholecystectomy) or open surgery with incision above the umbilicus
Different Arm Positions During Single Leg Squat

The aim of this study is to compare the effects of different arm positions on muscle activity during single leg squat.

The aim of our study is to examine the effect of different positions of the arms on lower extremity muscle activations during Single Leg Squat (SLS). This prospective cross sectional study included single leg squat test assessments in different arm positions: 1) Arms free, 2) Arms flexed 90 degrees, 3) Hands on hip, 4) Arms across the chest. Inclusion criteria were being a young adult (20-30 years old), physical activity level of at least 4 on the Tegner Activity Scale, and volunteering to participate in the study. Those with a history of lower extremity injury in the last 1 year will be excluded from the study. Our study will contribute to distinguishing SLS variations for clinicians and researchers and choosing the appropriate SLS for evaluation and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 20-30
* Physical activity level of at least 4 on the Tegner Activity Scale,

Exclusion Criteria:

* History of lower extremity injury in the last 1 year
* Central or peripheral vestibular disorders
Oncologic Therapy Support Via Means of a Dedicated Mobile App

The present single-center prospective exploratory study, conducted at Heidelberg University Hospital, assesses the feasibility of introducing a concept for additional patient care based on a mobile application for patients undergoing radiotherapy. Patients presenting themselves for the irradiation of thoracic or pelvic tumors will be surveyed regarding general performance, treatment-related Quality of Life (QoL) and symptoms and their need to personally consult a physician on a treatment-daily basis by means of a mobile application. The primary endpoint of feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day. Furthermore, treatment-related patient satisfaction and diagnosis-related QoL is assessed by PSQ-18 and EORTC questionnaires at the end of radiotherapy and at the first follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Indication for radiotherapy with potentially curative intent of a primarily thoracic or pelvic target
* Karnofsky performance score (KPS) ≥ 70%,
* Ability to initiate the therapy as an outpatient
* ≥ 18 years of age

Exclusion Criteria:

* Inability to give informed consent
Interleukin23 in Systemic Lupus

assement of interleukin 23 in serum of patients with systemic lupus erythematosus related interstial lung disease .

for all patients detailed history taken clinical and rhumatological examination will be assessed and SLEDAI score will be collected from the case record of the patients\&laboratory investigation included 1_erythrocytic sedimentation rate.2_complete blood count.3_interleukin23 .4_complement 3\&4.5_Antinuclear Antibodies.6_Anti double stranded antibodies.7_full basic biochemical test(24 urine protien)8_high resolution computed tomography.

Eligibility Criteria:
Inclusion Criteria:

* patients with systemic lupus erythematous and patients with systemic lupus erythematosus with interstial lung disease.

Exclusion Criteria:

* patients with chest conditions rather than interstial lung disease \&who receiving biological blocking antibodies\& those treated with immunosuppressive drugs.
Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections

This is a randomized, single-center clinical trial that will compare the efficacy of two substances used in the submucosal cushion formation stage of endoscopic submucosal resections of early esophageal malignant neoplasms. Such substances are hyaluronic acid in the form of TS-905 Blue Eyeₒ and hydroxyethylamide (Voluven®).

1. Design of the study:

   This is a randomized clinical trial in a single center. The lesions will be randomized into three blocks based on the diameter of the largest axis (less than 3 cm, between 3 - 5 cm and greater than 5 cm).
2. Selection of patients:

   The population studied will be patients with early esophageal neoplasia diagnosed and/or referred for submucosal endoscopic dissection at the São Paulo Cancer Institute (ICESP), University of São Paulo.
3. Evaluation of effectiveness and definitions:

Effectiveness will be measured from the degree of usefulness. The degree of utility will be determined from two variables: obtaining or not a complete block resection and additional number of submucosal injections performed during endoscopic dissection. The solution that results in a complete block resection with a number of additional injections of 0 (excellent utility degree) or 1 (good utility degree) will be considered effective.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Superficial esophageal adenocarcinoma or squamous cell carcinoma with indication of ESD after discussion in a multidisciplinary oncological board
* Signed informed consent form

Exclusion Criteria:

* Residual or recurrent esophageal lesions
* Ulcerated esophageal lesions
* Patients with severe cardiovascular, kidney or liver disease
* History of hypersensitivity to hyaluronic acid
* Pregnant or lactating women
A Survey of Financial Toxicity in Rural Cancer Patients

This project aims to elucidate the prevalence of financial toxicity, identify significant risk factors for toxicity, and understand the burdens of the specific St. Johnsbury rural population. These data will drive future, larger studies to investigate how to alleviate the burden of financial toxicity, especially in vulnerable patient populations.

"Financial toxicity" refers to a side effect of cancer treatment that is financial in nature, and has become increasingly important to oncologists, patients, and researchers because of its implications in adverse social outcomes for patients. Financial toxicity in the context of cancer care is the monetary cost, and subsequent social implications of the cost, on patients undergoing cancer treatment. Although financial toxicity for patients undergoing cancer treatment has some research attention, financial toxicity associated with radiation therapy for cancer patients has not. There is preliminary data that has shown that there are two forms of financial toxicity: the direct cost of cancer therapy (medical services) and the indirect costs (gas for travel, lost wages for sick days, etc.). However, the degree of cost and sources have not been fully investigated. Specifically, financial toxicity in the context of cancer patients from rural populations (such as those at NCCC) has not been fully explored. This project will attempt to understand the salient factors, costs, and magnitudes of financial toxicity in radiation therapy that will allow for more targeted studies to investigate vulnerable patient populations who experience greater financial toxicity.

Study recruitment temporarily halted due to COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Undergoing treatment at Norris Cotton Cancer Center North, St. Johnsbury, VT
* Current radiation/oncology patient
* Ability to speak or write in English
E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients

The objective of this study was to assess the long-term safety and efficacy of eculizumab in hemolytic PNH patients who completed the 4-week screening and 12-week treatment period of the C07-001 study. In addition, pharmacokinetic and pharmacodynamic assessments of eculizumab were conducted.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have fully completed C07-001 study 12-week treatment period

Exclusion Criteria:

* Patients who terminated early from the C07-001 study
A Cost Effectiveness Analysis of Robotic Versus Laparoscopic Distal Pancreatectomy

This is a clinical and cost-effectiveness analysis within a retrospective comparative study of RDP and LDP conducted at Sanchinarro University Hospital from 2011 to 2017. Outcome parameters included surgical and post-operative costs, quality adjusted life years (QALY), and incremental cost per QALY gained or the incremental cost effectiveness ratio (ICER). A sensitivity analysis was carried out in order to propagate the uncertainty of the estimations to the results of the model. The investigators use a multivariate and stochastic sensitivity analysis performed by 5000 Monte Carlo simulations. The cost-effectiveness plane was used to represent all pairs of solutions of the model.


Eligibility Criteria:
Inclusion Criteria:

* Patients (aged over 18 years) with benign or malignant mass without evidence of major vessel involvement were included.
* The indication for resection was given in the context of a multidisciplinary institutional committee

Exclusion Criteria:

-
Fetoscopic Open Spina Bifida Repair Using the SAFER Technique

Children submitted to fetoscopic in utero myelomeningocele repair using the SAFER (Skin-over-biocellulose for Anternatal FEtoscopic Repair) technique will evaluate at 30 months or more, regarding ambulation, neurodevelopment, urinary and fecal status.

Children submitted to fetoscopic in utero myelomeningocele repair using the SAFER (Skin-over-biocellulose for Anternatal FEtoscopic Repair) technique will evaluate the neuropsicomotor development at 30 months of chronological age. The mental evaluation will use the Bayley III and thePEDI neurodevelopmental scale. The motor development will use the difference between anatomic and motor level of the lesion. Urinary and fecal continence will be evaluated using clinical and ultrasonographic parameters. For the anatomical level determination, immaging of the spine at the lesion level will be used. Motor level and ambulation will be evaluated through standard clinical examination.

Eligibility Criteria:
Inclusion Criteria:

Children operated in utero using the SAFER technique

Exclusion Criteria:

Death before 30 month
A Study of Tongue Conservation Surgery for Oral Tongue Cancer

This is an open-label, non-comparative phase II clinical trial to assess efficacy and safety of tongue conservation treatment with sequential induction chemotherapy, tongue conservation surgery and postoperative concurrent chemoradiotherapy (CCRT) in patients with advanced oral tongue cancer.

Surgical resection remains the most important component of standard treatment for oral tongue cancer, but may lead to profound functional impacts not effectively compensated by reconstruction surgery. The volume of tongue resection remains one key factor for the post-treatment deterioration of the functional outcomes and quality of life in large oral tongue cancer. Primary chemoradiotherapy without surgical resection has not been accepted for oral tongue cancer because of the concerns about possible poorer response and sequelae. Breast conservation treatment, by the sequential use of induction chemotherapy (ICT), limited surgical resection and chemoradiotherapy, has become a standard treatment for human breast cancer of various stages. However, similar tongue conservation treatment for advanced oral tongue cancer has not been studied in trials. Based on these data, it will be reasonable, in locally advanced (\> 3 cm) resectable oral tongue cancers, to test whether ICT followed by tongue conservation surgery and postoperative CCRT can safely enhance the possibility of tongue conservation with improved post-treatment functions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histological proof of squamous cell carcinoma of oral tongue
* b. cT2-4, N0-2,M0, by clinical or radiographic examinations
* Either mandibulotomy, mandibulectomy or flap reconstruction is required by standard surgical planning
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Between 20 and 70 years of age
* Adequate hematopoietic function as defined below:

Hemoglobin \>= 10g/dl Absolute neutrophil count (ANC) \>= 1,500/µL Platelets \>= 100,000/µL

* Adequate organ function as defined below:

Total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine \<= 1.5 x upper limit of normal Creatinine clearance \> 50 ml/min

* Signed study-specific consent form prior to study entry

Exclusion Criteria:

* Patients received gross oral tongue tumor resection before evaluation
* Primary subsites other than oral tongue
* Histologic diagnosis other than squamous cell carcinoma
* Patient with synchronous primary cancers (within 6 months)
* Clinical or radiographic findings as below:

T1 tumors Gross invasion to mandible, tonsil or \>1/3 base of tongue N3 disease or distant metastasis (M1)

* Prior head and neck chemotherapy or radiotherapy
* Prior esophageal cancer history
* Active cardiac disease defined as: unstable angina, uncontrolled arrhythmia, myocardial infarction within 6 months.
* Severe chronic obstructive pulmonary disease (COPD) requiring ≥ 3 hospitalizations over the past year
* Mental status not fit for clinical trial.
* Pregnant or breast feeding women, or women of child-bearing potential unless using a reliable and appropriate contraceptive method.
Integrated Care for Migraine and Chronic Tension-type Headaches

Chronic headache is among the most common neurological disorders with major physical, psychological, social and economic impact. The aim of this prospective observational study isto investigate the effects of an interdisciplinary multimodal integrated care program in patients with chronic migraine and/or tension-type headache.

158 patients with chronic migraine or tensions-type headache at least five days per month for at least 6 months and current intake of triptans (migraine) or analgesic drugs (tension-type headache) are eligible. Patients undergo inpatient, outpatient and/or semi-stationary treatment including conventional headache diagnostics and therapy as well as traditional Chinese medicine, European naturopathy, and mind-body-medicine approaches. Headache frequency is defined as the primary outcome; secondary outcomes include pain (visual analog scale, Pain Perception Scale), triptans and analgesics use (headache diary), health-related quality of life (SF-36), function (Headache Disability Inventory, Patient-specific Functional Scale), depression and anxiety (Hospital Anxiety and Depression Scale), and pain self-efficacy (Pain Self-Efficacy Questionnaire). Outcomes are assessed at treatment start, treatment end and 6 months after treatment end.

Chronic headache is among the most common neurological disorders with major physical, psychological, social and economic impact. The aim of this prospective observational study isto investigate the effects of an interdisciplinary multimodal integrated care program in patients with chronic migraine and/or tension-type headache.

158 patients with chronic migraine or tensions-type headache at least five days per month for at least 6 months and current intake of triptans (migraine) or analgesic drugs (tension-type headache) are eligible. Patients undergo inpatient, outpatient and/or semi-stationary treatment including conventional headache diagnostics and therapy as well as traditional Chinese medicine, European naturopathy, and mind-body-medicine approaches. Headache frequency is defined as the primary outcome; secondary outcomes include pain (visual analog scale, Pain Perception Scale), triptans and analgesics use (headache diary), health-related quality of life (SF-36), function (Headache Disability Inventory, Patient-specific Functional Scale), depression and anxiety (Hospital Anxiety and Depression Scale), and pain self-efficacy (Pain Self-Efficacy Questionnaire). Outcomes are assessed at treatment start, treatment end and 6 months after treatment end.

Eligibility Criteria:
Inclusion Criteria:

headache at least five days per month for at least 6 months current intake of a) at least 10 triptans per month or b) analgesic drugs that can themselves elicit headache

Exclusion Criteria: None.
QST-Pupillometry in Sickle Cell Disease Patients

There has been little progress for effective treatment of pain in sickle cell disease (SCD) patients. Many organizations have recognized that understanding the causes and reducing the burden of pain in SCD is critical in order to improve the quality of life in SCD patients. As patients with SCD face the challenge of living with both acute and chronic pain which is often improperly treated, our translational and interdisciplinary project aims to identify objective measures of pain sensitivity and its biochemical and genetic correlates. We hypothesize that SCD patients will have decreased tolerance to thermal and electrical stimuli.


Eligibility Criteria:
Inclusion Criteria:

* SCD with severe phenotype (HbSS, HbSbeta0 thalassemia, HbSOArab)
* Relatives of SCD patients who do not have sickle cell trait or SCD; healthy controls

Exclusion Criteria:

* Completed overt clinical stroke or transient ischemic attack;
* Known severe vasculopathy or Moyamoya disease on brain MRA (Magnetic Resonance Angiography).
* history of having consumed alcohol within the last 12 hours prior to testing.
Chlorhexidine vs Povidone Iodine Vaginal Prep in Decreasing Postoperative Infection in Total Laparoscopic Hysterectomy

This is a randomized control trial which will randomize patients who will be undergoing laparoscopic (conventional or robotic assisted) total hysterectomy to vaginal prep with 4% chlorhexidine gluconate vs 10% povidone iodine. There is paucity of information regarding the superiority of one over the other.

This is a randomized control trial. During surgery, preoperative vaginal prep is routinely done for hysterectomies. This can be completed with 10% povidone iodine or with 4% chlorhexidine preparation. This study will investigate whether the routine use of betadine vaginal prep in comparison to chlorhexidine prep is superior. Patients will be informed of the study at the time of their preoperative visit in the gynecology clinic at time of surgical scheduling. The attached informed consent sheet will be given to the patient for their signature. The patients will be randomized to receive either 10% povidone iodine or with 4% chlorhexidine vaginal preparation solution. This is not anticipated to take extra time or resources in the operating room setting because the surgical vaginal preparation solutions are typically readily available in the operating room setting. The patients will be assigned an envelope when they are in clinic after they have signed the consent form and that will be the group they are randomized to.

Once the patients are randomized, it is anticipated that 50 patients will be enrolled in each study arm. Following randomization patients will receive the vaginal preparation per the randomization assignment. The patient will be blinded to the study arm. The provider will not be blinded. Follow-up will occur on postoperative day #1 by phone call, and at the 2-week and 6-week follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for total laparoscopic hysterectomy

Exclusion Criteria:

* not able to consent in English or have allergy to the 10% povidone betadine or 4% chlorhexidine solution.
Community Health Assessment Program in the Philippines (CHAP-P)

This study aims to evaluate the effectiveness of the Community Health Assessment Program in the Philippines (CHAP-P), looking at the differences between communities implementing CHAP-P versus communities not implementing CHAP-P.

In this study, the investigators are evaluating the effectiveness of the CHAP-P intervention in communities of the Zamboanga Peninsula, Philippines. Specifically, the investigators are looking at the difference between hemoglobin A1c (HbA1c) levels in randomly selected residents of control communities versus those in communities implementing the CHAP-P intervention. The investigators are also looking at the differences between control and intervention communities in modifiable lifestyle risk factors for diabetes, screening rates for diabetes, rates of newly diagnosed cases of diabetes, general diabetes management, and hospital admission rates, as well as the cost effectiveness of CHAP-P.

The CHAP-P intervention consists of initial and follow-up sessions where trained local volunteers (Barangay Health Workers, or BHWs) take physical measurements (blood pressure, height, weight, waist circumference) and facilitate a diabetes risk survey; based on these findings, they provide education, materials, and referrals to local health resources as needed.

The participant groups in this evaluation include those that attend CHAP-P sessions, randomly selected community members that provide consent for a survey and HbA1c testing, and community members and BHWs/other Lead Local Organization staff who provide consent for focus groups and interviews.

Eligibility Criteria:
Inclusion Criteria (Community Survey Participants \& CHAP-P Session Participants):

* Aged 40 years of age or older
* Resident of community

Exclusion Criteria (Community Survey Participants \& CHAP-P Session Participants):

* Under 40 years of age
* Resident of a different community

Inclusion Criteria (Barangay Health Workers \[BHW\]/Lead Local Organization \[LLO\] Staff)

- Must be a BHW or other LLO staff who is participating in the CHAP-P Intervention