cyrilzakka/clinical-trials huggingface dataset:
Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen

The aim of this study is to evaluate the outcomes of transvaginal natural orifice specimen extraction (NOSE) in patients who are planning multiport laparoscopic surgery for resection of solid organs including kidney, liver, stomach, adrenal gland and bladder.

Study design:

This was a prospective, single center, single arm study. This clinical trial was approved by the Institutional Review Boards.

Study process:

All patients gave informed written consent after being informed of the details of the study. All participants underwent demographic and history taking, laboratory tests and a gynecological examination to determine whether specimen removal through vagina is possible. The patients who was adequate for this study were planned to perform multiport laparoscopic surgery and patients were subjected to transvaginal NOSE.

To perform transvaginal NOSE procedure, the patients were placed in the lithotomy position with Trendelenburg position. After about 1-2cm incision at the posterior vaginal fornix, endopouch was introduced into the abdominal cavity through vaginal incision site. The specimen was placed inside a endopouch and removed through vagina. Closure of vaginal incision site was achieved by transvaginally with 2/0 absorbable suture.

During the second and third visit at 1 week and 8 week, Patient and Observer Scar Assessment Scale (POSAS) was performed to assess cosmetic outcomes of scar. Subjects with sexual activity carried out Female Sexual Function Index (FSFI) questionnaire to assess sexual function at final visit which occurred at 6 months after surgery.

Statistical analysis:

All data are summarized as means ± standard deviation or as numbers with proportions. A p \< 0.05 was considered to indicate significance. Student's t-test and Mann-Whitney U test were conducted to compare continuous parametric variables and non-parametric variables, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are accessible with vaginal approach
* Patients scheduled for laparoscopic resection of stomach, colon, kidney and spleen for benign or malignant diseases
* Patients with normal cervical cancer screening tests within the last 3 years except inflammatory findings

Exclusion Criteria:

* Patients without sexual intercourse
* Patients who are considered unable to remove specimen through vagina due to narrow introitus in gynecological examination
* Patients who are expected to have severe adhesion due to deep infiltrative endometriosis or previous pelvic surgery history
* Patients with abnormal cervical cancer screening tests
* Patients scheduled to perform concomitant hysterectomy
B Cell Responses in COVID-19

In this study, we will develop techniques to optimize the in vitro production of human monoclonal antibodies.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 at time of signing informed consent form
* Signed informed consent form

Exclusion Criteria:

* Ongoing drug abuse
* Active or history of neoplastic malignancy
* Active autoimmune disease ongoing treatment with immunosuppressive therapy
* Ischemic heart disease
* Evidence of positive HIV, HCV, HBV test
* Diabetes
* Failure to sign informed consent form
Laser Induced Bioengineered Remodeling of Thermally Injured Skin Trial

This study will evaluate the efficacy of pulsed dye laser (PDL) and carbon dioxide (CO2) laser in conjunction with usual care (MED) for the treatment of hypertrophic burn scars and will determine the optimal sequence and timing of lasers and usual care.

The investigator will compare usual care (MED), which will be offered to all patients, to two types of laser treatment (PDL and CO2), which the investigators hypothesize to be beneficial. The timing and sequence of therapy will be randomized, but all patients will receive some form of laser treatment. If the investigators simply stopped at the end of Aim 1, the investigators would complete a traditional randomized control trial (RCT), with some patients potentially receiving laser treatment. However, the investigators are interested in determining whether the sequence of laser treatments is beneficial; therefore, the investigators will be employing a sequential multiple assignment randomized trial (SMART) design. Because of the nature of the study and SMART design, the investigators will offer all patients some form of laser therapy.

Eligibility Criteria:
Inclusion Criteria:

* have a burn injury which will be at least 6 months old at the time of first treatment,
* have one or more symptomatic burn scars (with at least one or more symptoms such as erythema, pruritus, surface irregularity, or tightness not caused by a contracture that would be better served with surgical treatment),
* desire laser treatment,
* be at least 6 months of age at the time of treatment,
* agree to have no aesthetic treatments for their burn scars, such as peels or fillers, until they have completed the study (two-year period),
* agree to be randomized into one of the study's treatment conditions,
* agree to return for all treatment and follow-up visits for the two-year study period,
* agree to refrain from participating in any other treatment-oriented clinical trial for the duration of this study, and
* be able and willing to follow the protocol requirements.

Exclusion Criteria:

* be women who are pregnant or planning to become pregnant during the study,
* have had any previous laser treatment of their burn scars,
* have open wounds that are not re-epithelialized in the areas of proposed study treatment,
* be taking systemic steroids or immunosuppression medication,
* have a connective tissue disorder,
* be receiving or planning to receive chemotherapy or radiation during the study,
* be medically unable to tolerate anesthesia, or
* have other conditions that in the opinion of the investigators or clinicians may affect participant safety or compromise study objectives.
Respiratory Care in Intensive Care Unit for Neuromuscular Patients

Retrospective multicentric observational study exploring the population of adult neuromuscular patients presenting a respiratory distress requiring their admission in an Intensive Care Unit (ICU) for ventilatory support.

Research of markers associated with long term mortality and ventilatory status.


Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years old
* First stay in a ICU ward
* Inclusion period : Admission in ICU between 01/01/2007 and 31/12/2015
* Presenting an acute respiratory distress at admission or during ICU stay
* Diagnosis of neuromuscular disease confirmed before Hospital discharge

Exclusion Criteria:

* Absence of respiratory failure during ICU stay (ICU stay for monitoring or for a specialized invasive procedure in the absence of respiratory failure, for example)
* Neuromuscular disease not proven or uncertain diagnosis
* Anterior admission in ICU ward for vital organ failure
MS PATHS Normative Sub-Study

The primary objective of this study is to determine the normative range of brain volume and brain volume change in healthy control (HC) participants whose age, race, and gender distribution is approximately matched to the age, race, and gender distribution of patients with Multiple Sclerosis (MS) enrolled in Study 888MS001. The secondary objective is to use the results of the primary endpoint to ensure consistency of brain volume measurements across MS PATHS centers.


Eligibility Criteria:
Key Inclusion Criteria

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local participant privacy regulations.

Key Exclusion Criteria

* History of human immunodeficiency virus.
* Confirmed or suspected pregnancy.
* Diagnosis of migraine requiring medication or any other participant-reported diagnosis of a neurological disease or condition (e.g., stroke, transient ischemic attack, epilepsy, brain infection, brain surgery, prior head injury or concussion, or brain tumor).
* Any participant-reported diagnosis of an autoimmune disorder (e.g., rheumatoid arthritis, Sjögren's syndrome, scleroderma, or systemic lupus erythematosus).
* Standard MRI exclusion criteria, including claustrophobia, inability to lay still in the magnet (e.g., tremor), or any type of implanted metal in the body that would be affected by the strong magnetic field.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Enteric Immune-nutrition Formula (ANOM®) for Patients Receiving Major Upper Gastrointestinal Surgery

Perioperative usage of immunonutrition (ANOM®) can attenuate the pro-inflammatory cytokines and reduce postoperative infectious complications and length of hospital stay after major upper gastrointestinal surgery.

(ANOM®)immunonutrition product name

Background: Perioperative usage of immunonutrition can attenuate the pro-inflammatory cytokines and reduce postoperative infectious complications and length of hospital stay after major upper gastrointestinal surgery. The aim of this study was to elucidate the effect of immunomodulating diets, ANOM®, on surgical outcome in elective major upper gastrointestinal tract operations.

Material and Methods:

Design: Prospective, randomized, controlled trial. Participants: Seventy upper gastrointestinal tract cancer patients planned to undergo major upper gastrointestinal surgery in eesophagus、stomach、pancreas or duodenum, Interventions: Patients will be divided randomly into two groups to receive ANOM® or standard diet. Before surgery, 800ml ANOM® or standard diet (SEN) will be given for 5 days by mouth. After operation, 5% Distill water (D5W) combined with ANOM® or standard diet since the 2nd post-operation day (POD2) until day 14 (POD14) or until discharged day by enteric route using nasogastric tube(NG) tube or jejunostomy. Postoperative parenteral nutrition will be given to maintain adequate nutrition.

Clinical Assessment: The preoperative and postoperative immunological parameters, infection complications, and hospital stay will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. Age ranged from 18 to 80 years old
2. Patients with upper gastrointestinal diseases, and was planning to receive elective major upper gastrointestinal tract surgery, such as subtotal gastrectomy, proximal gastrectomy, total gastrectomy, esophagectomy, pancreatectomy, pancreaticoduodenectomy, duodenectomy, etc.
3. Patient is able to understand the requirements of the study and signs the Informed Consent Form.

Exclusion Criteria:

1. Patient with severe malnutrition condition, albumin \< 2.6mg/ml
2. Patient with severe pulmonary, cardiovascular, renal or hepatic disease
3. Patient with immunosuppressive therapy or immunological disease recently
4. Patient with on-going infection with any condition
5. Patient with emergency operation
6. Patient with widespread metastatic disease before surgery
7. Patient with bowel obstruction disease
8. Investigator judges as subjects to be inappropriate for the clinical study (e.g., patient with severe complications)
Intraperitoneal Carbon Dioxide Concentration Measurement During Standard Laparoscopy With a New Airseal Access Port

The new AirSeal access port for laparoscopic surgery does not use a mechanical valve on the port to maintain gas in the peritoneal cavity. It uses an invisible barrier created by high flow gas jets within the port. The percentage of carbon dioxide, the standard gas used for laparoscopy, during laparoscopic surgery has not been previously measured, but is probably high. The investigators aim to measure the percentage of intraperitoneal carbon dioxide with standard ports and the AirSeal port during a variety of conditions during laparoscopic procedures including suturing and suctioning. The study period will commence at the start of the operation, and be completed upon discharge from the hospital or postoperative day 5, whichever is shorter. All devices are approved for use in humans by the FDA, and are being used for their intended purpose.

The SurgiQuest AirSeal system is approved by the Food and Drug Administration (FDA) as access port for laparoscopic surgery that utilizes an invisible air curtain rather than a mechanical barrier to maintain pneumoperitoneum. In addition to the cannula, there is special filtration tubing and an air pump that act in concert with an existing CO2 insufflator. The system has been approved for use and purchase at Baystate Medical Center by the value analysis committee. Despite FDA approval and extensive laboratory testing, there is still no human data regarding intraperitoneal CO2 levels under a variety of conditions one would normally experience during a laparoscopic operation. The specific aim of this study is to measure these levels during laparoscopic cases in humans. We hypothesize that there will be no more than minimal alteration of intraperitoneal CO2 levels when using the AirSeal system when compared to the standard laparoscopic system. The follow-up to this is examining evidence of extraperitoneal gas extravasation. This will occur as part of routine post-operative care, but we will be collecting data, that will be de-identified in the post-operative period.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing a laparoscopic operation

Exclusion Criteria:

* pregnancy
Xeltis Hemodialysis Access Graft: aXess Pivotal Study

A prospective, single arm, non-randomized pivotal study to evaluate the safety and performance of the Xeltis hemodialysis access graft in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with end-stage renal disease (ESRD) who require placement of an AVG in the upper extremity to start or maintain hemodialysis therapy
2. At least 18 years of age at screening
3. Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an aXess graft
4. The patient, or legal representative, has been informed about the nature of the study, agrees to its provisions, and has provided written informed consent
5. The patient has been informed and agrees to pre- and post- procedure follow-up
6. Life expectancy of at least 12 months

Exclusion Criteria:

1. History or evidence of severe cardiac disease (NYHA Functional Class IV and/or EF \<25%), myocardial infarction within six months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
2. Uncontrolled or poorly controlled diabetes
3. Abnormal blood values that could influence patient recovery and or/ graft hemostasis
4. Reduced liver function, defined as: \>2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) \>1.5 or prothrombin time (PT) \>18 seconds
5. Any active local or systemic infection
6. Known heparin-induced thrombocytopenia
7. Known active bleeding disorder and/or any coagulopathy or thromboembolic disease
8. Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically
9. Anticipated renal transplant within 6 months
10. Known or suspected central vein obstruction on the side of planned graft implantation
11. Previous dialysis access graft in the operative limb unless the aXess graft can be placed more proximally than the previous failed graft
12. Previous enrolment in this study
13. Subject is participating in another study
14. Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
15. Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit

Intra-operative exclusion criteria:

1. Unsuitable anatomy to implant the aXess graft (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)
Effects of Botulinum Toxin Injection Combined with RESWT in Lower Extremity Spasticity in Children with Cerebral Palsy

This study aimed to check and compare the effects of botulinum toxin injection combined with shock wave therapy versus botulinum toxin injection only for lower extremity spasticity in children with cerebral palsy

20 pediatric patients diagnosed with cerebral palsy who received botulinum toxin type A injection for lower extremity spasticity were divided into two groups. The first group will receive only conventional treatment after the injection, while the second group will receive extracorporeal shockwave therapy for injected muscles. The shock wave therapy is planned as 3 sessions per week, starting one week after the injection. Patients will be compared in terms of MAS scores, MTS scores, passive joint range of motion, modified timed up and go test, pain scores, (faces pain scale-revised) and Goal Attainment Scaling scores. Patients will be evaluated 1 week, 1 month and 3 months after the injection with pre-injection data.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cerebral palsy.
* Spasticity in at least one of the lower extremity muscle groups.
* No contraindications to shockwave therapy.
* Applied Botulinum Toxin Type A injection for at least one spastic muscle of lower extremity.
* Agreed to participate to study (patient/primary caregiver)

Exclusion Criteria:

* Surgery history within the last year of the muscle to be injected and treated
* Having uncontrolled epilepsy.
* Having infection
* Coagulopathy
Inter Scorers Agreement for OSA Screening Scores.

Four scores are usually performed to detect OSA (Obstructive Sleep Apnea) patients. These four scores are: STOP-Bang, P-SAP, OSA50 and DES-OSA. These scores have been previously validated. However, a comparison between scorers in the realization of these scores has never been performed.

Four scores are usually performed to detect OSA (Obstructive Sleep Apnea) patients. These four scores are: STOP-Bang, P-SAP, OSA50 and DES-OSA. These scores have been previously validated. However, a comparison between scorers in the realization of these scores has never been performed. The aim of this study was to evaluate this agreement using statistical methods.

Eligibility Criteria:
Inclusion Criteria:

* All preoperative patients in the Cabinet Medical ASTES

Exclusion Criteria:

* Patient's refusal
Evaluation of Relapse Presence in Multiple Sclerosis

Purpose: This study aims to investigate the demonstrability of increased inflammation and neurodegeneration in multiple sclerosis (MS) patients in relapse period compared to MS patients in remission by cross-sectional analysis of in-vivo corneal confocal microscopy (IVCM), and to evaluate the alternations with a second IVCM administered at least 6 months after the relapse period.

Methods: This prospective, non-randomized-controlled, cross-sectional study included 58 MS patients which were grouped regarding the presence of relapse (MS-Relapse group \[n=27\] and MS-Control group \[n=31\]), and age-sex matched 30 healthy controls (HC). The corneal nerve fiber density (CNFD), the corneal nerve branch density (CNBD), the corneal nerve fiber length (CNFL), and dendritic cell (DC) density were evaluated in all MS patients and HCs by IVCM. If the patients in the MS-relapse group did not have an attack within 6 months, the same parameters were evaluated with the second IVCM. The patients with a history of optic neuritis or trigeminal symptoms were excluded.


Eligibility Criteria:
Inclusion Criteria:

* Patients for whom the administration of intravenous corticosteroids was decided due to the diagnosis of new relapse
* Patients who were followed up with the diagnosis of RRMS
* Healthy controls

Exclusion Criteria:

* Being younger than 18 years old
* Having any other neurological or metabolic diseases
* Ophthalmological diseases
* A history of optic neuritis and trigeminal symptoms
* Ocular trauma or surgery
* Contact lens use
* The patients who had a relapse attack 6 months prior to the study
Health Benefits of Chronic vs. Acute Exercise in Overweight Adults

Compare the effects of single session of exercise vs. chronic exercise training on key risk factors associated with Metabolic Syndrome (e.g., glucose tolerance, blood lipid profile, and blood pressure) in overweight adults.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index: 27-34 kg/m2;
* Regular exercisers(≥4 days/wk of aerobic exercise;
* 30-60min/session at moderate and vigorous intensities);
* Non-exercisers (no regularly planned exercise/physical activity);
* Women must have regularly occurring menses and must be premenopausal.

Exclusion Criteria:

* Pregnant or lactating;
* Evidence/history of cardiovascular or metabolic disease;
* Currently taking medications known to affect lipid or glucose metabolism.
Analysis of Thrombo-embolic Complications After Endovascular Treatment of Unruptured Intracranial Aneurysms

Endovascular treatment of ruptured and unruptured intracranial aneurysms presents complications, mainly the thrombo-embolic complication. No specific studies have been conducted to study factors associated with the occurrence of thromboembolic complications (symptomatic or not) post endovascular treatment of intracranial aneurysms.

In this multicenter, prospective study, patients with treatment of unruptured intracranial aneurysms will be recruited. The thromboembolic complications will be research using diffusion-weighted MRI.

Eligibility Criteria:
Inclusion Criteria:

* patient having a programmed endovascular treatment for unruptured intracranial aneurysm
* patient older than 18 years
* patient consenting to participate to the study
* patient enrolled in the national healthcare insurance program

Exclusion Criteria:

* patients with contraindications for MRI
* patients whose clinical condition does not allow sufficient cooperation to the realization of MRI
* patients with arteriovenous malformation intracranial
Double-Blind Study of Miglitol in Japanese With type2 Diabetes

To investigate the efficacy and safety of miglitol in Japanese patients with type 2 diabetes that is insufficiently controlled diet alone.


Eligibility Criteria:
Inclusion Criteria:

* Type2 diabetic patient on Dietary Therapy
* Criteria for postprandial plasma glucose and HbA1c are met

Exclusion Criteria:

* Type1 diabetes
* Patients treated with antidiabetic drugs or Insulin