cyrilzakka/clinical-trials huggingface dataset:
A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma

This study will investigate the efficacy and safety of bevacizumab + fotemustine in patients with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic disease. Patients will receive Avastin (15mg/kg intravenously\[IV\]) on Day 1 of every 3 week cycle, in combination with fotemustine (100mg/m² IV) on Days 1, 8 and 15, followed by 4 weeks rest, followed by 100mg/m² IV every 3 weeks for 4-6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* cutaneous malignant melanoma;
* advanced, inoperable stage IV melanoma;
* measurable and/or evaluable sites of metastases.

Exclusion Criteria:

* prior chemotherapy and/or IFN/IL2 based immunotherapy for metastatic disease;
* prior malignancies within past 5 years, with the exception of cured non-melanoma skin cancer, or in situ cancer of cervix;
* clinically significant cardiovascular disease;
* ongoing treatment with aspirin (\>325mg/day) or other medications known to predispose to gastrointestinal ulceration.
The Effect of OMT on Patients With COPD: Correlating Pulmonary Function Tests With Biochemical Alterations

This project proposes to test the hypothesis that osteopathic manipulative treatment (OMT) given to patients with moderate to severe chronic obstructive pulmonary disease (COPD) enrolled in a 12-week pulmonary rehabilitation program (PRP) will result in improved respiratory pump function over and above that seen in sham and control groups. Specifically, we will study the effects of three OMT techniques: (a) thoracic inlet indirect myofascial release; (b) rib raising with continued stretch of the paraspinal muscle to the L2 level; and (c) cervical paraspinal muscle stretch with suboccipital muscle release. The key clinical readouts will include: spirometry, P100 (and index of diaphragm and inspiratory muscle efficiency), maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), as well as laser evaluation of chest wall excursion. Supplementing these objective parameters will be several more subjective clinical outcome measures: exercise tolerance (6-minute walk test), dyspnea (shortness of breath questionnaire), and quality of life questionnaire. Finally, an attempt will be made to correlate biochemical alterations that may shed light on the biological mechanism underlying the OMT procedures.

According to the above directions (provide a more extensice description, if desired), I am choosing to just submit the brief summary.

Thank you, Sherman Gorbis, DO

Eligibility Criteria:
Inclusion Criteria:

* postbronchodilator FEV1/FVC \<0.7 and FEV1 \<80% predicted \[FEV1 =volume that has been exhaled at the end of the first second of forced expiration\] and FVC volume of air that can be forcibly blown out after full inspiration\]
* history of smoking \>20 pack-years
* stable condition at inclusion with no infection or exacerbation for at least two months
* optimal medical therapy for at least eight weeks with no change

Exclusion Criteria:

* history of active pulmonary disease such as asthma
* positive bronchodilator test
* treatment with N-acetylcysteine
* previous diagnosis of hypertension or current anti-hypertensive treatment
* known unstable or moderate to severe heart disease (arrhythmia, ischemic heart disease, or cardiomyopathy)
* previous diagnosis of chronic illness such as diabetes, renal failure, hypercholesterolemia, hepatic cirrhosis, cancer, rheumatoid arthritis or any other systemic inflammatory disease
* neuromuscular or disabling cognitive problems
* engagement in any exercise-training program during the past three months
* substance abuse in the preceding six months
Exploring Muscle Breakdown During Exercise Recovery

This study will allow researchers to explore how muscle responds to heavy exercise. The researchers will characterise rates of muscle protein breakdown and synthesis 24hours after heavy exercise with a post exercise protein polyphenol or placebo supplementation. This will inform strategies to help people recover from heavy exercise.

It is well known that resistance exercise increases rates of muscle protein synthesis and breakdown, with the rise in synthesis greater in magnitude and duration. The time course of rates of muscle protein synthesis increase dramatically 24-72h following eccentric exercise, even in a non-exercised control leg. This data is consistent with a much larger increase in muscle protein breakdown than previously thought. However, the response of muscle protein breakdown following damaging eccentric exercise, and its relationship with muscle protein synthesis, has not yet been elucidated. Moreover, it is unclear whether a protein and polyphenol nutritional intervention influence rates of muscle protein breakdown to accelerate recovery. This study will allow researchers to test the hypothesis that eccentric exercise increases rates of muscle protein breakdown independently of muscle contraction per se. If this hypothesis is supported, it will highlight that recovery strategies from muscle damage should also target supporting muscle protein breakdown.

Eligibility Criteria:
Inclusion Criteria:

* Recreationally active
* 18-40 years of age

Exclusion Criteria:

* Regular and structured involvement in resistance training
* Inactive participants
* Habitual dietary protein intake \<0.8g/kg bw/day and \>2.0g/kg bw/day
* Regular use of nutritional supplements known to suppress inflammation or modulate protein metabolism Any diagnosed metabolic conditions (diabetes), cardiovascular disease or hypertension
* Current musculoskeletal injury
* Chronic use of anti-inflammatory medicines
* Any known disorders in muscle metabolism
* Individuals with an allergy to egg, fish, wheat or soy ingredients as the product is manufactured in a facility that contains these ingredients
* Allergy to lidocaine
* Having received or ingested a stable isotope tracer containing 15N in the past
* A personal or family history of epilepsy, seizures or schizophrenia
* Stomach bleeding or stomach ulcer
* Kidney failure
* Liver problems, such as fibrosis, cirrhosis or failure
* Crohns disease or ulcerative colitis
* Chickenpox or shingles
* Pregnant or trying to get pregnant
* Any diagnosed cardiovascular disease (e.g. deep vein thrombosis) or hypertension.
* Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)
* Recent (within the last 6 months) or current musculoskeletal injury (leg fracture)
Bariatric Surgery and Pharmacokinetics of Irbesartan

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on irbesartan are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
Mini-invasive Preventive Fixation of the Contralateral Femoral Neck in Patients Operated on for a Femoral Neck Fracture

In France, the annual incidence of hip fracture is about 80 000 with more than 75% of these fractures occurring in patients aged 80 years old or more. About 10% percent of patients presenting with a hip fracture will sustain a contralateral hip fracture, most within 3 years. The consequences of a hip fracture are dramatic: 20% of patients die in the first year and less than half those who survive regain their previous level of function. Hip fractures are invariably associated with chronic pain, reduced mobility, disability, and an increasing degree of dependence. The efficacy of pharmacological treatments to prevent a contralateral hip fracture is marginal and postponed and compliance is known to be poor.

Osteoporosis is associated with cortical thinning and trabecular bone loss. Therefore, the mini-invasive preventive fixation (MIPF) of the contralateral femoral neck is appealing. The effect is immediate and compliance is certain. Morbidity is minimal because it is performed during the same operation as the fixation of the femoral neck fracture.

The main objective of this study is to determine whether the mini-invasive preventive fixation (MIPF) of the contralateral femoral neck in patients having a femoral neck fracture is superior to no fixation regarding the occurrence of a contralateral hip fracture within 3 years.


Eligibility Criteria:
Inclusion Criteria:

* women and men
* 80 years or older
* operated on for a femoral neck fracture
* presenting one, or more, added clinical risk factor of hip fracture\*
* a fragility fracture in the past five years
* a history of fall in the past 12 months (not considering the fall that led to the present fracture)
* a very high risk of falling: use of psychoactive medication or impaired vision or impaired neuromuscular function
* BMI lower than 20kg/m2
* giving her/his consent.
* affiliated to the social security

Exclusion Criteria:

* history of a contralateral proximal femoral fracture
* history of a surgical operation of the contralateral proximal femur
* ongoing infection (bone or soft-tissue) on the contralateral hip
* contraindication of MIPF of the contralateral hip
* non ambulatory patients
* patients already included in the study
* patients with contraindication to the medical devices under evaluation
* patients not suitable for a surgical procedure (including not suitable for an anaesthetic)
* patients with a benign or malignant bone lesion of the contralateral femur
* patients included in another clinical research which could directly have an effect on the femoral neck bone strength
* patients presenting with a grade 4 Kellgren-Lawrence osteoarthritis of the contralateral hip and reporting significant clinical symptoms
* patients with an life expectancy of less than 3 months
* patients with a legal representative (tutorship or guardianship) and insane patients will be excluded
The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD

The purpose of this study is to evaluate the safety of vagal nerve neuromodulation in a cohort of patients operated on for Crohn's disease, in a prospective, single centre, cohort study.


Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 years or older with Crohn's disease who undergo resection with an endoscopically accessible primary anastomosis which results in macroscopic normality.
* Patients having a reversal of a temporary ileostomy created after previous surgery for Crohn's disease may be enrolled provided that the reversal of the ileostomy results in a primary anastomosis and macroscopic normality of the remaining bowel.
* Patients with co-existing perianal disease may be included provided the resection has led to a primary anastomosis and macroscopic normality of the intestine.
* Patients must have proven history of Crohn's disease based on (clinical, radiologic, endoscopic and histologic criteria).

Exclusion Criteria:

* Patients with anastomosis which is endoscopically inaccessible by standard colonoscopy.
* Patients in whom there is persisting macroscopic abnormality post-surgical resection.
* Patients with Crohn's disease who have an end stoma (ileostomy or colostomy).
* Patients for whom endoscopy is not suitable due to co-morbidities or unwell clinical state
* Inability to give informed consent.
* Inability to obtain access to the anastomosis at colonoscopy.
* Suspected perforation of the gastrointestinal tract.
* Patients who are pregnant or breastfeeding.
Adrenaline Solution Irrigation and Bleeding During Sinus Surgery

Intranasal irrigation with normal saline is routinely used in sinus surgery to clean the tip of the nasal endoscope and clear the surgical field from blood. The purpose of this study is to evaluate the difference in the surgical visualization, surgeon satisfaction and total blood loss when intraoperative irrigation was performed with a solution of normal saline with adrenaline as compared to irrigation with normal saline alone in FESS.

Functional Endoscopic Sinus Surgery (FESS) is a common, effective and minimally invasive surgical procedure indicated mainly to treat medically resistant chronic rhinosinusitis with or without nasal polyposis.

The surgery is often performed under general anesthesia and proceeds in anatomically based surgical landmarks steps to facilitate drainage and ventilation of the paranasal sinuses. As any other endoscopic and laparoscopic procedures the operation requires dry surgical field to ensure accurate identification and visualization of structures and smooth surgical dissection progression. Intranasal bleeding during FESS will increase time of surgery and perioperative complications. Also it could affect healing process, increase adhesion formation and lengthening recovery period .

Different methods and maneuvers have been described in the literature to reduce intra-operative bleeding during sinus surgery. These include: elevation of the patient's head, the use of bipolar cautery and powered instruments; premedication with beta blockers; a controlled hypotensive anesthesia technique; total intravenous anesthesia, topical hemostatic biomaterials and local application of vasoconstrictors.

Adrenaline is one of the most commonly used topical vasoconstrective agent. Because systemic absorption of infiltrated adrenaline can give rise to a sudden increase in blood levels of catecholamine compared to topical instillation and thus various life-threatening complications, such as : cardiac arrhythmia, cardiac arrest, cardiomyopathy, pulmonary edema, and central retinal artery occlusion; many surgeons prefer to use instillation of adrenaline over infiltration in FESS

Eligibility Criteria:
Inclusion Criteria:

* Patients with American Society of Anesthesiologist (ASA) classification \<2
* Patients with chronic with or without nasal polyposis refractory to medical treatment

Exclusion Criteria:

* Patients with a history of of bleeding diathesis
* Patients with severe ischemic heart disease , pulmonary and renal disease
* Patients with tumours or vascular anomalies
* Patients with cystic fibrosis, allergic fungal sinusitis and granulomatous disorders
* Patients who are unable to speak, read and write English
Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors

This clinical trial studies a supportive education program for Latina breast cancer survivors. The Bilingual Breast Cancer Education Intervention (BBCEI) may help Latina breast cancer survivors know what to expect after completing breast cancer treatment and prepare them to cope with cancer related survivorship issues

PRIMARY OBJECTIVES: I. Describe the feasibility of implementing the BBCEI. II. Describe the cultural and linguistic appropriateness of the BBCEI. III. Determine topics requiring further emphasis in the BBCEI. IV. Identify ways to enhance program content, format, and materials. OUTLINE: Participants undergo 2 tailored BBCEI sessions within 1 month. At the beginning of the first session the research nurse will present the participants with a list of common physical and social concerns. The participant will then be asked to identify 3 topics that she wants to discuss. The research nurse will discuss with the participant any relevant supportive care resources and make the appropriate referrals. At the second session the focus of the BBCEI will be on psychological and spiritual well-being.

Eligibility Criteria:
The population will consist of Latinas with breast cancer who have completed primary cancer treatment. A total of 10 subjects will be accrued.

Inclusion Criteria:

* Diagnosis of Stage I, II or III.
* Self-identification as Hispanic/Latina.
* Able to read and understand English or Spanish to participate in the education sessions.
* Ability to read and/or understand the study protocol requirements, and provide written informed consent
* Subjects maybe be on hormonal therapy after treatment for initial breast cancer.

Exclusion Criteria:

* Actively receiving treatment with surgery, radiation therapy, or chemotherapy.
* Patients who have recurrence, metastasis, or a second primary cancer
Care Pathway for Patients Undergoing VATS Lobectomy or Segmentectomy

The goal of this study is to create a unified SOP for care of subjects undergoing VATS lobectomy and segmentectomy by members of the Division of Thoracic Surgery. Other academic centers have created standardized algorithms for the care of their subjects and this enables the centers to determine which subjects can be placed on an accelerated pathway to discharge and which cannot. Some of these SOPS dictate uniform treatment algorithms with reduction in what may be unnecessary tests to simplify patient care and likely accelerate them towards safe and more timely discharge from the hospital.

This is a prospective, study to develop, test, fine-tune and refine an SOP for the post-operative care for patients who undergo a VATS lobectomy or segmentectomy performed by one of the surgeons in The Division of Thoracic Surgery. This study will be conducted in two phases. Phase 1 will be focused on early feasibility of the SOP and this will be done by enrolling 50 participants among the subgroup of Thoracic VATS Surgeons who participate. An analysis will take place upon the completion of the phase 1 to look at the percentage of participants who were able to be discharged on or prior to POD 3. Upon this analysis, modifications across all areas of the care pathway will be evaluated and altered if deemed necessary by the PI and other members of the study team. This analysis will drive any modifications needed that will be incorporated into the phase II design prior to its implementation. The treating Thoracic Surgeon for each patient will follow the SOP as it is outlined and the steps the post-operative team will follow will be dependent on which phase the participant is enrolled too. Data will be collected for each participant starting just prior to the VATS operation and continue through the discharge and conclude once the participants have reached their 90-day post-discharge date. Upon discharge from the hospital the participant will enter the follow-up period of the study.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects
* Age ≥ 18 years
* Subjects planned to undergo a VATS lobectomy or segmentectomy procedure for lung nodules

Exclusion Criteria:

* Subjects who cannot undergo VATS surgery
* Subjects undergoing any kind of resection in addition to VATS Lobectomy or Segmentectomy
Comparative Study on AQP4 Antibody Detection Methods

This study aims to determine which method is more suitable for clinical application by comparing the sensitivity, specificity, and accuracy of serum AQP4-IgG detection using live cell CBA and fixed cell CBA methods, thereby improving the diagnostic accuracy of neuromyelitis optica spectrum disorders (NMOSD).

This is a multi-center comparative real-world study on AQP4 Antibody Detection Methods Using Live Cell and Fixed Cell-Based Assay Technologies. This study aims to determine which method is more suitable for clinical application by comparing the sensitivity, specificity, and accuracy of serum AQP4-IgG detection using live cell CBA and fixed cell CBA methods, thereby improving the diagnostic accuracy of neuromyelitis optica spectrum disorders (NMOSD). One hundred and twenty patients from 3 centres in China will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* NMOSD: Confirm a diagnosis of NMOSD according to 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis) suspected NMOSD: cases having features suggestive of NMOSD but can not confirm a diagnosis of NMOSD according to 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis).

the following 'high risk' clinical and laboratory features had to be met

1. optic neuritis that was either severe with poor recovery (residual visual acuity in better eye worse or equal to 6/36), bilateral (simultaneous orsequential within 3 months) or recurrent (more than 2 attacks) as the sole clinical manifestation of demyelinating disease,
2. severe transverse myelitis with a central cord syndrome (symmetrical, motor, sensory and bladder involvement) and poor recovery (residual EDSS greater than 5.0) or a longitudinally extensive lesion of the spinal cord spanning 3 or more vertebral segments on magnetic resonance imaging (MRI) or
3. demyelinating disease clinically confined to the optic nerve and spinal cord with at least one of the following: normal or atypical MRI of the brain (fewer than 2 periventricular lesions), negative oligoclonal bands in cerebrospinal fluid, raised CSF protein or a CSF pleocytosis (more than 10 cells per μl) 2.All subjects provided written informed consent.

Exclusion Criteria:

* 1.Patients with incomplete clinical information. 2.Patients without serum samples.
Simulation Efficacy in Neurosurgical Education

This study aims to investigate the efficacy of simulation in neurosurgical training.

This study aims to investigate the efficacy of simulation in neurosurgical training. This will be assessed using accuracy and speed tests in the placement of external ventricle drain catheters (EVDs). EVD placement is a relatively simple neurosurgical procedure aimed at inexperienced young trainees.

This study has two arms. The recruits are inexperienced trainees and/or interns and students who have never performed EVD placements before. The recruits are randomly assigned (using computer-based randomisation) to either Arm A or Arm B.

Recruits to Arm A undergo simulation training (computer simulation of the procedure, followed by simulation on a dead animal model), after which the recruits will attempt to perform an EVD procedure on their own, on a 3D-printed skull model that we designed.

Recruits to Arm B will witness an EVD placement as performed by an experienced surgeon, after the recruits will attempt to perform an EVD procedure on their own, using the aforementioned 3D-printed skull model. This mimics the ''see one, do one'' paradigm prevalent in surgical training.

The efficacy of the simulation training will be assessed using the following criteria:

i. Accuracy test:

The accuracy of the catheter placement is assessed in both arms and compared to investigate whether there is a difference in the accuracy of the catheter placement in both arms.

ii. Speed test:

The speed of catheter placement is assessed in both arms and compared to investigate whether there is a difference in the speed of the catheter placement in both arms.

iii. Subjective surveys

The researchers will gauge the extent of the trainees' confidence in their surgical skills and their satisfaction with their training before and after completion of the simulation training using a questionnaire to be designed for this purpose. The trainees will assess their own familiarity with and confidence in the procedure using a scale from 0 ("not familiar with the procedure", "I have no confidence in being able to perform this procedure independently") to 10 ("I am an expert at this procedure", "I am able to perform this procedure independently with complete confidence"). This data will be collected and input into a statistical software (Statistical Lab v. 3, CeDiS) to analyse the difference (if any) in the trainees' familiarity with the procedures and their confidence in being able to perform them in both arms.

Eligibility Criteria:
Inclusion Criteria:

* never performed EVD placements before

Exclusion Criteria:

* any surgical experience with EVD placement