cyrilzakka/clinical-trials huggingface dataset:
Interferon Alfa or No Further Therapy Following Surgery in Treating Patients With Stage II, Stage III, or Recurrent Melanoma

RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet known whether interferon alfa following surgery is more effective than surgery alone in treating patients with melanoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with no further therapy following surgery in treating patients with stage II, stage III, or recurrent melanoma.

OBJECTIVES: I. Determine the effects of adjuvant low-dose extended-duration interferon alfa on disease-free and overall survival in patients with completely resected malignant melanoma at high risk of recurrence. II. Determine any correlation between patient age or sex and the effects of interferon therapy on disease-free and overall survival. III. Describe the toxic effects of this treatment. IV. Evaluate the economic implications of implementing effective interferon therapy in these patients.

OUTLINE: This is a randomized study. Patients will be stratified by age, sex, disease status at entry, and participating institution. Patients are randomized to observation only or to receive interferon alfa by subcutaneous injections 3 times weekly for 2 years, or until disease progression or toxicity intervenes. Patients are followed monthly for 6 months, quarterly for 18 months, and every 6 months thereafter.

PROJECTED ACCRUAL: A total of 1,000 patients will be entered over 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma definitively resected within 12 weeks prior to entry One of the following categories: Stage II disease (greater than 4 mm Breslow thickness) Stage III disease (regional lymph node involvement) Recurrent non-nodal superficial regional disease (local or in transit) Recurrent regional nodal involvement

PATIENT CHARACTERISTICS: Able to tolerate interferon No second malignancy except curatively treated: Carcinoma of the cervix Nonmelanomatous skin cancer No pregnant or nursing women

PRIOR CONCURRENT THERAPY: No prior immunosuppressive therapy, including systemic steroids No prior biologic therapy Recovered from surgery
Brain Oximeter Calibration and Validation Study

The purpose of the study is to calibrate and to validate the accuracy of the oximeter with an estimate of brain oxygen levels assessed by measuring arterial and internal jugular vein blood oxygen saturations.

The device is a non invasive NIRS monitor. It detects signals from which are derived venous and arterial blood brain oxygen levels.

The device will be used as a adjunct monitor in patients with a brain injury or at risk of a brain injury.

The primary objective of the study is to measure the absolute and relative accuracy of the StO2 device by comparing the NIRS-derived brain tissue oxygen saturation with blood-referenced CO-oximeter oxygen saturation values. The CO-oximeter oxygen saturation values from paired arterial and internal jugular venous blood gas samples are then inserted into a weighted-equation to derive the calculated brain tissue oxygen saturation. Accuracy is reported over a range of oxygen saturations with study subjects exposed to a controlled oxygen desaturation with serial sampling of paired arterial and internal jugular venous blood gas samples.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, male or female subjects between the ages of 18 to 45 years;
* Completion of a health screening for a medical history by a licensed physician, nurse practitioner, or physician assistant;
* Minimum weight 40kg;
* BMI within range 18.0 - 35.0;
* Assigned American Society of Anesthesiologists (ASA) Physical Status 1 by Principal Investigator or delegate

Exclusion Criteria:

* Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) \[self- reported\];
* Prior known severe allergies to medical grade adhesive/tape (Band-Aid) \[self-reported\];
* Taking any medication other than birth control\[self-reported\];
* Is currently participating in, or has recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational drug, device, or biologic study \[self- reported\];
* Has a negative Allen's Test to confirm non- patency of the collateral artery \[clinical assessment by PI or delegate\];
* Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure \[self-reported\];
* Is female with a positive pregnancy test \[serum or urine\], or is female and is unwilling to use effective birth control between the time of screening and study procedure or is breast feeding;
* Has anemia \[lab values specific for gender\];
* Has heparin allergy
* Has a history of sickle cell trait or thalassemia \[self-reported\];
* Has an abnormal hemoglobin electrophoresis result \[lab measurement\];
* Has a positive urine cotinine test or urine drug screen or oral ethanol test;
* Has a room air saturation less than 95% by pulse oximetry \[measurement by PI or delegate\]
* Has a clinically significant abnormal EKG \[assessment by PI or delegate\];
* Has a clinically significant abnormal pulmonary function test via spirometry \[assessment by PI or delegate\];
* Has a COHb greater than 3%, or MetHb greater than 2% \[measured by venous blood sample co- oximetry\].
Magseed Enabled Long-Term Localization of Axillary Lymph Nodes

The purpose of this study is to provide prospective evidence that the use of Magseed/Sentimag in marking axillary lymph nodes and guiding surgical localization in patients with breast cancer following neo-adjuvant chemotherapy (NAC) is effective.

This is a post-market, prospective, open-label, single arm study of Magseed and Sentimag in patients with breast cancer with biopsy-proven axillary node metastases who had a clip placed to mark the metastatic node and are having that clipped node selectively removed at surgery following neo-adjuvant chemotherapy (NAC). Subjects will have the Magseed placed to mark axillary lymph nodes with biopsy-proven metastasis under ultrasound guidance before initiating NAC. After completion of NAC, the Magseed will be localized using the Sentimag system during surgery and removed with the targeted lymph node.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older at time of consent
* Histologically confirmed cT0-4, N1 breast cancer
* Axillary lymph node metastasis with pathologic confirmation by needle biopsy
* Clip placed in the sampled axillary lymph node before initiation of chemotherapy
* Planned for neo-adjuvant chemotherapy prior to surgical resection
* Eligible for targeted axillary dissection (defined as selective localization and removal of the clipped node and SLND) at the completion of neo-adjuvant chemotherapy
* ECOG performance status 0-2

Exclusion Criteria:

* Distant metastases
* Inflammatory breast cancer
* Prior ipsilateral axillary surgical procedure including SLND or axillary node excision
* Prior history of breast cancer in the ipsilateral breast
* History of lymphoma
* Subject is pregnant
* Previous radiation to the breast or axilla
* Pacemaker or other implantable cardiac device in the ipsilateral chest wall
RCT on Nonoperative Versus Operative Treatment for Acute Complete tearS of the Ulnar Collateral ligAment of the Thumb

A complete rupture of the ulnar collateral ligament (UCL) of the thumb must heal in order to regain proper function of the thumb. Guidelines recommend surgery for complete UCL ruptures, including Stener lesions. This recommendation is based on expert opinion, anatomic theories and low quality retrospective case series. High quality studies comparing cast immobilization with operative treatment are lacking. Research has shown that in about 9 out of 10 patients, a complete UCL rupture, including Stener Lesions, can also be treated with a cast alone for 6 weeks and no surgery is needed. We hypothesize that cast immobilization is non-inferior regarding functional outcome and carries concomitant lower costs compared with operative treatment for complete UCL ruptures, including Stener Lesions.

The project aims to conduct a multicenter randomized controlled trial and cost-effectiveness analysis comparing operative and nonoperative treatment for complete UCL ruptures, including Stener Lesions. The project will take four years, from preparation to reporting of the results. In the following years, implementation will be achieved in collaboration with the Dutch hand surgery committees (NVvH and NVPC), health insurance companies, and medical experts.

Research question Is nonoperative treatment with splint immobilization non-inferior to immediate operative treatment regarding functional outcome and does it lead to lower costs in adult patients with an acute complete UCL rupture, including Stener Lesions?


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years and older
* Dutch or English speaking patients
* Patients with an acute complete UCL rupture, with or without a Stener Lesion, diagnosed using physical examination, performed by the hand surgeon. When providing radically directed force to the proximal phalanx (radial deviation stress) as the thumb metacarpal is stabilized, criteria 1 AND 2 must be present to confirm the diagnosis of a complete UCL rupture:

  * no firm endpoint in the MCP joint AND
  * at least more than 35 degrees of laxity in the MCP joint (measured with the MCP joint in extension or in 30 degrees of flexion) OR more than 15 degrees difference in laxity compared with the uninjured side.

Exclusion Criteria:

-
The Effectiveness of Blastocentesis Versus Trophectoderm Biopsy

For the purpose of this study, the investigators will perform the removal of trophectoderm (TE) the cells as required for the purpose of pre-implantation genetic screening, in order to perform the genetic analysis. Additionally, the investigators will remove the blastocoelic fluid (BF) and perform additional genetic analysis on the embryo in order to determine the agreement of the genetics results between TE cells and BF.

The human embryo (fertilised egg) develops from a single cell and goes through several developmental stages in order to prepare for implantation inside the womb. During the fifth and sixth day post fertilisation, the embryo becomes a blastocyst. It consists of 100-150 cells and has two cell types. The inner cell mass (ICM) will give rise to the baby and the trophectoderm cells will become the placenta. The trophectoderm (TE) cells surround the ICM. Following the formation of the two cell types, the TE cells start producing fluid. The progressive accumulation of fluid leads to the formation of a cavity that expands to form the blastocele cavity. This cavity contains fluid is known as blastocoelic fluid (BF). The fluid can contain proteins, cells and genetic material. Traditionally to make a genetic diagnosis or when to screen embryos for abnormal chromosome number, cells are removed (biopsy) from the trophectoderm. In experienced hands, this is a very safe procedure and causes minimal damage to the embryo. However, recent studies have shown that blastocoele fluid may contain genetic material which can be aspirated (drawn out) from the blastocole cavity (blastocentesis) and used for genetic analysis of an embryo. This is potentially less invasive and harmful to the embryo. The aim of this study is to compare genetic analysis obtained following blastocentesis versus trophectoderm cell biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Couples undergoing assisted reproduction for pre-implantation genetic diagnosis

Exclusion Criteria:

* Any other couples undergoing assisted reproduction
Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men

The goal of this study is to determine the effectiveness and safety of an annual intravenous treatment of zoledronic acid for the treatment of osteoporosis in men. All patients will receive calcium and vitamin D supplements.


Eligibility Criteria:
Inclusion Criteria:

* Male, 25-85 years old

Exclusion Criteria:

* Current users of bisphosphonates such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel ® (residronate), Skelid® (tiludronate)
* History of severe liver, kidney or eye disease

Other protocol-defined inclusion/exclusion criteria may apply.
User Evaluation in Healthy Volunteers to Verify no Pelvic Floor Contraction is Stimulated When the Modified Neurotech Vital Device is Used Compared to the Neurotech Vital Device

This user evaluation study is to verify that the Modified Neurotech Vital Device does not stimulate the pelvic floor muscles compared with the Neurotech Vital Device.

This user evaluation study is to verify that the Modified Neurotech Vital Device does not stimulate the pelvic floor muscles compared with the Neurotech Vital Device. Stimulation of the pelvic floor muscles will be assessed by using sonographic/real time ultrasound imaging/recording with displacement measurement using onscreen callipers on the sonogram unit to assess contractions.

Eligibility Criteria:
Inclusion Criteria:

Subjects who meet the following inclusion criteria will be included in the study.

* Subjects who are female and at least 18 years of age.
* Subjects who, in the opinion of the Investigator, are deemed healthy.
* Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained.
* Subjects who are able to understand this study and are willing to complete all the study assessments.

Exclusion Criteria:

* Subjects who meet any of the following criteria will be excluded from participation in the study.

  * Subjects who have an existing medical condition that would compromise their participation in the study.
  * Subjects who have a physical condition that would make them unable to perform the study procedures.
  * Subjects with a history of any respiratory condition including a chronic cough.
  * Subjects with a history of an underlying neurological condition.
  * Subjects with a history of low back pain involving the spinal nerve root.
  * Subjects with a blood clotting disorder or who are taking anti-coagulant medications.
  * Subjects who have previously had any uro-gynaecological related surgery excluding hysterectomy.
  * Subjects with a clinical diagnosis of prolapse greater than Stage 2.
  * Subjects who are pregnant or could be pregnant.
  * Subjects who are less than 6 months post-partum or who are lactating.
  * Subjects who have any intra-uterine devices or metal implants in the pelvic area, including hip and lumbar spine.
  * Subjects with pelvic pain or fibromyalgia or paravaginal defect.
  * Subjects with an active implanted medical device (ie pacemaker, pump etc).
  * Subjects with a history of heart disease or stroke.
  * Subjects with a known cancer.
  * Subjects with an injury or disability affecting any part of their body which will be in contact with the garment.
  * Subjects who are currently involved in any injury litigation claims.
  * Subjects who have been committed to an institution by virtue of an order issued either by the courts or by an authority.
  * Subjects who have participated in a clinical study in the last 3 months.
Effectiveness of Non-invasive Phrenic Nerve Neuromodulation in Subjects With Inflammatory Bowel Disease and Neck Pain.

Inflammatory bowel diseases (IBD) are chronic relapsing diseases that generate an autoimmune response against the bowel and its microbiota. Its prevalence is increasing worldwide. These include Ulcerative Colitis (UC) and Crohn's Disease(CD).

The Phrenic nerve originates at the roots C3-C4-C5 carrying motor and sensory information. Directly or through connections it innervates the diaphragm, pleura, right atrium, pericardium, oesophagus, peritoneum, stomach, falciform and coronary ligaments of the liver, Glisson's capsule, hepatic and inferior vena cava, liver (parenchyma), gallbladder and the rest of the biliary tract, pancreas, small intestine and adrenal glands. It also has fibres of the autonomic nervous system.

Studies show that there is a link between people suffering from IBD and hepatopancreato-biliary diseases. It can therefore generate referred pain to the C3-C4-C5 dermatomes.

Based on the above, the main objective would be to analyse whether non-invasive neuromodulation of the Phrenic nerve reduces neck pain in people with IBD. Secondary objectives were to assess the impact of treatment on quality of life and to study the relationship between IBD and cervical pain.

Hypothesis:

Non-invasive Phrenic nerve neuromodulation in subjects suffering from inflammatory bowel disease and neck pain will improve their quality of live, disability and sensitisation, as well as neck pain and mobility.


Eligibility Criteria:
Inclusion Criteria:

* Crohn's Disease or Ulcerative Colitis.
* Be over 18 years old.
* Disorder of the peridiaphragmatic abdominal viscera.
* Chronic mechanical neck pain.

Exclusion Criteria:

* Previous trauma or surgery to the cervical spine.
* Infection.
* Congenital vertebral anomaly.
* Neurological diseases.
* Signs of neural compression or spinal stenosis.
* Impossibility of applying neuromodulation (fever, pregnancy, pacemaker, epilepsy, neoplastic processes close to the cervical area and skin alterations).
* Severe cognitive impairment and communication deficits.
* Application of physiotherapeutic treatment three months prior to the study.
* Use of analgesics, anti-inflammatory drugs or relaxants in the 24 hours prior to the intervention.
Endeavor to Stop Nausea/Vomiting Associated With Pregnancy (E-SNAP)

The primary objective of this proposal is to conduct an early Phase 2 clinical trial to determine the acceptability, dosing, tolerability and safety of mirtazapine for severe nausea and vomiting of pregnancy (sNVP) that is not adequately responsive to current standard treatments. This plan mirrors clinical practice since commonly prescribed antiemetic/ antinauseant drugs will be tested for efficacy before treating with mirtazapine.

Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (PAR-20-299) supports research to "enhance the usage of existing drugs or drug repurposing for safer and more effective treatment for pregnant women" for "the early and conceptual stages of these projects. The primary objective of this proposal is to conduct an early Phase 2 clinical trial to determine the acceptability, dosing, tolerability and safety of mirtazapine for severe nausea and vomiting of pregnancy (sNVP) that is not adequately responsive to current standard treatments. This plan mirrors clinical practice since commonly prescribed antiemetic/ antinauseant drugs will be tested for efficacy before treating with mirtazapine.

Mirtazapine is a promising drug to repurpose for sNVP. It has potent anti-emetic properties and is available as an oral disintegrating formulation. It is used off-label to treat NV during cancer chemotherapy, prevent post-surgical nausea and vomiting and for gastroparesis. It is marketed as the serotonin-norepinephrine reuptake inhibitor antidepressant Remeron®. Mirtazapine has multiple receptor effects beyond those involved in reducing depressive symptoms. In cancer and chemotherapy patients, it produces rapid resolution of nausea and vomiting by blocking physiologic inputs that coordinate emesis. It is hypothesized that repurposing mirtazapine for obstetric use overcomes the challenges of traditional pathways to develop new agents because its pharmacokinetics, safety and dosing have been established for general populations of patients and exposure data are available because it is prescribed to pregnant persons with depression.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* inpatient or outpatient status
* English speaking
* obstetrician's evaluation and diagnosis of sNVP or HG
* tolerance of oral disintegrating tablet at bedtime
* PUQE score of 10-15; moderate/high or severe
* refractory sNVP
* blood pressure range 70-200 / 45-120
* normal ECG

Exclusion Criteria:

* allergic or adverse reaction to mirtazapine
* patient has bipolar disorder
* subjects with active depression, or history of or current active suicidal ideation or attempt
* subjects with renal or hepatic impairment
* substance about in last 6 months
* use of medicinal or recreational cannabis-derived products in the last 6 months
* taking MAOIs, strong CYP3A inducers or inhibitors, and SSRIs
Romiplostim in Thoracic Transplantation

The investigators developed a platelet transfusion saving strategy based on thrombopoietin administration in heart or lung transplantation (HLT) patients or assist device implantation in bridge-to-transplantation (BTT) or bridge to-decision (BTD). This strategy was applied from May 2014 to October 2015 in patients whose platelet counts were below 100 Giga per liter (G/L). As part of a health care quality improvement project, the investigators evaluated this strategy in a before/after design. January 2010 to December 2013 constituted the before period.

In may 2014, after Heart or Lung transplantation or assist device implantation, the investigators decided to off-label administered Romiplostim in patients with thrombocytopenia below 100 Giga per liter. The purpose was to reduce platelets transfusion side effects. Romiplostim was used off treatment algorithm was based on previously published data in idiopathic, thrombocytopenia, cirrhotic and hematological patients. The first subcutaneous injection of 1.5 to 2 μg/kg of romiplostim was administered in the postoperative periods. An algorithm based on patient weight and platelet count evolution was established to determine romiplostim doses to administered weekly. Romiplostim posology was adjusted between 2 and 5μg/kg according to platelet count with a maximum of 4 administrations in the ICU. If platelets remained below 50 Giga per liter after 2 injections, bone marrow analysis after hematologist referral was discussed. Platelet count until day 15 after the last injection was monitored to detect thrombocytosis.

In January 2016, the investigators decided to retrospectively assess Romiplostim implementation in the standard of care in the ICU through a Healthcare quality improvement project in a before/after design.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in ICU after HLT, BTT or BTD assist device implantation with platelet counts below 100G/L at least once in the post-operative period

Exclusion Criteria:

* age under 18 or over 65, combined heart and lung transplantation, multiple organ dysfunction syndrome (MODS), pericardial effusion, active surgical bleeding, assist device dysfunction or suspected/diagnosed heparin-induced thrombocytopenia. We also excluded patients with myelodysplastic or myeloproliferative syndrome, hematological malignancy, severe liver cirrhosis with a Child-Pugh score superior to 6, receiving antiplatelet therapy, aplasia diagnosed on bone marrow analyses, pregnancy, thrombophilia, prior pulmonary embolism or stroke in the previous 6 months. Thrombophilia was defined as factor V Leyden mutation, activated protein C resistance, protein S deficiency, protein C deficiency, prothrombin gene mutation, factor VIII excess, ATIII deficiency or antiphospholipid syndrome. For the assistance population, the protocol also excluded destination-therapy devices or patients with transplantation contraindications