cyrilzakka/clinical-trials huggingface dataset:
Comfort Talk and Economic Outcomes in MRI

Annually, an estimated 700,000 patients do not complete their scheduled MRI scans because of claustrophobia or inability to hold still. Training staffs working in MRI facilities to provide Comfort Talk® will enable patients to complete high quality imaging without medication, which will increase satisfaction and comfort while reducing sedation risks for patients, and increase efficiency and reduce loss of revenue for facilities. The effect of such training will be tested at 12 MRI sites in a randomized design. Outcome data will be collected for one year.

Claustrophobia and disruptive patient motion are common impediments to MRI examination, but they may be prevented or ameliorated with a non-pharmacologic behavioral intervention administered by trained staff. The potential benefits of such an intervention are highly significant, considering that the alternatives are to cancel the study or administer sedation. Inability to complete their MRI scans adversely affects an estimated 700,000 patients every year in the US. These patients are either deprived of a diagnosis, subject to diagnostic delays and interpretation errors due to motion artifact, or are exposed to risks of pharmacologic sedation, including death. The imaging facilities typically cannot fill the suddenly vacated examination slots in time before the next scheduled patient and incur considerable lost revenue and efficiency. A negative patient experience further jeopardizes Value-Based reimbursement by the Centers for Medicare and Medicaid Services (CMS) towards which patient satisfaction counts 30%. The long term goal is to provide a validated, clinically feasible means for non-pharmacologic amelioration of claustrophobia and disruptive patient motion, achieved by training facility staff in Comfort Talk®.

Comfort Talk® training consists of a proprietary, standardized R3 Process of Rapport, Relaxation, and Reframing including 2 x 8-hrs class-room interaction, onsite coaching, and institution-specific web-based support to help the MRI team to further develop its own language style and skill set.

The effect of Comfort Talk® training will be quantified in a prospective randomized design at 12 MRI satellites of the Ohio State University Medical Center and Duke University Medical Center. Return of investment of training will be based on a decision-analysis model with focus on number of scans performed, cancellations from no-shows and refusals; patients unable to start or complete a scan; and sedation rates in relation to capacity, cost, and reimbursement schedule. Patient satisfaction scores will be compared using Press Ganey national benchmark percentile rankings and CMS quality standards.

Eligibility Criteria:
Inclusion Criteria:

* Must routinely perform MRI examinations
* Must capture data on noncompletion of MRI scans

Exclusion Criteria:

* No dedicated MRI unit
* Unable to reliably capture data on noncompletion of MRI scans
Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy

Magnetic tracer injected before preoperative chemotherapy in breast cancer patients for sentinel lymph node detection. Also, magnetic tracer in combination with magnetic clip for index node identification.

This is an interventional single arm study. The aim is to see if sentinel lymph nodes marked with a magnetic tracer injected before preoperative chemotherapy can be detected at surgery three to six moths later. The investigators also want to see if they can find the same nodes with a tracer injected before chemotherapy as with a tracer injected after chemotherapy. The hypothesis is that the chemotherapy might affect the lymph drainage and the nodes marked before the chemotherapy are the true sentinel lymph nodes.

Furthermore, in patients with known lymph node metastases before chemotherapy one metastasis is marked with a magnetic clip before the chemotherapy. This is a well known method but it has not been done in combination with the magnetic tracer. We will show that this is feasible.

All patients included in the study will receive their treatments according to the current standard national guidelines as both the magnetic tracer and the routinely used radioactive tracer are used in parallel. The magnetic clip is also used at several sites in Sweden today.

Eligibility Criteria:
Inclusion criteria:

* Patients 18 years of age or older.
* Patients with breast cancer planned to undergo NACT with

  * planned sentinel lymph node dissection (SLND), or
  * targeted axillary lymph node dissection (TAD), in conjunction with the
* breast surgery after NACT.

Exclusion Criteria:

* Intolerance / hypersensitivity to iron or dextran compounds or SPIO.
* Patients who are required to undergo MRI to evaluate tumour response.
* Pregnancy or breast feedin.g
* Patients with an iron overload disease.
* Patient deprived of liberty or under guardianship.
* Inability to understand given information and give informed consent or undergo study procedure
Shortystrap Effectiveness in the Treatment of the Pathology Pubic and Abdominal Pathology in Athletes

The pubic and abdominal pathology is common among athletes. It leads to a shutdown of physical activity for several months, and requires rehabilitative care, or surgery for a permanent cure. Shortystrap is designed to avoid surgery and allow the continuation of sports.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Sports practicing physical activity at least 3 hours per week
* Practicing a team sport with a major part of running (football, rugby, ...)
* Presenting a pubic and abdominal pathology for at least 4 weeks
* In primary consultation
* Age from 18 to 40 years
* Informed consent signed

Exclusion Criteria:

* Professional athlete
* Cyclist
* Having already received usual medical treatment (anti-inflammatory treatment and rest)
* Introducing another disease requiring treatment with NSAIDs
* Allergy neoprene
* Contraindications to performing MRI (claustrophobia, any metal device, pacemaker, etc.)
* Simultaneous participation in another biomedical research
* Major person under legal protection (backup justice, trusteeship, guardianship), person deprived of liberty.
Donor Breast Milk and Serum Ferritin Levels in Very Preterm Infants

This study compares the iron levels in very preterm infants receiving donor breast (DBM) milk to very preterm infants receiving maternal breast milk (MBM).


Eligibility Criteria:
Inclusion Criteria:

1. All preterm infants born between 29 weeks and 0 days -32 weeks and 6 days of gestational age and admitted to the NICU at Advent Health for Children
2. Received either MBM or DBM starting between 5 to10 days of life

   a. Infants receiving \>50% feeding volume by DBM for the first 14 days of life will be considered to have received predominantly DBM. The comparison group will be infants who received \> 50% of MBM for the first 14 days of life.
3. Parent able to read and write in the English language.

Exclusion Criteria:

1. Death prior to completion of participation
2. Extremis with likelihood of death prior to completion of participation in the study
3. Blood transfusion as determined by clinical team during the study
4. Major congenital anomaly or genetic syndrome and
5. Major surgical GI conditions that preclude feeding
Laparoscopic Right Hemicoloectomy for Right Colon Cancer With a Medial-to-lateral Approach Orientated by SMA or SMV

A randomized controlled clinical trial to compare the outcomes of SMA- and SMV- orientated laparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach

In 2008, Germany scholar W. Hohenberger proposed the idea of complete mesocolic excision (CME) and central vascular ligation (CVL) for the standardization of colonic cancer surgery. This concept has been widely recognized and accepted. This radical operation attempts to remove the mesocolon intactly by careful dissection along the embryologic tissue planes and transection of the supplying vessels at their origin. For right-sided colon cancer, this approach involves division of the vessels at their origin from the superior mesenteric artery (SMA) and superior mesenteric vein (SMV). In our opinion, full exposure of the SMA and SMV is necessary to make sure that the origin of the colonic arteries being truly exposed and tied centrally at their origin and a maximal harvest of the regional lymphnodes. For locally advanced colon cancer, SMA- orientated surgery may be more meaningful to recerve a radical lymphadenectomy and bring benefit for their survival. However, in the traditional practise, the lymph node dissection is orientated by SMV and SMA is not exposed, tissue around SMA is left behind.

In this study, eligible patients with right colon cancer will be randomly allocated to receive either SMA- or SMV- orientated laparoscopic right hemicoloectomy. 100 patients will be enrolled in each group. In SMV- orientated surgery group, SMA is not exposed and the left boundary of resection is the left side of SMV. In SMA- orientated surgery group, the left boundary of resection is the left side of SMA and SMA is exposed.Artery sheath is not necessarily to be opened. Postoperative pathology will be analyzed with the number of lymph nodes retrieved. Postoperative recovery process and long term survival will be followed.

Eligibility Criteria:
Inclusion Criteria:

* Patients suitable for curative surgery between 18 - 85 years old;
* American Society of Anesthesiologists(ASA) grade I-III;
* Preoperative pathological diagnosis of adenocarcinoma;
* Tumor located at the right colon;
* Informed consent;
* No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.

Exclusion Criteria:

* Pregnant patient;
* History of psychiatric disease;
* Use of systemic steroids;
* Simultaneous multiple primary colorectal cancer;
* Preoperative enhanced CT scan of chest, abdominal and pelvic cavity shows:

  1. Tumor involves the surrounding organs and combined organ resection needed to be done;
  2. distant metastasis;
  3. unable to perform R0 resection;
* History of any other malignant tumor in recent 5 years;
* Patients need emergency operation: mechanic ileus, perforation.
* Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).
* Conversion from laparoscopic surgery to laparotomy;
Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion

This study evaluates dextromethorphan as a non-opioid adjunctive medication for pain control during medication abortion. This is double-blinded, four-arm randomized controlled trial enrolling 156 women over a period of 9-12 months: Receiving narcotics+dextromethorphan, narcotics and placebo (microcrystalline cellulose), no narcotics and dextromethorphan and no narcotics and placebo (microcrystalline cellulose).

Medication abortion using mifepristone and misoprostol is common, accounting for nearly one-third of abortions in the United States in 2014. Although women generally tolerate medical abortion well, pain and bleeding are common and expected side effects. Up to a quarter of women rate their pain as severe during their procedure. Pain management for medical abortion is challenging given that the most acute pain occurs at home rather than under the supervision of medical professionals. Currently there is insufficient evidence to recommend an optimal regimen for pain control in medication abortion and there are concerns surrounding narcotic prescribing and the opiate abuse epidemic. This is a four-arm, prospective, double-blind, randomized controlled trial comparing dextromethorphan administration in conjunction with the current standard regimen (NSAIDs and narcotic medication by request- commonly oxycodone or codeine) to the standard regimen alone. Pain will be evaluated by analgesia usage and self-reported pain scores. Investigators will also investigate factors influencing pain and subjective components of the patient narrative. Ideally, a non-opioid adjunct to NSAIDs or narcotics could be used to control pain and significantly curtail or avoid opioid use. Investigators seek to test the efficacy and safety of dextromethorphan as a non-narcotic analgesic for medication abortion.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 and over
* Willing to give voluntary consent
* English-speaking
* Eligible for medication abortion per Planned Parenthood of Western Pennsylvania protocol
* Self-reported reliable cellular phone access for the duration of study participation
* Able to receive and reply to a "test" text at time of consent
* Willing to comply with the study protocol

Exclusion Criteria:

* Use of selective serotonin reuptake inhibitors or monoamine oxidase inhibitors due to risk of Serotonin Syndrome
* Allergy to any component of the medication abortion regimen or study drug
* Has any other condition that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, complicate the interpretation of the study outcome data, or otherwise interfere with achieving the study objectives
* Anticipated use of dextromethorphan during study period
Gemcitabine,Vincristine and Cisplatin as Second Line Combination Therapy in Patients With Sarcoma

The primary objective of this study is to evaluate PFS of gemcitabine,vincristine and cisplatin as second line therapy in patients with sarcoma. 40 patients will be treated into this study.


Eligibility Criteria:
Inclusion Criteria:

* Give written informed consent prior to study, with understanding that the patient has the right to withdraw from the study at any time without prejudice
* Be female of male and ≥18 and ≤75 years of age
* Be ambulatory and have ECOG performance status of ≤1
* Have histological confirmed sarcoma
* Locally advanced or metastatic sarcoma who receive first-line chemotherapy.
* Have at least one target lesion according to the RECIST criteria.

Exclusion Criteria:

* Pregnant or lactating women
* patient has received chemotherapy drugs including gemcitabine,vincristine and cisplatin
* Chemotherapy within four weeks preceding treatment start
* ECOG ≥ 2
* Radiotherapy to the axial skeleton within the 4 weeks preceding study treatment start or insufficient recovery from the effects of prior radiotherapy
* Participation in any investigational drug study within 4 weeks preceding treatment start
* History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix .Abnormal laboratory values: hemoglobin \< 8. 0g/dl, neutrophil\< 1.5×109/L, platelet\< 100×109/L.
* serum creatine \> upper limit of normal (ULN)
* serum bilirubin \> ULN
* alanine aminotransferase(ALT) and aspartate aminotransferase(AST)\>5×ULN
* alkaline phosphatase(AKP)\>5×ULN
* Serious uncontrolled intercurrence infection
* Life expectancy of less than 3 months
Study for the Treatment of Ulcerative Colitis With Adacolumn (Companion to US Study 512-04-205)

The purpose of the study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.

Study Type: Interventional Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study.

Eligibility Criteria:
Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty

This study aims to assess analgesia efficacy between liposomal bupivacaine single injection interscalene blockade vs. continuous interscalene nerve block for patients undergoing primary total shoulder arthroplasty.


Eligibility Criteria:
Inclusion Criteria

* Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
* Patients presenting for unilateral primary total shoulder arthroplasty (includes anatomic and reverse total shoulder arthroplasty).
* Patients 18 years of age and older
* Able to provide informed consent for him or herself

Exclusion Criteria

* Chronic pain syndromes
* Chronic opioid use (\>1 month) with OME \>5 mg/day OR acute opioid use (\< 1 month) with OME \> 30 mg/day.
* Body mass index (BMI) \> 45 kg/m2
* Severe drug allergy\* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib) and local anesthetics. \*defined as an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing, and fever
* Personal or family history of malignant hyperthermia.
* Major systemic medical problems such as:

  * Pre-existing severe renal disorder defined as glomerular filtration rate (GFR) \<50 units/m2 (if labs are available), currently on dialysis, or highly suspected based on history.
  * Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver
  * Pre-existing medical history of moderate to severe pulmonary disease requiring medical therapy (obstructive and/or restrictive), use of home oxygen, preoperative baseline oxygen saturation \< 93% on room air.
  * History of contralateral hemidiaphragm dysfunction (e.g., paralysis) or phrenic nerve injury.
* Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy+ in the operative extremity, coagulopathy, sepsis, infection at site of injection, uncooperative, and refusal).

  o + pre-existing neuropathy includes sensory and/or motor deficits due to nerve insult of surgical extremity, radicular symptoms of surgical extremity, history of unresolved brachial plexus injury/brachial plexopathy, and tumors of the brachial plexus. Patients with nerve compression distal to site of surgery, such as history of carpal tunnel syndrome or cubital tunnel syndrome, are NOT considered contraindications to regional anesthesia.
* Known to be currently pregnant or actively breastfeeding++

  o ++ All surgical patients are currently screened using a standardized Pregnancy Assessment tool (http://mayoweb.mayo.edu/sp-forms/mc8800-mc8899/mc8801-161.pdf)
* Impaired cognition (e.g. Alzheimer's disease, moderate to severe dementia, encephalopathy)
* Non-English speaking
Skin Tracker: A Mobile Health App to Monitor Skin Disease Activity and Treatment Use

Design and beta-test a research-oriented mobile health app to assess disease activity, quality of life, treatment patterns, adverse medication effects, and lifestyle factors in patients with atopic dermatitis.

Mobile health technology, including smartphone apps and wearable monitors, has tremendous potential to transform clinical research. Recording of patient outcomes on a smartphone device and camera in the home setting can greatly reduce the number of in person research visits, saving tremendous costs, time, and effort associated with data entry. This also allows for easier recruitment of study subjects, who can be enrolled in geographic locations beyond academic research centers. After FDA approval of a therapy, mobile health technology can help researchers understand how that particular therapy is being used in a real-world setting, including frequency of use, adverse events, and impact of use on disease symptoms and patient quality of life. In this study, the investigators will create a mobile app to help the atopic dermatitis community understand the types of data and quality of data that can be gathered from atopic dermatitis patients longitudinally. A review of existing atopic dermatitis mobile apps on the market reveals they are consumer-oriented and may not be able to fully capture high-quality research data. The investigator proposed app is specifically geared for research, and thus fills an important gap. The research team will develop SkinTracker, a research-oriented eczema app to longitudinally track atopic dermatitis severity, symptoms, quality of life, physical activity, medication usage, and adverse events in a real-world setting.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide written informed consent and comply with the protocol.
2. At least 13 years of age.
3. Diagnosis of atopic dermatitis by dermatologist for at least 6 months.
4. Physical exam within clinically acceptable limits.
5. Own or have access to a mobile device that is compatible with study mobile application SkinTracker.

Exclusion Criteria:

1. Subject is unable to provide written informed consent or comply with the protocol.
2. Unable to input data into SkinTracker mobile app.
3. Subject is younger than 13 years of age.
4. Serious known infection.
5. History of immunosuppression (including human immunodeficiency virus (HIV)).
6. History of malignancy within 5 years prior to screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
7. Severe concomitant illness.
8. Physical exam not within clinically acceptable limits.
9. Subjects possess other diagnoses that, in the investigator's opinion, preclude him/her from safely participating in this study or interfere
Prediction of Morbidity and Mortality With Medical Pre-Operative Fitness Assessment

Aim to measure the predictability of medical pre -Operative Fitness Assessment to the actual rates of morbidity and mortality related to surgery in Assiut university Hospital.

Perioperative morbidity and mortality remain the mostly important barrier to surgical interventions worldwide. Therefor, decision making relies upon accurate risk Assessment to be balanced with hoped benefit.

For elective surgeries, multiple clinical tools have been used to Assessment perioperative Fitness, but with limited applicability. For instance, the american society of anesthesiologists phesical status score (ASA-PS) does not consider the type of surgery, nor the patient's age.

The physiological and Operative severity score for the enumeration of mortality (POSSUM) evaluates the intra-operative difficulties, limiting the preoperative prediction.

Recently, researchers layer and his colleagues at University Hospital Bonn, modified the preoperative score to Predict Postoperative Mortality (POSPOM) to be applied in daily practice.

In investigator 's practice, Assiut university Hospitals already have a Pre-Operative Fitness Assessment (POFA) clinical and investigator aim to adapt and evaluate the POSPOM system in investigator' s practice.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years old ) preparing for elective intervention.

Exclusion Criteria:

* those who do not require anaesthesia Those who did not undergo surgery