cyrilzakka/clinical-trials huggingface dataset:
Regulated Negative Pressure-Assisted Wound Therapy Device

Regulated negative pressure-assisted wound therapy (RNPT) is regarded as a gold standard technology for treatment of various chronic and acute wounds. The investigators plan to evaluate the efficacy and ease of use of this device.


Eligibility Criteria:
Inclusion Criteria:

* Chronic or acute wounds

Exclusion Criteria:

* Uncontrolled bleeding
* Neoplasms in wound
* Exposed blood vessels
* Exposed internal organs
Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure

Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Able to provide a signed, executed written informed consent
2. Healthy non-smoking adult volunteers: Male or Female subjects 18 to 45 years old
3. Female subjects who are practicing adequate contraception
4. Stable cardiac status
5. Normal hemoglobin values
6. Normal Echocardiogram
7. Normal or not clinically significant 12-lead Electrocardiogram
8. Demonstrated ability to properly use the Tempo® Inhaler
9. Subject has not donated blood in the last 56 days

Exclusion Criteria:

1. Contraindication to dihydroergotamine mesylate (DHE)
2. Use of any excluded concomitant medications within the 10 days prior to Visit 1
3. History of hemiplegic or basilar migraine
4. Participation in another investigational trial during the 30 days prior to Visit 1
Retrospective Observational Research Study to Describe the Real World Use of Bosutinib in a Single Centre in Scotland

This study will describe the efficacy and safety of bosutinib in patients with chronic myeloid leukaemia (CML) used in a real world clinical practice setting.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of Ph+ CML aged ≥18 years at bosutinib initiation.
* Patients prescribed bosutinib (irrespective of the phase of their disease) EITHER in normal clinical practice since it received marketing authorisation (27 March 2013) by the EMA OR via the compassionate use programme prior to marketing authorization.
* Where required, evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Patients prescribed bosutinib as part of an interventional clinical trial programme.
* Patients initiated on bosutinib less than 3 months prior to data collection taking place.
* Patients prescribed bosutinib as exclusively post-allograft therapy.
TIVA vs Inhalational Mode of Anaesthesia

Sevoflurane based inhalational anaesthesia is the preferred mode of anesthesia for small duration cases. But in recent times, concept of rapid discharge, day care procedures, and green environment has created the need of new modalities of anaesthesia for such cases. Considering such factor, investigators have planned using TIVA i.e. total intravenous anaesthesia with Inj. Propofol and Inj. Dexmedetomidine infusions for maintenance of anesthesia in Modified Radical Mastectomy (MRM). By comparing the two modalities of anaesthesia i.e. TIVA vs Inhalational investigators are trying to find out whether TIVA is feasible, cost effective and comparable to inhalational anaesthesia in terms of intraoperative hemodynamic stability, pain, intraoperative awareness and recovery profile. This comparison and analysis will help to determine if TIVA can be used as the sole mode of anaesthesia during MRM as it will initiate early discharge of patient and will contribute to the Green OT concept.

Aim: To compare TIVA Vs Inhalational mode of anaesthesia in patients undergoing Modified Radical Mastectomy

Objective:

* Feasibility of TIVA in Modified Radical Mastectomy
* Cost - effectiveness of TIVA Vs Inhalational anesthesia
* Effectiveness of TIVA as compared to Inhalational Anaesthesia by comparing intraoperative hemodynamic parameters and recovery profile.

Study design: It will be a prospective randomized controlled interventional type of study.

Sample size: Total 100 patients will be recruited for two groups i.e. 50 each in -TIVA (T) and Inhalational (I) group. Groups will be allocated as per chit system to remove the bias.

In group T: (TIVA): Inj. Dexmedetomidine will be started at induction @1mcg/kg over 10 min followed by 0.2 to 0.7 mcg/kg/hr along with propofol @ 75mcg/kg/min (25-100 mcg/kg/min) for maintenance of anaesthesia.

In group I: (inhalational): both nitrous oxide (in ratio of 50:50 with oxygen) and sevoflurane will be started at induction.

In both groups drugs and gases (respective to groups) will be titrated to maintain a bispectral index value between 40-60. Anaesthetic drugs will be stopped at last skin suture. Soon after reversal- recovery profile, modified Aldrete score will be recorded along with time taken to first eye opening and attainment of BIS value of \>90. At the end of case amount of each agents consumed will be recorded - i.e. nitrous oxide, sevoflurane, propofol, dexmedetomodine- for cost analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age group: 30-65 yrs
* ASA status: 1-3
* Use of endotracheal tube for securing the airway

Exclusion Criteria:

* CKD, CLD patients
* Cardiac dysfunction
* Psychotic and neurotic disorders
* Drug addiction
* BMI \> 30
* Use of supraglottic device
* Use of any nerve blocks
Autonomic Phenotype Before and After Akt Inhibition

Some Akt inhibitors have produced functional cardiovascular effects such as marked hypotension that may limit their clinical benefit. There are no current data on whether this autonomic failure presents in humans at clinically used doses. We will test the hypothesis that Akt inhibition causes an acute decrease in sympathetic tone and lowers blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with melanoma with a BRAF mutation and relapse following therapy with a BRAF inhibitor
* Enrolled in a clinical trial through the Vanderbilt Ingram Cancer Center (VICC) including an arm with an oral Akt inhibitor
* Able and willing to provide informed consent

Exclusion Criteria:

* Factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies or an unpredictable schedule
* Unable to give informed consent
Standard Operating Procedures in Daily Clinical Routine

Primary study endpoint: blood sugar values

Patients: Patients admitted to an ICU

5 steps:

1. Routine treatment,
2. Implementation of SOP for blood sugar monitoring and intervention,
3. Education of intensive care nurses,
4. 6 months free interval without further education or check-up of SOP implementation,
5. Check of SOP implementation and clinical outcome concerning range of blood sugar

SOP for blood glucose monitoring and treatment was implemented on an intensive care unit. Staff was trained. After a free interval patient's outcome was monitored in terms of daily blood sugar profile prior implementation of SOP and after implementation+free interval of SOP.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to an ICU

Exclusion Criteria:

* Patient's or close relative's refusal
Effect of Intermittent Infusion Versus Continuous Infusion of Vancomycin on Kidney Failure in Critically Ill Patients

This is a randomized, controlled multicenter clinical trial. The purpose of this study is to compare the continuous infusion of vancomycin with intermittent infusion regarding the effectiveness to reach the target serum level and the relationship between infusion type and nephrotoxicity in critically ill patients.

The vancomycin is a glycopeptide antimicrobial which has been used for 50 years against gram-positive microorganisms and remains effective against multiresistant bacteria as the methicillin resistant Staphylococcus aureus (MRSA), the main microorganism causing nosocomial infections. Around the world, the continuous infusion of vancomycin has been studied and associated with less rate of nephrotoxicity. This is a randomized, controlled multicenter clinical trial that will compare continuous infusion with the intermittent vancomycin infusion, the relationship between infusion type with rate of nephrotoxicity and the time to target therapeutic serum in critically ill patients at the intensive care units of the Cancer Institute of the State of Sao Paulo (ICESP) and the Heart Institute (Incor).

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients
* Treatment with vancomycin
* Preserved renal function.

Exclusion Criteria:

* Cystic fibrosis
* Chronic renal failure
* Acute renal failure
* Having received vancomycin in the last 24 hours
* Vancomycin hypersensibility
A Multi-center, Prospective Evaluation of Infants and Children With Congenital Ichthyosis

This project will follow babies with ichthyosis over time in order to better understand the natural course of ichthyosis in infants and children and to examine how specific genetic mutations affect clinical characteristics.

The investigators hypothesize that early complications and comorbidities in infants with congenital ichthyosis are genotype-dependent, such that clinical standards of care can be tailored to the genetic diagnoses. Definition of clinical groups based upon phenotype may also provide useful predictors of outcome. Information gained from this study will provide the basis for the development of rational standards of care for the future management of children with congenital ichthyosis.

Eligibility Criteria:
Inclusion Criteria:

* One parent must be able to understand and sign an informed consent document.
* Newborns who present at or within 2 months of birth with a clinical diagnosis of ichthyosis.
* Families must consent to providing DNA for genetic analysis
* Families must agree to the intake evaluation followed by 10 follow-up evaluations, which will occur at ages 1, 2, 3, 6, 9, 12, 18, 24, and 36 months.

Exclusion Criteria:

* Subjects with non-English speaking parents
* Patients with a family history of ichthyosis vulgaris
* Patients with X-linked ichthyosis
Personalized Physical Back Training Program to Improve Physical Functioning in People With Non-specific Low Back Pain

Personalized medicine and individualized therapeutic approaches are prominent in current research. But are these approaches also effective for treating non-specific low back pain (NSLBP)? NSLBP is one of the most common musculoskeletal issues, which can impair physical well-being, reduce the quality of life, and limit physical functioning. Additionally, it contributes to substantial direct and indirect healthcare costs, such as frequent doctor visits and work absences. Despite NSLBP being a significant burden for both individuals and society, effective alleviation methods remain unclear. The investigators' research project therefore aims to investigate whether personalized therapy, specifically a personalized physical back training program, can effectively address NSLBP. Within the context of NSLBP, the investigators' specific aim is to improve physical functioning as this outcome is considered relevant from all perspectives, including those of patients, clinical professionals, researchers, and guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Access to the University Sports of the Lucerne Universities (i.e., students, employees, alumni, subscribers)
* NSLBP for at least 6 weeks
* Activity limiting NSLBP (at least one activity with a PSFS Score of ≤ 50/100 on a scale from 0 = unable to perform due to NSLBP to 100 = able to perform at the same level as before NSLBP)
* Age between 18 and 65 years
* Understand the German language
* Willing to participate in the study
* Written informed consent

Exclusion Criteria:

* Specific LBP
* Red flags associated with any serious pathology or specific LBP,
* Beeing on a waiting list for or less than 12 months post any surgery of the lower back
* Pregnancy or given birth within the last 12 months
* Diagnosed central neurological disease
* Not allowed to exercise
* Participant in the feasibility study
* Expecting to be absent for more than 2 weeks during the intervention period
Safety Study of Farletuzumab, Carboplatin and Pegylated Liposomal Doxorubicin (PLD) to Treat Platinum-sensitive Ovarian Cancer

The purpose of this study is to evaluate whether combination therapy with farletuzumab (MORAb-003), carboplatin, and pegylated liposomal doxorubicin (PLD) is safe.

Farletuzumab (MORAb-003) is a monoclonal antibody that has the potential to be an effective agent against epithelial ovarian cancer (including primary fallopian tube and peritoneal adenocarcinoma) in combination with other drugs. Farletuzumab works by a different mechanism from other cancer therapeutics and has been shown to be well tolerated. This study allows the opportunity to determine if the combination therapy of farletuzumab, carboplatin, and PLD

1. is safe, or
2. to assess the potential drug-drug interaction, and
3. to prolong response to chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of epithelial ovarian cancer
* Must have measurable disease by CT or MRI scan
* Must have relapsed as defined by CA-125 or radiologically within 6 months or more of completion of first- or second-line platinum chemotherapy
* Must have been treated with surgery and be a candidate for repeat carboplatin therapy
* Must have a normal cardiac ejection fraction at baseline

Exclusion Criteria:

* Subjects who never responded to first- or second-line platinum-based chemotherapy or whose relapse occurs \<6 months from the last platinum therapy
* Subjects who have received other therapy to treat their ovarian cancer since last relapse
* Known central nervous system tumor involvement
* Evidence of other active invasive malignancy
* Clinically significant heart disease
* Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA
* Previous treatment with MORAb 003 (farletuzumab)
* Previous treatment with anthracyclines
* Clinical contraindications to use PLD
Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syndrome Patients, CORAL Study

This study collects blood and stool samples from patients with suspected or diagnosed Lynch syndrome to evaluate a deoxyribonucleic acid (DNA) screening technique for the detection of colorectal cancer in Lynch syndrome patients.

PRIMARY OBJECTIVE:

I. To determine the sensitivity and specificity of the multitarget stool DNA (mt-sDNA) 2.0 test, for colorectal neoplasia in patients with Lynch syndrome.

SECONDARY OBJECTIVE:

I. Develop a biorepository of samples (stool and blood) from patients with Lynch syndrome and early onset (\< 50 years old) colorectal cancer.

OUTLINE:

Patients undergo collection of blood and stool samples no more than 90 days prior to or between 7-90 days after standard of care colonoscopy or flexible sigmoidoscopy. Patients' medical records are also reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years of age
* Individuals diagnosed with Lynch syndrome (mutation in MLH1, MSH2, MSH6, PMS2, EPCAM) or suspected Lynch syndrome or individuals diagnosed with early onset colorectal cancer (CRC) (\< 50 years old)
* Colonoscopy/flexible sigmoidoscopy (flex sig) scheduled +/- 90 days from sample collection
* Patient has agreed to participate and has signed the study consent form

Exclusion Criteria:

* Patient has known cancer (stage I-IV) 5 years prior to current sample collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible)
* Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current sample collection
* Patient has had any abdominal radiation therapy prior to current sample collection
* Patient had therapy to the target lesion with intent to completely remove or debulk the lesion prior to sample collection \[examples include snare polypectomy, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), surgical resection, trans anal excision\]
* Patient has prior diagnosis of non-lynch hereditary colon cancer syndrome \[familial adenomatous polyposis (FAP), MUTYH-associated polyposis (MAP), Peutz-Jeghers syndrome (PJS), juvenile polyposis syndrome (JPS), PTEN, POL\]
* ADDITIONAL STOOL EXCLUSIONS:
* Bowel prep \< 7 days prior to stool collection
* Oral or rectal contrast given within 7 days prior to stool collection
* Removal of more than 50% of colon or presence of ileostomy
* Enteral feeds or total parenteral nutrition (TPN)
* Diagnosis of inflammatory bowel disease
Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse

The Colpopexy and Urinary Reduction Effort (CARE) trial is a research study designed to evaluate whether the addition of a second surgical procedure in addition to a procedure for female pelvic organ prolapse (POP) affects the rates of urinary incontinence. This study will follow women in the CARE study for 10 years from the time of the surgery to compare success and complication rates in the two groups. Recruitment into this study is open only to women that already participated in CARE. Recruitment into CARE is closed.

The primary aims of this prospective cohort study are:

1. To determine the long-term (up to 10 years) anatomic success rate of sacrocolpopexy (defined as Stage 0 apical prolapse AND \<= Stage 2 anterior and posterior prolapse AND no re-operation or pessary treatment for POP), and whether anatomic success differs between women who had vs. those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy;
2. To determine whether there is a difference in long-term stress continence (by symptoms) between women who had vs. those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy;
3. To determine whether there is a long-term difference between overall pelvic floor symptoms and pelvic-floor specific quality of life between women who had vs. those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy.

Eligibility Criteria:
Inclusion Criteria:

* Women enrolled in CARE

Exclusion Criteria:

* Inability to provide informed consent.
* Subjects who, at the time of enrollment into E-CARE, are long-term residents of a skilled nursing facility (that is, residency is not limited to short-term rehabilitation).
Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem

This is a prospective, consecutive series, multicenter clinical study of clinical outcomes following total hip arthroplasty with the SMF stem.

The objectives of this study are to evaluate the safety and efficacy of the study device. This study will document any device-related, surgical or post-operative complication and adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems. Outcome measures will be quantified through statistical analysis of study device , HOOS questionnaire, radiographic assessments, Harris Hip Score, and adverse event reports.

Eligibility Criteria:
Inclusion Criteria:

* Patient presents with non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, avascular necrosis, rheumatoid arthritis of or any of it's composite diagnosis.
* Patient is of legal age to consent, is skeletally mature and at least 18 years old.
* Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form.
* Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological or other conditions that would pose excessive operative risk.

Exclusion Criteria:

* Patient has poor bone stock and would make the procedure unjustifiable: A) patients which are under medical care for osteoporosis (taking hormones, Calcitonin or biphosphates) or for other metabolic pathologies, which could influence the quality of the bone (for example hyperparathyroidism, hyperthyreoidismus and osteomalacie) will be excluded from the study. B) patients suffering from Morbus Paget (osteodystrophia deformans) will be excluded from the study.
* Patient has conditions that tend to place increased loads on implants such as weight, chargot joint, muscular deficiencies and activity level, which are incompatible with a satisfactory long-term result: A) patients with a BMI \> 40 will be excluded from the study B) patients participating in high-impact sports like baseball, basketball, football, handball, hockey, karate, racquet-ball, running, soccer, water skiing or similar impact sports will be excluded from the study.
* Patient is over the age of 75.
* Skeletal immaturity: patients must be at least 18 years at the time of the operation.
* Patient has an active, local infection that would lead to increased bone resorption.
* Mental or neurological conditions that tend to pre-empt the patient's ability or willingness to restrict activities.
* Known sensitivity to materials of the implant.
* Patient is pregnant or plans to be come pregnant during the course of the study.
* Patient is a prisoner.
Resident Physician Burnout and Well-being

Pilot study shows that two hours of weekly protected non-clinical time is associated with decreased burnout and increased well-being in otolaryngology residents

Burnout amongst physicians is high with resulting concern over quality of care. With burnout beginning early in training, much-needed data is lacking on interventions to decrease burnout and improve well-being amongst resident physicians. The primary objective was to design and evaluate the impact of a departmental-level burnout intervention for otolaryngology residents. The secondary objective was to describe how residents utilized and perceived the study intervention.

All current residents in the Department of Otolaryngology at the University of Minnesota were solicited for participation. Inclusion criteria included all residents willing to complete the study protocol. Exclusion criteria included the principal investigator. All 19 eligible residents consented to participate. All participants were assigned two hours of weekly, protected non-clinical time alternating with a control period of no intervention at 6 week intervals.

Burnout was measured by the Maslach Burnout Inventory (MBI) and Mini-Z Questionnaire (Mini-Z). Well-being was measured by the Resident and Fellow Well-Being Index (WBI) and a quality-of-life (QOL) single-item self-assessment (SA). In addition to baseline demographic survey, participants completed the aforementioned surveys at approximately 6-week intervals from October 2017 to July 2018.

Eligibility Criteria:
Inclusion Criteria:

- all resident physicians (PGY1 - PGY5) in the Department of Otolaryngology that were willing to complete the study protocol

Exclusion Criteria:

- principal investigator(s) were excluded from participation