cyrilzakka/clinical-trials huggingface dataset:
Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus

The purpose of this research study is to determine the feasibility and safety of giving the combination of oxaliplatin and gemcitabine followed by radiation therapy and to learn whether or not this drug combined with radiation therapy works in treating women with Mullerian tumors of the uterus.

OBJECTIVES:

Primary To determine the feasibility of dual modality therapy described as cytotoxic therapy followed by radiation therapy for the management of Malignant Mixed Mullerian Tumors (MMMTs).

Secondary

\* To describe the response rate by Response Evaluation Criteria in Solid Tumors

STATISTICAL DESIGN:

This study used a two-stage design to evaluate feasibility of oxaliplatin and gemcitabine prior to radiation therapy defined as completing 3 cycles of chemotherapy. The null and alternative therapy completion rates were 25% and 50%. If 3 or more participants enrolled in the stage one cohort (n=9 participants) complete therapy than accrual would proceed to stage two (n=15 participants). If therapy was completed by at least 10 participants in the final set of 24 evaluable participants then this regimen would be deemed worthy of further study. This design had 80% power given one-sided type I error of 5% with the probability of stopping early 0.60.

Eligibility Criteria:
Inclusion Criteria:

* Surgically staged and histologically confirmed diagnosis of MMMT
* 18 years of age or older
* ECOG Performance Score of 0-2
* Adequate bone marrow function
* Adequate renal function
* Adequate hepatic function
* Patients must be recovered from both the acute and late effects of any prior surgery

Exclusion Criteria:

* Patients with an active infection
* Patients with CNS metastases
* History of prior malignancy within the past 5 years except curatively treated basal cell carcinoma of the skin, or cervical intraepithelial neoplasia
* Known hypersensitivity to any of the components of oxaliplatin or gemcitabine
* Prior radiation to the pelvis
* Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days
* Peripheral neuropathy greater or equal to Grade 2
* Stage IV visceral disease (lung and liver metastases at presentation)
* Any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent
* Known HIV or Hepatitis B or C (active, previously treated or both)
* Pregnant or breast feeding
Open-source Hearing Aid Platform Comparisons

New discoveries for hearing loss intervention are often impeded by the proprietary nature of commercial hearing aids and their use in scientific research as "black boxes". An open-source speech platform (OSP) was developed to bridge the gap between audiology research and commercial hearing aid features, to promote innovative solutions to meet the needs of the hearing loss community. The OSP can replicate functions found in commercial hearing aids, and provides tools to researchers to access those functions. The purpose of this study is to evaluate portable and cloud-based platforms of the OSP that will enable a wide range of lab and field applications. All human subjects-related activities will be conducted at Northwestern University (single-site study).

New discoveries for hearing loss intervention are often impeded by the proprietary nature of commercial hearing aids and their use in scientific research as "black boxes". An open-source hearing aid (open-source speech platform or OSP) was developed to bridge the gap between audiology research and the commercialization of hearing aid technologies and to promote innovative solutions to meet the needs of the hearing loss community. The OSP can replicate functions found in commercial hearing aids, and provides tools to researchers and listeners to access those functions. The purpose of this study is to evaluate portable and cloud-based platforms of the OSP that will enable a wide range of lab and field applications by measuring speech perception abilities with the open-source hearing aid in quiet and in noise for adults with and without hearing loss.

The study is a within-subjects design that allows for the comparison of outcomes within the same participant. The study will compare performance with two platforms of the open-source hearing aid (portable and cloud-based) for adults with hearing loss and normal hearing. The study will measure performance using tests of word identification. We will test aided performance with clinically validated hearing aid settings in quiet and in noise. Each participant will be presented with all the test conditions, and the order of presentation of the test conditions will be randomized across participants. Statistical analyses will use a repeated measures model to control for correlation between outcomes for the same participant.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years of age; any sex
* Sensorineural hearing loss with pure-tone thresholds between 25-85 decibel hearing level (dB HL) at octave frequencies between 250 and 3000 Hz
* Speak English as their primary language
* Normal or corrected-to-normal vision
* Participants will be in good health (self-report)

Exclusion Criteria:

* Clinically significant unstable or progressive medical conditions
* Participants who score \< 23 on the cognitive screening test (Montreal Cognitive Assessment)
* Evidence of conductive hearing loss or middle ear issues
* Significant history of otologic or neurologic disorders
* Non English-speaking or non-native English speaking
Alternative Splicing and Leukemia Initiating Cells

Aberrant RNA splicing and mutations in spliceosome complex in acute myeloid leukaemia (AML) are frequent. It have been shown that some splicing variants had a prognostic value in AML.

AML are characterized by their propensity to relapse because of the persistence of leukaemia initiating cells (LICs).

The aim of this study is to determine the splice variants on AML initiator cells and define a splicing pattern.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years-old
* Patients treated at the south lyon hospital center
* Patients with a diagnosis of acute myeloid leukemia confirmed in cytology and whose involvement of the 11q23 locus was confirmed by in situ hybridization
* Patients for whom a sample is available in the cytogenetic laboratory of the south lyon hospital center

Exclusion Criteria:

None
The Utility of Levofloxacin-Rifampin in the Therapy of Prosthetic Joint Infection

Prosthetic joint infection is a devastating complication of total joint arthroplasty ultimately leading to the failure of the total joint arthroplasty function and possibly death. Optimal treatment requires the resection of the infected total joint arthroplasty followed by prolonged parenteral antimicrobial therapy. This procedure is followed by reimplantation of a new total joint arthroplasty at a later date. Surgical debridement and retention of the infected total joint arthroplasty offers a more conservative surgical approach and has been proven to be cost-effective in selected groups of patients. Traditional medical therapy for staphylococcal infection would require an initial parenteral antimicrobial followed by chronic oral non-rifampin containing antimicrobial suppression regimen for the life of the total joint arthroplasty. With this strategy the success rate is close to 30%. Recently, several prospective studies of patients with THA, TKA and fracture fixation device infections conducted in Europe showed that the success rate with a 3-6 month course of a quinolone-rifampin combination is effective in 70% to 100% of cases. The proposed study will be a prospective open label observational cohort that will evaluate the outcome of Patients with S. aureus PJI treated with a medical regimen that includes oral levofloxacin- rifampin and debridement and retention of components. This medical regimen was approved for use by the Orthopedic Infectious Diseases focus group, Mayo Clinic, Rochester. 15 patients will be enrolled over a one-year period and followed up to minimum of 1 additional year. The outcome of this group will be compared to a historical group that is treated with traditional therapy.


Eligibility Criteria:
A maximum of 15 adult participants with total hip or total knee arthroplasty are approved for enrollment in this protocol at Mayo Clinic Rochester.
Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal Movement and Uterine Activity Detection

Owlet Baby Care, Inc. has developed a wearable fabric band pregnancy monitor, to be worn around the maternal abdomen incorporating electrocardiogram sensors. The purpose of this proposed test is to collect overnight "at-home" fetal ECG recordings on women during the second half of pregnancy using the pregnancy monitor.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman, 18 years of age and up.
* Singleton or twin pregnancy.

Exclusion Criteria:

* Self-reported substance abuse problems.
* Anyone unable or unwilling to give informed consent.
Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of CIN

The purpose of this study is to determine whether Palonosetron and Olanzapine without dexamethasone for the Prevention of moderate risk Chemotherapy-Induced Nausea and vomiting.

This study was designed to evaluate efficacy and safety of olanzapine compared with 5-hydroxytryptamine3 receptor antagonist for prevention of moderate risk chemotherapy induced nausea and vomiting.

Eligibility Criteria:
Inclusion Criteria:

* European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* no severe cognitive compromise
* Moderate risk chemotherapy induced chemotherapy induced nausea and vomiting in 1st cycle
* Confirmed histology

Exclusion Criteria:

* European Cooperative Oncology Group (ECOG) performance status of 3 and 4
* Nausea or vomiting in the 24 hours before enrollment
* History of Nausea or vomiting Grade 3 before previous chemotherapy
* Known history of central nervous system disease (e.g., brain metastases or a seizure disorder)
* Bowel obstruction
* Serum creatinine level of 2.0 mg per deciliter (177 μmol per liter) or more
* Aspartate or alanine aminotransferase level that was more than 3 times the upper limit of the normal range
* Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment
* Treatment with another antiemetic agent before 48 hours before enrollment
* Uncontrolled severe infection or uncontrolled severe comorbidity
* Concurrent abdominal radiotherapy
* Known hypersensitivity to olanzapine, palonosetron
* Known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 month
Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm Infants

The authors hypothesize that adjusted individual feeding (AIF) for preterm infant starting from transition to oral feeding (33 weeks corrected age) will result in less episodes of apnea/bradycardia, early achievement of full oral feeding, improved weight gain and shorten hospitalization duration in the short term.

In the long term AIF will result in higher scores on the Griffith's developmental scales, decreasing parental anxiety and feeding disorders .

Preterm infants born at \<32 weeks of gestation at our institute will qualify for this study. Recruitment will occur between day 7-14 of life after sever brain malformations or intraventricular bleeding will be ruled out. Randomization to control or intervention will be via sealed envelopes. In the control group - infants will be treated according to the common practice in the neonatal intensive care unit. Transition to oral feeding will occur at 33 wkks (breast feeding) and 34 wks (bottle feeding). Meals will be given every 3 hours, the amount will be written by the care giving physician and will be written as a strict number (i.e 30 ml every 3 hours) Parents in the intervention group will be taught be the nurses (NIDCAP trainees) to identify their infants' ques (self regulation or withdrawn as well as signs of hunger), This parents will be taught the physiology of maturation of feeding, as well as various techniques of infants feeding amongst them pace feeding. During the study parents in both groups will be interviewed every 14 days as for their satisfactions, anxieties, infants ability to cope. video typing during Kangaroo care at 32 and 35 wks as well as during feeding at 35 weeks will be done and evaluated. General movements assessment (neurodevelopment) will be done at 33 -35 weeks gestational age, as well as at 52 weeks. Alberta infant motor scales will be evaluated at 4 and 8 month corrected age,Automated Brain stem evoked Response (ABR) will be done at 33 wks for assessment of brain stem maturity, duration of hospitalization, weight gain per week at 33, 34 and 35 weeks will be calculated, age at full oral feeding will be noted. At the age of 6 month Griffith's developmental scales will be performed

Eligibility Criteria:
Inclusion Criteria:

- birth at less than 32 weeks of gestation

Exclusion Criteria:

* High grade intraventricular hemorrhage (grade 3 or4)
* genetic syndrome
Fluid Resuscitation With HES 200/0.5 10% in Severe Burn Injury

HES 200/0.5 10% is equal to ringers lactat solution.

30 Patients were enrolled to the study, either to the hyperoncotic HES 200/0.5 (10%) group or to the crystalloids only group. After a treatment protocol of 72 hours we collected data about complications like pulmonary failure and abdominal compartment syndrome. Furthermore, we addressed the question of incidence of mortality and renal failure.

Eligibility Criteria:
Inclusion Criteria:

* All burn victims with burned surface area bigger than 20%

Exclusion Criteria:

* Pregnancy
To Study the Immunomodulating Effects and Safety Profile of ω3 and ω6 PUFA Containing Intravenous Lipid Emulsion in Patients With Acute on Chronic Liver Failure

Study population: Patients admitted or seen in OPD (Out Patient Department), Department of Hepatology.

Study design- Prospective Randomized Controlled Trial. Study period-January 2016 to May 2017 Intervention- Subjects will be randomized into 3 groups Group A subjects will receive ω3 PUFA (Polyunsaturated Fatty Acids) (10% Omegavan 100 ml).

Group B- will receive ω6 PUFA (Polyunsaturated Fatty Acids) (10% Intralipid 100 ml).

Group C -Placebo group

Monitoring and assessment- :- The following tests will be done in these patients:-

1. Complete clinical examination.
2. Serum electrolytes- sodium, potassium, calcium, magnesium, phosphate levels
3. BUN (Blood Urea Nitrogen)
4. Serum free fatty acid levels
5. Lipid profile.
6. Arterial ammonia
7. Arterial lactate
8. Blood sugar and serum insulin levels


Eligibility Criteria:
Inclusion Criteria:

* Acute on Chronic Liver Failure (ACLF) patients aged 18 years and above
* Patients tolerating enteral nutrition
* Patients with no overt sepsis - no fever, sterile blood and urine cultures, procalcitonin \<2

Exclusion Criteria:

* Active ongoing GI bleed
* Allergy to soya oil, eggs, peanuts or other ingredients of intralipid.
* Co-morbidities like Diabetes mellitus, hyperlipidemia, CAD and hypothyroidism.
* Renal failure (S.creatinine \> 2.5mg%)
* Pregnancy
* Patients with shock requiring vasopressor support
* Patients on anticoagulants
* Refusal to participate in the study
Targeted Internal Radiation Therapy in Advanced HCC Patients.

The aim of this study is to evaluate the 131I-chTNT-1/B treatment effect and safety of individual therapy using randomized controlled study, in order to acquire the evidence of evidence-based medicine and create a new program of targeted internal radiation therapy in advanced HCC patients.


Eligibility Criteria:
Inclusion Criteria:

1. Via clinical diagnosis and confirm it is advanced hepatocellular carcinoma
2. mRECIST estimation: necrosis region in HCC
3. Negative iodine allergy test
4. Liver function ：Child-Pugh A/B

Exclusion Criteria:

1. reject to attend；
2. impossible to come to our hospital for physical examination regularly.
3. Blood clotting function hindrance; 4, Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
Efficacy Study of Prucalopride to Treat Chronic Intestinal Pseudo-Obstruction (CIP)

This study was designed to investigate the clinical safety, tolerability and efficacy of prucalopride in improving the symptoms associated with chronic intestinal pseudo-obstruction (CIP) in subjects with CIP. The study hypothesis was that prucalopride at doses up to 4 mg is safe, well tolerated, efficacious and improves the symptoms associated with CIP.

This phase II, double-blind, placebo-controlled, two-treatment four periods cross-over trial investigated the clinical safety, tolerability and the efficacy of R093877 (prucalopride) in improving the symptoms associated with chronic intestinal pseudo-obstruction (CIP) in subjects with CIP.

Subjects were treated for 4 periods of 12 weeks each with either R093877 2 mg (2 periods) or placebo (2 periods). In each of the first and second 6 month period, there was a placebo (PLA) and an active drug (PRU) treatment period. There were no wash-out periods. In total,7 subjects were randomized; 2 were assigned to the PLA-PRU-PLA-PRU, 2 to the PRUPLA-PRU-PLA, 2 to the PLA-PRU-PRU-PLA, and 1 to the PRU-PLA-PLA-PRU sequence group. Subjects were allowed to use up to 4 mg of prucalopride per day if the 2 mg dose seemed to be insufficient. Two subjects used an average of 3 mg of prucalopride per day during the active drug periods.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years;
* A history of chronic pseudo-obstruction for at least 3 months;
* Subjects with chronic idiopathic pseudo-obstruction or chronic pseudo-obstruction secondary to scleroderma or intestinal polyneuropathy;
* CIP had been diagnosed by a Barium-imaging study showing the presence of dilatation of any part of the small bowel (with or without the presence of large bowel dilatation);

Exclusion Criteria:

* Subjects with organic obstructing lesions causing intestinal obstruction;
* Current uncontrolled cardiovascular or lung disease, neurologic or psychiatric disorders (including substance abuse but with the exception of nicotin), alcoholism, cancer or AIDS and endocrine disorder;
* Impaired renal function
* A serum amylase, a serum glutamic-oxaloacetic transaminase (SGOT) or a serum glutamic-pyruvic transaminase (SGPT)concentration of \> 2 times the normal limit;
* Laboratory values outside the reference range of the laboratory, unless explained by the disease or felt by the investigator to be clinically unimportant;
* Use of disallowed concomitant therapy;
* Female subjects who were pregnant or wished to become pregnant during the course of the trial or who were lactating;
Hearing Aid Education and Adaptation System

This RCT will have two arms: A control group that receives the standard of care from audiologists and an experimental group that receives both the standard of care and the at-home use of the TELLYHealth intervention. Subjects in each group will complete questionnaires at enrollment, mid-study and at the end of the study.

HTM will develop the "TELLYHealth (tm) system" that will provide education on hearing aid use and maintenance. HTM will conduct a randomized controlled trial (RCT) to quantify the benefits of TELLYHealth to patients and audiologists including: reductions in hearing handicap, improved knowledge of hearing aid handling, use and communications strategies; and improved audiologist aftercare. The investigators will recruit 80 subjects (half in each group) and each subject will participate in the study for 8-12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Speaks and reads English fluently
* Has mild (25-40 dB) to severe (70-95 dB) monaural sensorineural hearing loss
* Will be fitted with one or two hearing aids at the time of enrollment
* Owns a standard TV
* Has Internet access at home
* Has sufficient corrected vision to watch videos and read text on the TV and mobile device
* No signs of dementia

Exclusion Criteria:

* Lives with person who has enrolled in the study
MyoVista Measurements in Patients With Atherosclerosis and CAD

The MyoVista system is a novel electrocardiogram technology that provides non-invasive assessment of myocardial abnormalities by analyzing energy changes at the cellular level of the myocardium.

The MyoVista iECG Electrocardiograph is a diagnostic device used to process electrical signals transmitted through electrocardiograph electrodes and to detect ischemia abnormalities based on electrical waveform, patient data, demographics, algorithmic sensitivity and software based informatics. The MyoVista provides the clinician with a standard ECG conventional waveform, along with an additional report derived from the proprietary informatics exclusive to the MyoVista.

The device holds a lot of promise for early intervention to properly diagnose and treat patients under risk timely and effectively. The MyoVista captures and amplifies signals from the myocardial tissue. These signals are then processed and compared to an algorithm that looks for certain changes occurring in these processed waveforms. The changes that have been identified occur much sooner than those processed by a traditional electrocardiogram (ECG). These recordings focus on early detection of myocardial abnormalities by non-linear analysis of electrical activity and physiological phenomenon. This novel assessment might be capable of detecting subclinical myocardial dysfunction in a variety of heart diseases.

The study would compare MyoVista results to subclinical measures of atherosclerosis (CAC and CT angiography) in 200 subjects at risk for coronary disease. Correlations between the MyoVista reading and the presence of calcified plaque, soft plaque, CTA stenosis, will be determined.

This study has the potential to confirm MyoVista as a reliable and sensitive marker of atherosclerosis. Findings may provide a strong indication for the value of a MyoVista test to confirm CAD in clinical practice, and for the clinical application of MyoVista in management of coronary disease and atherosclerosis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female gender
* From (and inclusive of) ages of 18 to 80 years
* Body mass index (BMI) between 18 and 39.9 (kg/m2)
* Able to lie (supine) still comfortably on the back for at least 20 minutes

Exclusion Criteria:

* Known history of cancer, other than non-melanoma skin cancer
* Known history of heart disease or heart rhythm abnormalities
* Known history of cardiovascular disease
* Known history of Peripheral Artery Disease (PAD)
* Known history of claudication
* History of amputation or loss of limb(s)
Evolution of Body Connection After Surgery

Evaluation of psychological impact of patients after pancreatectomy because of cancer diagnosis. Patients will be evaluated with questionnaires after and before intervention. 3 control groups will be used to compare de psychological impact.


Eligibility Criteria:
Inclusion Criteria:

* Patient is older than 18 years old
* With a good understanding and practice of the French language
* And depending on the group, experimental or control, presenting:

  * pancreatic cancer expected to be treated with pancreatectomy or planned to be treated with pancreatectomy excluding cancer or breast cancer scheduled to be treated with mastectomy or acute leukaemia at a recent diagnosis (21 days).
* No patient's opposition to the information provided
* Affiliated to the social security plan or beneficiary

Exclusion Criteria:

* Other medical or psychiatric condition,
* Level of cognitive efficiency incompatible with response to questions about himself,
* A person in an emergency situation, a person under legal protection or unable to express the non opposition to their participation to research.