cyrilzakka/clinical-trials huggingface dataset:
Safety and ASCT-related Symptom Burden Optimization of Tocilizumab in ASCT Following HD Melphalan Conditioning for Multiple Myeloma Patients

Background: Autologous hematopoietic stem cell transplantation(ASCT) is an important part treatment for patients with multiple myeloma. Retrospective analysis from our center showed that incidence of oral mucositis and gastrointestinal symptoms was higher during ASCT for melphalan as conditioning regimen in patients with multiple myeloma. Objective: Safety and optimization of ASCT-related symptom burden of tocilizumab for melphalan as a conditioning regimen in ASCT for multiple myeloma is explored. Methods: The patient who is enrolled will be randomly divided into two groups in a proportion of 1:1 to respectively receive tocilizumab(8mg/kg) at day -7 before transfusion of stem cells or not. There will be enroll 48 patients according to inclusion and exclusion criteria totally. Adverse events and MDASI score during ASCT between two groups will be recorded and analyzed. Primary endpoint: MDASI, Security; Secondary endpoints: time to neutrophil engraftment; time of platelet implantation; efficacy (ORR) after autologous hematopoietic stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with multiple myeloma eligible for autologous hematopoietic stem cell transplantation;
2. Secretory MM should have measurable markers, including:

   1. specific M protein value (≥5g/L)；
   2. and/or involved flc ≥100mg/L；
   3. and/or measurable extramedullary foci (diameter\>1cm on CT);
3. Age ≥ 18 years and ≤ 70 years, male or female;
4. PR and above are obtained after induction therapy according to the IMWG response criteria;
5. Mononuclear cells ≥2×10\^8/kg body weight, CD34+ cells≥2×10\^6/kg body weight;
6. ECOG 0-2, with life expectance ≥3 months;
7. ALT/AST level ≤2.5 times of the maximum of normal range; total bilirubin≤2 times of normal maximum；
8. Neutrophil count≥ 1.5×10\^9/L, platelet count ≥50×10\^9/L;
9. Normal Left ventricular ejection fraction , NYHA stage 1, lung function GOLD stage 1;
10. Willing to accept the possibility of potential adverse events and efficacy observation by the investigators;
11. Being able to understand and signing the written consent, which should be signed prior to any procedure of the trial.

Exclusion Criteria:

1. With ≥2 degree of peripheral neuropath or with pain;
2. Having received any of the medicine of the experiment regimen within 30 days prior to enrollment, pain-relieving radiotherapy is allowed;
3. With severe pulmonary/cardiac disfunction (including history of QT interval elongation, ventricular tachycardia, ventricular fibrillation, myocardial infraction) or other severe organ malfunction;
4. Patients in pregnancy or lactation;
5. Allergic constitution or being allergic to any drug within the regimen of the trial;
6. With uncontrolled mental diseases;
7. With active infection;
8. With active hepatitis;
9. HIV positive;
10. History of other malignant tumor within 5 years prior to enrollment; except for the case of in situ cervical cancer and non-malignant melanoma;
11. With other conditions that the investigators think unfit for the trial.
Pregnancy Outcomes According to the Gestational Age of Acquiring COVID-19

A new coronavirus, called severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) appeared in Wuhan, China and it arrived to Europe 2-3 months later. It infected millions of persons and led to the death of thousands until May 2020 where numbers of infections per week decreased significantly. However, starting September, number of infections started to escalate again and continued to rise until now.

Hundreds of good quality articles were published during this period to study the relationship and effects of this virus on pregnancy and vice versa, as well as to determine the adverse neonatal and obstetrical outcomes following the infection. In a case-control study using propensity score matching at the level of age, body mass index and comorbidities (diabetes, hypertension, asthma), pregnant women over 20 week's gestation had significantly higher risk for intensive care unit stay, endotracheal intubation, hospitalization for disease related symptoms and need for oxygen therapy. A new systematic review also demonstrated increased risk for ICU admission in pregnant women compared to non-pregnant women and to non-infected pregnant women.

On the other hand, many researchers have demonstrated that the rates of preterm delivery and cesarean delivery have increased as well, others reported a close relation between SARS-CoV2 infection and preeclampsia or preeclampsia like condition. Enormous effort was done in order to understand adverse outcomes related to this infection, however, most studies included patients in the third or late second trimester. Few studies stratified adverse outcomes of the patients according to the trimester of infection.


Eligibility Criteria:
Inclusion Criteria:

Pregnant women with viable fetus after 10 weeks' gestation and known pregnancy outcome during the period starting on February 1st 2020 and ending on November 30th 2020.

Exclusion Criteria:

All ongoing pregnancies, those with unknown outcomes, those terminated medically or voluntary, as well as patients with spontaneous abortion before the 11th gestational week.
Day Case Colectomy: Optimizing Short Stay-surgery.

HRV measurement of patients recovering from laparoscopic colorectal resection for any pathology.

Patients scheduled for colorectal surgery are recruited to the study. HRV parameters including e.g. RMSSD are evaluated before and after surgery. The effect of surgery and possible complications associated with it on parameters and relationship with specific adverse effects caused by complications are evaluated.

Eligibility Criteria:
Inclusion Criteria:

• Colorectal resection for any pathology

Exclusion Criteria:

• Arrhytmias likely to cause problems with HRV measurements
Micardis®. Observational Study in Patients With Essential Hypertension

This study is designed to supplement, under conditions of usual clinical practice, the data on the efficacy and safety of Micardis® collected during the clinical studies.


Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex over the age of 18 years suffering from essential hypertension requiring treatment according to the physician

Exclusion Criteria:

* Hypersensitivity to the active component or to any of the excipients
* Pregnancy and lactation
* Biliary obstructive disorders
* Severe hepatic impairment
* Severe renal impairment
INNOVE Study: A Study of 3 Months Induction With Fuzeon (Enfuvirtide) + Optimized Background (OB) Versus OB Alone in HIV-1 Infected Patients With Virological Failure.

This 2 arm study will assess the efficacy and safety of a new regimen of Fuzeon

+ optimized background antiretroviral treatment, in Fuzeon-naive HIV-1 infected patients with virological failure. Eligible patients will be randomized to recei ve either new optimized treatment alone, or optimized treatment + Fuzeon 90mg s.

c. twice daily, to determine the effect of 3 month induction with Fuzeon.It will be possible for a patient to receive several additional 3 month periods with F uzeon, in the case of new virological failure. The anticipated time on study tre atment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* HIV-1 infection, with virologic failure;
* on same stable HAART for \>4 weeks, with viral load \>1000 RNA copies/mL;
* Fuzeon-naive.

Exclusion Criteria:

* coinfection with HIV-2;
* active opportunistic infection in 4 weeks prior to screening;
* cirrhosis or severe liver failure;
* severe renal disease.
Epidural Spinal Cord Stimulation for Hypertension in Patients With Neuropathic Pain

The purpose of the ESCAPE Study is to determine the extent to which epidural spinal cord stimulation (SCS) reduces arterial blood pressure (BP) in patients which chronic low back pain and hypertension. We also aim to determine the extent to which higher baseline BP (i.e., hypertension) predicts reductions in pain following SCS implant. This is an observational study of patients undergoing an implantation of a SCS device.

The broad research goal of this study is to examine the extent to which arterial blood pressure (BP) and blood markers related to hypertension and kidney function are reduced in a prospective cohort of patients undergoing implantation of an epidural spinal cord stimulator (SCS) for the purpose of managing chronic pain in the lower back and/or limbs.

Specific aims:

1. Examine the extent to which BP (primary variable), norepinephrine (marker of sympathetic nerve activity in the blood), and a vascular ultrasound scan are improved following the implant of a SCS device among patients with chronic pain and hypertension.
2. Examine the extent to which markers of kidney function in the blood \[serum creatinine, glomerular filtration rate (GFR), and blood urea nitrogen (BUN)\] are reduced following the implant of a SCS device among patients with chronic pain and hypertension.
3. Determine the extent to which BP predicts reductions in pain following the implant of a SCS device.

Eligibility Criteria:
* Planning to have an epidural spinal cord stimulation device implanted at KUMC
* Male or Female, age 30-89
* Low back pain for more than 3 months
* Willing to visit research lab
* Willing to undergo a blood draw and blood pressure measures
* Able to provide written informed consent
Superficial Partial-Thickness Burn Study

This study is an investigator initiated, single site, University of Pittsburgh, prospective, parallel group, randomized controlled trial comparing SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel (intervention group) to the current gold standard treatment Silvadene (control group). Both groups will receive the same care other than the treating agent. Subjects will be recruited form the UPMC Mercy Burn Center adult patient pool who have sustained superficial partial-thickness burn wounds that comprise less than or equal to 10% of total body surface area (TBSA)

Current effective dressings for burn wounds contain silver (nanoparticulate or ionic), hypochlorite, hydrogen peroxide, sulfa agents, chlorhexidine, iodine or other dilute antiseptics meant to provide some measure of antimicrobial protection. However, all of these materials have some proven limitations in facilitating wound healing and also have notable local and systemic adverse effects. None of the current clinical treatments enhance healing and/or reduce scar formation. The purpose of this study is to test the safety and effectiveness of SynePure™ Wound Cleanser when used in combination with Catasyn™ Advanced Technology Hydrogel for the treatment of superficial partial-thickness burn wounds.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* 18 years of age or older, male and female
* Patients who have sustained superficial, partial-thickness burn wounds ≤ to 10% of total body surface area (TBSA)
* Patients otherwise in good general physical and mental health, as per the investigator's clinical judgment

Exclusion Criteria:

* Inability to provide informed consent
* Deep partial-thickness burns and full-thickness burns
* Radiation, chemical, or electrical burn injury
* Patients with burns primarily located to the face, genitals, or span across joints
* Patients whose burn injury was ≥ to 48 hours prior to entry into the UPMC Mercy Burn Center Clinic.
* Patients with uncontrolled cerebrovascular disease, cardiovascular disease, endocrine disease, hepatic disease, or renal disease; or other severe conditions for whom, in the physician investigators' discretion, would render study participation unsafe
* Patients with documented or self-reported shellfish allergies
* Current pregnancy
* Patients with concurrent burn related injuries or inhalation injury that would put the patient at increased risk, per physician discretion
* Any condition to which in the investigator's discretion would render study enrollment a safety concern for the patient
The Influence of Omega-3 Fatty Acid on the Violence of Schizophrenia Patient and the Possible Mechanism

Investigators plan to explore whether Omega-3 fatty acid have effect on the violent behavior of the schizophrenia patients. Investigators will use PET to explore the influence on serotonin function of the brain to understand the mechanism of how Omega-3 fatty acid works. This study will enroll 100 patients of schizophrenia with violent behavior.Participants will be split into two groups randomly. In one group, participants will receive one pill of placebo per day, and in the other, participants will have one pill of 900mg Omega-3 fatty acid per day. This intervention will last 3 months.At week 0, week 4, week 8 and week 12, some scales will be evaluated. Meanwhile, the density of eicosapentaenoic acid(EPA),docosahexaenoic acid (DHA),noradrenalin(NE), dopamine(DA) and serotonin(5-HT) in blood will be tested.At week 0 and week 12, 10 patients of each group will be randomly selected to have the exam of PET.


Eligibility Criteria:
Inclusion Criteria:

* the sore of MOAS scale \>=4 more than 2 violent behavior in recent 6 months by self repot

Exclusion Criteria:

* serious diseases,such as cardiovascular diseases,nervous system disease. allergy to fish oil
Epiction of the Genomic and Genetic Landscape Identifies CCL5 as a Protective Factor in Colorectal Neuroendocrine Carcinoma

Background: Colorectal neuroendocrine carcinomas (CRNECs) are highly aggressive tumours with poor prognosis and low incidence. To date, the genomic landscape and molecular pathway alterations have not been elucidated.

Methods: Tissue sections and clinical information were collected as an in-house cohort (2010-2020). Large-scale genomic and genetic panels were applied to identify the genomic and genetic alterations of CRNEC. Through the depiction of the genomic landscape and transcriptome profile, we compared the difference between CRNEC and CR neuroendocrine tumours (CRNETs). Immunohistochemistry (IHC) staining and immunofluorescence (IF) staining were performed to confirm the genetic alterations.


Eligibility Criteria:
Inclusion Criteria:

- tissues from colorectal neuroendocrine carcinomas

Exclusion Criteria:

- no
Effect of Topiroxostat on Urinary Albumin Excretion Early Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout

The purpose of this study is to investigate the effect of topiroxostat on urinary albumin excretion and the safety in patients with early stage diabetic nephropathy and hyperuricemia with or without gout. Participants are randomized to placebo (n=20) or topiroxostat (n=40) for 28 weeks. The investigational drugs for this study are supplied by FUJI YAKUHIN CO., LTD.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes patients
* Clinically or pathologically diagnosed diabetic nephropathy
* Hyperuricemic or gout patients
* Estimated glomerular filtration rate (eGFR) \>= 30 mL/min/1.73m\^2 and urine albumin creatinine ratio (UACR) greater than or equal to 45 and less than 300 mg/g

Exclusion Criteria:

* Patient has known non-diabetic nephropathy (other than nephrosclerosis)
Respiratory Quotient in Post Roux-en-Y Gastric Bypass Patients

Through the values of respiratory quotient (RQ) it is possible to estimate the utilization of energy substrates by the body, or if there is a higher or lower fat oxidation. Experimental and clinical studies have shown that after Roux-en-Y Gastric Bypass (RYGBP) there is a decrease in the values of RQ, which may be associated with increased lipid oxidation in the postoperative period.

Diet Induced Thermogenesis (DIT) is an important part of Total Energy Expenditure. We would like to know how it functions among RYGBP patients.

The purpose of this study is to evaluate the RQ and DIT of patients in the post operative phase and compare the result with a control group consisting of morbid obese population.


Eligibility Criteria:
Inclusion Criteria (bariatric patients post-op)

* With more than 1 year after surgery
* Consent given to participate

Exclusion Criteria:

* Pregnant women
* Malnourished patients (anemia)
* Tiroid disorders without treatment
Aesthetic Outcomes of Oncoplastic Breast Surgery for Breast Cancer in the Upper Inner Quadrant

Oncoplastic breast surgery, combining oncological resection with plastic surgical techniques, has emerged as an important surgical strategy to optimize conventional breast-conserving surgery. The upper inner quadrant is one of the most difficult and challenging tumor locations for surgeons to perform oncoplastic breast surgery. There is a pressing need to develop a simple and effective oncoplastic surgical technique to cope with the unfavorable anatomy and location of tumors in the UIQ. Here, we present a new oncoplastic volume displacement technique for UIQ using the DSG flap. This trial was design to estimate the aesthetic outcomes of an oncoplastic technique using a droplet-shaped glandular flap for breast cancer in the upper inner quadrant.


Eligibility Criteria:
Inclusion Criteria:

* Signed the informed consent.
* Female aged between 18 and 70 years.
* Pathologically diagnosed operable breast cancer.
* WHO Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Cancer located in the upper inner quadrant; Single tumor or multiple tumors in the same quadrant.
* The important organ functions meet the following criteria:
* WBC \>=3.0 x 10\^9/L; Neutrophilic granulocytes \>=1.5×10\^9/L; Platelet \>=100 x 10\^9/L; Hb \>=9 g/dL;
* Total bilirubin no more than 1.5 times the normal upper limit (ULN); AST and ALT no more than 1.5 times ULN; AKP no more than 2.5 times ULN;
* Serum creatinine no more than 1.5 times ULN or Clearance rate of creatinine \>= 60ml/min;
* Thyroid stimulating hormone (TSH) \<= ULN (T3, T4 levels need to be detected simultaneously if abnormalities, the patient can be included if T3, T4 levels is normal);
* LVEF basement \>= 50%.
* Adjust to the criteria of breast conserving surgery.

Exclusion Criteria:

* Multifocal or multicentric disease.
* Tumor localized in the central quadrant or the distance to the nipple \< 2 cm；
* Diffused calcifications with fine plemorphic or fine linear or fine-linear branching morphology.
* The ratio of tumor to breast \> 20%;
* The diameter of tumor is up to 4 cm;
* Women in the early or intermediate stage of pregnancy;
* Prior history of breast radiation;
* Any severe comorbidities, inability to give informed consent or unavailability for follow-up.
Pharmacokinetic Study of Spironolactone 25 mg, 50 mg and 100 mg Tablets

Objective is to investigate pharmacokinetics and to estimate the level of dose linearity of spironolactone and its metabolites canrenone and 7α-thiomethylspirolactone from Spironolactone 25 mg, 50 mg and 100 mg Tablets


Eligibility Criteria:
Inclusion Criteria:

* Subjects with normal findings as determined by baseline history, physical examination and vital signs, haemogram, biochemistry, infectious disease screening, urinalysis, 12 lead ECG

Exclusion Criteria:

* Any condition requiring regular concomitant medication or likely to need any concomitant medication during the study.
Identifying Biomarkers for Early Detection of Cancer in Patients With Cervical Dysplasia or Carcinoma in Situ of the Cervix

RATIONALE: Studying the genes expressed in samples of tissue from patients with abnormal cells may help doctors identify biomarkers related to cancer.

PURPOSE: This clinical trial is identifying biomarkers for early detection of cancer in women with cervical dysplasia or carcinoma in situ of the cervix.

OBJECTIVES:

Primary

* To identify and catalogue genetic alterations and protein changes associated with developmental stages of cervical cancer.
* To identify a ranked list of candidate genes that drive the transformation of premalignant lesions to tumors for further study and validation as molecular targets for novel early detection and treatment design.

Secondary

* To complete genome scans at high density and analysis of gene and protein expression to identify recurrent genetic and protein changes in cancer.
* To confirm changes clustered to specific chromosomal regions which harbor tumor suppressors or oncogenes.

OUTLINE: Patients undergo biopsy of cervical tissue followed by loop electrocautery excision procedure (LEEP) (removing all of the tissue surrounding and under the area biopsied). RNA, DNA, and protein is extracted from the cells to provide material for the construction of libraries for Serial Analysis of Gene Expression (SAGE analysis); for hybridization against Bacterial Artificial Chromosome Comparative Genome Hybridization arrays (BAC CGH arrays); and for analysis using protein chip arrays and proteomics. Resulting data from coded samples provide gene expression and protein profiles. The coded molecular datasets are linked, analyzed, and compared using a variety of statistical software to identify putative genes, gene alterations, and proteins of interest. Some samples may be banked for future studies.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed premalignant lesion, dysplasia, or carcinoma in situ of the cervix
* Clinically documented disease
* Attending Vancouver General Hospital and referred to colposcopy for loop electrocautery excision procedure (LEEP)

PATIENT CHARACTERISTICS:

* Not pregnant
* No lack of informed consent due to language difficulty, physical and mental condition

PRIOR CONCURRENT THERAPY:

* No prior operation for removal of the cervix
* Concurrent therapy allowed
Weekly Docetaxel/Irinotecan for Non-resectable Gastric Cancers After Cisplatin Plus 5-FU/Leucovorin

In this study, the investigators will use P-HDFL, a regimen with high tumor remission rate (\~ 60-70%) and with only modest treatment-associated toxicities, as induction chemotherapy for patients with non-resectable gastric cancer. For those patients who have achieved complete response (CR) or partial response (PR), DI will be used to "consolidate" the remission. For those patients who fail to achieve remission by P-HDFL, DI will be used as salvage chemotherapy. The efficacy and toxicities of DI in these two settings will be evaluated in this prospective study.

1. To evaluate if weekly Docetaxel-Irinotecan,a potentially non-cross-resistant regimen,can prolong the overall survival (OS) or the duration of remission in those patients who have achieved CR or PR by P-HDFL regimen
2. To evaluate the efficacy of weekly Docetaxel-Irinotecan combination as salvage regimen for those patients who have either failed to achieve remission or have recurred from P-HDFL chemotherapy
3. To find out the optimal doses for docetaxel and irinotecan in a weekly dosing schedule for gastric cancer patients
4. To evaluate the toxicities of weekly Docetaxel-Irinotecan regimen in inoperable gastric cancers

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed gastric adenocarcinoma
2. Measurable or evaluable disease
3. No previous C/T
4. Age 16 \~ 75 years
5. Karnofsky Performance Status of 60%
6. 4 weeks after R/T
7. Adjuvant C/T: the last dosing of C/T 6 months before enrollment
8. WBC \>= 4,000, platelets \>= 100K, Creatinine \<= 1.5mg/dl and proteinuria \<1+, normal serum bil, transaminase \<= 3.5x ULN, TG \> 70mg/dl

Exclusion Criteria:

1. CNS metastasis
2. Patients receive concomitant anti-cancer C/T or R/T
3. Patients who are pregnant and with an expected life expectancy less than 3 months
4. Symptomatic heart disease, active infection, extensive liver disease, or liver cirrhosis