cyrilzakka/clinical-trials huggingface dataset:
Study on Cefotaxime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection

In the proposed study, the investigators plan to evaluate the efficacy and safety of Cefotaxime sodium and sulbactam sodium for injection (2:1)for the treatment of respiratory and urinary tract acute bacterial infection under the widely used in clinical conditions.

Cefotaxime is a third-generation cephalosporins.Cefotaxime sodium and sulbactam sodium for injection (2:1)plays a therapeutic role by the former inhibiting bacterial cell wall synthesis by irreversible competitive inhibition of β-lactamase.The antimicrobial effect of cefotaxime can be enhanced by the two combined.The compound specifically aims to the mechanism of bacterial resistance, extending the life of cefotaxime in the treatment-resistant pathogen infections.

Eligibility Criteria:
Inclusion Criteria:

1. patients who qualify for moderate and severe acute respiratory or urinary tract bacterial infection of acute bacterial infections need for systemic antibiotic therapy.
2. Age\>18 years old, Gender: both
3. Women of childbearing age were to be negative pregnancy test and agree to take contraceptive measures during the trial;
4. patients were volunteers and signed informed consent form;
5. patients did not participate in other clinical trials.

Exclusion Criteria:

1. Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor
2. Pregnant and Lactating women
3. Patients have severe liver,kidney,cardiovascular,cerebrovascular,endocrine and hematopoietic system of primary diseases and that of immunodeficiency,advanced cancer or mental illness.
4. Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.
Erector Spinae Block Versus Combined Pecto-intercostal and Recto-intercostal Fascial Plane Block in Cardiac Surgery

The aim of this study is to compare the analgesic effects of ultrasound-guided bilateral erector spinae plane block versus ultrasound-guided bilateral combined Pecto-intercostal fascial plane block and recto-intercostal fascial plane block in patients undergoing cardiac surgery.

The incidence of severe acute postoperative pain after median sternotomy is as high as 49 %. A number of regional techniques have been used to treat sternotomy pain such as thoracic epidural, intercostal nerve block, paravertebral nerve block \& thoracic erector spinae plane block which has been used extensively in cardiac surgery providing adequate postoperative pain control. Pecto-intercostal fascial plane block is a minimally invasive, regional fascial plane block technique that can be administered as a part of a multimodal analgesic regimen. It targets the anterior intercostal nerves as they run in the fascial plane between the pectoralis major muscle and the external intercostal muscles and emerge on either side of the sternum. Recently, Tulgar et al. have described a novel block named "recto-intercostal fascial plane block" which is performed between the rectus abdominis muscle and costal cartilages of ribs 6-7 (insertion of RAM). In their cadaveric examination, they reported that the dye spread extensively to the anterior branches of the T6-T9 thoracic nerves, and laterally to the entire lower thorax. The investigators assume that the incomplete dermatome coverage by Pecto-intercostal fascial plane block might be responsible for its inferior analgesic quality compared to erector spinae plane block which was reported in some previous reports. So, the investigators will conduct this novel study to investigate and compare the analgesic effects of erector spinae plane block and combined Pecto-intercostal fascial plane block and recto-intercostal fascial plane block in patients undergoing cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age from 21 to 65 years.
* Both sexes.
* Scheduled for open heart surgery with cardiopulmonary bypass and midline sternotomy.

Exclusion Criteria:

* History of chronic pain or Long-term or recent use of opioids.
* History of allergy to local anesthetic drugs.
* Ejection fraction of left ventricle less than 30%.
* History of psychiatric diseases or any neurological disorders.
* Pre-existing major organ dysfunction as hepatic or renal failure.
Donor Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Relapsed or Refractory Metastatic Kidney Cancer

RATIONALE: A peripheral stem cell transplant or bone marrow transplant from a brother or sister may be an effective treatment for kidney cancer.

PURPOSE: This phase II trial is studying how well a donor peripheral stem cell or bone marrow transplant works in treating patients with relapsed or refractory metastatic kidney cancer.

OBJECTIVES:

* Determine the efficacy of nonmyeloablative sibling allogeneic peripheral blood stem cell transplantation in patients with relapsed or refractory metastatic renal cell carcinoma.
* Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a pilot study.

* Conditioning regimen: Patients receive cyclophosphamide IV on days -7 and -6 and fludarabine IV on days -5 to -1. Patients receiving 5/6-mismatched cells also receive anti-thymocyte globulin IV on days -5 to -3.
* Allogeneic peripheral blood stem cell (PBSC) infusion: Patients undergo allogeneic PBSC or bone marrow transplantation on day 0.
* Graft-versus-host disease (GVHD) prophylaxis: Patients receive oral mycophenolate mofetil twice daily on days 0-30. Patients receive tacrolimus IV continuously or orally twice daily beginning on day -2 and continuing up to day 44-100 in the absence of GVHD.
* Donor lymphocyte infusion: Patients with partial or complete T-cell chimerism receive up to 3 donor lymphocyte infusions in the absence of GVHD or progressive disease.

After completion of study treatment, patients are evaluated periodically for 3 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic renal cell carcinoma

  * Relapsed or refractory disease
  * Tumor not amenable to complete surgical resection
* No bone metastases only
* No untreated brain metastases
* Measurable disease
* Available sibling donor who is HLA-identical or who has a mismatch at a single HLA locus (i.e., a 6/6 or 5/6 match at the HLA-A, -B, and -DR loci)

PATIENT CHARACTERISTICS:

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Bilirubin \< 3 mg/dL

Renal

* Creatinine \< 2 mg/dL
* No untreated hypercalcemia

Cardiovascular

* LVEF ≥ 40%

Pulmonary

* DLCO ≥ 40%

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception
* Negative pregnancy test
* HIV-1 and -2 negative
* No uncontrolled infection
* No other active malignancy except basal skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

* At least 15 days since prior treatment for renal cell carcinoma
* No other concurrent anticancer therapy
Validation of a Portable Indirect Calorimeter

This study plans to test the accuracy of a new device (the Apollo EE Device) that measures resting energy expenditure (REE) using only oxygen consumed (VO2). Findings from this study will help determine how this new device compares to the gold standard, indirect calorimetry, which measures REE using VO2 and carbon dioxide production (VCO2). Findings may help develop less expensive and more accessible means of measuring energy expenditure.

The gold standard for measuring resting metabolic rate (RMR) is metabolic carts that measure oxygen consumption (VO2) and carbon dioxide production (VCO2). The energy equivalent of VO2 ranges from \~4.7-5.0 kcals/L, depending on the ratio of carbohydrate, fat, and protein oxidized. However, RMR can be measured based solely on VO2, because VCO2 has a relatively small effect on energy expenditure estimation. A device that measures RMR based on VO2 and eliminates the need for measuring VCO2 could provide a simple and less expensive alternative to metabolic carts and may have important clinical applications. The overarching goal of this proposal is to validate such a metabolic system by comparing its ability to accurately measure RMR against a metabolic cart.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* 19-99 yrs of age

Exclusion Criteria:

* Pregnancy
Relative Oral Bioavailability of GABA From Tomatoes

In this four-way crossover study, a plasmakinetic profile of GABA from tomatoes as compared to a gamma-aminobutyric acid (GABA) supplement in healthy young men will be established. In addition, a plasmakinetic profiles of glutamate from a supplement and from tomatoes as well as the effects of glutamate from tomatoes and a supplement on the GABA plasma levels will be determined. This study will therefore provide information about the effect of a food matrix on GABA plasmakinetics.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5 and 25 kg/m2
* Age is between 18 and 28 years
* Good general health
* Male
* Veins suitable for blood sampling
* Able to speak Dutch

Exclusion Criteria:

* Is currently suffering from a disease including mental disorders
* Has had any gastrointestinal condition/disease within the 3 months prior to the intervention
* Haemoglobin (Hb) level \< 8.5 mmol/L
* Has used medication in the two months before and/or during the intervention. Occasional use of NSAIDs or paracetamol (\<once a week on average) are is allowed.
* Reported weight loss or weight gain of \> 2 kg in the month prior to the intervention
* Use of dietary supplements, 3 weeks before-, or during the intervention.
* Allergic to products that are provided as part of the standardised diet
* Unwilling to consume the products that are part of the standardised diet
* Allergic to tomatoes
* (History of) drug abuse, in this case meaning \>1 x per month use of recreational drugs
* Smoking
* Alcohol consumption of \>10 standardised glasses per week.
* Not able to refrain from alcohol consumption 2 days before each test day
* Recent or planned blood donation (\<3 month prior to first study day or during intervention)
* Personnel of Wageningen University, department of Human Nutrition and Health,
* Currently participating in other research or was participating in another study within 1 month of the intervention or within 3 months if invasive procedures were used.
Effect of Rimonabant and Metformin Combination on Glycemic Control in Patients With Type 2 Diabetes

The primary objective of the study is to determine the effect of rimonabant 20 mg daily when added to ongoing metformin therapy on glycemic control (HbA1c) over a 36 week period in patients with type 2 diabetes.

Secondary objectives include evaluation of other markers of glycemic control, lipid profile, body weight, and abdominal obesity. Also, the trial will study the safety of rimonabant when added to metformin over a period of 47 weeks.

The total duration per patient will be approximately 49 weeks including a 36-week double-blind treatment period.

Eligibility Criteria:
Inclusion Criteria:

* History of type 2 diabetes
* HbA1c between 7% to 10% at screening visit
* Treatment with metformin only with a fixed and stable dose of 1500 mg/day or more for at least the past 3 months prior to screening visit

Exclusion Criteria:

* Within 3 months prior to screening visit: change in lipid modifying agent, administration of systemic corticosteroids for more than 10 days, use of any anti-obesity agent or drugs for weight loss
* Weight loss of more than 5 kg within 3 months prior to screening
* Administration of other investigational drugs within 30 days prior to screening visit
* Prior exposure to type 1 cannabinoid receptor (CB1) antagonists including rimonabant
* Presence or history of cancer within the past five years
* Pregnant or breast-feeding women
* Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Moderated-fat Diet Complemented With Green Tea Reduces oxLDL and Fat Mass in Obese Women

Background: Obesity is a chronic degenerative disease, considered as cardiovascular risk factor, characterized by systemic inflammation and high levels of oxLDL. Clinical studies have suggested that drink green tea could improve these complications.

Objective: Analyze the effect of a moderate-fat diet complemented with green tea on oxLDL, fat mass and TNFa in obese women.

Design: Randomized, controlled clinical trial. Obese women, without other chronic-degenerative disease were divided using a computer-generated random sequence: control group (CON) with n=32, and intervention group (INT) with n=32; and were instructed to consume a moderate-fat diet, and INT group was instructed to complement the diet with green tea. Anthropometric and biochemical measurements were performed, and oxLDL and TNFa s levels were determined by ELISA. All parameters were realized at baseline and in the 1st, 2nd and 3rd months post-intervention. TNFa mRNA expression was determined by real-time RT-PCR (basal and final). The changes on lipid profile, oxLDL, fat mass and TNFalpha expression were reported of the comparison between basal and final time points. The statistical analysis was performed with SPSS software.

The investigators assessed 114 women with the eligibility criteria: obese women older than 18y, in good health, as determined by a medical history questionnaire, and normal results of clinical laboratory tests excluding lipids. Exclusion criteria was: history of cardiovascular, hepatic, gastrointestinal, or renal disease; no alcoholism, no smoking, no exogenous hormone use or other medication; no supplemental vitamin or infusion drinking (tea, coffee); or treatment for weight loss 3 months before the start of the study. A total of 64 female, Mexican obese patients were included. We conducted the trial between April 2007 and December 2007 in Guadalajara, Jalisco, Mexico. All of the studies were conducted at Departamento de Biología Molecular en Medicina, Hospital Civil "Fray Antonio Alcalde". This study was approved by the Ethical Committee for Human Research, Universidad de Guadalajara (registration number 028/10). The procedures were in accordance with this institution's guidelines and written consent was obtained from each study subject.

Eligibility Criteria:
Inclusion Criteria:

* obese women older than 18 years,
* in good health, as determined by a medical history questionnaire, and
* normal results of clinical laboratory tests excluding lipids

Exclusion Criteria:

* history of cardiovascular, hepatic, gastrointestinal, or renal disease;
* no alcoholism, no smoking, no exogenous hormone use or other medication;
* no supplemental vitamin or infusion drinking (tea, coffee); or
* treatment for weight loss 3 months before the start of the study
Evaluation of Endobronchial Ultrasound (EBUS) for Staging Lung Cancer

This study will compare two different methods of staging lung cancer to determine whether endobronchial ultrasound (EBUS) staging of mediastinal lymph nodes will provide good diagnostic yield in detecting lung cancer, when compared to current methods of a staging bronchoscopy and cervical mediastinoscopy.


Eligibility Criteria:
Inclusion Criteria:

Patients, \> 18 years of age,

Gender- Males and Female

Diagnosis of Non Small Cell Lung Cancer.

Patients who have consented on an Ottawa Hospital consent form to undergo a mediastinoscopy procedure or EBUS-TBNA, and a Positron emission tomography (PET) of the chest for lung cancer staging.

Exclusion Criteria:

Females who are pregnant (or found to be pregnant) during the course of this research study.

Patients who do not provide their Ottawa Hospital consent to undergo a staging bronchoscopy , cervical mediastinoscopy or EBUS-TBNA.
Estriol and Trimegestone Dose-response Trial With Single Dose Application of Vaginal Rings

This clinical trial is performed as proof of pharmacological action investigation by demonstration of ovulation inhibition (dose-response study) under treatment with three Test vaginal rings releasing varying doses of estriol (E3) and trimegestone (TMG).

Blood samples for determination of estradiol (E2) and progesterone (PG) levels will serve as pharmacodynamic surrogate parameters for characterization of the treatment effect on the endogenous hormones.

Blood samples for determination of E3 and TMG in plasma will be collected in order to characterize pharmacokinetic parameters.

Additionally, local tolerability characterized by gynecological inspection of the vaginal mucosa prior to and after insertion of the Investigational Medicinal Product (IMPs) is planned to be assessed

The IMPs, releasing either 0.400 mg E3 and 0.06 mg TMG, or 0.300 mg E3 and 0.12 mg TMG, or 0.200 mg E3 and 0.18 mg TMG per 24 h, will be applied intravaginally and remain in the vagina for the subsequent 21 days (single dose, 1 treatment cycle). A total of 36 female subjects, 12 per treatment group, are intended to be randomized.

Blood samples for determination of E2 and PG levels will be collected during treatment and until 20 days after removal of the ring. Blood samples for determination of E3 and TMG in plasma will be collected over the treatment period and until 48 h after removal of the ring.

Bleeding intensity will also be documented during treatment and until 20 days after removal of the vaginal ring in a diary to characterize the effects of the different treatments.

Eligibility Criteria:
Inclusion Criteria:

* Under treatment with a commercially available combined oral contraceptive containing 30 µg ethinylestradiol (EE) and 150 µg levonorgestrel (LVN) for the last 3 months prior to enrolment
* Body-mass index (BMI): ≥ 18.5 kg/m² and ≤ 30.0 kg/m²
* Good state of health
* Non-smoker, ex-smoker for at least 3 months
* Regular menstrual cycle with a length between 21 and 35 days
* Written informed consent, after having been informed about benefits and potential risks of the clinical trial

Exclusion Criteria:

* Existing diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the IMPs
* Subjects with severe allergies or multiple drug allergies
* Positive anti human immunodeficiency virus (anti-HIV) test, hepatitis B surface antigen (HBs-AG) test or anti hepatitis C virus (anti-HCV) test
* Presence or history of venous or arterial thrombosis, cerebrovascular accident, or increased risk of thrombosis
* Diabetes mellitus
* Unclarified vaginal bleeding or frequent infections of the urogenital tract
* Severe or chronic constipation
* Presence or history of migraine
* Drug or alcohol dependence
* Blood donation or other blood loss of more than 400 ml within the last 3 months
* Participation in a clinical trial during the last 6 months
* Pregnant or lactating women
* Subjects who do not agree to apply a barrier method for contraception
Urine, DNA and Clinical Information Collection From Patients With Alport Nephropathy.

This biomarker study is a follow-up to CPLATFRM2201. The goal of CBASICHR0005 is to collect another urine sample, interval clinical information, and an optional DNA sample from as many of the original 80 patients as possible. This new information will transform the data obtained in PLATFRM2201 from a cross-section to a temporal profile, which will (a) further enable the identification of biomarkers predictive of faster progression, and (b) satisfy the FDA's recommendation to perform "natural history studies" in rare diseases.


Eligibility Criteria:
Inclusion Criteria:

• Able to communicate well with the investigator, to understand and comply with the requirements of the study and able to provide written informed consent (parent or legal guardian for pediatric and adolescent subjects), which must be obtained before any assessment is performed.

Alport Subject-Specific Inclusion Criteria:

* Participation in CPLATFRM2201
* Physically able to provide a single first-morning urine sample of at least 30 mL (one ounce). Alport patients who have initiated dialysis therapy since participation in CPLATFRM2201 are exempt from this criterion and may still participate in this study.

Healthy Volunteer-Specific Inclusion Criteria:

• Male and Female Volunteers (may include healthy siblings of Alport patients) aged 5 to 15 years.

Exclusion Criteria:

Alport Subject-Specific Exclusion Criteria:

• None

Healthy Volunteer-Specific Exclusion Criteria:

* Use of investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
* Known history of one of more of (a) hematuria (gross or microscopic), (b)audiological deficits, (c) fixed (non-orthostatic) proteinuria, or (d) reduced renal filtration function with serum creatinine (Cr) above the upper limit of the normal age-specific reference range, on at least 2 prior occasions (serum Cr need not be measured specifically for eligibility).
* Any other clinically significant underlying medical conditions as judged by the PI.
Intraoral Hypothermia Device for Preserving Taste During Radiation

Radiation therapy to the head and neck region is known to cause taste dysfunction. Preliminary studies showed that cooling normal structures may lower damage caused by radiation. The purpose of this research study is to see if it is feasible to use an intraoral cooling device during radiation treatments to preserve or lower the decline of taste function.


Eligibility Criteria:
Inclusion Criteria:

* Patients being treated with combination radiation therapy and chemotherapy (definitive) for locally advanced (AJCC 8th cT3-4 or cN+) squamous cell carcinoma of the larynx.
* Age ≥ 18.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Patients will engage in the informed consent process and provide study-specific informed consent prior to study entry and must be able to fill out toxicity and quality of life related questionnaires.
* Patients should be concurrently treated with any of the following chemotherapy drugs: cisplatin, carboplatin, and cetuximab.

Exclusion Criteria:

* Patients receiving other forms of therapy intended to reduce taste dysfunction.
* Patients with metastatic disease.
* Patient with allergies or hypersensitivity to materials in the intraoral bolus.
* Patients who have received prior chemotherapy or radiation therapy for head and neck cancer.
* Patients who decline to use or cannot tolerate the intraoral device.
* Patients who are current or recent (within 3 months of treatment initiation) cigarette smokers.
* Patients who are unable to complete the required forms; however, verbal completion is adequate if recorded on the form daily.
* Patients with uncontrolled serious illness including, but not limited to, ongoing or serious active infection requiring IV antibiotics for over 30 days, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than chronic, stable atrial fibrillation, immunocompromised state, significant hepatic insufficiency, significant hematological disease, and any serious or unstable psychological condition.
* Patients who are on any of the following medication that cannot find a suitable substitute during the study period: acetazolamide, maribavir (TAK-620, Phase 3 trial drug), eszopiclone, topiramate, captopril, lithium, procainamide, terbinafine, and amiodarone.
* Patients who have taste loss at baseline, assessed subjectively and objectively at the first encounter, will be excluded from the study and all analysis. They will be replaced with a new patient.
* Patients who have tested positive for COVID-19 during the study period.