cyrilzakka/clinical-trials huggingface dataset:
A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients

This is a Phase I study which addresses the feasibility and toxicity of adding taxol to the two drug combination which now comprises the standard of care in newly diagnosed advanced stage ovarian cancer, cisplatin and cyclophosphamide. These drugs will be given in a dose intensive fashion with the colony-stimulating factor, G-CSF. Newly diagnosed patients with ovarian cancer will be treated with this regimen to determine the optimal dose of this combination. The pharmacokinetics of taxol and cisplatin DNA-adducts will be studied as well.

This is a Phase I study which addresses the feasibility and toxicity of adding taxol to the two drug combination which now comprises the standard of care in newly diagnosed advanced stage ovarian cancer, cisplatin and cyclophosphamide. These drugs will be given in a dose intensive fashion with the colony-stimulating factor, G-CSF. Newly diagnosed patients with ovarian cancer will be treated with this regimen to determine the optimal dose of this combination. The pharmacokinetics of taxol and cisplatin DNA-adducts will be studied as well.

Eligibility Criteria:
All patients must have biopsy proven ovarian cancer as determined by evaluation in the Laboratory of Pathology, NCI.

Germ cell and borderline histologies are specifically excluded.

Patients must have FIGO stage III and IV disease, or FIGO Stage IIC disease with poorly differentiated histology, and will undergo attempted surgical debulking prior to the initiation of chemotherapy.

Prior chemotherapy or radiation therapy will make a patient ineligible.

Performance status: less than or equal to ECOG 2.

Patients must have the following end organ function:

No brain involvement.

No history of myocardial infarction, cardiac arrhythmias requiring

therapy, right bundle branch block with left anterior hemiblock, and left bundle branch block.

Renal function: creatinine clearance greater than or equal to 60 cc/min; patients with ureteral obstruction must have this corrected prior to starting therapy.

Hepatic function: normal coagulation parameters, serum transaminases within 3 times upper limit of normal.

Neurologic function: no preexisting dysfunction greater than grade 1 (exclusive of mild vibratory delay).

No recent history of active GI bleeding.

Hematologic parameters prior to starting cycle 1 of therapy: total granulocyte count greater than 2000 and platelet count greater than 100,000.

Patients may not have had prior history of invasive malignancy with the exception of nonmelanoma skin cancer curatively treated.

Patients must be able to give written informed consent and express a willingness to meet all of the expected requirements of the protocol.

Patients must be able to begin therapy within 8 weeks of staging laparotomy and should have a central venous catheter placed for infusion of chemotherapy.

All patients must be registered by calling the Orkand Corporation at 402-1732 between the hours of 8:30 AM and 5:00 PM; eligibility criteria will be queried.
Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine

Glycemic imbalances are very common in shock patients admitted to intensive care units. A blood glucose control every 2 hours is routinely performed in patients requiring insulin therapy. In practice, we use a protocol and management software called "CPG" (Personalized Control of Blood Glucose). This involves taking capillary samples from the fingertips. In addition to the pain generated, local haematomas and sensitivity disorders have been described. Night-time sampling also leads to repeated awakenings. The "CGM GUARDIAN 2" system has been validated for the measurement of glucose in interstitial fluid in insulin-dependent diabetic patients. An electrode is placed on the patient's abdomen or arm for up to 6 days. This electrode consists of a needle that is inserted subcutaneously only during the placement. The sugar level is read using a sensor placed on the electrode and an insulin pump (which will not deliver therapy (for our study) and which will be used only as an information reader to know the glucose level and trends). Interstitial fluid is automatically drawn from the electrode every minute and averaged every 5 minutes.

This device has not yet been validated in resuscitation patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient in septic shock
* Arterial hypotension requiring noradrenaline
* Hyperglycaemia requiring insulin therapy

Exclusion Criteria:

* Patients under guardianship, curatorship or deprived of liberty
* Pregnant or breastfeeding women
Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults

To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV) ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and dasabuvir with full dose ribavirin, low dose ribavirin or without ribavirin for 2 weeks in treatment-naive HCV genotype (GT) 1a-infected adults.


Eligibility Criteria:
Inclusion Criteria:

1. Screening laboratory result indicating HCV genotype 1 (GT1) a infection.
2. Chronic HCV infection.
3. Subjects must be non-cirrhotic.
4. Subjects must be able to understand and adhere to the study visit schedule and all protocol requirements as well as voluntarily sign and date an institutional review board (IRB) approved informed consent.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.
2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay.
3. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject unsuitable for this study or treatment.
4. Current enrollment in another interventional clinical study. Previous use of any HCV treatments including pegylated interferon (pegIFN), ribavirin, or any direct acting antiviral agent, either investigational or approved, for HCV including protease inhibitors, nucleoside or non-nucleoside polymerase inhibitors, or nonstructural viral protein 5A (NS5A) inhibitors.
5. History or solid organ transplant.
6. Screening laboratory analysis that shows abnormal results.
Computer-Assisted Provision of Reproductive Health Care

This project seeks to demonstrate that computer kiosks in a clinic waiting room can improve access to hormonal contraception and screening for sexually transmitted infections. The study will be a randomized controlled trial which will evaluate the use of a computer kiosk module to compare the proportion of women of reproductive age who receive a prescription for hormonal contraception when computer-assisted provision of hormonal contraception is offered (intervention) to encounters when the study clinic provides standard contraceptive care (control). Subjects will be contacted approximately 3 months (range 2-4 months) after the clinic visit to complete a follow-up phone interview. The study population will include English and Spanish-speaking women ages 18-45 who seek care at this clinic. Our hypothesis is that computer-assisted provision of hormonal contraception (intervention)will increase the proportion of women of reproductive age who receive a prescription for hormonal contraception versus standard contraceptive care(control).

Data collection has been completed

Eligibility Criteria:
Inclusion Criteria:

* women who speak English or Spanish who visit a study clinic

Exclusion Criteria:

* women who do not speak English or Spanish
Inflammation and Cerebral Oxygenation in Preterm Newborns Following Fetal Red Blood Cell Transfusion Compared to Adult Red Blood Cell Transfusion

Among diseases associated with premature birth, retinopathy of prematurity (ROP) is one of the most important causes of childhood blindness. ROP develops in the immature retina as a consequence of prolonged exposure to hyperoxia. A body of evidence suggests a connection between ROP and the number of red blood cell (RBC) transfusions. Moreover, in newborns receiving repeated transfusions, fetal hemoglobin (HbF) progressively declines. Our NICU participate to the BORN (umBilical blOod to tRansfuse preterm Neonates) trial, a double-blind, multi-center, randomized controlled trial with the aim of evaluating if preterm newborns randomized to receive cord blood (CB)-transfusions have a lower incidence of ROP, compared to newborns transfused with adult RBC cells. In the context of BORN trial, with this ancillary INCONTRA study, the investigators aim to explore the inflammatory burden, potentially impacting on development of the preterm newborn comorbidities, following CB-RBC transfusions, compared to adult RBC transfusions. to estimate the change in pro-inflammatory cytokine (IL-1β, IL-8, TNF-α) and MCP-1, MIF, s-ICAM levels levels circulating in preterm newborns before and after transfusion, Moreover, we want to monitor cerebral oxygenation and oxygenation delivery to the brain during and after the transfusion of the two different RBC products. Moreover, the investigators aim to monitor cerebral oxygenation and oxygenation delivery to the brain during and after the transfusion of the two different RBC products.


Eligibility Criteria:
Inclusion criteria:

* gestational age (GA) at birth \< 28 weeks
* signed informed consent of parents.

Exclusion criteria:

* maternal-fetal immunization, hydrops fetalis
* major congenital malformations associated or not with genetic syndromes
* previous transfusions
* hemorrhage at birth requiring transfusion (within 12 hours from birth)
* congenital viral infections
* outborn infants who received RBC transfusions before admission to the Neonatal Intensive Care Units participating to the study
* health care team deeming it inappropriate to approach the infant's family for informed consent
* Severe IgA deficiency
* Any life-threatening comorbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion.
Double Ligation and Topical Silver Nitrate

To study and compare the efficacy and safety of Double Ligation and Topical Silver Nitrate Solution while treating children with Umbilical Granulomas

The patients underwent one treatment option and then followed up for three weeks and the results noted in terms of success/failure and complications specific to each treatment option and analysed accordingly

Eligibility Criteria:
Inclusion Criteria:

1. Patients of Umbilical Granuloma, less than 1 year age

Exclusion Criteria:

1. Patients who already had any treatment
2. Parents refused to give consent for enrollment
3. Patients lost in follow up
Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients

The investigation will be conducted for the purpose of determining the condition of occurrence of Adverse Events under the actual post-marketing use of Zithromac 600mg Tablet, verifying the therapeutic effects, detecting unknown Adverse Drug Reactions and drug interactions and determining the factors affecting safety and efficacy.

All the patients whom an investigator prescribes the first Zithromac Tablets 600mg should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

Patients need to be administered Zithromac Tablets 600mg in order to be enrolled in the surveillance.

Exclusion Criteria:

Patients not administered Zithromac Tablets 600mg.
Early Response-adapted Intensification of Induction Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma (MM)

In this study, the investigators will analyze the long-term outcomes of remission and survival, and identify those with primary resistant disease as more likely to benefit from CTD (thalidomide, cyclophosphamide, dexamethasone) and early intensification of Vel-CD (bortezomib and CD) as induction chemotherapy followed by autologous stem cell transplantation for the patients with newly diagnosed multiple myeloma.

This study aims to assess the efficacy and toxicities of CTD and Vel-CD induction followed by high-dose therapy with autologous stem cell transplantation as a first line treatment for the patients with multiple myeloma.The investigators already investigated the thalidomide-based chemotherapy in patients with newly diagnosed MM. The combined regimen consisted of cyclophosphamide, thalidomide and dexamethasone (CTD) for induction treatment. CTD chemotherapy resulted in a favorable response with 79.4% overall response rate including 42.6% complete response (CR) or very good partial complete response (VGPR), and tolerable toxicity in MM patients. Moreover, CTD chemotherapy did not affect the yield of the stem cell collection.The investigators also published that the clinical efficacy and safety of a four-drug combination of bortezomib, cyclophosphamide, thalidomide, and dexamethasone was assessed for patients with relapsed or refractory multiple myeloma Vel-CTD chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed MM
2. Aged between 18 and 65 years old
3. With following measurable lesions (serum M-protein ≥ 1 g/dL or urine M-protein ≥ 400 mg/day, or free light chain ≥ 100 mg/L)

Exclusion Criteria:

1. Smoldering or indolent myeloma
2. ECOG performance status \> 3 point
3. Known hypersensitivity to cyclophosphamide, thalidomide or dexamethasone
4. Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3
5. Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, NYHA Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis, cardiac ejection fraction \<0.5 : Severe conduction disorder : Hypotension (sitting systolic BP ≤ 100 mmHg and/or sitting diastolic BP ≤ 60 mmHg
6. Impaired hepatic function (AST or ALT ≥ x 3 upper normal, T-bilirubin ≥ x 2 upper normal)
7. Creatinine clearance \< 20 ml/min
8. Corrected serum calcium ≥ 14 mg/dL
9. Sepsis or current active infection
10. Pregnancy or breast feeding
11. Uncontrolled Diabetes Mellitus
12. Previous history of Recurrent DVT or pulmonary embolism
13. Active ulcers detected by gastroscopy
14. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
15. Receipt of extensive radiation therapy within 4 weeks
On Probiotic, Dental Caries, and Orthodontic Patients

To investigate the short term effect of probiotic oil on plaque acidogenicity among orthodontic patients. Shortage on testing the effect of probiotic on Orthodontic patients can be seen on litterateurs making a gap of whether is product of help in preventing dental caries or not ?

To investigate the short term effect of probiotic oil on plaque acidogenicity among orthodontic patients and to investigate the effect of probiotics on mutan streptococci and lactobacilli in plaque and saliva.

The null-hypothesis is that: The effect of probiotics would not differ from placebo-treated control group.

This product might decrease the chance of getting caries but also cooperation and cost effectiveness should be considered

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing bimaxillary fixed orthodontic treatment
* Number of S. mutans counts (\>10.000 CFU/ml)
* Permanent dentition
* 3-12 months into the treatment (study from Sweden by Andrea)
* Medically healthy
* Not taking any medication
* Ability to understand the nature of the study and sign the consent form

Exclusion Criteria:

* Cleft lip and palate patients as well as handicapped and patients with mental impairments
* Systemic diseases or conditions that could interfere with our study (diabetes, immunosuppression diseases, pregnancy or ongoing therapy).
* History of probiotics/anti-inflammatory drugs taken during the last 4 weeks prior to baseline examination
* Local or general antimicrobial substances taken during the last 4 prior weeks prior to baseline examination
* Habitual consumers of xylitol chewing gums
* No active or untreated carious lesions and reported daily tooth brushing habit using fluoridated toothpaste
50/50% Tilt and Tuned Defibrillation Waveform

Study Description The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform utilizing High Voltage Lead Integrity Check (HVLIC) impedance.

Hypothesis The Tuned waveform reduces defibrillation thresholds (DFTs) when compared to the 50/50% tilt waveform.

Study Methods

* This is an acute, paired-sample, randomized (waveform testing sequence) study
* Patients are implanted with an Food and Drug Administration (FDA) approved St. Jude Medical (SJM) EpicTM+ DR/VR Implantable Cardioverter Defibrillator (or any other standard output ICD after Epic+) and defibrillation lead system.
* All study testing is completed at implant.
* Patients are randomized to begin DFT testing with either the 50/50% tilt or Tuned waveform.
* The HVLIC feature is used to measure the high voltage lead impedance and to program the Tuned and 50/50% tilt waveform pulse widths.
* The DFT is determined by an optimized binary search method that is designed to reduce the overall number of VF inductions to an average of 5.13 while maintaining very high resolution and accuracy.
* Total # of centers - 15 centers
* Sample size - 60 patients


Eligibility Criteria:
Inclusion Criteria:

* Patient is a candidate for ICD implantation.
* Patient is able to tolerate DFT testing.

Exclusion Criteria:

* Patient has a mechanical valve in the tricuspid position.
* Patient is pregnant.
* Patient is less than 18 years old.
Safety of Norepinephrine Administered Through Peripheral Venous Catheter

Norepinephrine is a drug that elevates the blood pressure. It is routinely administered through peripheral catheters during surgery. There is a risk of tissue damage in case of leakage of Norepinephrine from the catheter to the surrounding tissue. Another risk is irregular administration of Norepinephrine due to kinking of the peripheral catheter. This could lead to fluctuations in blood pressure. The primary aim of the study is to investigate complications from Norepinephrine administered in peripheral venous catheters. The secondary aim is to investigate if comorbidity, placement of the peripheral catheter or the duration of the infusion are associated with a higher rate of complications. 1000 patients will be included. Inclusion criteria: Patients who will undergo surgery with need for vasopressor support. Exclusion criteria: The patient has a central venous catheter, a peripherally inserted central venous catheter or lack of informed consent.

In many hospitals in Sweden, Norepinephrine is administered through peripheral venous catheters in the operating room. However there are very few studies to support the safety of peripherally administered Norepinephrine.

Norepinephrine of the concentration 8 respectively 40 microg/ml will be investigated. The primary aim of the study is to investigate complications from Norepinephrine administered in peripheral venous catheters. The secondary aim is to investigate if comorbidity, placement of the peripheral catheter or the duration of the infusion are associated with a higher rate of complications.

The localisation and size of the peripheral venous catheter will be registered. The blood pressure will me measured every 5 minutes and every minute in case of systolic blood pressure over 220 mm Hg.

The site of administration will regularly be monitored for complications. If subcutaneous infusion of Norepinephrine is suspected, the patient will be followed up for up to 48 hours or until hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patient who has general anesthesia or central blocks
* Need for vasopressors in the pre, per or postoperative period to maintain adequate mean arterial blood pressure
* Age ≥18 years

Exclusion Criteria:

* The patient has a central venous line
* The patient has a peripherally inserted central line
* Lack of informed consent
Synbiotic as an Adjunct to Mechanical Treatment of Gingivitis

The aim of this study is to evaluate the efficacy of oral administration of synbiotic tablets on the clinical parameters and the levels of selected inflammatory mediators in gingival crevicular fluid (GCF) in smokers and non-smokers with gingivitis.

This study designed as a double-blind randomized placebo-controlled clinical trial.

Some patients like smokers have ongoing host response even after bacterial plaque removal achieved. Therefore efforts to develop effective treatment approaches remain an important objective in the treatment of gingivitis to prevent periodontitis especially in patients at high risk for developing periodontitis as smokers.

Smoking is a major risk factor for the incidence and the progression of periodontal diseases. The increased periodontal disease susceptibility in smokers is predominantly caused by changes in inflammatory and immune responses. Cigarette smoking also influences the amount and the composition of subgingival plaque. Smokers have higher numbers of pathogens in their resident biofilm and display an ongoing host response even after biofilm removal. Different approaches were explored to reduce the negative effects of smoking on the outcomes of periodontal therapy Synbiotic were defined as a mixture of probiotics and prebiotics that beneficially affects the host by improving the survival and implantation of live microbial dietary supplements in the gastrointestinal tract, by selectively stimulating the growth and/or by activating the metabolism of one or a limited number of health-promoting bacteria, and thus improving host welfare. Also in some cases, this may lead to a competitive advantage for the probiotics among with other bacteria.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy subjects
* Clinical diagnosis of gingivitis

Exclusion Criteria:

* Subjects who had used any systemic antibiotics in the previous 3 months,
* Subjects who had used a product containing probiotics in the previous month
* Systemic disease or condition that could interfere with the study results
* Ongoing drug therapy that could affect the signs of gingivitis
* Subjects who were received periodontal treatment in the last 6 months and
* Allergic to milk and milk products
Safety of Catheter Lock With or Without Heparin in Implanted Central Venous Catheters

Long-term central venous access devices are considered as safe for the administration of medication as chemotherapy, but are also used for blood sampling. For years these catheters have been locked with a heparin solution in order to avoid occlusion. However, no scientific evidence supports heparin locking when the device is not in use. Advanced technology as needleless caps and valved catheters and port reservoirs confirms this trend to use 'saline only' for locking these devices. Therefore the investigators hypothesize is that there will be no difference in proportion of occlusions and catheter related bacteremia in long-term venous access devices locked with 'saline only' versus with heparin.


Eligibility Criteria:
Inclusion Criteria:

* Oncology and hematology patients
* Life expectancy of minimum of 180 days

Exclusion Criteria:

* second or femoral long-term central venous access device
* known allergy to heparin (HIT)
* coagulation disorders(INR \>2, Blood platelets \> 1,000,000/mm3)
* therapeutic intravenous heparin administration