cyrilzakka/clinical-trials huggingface dataset:
Two Different Dosages of Irinotecan Combined With Cisplatin Scheme in Extensive Disease-Small Cell Lung Cancer

As the gene polymorphism of uridine diphosphate glucuronosyl transferase 1A1(UGT1A1)is related to the side effect of diarrhea induced by irinotecan. UGT1A1 gene \*28 (6/6 and 6/7) and \*6 (G/G and G/A) is related to low probability of diarrhea and UGT1A1 gene \*28 (7/7) and \*6 (A/A)is related to high probability of diarrhea. The purpose of this study is to find out the efficacy and side effect between two different dosages of irinotecan combined with cisplatin scheme in extensive disease-small cell lung cancer with UGT1A1 gene \*28 (6/6 and 6/7)and \*6 (G/G and G/A), based on the hypothesis that the UGT1A1 gene \*28 (7/7) and \*6 (A/A)is few in the Chinese population and increasing the dose of irinotecan can improve the efficacy without increasing the side effect in the patients with UGT1A1 gene \*28 (6/6 and 6/7)\*6 (G/G and G/A).


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of small-cell lung cancer
* Extensive-stage disease, defined as disease extending beyond one hemithorax involving contralateral mediastinal, hilar or supraclavicular lymph nodes, and/or pleural effusion.
* Males or females between 18 to 75 years
* No prior chemotherapy, if the surgery or radiotherapy has been administered, the interval is at least above four weeks.
* Performance status of 0-2 on the ECOG criteria. Expected survival is above three months.
* At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
* Patient compliance that allow adequate follow-up. Informed consent from patient or patient's relative.
* Adequate hematologic (neutrophil count \>= 1,500/uL, platelets \>= 100,000/uL), hepatic (transaminase =\< upper normal limit(UNL)x2.5, bilirubin level =\< UNL x 1.5), and renal (creatinine =\< UNL) function
* The gene type of UGT1A1 \*28 is 6/6 and 6/7.
* If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device \[IUD\], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative HCG test within 7 days prior to the study enrollment.
* No concomitant prescriptions including cyclosporin A, valproic acid, phenobarbital, phenytoin, ketoconazole.

Exclusion Criteria:

* Non small cell lung cancer and carcinoid
* Medically uncontrolled severe diarrhea in recent three weeks.
* Inability to comply with protocol or study procedures.
* Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease
* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
* Pregnant or breast-feeding.
* Enrollment in other study within 30 days
* Brain metastasis with symptoms
Microbiological Assessment After Chemo-Mechanical Caries Removal Using Papain-based Enzyme Versus Conventional Rotary Tools in Occlusal Carious Lesions

This study will be conducted to assess the efficacy of caries excavation using the papain-based chemo-mechanical method (Brix 3000) in comparison to conventional rotary tools in the reduction of the bacterial population in occlusal carious cavities

Twenty-three patients who will fulfill the inclusion criteria will be enrolled to the study. For every patient two contra-lateral class I carious molars will be selected, so the total number of included molars will be 46 molars. One contra-lateral molar will be randomly assigned to the chemo-mechanical (Brix 3000) caries removal technique and the other will be assigned to the conventional rotary one. From every molar two dentin specimens will be collected (baseline and after excavation) with a total of 92 samples

Eligibility Criteria:
Inclusion Criteria:

1. Class I carious lesions
2. Lower molars
3. Bilateral lesions
4. 18 -50 years
5. Males or Females (Both genders)
6. Good oral hygiene
7. Co-operative patients approving the trial

Exclusion Criteria:

1. Pregnancy
2. Systemic disease or severe medical complications
3. Periodontal problem
4. Mobile teeth, arrest caries and non-vital teeth
5. Smokers
6. Xerostomia
7. Lack of compliance
8. Not received antibiotic therapy since 1 month before sampling
Early Start of Oral Sildenafil 100mg for Erectile Dysfunction After Robotic Assisted Laparoscopic Radical Prostatectomy

The investigators try to investigate the benefit of early administration (immediately after urethral catheter removal) of sildenafil after nerve-sparing RALP for 3 months. The investigators will compare the potency rates up to 2 years after nerve-sparing RALP in men with on- demand sildenafil 100mg dosing from the early postoperative period (immediately after urethral catheter removal) with from the delayed postoperative period (3 months after RP).

Various studies using animal models of CN neuroparaxia and clinical trials have demonstrated somewhat beneficial effect of PDE-5 inhibitors on smooth muscle cells of the corpus cavernosum. PDE-5 inhibitors including sildenafil have demonstrated the effectiveness in the management of postprostatectomy ED. In the animal experiments, PDE-5 inhibitors lowered the severity of the fibrosis in the corpus cavernosum of rats with CN cutting. In the clinical trials, on-demand dosing or routine dosing of PDE-5 inhibitors improved the potency rates in men received NSRP, and improvements of the potency rate did not appear to be statistically different among two dosing regimens.

But, there are few studies on the potency rate according to the start time of the administration of PDE-5 inhibitors (eg. early vs. delayed post-operative dosing). At present, it is not conclusive that whether nerve-sparing RALP provides more higher potency rate than conventional surgery in men with prostate cancers. But, with more precise dissection of CN, the robotic surgery appears to have more chances to maintain the potency in men received RP.

Eligibility Criteria:
Inclusion Criteria:

* Patients with agree to participate with the study
* Korean male subjects aged 50 years or older with clinically localized prostate cancer
* Preoperative potent men (IIEF-5 score 17 or more than 17)
* Patients in a stable, heterosexual relationship with a single partner for at least the past six months
* Suitable for nerve sparing indication

Exclusion Criteria:

* Genital anatomical deformities that would significantly impair erection
* Other sexual disorders (e.g. hypoactive sexual desire) that are considered to be the primary diagnosis when there is a coexisting diagnosis of erectile dysfunction.
* Known raised prolactin level (\>3 times the upper limit of the normal range) or low free testosterone level (confirmed to be \>20% below the lower limit of the normal range on blood collected between 09:00 and 11:00 hours).
* Major psychiatric disorder (including major depression or schizophrenia) that is not well controlled on treatment.
Combination of Erlotinib and Bevacizumab as Second-line Treatment in Patients With Non-small Cell Lung Cancer

The purpose of this study is to evaluate the efficacy and toxicity of combination of erlotinib and bevacizumab in patients with locally advanced or metastatic, non-squamous non-small cell lung cancer, who progressed after first line treatment. Pretreatment with one of the two agents would not excluded patients from the study, in order to evaluate whether the combination of the two biologic agents could reverse tumor resistance.

A randomized, placebo-controlled phase III trial of erlotinib versus placebo, demonstrated that therapy with this tyrosine kinase inhibitor (TKI) prolongs survival after first or second line therapy in patients with advanced NSCLC. Moreover, the addition of bevacizumab, a monoclonal antibody against Vascular Endothelial Growth Factor bevacizumab (VEGF), to systemic chemotherapy, improved both the response rates and the time to tumor progression in two trials. Early data from phase I/II trials examining the combination of these two biological agents in pre-treated patients with non-squamous NSCLC, showed no major pharmacokinetic interactions and promising clinical activity.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC
* Progression to first-line therapy for advanced/metastatic NSCLC
* Bi-dimensionally measurable disease (not included in radiation field)
* ECOG performance status of 0-2
* Life expectancy of more than 6 months
* Adequate liver (serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases,adequate renal function (serum creatinine \<1.5 times the upper normal limit),and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
* Signed informed consent

Exclusion Criteria:

* Central nervous system involvement (unless if the patient has being previously irradiated and is clinically stable)
* Presence of a centrally located mass or a tumor mass in close relation to large vessels or a mass with cavitation.
* Surgery or radiation therapy within the last 14 days from study entry
* Active infection
* History of life-threatening hemoptysis / hematemesis, history of thrombosis or use of anti-coagulation therapy
* History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction, ventricular arrhythmias) or stroke within the previous 6 months or uncontrolled hypertension
* Patients on other experimental treatment protocols
* History of a second primary malignancy (other than basal-cell skin carcinoma or in situ carcinoma of the cervix)
* Psychiatric illness or social situation that would preclude study compliance
* Pregnant or lactating women
Barriers to Use of Remote Monitoring in Patients With Implantable Cardioverter Defibrillators

The purpose of this study is to determine whether a teaching intervention can help increase the use of remote monitors in patients with implantable cardioverter defibrillators.


Eligibility Criteria:
Inclusion Criteria:

* Received a Medtronic implantable cardioverter defibrillator (ICD) at Yale Electrophysiology, between January 2007 and June 2012
* ICD is compatible with Carelink, Medtronic's remote monitoring system

Exclusion Criteria:

* Less than 18 years of age
* From a vulnerable population
* Incompetent/suffers from dementia
* Non-English speaking
Identifying the Most Accurate Method for Predicting the Safe Depth of Orally Placed Neonatal Endotracheal Tubes (ETT).

Placing artificial airways in infants is often performed under emergent life-saving conditions, which necessitates a procedure that is both accurate and efficient. Intubations of the newborn are often necessary before an accurate weight can be reported and estimations are often inaccurate. The current national standard uses body weight to predict the appropriate tube depth yet this approach tends to place the tube too deep for the smallest and most vulnerable neonate; and placement accuracy of any size infant is only 50-70%. The consequence of malpositioned ETTs resulting from poor oxygenation, lung hyperinflation, pneumothoraces and death has been suggested to cost $20 to $54 million annually.

The morbidity and the financial impact suggest an optimal and accurate approach to place ETT in neonates has not been identified. Other methods to estimate the proper depth of the orotracheal tube have shown promise yet no comparison studies have been performed. Identifying the most accurate method to safely place neonatal orotracheal tubes will improve placement precision and reduce adverse events and their associated costs.

Hypothesis

Compared to weight, sternal to xyphoid length and shoulder to elbow length, the nasal to tragus length will become the most accurate method for predicting the safe depth of orally placed neonatal endotracheal tubes.


Eligibility Criteria:
Inclusion Criteria:

* Infants orally intubated and admitted into the Neonatal Intensive Care Unit.

Exclusion Criteria:

* Previous intubation
* Hydrops fetalis
* Thoracic congenital anomalies
* Facial abnormalities
* Naso-tracheal intubation
The Effect of Nitric Oxide on Spatial Working Memory in Patients With Schizophrenia - Pilot Study

Spatial working memory (ability to remember where objects are in space) is impaired in patients with schizophrenia. It is thought that this impairment occurs due to problems with the chemical messenger (neurotransmitter), glutamate, and the N-methyl-D-aspartate (NMDA) glutamate receptor, particularly in the hippocampal brain region. NMDA receptor activation leads to increases in the release of the second messenger Nitric Oxide. Impaired NMDA receptor function would therefore be predicted to lead to reductions in Nitric Oxide production. Recent work suggests that a drug, sodium nitroprusside, which releases nitric oxide, enhances some aspects of cognition in schizophrenia (specifically related to negative symptoms). In this study, the investigators will test the hypothesis that sodium nitroprusside improves spatial working memory in patients with schizophrenia. 15 patients will receive sodium nitroprusside, and 15 will receive a nonactive compound (placebo). Their performance on a spatial working memory task will be tested before and after administration of sodium nitroprusside or placebo.


Eligibility Criteria:
Inclusion Criteria:

Patients with a diagnosis of schizophrenia or schizoaffective disorder, currently experiencing an exacerbation of symptoms (a score \> 20 for PANSS-Positive subscale), currently taking antipsychotics and who have given informed consent to participate.

Exclusion Criteria:

History of hypertension or current resting systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg. Relevant medical illness (renal, hepatic, cardiac), prior history of intolerance to sodium nitroprusside, presence of a seizure disorder, any change in psychotropic medication in previous 6 weeks, diagnosis of substance abuse, pregnancy (as determined by urine test) or breastfeeding.
Determinants of Disease Severity in Amyotrophic Lateral Sclerosis

OBJECTIVES:

I. Determine specific clinical features, molecular abnormalities, and laboratory-based biological markers of free radical stress that are associated with amyotrophic lateral sclerosis and influence disease severity.

PROTOCOL OUTLINE: This is a screening and diagnostic study. Blood and urine samples are collected from patients every 2 months for 1 year. All samples are evaluated for measures of free radical damage and levels of the body's own antioxidant activity.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Clinically diagnosed probable or definite, sporadic or familial amyotrophic lateral sclerosis

--Patient Characteristics-- Pulmonary: No artificial ventilation required Other: No other neurodegenerative diseases No concurrent or history of unstable medical illness
Shared Decision-Making Tool for Opioid Prescribing After Ambulatory Hand Surgery in Veterans

The purpose of this study is to determine if an educational patient-centered presentation reduced the amount of opioid pills requested and utilized by patients compared to standard of care group.


Eligibility Criteria:
* 1. Inclusion Criteria:
* a. 18-89 years of age
* b. Patient at the Orthopedic Department at the Veterans Health Administration
* c. Indicated for upper extremity surgeries: E.g., Carpal Tunnel Release, Trigger Finger Release, Cubital Tunnel Release, Ganglion Cyst Excision
* 2. Exclusion Criteria:
* a. History of opioid use disorder
* b. Had any recent surgery within four weeks of upper extremity procedure
* c. Taking opioids prior to surgery
* d. Returning to an institutionalized setting
* e. Pregnancy
* f. Unable to communicate in the English language
* g. Allergy to any medication recommended for post-operative analgesia
Validation of the English Version of the FIMA Questionnaire

The purpose of this study was to determine the validity and reliability of the English version of the Questionnaire for Health-Related Resource Use in an Elderly Population (FIMA).


Eligibility Criteria:
Inclusion Criteria:

-65+.

Exclusion Criteria:

* younger than 65+
* severe visual impairment
* severe auditory impairment
* poor command of English
* no consent to participate in the study
XprESS Registry Study

This is a prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the XprESS device per the device indication for use (IFU).

Endoscopic balloon-only and hybrid-balloon procedures involving dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia were performed in 175 patients.

One-month follow-up was required for all patients. The first 50 patients enrolled also consented to a 1-year follow-up. Complications and sinus symptom severity were assessed at the 1-month visit. Symptom severity and ostial patency of the treated sinuses were evaluated at the 1-year visit.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Scheduled to undergo sinus surgery with planned use of the XprESS Balloon Device consistent with the tool's Indication for Use
* Willing and able to provide consent

Exclusion Criteria:

* Known Samter's Triad
* History of primary ciliary dysfunction
* History of cystic fibrosis
* Known to be immunosuppressed
* Hemophilia
* Currently enrolled in another pre-approval investigational study
The Effect of Gluten in Patients With Irritable Bowel Syndrome and Healthy Volunteers

Patients with Irritable Bowel Syndrome (IBS) often link their symptoms to foods. Interest in dietary management recently increased, including the use of a gluten-free diet.

To investigate relation of gluten-free diet (GFD) and IBS, a randomized, double-blind, placebo-controlled cross-over trial will be carried out in adults (\>18) and patients with IBS according to Rome IV criteria. The aim is to assess gluten-free versus gluten-containing diet in IBS patients and Healthy Volunteers.

The study is a randomized, double-blind, placebo-controlled, cross-over trial.

The aim is to assess the effects of gluten-free diet (GFD) compared to gluten-containing diet (GCD) in IBS patients and Healthy Volunteers on gastrointestinal symptoms, visceral sensitivity, bacterial fermentation, psychological factors and quality of life. The primary hypothesis is that GFD decreases gastrointestinal symptoms compared to GCD and that this change is accompanied with reduced visceral sensitivity and change in bacterial fermentation. The secondary hypothesis is that GFD positively influences psychological factors and quality of life.

IBS patients (Rome IV) and Healthy Volunteers are challenged with gluten in this randomized, double-blind, placebo-controlled, cross-over study. They start with GFD or GCD and cross over to the other intervention (both for 14 days). In between there is a wash-out period of at least 14 days. The subjects will get gluten-free meals (lunch and dinner) and have to sprinkle powder over the meals, concealed in sachets with either gluten (vital gluten) or placebo (rice starch). The subjects will follow a strict GFD during the GFD and GCD periods. The subjects will eat and drink as before the study during the washout period.

Primary outcomes are change in gastrointestinal symptoms, assessed by questionnaires, including IBS Severity Scoring System (IBS-SSS) and Gastrointestinal Symtom Rating Scale-IBS (GSRS-IBS). A 50-point reduction in IBS-SSS indicates clinical response. Bacterial fermentation (exhaled hydrogen and methane) and visceral sensitivity will be measured using the Lactulose-Nutrient Challenge Test. Secondary outcomes are change in psychological factors and quality of life assessed by questionnaires, including CSI, HADS, HSPS, IBSQOL, PHQ-15 and VSI.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with IBS according to Rome IV criteria

Exclusion Criteria:

* allergy or documented intolerance to food,
* severe cardiovascular, hepatic, neurological or psychiatric disease
* serious gastrointestinal disease: including celiac disease and inflammatory bowel diseases (IBD),
* diabetes
* bowel dysfunction related to previous surgery
* pregnant or lactating women
* usage of antibiotics within 4 weeks before inclusion
* strict avoidance of foods
A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)

The purpose of this study is to evaluate the efficacy and safety of enclitide chloride, an oral PCSK9 inhibitor, in lowering low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia. The primary hypothesis is that at least one of the four doses of enclitide chloride tested in this study is superior to placebo on percent change from baseline in LDL-C at Week 8.


Eligibility Criteria:
Inclusion Criteria:

* History of clinical atherosclerotic cardiovascular disease (ASCVD), or has an ASCVD risk equivalent and/or a 10-year risk of having an ASCVD event ≥5.0%, AND has a corresponding LDL-C that falls within the protocol-specified range at screening.
* Treatment with a stable dose of one or more lipid-lowering therapies for ≥30 days before screening, or has not received treatment with any lipid-lowering therapy for ≥30 days before screening.
* A female participant is not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance during the intervention period and for at least 8 weeks after the last dose of study intervention.

Exclusion Criteria:

* History of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria.
* History of nephrotic syndrome.
* History of unstable angina, a myocardial infarction, percutaneous transluminal coronary angioplasty, transient ischemic attack, or stroke within 3 months before Screening.
* Has poorly controlled diabetes mellitus, defined as hemoglobin A1C (A1C) ≥9.0% at Screening.
* History of malignancy ≤3 years before screening, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, which have no timeframe limitations relative to screening.
* Currently participating in or has previously participated in an interventional clinical study within 3 months before Screening.
* Has moderate or greater renal insufficiency.
Study of CCNU (Lomustine) Plus Dasatinib in Recurrent Glioblastoma (GBM)

To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma


Eligibility Criteria:
Inclusion Criteria:

* Patients with histological or cytological proven glioblastoma multiforme
* Recurrent or progressive disease documented by magnetic resonance imaging (MRI)
* World Health Organization (WHO) Performance status 0 - 2
* Patient may have been operated for recurrence
* For non operated patients, recurrent disease must be at least one bidimensionally measurable target lesion with one diameter of at least 2cm
* Patients must be on a stable or decreasing dose of corticosteroids for at least 1 week prior to baseline MRI

Exclusion Criteria:

* Patients with histological or cytological proven glioblastoma multiforme
* Completion of radiotherapy to the brain less than 3 months prior to registration/randomization
* Prior treatment with high dose radiotherapy, stereotactic radiosurgery or internal radiation therapy
* Previous or current malignancy at other sites within prior 3 years