cyrilzakka/clinical-trials huggingface dataset:
Erlotinib and Chemotherapy for 2nd Line Treatment (Tx) of Metastatic Colorectal Cancer (mCRC)

The purpose of this study is to see if alternating chemotherapy with erlotinib increases tumor shrinkage in people with metastatic colorectal cancer. The investigator will also be studying the side effects (good and bad) of alternating chemotherapy with erlotinib on metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

Patients must fulfill all of the following criteria to be eligible for study entry:

* Age 18-80
* Able to provide informed consent
* Biopsy proven unresectable metastatic adenocarcinoma of the colon or rectum
* Documented progression on prior first-line oxaliplatin-based or irinotecan-based regimen for metastatic colorectal cancer
* Radiographically measurable disease with at least one bidimensionally measurable lesion of \> 1 cm
* Prior first-line regimen must have been completed at least 4 weeks prior to study treatment
* Use of biologic agents with first-line chemotherapy permitted
* Previous adjuvant regimens must have been greater than 6 months before inclusion
* Adequate organ function including bone marrow, liver and renal function as defined by the following values: absolute neutrophil count \> 1500/microliter; Hgb \> 9 g/dL; platelets \> 90,000/microliter; International Normalized Ratio \< 1.8 (unless in therapeutic range if taking warfarin or other warfarin-derivative anticoagulants and are being monitored regularly for changes in prothrombin time or International Normalized Ratio); bilirubin \< 2 times the Upper Limit of Normal; alkaline phosphatase \< 3 times the Upper Limit of Normal; aspartate aminotransferase/alanine aminotransferase \< 5 times the Upper Limit of Normal; serum creatinine \< 1.5 times the Upper Limit of Normal
* Eastern Cooperative Oncology Group status \< 2

Exclusion Criteria:

Patients meeting any of the following criteria are ineligible for study entry:

* Prior second-line chemotherapy regimens for colorectal cancer
* Prior treatment with erlotinib or gefitinib
* Central Nervous System metastasis
* Second malignancies less than 5 years prior to enrollment. Completely resected basal or squamous cell carcinoma of the skin is allowed.
* Untreated/unresolved bowel obstruction
* Inability to take oral mediations
* HIV positive
* Pregnancy
* Other uncontrolled medical illnesses
* Current diarrhea \> grade 2
* Symptomatic angina or uncontrolled congestive heart failure
Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis

Neonatal bacterial sepsis is a major cause of mortality and morbidity and early antibiotic therapy is crucial for treatment success.

Objective: To evaluate the effect of Procalcitonin-guided decision making on duration opf antibiotic therapy in suspected neonatal early-onset sepsis.

This single-centre, prospective randomized intervention study was conducted in a tertiary neonatal and paediatric intensive care unit in the Children's Hospital of Lucerne, Switzerland between June 1, 2005 and December 31, 2006. All term and near term infants with suspected early-onset sepsis were randomly assigned either to standard treatment based on conventional laboratory parameters (standard group) or to Procalcitonin-guided treatment (Procalcitonin-group). Minimum duration of antibiotic therapy was (48)-72 hours in the standard group, whereas in the Procalcitonin group antibiotic therapy was discontinued when two consecutive Procalcitonin values were below predefined age-adjusted cut-off values.

Eligibility Criteria:
Inclusion Criteria:

* Term and near-term infants with a gestational age of more than 34 weeks
* Admitted to the Children's Hospital of Lucerne, Switzerland
* Suspected neonatal early-onset sepsis
* Antibiotic therapy
* Parental consent

Exclusion Criteria:

* Surgery in the first 3 days of life
* Severe congenital malformations
* Chromosomal abnormalities
Clinical/Behavioral Approach to Overweight in Latino Youth

This randomized controlled trial tests the efficacy of a culturally and linguistically appropriate, evidence-based intervention to slow weight gain or promote weight loss among overweight 6-9 year old Mexican-American children.

Overweight and obesity is a serious problem for Mexican-American children, due in part to poverty, acculturation, genetic predisposition or other factors. Clinic-based weight control studies have shown promise, but often include convenience samples with few or no Latino children. This randomized controlled trial tests the efficacy of a culturally and linguistically appropriate, evidence-based intervention to lower Body Mass Index (BMI) or slow weight gain among overweight 6-9 year old Mexican-American children randomly sampled from a large (36,192 pediatric patients) community clinic providing services to low and medium income families in a US-Mexico border community (San Ysidro, CA). Intervention and measurement design and selection are based on a "Socioecological Model for Latino Health Promotion". Children and their parents will be randomly assigned to either a Special Intervention (SI) or Usual Care (UC) group. The SI group will participate in the following behavior change activities based on Prevention Plus and Structured Weight Management approaches:

1. classes providing culturally-sensitive health education regarding healthy eating, increasing physical activity, decreasing sedentary behaviors, and effective parenting behaviors to model and reinforce children's health behaviors, instruction on how to modify both social and structural aspects of the home environment, and skills-building to navigate community resources;
2. clinical visits with a Health Educator and Mid-Level Provider (MLP);
3. family visits with primary care providers (PCP); and
4. phone calls to reinforce goal setting.

The UC group will receive standard health education for childhood obesity already provided by the community clinic. The primary outcome for the study is child BMI, which along with other changes in physical outcomes, child health behaviors and parenting behaviors will be evaluated at four time-points (baseline, 6-, 12-, and 18-months). The primary hypothesis is that the SI group will demonstrate lower mean BMI than the UC group at the end of a 6 month intervention with a maximum difference occurring at 12 months, and will sustain this difference for an additional six months (18 months after baseline). Secondary aims include examining intervention effects on children's energy balance, physical activity levels, sedentary behavior and parenting strategies related to their children's health behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as Latino
* Have made a clinic visit within past 24 months prior to enrollment in study
* Have a BMI % for age/gender between 75 - 99.9th
* Plan on living in target area for following 18 months
* Have transportation to participating clinic
A Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in Non-satisfied Patients With Previous Antipsychotic Drug

The purpose of this study is to compare the patient satisfaction between continued administration of previous antipsychotics versus switched administration to paliperidone ER in non-satisfied patients with previous (paliperidone)

This is a randomized (patients are assigned to intervention by chance), prospective, open-label (all people involved know the identity of the assigned drug), switch study designed to evaluate patient-assessed medication satisfaction after 12 weeks of treatment in patients with schizophrenia. The total duration of this study is 12 weeks. Outpatients who treated atypical antipsychotics and report dissatisfaction (Medication Satisfaction Questionnaire \[MSQ\] \<4) with their current treatment response are eligible to participate in the study. Patients will be randomized into two groups, 1) Patients randomized to an immediate initiation of paliperidone ER for a total 12 weeks 2) Patients randomized to a delayed initiation will continue their previous atypical antipsychotics for 8 weeks and then be initiated on paliperidone ER at Day 56 for 4 weeks. During the study treatment optimization will be done by dose adjustment (dose increase or decrease) and by adding psychotropic agents except the antipsychotics.

Eligibility Criteria:
Inclusion Criteria:

* Must be diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
* Have taken atypical antipsychotics (aripiprazole, olanzapine, risperidone) at least 6 weeks prior to start of study.
* Have Medication Satisfaction Questionnaire (MSQ) score of ≤3
* Competent patients who manage to answer the questionnaires

Exclusion Criteria:

* Have had a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome
* Have had relevant history of or current presence of any significant or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic, morbid obesity (BMI≥40), or other systemic disease
* Had received two or more different kind of antipsychotics.
* Had a history of taking paliperidone extended release (ER).
* Allergy or hypersensitivity to risperidone or paliperidone ER.
* Have been on clozapine or long-acting injectable antipsychotic medication during the last 3 months.
* Have had Medication Satisfaction Questionnaire (MSQ) score\>3
* Have been hospitalized for longer than 8 continuous weeks during the past 6 months
* Had history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or inability to swallow the oral tolerability medication whole with the aid of water for patients requiring oral tolerability testing
* Current substance dependence (DSM-IV) or past history of dependence (more than 6 months)
Evaluation of HDL Subfraction Changes and HDL-Associated Enzymes in Liver Failure Patients and Healthy Donors

This study aimed to determine high-density lipoprotein (HDL) subfraction profile and HDL-associated enzyme changes in liver failure patients and healthy donors.

Objectives: This study aimed to determine high-density lipoprotein (HDL) subfraction profile and HDL-associated enzyme changes in liver failure patients and healthy donors.

Materials and Methods: Twenty liver failure patients and twenty healthy donors are selected. Blood samples obtained from all patients prior to transplant will analyzed. HDL subfraction analysis will done by continuous disc polyacrylamide gel electrophoresis. Plasma levels of apolipoprotein A-1 (ApoA-I), cholesteryl ester transfer protein (CETP), and lecithin-cholesterol acyltransferase (LCAT) will determined by enzyme-linked immunosorbent assay.

Eligibility Criteria:
Inclusion Criteria:

* Liver failure patients

Exclusion Criteria:

* patients not giving consent
* Participants who had oncological and hematological diseases, coronary failure, kidney failure, malnutrition, diabetes, traumatic brain injury, or cadaveric LT and who were using psychoactive medicines or having a respiratory system or CNS diseases were excluded from the study
Retinal Imaging Using NOTAL-OCT V2.5

Primary objectives:

To compare between retinal measurements, done by the NOTAL-OCT V2.5 device and a commercial OCT.

Secondary objectives:

1. To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula.
2. To evaluate the repeatability of the NOTAL-OCT V2.5

Study population:

1. AMD population - intermediate and advanced AMD (with active and nonactive CNV)
2. DR population. Patient with and without DME

Eligibility Criteria:
1. Inclusion Criteria:

   a- Ability and agreement to give informed consent (IC) b -Diagnosis of AMD or DR in SE by OCT c- Ability to undergo OCT scans d- VA of 20/400 (6/120) or better in SE
2. Exclusion Criteria:

   1. AMD and DR in the same SE
   2. Evidence of macular disease other than AMD or DME in SE
   3. Patient with dilated eye(s)
Study to Evaluate Efficacy of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Bone Micro-architecture and Overall Safety in Postmenopausal Women (MK-0822-031)

This study will evaluate the safety and treatment effect of 50 mg odanacatib (MK-0822) with Vitamin D versus placebo with Vitamin D in postmenopausal women with low bone density. The primary efficacy hypothesis is that odanacatib will increase aBMD at the lumbar spine compared to placebo at 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Participant has been postmenopausal for 3 years
* Participant has BMD t-score at the total hip, hip trochanter, femoral neck, or lumbar spine ≥ -1.5 but \> -3.5
* Participant has 2 hips that are evaluable by dual-energy X-ray absorptiometry (DXA) and quantitative computed tomography (QCT), e.g. contain no hardware from orthopedic procedures
* Participant is ambulatory

Exclusion Criteria:

* Participant has had a previous hip fracture
* Participant has had \>1 prior clinical vertebral fracture AND is a candidate for osteoporosis therapy
* Participant has been treated with oral bisphosphonates, strontium, parathyroid hormone (PTH) or other agents with an effect on bone
* Participant has had metabolic bone disorder other than osteoporosis
* Participant has renal stones, Parkinson's disease, multiple sclerosis (MS) or active parathyroid disease.
Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

The purpose of this study was to assess and compare the effect of the repeated usage of two different contact lens care systems (one hydrogen peroxide-based cleaning and disinfecting system, and one polyaminopropyl biguanide (PHMB)-containing multipurpose system) with silicone hydrogel contact lenses worn on a daily wear basis for three months. The specific aspect of interest was the effect on the ocular tissue, in particular the eyelids and their associations with the contact lens surface wettability and surface contamination.

The subjects attended the enrollment visit having worn their habitual silicone hydrogel contact lenses for at least six hours on the day of the visit. The enrollment visit was scheduled so that the subjects' habitual lenses were at least 14 ± 3 days old for the subjects replacing their lenses bi-weekly and at least 30 ± 5 days old for those replacing their lenses monthly.

Eligibility Criteria:
Inclusion Criteria:

* Read and understand Participant Information Sheet;
* Read, sign, and date Informed Consent;
* Successfully wearing silicone hydrogel contact lenses under a frequent replacement (biweekly or monthly) daily wear modality;
* Using a PHMB-containing multipurpose contact lens solution;
* Symptomatic, as specified in protocol;
* Best corrected visual acuity of 6/9 or better in each eye;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any known sensitivity or intolerance to the contact lenses or len care products to be used;
* Systemic disease/medication which might interfere with contact lens wear or produce dry eye side effects;
* Ocular allergies or ocular disease which might interfere with contact lens wear;
* Use of any concomitant topical ocular medications during the study period;
* Participation in an investigational drug or device study within 30 days of entering the study;
* Other protocol-defined exclusion criteria may apply.
Women's Perspective on First-trimester Preeclampsia Screening

The aim of this study is to evaluate women's perception on first-trimester preeclampsia screening as it is performed currently in daily practice. Thus, the investigators will assess the degree of satisfaction regarding the information received previously to the date of screening, and on the same day the screening is performed (at the time of first-trimester scan).

Women's unsderstanding regarding preeclampsia screening will be evaluated by means of an anonymous online questionnaire. Anxiety and stress related to the results will also be assessed.

Preeclampsia screening was established in Catalonia in 2018. However, little training for professionals (doctors and midwifes) was performed. Women's opinion regarding screening was not asked prior to its implementation, and most women no dot receive any information prior to be screened.

Women's opinion on their pregnancy follow-ups is important, but this aspect is often not included in clinical practice policies. Thus, the objective of the study is to evaluate women's perception regarding current clinical practice in screening of preeclampsia, and their degree of satisfaction.

Screening and risk-assessments during pregnancy are also a potential cause of stress for women. Anxiety and stress regarding preeclampsia screening results will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Older that 18 years old
* singleton pregnancy
* low risc of cromosomal abnormalities (\<1/1100)
* normal first trimester ultrasound (no evidence of fetal malformations)

Exclusion Criteria:

- Pacients will diagnosed mental disorders (including depression and anxiaety disorder)
A Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours

The purpose of this study is to explore safety and efficacy of varlitinib administered as monotherapy in Japanese subjects with advanced or metastatic solid tumors, and administered as combination with capecitabine in Japanese subjects with advanced or metastatic biliary tract cancer. Also to evaluate pharmacokinetics (PK) of varlitinib, capecitabine and its metabolite.


Eligibility Criteria:
Inclusion Criteria:

* Study I: Subjects with a solid tumour (excluding haematologic tumors) in advanced or metastatic stage
* Study II: Subjects with advanced (unresectable) or metastatic biliary tract cancer (IHCC, EHCC, gallbladder cancer or ampullary carcinoma)

Exclusion Criteria:

* Subjects with concurrent multiple primary cancers.
* Subjects with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis, or with a history of interstitial lung disease or current interstitial lung disease
* Subjects receiving proton pump inhibitors for established, symptomatic gastro-duodenal ulceration or gastroesophageal reflux disease (including the preventive use)
Observational Study of NovoMix® 50 for Treatment of Type 2 Diabetics for 12 Months

This study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with type 2 diabetes currently on a therapy with human biphasic insulin. An additional objective is also to observe the different regimes of starting and maintaining the treatment with NovoMix® 50 during one year.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes treated with biphasic human insulin with or without metformin
* Inadequate glycaemic control or is experiencing hypoglycaemic events or would, in the physician's opinion, benefit from treatment with NovoMix® 50

Exclusion Criteria:

* Subjects with diagnosed type 1 diabetes mellitus
* Subjects treated with short acting or intermediate acting human insulin or any insulin analogue
* Subjects who are unlikely to comply with study description, e.g. uncooperative attitude, inability to come for regular visits
* Subjects with a hypersensitivity to biphasic insulin aspart 50 (NovoMix® 50 )or to any of the excipients
* Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months
Retinal Nerve Fiber Layer and Macular Thickness Changes During Pregnancy

Purpose:

Primary: to prospectively measure Retinal Nerve Fiber Layer (RNFL) and macular thickness changes during pregnancy by Optical coherence tomography

Secondary: The effect of pregnancy abnormalities on RNFL and macular thickness in participants who develop systemic or ocular complications during the study period.

There are several known ophthalmic physiologic changes in pregnancy:

1. Refractive Change: progesterone-mediated changes in fluid content partially accounts for refractive change of lens and cornea; myopic shift of less than 1 D was observed in in 15% of participating pregnant women
2. Night vision decreased mainly with low serum vitamin A levels in pregnant women.
3. Fall of the IOP in second half of pregnancy (about 10% drop)
4. Corneal changes (increased thickness; decreased sensitivity) = contact lens intolerance

The retina and optic nerve are considered part of central nervous system, the retina and choroid are highly vascularized. Due to changes in CSF and brain volume, vascular and fluid changes all over the pregnant woman's body we expect to find changes in RNFL and macular thickness during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* 1st trimester (6-14w) pregnant healthy women
* No known medical problems related to their current pregnancy on recruitment
* Age 18-45yrs
* No known retinal or optic nerve disease
* Refraction between +3.0 and -4.0 diopters
* Agrees to participate in the study

Exclusion Criteria:

* Retinal or optic nerve disease
* Refractive errors more than +3.0 and -4.0.
* If already finished 14w gestation when recruited to the 1st OCT examination
* Known to have HTN or DM before gestation
* Ocular media abnormality that obscures OCT view or examination
Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter

The purpose is to compare long term occurrence of atrial arrhythmias including atrial fibrillation (AF) and thromboembolic complications including cerebrovascular events (CVE) in patients with typical atrial flutter (AFLT) undergoing cavo-tricuspid isthmus (CTI) ablation alone versus CTI ablation combined with pulmonary vein isolation (PVI).

Typical Atrial Flutter (AFLT) is a common cardiac arrhythmia. Studies have demonstrated the safety and superiority of ablation procedure over antiarrhythmic drug (AAD) therapy. Long term freedom from typical AFLT has been consistently shown after successful ablation, but up to 30% of these patients can experience new onset of a different arrhythmia i.e., Atrial Fibrillation (AF). AF results from triggers in the back of the left upper chamber in the heart (left atrium - LA). These triggers typically arise from in and around the opening of the 4 veins (pulmonary veins - PVs) that bring blood from the lungs into the heart. The highest incidence of AF in patients undergoing ablation for typical AFLT was observed where the follow-up duration exceeded a year after the AFLT ablation. This would suggest that AF development in patients undergoing typical AFLT ablation is progressive and inevitable.

Eligibility Criteria:
Inclusion Criteria:

All patients with typical AFLT confirmed by a 12-lead ECG that are referred for ablation and manifest ≥ 2 risk factors associated with future development of AF will be eligible to participate in the study.

Risk factors for predicting future occurrence of AF will include:

1. prior remote history of AF (≤ 2 episodes ≥ 1 year from the date of evaluation for study participation),
2. LA size \> 4.0 cm,
3. left ventricular ejection fraction (LVEF) ≤ 50%,
4. hypertension, and/or 5) obstructive sleep apnea.

Exclusion Criteria:

1. Subjects with documented ≥ 2 AF episodes within the preceding 6 months of enrollment,
2. inability or unwillingness to take 6 weeks of oral anticoagulation after the procedure and
3. failure to provide informed consent.