cyrilzakka/clinical-trials huggingface dataset:
SCH 727965 in Patients With Advanced Breast and Lung Cancers (Study P04716)

To determine the activity of SCH 727965 in participants with breast cancer and in participants with nonsmall-cell lung cancer (NSCLC) compared to standard treatment. The standard treatment used is capecitabine for breast cancer and erlotinib for NSCLC. The study will also determine the activity of SCH 727965 treatment in participants who experience cancer progression after standard treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years, either sex, any race.
* Histologically or cytologically confirmed breast cancer or NSCLC; and radiographic or clinically advanced disease.
* BREAST CANCER:

  * participant must have previously received both a taxane and an anthracycline (unless anthracycline therapy is contraindicated) in the adjuvant and/or metastatic setting,
  * participant with HER2-positive disease must have progressed after trastuzumab and concomitant or subsequent lapatinib,
  * participant must have received at least one, but no more than two prior regimens for recurrent or metastatic disease (endocrine and biologic therapies do not count as chemotherapeutic regimens).
* NSCLC: at least one, but no more than two prior chemotherapeutic regimens for advanced disease.
* Measurable disease by the RECIST.
* Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
* Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
* Ability to swallow tablets.

Exclusion Criteria:

* Known brain metastases. For NSCLC only, a participant with central nervous system metastasis is eligible provided the participant has received definitive local therapy (ie, radiation therapy or surgery), has stopped receiving treatment with corticosteroids, and is without symptoms for at least 4 weeks before randomization.
* History of previous radiation therapy to \>25% of total bone marrow.
* Known HIV infection.
* Known active hepatitis B or hepatitis C.
* Previous treatment with SCH 727965 or other cyclin-dependent-kinase inhibitors.
* BREAST CANCER:

  * known dihydropyrimidine dehydrogenase deficiency,
  * previous treatment with capecitabine.
* NSCLC: previous treatment with erlotinib.
Alimta and Gemcitabine in Non-Small Cell Lung Cancer

The aims of this study are: (1) to assess the safety and activity of gemcitabine plus Alimta (pemetrexed) regimen (GA regimen) in patients with advanced NSCLC patients in the context of a randomized trial, and (2) to compare the GA with the paclitaxel plus gemcitabine (PG regimen) in terms of toxicity and QoL

Patients with stage IIIB or IV non-small cell lung cancer will be randomly allocated to receive: (a)PG regimen: paclitaxel 120 mg/sqm followed by gemcitabine 1,000 mg/sqm i.v. on days 1 \& 8 q 3 weeks; (b)GA regimen: gemcitabine 1,250 mg/sqm i.v. on day 1 (plus folinic acid 350 μg daily orally and vitamin B12 1,000 μg i.m. q 9 weeks), pemetrexed (Alimta®) 500 mg/sqm i.v. on day 8 followed by gemcitabine 1,250 mg/sqm, q 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) NSCLC
2. No previous adjuvant or palliative chemotherapy
3. No previous radiotherapy
4. Presence of at least one unidimensionally measurable lesion (Appendix 2)
5. ECOG performance status of 0 or 1 (Appendix 3)
6. Charlson score ≤ 2 (Appendix 4)
7. Adequate bone marrow function (absolute neutrophil count ≥ 2 x 109/L, platelet count ≥ 100 x 109/L, and hemoglobin level ≥ 100 g/L), and adequate liver function (bilirubin level \< two times the upper limit of normal, AST and/or ALT \< three times the upper limit of normal, prothrombin time \< 1.5 times control), and creatinine clearance ≥ 60 ml/min.
8. Absence of symptomatic CNS metastases (patients with cerebral metastases treated with brain irradiation may be included), severe cardiac arrhythmia or heart failure, second or third degree heart block or acute myocardial infarction within 4 months prior to study entry.
9. No major surgery or pleurodesis within 14 days prior to enrollment.
10. Life expectancy of at least 12 weeks.
11. No previous or concurrent malignancy, except inactive non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer if the patient has been disease-free for more than 5 years.
12. Written informed consent

Exclusion Criteria:

1. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
2. Patients with clinically significant effusions.
3. Any other malignancies within 5 years that could affect therapy evaluation
DIALOOG: Crestor in Patients With Diabetes Mellitus Type 2: Lowering of LDL-C Levels to New European Guidelines

The purpose of this study is to determine in DM II patients the efficacy of Crestor in obtaining the new European LDL cholesterol guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus Type 2, LDL-C \> 2,5 mmol/l, no cholesterol lowering medication used last 3 months, starts with Crestor 10 mg, permission to use patient data by AZ
Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week

Open label, 1-week daily disposable, dispensing study

Evaluate the clinical performance of habitual wearers of FILCON IV 1 sphere lenses when refitted with ocufilcon D asphere for 1 week of daily disposable wear.

Eligibility Criteria:
Inclusion Criteria:

* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted Avaira sphere contact lens wearer (at least 1 week in Avaira sphere)
* Has a contact lens spherical prescription between + 2.25 to - 8.00 (inclusive)
* Has a spectacle cylinder up to 0.75D in each eye.
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter.
* Patient contact lens refraction should fit within the available parameters of the study lenses.
* Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so).
* Is willing to comply with the visit schedule

Exclusion Criteria:

* Is not a habitual wearer of Avaira sphere lenses
* Has a CL prescription outside the range of the available parameters of the study lenses.
* Has a spectacle cylinder ≥1.00D of cylinder in either eye.
* Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
* Presence of clinically significant (grade 2-4) anterior segment abnormalities
* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
* Slit lamp findings that would contraindicate contact lens wear such as:

  * Pathological dry eye or associated findings
  * Pterygium, pinguecula, or corneal scars within the visual axis
  * Neovascularization \> 0.75 mm in from of the limbus
  * Giant papillary conjunctivitis (GCP) worse than grade 1
  * Anterior uveitis or iritis (past or present)
  * Seborrheic eczema, Seborrheic conjunctivitis
  * History of corneal ulcers or fungal infections
  * Poor personal hygiene
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea.
* Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study
Effectiveness of Manual Physical Therapy to Improve Endocrine Levels in Women

This study will examine the impact of manual physical therapy on endocrine function in women diagnosed as being infertile due to elevated follicle stimulating hormone (FSH) levels (10 mIU/mL or higher) on days 2-5 of their menstrual cycle. It is hypothesized that the manual physical therapy will decrease FSH levels.

This study will investigate the effect of manual physical therapy on the endocrine levels of women by comparison of pre- and post- treatment hormone levels (FSH, LH and Estradiol). Secondary measures include assessment of pain and sexual function via questionnaires.

Hormones will be measured at prescribed time points:

* baseline: 30-60 days before treatment
* pre-treatment: 7-30 days before treatment
* post treatment 1: 10-30 days post treatment
* post treatment 2: 30-60 days post treatment

Pain and sexual function questionnaires will be completed:

* baseline: 30-60 days before treatment
* pre-treatment: 7-30 days before treatment
* post treatment 1: 30 days post treatment
* post treatment 2: 60 days post treatment

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as infertile
* FSH greater than 10mIU/mL on days 2-5 of menstrual cycle
* Regular menstrual cycle
* Residing in the US, accessible to a LabCorp testing facility

Exclusion Criteria:

* Active infection including HIV or inflammation
* Cancer within the past 5 years
* Currently pregnant
* Hemophilia, abnormal bleeding or clotting disorder
* Immune system disorder
* Abnormal ovarian cyst or endometrioma
* BMI of 35 or greater
* Any other condition in which deep manual physical therapy is contraindicated
* Currently taking any fertility medications or planning to take any fertility related medications during the course of the study. This includes all ovarian stimulating medications, artificial hormones and birth control medications.
* Participation in any assisted reproductive technique (such as IVF) other than intra-uterine insemination during the course of the study.
Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department

Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department

Rate of Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* age \>18 years
* Acute non-traumatic acute headaches
* patients treated in ED
* Magnesium sulfate and aspirin administered intravenously (IV)

Exclusion Criteria:

* Current regular use of analgesics, anticonvulsants or antidepressants
* Renal disorder with a low glomerular filtration rate (\<60 ml/min)
* Neuromuscular disorder
* Pregnant woman
* Contrindication
* Allergy to NSAID
* Traumatic Headache
* Chronic headache ( headache occurring at least 15 days per month for at least 3 months)
* Hemodynamic instability
Iterative Beta Testing of Videos for the DIPPer Academy

The purpose of this research is to develop DIPPer Academy, a parent-focused, mobile health (mHealth) behavioral intervention to promote glycemic control in young children.

Because many young children with T1D have glucose levels that exceed targets, investigators need to develop efficacious, accessible, and readily disseminable interventions to help them to improve their glycemic control. To do this, the investigators need efficacious interventions that specifically address the challenges that parents of young children face in daily T1D management. Providers need mHealth interventions that minimize barriers that parents experience when trying to access face-to-face or in clinic interventions. Finally, interventions are needed that are packaged to be easily deployable by other diabetes centers. The investigator's proposed intervention, DIPPer Academy, will include all of these recommended advancements.

Eligibility Criteria:
Inclusion Criteria:

* Parents of a young child who is between 3-5.99 years old and at least 6 months post T1D diagnosis
* Parents who are English-speaking.

Exclusion Criteria:

* Parents of young children with evidence of type 2 diabetes or monogenic diabetes.
* Parents with evidence of severe psychiatric disorder.
* Parents of young children with a comorbid chronic illness (e.g., renal disease) that requires ongoing care beyond T1D.
* Parents of young children with a history of anemia or medication use that may interact with glycemic control (e.g., systemic steroids).
Comparison of 2-Dimensional and 3-Dimensional Laparoscopic Visions

This study tests the hypothesis that use of the 3-D laparoscopic vision system (Viking Systems, La Jolla, CA) can significantly improve technical ability on a complex laparoscopic tasks in an experimental model.

7 tasks on a 3-D laparoscopic instrument fitted to the trainer box and subjective criteria (4 point lickert scale) were evaluated for this study. Totally twenty-four participants (8 experienced, 8 minimal experienced and 8 novices) were evaluated for different 10 tasks (touch the marked circle, pass the two circle with needle, pick-beads and place, grape the suture, move the needle from one instrument to another instrument, pick-and-place, cutting, three different suturing) in term of total task time and error number. Statistical Package Program was used to perform statistical analyses. The data were presented as arithmetic means and standard deviations were calculated in each group. A P value of \<0.05 was considered to be statistically significant.

Eligibility Criteria:
Inclusion Criteria:

medical doctors

Exclusion Criteria:

disabled person (about arms or vision problems)
Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts Scanned With A Sequential Scan Protocol

The objective of this study is to compare radiation dose of a standard spiral scan with the a new sequential scan protocol. We hypothesize that the sequential scan protocol is associated with a reduction in dose estimates of at least 20%, while the diagnostic image quality is not inferior.

Secondary endpoints of the study include quantitative image quality parameters, diagnostic accuracy for spiral versus sequential studies compared to invasive angiography in patients who underwent subsequent invasive coronary angiography.

All patients scheduled for a coronary CT scan are screened for inclusion and exclusion criteria. Patients are included if they have stable sinus rhythm (heart rate \<75 bpm for dual source CT and \<65 bpm for 64-slice CT). Informed signed consent is obtained from these patients and the CT scan is prepared. After topogram scan and the native scan for Ca-Scoring, patients are randomized in two groups with the use of sealed envelopes. After that contrast-enhanced coronary CT angiography is performed with the standard spiral protocol or with the sequential protocol.

The CT examination is evaluated by two experienced investigators on a per-vessel basis and all results and study-related data are collected in a dedicated database. For assessment of image quality, a previously established 4-point score system is used and quantitative image quality parameters are measured.

A 30 day follow-up after the CT examination aims to evaluate if patients underwent invasive coronary angiography or were scheduled for a myocardial stress / perfusion test (such as stress-echocardiography, myocardial scintigraphy or stress perfusion imaging by MRI).

Eligibility Criteria:
Inclusion Criteria:

* patients with an indication for a coronary CT angiography (planned evaluation of the coronary arteries)
* stable sinus rhythm
* heart rate \< 75 bpm with dual-source CT or \< 65 bpm with single-source CT
* signed informed consent

Exclusion Criteria:

* non-ECG triggered studies
* non-coronary CTA studies, e.g. bypass graft CTAs, pre- or post EP studies, CABG planning studies
Symptomatic Treatment of Distal Tubercle Fractures of the Scaphoid

AIM:

The aim of this study is to assess whether patients with an acute distal tubercle fracture of the scaphoid treated with a removable brace for 4 to 6 weeks have the same level of symptoms and disability 6 months after injury as the average for the normal population.

NULL HYPOTHESIS:

Patients with an acute distal tubercle fracture of the scaphoid have Quick DASH (Disabilities of the Arm Shoulder and Hand) scores at or above the population norm (a score of 13 in Norway and 10.9 in the United States) 6 months after injury when treated symptomatically with a removable brace.

Fractures of the distal scaphoid tubercle are uncommon and seem relatively benign. Not a lot is known in literature about this specific type of avulsion fracture and the treatment. Some surgeons recommend a cast for 4 to 6 weeks while others treat their patients with a removable brace. The only non-union reported in literature is Jonssen who published a case in 1990 about a non-union of a tubercle fracture in a patient with repeated trauma. Kraus et al studied 81 cases of acute scaphoid fractures and found 4 cases of tubercle avulsion fractures in this group. We suspect some patients will not seek care for this condition as it hurts for a bit and then causes no problems.

Response variables:

* Quick DASH measured 6 months after injury
* 11-point ordinal measure of overall pain intensity 6 months after trauma

Explanatory variables:

* Socio-demographics
* Age, sex, ethnicity, race, marital status, education, work status
* Questionnaires
* Quick DASH after trauma (\< 2 weeks)
* 11-point ordinal measure of overall pain intensity 6 months after trauma
* 11-point ordinal measure of satisfaction with treatment 6 months after trauma

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Fracture of the distal tubercle of the scaphoid on radiographs
* Interval between injury and diagnosis of less than 2 months
* English or Spanish fluency and literacy

Exclusion Criteria:

* Pregnant women
* Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness)
* Patients with other fractures or injuries
Evaluating and Establishing the Relationship in the Five Critical X-ray Time Points in Spinal Deformity Realignment

To establish the relationship in the five critical X-ray time points during multilevel posterior column osteotomies (MPCO) spinal deformity realignment in patients with adult spinal deformity and to follow the participants longitudinally to examine any follow-up X-rays and clinical data to compare to the post-operative standing scan and pre-operative data.

Studies in adult spinal deformity (ASD) have found that the presence of sagittal imbalance directly correlates with worsening quality of life. Multilevel posterior column osteotomies (MPCOs) is a technique that can provide correction to adult spinal deformity. MPCOs can be utilized for revision surgery as an alternative to 3-column osteotomies and have the ability to aggregate large amount of lordosis segmentally. The success of the MPCO technique largely depends on radiographs taken during these surgeries to aid the surgeon in establishing the best screw and rod placement and making intraoperative adjustments. Imaging plays a vital role in evaluating hardware positioning and assessing hardware integrity as well as evaluating potential complication. The investigator plans to evaluate and establish the relationship in the five critical X-ray time points (preoperative standing and supine, intraoperative pre- and post-correction, and postoperative standing films) during MPCO spinal deformity realignment and measure pre- to post-operative outcome longitudinally. The investigator will investigate lumbar lordosis and sagittal and coronal alignment at those 5 time points and examine the relationship between pre-op, intra-op, and post-op images to understand impact of the MPCO technique and examine expected outcome to final outcome. Additionally, if the O-Arm 2D long film scanner is utilized during the surgery, the investigator will analyze that film and compare it to the other X-rays taken.

Eligibility Criteria:
Inclusion Criteria:

* Surgical Candidate for posterior only surgery for adult spinal deformity
* Patients must require deformity correction greater than 3 levels
* Adults Between the ages of 18-80
* Decisional capacity to consent to the study
* Both Primary and revision surgeries will be included

Exclusion Criteria:

* 1) Not meeting candidacy for posterior spine surgery
Gao NARASD Lithium Study

This study is a 4-month open-label study of lithium in the acute treatment of patients with bipolar I or II disorder. Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels \> 0.6 mEq/L. Blood samples are collected at baseline and at the end of study. Analyses of 45 molecule expressions in mononuclear blood cells at baseline and endpoint will be carried out after the completion of study. Fifty patients meeting Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria for bipolar I or II will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

For inclusion in this study, subjects must meet all of the following criteria:

1. Able to provide informed consent before beginning any study-specific procedures;
2. Male or female, 18-70 years old;
3. Meets current DSM-5 criteria for bipolar I or II disorder as assessed by the The M.I.N.I. International Neuropsychiatric Interview (MINI);
4. Any symptomatic phase of bipolar I or II disorder including, depressive, manic, mixed or hypomanic
5. Global Clinical Impression-Severity for Bipolar Disorder (CGI-S-BD) ≥3;
6. Willing to take lithium;
7. If a sexually active female of childbearing potential, be using a reliable method of contraception;
8. Women with reproductive potential must have a negative urine pregnancy test;
9. Willing to have blood drawn:

Exclusion Criteria:

Any of the following is regarded as a criterion for exclusion from the study:

1. Unwilling to comply with study requirements;
2. Renal impairment (serum creatinine \>1.5 mg/dL);
3. Thyroid stimulating hormone (TSH) over \>20% above the upper normal limit (participants maintained on thyroid medication must be euthyroid for at least 3 months before Visit 1;
4. Other contraindication to lithium,
5. Patients who have had severe adverse reaction to Lithium;
6. Patients who require inpatient care;
7. Drug/alcohol dependence requiring immediate acute detoxification;
8. Pregnancy as determined by serum pregnancy test or breastfeeding;
9. History of nonresponse to lithium at doses ≥ 900 mg/d for ≥ 8 weeks;
10. Unwilling to have blood drawn
11. Patients with chronic medical conditions such as diabetes, coronary artery disease, immune diseases, infectious diseases and neurological disorders;
12. Active suicidal ideation with a plan or intent, a suicide attempt within past 6 months or more than 2 suicide attempts within the past 2 years.
13. Currently on lithium