cyrilzakka/clinical-trials huggingface dataset:
Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer

This study aims to use a type of radiation (adaptive radiotherapy) to deliver curative-intent treatment to patients with non-small cell lung cancer, whose tumors would otherwise be too large for standard curative treatment. The study will use adaptive radiotherapy to achieve these goals. Adaptive radiotherapy is a process whereby treatment plans are modified during the course of treatment due to patient and tumor variations (ie. weight loss or tumor shrinkage). This may allow for dose escalation, while limiting the side effects.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Willing to provide informed consent
* ECOG performance status 0-2
* Histologically confirmed non-small cell lung carcinoma
* Locally advanced stage IIIA or IIIB lung carcinoma according to AJCC 7th edition
* Expected lung V20 of 35-60%, as determined at the time of 4D-CT simulation
* Assessment by medical oncologist and radiation oncologist, with adequate hepatic and renal function for administration of cisplatin-based doublet chemotherapy, at the discretion of the medical oncologist

Exclusion Criteria:

* Serious medical comorbidities or other contraindications to radiotherapy or chemotherapy
* Prior history of lung cancer within 5 years
* Prior thoracic radiation at any time
* Metastatic disease
* in some select cases, patients with a solitary metastasis (i.e. brain metastasis) may receive radical chemoradiotherapy after resection/ablation of their metastatic lesion, as standard practice. In such cases, the patient may be enrolled onto this study at the discretion of the local principle investigator once the metastasis has been treated.
* inability to attend full course of radiotherapy of follow-up visits
* Pregnant or lactating women
Safety and Efficacy Study of the Treatment of Kidney Infections With Short Course Levofloxacin

The purpose of the study is to compare the safety and effectiveness of the antibiotic levofloxacin by administering a higher dose of levofloxacin using a shorter course of therapy to treat patients with infections of their kidney.

The goal is to complete a pilot study of short course (5 days), high dose, levofloxacin treatment for women with acute uncomplicated pyelonephritis. Specific study objectives include:

1. To assess the efficacy and tolerability of levofloxacin 750 mg once daily for treatment of acute uncomplicated pyelonephritis in 25 women.
2. To describe the population pharmacokinetics of levofloxacin 750 mg once daily in treatment of young women with acute pyelonephritis.
3. To identify urine proteins associated with the inflammatory response of acute pyelonephritis, and characterize the time course of resolution of these proteins following initiation of treatment.

Eligibility Criteria:
Inclusion criteria:

* Recent onset (less than 7 days) of costovertebral angle pain or tenderness with or without fever, and with or without lower urinary tract symptoms (dysuria, frequency, urgency). Diabetic women without long term complications of diabetes (retinopathy, nephropathy, or neuropathy) may be enrolled.
* Stable hemodynamic status and able to tolerate oral medication.
* Pretherapy urine culture \>107 cfu/L (\>104 cfu/ml) of a uropathogen (E. coli, other Enterobacteriaceae, S. saprophyticus). Patients will be enrolled into the study prior to urine culture results being known. If pretherapy cultures are subsequently not positive (usually at 48 hours), subjects will be discontinued.
* Pyuria (\> 10 wbc/mm3 or \> 10 X106 wbc/L by hemocytometer; \> 6-10 wbc/hpf, or \> 1+ LE (leukocyte esterase) dipstick).

Exclusion Criteria:

·Pregnancy, breastfeeding, fluoroquinolone allergy, and any underlying structural or functional genitourinary abnormality.
Ultrasound Guided Inguinal Indocyanine Green Injection to Identify and Pre-emptively Seal Lymphatic Leaks

Goal is to determine whether intraoperative ICG injection can be used to identify and reduce formation of symptomatic lymphoceles in patients receiving robot-assisted prostatectomy.

The goal of this clinical trial is to determine whether intraoperative ICG injection can be used to identify and reduce formation of symptomatic lymphoceles in patients receiving robot-assisted prostatectomy. The main question is if it could improve patients' quality of life and infection risk post-surgery. It would also help to decrease emergency room visits as well as additional procedures. Researchers will compare those who receive the ICG and those who do not.

Patients will be randomized into the ICG arm versus no ICG arm after pelvic lymphadenectomy is done.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing robotic assisted laparoscopic lymph node dissection

Exclusion Criteria:

* Patient not undergoing extended lymph node dissection
* History of allergy to iodides
Does Coronary Angiography Cause Cognitive Dysfunction?

The purpose of the study is to study if coronary angiography cause cognitive dysfunction.

We have previously shown, using transcranial doppler, that coronary angiography cause cerebral microembolism. Cerebral microemboli were more common using the radial than femoral approach. Previously, cerebral microembolism has been associated with new cerebral lesions on MRI. The clinical significance of these new lesions is not determined. The primary aim of this pilot study is to see if coronary angiography cause cognitive dysfunction determined by the MoCA-test. A secondary aim is to relate cognitive dysfunction to cerebral microembolism measured by transcranial doppler. A third aim is to study potential differences between the femoral and radial approaches.

Eligibility Criteria:
Inclusion Criteria:

* Elective coronary angiography irrespective of cause

Exclusion Criteria:

* Previous CABG, language problems, not willing to participate
Simvastatin in Patients With Septic Shock

The beneficial effect of statins to prevent cardiovascular events in patients at risk is well established. Recent trials demonstrated that statins can exert a number of vascular actions independent of lipid lowering. Short-term simvastatin therapy recently has been reported to reduce mortality in 2 different animal models of sepsis. Pleiner and coworkers could demonstrate potent vasoprotective properties of simvastatin during Escherichia coli endotoxin induced endotoxemia in healthy volunteers. In a population-based cohort analysis it was demonstrated that administration of statins was associated with a reduced risk of subsequent sepsis. Thus, simvastatin treatment may offer a new therapeutic strategy for clinical conditions associated with inflammation like severe sepsis and septic shock. The aim of the present study is to test the hypothesis that short term treatment with simvastatin may mitigate the detrimental vascular effects of acute inflammation in patients admitted to the intensive care unit requiring treatment for septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Septic Shock for less than 48 hours

Exclusion Criteria:

* Pregnancy
* Unable to receive enteral medications
* Expected survival of less than 72 hours
* Treatment in the previous 3 weeks with simvastatin or other HMG-CoA reductase inhibitors
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* History of known or suspected porphyria
* High risk of rhabdomyolysis (multiple trauma, crush injuries, extensive burns, baseline creatinine kinase (CK) ≥ten-times upper limit of normal
* Hemorrhagic shock
β-cell Function in Type 1 Diabetes May Not Be As Low As Presumed

Enhancing endogenous insulin production in type 1 diabetic patients (T1DP) can improve glycemic control and decrease complications and rates of mortality. However, it can be succesfull even if sufficient β-cell function is present. We aimed to evaluate the extent of β-cell function by determining fasting levels of C-peptide and those after meal stimulus.

Background and aims: Enhancing endogenous insulin production in type 1 diabetic patients (T1DP) can improve glycemic control and decrease complications and rates of mortality. However, it can be succesfull even if sufficient β-cell function is present. We aimed to evaluate the extent of β-cell function by determining fasting levels of C-peptide and those after meal stimulus.

Materials and Methods: One hundred and thiryfive T1DP were planned to enrolı to the study. Ethics comittee of our hospital approved the study protocol, which was in accordance with the Helsinki Declaration. Fasting C-peptide levels of all participants and stimulated (at 90 th minute post mixed meal) C-peptide levels of 54 will be measured by using an electrochemiluminescence assay. Two categorizations will be done using fasting (the first categorization ) and at 90th minute post mixed meal test (the second categorization) of C-peptide levels. For the first categorization; the groups will be classified as follows: patients with undetectable ≤0.1 ng/mL (group 1); with minimal 0.1-0.8 ng/ml (group 2); and with sustained ≥0.8 ng/mL(group 3) C-peptide levels. For the second categorization, groups will be as follows: patients with undetectable ≤0.1 ng/mL (group 1); with minimal 0.1-0.8 ng/ml (group 2); and with sustained ≥0.8 ng/mL (group 3) C-peptide levels which increased at the 90th minute after the meal ≥150% of fasting C-peptide level.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetic patients who have accepted to have mixed meal tolarance test

Exclusion Criteria:

* Patients with type 2 diabetes,
* patients with MODY
Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation

Adult patients who are diagnosed new onset atrial fibrillation with rapid ventricular response within 7 days after non-cardiac non-thoracic surgery are enrolled.

After randomization, they are allocated to rhythm control strategy group or rate control strategy group. In rhythm control strategy group, patients are given amiodarone primarily for the purpose of sinus conversion of cardiac rhythm. In rate control strategy group, patients are given diltiazem or esmolol for the purpose of rate control. the rate of sinus conversion within 48 hours after treatment are compared.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Newly diagnosed atrial fibrillation or flutter
* Patients with atrial fibrillation or flutter that occurred within 7 days after non-cardiac non-thoracic surgery
* Atrial fibrillation or flutter with rapid ventricular response(HR ≥110/min)
* Patients without hemodynamic instability (MBP≥65mmHg with norepinephrine continuous infusion less than 5mcg/min or without vasopressor support)

Exclusion Criteria:

* Atrial fibrillation or flutter prolonged more than 48 hours without anticoagulation
* Patients who have decreased cardiac function or heart failure (EF \<40%)
* Patients who have cardiac conduction disorder, QT prolongation(QTc ≥500ms)
Maintenance Therapy Post-HSCT in High-risk Aggressive Lymphoma

Relapse after autologous hematopoietic stem cell transplantation (ASCT) is still challenging for high-risk aggressive lymphoma. This study was to investigate the efficacy and safety of maintenance therapy post-ASCT.


Eligibility Criteria:
Inclusion Criteria:

* Age 14-70 years
* High-risk aggressive lymphoma underwent auto-HSCT
* Presence of 2 or more signs of unfavorable prognosis (IPI 2-4)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Adequate hematological function
* Offer informed consent

Exclusion Criteria:

* Concomitant other cancer
* Congestive heart failure, unstable angina, severe cardiac arrhythmias and conduction disturbances, myocardial infarction
* Renal insufficiency (serum creatinine greater than 0.2 mmol/L) (except cases with specific kidney infiltration, urinary tract compression by tumor conglomerate or presence of uric acid nephropathy due to massive cytolysis syndrome)
* Liver failure (except cases with liver tumor infiltration), acute hepatitis or active phase of chronic hepatitis B or C with serum bilirubin greater than 1.5 standards, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 3 standards, prothrombin index less than 70%
* Severe pneumonia (except cases with specific lungs infiltration), accompanied by respiratory failure (dyspnea \> 30 in min., hypoxemia less than 70 mm Hg, when it is impossible to compensate situation in 2-3 days)
* Severe mental disorders (delusions, severe depressive syndrome and other manifestations of productive symptoms) not related with specific infiltration of central nervous system
* Pregnancy
Safety and Efficacy of Insulin NPH Compared to a New Insulin Formulation in Subjects With Type 2 Diabetes

This trial is conducted in South America. This trial aims for a comparison of the safety and efficacy of insulin NPH and a new insulin formulation on blood glucose control.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 12 months
* Current NPH treatment for at least 3 months - alone or as the only insulin in combination with OADs
* Body Mass Index (BMI) less than or equal to 40 kg/m2
* HbA1c less than or equal to 9.5%
* FPG less than or equal to 12 mmol/L

Exclusion Criteria:

* Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
* Treatment with more than 1 IU/kg NPH insulin daily
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
* Known or suspected allergy to trial products or related products
* Receipt of any investigational drug within one month prior to this trial
* Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
Safety and the Efficacy of a Sublingual Administration of Flumazenil to Reverse the Effect of Hypnotic Drugs in Healthy Adults

The purpose of this study is to evaluate the safety and effectiveness of treatment with sublingual (s/l) Flumazenil in healthy volunteers as reversing the effect of the sleep/hypnotic drugs. This study is designed to collect short-term safety and tolerability data.

In addition, the psychomotor/ cognitive and behavioral effects of Flumazenil will be assessed to monitor the degree and the duration of action in a single use of Flumazenil.


Eligibility Criteria:
Inclusion Criteria:

1. The subject understood and voluntarily signed an informed consent form prior to any study-mandated procedure.
2. Male or female aged 18-65 at screening. Women of childbearing potential must have a negative pregnancy test at the screening visit and use a reliable method of contraception during the entire study duration (e.g.

   Contraceptive pill; Intra-uterine device; Contraceptive injection (prolonged-release gestagen); Subdermal implantation;Vaginal ring or Transdermal patch).
3. Body mass index ≥ 18.5 and \< 32 kg/m2.
4. Normal sleep habits, i.e. usual self-reported total sleep time \> 6 h; usual self-reported time to fall asleep \< 30 min; usual bedtime between 10:30 pm and 01:00 am.
5. Subject is in good health as determined by a medical history, physical examination and ECG.
6. Negative any use of illicit drug, alcohol (ethanol), stimulants.

Exclusion Criteria:

1. Any use of medications within 1 month prior to screening visit, except for contraceptive pills.
2. Any sleep associated complains.
3. Previous exposure to Benzodiazepines and/or non-Benzodiazepine hypnotic drugs within 3 months prior to study initiation.
4. History of Epilepsy and or anti-epileptic drugs.
5. Excessive caffeine consumption (≥ 500 mg per day).
6. Pregnancy or breast feeding.
7. Night shift workers within 1 month prior to the screening visit.
8. Clinically relevant ECG abnormalities.
9. History of alcohol or drug abuse within 3 years prior to the screening visit.
10. Cognitive Behavioral Therapy (CBT) started within 1 month prior to the screening visit.
11. Known hypersensitivity to drugs of the same class as the study treatment, or any excipients of the drug formulation.
12. Treatment with another investigational drug within 1 month prior to the screening visit.
13. History of severe head injury.
Clinical Study to Monitor Plasma Levels of 24OHC in Subject with HD

A 2-year clinical longitudinal study to measure plasma concentrations of 24S-hydroxycholesterol, a brain-derived cholesterol catabolite, in subjects with Huntington disease, from the presymptomatic to the symptomatic stages.

In cross-sectional studies, the plasma level of brain-derived 24S-hydroxycholesterol (24OHC) has been found to be significantly diminished in HD patients from the first stages of the disease. Furthermore, in HD gene-positive pre-symptomatic (pre-HD) the plasma levels can predict the development of motor signs of disease in subjects closer to onset, better than in subjects far from onset. These data suggest that circulating 24OHC might be a candidate biomarker for phenotypic conversion and for disease progression in different stages of the disease.

Detailed neurological, cognitive and imaging data and blood samples will be collected at baseline, and after two years to investigate the rate of changes along the longitudinal study. Isotope dilution mass spectrometry (assay performed at Istituto di Ricerche Farmacologiche Mario Negri IRCCS) will be used to measure the plasma levels of brain-derived 24OHC and other sterols reflecting peripheral cholesterol synthesis. The investigators expect to establish whether changes in plasma 24OHC mark disease progression and, eventually, phenoconversion from pre-symptomatic to symptomatic stages in combination with clinical, cognitive and imaging parameters.

Eligibility Criteria:
Inclusion Criteria:

Symptomatic HD subjects

1. Age ≥ 18 years
2. Known family history of HD and genetically confirmed disease by direct DNA test (CAG expansion \> 35 repeats)
3. Clinical diagnostic motor features of HD, defined as score\> 5 at the motor Unified Huntington Disease Rating Scale (mUHDRS)
4. Stage I or II or III HD, defined as UHDRS Total Functional Capacity (TFC) scores between 3 and 13 inclusive (Marder, 2000)

Presymptomatic HD subjects

1. Age ≥ 18 years
2. Known family history of HD and genetically confirmed mutation by direct DNA test (CAG expansion \> 35 repeats)
3. Absence of clinical motor features of HD, defined as mUHDRS rating scale ≤ 5

Healthy Subjects

1. Age ≥ 18 years
2. Absence of known family history of HD or genetically confirmed negative DNA test for HD (CAG expansion ≤ 35 repeats)
3. Absence of clinical motor features of HD, defined as mUHDRS rating scale ≤ 5

Exclusion Criteria:

1. Participation in clinical pharmacological trials
2. Inability to undergo and tolerate MRI scans (e.g. claustrophobia, severe chorea, MRI-incompatible intrauterine devices, metal implants, ect)
3. Inability or unwillingness to undertake any of the study procedures
Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes

This trial was conducted in Europe and North America. The aim of this clinical trial was to compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes (diagnosed clinically) for at least 6 months
* Insulin naïve subjects (allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
* Current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000 mg daily)-Insulin secretagogue (sulfonylurea (SU) or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
* HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
* BMI (Body Mass Index) below or equal to 45.0 kg/m\^2

Exclusion Criteria:

* Use within the last 3 months prior to Visit 1 of: Thiazoledinediones (TZDs), Exenatide or Liraglutide
* Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
* Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
* Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)
Physical Activity Intervention for Lung Cancer Survivors

The purpose of this study is to learn how many lung cancer survivors will agree to a physical activity program. We also want to know if lung cancer survivors benefit from this program. This information will help us to develop our services for lung cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis and treatment at MSKCC of primary NSCLC; and/or pulmonary carcinoid;
* At least one year post thoracic surgical resection;
* Have no evidence of NSCLC or any other cancer at the time of study enrollment and not receiving any cancer treatment;
* Currently sedentary or insufficiently active, defined by the American College of Sports Medicine (ACSM) and the Centers for Disease Control and Prevention as less than a total of 150 minutes of at least moderate intensity PA per week;
* Able to complete a six-minute walk test (6MWT);
* Able to provide informed consent.

FOCUS GROUP ONLY:

• Completed the Physical Activity program offered through this study (08067);

Exclusion Criteria:

* Presence of one of the following medical factors at screening:

  * regular use of an ambulatory aid (cane or walker);
  * resting oxygen saturation less than 88%;
  * inability to walk due to severe arthritis or other musculoskeletal problems;
  * a diagnosis of unstable angina in the previous 6 weeks;
  * a heart attack, angioplasty or heart surgery in the previous 3 months;
  * current heart rate \<50 or \>120 at rest; current uncontrolled hypertension;
  * current significant valvular heart disease or decompensated congestive heart failure and
  * patient reported pain of any origin that would preclude participation in the proposed PA intervention
* Evidence of significant medical cognitive or psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in the intervention
* Self-reporting of greater than 60 minutes of vigorous activity per week or 150 minutes of moderate intensity PA per week.
* Patient resides at more than two hours travel distance from the Center
* Insufficient English fluency to complete evaluation tools.