cyrilzakka/clinical-trials huggingface dataset:
A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies

An open non-randomized study using biology driven selection of therapies. WINTHER study will explore matched tumoral and normal tissue biopsies and will use a novel method for predicting efficacy of drugs. The aim is to provide a rational personalized therapeutic choice to all (100 %) patients enrolled in the study, harboring oncogenic events (mutations/ translocations/ amplifications, etc.) or not. The total number of patients treated in the study will be two hundred across all participating cancer centers (European countries -France; Spain-, Israel, USA and Canada). All centers will realize the same study independently.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Any histologic type of metastatic cancer, (except for lung and brain at US sites), in which histologic normal counterpart can be obtained.
* Progression by RECIST (Response Evaluation Criteria In Solid Tumors) or other criteria on at least one prior regimen for advanced disease.
* Ability to undergo a biopsy or surgical procedure to obtain fresh tumor biopsy paired with its normal counterpart.
* Age from 18 years
* Life expectancy of at least 3 months
* ECOG Performance status of 0 to 1
* Measurable or evaluable disease according to RECIST 1.1 criteria
* For U.S. sites, advanced cancer patients that have exhausted all effective therapy for their disease and have progressed after previous line of therapy (documented disease progression under last treatment received) and conventional methods of assigning new therapy would not be expected to increase survival by more than 3 months.

Exclusion Criteria:

* Any patient that might require a lung or brain biopsy are excluded (at US sites)
* Alteration of organ function or hematopoietic function as defined by the following criteria:

  1. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) \>2.5 x upper limit of normal (ULN), except for patients with liver metastases, for which AST and ALT \> 5.0 ULN is the exclusion criteria.
  2. Bilirubin \> 2.0 ULN
  3. Polynuclear neutrophil \< 1.5 x 109/L
  4. Platelets \< 100 x 10 9/L
  5. Hemoglobin \< 90 g/L
  6. Creatinine \> 1.5 ULN
  7. Calcemia \> 1.5 ULN
  8. Phosphatemia \> 1.5 ULN
* Coagulation abnormality prohibiting a biopsy
* Symptomatic or progressive brain metastases detected by radio imaging, or meningeal
* Patient who received a personalized therapeutic treatment based on molecular anomaly during the treatment period prior to the WINTHER directed treatment (defining the PFS1). Hormonal therapy may be continued during WINTHER suggested therapy. The exclusion of prior matched targeted therapy includes but is not limited to all targeted therapeutics that are EMA approved and genomically matched to patients. If there are questions about whether or not a prior therapy is matched targeted treatment it will be agreed on by discussion between PIs who are also Clinical Management Committee members; the resolution should take place prior to starting WINTHER directed treatment.
Diagnostic Value of Next-Generation Sequencing Analysis in Biliary Tract Tumours

The aim of this study is to identify a dysplasia- and CCA-specific NGS panel to increase the diagnostic sensitivity of histological and/or cytological examination of biliary tract stenosis.

Patients undergoing biliary tract resection, as part of the normal course of care, at the O.U. General Surgery and Transplantation will be enrolled. Tissue samples will be processed and analysed at the O.U. of Pathological Anatomy.

Clinical, serological and instrumental data from patients, considered necessary for the intended analyses, will be collected for the purposes of the study.

The study will have a total duration of 36 months. It is planned to enrol 50 patients, all belonging to the U.O. Hepatobiliary and Transplant Surgery of the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The size of the population is estimated on the basis of the number of cases/year from the U.O. Hepatobiliary and Transplant Surgery, and is considered sufficient to achieve the primary objective, since it is an exploratory study. Surgical material (resection of biliary tract, possibly hepatectomy or duodenocephalopancreasectomy), which will be sampled according to clinical practice and sent to the O.U. of Pathological Anatomy of the IRCCS AOUBO, where it will be sampled, fixed in formalin, included in paraffin and processed. From paraffin blocks (selected from those obtained from the sampling of surgical pieces according to clinical practice) 2 µm sections will be cut for Next Generation Sequencing investigations.

Eligibility Criteria:
Inclusion Criteria:

* Availability of enough tissue for histological and NGS analysis (at least 20 ng DNA).
* Age greater than/equal to 18 years.

Exclusion Criteria:

* None
Correlation of Insulin Resistance With Hormonal and Ovarian Morphological Characteristics in Patients With Polycystic Ovarian Syndrome

We designed a study to determine if ovarian volume (OV) and/or follicle number (FN) are independently associated with abnormal metabolic findings in women diagnosed with PCOS. We hypothesized that ovarian morphology but not follicle number would be associated with a significantly higher odds of hyperinsulinemia among women with PCOS.


Eligibility Criteria:
Inclusion Criteria:

A-patients met the Rotterdam criteria of PCO with two out of three of the following:

1. oligo-or-anovulation
2. clinical and/or biochemical hyperandrogenism
3. the presence of 10 or more antral follicles in one ovary and/or a maximum ovarian volume \> 10cc B-reproductive age group (16:45 years) C-BMI \<40

Exclusion Criteria:

A-age \>40 years B-BMI\>40 C-previous ovarian surgery D-chronic medical disorders \[DM , HTN , ...\]
Assessment of Verbal Comprehension and Cognitive Processes in Patients Admitted to the Palliative and Supportive Care Unit

This study investigates the use electroencephalography (EEG - a test that measures brain waves) to learn if patients who appear unresponsive (do not respond to noises, words, or touch) retain any consciousness. Families want to know if their loved ones who are unresponsive can still hear them or feel any discomfort. Information gained from this study may have important impact in how patients, caregivers, and doctors make decisions.

PRIMARY OBJECTIVES:

I. To estimate the magnitude of electroencephalography (EEG) response to verbal stimuli among cancer patients in the last days in life admitted to a palliative and supportive care unit (PSCU).

II. To examine the feasibility of conducting EEG in cancer patients in the last days of life.

SECONDARY OBJECTIVES:

I. To compare the magnitude of EEG response between impending death cohort and control cohort.

II. To determine the association between the magnitude of EEG response and clinical assessments (e.g. JFK Coma Recovery Scale-Revised \[CRS-R\], Glasgow Coma Scale \[GCS\], Richmond Agitation Sedation Scale \[RASS\], Memorial Delirium Assessment Scale \[MDAS\]) in impending death cohort and control cohort separately.

III. To determine the magnitude of EEG response to pressure/noxious stimuli in impending death cohort and control cohort separately.

IV. To examine serial EEG changes in auditory cortex activation and cognitive processing in cancer patients over the last days of life.

OUTLINE:

Patients undergo EEG over 30 minutes daily until death or discharge and complete questionnaires over 30 minutes daily until death or discharge to check level of consciousness, thought, and ability to communicate.

Eligibility Criteria:
Inclusion Criteria:

1. \[Both cohorts\] Diagnosis of advanced cancer (defined as locally advanced, metastatic, recurrent, or incurable disease)
2. \[Both cohorts\] Admitted to the PSCU at MD Anderson Cancer Center or seen by the specialist palliative care inpatient consultation team (control cohort only)
3. \[Impending death cohort\] Clinician judgement of .3 days of survival or .1 late sign of impending death\*
4. \[Impending death cohort\] Palliative Performance Scale score of 10-20%
5. \[Control cohort\] Able to communicate for the past 24 hours
6. \[Control cohort\] Clinician judgement of .1 month of survival
7. \[Both cohorts\] English-speaking

Exclusion Criteria:

1. \[Both cohorts\] Hearing impairment that significantly impacts daily communication with caregiver prior to entering impending death phase OR requiring hearing aid
2. \[Impending death cohort\] Mental status changes only related to medications as per clinician judgement
3. \[Control cohort\] Diagnosis of delirium (i.e. MDAS .13)
4. \[Both cohorts\] Pregnant women
5. \[Both Cohorts\] Age \< 18 years old
Muscle Atrophy In Patients With Chronic Obstructive Pulmonary Disease

Limb muscle dysfunction, characterized by atrophy and weakness, is amongst the most troublesome systemic consequences of chronic obstructive pulmonary disease (COPD) leading to poor functional status and premature mortality.

One prevailing hypothesis stipulates that the deterioration in muscle structure and function during COPD results from a spillover of inflammatory mediators from the lungs to the systemic circulation and then to the muscles.

The investigators objective is to investigate the impact of COPD on key signaling pathways involved in the muscle atrophy. Moderate to severe COPD patients (FEV1 under 60% of predicted) and healthy controls will be recruited. All of the investigators patients will undergo a thorough baseline assessment in pulmonary capacity, muscle force and body composition. Blood sampling and biopsy of the quadriceps will be done. Key proteins of signaling intramuscular pathways involved in protein synthesis and degradation will be measured in the quadriceps.

Eligibility Criteria:
Inclusion Criteria:

* male
* COPD with an FEV1 of under 60% of predicted
* non-smoker
* between 55 and 75 years old

Exclusion Criteria:

* all inflammatory disease (HIV, cancer, renal and cardiac deficiency)
* hormonal dysregulation
* inferior limb pathology
* neuromuscular pathology
* history of tobacco or alcool abuse
* oxygen dependent
* recent exacerbation (2 months) of the symptoms of COPD
Nonalcoholic Steatohepatitis in Chinese Children

Nonalcoholic steatohepatitis (NASH) is now recognised as an increasing clinical problem in children. Steatosis without significant liver cell injury or fibrosis is the most common form of nonalcoholic fatty liver disease (NAFLD) in both adults and children. Studies in the adult population have variably suggested that steatosis is a benign nonprogressive condition and NASH is recognised as a potentially serious condition with significantly risk of morbidity and mortality.

A growing body of evidence suggests that children with NASH frequently show histopathological features that differ from those of adults. The prevalence of this pattern in a wide range of paediatric cases as well as other histopathological lesions and their relevance and prognostic significance in children with NAFLD remains to be determined. Thus the investigators would like to conduct a study of biopsies and clinical information to document the histological features of paediatric NAFLD, to explore the natural history of paediatric NAFLD, and to determine the frequency and prognostic value of these features.


Eligibility Criteria:
Inclusion Criteria:

* age 1-18 with biopsy-proven NAFLD
* Alcohol consumption less than 20g/day and 10g/day for boys and girls respectively

Exclusion Criteria:

* with viral hepatitis, e.g. HBV, HCV
* with a1-anti-trypsin disease
* with autoimmune hepatitis
* with Wilson disease
* with liver impaired by drugs
Hot and Cold Biopsy Forceps in the Diagnosis of Endobronchial Lesions

A new electrocautery bronchoscopy biopsy forceps is now commercially available and may prevent bleeding following biopsy. Only one study used this device wherein the authors concluded that the use of hot biopsy forceps for endobronchial biopsy does not appear to have a negative impact on the pathological samples, and that there was a statistically significant, albeit clinically insignificant reduction in bleeding score with hot biopsy forceps. Therefore, a randomized controlled study is required in which the hot and cold biopsies are performed to evaluate the tissue effect of the hot biopsy forceps on histopathological diagnosis.

In recent years, a number of innovative non-thoracotomy techniques have been introduced for the diagnosis of indeterminate pulmonary disease but none has had greater impact on pulmonary medicine than flexible fiberoptic bronchoscopy. Since its introduction in 1968, fiberoptic bronchoscopy has become the procedure of choice for diagnosis and management of many bronchopulmonary disorders. It is accompanied by a low incidence of complications and can be performed satisfactorily by the transnasal approach without general anesthesia. Donlan et al, in 1978, and Ackart and colleagues, in 1983, demonstrated the safety of fiberoptic bronchoscopy as an outpatient procedure.

Transbronchial biopsy was first attempted, through a rigid bronchoscope in 1965, but was associated with a high occurrence of pneumothorax. Reports began to appear from 1974 onwards of lung biopsies done for diffuse pulmonary disease using the standard fiberoptic bronchoscope. Forceps biopsy through flexible bronchoscopy is commonly used to make the cytological or histological diagnosis. Of the procedures performed through bronchoscopy, forceps biopsy provides the best diagnostic yield of 71% to 93%.

A new electrocautery ''hot'' bronchoscopy biopsy forceps is now commercially available and may prevent bleeding following biopsy. Only one study used this device wherein the authors concluded that the use of hot biopsy forceps for endobronchial biopsy does not appear to have a negative impact on the pathological samples, and that there was a statistically significant (albeit clinically insignificant) reduction in bleeding score with hot biopsy forceps. However, limitations in this study were small sample size, use of hot and cold biopsy in the same patient as well as interval between the two biopsies were short due to which it is difficult to decide which technique has contributed to the bleeding. Therefore, a randomized controlled study is required in which the hot and cold biopsies are performed to evaluate the tissue effect of the hot biopsy forceps on histopathological diagnosis.

Eligibility Criteria:
Inclusion Criteria:

1. All patients undergoing routine bronchoscopic biopsy for various indications
2. More than 18 years of age

Exclusion Criteria:

1. Bleeding diathesis
2. On pacemaker or implanted defibrillator
3. On anticoagulation therapy
4. Poor cardiopulmonary reserve
5. Marked hypoxemia
6. Uncooperative patient
7. Enrollment in the previous study
Evaluation Of Intra-Operative Neuro-Monitoring Alarm During Complex Spine Surgery

Iatrogenic spinal cord injury is the most feared complication of complex spine surgery. The incidence of neurological complications for spinal deformity surgery has been estimated by the Scoliosis Research Society as 1%, except when a combined approach is used, where the rate increases to 1.87% \[1\]. Intraoperative neuromonitoring (IONM) techniques are usually implemented during spine surgery to avoid nefarious abuse of the nervous system, which can cause postoperative problem \[2\].

In 1992 a Scoliosis Research Society study concluded that the use of intraoperative spinal cord neurophysiological monitoring during operative procedures including instrumentation should be considered ''a viable alternative as well as an adjunct to the use of the wake-up test during spinal surgery'' \[5\]. The benefit of using neuromonitoring has been validated by numerous studies involving scoliosis correction, revision surgeries and vertebral osteotomies.

The trend in IONM usage in the current literature, which may be a direct consequence of improved efficacy of the procedure, and the development of optimized treatment algorithm \[6\]. Nevertheless, it is well known that the use of somatosensory evoked potentials (SEPs) alone may be ineffective in detecting a motor tract deficit \[7, 8\]. As a result, various methods for monitoring the motor tract of the spinal cord have been developed. The most commonly used stimulation technique is transcranial electric stimulation (TES) of the primary motor cortex by corkscrew electrodes placed in the scalp, to produce myogenic motor evoked potential\[9\]. The combination of SEPs and TES-MEPs provides global monitoring coverage of spinal cord function \[10\]. Based on the available evidence, it is recommended that the use of multimodality neuromonitoring be considered in complex spine surgery where the spinal cord or nerve roots are deemed to be at risk \[11\].

Eligibility Criteria:
Inclusion Criteria:

* patient with spine deformities
* patient with sever cervical and lumbar degenerative diseases
* patient with combined cervical and lumbar diseases
* patient with spine tumours

Exclusion Criteria:

• cases with mild to moderate degenerative diseases simple spine procedures
Effects of a Cocoa Shot on the Human Brain 2

The Hershey Company is interested in investigating the effects of various chocolate beverages on brain physiology and cognitive function. The main substances in the drinks that are known to influence the brain are caffeine and related chemicals such as theobromine. Caffeine and chemicals related to caffeine are all naturally occurring and all potentially alter brain physiology. This study will evaluate changes in brain blood flow and cognition following the consumption of drinks with various combinations of the Primary Ingredients. The study proposed here will evaluate ingredients in a 4-arm cross-over double-blind design in an attempt to understand the differential effects of these compounds in chocolate drinks.


Eligibility Criteria:
Inclusion Criteria:

* Consume 200-500 mg caffeine daily
* Willing and capable of signing the informed consent
* Willing to attend 4 testing sessions that will take 4-6 hours each AND will be at least 10 days apart
* Willing to abstain from caffeine for 16 hours before each testing session
* Willing to and able to have MRIs

Exclusion Criteria:

* As determined from the medical screening session

  * active neurological dysfunction (such as a major Axis I psychopathology, Alzheimer's disease, Parkinson's disease, prior history of stroke, epilepsy, or serious central nervous system (CNS) trauma)
  * attention deficit hyperactivity disorder (ADHD)
  * migraines
  * hypertension
  * diabetes
  * peripheral vascular disease
  * taking vasoactive medications (such as anti-hypertensive medications)
  * depression that has not been on a stable medical treatment for at least 4 weeks
  * Pregnancy
  * Allergy to chocolate, peanuts, tree nuts, egg, soy, milk, wheat
* Color blindness
* Individuals who are or potentially may be cognitively or psychologically impaired, or who otherwise have a limited capacity to provide consent
Reliability and Validity of the Taiwan-version of Multidimensional Fatigue Inventory and Fatigue Severity Scale

The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity.

Fatigue Severity Scale (FSS) contains nine statements that rate the severity of fatigue symptoms. The purposes of this study are to translate fatigue questionnaires of -MFI- and -FSS- to Taiwan-version, and to examine the reliability and validity of the scales.

A hundred adult people without diagnosed physical nor mental disabilities will be recruited. Subjects will fill out the Taiwan-version of MFI, FSS, SF-36 and Pittsburg Sleep Quality Index (PSQI) to establish the validity. Subjects will re-fill the MFI and FSS one week later to evaluate the test-retest reliability.

Another twenty people who are familiar with both English and Chinese will be recruited to evaluate the translation reliability. Subjects will fill out the English version of MFI and FSS and, then, fill out the Taiwan-version of the MFI and FSS with at least ten minutes apart. The translation reliability will be evaluated by paired t test and the intraclass correlation coefficient.


Eligibility Criteria:
Inclusion Criteria:

* No cognition or mental disorders
Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study

This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal.


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients 65 years of age and older.
* Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
* At the randomization visit patients must have an office msSBP greater than or equal to 150 mmHg and \< 180 mmHg (msDBP \<110 mmHg) with a less than or equal to 15 mmHg difference during the last two visits of the single blind run-in period.

Exclusion Criteria:

* Severe hypertension \[Office msDBP ≥110 mmHg and/or mean sitting systolic blood pressure (msSBP) ≥ 180 mmHg\].
* History or evidence of a secondary form of hypertension.
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
* History of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (TIA).
* Current diagnosis of heart failure (NYHA Class II-IV).
* History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
* Current angina pectoris requiring pharmacological therapy other than nitrates.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation

This trial is designed to establish invasive and non-invasive measures of arterial stiffness as potential predictors of treatment response to renal sympathetic denervation

Regardless of the ongoing debate on the general effect of renal sympathetic denervation in therapy resistant hypertension, all trials published so far face the problem of a certain proportion of nonresponders to treatment. Previous data shows, that to some extent this might be attributable to arterial stiffening. Elevated invasive pulse wave velocity as an established marker for arterial stiffness has been found to be associated with nonresponse to renal denervation treatment in a smaller trial population. This trial attempts to assess the predictive value of different invasive and non-invasive markers for arterial stiffness in an adequately powered population.

Eligibility Criteria:
Inclusion Criteria:

* Patients with therapy resistant arterial hypertension (\>=3 antihypertensive drugs including at least one diuretic without any dosage change in the preceding 4 weeks) and office BP \>160 mmHg systolic or 90 mmHg diastolic

Exclusion Criteria:

* average systolic daytime BP \<135 mmHg in 24h ambulatory blood pressure measurement (ABPM)
* pregnancy
* known renal artery stenosis
* \>= 1 renal artery diameter \< 4 mm
* life expectancy \<6 months
* participation in any other clinical trial