cyrilzakka/clinical-trials huggingface dataset:
Prognostic and Dynamic Change of CTC Enumeration in Advanced NSCLC With Chemotherapy and Targeted Therapy

TITLE : A Multicenter, Prospective, Observational Trial on the Prognostic and Dynamic Change of CTC Enumeration in Advanced NSCLC with 1st or 2nd line chemotherapy and targeted therapy

BACKGROUND : Circulating tumor cells (CTC) identification is a new field of research in oncology, and some studies have been conducted with success on breast and prostate cancer. Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV). CTC identification and monitoring these cells after treatment could help the clinicians to detect relapse or be a prognostic factor.

PRIMARY OBJECTIVE : To study the relationship between CTC count and clinical outcome of treatment (Overall response rate and Progression-free survival).

SECONDARY OBJECTIVES :To study the relationship between CTC and overall survival.

STUDY DESIGN : This is a prospective, observational study.

Duration of the inclusions: 12months.

SAMPLE SIZE : 1200 patients

This is a prospective observational non-intervention study evaluating the dynamic CTC count during the chemotherapy and targeted-therapy. Patients provide written informed consent and pass the screening. Peripheral blood will be drawn before and after the treatment. Relationship between CTC count and clinical outcome will be analysed. The time points of blood drawing are set as following: for patients receiving chemotherapy, once prior to 1st cycle of chemotherapy, once 3 days prior to 2nd cycle of chemotherapy, posterior to 3th cycle (or less than 4th cycle) of chemotherapy and once when progressive disease (PD); for patients receiving targeted-therapy, once prior to treatment, once 1 month after treatment, and once when PD. The clinical outcome of treatment will be ultimately obtained.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically documented, locally advanced or recurrent (stage IIIb and not amenable or combined modality treatment) or metastatic (stage IV) non-small cell lung cancer.
* ECOG functional status≤2
* Chemotherapy:According to routine 1st line doublet chemotherapy in clinical practice, Cisplatin or carboplatin combined with gemcitabine or paclitaxel or docetaxol or Vinorelbine were recommended. According to routine 2nd line chemotherapy in clinical practice,pemetrexed or docetaxol
* Targeted therapy：According to clinical criteria, patients with EGFR-TKI sensitive mutant accept first line TKI therapy.
* Patients must have measurable disease according to the RECIST (version 1.1) criteria
* Patients with a life expectancy greater than 12 weeks
* Written (signed) informed Consent to participate in the study

Exclusion Criteria:

* Patients with history of any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
* Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids.
* Unwilling to write informed consent to participate in the study
* Patients who is unwilling to accept the follow-up.
Theranostic Tool During Erlotinib Treatment in Non-small Cell Lung Cancer Patient

In France, lung cancer is the leading cause of death induced by cancer. Therapeutic advances have been made in therapy of unresectable non-small cell lung cancer (NSCLC) with tyrosine kinase receptor inhibitors blocking the Epidermal Growth Factor Receptor (EGFR), as erlotinib.

This drug usually does not induce rapid shrinking of NSCLC tumour explaining why RECIST criteria are less reliable with erlotinib than cytotoxic drugs after 8 weeks of treatment.

Among patients with unresectable NSCLC, 3'-deoxy-3'-18F-fluoro-L-thymidine (18F-FLT) and 18F-2-18F-fluoro-2-deoxy-D-glucose (18F- FDG) Positron Emission Tomography (PET) has identified early responding patients and with better progression-free survival in erlotinib first line and in the second or third line.

To date, none medico-economic study has been conducted to determine if this strategy will be cost-effective.

The purpose of this study is to confirm that an early metabolic imaging with 18 F-FLT and 18FFDG PET could have theranostic issue by identifying at the fourteenth day of erlotinib (second line or more) the subjects that do not respond to erlotinib, i.e. 6 weeks prior to the morphological evaluation based on the new RECIST 1.1, that is typically done at week 8 of erlotinib treatment.

A health economics ancillary study will be achieved. Indeed, recent therapeutic improvements, in particular targeted therapies in NSCLC, have improved quality of life and life expectancy, but have also induce an important increase of the health costs. According to studies, the mean cost of the treatments of NSCLC has been increased by a factor 3 during the 10 last years. More efficient strategies that would permit to stop early with objective endpoints, expensive therapies is a main achievement in thoracic oncology.

The potential clinical impacts of this work are 1) to stop early erlotinib in non-responders and replace another treatment before a deterioration in their physical status, 2) reduce the risk of side effects and costs of unnecessary treatment and 3) to propose a customization treatment after the first line therapy.


Eligibility Criteria:
Inclusion Criteria:

* age over superior to 18
* NSCLC proved by a histological biopsy
* EGFR mutation status known with no activating EGFR mutation
* indication of erlotinib therapy after at least one previous therapy
* patients who have signed an informed consent to participate in this study
* life expectancy exceeding 12 weeks
* WHO activity score between 0 and 2.

Exclusion Criteria:

* contraindication for the initiation of erlotinib
* refusal to sign the consent
* progressive inflammatory disease
* infection with the HIV virus
* other malignant disease
* life expectancy less than 12 weeks
* major adults protected by French law
Inflammatory Bowel Disease and Atherosclerosis Development

The study will show the influence of inflammatory bowel disease on the risk of development of atherosclerosis


Eligibility Criteria:
Inclusion Criteria:

* Inflammatory bowel disease
* Signed informed consent

Exclusion Criteria:

* Pregnancy
* Other conditions affecting the prognosis
* Psychiatric disorders affecting the participation in the study
Transcutaneous Auricular Vagus Nerve Stimulation for Pediatric Epilepsy

The purpose of this study is to determine whether transcutaneous auricular vagus nerve stimulation as a complementary therapy is effective in the treatment of pediatric epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as epilepsy;
* With age between 2-18 years old;
* The number and dose of the medication was kept constant no less than eight weeks before intervention;
* The patients or their guardians can count the frequency of the seizures and finish the study.

Exclusion Criteria:

* The patient is receiving the VNS therapy;
* Accompanied with progressive central nervous system diseases;
* Have severe heart, liver ,kidney or blood diseases;
* Be pregnant or having the schedule of pregnancy in the study period.
A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes

The purpose of this study is to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* BMI 20-45kg/m2 inclusive

Exclusion Criteria:

* females who are pregnant, lactating, or less than 6 weeks post-partum
* current symptomatic heart failure (NYHA Class II-IV)
Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture

A one third of all ankle fractures are bi- or trimalleolar. Traditionally these fractures are treated by both medial and lateral osteosynthesis, sometimes accompanied by osteosynthesis of the posterior malleolus. There is significant evidence that fractures of the lateral malleolus can be treated conservatively if the medial side is stable. However, there isn't a single study comparing standard bi- or trimalleolar fixation with only medial side osteosynthesis and postoperative immobilization with a cast.


Eligibility Criteria:
Inclusion Criteria:

* Weber B bi- or trimalleolar ankle fracture (fracture of the lateral and medial malleolus +/- posterior malleolus sized under 30% of the distal tibia joint line measured from the lateral projection of the standard ankle radiographs)
* Age: 16 years or older
* Voluntary
* Operated within 7 days of the trauma
* Able to walk unaided before the current trauma

Exclusion Criteria:

* Peripheral neuropathy
* Pilon fracture
* Bilateral ankle fracture
* Concomitant tibial fracture
* Pathological fracture
* Active infection around the ankle
* A previous ankle fracture on either side
* In trimalleolar fractures, posterior malleolus fracture sized over 30% of the distal tibia joint line measured from the lateral projection of the standard ankle radiographs
* Inadequate co-operation
* Permanent residence outside the catchment area of the study hospital
SPECT/CT for the Characterization of Renal Masses

This trial studies how well technetium Tc-99m sestamibi single-photon emission computed tomography/computed tomography (SPECT/CT) works on clinical decision making in patients with kidney tumors. Diagnostic procedures, such as technetium Tc-99m sestamibi SPECT/CT may be a less invasive way to check for kidney tumors.

PRIMARY OBJECTIVES:

I. To determine the impact of technetium Tc-99m sestamibi (MIBI) SPECT/CT on patient management decisions.

SECONDARY OBJECTIVES:

I. To evaluate the impact of MIBI SPECT/CT on patient management decisions for tumors 1.5-3.0 cm and 3.1-5.0 cm.

II. To assess the impact of MIBI SPECT/CT on decisional conflict score. III. To assess the impact of MIBI SPECT/CT on physician management recommendation.

IV. To evaluate the sensitivity and specificity of MIBI SPECT/CT for the identification of an oncocytic renal mass (oncocytoma, chromophobe, and hybrid oncocytic tumor) with respect to tumor histology identified by renal mass biopsy or surgical resection.

V. To compare the specificity of MIBI SPECT/CT with conventional cross-sectional imaging in predicting an oncocytic renal mass.

VI. To assess the correlation between MIBI SPECT/CT outcomes to final treatment decisions.

EXPLORATORY OBJECTIVES:

I. Evaluate the mitochondria content in tumors that had positive MIBI SPECT/CT findings.

OUTLINE:

Patients receive technetium Tc-99m sestamibi intravenously (IV) then undergo SPECT/CT.

After completion of study, patients are followed up for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Performance status Eastern Cooperative Oncology Group (ECOG) \< 2.
* Life expectancy (\> 1 year).
* New diagnosis of a renal tumor (within past 3 months).
* Measurable, predominantly (\> 80%) solid renal neoplasm between 1.5-5.0 cm.
* Lesion concerning for kidney cancer bases on a contrast-enhanced CT or magnetic resonance imaging (MRI).
* No definitive evidence of metastatic disease.
* Does not require urgent surgical treatment.
* Candidate for surgical, ablative, and surveillance approach.
* Willingness to obtain more information to aid decision-making.
* Understanding and willingness to provide consent.

Exclusion Criteria:

* Presence of multiple solid renal tumors.
* A prior needle biopsy of the mass resulting in histologic diagnosis.
* A prior diagnosis of kidney cancer.
* Presence of an active, untreated, non-renal malignancy.
* History of bleeding diathesis or recent bleeding episode.
* Prior surgery or radiation therapy to the kidney.
* Unwillingness to fill out questionnaires.
Adherence to Antihypertensive Therapy--Data Analyses

To assess factors that may influence adherence to antihypertensive drug therapy.

BACKGROUND:

High blood pressure continues to be a highly prevalent condition affecting about 20 percent of the U.S. population. Untreated, it may lead to coronary heart disease, stroke, kidney failure, and other complications. Medication is a major means of controlling hypertension and averting these debilitating consequences. Treatment with drugs, however, is undermined by suboptimal adherence to therapy. Forgetting to take medications is the most commonly elicited reason for lapses in medication use; but side effects, health beliefs, lack of knowledge of disease and treatment instructions, and financial barriers may also interfere. Determining those factors that (1) are predictably associated with fluctuations in adherence (such as day of the week, holidays, medication appointments); (2) ameliorate the impact of nonadherence, such as pharmacologic properties of drugs that protect patients during adherence lapses; and (3) correlate with the accuracy of adherence reporting by patients will assist in anticipating and addressing adherence obstacles and serve as the objectives of the study.

DESIGN NARRATIVE:

The study used data collected from electronic adherence monitors, questionnaires, and computerized medical records that contained blood pressure readings during a prior investigation of antihypertensive adherence. This earlier investigation, conducted from 1994 to 1997, involved 286 members of Harvard Pilgrim Health Care who were on single drug therapy for mild to moderate hypertension. Objective 1 evaluated the impact of temporal factors such as weekend versus weekday, holidays, seasons, and impending medical appointments on adherence by analyzing their effects on the daily rate of dosing recorded by electronic medication monitors. Time trend models were used for this purpose. Objective 2 assessed the impact of pharmacologic duration of action on the level of antihypertensive adherence required to maintain a goal blood pressure of \<140/90 mmHg. This involved determining if the relationship between adherence and blood pressure was modified by the duration of drug effect. Objective 3 concerning correlates of accuracy of reported adherence was approached by verifying reported adherence against electronically measured adherence. Predictors and correlates of accurately reported adherence such as patient age, gender, race/ethnicity, education, socioeconomic status, health beliefs, and measures of health status were then identified by cross tabulating and statistical modeling accurate reporting against these factors.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Effects of Cervical Extension Traction With & Without Modified Cervical and Shoulder Retraction Exercises in Neck Pain

The study aims to explore whether the modified cervical and shoulder retraction exercise program restores cervical sagittal alignment and reduces neck pain in patients with non-specific neck pain.

Neck pain is a musculoskeletal system disorder that causes social and economic loss by reducing the quality of life (QOL) of the individual, and its prevalence varies from 16.7 to 75.1% in the adult population. Non-specific neck pain (NNP) is a symptom related to a postural or mechanical cause. NNP is also associated with loss of cervical curvature. In healthy spines, the axial load along the cervical spine is supported along the ventral column of the spine. However, in spines with the loss of lordosis, the load moves more anteriorly, which causes neck pain. Cervical exercise has been shown to be an effective treatment for neck pain and cervical alignment, but there is still a need for more clinical trials evaluating the effectiveness of the exercise approach. It seems reasonable to assume that naturally good neck muscle strength and range of motion are likely to be protective factors against neck pain.

As per previous research, the effects of exercise therapy on non-specific neck pain have been examined but there is limited literature available for use of cervical and shoulder retraction exercises in patients with nonspecific neck pain. Most of the studies have been done with neck isometrics, manual mobilization, and deep cervical flexors training and there is less scope of practicing cervical extension traction in contrast with modified cervical and shoulder retraction exercises. Previous research is limited by no use of a control group in a modified retraction exercise regime. To fill this literature gap this study is proposed which will focus on the clinical significance of modified cervical and shoulder retraction exercises on pain, disability, and Cobb's angle in the management of non-specific neck pain.

Eligibility Criteria:
Inclusion Criteria:

* Neck pain history
* Patients with Lateral Cervical Radiograph
* Patients who agreed for a follow up of 6 weeks

Exclusion Criteria:

* Congenital abnormalities e.g. torticollis
* Past surgical history of cervical spine
* Positive VBI sign
* Patients with inflammatory or rheumatic diseases
* Already undergoing physiotherapy treatment
Pedal Arch Revascularization in Patients With Chronic Limb Threatening Ischemia

Chronic limb threatening ischemia (CLTI) is a major cause of morbidity and mortality worldwide and is characterized by multilevel disease, often involving the tibiopedal vessels . CLTI is an undesirable clinical consequence of peripheral arterial disease (PAD) . It affected ∼8 million people in the USA and affects 12-20% of American people aged more than 65 years. Within 1 year of diagnosis, 25% of those patients progress to a major amputation and the other 25% die due to co-morbid conditions

Revascularization is the cornerstone of Chronic limb threatening ischemia (CLTI) treatment for lower limb preservation . Endovascular revascularization is the favored approach in many centers because of its lower morbidity and mortality than open surgery . In a subset of patients with Chronic limb threatening ischemia, particularly in longstanding type 1 diabetic patients, a predominance of disease involving the pedal vessels can exist with relative sparing of the tibial vessels .The pedal arch describes the connection between the anterior and posterior circulation in the foot, this typically runs from the lateral plantar artery into the dorsalis pedis and represents the final arcade of outflow for the lower extremity vasculature . Secondary or "deep" pedal plantar loops connecting the medial and lateral tarsal arteries to the medial and lateral plantar arteries can also exist . A strong understanding of the pedal arch anatomy and its multiple connections is important for the physician performing not only pedal arch interventions, but tibial interventions as well . Familiarity with the arch anatomy increases procedural success rates in tibial intervention, as it gives the operator another collateral pathway to approach the target occlusion in a retrograde fashion . An intact pedal arch has been associated with improved wound healing, as well as a higher patency rate for bypass grafting and percutaneous interventions for inflow disease . An Angio some-directed revascularization strategy, however, has clearly been shown to improve wound healing and limb salvage rates in both surgical and endovascular series . Pedal arch intervention should therefore be considered in patients with advanced tissue loss, with a goal of restoring inline flow to the corresponding angiosomes, this could mean the difference between a major and minor amputation, as the options for these patients are limited and major amputation rates are high .

Eligibility Criteria:
Inclusion Criteria:

All patients with Chronic limb threatening ischemia present with one or more of the following:

* Rest pain (Rutherford category 4)
* Minor tissue loss (Rutherford category 5) admitted to the department of Vascular surgery for Endovascular Intervention with provided written informed consent.

Exclusion Criteria:

* Patients presented with proved vasculitis.
* Patients with Chronic liver disease if there is prolonged PT.
* Patients with Heart failure if the patient is orthopneic and cannot lay on table for long time).
* Patients with impaired renal function.
Effects of Xal-Ease on Patient Compliance With Xalatan

The study hypothesis is that the Xal-Ease with increase patient compliance with XALATAN


Eligibility Criteria:
Inclusion Criteria:

* 40 to 80 years old
* Diagnosis warranting treatment with Xalatan eye drops.
* ambulatory and well functioning

Exclusion Criteria:

* non-ambulatory
* less than 40 or greater than 80 years old
* Not using Xalatan eye drops
Study Comparing Cyclosporin Dose Reduction With Cyclosporin Elimination in Kidney Transplant Recipients Taking Sirolimus

To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving induction therapy with cyclosporin (CsA, Neoral) and Rapamune® followed by CsA dose reduction and concentration-controlled Rapamune® versus induction with CsA and Rapamune® followed by discontinuation of CsA and concentration-controlled Rapamune®.


Eligibility Criteria:
Inclusion Criteria:

* Age: = to ≥ 18 years.
* End-stage renal disease, with patients scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related donor.
* Patients with second and subsequent transplants must have maintained their primary graft for at least 6 months after transplantation (with the exception of graft failure due to technical reasons).

Exclusion Criteria:

* Evidence of active systemic or localised major infection prior to initial Rapamune® administration.
* Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during screening.
* Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase. Exception: the use of erythropoiesis stimulating products. In these cases, erythrocyte-stimulating products must be discontinued prior to administration of Rapamune®.
Knee Alignment Contributions to Anterior Cruciate Ligament (ACL) Injury

This study evaluates the the anatomic factors of the knee that may predispose to ACL injury.

Despite intense study of anterior cruciate ligament injury during the past three decades, the mechanisms of this injury have not been clearly defined. A recent study by the Principle Investigator identified differences in leg alignment when a single leg landing during a sports activity resulted in a torn ACL and when it did not (provocative versus control alignment, respectively).

The purpose of the study is to quantify the tibiofemoral alignment in the lateral compartment of the knee in the provocative landing position and the control landing position. in order to elucidate possible mechanisms of ACL injury Material and Methods: 25 normal controls will be recruited from the greater Washington DC population. Magnetic resonance images in the sagittal plane will be acquired for a single leg of each subject. These images will cover the lateral compartment of the knee and will be acquired with the leg in three positions, one that emulates the injury position, one that exagerrates the injury position, and one that emulates the control landing position. Statistical analysis of the measurements between the provocative, exagerrated provocative, and control positions will then be performed.

These insights could then be applied to improving training focused on reducing the incidences of ACL rupture; improving bracing designs to help athletes most at risk of ACL rupture or those recovering from ACL injury/surgery; and improving ACL replacement surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Healthy controls
* Ages 18-45 years old

Exclusion Criteria:

* Previous knee injury or surgery
* Metal implants in body