cyrilzakka/clinical-trials huggingface dataset:
Recurrent Predictive Power of Circulating Tumor Cells for Non Small Cell Lung Cancer Patients

From literature review, circulating tumor cell was demonstrated its possible role in disease relapse. It was rare nit could be identified in all lung cancer patients. In addition, circulating tumor cell usual aggregate to form circulating tumor micro-emboli and caused distant metastases. Therefore, circulating tumor cell could play a role in detect disease relapse and appropriate treatment could be given more earlier and further prolong patients' survival. However, the detail clinical significance of circulating tumor still remains unknown. The aim of this study was evaluate the clinical significance, including present timing, numbers, and correlation to disease relapse, of circulating tumor cell in lung cancer patients. The investigators want to clarify the clinical significance between circulating tumor cell and clinical presentation of lung cancer in order to establish new prediction model and improve lung cancer patients' survival.

Study subject:

Inclusion criteria 1. Patients with clinical stage 1 to 3a non-small lung cancer 2. Patients with a resectable suspicious pulmonary lesion which is difficult for pre-operation tissue prove or refused for pre-operation biopsy 3. Received curative intended tumor resection Exclusion criteria

1. Small cell lung cancer component which identified in pathology
2. Patients who presented as stage IIIb or IV
3. Not received curative intended surgery due to multi-comorbidities
4. Patients who presented in tumor seeding or positive resection in pathology confirmation
5. Patients who received neoadjuvant therapy

Data collection:

medical record review and blood sampling for circulating tumor cell purification

Timing of blood sampling:

a.Pre-operation, post-operation, post-operation day 1, post-operation day 3 b regular OPD surveillance (3 month-interval) for 3 years

Blood sampling: 20 ml blood that withdrawn from a peripheral vein

Circulating tumor cell purification: two-step procedure

1. cell isolation: centrifugation, isolated karyocyte \> 10 micrometer
2. negative selection: wash out RBC, WBC depletion
3. positive selection: purify circulating tumor cell (karyocyte which presented CD 45 negative, Epi-CAM positive, diameter greater 10 micrometer

Result analysis:

Combine the medical record to analyze the relationship between circulating tumor cells and disease relapse

Eligibility Criteria:
Inclusion Criteria:

1. Non-small cell lung cancer patients with stage I to III
2. Patients with resectable suspicious pulmonary malignant lesion

   1. no pre-operation diagnosis ( patients refused biopsy or difficult for biopsy)
   2. image survey showed clinical stage I to III

Exclusion Criteria:

1. Final pathology coexisted with small cell lung cancer component
2. Patients who presented as stage IIIb or IV.
3. Not received curative intended surgery due to multi-comorbidities.
4. Patients who presented in tumor seeding or positive resection in the final pathology
5. Patients who received neoadjuvant therapy.
Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid Arthritis

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and tolerability of the drug Anti-IL-20 in subjects with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities
* A diagnosis of rheumatoid arthritis made at least 3 months prior to screening
* Active rheumatoid arthritis, characterised by a DAS28 equal or above 3.2
* Methotrexate treatment (stable dose, equal or below 25 mg/week) for at least 4 weeks prior to study start (subjects receiving stable doses of oral corticosteroids, and/or non-steroidal anti-inflammatory drugs and/or acetaminophen and/or opioids according to prescribed recommended doses can be included)
* Male subjects and female subjects of non-child bearing potential

Exclusion Criteria:

* Body mass index (BMI) less than 18.5 or above 35.0 kg/m2
* Subjects with chronic inflammatory autoimmune disease other than rheumatoid arthritis
* History of or current inflammatory joint disease other than rheumatoid arthritis
* Chronic or ongoing infectious disease requiring systemic anti-infectious treatment within 2 weeks prior to study start
* Past or current malignancy (as judged by the investigator)
* Clinically significant cardiac or cardiovascular disease
* Positive for human immunodeficiency virus (HIV), hepatitis or tuberculosis
* Blood donation or blood loss of more than 0.45L within 2 months prior to study start, or longer if required by local regulations
* Breast-feeding women
Sarcopenia and Risk of Falls in Patients With Major Chronic Diseases

The objective of this study is to investigate the effects of therapeutic exercise and nutrition intervention for sarcopenia and risk of falls in patients with major chronic diseases. The outcomes will be analyzed regarding muscle strength, quality, and volume, etc., balance and gait, bone density, body composition, fall and quality of life after the intervention.

The main common chronic diseases in the elderly such as stroke, osteoporosis, chronic kidney disease and cancer, have been regarded as the fall high-risk patients. These patients are considered to be at risk for sarcopenia due to decreased exercise, nutritional status, and other reasons. Sarcopenia can be diagnosed and intervened effectively to delay the vicious cycle of health. Past studies have pointed out that in addition to drug intervention, treatment for sarcopenia must be accompanied by appropriate exercise and nutritional intervention (such as protein supplements, vitamin D) in order to achieve the best prevention and treatment.

Eligibility Criteria:
* Inclusion Criteria:

  1. 55-85 years old
  2. 3-6 months after onset
  3. walk independently for at least 10m
* Exclusion Criteria:

  1. lower limb Brunnstrom stage \>5
  2. combine other neuropathy diseases
  3. significant deformity of lower limb include: Modified Ashworth scale(MAS) \>3; contracture, fracture, chronic joint pain.
  4. joint arthroplasty
  5. unstable vital sign
  6. can not cooperate study
Topical Bevacizumab for Preventing Recurrent Pterygium

The purpose of this study is to determine whether bevacizumab eye drop is effective in the treatment of recurrent pterygium.

A pterygium is a degenerative and proliferative fibrovascular disorder of the ocular surface. Patients may be asymptomatic, irritation, decreased vision, diplopia or limit ocular movement. The mainstay treatment is surgical removal of the head, neck and body of the pterygium. However, if there is no adjunctive treatment, the recurrence is unacceptably high which is 63% in general. Various adjunctive measures are applied to prevent recurrence including use of mitomycin C, beta-irradiation and surgical methods such as conjunctival and amniotic membrane graft. However, each method has its advantages and disadvantages.

The histologic finding of recurrent pterygium often has aggressive fibrovascular growth. Vascular endothelial growth factor(VEGF)has been detected in increased amounts in pterygium tissue, compared with normal conjunctiva and it is also correlated with post-operative recurrence. Bevacizumab, an Anti-VEGF, binds to VEGF and prevents the interaction of VEGF to its receptors on the surface of vascular endothelial cells. Administration of bevacizumab leads to inhibition of endothelial cell proliferation and new blood vessel formation. Even though there are reported the efficacy of topical bevacizumab in inhibiting the impending recurrent pterygium, there is no study for preventing recurrence after primary pterygium removal.

We conduct a prospective, randomized, double-masked, controlled trial to evaluate the efficacy of topical bevacizumab 0.05% eye drops for preventing recurrence in primary pterygium.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with primary pterygium and plan for pterygium excision with bare sclera by single surgeon. (G.N.)
* Patients with pterygium who understand and can follow the study protocol.
* Patients of age more than 30 years

Exclusion Criteria:

* Patients who have corneal melt, corneal epitheliopathy, abnormal corneal epithelial wound healing.
* Patients who are pregnancy or lactation.
* Patients who have a history of allergy to bevacizumab.
* Patients who have a history of allergy to steroid eye drops
Dance Well Therapy: a Study for Evaluating Efficacy, Safety, and Feasibility

A new and in-teresting complementary approach for rehabilitation of parkinsonian patients is represented by "Dance Well", which is an artistic, multisensory dance intervention based on art and music. This study aims to evaluate the efficacy, feasibility, and safety of a 4-week Dance Well (DW) program in PD patients in early-medium disease stages.

Background/Objectives: Parkinson's disease (PD) is a complex neurodegenerative disorder re-sponsible for both motor and non-motor disturbances impairing the motor behaviour. This com-plexity needs for integrated, multidisciplinary and comprehensive models of care. A new and in-teresting complementary approach is represented by "Dance Well," i.e., an artistic, multisensory dance intervention based on art and music. This pilot study aims to evaluate the efficacy, feasibility, and safety of a 4-week Dance Well (DW) program in PD patients in early-medium disease stages. Methods: Twenty-four PD patients (H\&Y ≤ 3; MoCA score ≥ 13.8) were enrolled and randomly allocated into two groups, both with a twice per week frequency and lasting 4 weeks: one group underwent the DW program, while the other underwent conventional physiotherapy (CPT). De-mographic, biometric, and clinical data were collected. To study the treatment effect, motor (Unified PD Rating Scale-III, Timed-up and Go Test, Berg Balance Scale, 6-Minute Walk Test, and Falls Efficacy Scale), cognitive (Corsi Supra Span Test, Trial Making Test A and B-A), and affective (Beck Depression Inventory, State-Trait Anxiety Inventory, Apathy Evaluation Scale) outcome measures were as-sessed, before and after rehabilitation program. To study the treatment compliance and safety, number of dropouts and any adverse events (such as injuries and falls) were recorded.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of PD according to the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria; rate score 0-3 on the modified Hoehn \& Yahr (H\&Y) scale.

Exclusion Criteria:

* other neurological or psychiatric diseases other than PD;
* serious visual and/or auditory deficits;
* orthopedic-muscular and or co-morbid medical conditions precluding partici-pation in dance;
* cognitive decline (MoCA score \< 13,8)
A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma

Prospective, unmasked, evaluation of the iStent in patients that have primary open-angle glaucoma (OAG). Stent implantation in one eye will be used for analysis, with medication added at 6 months, as required.

One hundred patients will be enrolled in the study at up to 21 sites; follow-up is through 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary open-angle glaucoma
* Male or female at least 18 years of age and able to provide written informed consent
* Mean IOP (at baseline visit after washout of any medications) must be at least 22 mm Hg and no greater than 38 mm Hg
* Likely to be available and willing to attend follow-up visits

Exclusion Criteria:

* Angle closure glaucoma
* Secondary glaucomas
* Prior glaucoma procedures
* Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease
Effectiveness of Oral Hyaluronic Acid (A+ HA(tm), TOP Pharm.) in Knee Osteoarthritis: Clinical Trial

This is a double-blinded, placebo-controlled, randomized trial to assess the efficacy of oral solution of hyaluronic acid mixture (A+ HA(tm)). During 8 weeks treatment period, there were three follow-up visits requested (Week 2, Week 4 and Week 8).

Subjects were initially screened at the Randomization/Baseline Visit (Week 0). Eligible subjects were randomized at the same visit into treatment period, and received the assigned treatment in a double-blind fashion for 8 weeks. Efficacy was measured by the several questionnaire including Knee injury and Osteoarthritis (KOOS), the Short Form-36 (SF-36) and Pittsburgh Sleep Quality Index (CPSQI) for each visit. Incidences of adverse events (AEs) were monitored for each subject once the subject had received 1 dose of study medication; the incidence of serious AEs (SAEs) were monitored for each subject once the subject had signed the informed consent through to the End-of-Study or ET Visit. Vital signs were measured at baseline and End-of-Study or ET Visit.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 40 years old
2. Male or Female
3. With osteoarthritis of the knee based on the definition of Ahlback 1968 and with significant symptoms within 30 days before enrollment.
4. No limitation for use of concomitant medication

Exclusion Criteria:

1. Use of Glucosamine within 1 month before enrollment
2. Osteoarthritis of the knee due to exercise or occupational injury
3. Allergy with Oral Hyaluronic Acid
4. Bilateral Total Knee Replacement
5. Pregnant
6. Need use wheelchairs
7. BMI≥40
8. With at least one condition: Known other causes of arthritis (infectious arthritis, rheumatoid arthritis, connective tissue disease, gout, pseudogout, or psoriatic arthritis), bony or soft tissue malignancy or skin lesions or peripheral neuropathy involving the lower extremities, cardiopulmonary disease which limits walking more than knee pain. Knee instability defined as report of knee bucking or locking within the past month of the study knee, major neurologic deficit that affects gait, psychiatric illness that limits informed consent, and parkinsonism.
9. Cancer
Factors Determining the Prognosis in NSCLC Stage IV

This study is a cohort study with patients with advanced NSCLC. Patients will answer questionnaires about symptoms and quality of life and will be submitted to physical and blood tests, and computer tomography. The aim of this study is to estimate prognostic factors predicting survival to 3 months in patients with advanced NSCLC.

Non-small-cell lung cancer (NSCLC) is currently the neoplasm leading in deaths worldwide and in Brazil. NSCLC has a high incidence, is usually diagnosed in advanced stages and has poor survival rates. The ability to refine the prognosis of a disease has implications at the time of diagnosis and decision about treatment. Clinical and laboratory factors are studied to evaluated the prognosis of diseases. Palliative Prognostic Score (PaP score), Karnofsky Performance Status Scale (KPS), Palliative Prognostic Index (PPI) are applied in patients with many types of solid tumors. The Charlson Score evaluates comorbidities and the attributed risk for presence it. Others predictors of prognostic are cachexia, quality of life, inflammatory factors, sarcopenia. There is a need to improve the ability to estimate the prognosis and to identify the factors responsible to low survival rates in patients with NSCLC diagnosed at advanced stage, also as a tool for a better treatment selection.

This is an observational and prospective study, including patients diagnosed with NSCLC and admitted in ICESP, staged as IV at admission, with no previous systemic treatment and classified as ECOG 2-4. Demographic data, presence of a caregiver, anthropometry, MRC dyspnea scale, KPS, Edmont Symptom Scale, Charlson's Comorbidity Score, PPI and PaP were evaluated in each patient. Evaluation of sarcopenia and cachexia with abdominal CT (Slice-O-Matic, v.5), arm circumference, handgrip strength test and quality of life using EORTC score QLQ C-30 and QLQ-CAX-24 were also evaluated. Significant prognostic factors will be selected by multivariate analysis in a training set estimated as 217 patients.

Eligibility Criteria:
Inclusion Criteria:

* Advanced stage IVa or IVb NSCLC patients histologically diagnosis.
* Eastern Cooperative Oncology Group Performance status 2 - 4
* Treatment-naive

Exclusion Criteria:

* Initiate treatment before initiate
* psychiatric illnesses, except depression
* pregnant or breastfeeding women
* two concomitant neoplasms
A First Time in Man Study to Asses the Safety and Tolerability of AZD7624 in Healthy Subjects

This is a First in Human study to assess the safety and tolerability of AZD7624, following inhaled administration of single ascending doses in healthy male volunteers and female volunteers of non-child bearing potential. Pharmacokinetics (what the body does to the drug) and pharmacodynamic (what the drug does to the body) parameters will be also assessed as secondary objectives.

A Double-blind Placebo-controlled, Randomised, Single centre, First Time in Man Study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD7624 in Healthy Subjects

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects aged 18 to 55 years
* Able to inhale from the SPIRA nebuliser according to the provided instructions
* Females must have a negative pregnancy test at screening and on admission (Day 1) to the CPU, must not be lactating and must be of non-childbearing potential.
* Body mass index (BMI) between 18 and 30 kg/m2 inclusive and weighing at least 50 kg and no more than 100 kg inclusive.
* FEV1 \>80% of the predicted normal value.

Exclusion Criteria:

* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD7624
* History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
* History or family history of muscle diseases
* Known or suspected history of drug abuse as judged by the Investigator
* Use of any prescribed or non-prescribed medication including antacids, analgesics other than paracetamol/acetaminophen, herbal remedies, vitamins (excluding routine vitamins but including megadose \[intake of 20 to 600 times the recommended daily dose\])
Transciptomic Modification Induced by miRNAs in Endometrial Fluid

The purpose of this study is to understand the mechanism of communication between the uterine environment and the preimplantation human embryo. The investigators are interested in understanding how the in-utero environment during the window of implantation is different in normal weight and overweight/obese women and how this may impact the programming of the developing embryo.


Eligibility Criteria:
Inclusion Criteria:

* Meet the WHO criteria for normal weight (BMI \< 25) and overweight/obese (BMI \> 25)
* Age 21-45

Exclusion Criteria:

* Age \< 21 or \> 45
* Women with history of hysterectomy
Efficacy of ART to Interrupt HIV Transmission Networks

The investigators are conducting a study to learn more about the spread of HIV infection within different geographic regions and populations in San Diego County, with the goal of demonstrating that early use of HIV treatment can reduce the number of new infections in our community. At the study visits, participants will be examined by the study staff and asked to donate some blood. Participants will also be asked several questions about themselves, their background, behaviors, health, and the general geographic area in which they live. By collecting information about antiretroviral treatment choices that are made by study participants, the investigators will be better able to measure how effectively HIV treatment can interrupt (i.e., block) the spread of HIV. All of the information gathered at the study visits will be de-identified and analyzed. Study staff will use the information to better understand in which groups of people, and in what areas of San Diego, HIV is spreading most quickly. This information will be used to determine how well Antiretroviral Therapy (HIV treatment) by certain individuals can control the spread of HIV within the population.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years of age
2. Newly diagnosed HIV infection
3. ART naïve (≤7 days ART, previous use of PEP or PrEP are not exclusions)
4. Subject must be able to provide written consent
5. Subject must agree to study specific specimen collections and visit schedule.
6. Subjects with newly diagnosed HIV infection who were identified on or after May 1, 2014 will be eligible for enrollment as long as they are co-enrolled to either AEH020 (project 08-0278) or AEH030 (project 140093) and DID meet the above study inclusion criteria (items at the time of enrollment to protocols AEH020 or AEH030).

Exclusion Criteria:

1. Any factor or factors that in the opinion of the local investigator that could prevent compliance with study requirements.
2. Contraindication to phlebotomy or specimen collection.
Platelet Count and Function After Usage of Two Different Cell Saver Devices During Liver Transplant Surgery

Intraoperative cell salvage is commonly used in surgeries that carry a major hemorrhagic risk to reduce the administration of allogeneic red blood cells and thus improve the outcome for the patient. When processing the salvaged blood, however, a large part of the patient's plasma is washed out. This is a disadvantage with regard to an optimal coagulation status after these types of surgeries, especially liver transplantation.

There are currently various cell saver systems on the market. According to the manufacturers, the plasma is returned to the patient in different quantities as part of the processing procedure. Thus, it can be assumed that in addition to red blood cells, platelets (part of plasma) are re-transfused and contribute to an optimized coagulation. Unfortunately, there is a lack of studies in this regard in the liver transplant surgery population.

The investigators aim to study the performance of two different cell saver devices regarding preservation of platelet number and function.

- Study design: Randomized controlled bi-center trial

* Primary objective: to compare platelet number and function after processing and re-transfusion of the salvaged blood to the patient by using different cell saver devices.
* Secondary (main) objectives: to compare a) the coagulation profile and b) the usage of blood products (frequency of administration of labile and stable blood products).

Eligibility Criteria:
Inclusion Criteria:

* All adult patients undergoing liver transplantation surgery

Exclusion Criteria:

* Age \< 18 years old
* Active liver malignancy
* Preoperative use of oral or intravenous anti-coagulants or antiplatelet agents (except aspirin)
* Inability to understand and sign the informed consent form