cyrilzakka/clinical-trials huggingface dataset:
Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Docetaxel for Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens: weekly docetaxel plus cisplatin followed by gemcitabine; and gemcitabine plus cisplatin followed by weekly docetaxel。

Lung cancer is the leading cause of cancer death in men and women worldwide. Shifting trends in the incidence of lung cancer closely follow the patterns of cigarette smoking, although other carcinogens have been implicated. Despite intensive treatment over the past several decades, the 5-year lung-cancer survival rate remains a dismal 8-14%.

Chemotherapy is the primary therapy to patients with stage IIIB/IV disease, and most investigators believe that treatment with a combination of two agents is the best first-line treatment for stage IV NSCLC. In the late 1970s and 1980s, studies were conducted using combinations of agents. Outcomes were improved and these agents were eventually incorporated into clinical practice.

Weekly docetaxel is being studied in combination with other commonly used NSCLC chemotherapeutic agents including carboplatin, navelbine, and gemcitabine. These combinations are being studied in both first- and second-line settings. Second line chemotherapy with docetaxel may affect survival (TAX 318, 1 year survival 37% vs. 11%). However, the optimal sequence of chemotherapy was rarely explored. Weekly docetaxel may offer better tolerability vs. 3-weekly schedule when combining docetaxel to cisplatin. Based upon these studied, we choose weekly docetaxel in combination with cisplatin as our regimen. We expected the regimen would be effective and well tolerated.

Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of stage IIIB/IV NSCLC, no prior chemotherapy
* Age \> 18 years and \< 75 years
* WHO PS: 0,1
* Unidimensional or bi-dimensional measurable disease
* Neutrophils \> 1.5 109/l, Platelets \> 100 109/l, Hemoglobin \> 10g/dl, Total bilirubin \< 1.5 UNL, AST (SGOT) and ALT (SGPT) \< 2.5 UNL, Alkaline phosphatases \< 5 UNL; except in presence of only bone metastasis and in the absence of any liver disorders
* Creatinine \< 1 UNL, and creatinine clearance should be \> 60 ml/min.
* Life expectancy \> 12 weeks

Exclusion Criteria:

* Pregnant, or lactating patients
* Known clinical brain or leptomeningeal involvement
* Pre-existing motor or sensory neurotoxicity of a severity \> grade 1 by NCIC-CTG criteria
* CHF, angina or arrhythmias
* History of significant neurological or psychiatric disorders
* Active uncontrolled infection
* Contraindication for the use of corticosteroids
* Concurrent treatment with other experimental drugs within 30 days prior to study entry
* Concurrent treatment with any other anti-cancer therapy
Nerve Stimulator for Patients With Upper Extremity Disease, Vascular or Orthopedic Surgery

To help determine if there is improved pain relief when a device that makes an arm muscle move (nerve stimulator) is used to place a needle in the area above the collarbone to prevent feeling of pain (anesthesia) of the upper arm.

The Investigators will use the assessment of onset of motor and sensory block Q 5 minutes to distinguish the difference between blocks performed with ultrasound guidance with or without a nerve blockade monitor.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and females 21 through 89
* Agree to study participation and signed the informed consent
* Scheduled for upper extremity surgery with ultrasound guided supraclavicular block -

Exclusion Criteria:

* Children
* Pregnant Women
* Persons with allergies to local anesthetics
* Persons with infections at or near site of needle insertion
* Patients with severe disturbance of cardiac rhythm and heart block
* Patients with severe respiratory compromise
* Patients requiring bilateral upper extremity anesthesia
* Patients with coagulopathy or medical anticoagulation
* Patients with traumatic nerve injury to neck or upper extremity
* Patients with preexisting neurological deficits in the distribution of the block
* Patients with previous surgery to the neck that may distort brachial plexus anatomy
Association Between Sagittal Patellar Offset and Anterior Knee Pain in Total Knee Arthroplasty

The aim of this study to evaluate whether the position of the sagittal patellar offset is a predictive factor for anterior knee pain in subjects having undergone bilateral multiradius total knee replacement.

A prospective, observational study. A total of to 80 subjects requiring bilateral multiradius knee arthroplasty will be enrolled. Anterior femoral offset, femoral diameter and patellar offset will be measured by orthopaedic surgeons. In addition, Visual Analogue Scale Score, Oxford Knee Score, WOMAC, SF12 and SF36 will be evaluated postoperative in patients long-term follow up to see if there is a relationship between anterior femoral offset and anterior knee pain.In the direct lateral knee joint radiograph, the distance between the two parallel axis extending from both cortices of the femur is measured as "femoral diameter".The remaining length between the anterior axis and the maximum peak at the anterior of the prosthesis is considered as an "anterior femoral offset"\[1\]. Sagittal patellar offset defined by us as the ratio of the anterior femoral offset to the remaining distance between the maximum anterior point of the patella and the posterior vertex in the direct lateral knee joint radiography.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 50 years of age with primary severe gonarthrosis who will undergo total knee replacement

Exclusion Criteria:

* Patients with severe gonarthrosis, with a history of malignancy, with severe extraarticular deformity, with posttraumatic and septic arthritis sequel
Efficacy Study of Switching to a Lutenizing Hormone-releasing Hormone (LHRH) Antagonist From a LHRH Agonist to Treat Progressive Castrate Resistant Prostate Cancer (CRPC)

Men with castrate resistant prostate cancer who are switched from a luteinizing hormone-releasing hormone (LHRH) antagonists from a LHRH agonist will experience a fall in prostate-specific antigen (PSA).

To determine the proportion of patients with castrate resistant Prostate Cancer who have a PSA decline of ≥50% from baseline PSA when switched from an LHRH agonist to an LHRH antagonist.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed adenocarcinoma of the prostate
* currently receiving LHRH agonist
* Anti-androgen oral therapy is permitted but will be discontinued upon enrollment
* PSA \> 2 ng/ml
* rising PSA despite LHRH agonist
* patients may or may not have clinical evidence off metastases. If metastases are present, they must be asymptomatic and in bone or lymph node only
* Prior chemotherapy allowed
* ECOG performance status 0-1

Exclusion Criteria:

* Patients with a history of other active malignancies, except: adequately treated non-melanoma skin cancer, superficial bladder cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 3 years.
* Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including: i)Significant cardiovascular condition including but not limited to: uncontrolled hypertension, unstable angina, significant congestive heart failure or myocardial infarction, deep venous thrombosis, pulmonary embolus or cerebrovascular attack within the last 6 months. ii) History of significant neurological disorder that would impair the ability to obtain consent
Activated Protein C and Microcirculation

Objective: to test the hypothesis that recombinant activated protein C (aPC) therapy improves the microcirculation of severe septic patients.

Design: Prospective, open study. Setting: University 12-beds intensive care unit. Patients: Septic patients with at least two sepsis-induced organ failures occurring within 48 hours of the onset of sepsis were included in a one year period.

Interventions: Patients who had no contraindication to aPC administration received aPC at a dose of 24 mcg/kg/h for 96 hours. Patients with contraindications to aPC infusion were considered as controls.


Eligibility Criteria:
Inclusion Criteria:

* Septic patients with at least two sepsis-induced organ failures occurring within 48 hours of the onset of sepsis

Exclusion Criteria:

* hematologic or advanced malignancies
* liver cirrhosis
* severely impaired consciousness (Glasgow Coma Scale score \<7 of 15)
* therapeutic limitations (do-not-resuscitate orders)
Comparison of the Safety and Cost of a Simplified Post-Operative Radiograph (SPOR) Protocol

The standard post-operative radiographic protocol for the monitoring of fractures at Health Sciences Centre includes post-operative in hospital radiographs as well as radiographs at the two week follow up appointment. This is in addition to good quality intra-operative radiographs. With current operative techniques and implants, orthopaedic surgeons can achieve reliably stable internal fixation. In fact, patients are often allowed to take weight through the fractured limb immediately post-operatively. In these cases, redundant post-operative radiographs likely represent an avoidable cost to the system financially, and an avoidable cost to the patient in additional time spent in hospital and unnecessary radiation exposure.


Eligibility Criteria:
Inclusion Criteria:

* At least one lag screw for each fracture line
* At least one compression plate across each fracture line
* Locked intramedullary nail
* Articular/peri-articular fracture with antiglide/under-contoured plate
* Tension band technique (plate included) in simple fracture pattern
* Operating surgeon is confident in fixation construct, despite non-load sharing criteria.

Exclusion Criteria:

* Fracture \>21 days old
* Age \<18 years, or open growth plates
* Articular fracture with depression
* Multiple orthopaedic fractures
* History or radiographic appearance of osteoporosis/osteopenia or poor operative bone quality
* Likely difficulty with follow-up in first 6 weeks
Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis

Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid treatment (commonly used in eczema) in patients with severe atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Severe atopic dermatitis
* 5% of total body surface area (TBSA) affected

Exclusion Criteria:

* Concurrent skin diseases (infections)
* Immunocompromised
* Recently received phototherapy or systemic therapy
Infraclavicular Block: Decreased Incidence of Tourniquet Pain, Compared to Axillary Brachial Plexus Block?

The purpose of this study is to determine whether the incidence of tourniquet pain is decreased if infraclavicular nerve block is administered, compared to axillary brachial plexus block, for surgical interventions at the level or distal to the elbow.

Pneumatic tourniquets are often used in orthopedic surgery to ensure bloodless surgical field. Besides their obvious positive effects, arterial tourniquets have some unfavorable properties. One of these is tourniquet pain, which can manifest in the presence of an otherwise adequate neuraxial or peripheral nerve block. If it develops, it is usually difficult to manage, and can be severe enough to necessitate conversion to general anaesthesia.

In the past the incidence of tourniquet pain, associated with different nerve blocks has been estimated in clinical trials for which it was a secondary outcome measure. One recent meta-analysis addressed the question: is infraclavicular block (ICB) associated with a lesser incidence of tourniquet pain compared to other brachial plexus blocks. The studies selected by this meta-analysis used different types of nerve block. However it did not address the clinically relevant question: using standard techniques for ultrasound guided brachial plexus block (USgBPB) is the infraclavicular approach associated with a lesser incidence of tourniquet pain than the axillary approach? The following nerves contribute to the perception of tourniquet pain: musculocutaneous, radial, medial cutaneous brachial (MCBN) and intercostobrachial (ICBN). The potential advantage of the ICB over the axillary brachial plexus block (ABPB) in regards to tourniquet pain comes from anatomical reasons. In the pyramid shaped infraclavicular space the cords are much closer to each other; thus the likelihood of achieving effective MCBN and ICBN block is greater. The infraclavicular route has proven to result in an equally effective, reliable and safe block of the brachial plexus, compared to the axillary approach. We hypothesize that the incidence of tourniquet pain is less with infraclavicular block compared to axillary brachial plexus block.

The aim of the study is, to compare the incidence and severity of tourniquet pain associated with ultrasound guided ICB and ABPB in patients undergoing orthopedic surgery at the level or distal to the elbow, with a tourniquet time longer than 45 minutes.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Orthopedic surgery at the level or distal to the elbow
* Expected tourniquet time \> 45 min (K-wiring not suitable)

Exclusion Criteria:

* Contraindication of regional anaesthesia, patient is allergic to local anesthetics
* Clinically significant cognitive impairment (Minimental state score \< 24)
* Chronic pain syndrome
* Preexisting nerve damage in the operated arm (sensory or motor deficit)
* Axillary clearance in the past
* History of peripheral neuropathy)
* Pregnancy
Macrophages, GM-CSF and MARS Proteinosis

Mutations in the MARS gene encoding methionyl-tRNA synthetase are responsible for a genetic form of alveolar proteinosis (PAP), but the pathophysiological mechanisms of the respiratory phenotype are not known.

The main hypothesis is that the PAP phenotype in these patients is secondary to a defective clearance of the surfactant by the alveolar macrophages.

The main objective of the study is to study the clearance capacity of lipoproteinaceous material by macrophages of patients with MARS related PAP. This will be investigate in cultured macrophages derived from peripheral blood monocytes of patients (patients with MARS related PAP) and controls (patients without MARS related PAP).

Pulmonary alveolar proteinosis (PAP) is a rare respiratory disease characterized by the accumulation of lipoproteinaceous material within the pulmonary alveoli, resulting in the majority of cases from a defective clearance of the surfactant by intra-alveolar macrophages.

Mutations in the MARS gene encoding methionyl-tRNA synthetase are responsible for a genetic form of alveolar proteinosis, but the pathophysiological mechanisms leading to mutations in the respiratory phenotype are not known.

The main hypothesis is that the alveolar proteinosis phenotype in these patients is secondary to a defective clearance of the surfactant by the alveolar macrophages.

The main objective of the study is to study the clearance capacity of lipoproteinaceous material by macrophages of patients with MARS related PAP. This will be investigate in cultured macrophages derived from peripheral blood monocytes of patients (patients with MARS related PAP) and controls (patients without MARS related PAP).

The subjects and the controls will be included during a hospitalization during which a blood sample and a bronchoscopy with broncoalveolar lavage must be performed as part of their care.

Eligibility Criteria:
Inclusion Criteria:

* Minors from 0 to 17 years hospitalized for their care at Necker Enfants Malades hospital and for whom a blood sample and a bronchoscopy with bronchoalveolar lavage must be performed as part of their care
* Information and consent of the holders of parental authority and the patient

Exclusion Criteria:

- Refusal of holders of parental authority or patient
The Effects of Point-of-care Ultrasonography

Background: When used with standard diagnostic testing, point-of-care ultrasonography (POCUS) might improve the proportion of patients admitted with chest pain (CP) who are correctly diagnosed, decrease length of stay (LOS) in emergency department (ED) and costs. We therefore assessed POCUS for the heart, lungs, aortic, hepatobiliary and deep vein in addition to the usual initial diagnostic testing in this patient population.

Methods: In a prospective, randomised-controlled, parallel-group trial in the ED at Sakarya University Training and Research Hospital, Turkey, patients (≥18 years) with CP were randomly assigned in a 1:1 ratio to a standard diagnostic strategy (control group) or to standard diagnostic strategy supplemented with POCUS (POCUS group).


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the emergency were included in this study if they had chest pain, or chest pain with back pain, neck and jaw pain, abdominal pain, arm pain and shortness of breath

Exclusion Criteria:

* permanent mental disability
* age younger than 18 years
* having chest trauma in the last 24 hours
* to be pregnant
* need for urgent angiography with ST elevation myocardial infarction
* to be referred to the ED as a diagnosis of external center
* failure to obtain complete patient information
Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting

The primary objective of the study is to determine how the short-term outcome of subjects implanted with the JOURNEY™ II BCS Total Knee System compares to subjects implanted with other PS total knee systems, and to determine if there is a difference in health care resources consumed that may result in economic savings to patients, the facility and/or the payer.

To address the study objectives, patient self-assessment questionnaires, and other objective measures of post-operative function and health care resource utilization will be used for data collection.


Eligibility Criteria:
Inclusion Criteria:

* Undergone unilateral primary total knee replacement with a JOURNEY™ II BCS Total Knee System or other Non-Smith \& Nephew Posterior Stabilized Knee System
* Will be initiating outpatient PT ≤ 7 days post-operatively
* Has a primary diagnosis of osteoarthritis, degenerative arthritis, or traumatic arthritis
* Has pre-operative ROM ≥ 90°
* Is skeletally mature in the PI judgment
* Is 21 years of age of older
* Is willing and able to participate in required follow-up visits at the study site and to complete study procedures and questionnaires
* Has consented to participate in the study by signing the IRB/EC approved informed consent for the study
* Agrees to follow post- operative physical therapy program

Exclusion Criteria:

* Significant preoperative varus or valgus deformities (\>15º)
* Has received a constrained or deep dish tibial insert
* Morbid obesity (BMI \> 40)
* Has not obtained required pre-rehabilitation, pre-operative and intra-operative records by week 2 visit
* Other comorbidities that may impact outcomes such as osteoporosis, uncontrolled diabetes and active infection
* Fibromyalgia requiring treatment
* Current or impending incarceration or is a prisoner
* In the opinion of the PI has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse
* Is known to be at risk for lost to follow-up, or failure to return for scheduled visits
* Undergone or is planning to undergo total knee replacement of the contralateral knee within 6 months of this total knee replacement
* Requires a Legally Authorized Representative to consent to the study
Safety and Tolerability of KH631 Gene Therapy in Participants With Neovascular Age-related Macular Degeneration

VAN-2201 is Phase I clinical trial to assess the safety and tolerability of KH631 in subjects with neovascular AMD. KH631 is gene therapy designed to deliver a protein which targets and blocks VEGF via an adeno-associated viral vector. The standard of care for patients with neovascular AMD are anti-VEGF treaments, which have demonstrated improvement in vision and reduction in fluid. A one time placement of a product which inhibits VEGF has the potential to reduce the patient burden of regular intraocular injections.

The VAN-2201 clinical trial is a multicenter, open-label, dose-escalating clinical study. The primary objective of the study will be to establish a safe and tolerable dose range in subjects with neovascular AMD. Five dose cohorts are planned to be included in the study, with approximately five subjects per cohort. Subjects who meet the eligibility criteria (i.e. all the inclusion and no exclusion criteria) will be enrolled to receive KH631. KH631 will be delivered at the dose level according to the cohort via intraocular injection. Subjects will be seen monthly until the primary outcome measurement at 24 weeks and through week 52. The subjects will be continued to followed with regular visits until they complete the 104 week visit.

Eligibility Criteria:
Inclusion Criteria:

1. Males and Females ages 50 to 85 (inclusive) with a study eye which meets the following criteria:

a. Previously received IVT treatment of anti-VEGF for neovascular AMD, with documented response to anti-VEGF therapy during the first 2 weeks of screening b. active macular CNV lesion secondary to AMD evidenced by SD-OCT c. Have a ETDRS BCVA letter score of 63 to 19 (approximately 20/63 to 20/400 Snellen equivalent) in the study eye at Screening for the first subject in each cohort (sentinel subject), followed by ETDRS BCVA letter score of 73 to 19 (approximately 20/40 to 20/400 Snellen equivalent) for the rest of the subjects each cohort; d. Pseudophakia in the study eye, with ocular media to permit high quality fundus imaging at screening and allow planned vitrectomy and subretinal injection; e. Are willing and able to sign the study written informed consent form (ICF).

Exclusion Criteria:

1. Have had any prior ocular or systemic treatment (investigational or approved) or surgery for the treatment of neovascular AMD except IVT anti-VEGF
2. Retinal pigment epithelial tears or rips at screening
3. Any history or presence of vitreous hemorrhage;
4. Have any condition preventing visual acuity improvement;
5. Have any other cause of CNV; prior pars plana vitrectomy or scleral buckling or retinal detachment surgery; macular hole, Epiretinal membrane or vitreo-macular traction; full thickness macular hole;
6. History of intraocular or periocular surgery in the prior 3 months;
7. Prior trabeculectomy or other filtration surgery ;
8. Any use of long-acting intraocular steroids, including implants, within six months prior;