cyrilzakka/clinical-trials huggingface dataset:
Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy

This study is multicenter, randomized, double-blinded, placebo-controlled Phase II study comparing vandetanib (300mg daily) plus best supportive care (BSC) to placebo plus BSC as maintenance treatment in patients with locally advanced or metastatic NSCLC, who have received and responded to prior platinum-doublet systemic chemotherapy. The primary objective of the study is to compare the Progression Free Survival (PFS) rate at 3 months in locally advanced or metastatic NSCLC patients with or without vandetanib maintenance.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic confirmation of locally advanced or metastatic NSCLC (IIIb-IV) at the time of original diagnosis.
* Completion of 4 cycles of chemotherapy of gemcitabine (1,000 or 1250mg/m\^2/day on day 1 and 8) and cisplatin (70-80mg/m\^2/day on day 1) every 3 weeks and have shown response, Complete Response(CR), Partial Response (PR) or stable disease (SD) by RECIST.
* WHO PS 0-1
* No prior radiotherapy to chest, immunotherapy or biologic therapy

Exclusion Criteria:

* Mixed small cell and non small-cell lung cancer history.
* Prior treatment with EGFR TKIs or VEGFR TKIs (prior treatment with cetuximab \[Erbitux\] or bevacizumab \[Avastin\] is not permitted.)
* Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol.
* Radiation therapy within 4 weeks before the start of study therapy. Major surgery within 4 weeks, or incomplete healed surgical incision before starting study therapy.
Pilot Study of the Safety and Efficacy of Oxandrolone in the Prevention and Treatment of Malnutrition in Infants

Oxandrolone is an anabolic steroid, marketed in the United States as an adjunctive therapy to combat weight loss resulting from chronic infection, extensive surgery, severe trauma, protein catabolism associated with prolonged administration of corticosteroids, and for the relief of bone pain accompanying osteoporosis. In children, it has been used to prevent and treat growth failure associated with severe burns (≥ 40% of total body surface area), Duchenne muscular dystrophy, Turner's syndrome, constitutional delay of growth and puberty, and chronic wasting in HIV-positive pediatric patients. Other applications in children have included treatment of central idiopathic precocious puberty, hereditary angioedema, and bilateral congenital anorchia. Growth failure is a common feature of infants with complex congenital heart disease, and can adversely affect outcome. This therapy has not been previously implemented in neonates thus we will evaluate the safety and efficacy of administering oxandrolone to improve growth in neonates with complex congenital heart disease who have undergone surgical palliation or repair by collecting anthropometric measurements and pharmacokinetic data.

Neonates with HLHS or variant with planned Norwood Procedure. The primary aims of this pilot study are to assess safety and efficacy of oxandrolone in this population. Our goal will be to enroll 5 patients in each phase of this pilot study. The incidence of adverse events will also be monitored and compared to untreated patients. Enrollment will continue until the target of 20 total patients has been met.


Eligibility Criteria:
Inclusion Criteria:

* Neonates with HLHS, with plan to undergo the Norwood Procedures

Exclusion Criteria:

* Neonates with a birth weight ≤2.5 kg and gestational age ≥38 weeks (indicating intrauterine growth retardation), gestational age \< 35 weeks (premature infants), and/or chromosomal or recognizable phenotypic syndrome of non-cardiac congenital abnormalities associated with growth failure (e.g. Trisomy 21, Trisomy 13, Noonan's syndrome, Turner's syndrome) will be excluded from enrollment. Neonates who will not be placed on the high risk feeding protocol postoperatively will also be excluded.
A Remote Physical Activity Program in the Population Suffering from Type 1 Myotonic Dystrophy

The COVID-19 pandemic exacerbates health problems by reducing access to adapted and advanced physical rehabilitation for several people who need rehabilitation services, including the population with myotonic dystrophy type 1 (DM1). The PACE tool, an innovative web tool integrating pragmatic physical activity programs, seems to be an interesting and innovative intervention to counter physical deficiencies of people with DM1, which are unfortunately accentuated by the pandemic, while reducing the risk of COVID-19 exposure. Objectives: 1) Evaluate the feasibility, usability and acceptability of the PACE tool in the DM1 population; 2) Evaluate the effects of the intervention on their physical and cognitive health; and 3) Estimate the cost-effectiveness ratio of this intervention. Method: Sixty people (experimental group = 40 and control group = 20) will participate in this randomized intervention study. Participants in the experimental group will be assigned to one of the 35 physical activity programs adapted to their condition of the PACE tool. The program must be performed on a daily basis for a period of 12 weeks. Physical and cognitive health will be assessed before and after the remote intervention via ZOOM, for all participants.


Eligibility Criteria:
Inclusion Criteria:

* DM1 diagnosis must be confirmed by genetic analysis (juvenile, adults or late-onset phenotypes);
* Aged between 18 and 60 years old;
* Be able to do exercise;
* Subjects must be able to give their consent freely and voluntarily.

Exclusion Criteria:

* Patients who already train (\>3 times per week or \>150min/week);
* Don't speak french or english;
* Are not able to do exercise (even in sitting position);
Kinetics of Perioperative Circulating DNA in Cancer Surgery

The aim of this study was to determine the kinetics of perioperative circulating DNA in three types of cancer. This first step will enable further studies comparing the potential impact of certain techniques or anesthetic products on cancer surgery.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is aged between 18-75
* Patient must weigh \>40kg
* The patient will receive adjusted carcinological surgery
* Indication of curative surgery
* The patient has already undergone tumoral biopsy prior to surgery
* The patient has stage M0 cancer of either colon (right or left colonic adenocarcinoma), prostate (adenocarcinoma) or breast (infiltrating carcinoma)

Exclusion Criteria:

* The subject is in a period of exclusion determined by a previous study
* The patient is under safeguard of justice
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is pregnant, parturient or breast feeding
* Chronic alcoholism
* The patient has received radiotherapy or chemotherapy periopratively
* Cancer other than colon, breast or prostate
* The patient has currently or in the past, had a cancerous lesion
* Neo-adjuvant therapy (immunotherapy, radiotherapy, chemotherapy)
* Emergency cancer surgery
Measurement of the Strength of the Posterior Tibial Muscle by Hand-held Dynamometer

Adult flat foot valgus is a degenerative pathology that causes damage to the ligaments of the hindfoot as well as dysfunction of the tendon of the posterior tibial muscle.

Currently, there is a lack of a tool allowing a standardized, reliable, reproducible and validated measurement of the strength of the tendon of the posterior tibial muscle in consultation of foot surgery.

The hand-held dynamometer could be that tool. The study would consist in measuring the strength of the tendon of the posterior tibial muscle in healthy subjects with a hand-held dynamometer (MicroFET2) by two examiners and compared to isometric reference measurements (CON-TREX CMV Multi-Joint) to validate the reliability of the measurement and its reproducibility.


Eligibility Criteria:
Inclusion Criteria:

* Patients from physical medicine and rehabilitation department hospitalized for pathologies other than neurological or osteo-articular pathologies affecting the lower limbs,
* Having no neurological or osteo-articular pathology affecting the lower limbs f one year,
* No history of surgery on the rear foot and ankle,
* Written informed consent from person,
* Socially insured patient person,
* Person willing to comply with all study procedures and study duration.

Exclusion Criteria:

* Neurological or osteo-articular pathologies affecting the lower limbs,
* Known pathologies of the tendon of the posterior tibialis muscle,
* Deformations of the foot (flat foot, hollow foot),
* History of hindfoot or ankle surgery,
* Pregnant or breastfeeding woman,
* Inability to receive information, consent and participate in the whole study,
* Person under judicial protection or deprived of liberty,
* Person participating in another clinical trial,
* No social insurance cover,
* No written consent.
Efficacy of Proprietary Cherry Juice Blend in Osteoarthritis of the Knee

The primary purpose of this research study is to test the ability of a proprietary cherry juice blend to be helpful in the treatment of osteoarthritis (OA) of the knee.

The primary objective is to determine if the proprietary tart cherry juice blend improves the pain and function in persons with knee osteoarthritis. A secondary objective is to ascertain if the blend lowers serum uric acid.

This is a prospective double blind, placebo controlled cross-over study.

The study will be performed in the Philadelphia VA Medical Center 1 South Rheumatology Clinic with patients meeting ACR criteria for Kellgren grade 2-3 knee osteoarthritis and 4-9 pain severity on a VAS. Fifty patients will be studied with each having 5 visits. Subjects will take either the proprietary cherry blend or placebo for 6 weeks and then switch. WOMAC pain and function will be the primary outcome with acetaminophen use, walking time and serum uric acid as secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Subject is capable of giving informed consent.
* Subject is over 18 years and less than 80 years
* Subject has mild to moderate osteoarthritis of the knee based on all of the following 3:

  1. Meets clinical ACR criteria
  2. Kellgren score of 2-3 on a Standing Knee x-ray within previous 24 months
  3. VAS pain score of 4-9 at screening visit

Exclusion Criteria:

* Rheumatoid arthritis or other systemic inflammatory condition
* Chronic pain syndrome (fibromyalgia)
* Corticosteroid medication in last 2 months, either intra-articular or oral
* Intra-articular injections of hyaluronic acid in last 9 months
* Pregnant women (weight gain might confound degree of knee pain)
* Diabetes
* Inability to discontinue prescription medication for arthritis
* Unstable medical conditions that would likely prevent the subject from completing the study
* Food allergies - cherries, apples
Shilla Growth Permitting Spinal Instrumentation System for Treatment of Scoliosis in the Immature Spine

The objective of this study is to retrospectively and prospectively review patients who have undergone this technique looking at age of the patient, magnitude of the curve preoperatively, postoperatively and over time, diagnosis, pulmonary function, surgical procedures, complications, and spinal growth.

The hypothesis is that Shilla growth permitting spinal instrumentation coupled with a surgical technique of aggressive correction of the apex of the scoliotic curve wil allow for natural growth of the spine in a guided fashion with a limited number of future surgeries required.

Traditional "growing rod" constructs of spinal instrumentation to treat severe scoliosis in young children require a return to the operating room every six to nine months until skeletal maturity. The Shilla system allows for more spinal growth with fewer surgical procedures necessary for lengthenings. This is a major advantage over existing growth permitting systems and allows surgery to be performed at younger ages with better deformity correction without concerns of repeated surgeries.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 1 yr and 10 yrs
* have severe, progressive scoliosis unresponsive to bracing
* have severe, progressive scoliosis who cannot tolerate bracing

Exclusion Criteria:

* none
Prevalence of Blindness, Visual Impairment in Chao Nan Area, China

This study will provide a profile of blindness/visual impairment, avoidable blindness and cataract surgery service in Chaonan, mainland China. We also evaluate the diagnostic accuracy of Rapid Assessment of Avoidable Blindness (RAAB) comparison with conventional survey.

This proposal describes a population-based study aimed at determining the prevalence of visual impairment, blindness and major causes in adults age 50 years old and above in Chaonan County of Guangdong province, where one of the Project Vision Charity Eye center was founded in 2009.

In the proposed study, we will examine 3700 Chaonan County residents aged 50 years and older, selected via a clustered, randomized sampling with probability proportional to size (PPS). The cluster will be at the village level, 50 subjects aged 50 years and older will be examined in each cluster includes Visual acuity, torch light, and fundus review, the major cause of blindness or visual impairment will be determined. We also randomly recruited 60% clusters,total 2250 participants, from RAAB survey to conduct a detailed conventional eye examination.

This study will provide a profile of blindness/visual impairment, avoidable blindness and cataract surgery service in Chaonan. we will evaluate the diagnostic accuracy of Rapid Assessment of Avoidable Blindness (RAAB) comparison with conventional survey. . It will provide important public health issues for the purposes of establishing a sustainable and suitable model to eliminate the cataract blindness in China.

Eligibility Criteria:
Inclusion Criteria:

* aged 50 years and above
* In each household all persons , residing in the household for six months or more over the past year
* "Residing in the household" is defined as "sharing meals from the same kitchen with the other members of the household for at least 6 months in a year. Exclude any visitors.

Exclusion Criteria:

* age \<50 years old
* Visitors in the villages
* Residing in the household\< 6 months
Phase I Study PK Study With OXP005 and Naprosyn

The Sponsor is developing a new form of naproxen (the study drug, OXP005), for the potential treatment of rheumatic and painful conditions. The study will compare the study drug to an already marketed formulation of prescription strength naproxen (Naprosyn® the reference product) by looking at how a single dose of the drug is taken up by the body. The safety and tolerability of the drug will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and non-pregnant, non breast feeding healthy female subjects aged 18 to 55 years
* Body mass index 18.0 to 30.0 kg/m2

Exclusion Criteria:

* History of or current significant diseases or conditions including any disease or condition affecting the haematopoietic, cardiovascular, renal, hepatic, endocrine, pulmonary, central nervous, immunological, dermatological, gastrointestinal or any other body system
Extension Study of Zemaira® i.v. Administration in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency.

This study is a continuation of the placebo-controlled study CE1226_4001 (NCT00261833) to evaluate the efficacy and safety of Zemaira® intravenous (i.v). administration in subjects with emphysema due to alpha1-proteinase inhibitor deficiency. The long-term verification of a disease-modifying benefit of Zemaira® on the progression of emphysema will be assessed by volume-adjusted lung density, measured yearly by computed tomography (CT).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed the 2-year treatment and observation period in the Phase 3/4 Zemaira® CE1226_4001 study (NCT00261833) and are willing to sign informed consent
* Males, and non-pregnant, non-lactating females, whose screening pregnancy test is negative and who are using contraceptive methods deemed reliable by the investigator

Exclusion Criteria:

* Individuals residing in the US
* Current evidence of alcohol abuse or abuse of drugs such as barbiturates, benzodiazepines, amphetamines, cocaine, opioids, and cannabinoids
* History of allergy, anaphylactic reaction, or severe systemic response to human plasma derived products, or known mannitol hypersensitivity, or history of prior adverse reaction to mannitol
* Current tobacco smoker (smoking must be discontinued for at least 6 months prior to study participation)
* Conditions or behaviors that interfere with attending scheduled study visits in the opinion of the investigator
* History of non-compliance
* Administration of any other experimental new drug or participation in an investigation of a marketed product
* Inability to perform necessary study procedures
Effect of Empagliflozin on NT-Pro Brain Natriuretic Peptide in Heart Failure Patients With Reduced Ejection Fraction

This study aims to evaluate the relationship between NT-proBNP and empagliflozin effects in patients with chronic heart failure with mildly reduced ejection fraction (HFmrEF 41-49%) and reduced ejection fraction (HFrEF ≤40%) whether diabetic or non-diabetic patients.

1. Ethical Committee approval has been obtained from ethics committee of Faculty of Medicine, Alexandria University.
2. Assigning an informed consent for agreement of participation should be taken by all participants in this clinical study.
3. Heart failure patients with reduced and mildly reduced ejection fraction will be recruited from Alexandria Main University Hospital (AMUH), private hospitals and clinics.
4. A Blood sample will be collected from 60 patients as baseline to test for N-terminal Pro-B-type Natriuretic Peptide.
5. The same 60 patients will take Empagliflozin for 6 months.
6. Another blood sample will be taken from the same 60 patients to test the effect on N-terminal Pro-B-type Natriuretic Peptide after Empagliflozin administration.
7. The appropriate statistical test will be hold according to study design and parameters to evaluate the significant results.
8. Results conclusion discussion and recommendations will be given.

Eligibility Criteria:
Inclusion Criteria:

* Chronic heart failure with mildly reduced ejection fraction (41-49%) and reduced ejection fraction (≤40%)
* 18-70 years
* Not receiving empagliflozin or any SGLT2 inhibitor
* Elevated plasma NT-proBNP (≥125 pg/ml)
* eGFR ≥ 20 ml/min/1.73m2

Exclusion Criteria:

* Acute Coronary Syndrome (ACS)
* Pulmonary embolism
* Myocarditis
* Valvular heart disease
* Hypertrophic or restrictive cardiomyopathy
* Congenital heart disease
* Pulmonary hypertension
* Surgical procedures involving the heart
* Heart contusion
* Cardioversion, Implantable Cardioverter Defibrillator (ICD) shock
* Patients receiving digoxin
* Advanced age (\>70years)
* Ischemic stroke
* Chronic Obstructive Pulmonary Disease
* Subarachnoid haemorrhage
* Severe infection (including pneumonia and sepsis)
* Anemia
* Renal dysfunction (eGFR \<20ml/min/1.73m2)
* Liver dysfunction (mainly liver cirrhosis with ascites- Child Pugh B \& C)
* Severe burns
* Paraneoplastic syndrome
* Severe metabolic and hormone abnormalities (e.g thyrotoxicosis, diabetic ketosis)
Interscalene Versus Costoclavicular Blocks for Shoulder Surgery

AIM: Shoulder surgeries are among the most painful surgical procedures in orthopedic practice. Interscalene brachial plexus block, although the most commonly utilized regional anesthesia technique for alleviating pain following shoulder surgery, may result in complications such as hemidiaphragmatic paresis, hoarseness. More distal blocks along the brachial plexus may provide postoperative analgesia while potentially having less effect on respiratory functions. The aim of this study is to determine whether there are differences in postoperative pain scores and opioid consumption between interscalene block (ISB) and costoclavicular brachial plexus block (CCB).

MATERIALS AND METHODS: Following ethical approval, all eligible patients undergoing for shoulder surgery under general anesthesia between 01.11.2022 and 01.11.2023 will be enrolled and to be divided into two groups following written informed consent, with one group receiving ISB and the other group receiving CCB. A blinded researcher will record pain scores at postoperative 0.5, 1, 6, 12, 18, and 24 hours. Demographic data of patients, postoperative opioid consumption, time to first analgesic request, rescue analgesic requirements, adverse effects and hemodynamic parameters will be compared statistically.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral shoulder surgery
* ASA (American Society of Anesthesiology) class I, II and III patients

Exclusion Criteria:

* Coagulopathy
* Chronic Pulmoner Disease
* Hypersensitivity to local anesthetics
* Ipsilateral neurological deficits
* Non-communicative patients
Extracorporeal Immune Support System (EISS) for the Treatment of Septic Patients

The purpose of this study is to investigate the effect of an extracorporeal application of a bed-side bioreactor containing human donor granulocytes on the course and outcome of septic shock in humans.


Eligibility Criteria:
Inclusion Criteria:

* sepsis with at least one organ failure (severe sepsis) or septic shock

Exclusion Criteria:

* Participation in another study within the last 30 days
* Earlier participation in this study
* Pregnancy
* Bleeding, clinically not controlled (needing more than 2 red blood cell-transfusions per day)
* Hemodynamic shock for more than 12 hours (systolic BP \<90mmHg) despite adequate therapy
* HIV infection
* HCV infection, active