cyrilzakka/clinical-trials huggingface dataset:
Effects of CSL324 in the Lung After Segmental Challenge

This is a phase 1b, randomized, double-blind, placebo-controlled study in healthy volunteers to investigate the antiinflammatory effect of pretreatment with CSL324 on response to a lipopolysaccharide (LPS) endotoxin challenge in a single lung segment. Saline will be instilled into a segment in the contralateral lung for the purpose of comparison.


Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteer.
* Between the ages of ≥ 18 and ≤ 65 years.
* Body mass index within the range of 18 to 32 kg/m2
* Female of nonchildbearing potential or of childbearing potential and willing to use a highly effective method of contraception (in addition to male partner condom with or without spermicide)
* Nonsmoker or an ex-smoker who has stopped smoking (including e-cigarettes or vaping devices) for \> 1 year with a smoking history of \< 10 pack-years.

Exclusion Criteria:

* Any clinically significant abnormalities in physical examination findings, electrocardiogram (ECG) readings, safety laboratory test results, or ANC \< 2.0 × 109 cells/L.
* History of myeloproliferative or lymphoproliferative disease.
* Current or previous history of any immunosuppressive condition.
* Currently receiving any immunosuppressive or immunomodulatory therapy, or history of undergoing such therapy.
Study to Evaluate the Safety and Efficacy of Levetiracetam in Patients Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic Seizures

This study will assess the efficacy, safety, and tolerability of adjunctive treatment with LEV (3,000 mg/day or a target dose of 60 mg/kg/day in children) compared to placebo in reducing PGTC seizures in subjects (4 - 65 years) suffering from idiopathic generalized epilepsy uncontrolled despite treatment with one or two concomitant AEDs.


Eligibility Criteria:
Inclusion Criteria:

* Subject with a confirmed diagnosis consistent with idiopathic generalized epilepsy experiencing primary generalized tonic-clonic seizures (IIE) that are classifiable according to the ILAE Classification of Epileptic Seizures.
* Presence of at least 3 PGTC seizures during the 8-week combined Baseline period.
* Absence of brain lesion documented on a CT scan or MRI.
* An EEG performed within 1 year of Visit 1 with features consistent with PGTC seizures or generalized idiopathic epilepsy.
* Male/female subject, \>=4 or \<=65 years of age at Visit 1.
* Subject on a stable dose of one or two AEDs during baseline.

Exclusion Criteria:

* Previous exposure to levetiracetam.
* History of partial seizures.
* History of convulsive or non-convulsive status epilepticus while taking concomitant AEDs within three months prior to Visit 1.
Tobacco Use in Pregnancy Intervention for Cessation

The proposed project will test the effectiveness of the novel delivery of an established tobacco cessation treatment among pregnant women in Kentucky. Tobacco use during pregnancy is one of the most modifiable risk factors associated with poor birth and maternal outcomes and yet smoking prevalence among pregnant women in Kentucky is among the highest in the county and estimated to be twice that of the national average, with no meaningful declines observed in twenty years.

The purpose of this pilot project is to test effectiveness of a tobacco-treatment cessation intervention (American College of Obstetricians and Gynecologists (ACOG) 5 A's) through use of a non-physician healthcare champion from within the clinic's existing infrastructure. This Tobacco use in Pregnancy Intervention for Cessation (ToPIC) will involve training the identified healthcare provider to become a Certified Tobacco Treatment Specialist (CTTS) and to administer the 5 A's to pregnant Medicaid patients receiving prenatal care through two high-volume Kentucky obstetrics clinics. This trial will provide evidence to evaluate this approach to delivering an established intervention in clinical practice.

The Investigators propose to test the effectiveness of the clinical intervention by using a two-armed cluster randomized controlled design. Eligible participants will be randomized to the intervention (ToPIC) or standard of care for smoking cessation in pregnancy. This pilot project will gather quantitative and qualitative data for a mixed-method, multi-stakeholder process evaluation of intervention training and delivery. Furthermore, the Investigators' use of Medicaid claims data to examine healthcare utilization outside of maternal and infant well-care visits will enhance understanding of the strengths and limitations of these data for future evaluations. This study has the potential to significantly impact the most vulnerable in Kentucky, where rates of tobacco use among pregnant women are among the highest in the nation.

Eligibility Criteria:
Inclusion Criteria:

* pregnant
* tobacco user
* able to read and write English
* Medicaid eligible

Exclusion Criteria:

* male
Effect of Hip Abductors Versus Knee Extensor Strengthening in Knee Osteoarthritis

This study will try to answer the following question:

Would strengthening of hip abductors be equal to, or more effective than, knee extensors strengthening in improving pain, function and knee extensors isometric strength in patients with knee Osteoarthritis

A total of 70 patients with knee Osteoarthritis will be recruited All patients who will participate in the study will be referred by orthopedists. Patients with knee osteoarthritis will be included with age ranges from 50-70. They will be randomized into 2 groups; hip abductors strengthening (HAS) group a will receive hip abductors strengthening exercises, and knee extensors strengthening (KES) group will receive quadriceps strengthening exercise.

All patients who will meet the study criteria will get a complete knowledge of the objectives and procedures of the study.

Inclusion criteria:

1. Patients with knee Osteoarthritis grade II- III Kellgren- Lawrence scores
2. Their age is 50-70\[Wang et al.,2019\].
3. Body mass index (BMI) 25-30.

Exclusion criteria:

1. Patients who had surgical intervention in the knee and/or hip.
2. Fracture in the lower limbs.
3. Malignancy
4. Any associated ligamentous injuries in knee or ankle.
5. Spinal Cord Injury.
6. Hormonal imbalance or on hormonal therapy
7. Knee injection within the last 6 months prior to the study. Outcome parameters including Quadriceps Muscle Strength, the arabic version of Western Ontario and McMaster Universities Arthritis Index questionnaire total score and 3 subscales and Timed Up and Go test score

Eligibility Criteria:
Inclusion Criteria:

1. Patients with knee OA grade II- III Kellgren- Lawrence scores
2. Their age is 50-70\[Wang et al.,2019\].
3. Body mass index (BMI) 25-30.

Exclusion Criteria:

1. Patients who had surgical intervention in the knee and/or hip.
2. Fracture in the lower limbs.
3. Malignancy
4. Any associated ligamentous injuries in knee or ankle.
5. Spinal Cord Injury.
6. Hormonal imbalance or on hormonal therapy
7. Knee injection within the last 6 months prior to the study.
Prediction Model for Advanced Gastric Cancer in Elderly

This study aims to develop and validate a Nomogram (mCNS) model for predicting long-term survival in elderly patients following curative resection for advanced gastric cancer. The study is a retrospective multi-center analysis involving 924 gastric cancer patients treated at the Department of Gastrointestinal Surgery of the Affiliated Union Hospital of Fujian Medical University between 2009 and 2013, and 512 patients aged 65 and above who underwent gastric resection at the Affiliated Zhongshan Hospital of Dalian University between 2011 and 2018. An online prognostic tool is introduced to assist clinicians in predicting patient prognosis and customizing treatment and follow-up strategies.

Data were collected from 1436 gastric cancer patients, of which 555 elderly patients with advanced gastric cancer were ultimately included after applying exclusion criteria. Patients were divided into training and testing cohorts from the Fujian Medical University Affiliated Union Hospital and Dalian University Affiliated Zhongshan Hospital. The study was approved by the institutional review boards with a waiver of informed consent due to the use of anonymized secondary data. The analysis utilized the Cox proportional hazards model to select key variables for predicting overall survival (OS). The study also implemented rigorous data handling procedures, including multiple imputations for missing data. The development of an online prognostic tool based on the Nomogram model is part of the project, designed to provide real-time survival predictions through a user-friendly interface for clinical application.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed as primary gastric adenocarcinoma by preoperative gastric endoscopy pathology;
* Underwent R0 laparoscopic radical gastrectomy for gastric cancer;
* Pathological stage T2-4a-N+;
* Age ≥ 65 years.

Exclusion Criteria:

* Pathological stage T1 and T2N0;
* Age \< 65 years;
* Presence of peritoneal or distant metastasis confirmed before or during surgery;
* Received neoadjuvant chemotherapy before surgery;
* Remnant gastric cancer;
* Emergency surgery or palliative exploratory surgery;
* Preoperative abdominal CT scan not available or preoperative examination time \> 1 month;
* Survival time less than 1 month;
* Incomplete clinical and pathological data.
Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation

This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.

The primary aim of this study is to examine the safety of administration of the unlicensed investigational NCBP hematopoietic progenitor cell-cord blood (HPC-CORD BLOOD) products in a multi-institution setting. Therefore, the study will evaluate prospectively the incidence of serious adverse reactions as well as the incidence of all infusion related reactions after administration of the unlicensed, investigational NCBP CBU.

Definitions of Infusion-related adverse reactions:

Mild - Moderate: reactions during or after the infusion of the cord blood (CB) product that require some medical intervention but do not affect the overall patient status or outcome.

Severe: serious, life-threatening or fatal infusion reactions, requiring major medical intervention. These include: anaphylactic shock, acute cardiac, pulmonary or renal failure, seizures, patient transfer to the Intensive Care Unit, or death within 48 hours of the CB infusion. Adverse Reactions will also be classified by grade, according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE).

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
2. Patients: Patients of any age and either gender
3. Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)

Exclusion Criteria:

1. Patients who are receiving licensed cord blood products (only)
2. Patients who are receiving unlicensed cord blood products from other banks (only)
3. Patients who are transplanted at non-US transplant centers
4. Patients who are receiving cord blood products that will be "manipulated" post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)
Correlation of Arterial Blood Gas (ABG) and Venous Blood Gas (VBG) in the Undifferentiated Critically Ill Patient

The primary objective of this study is to identify a correlation between the pH and pCO2 in arterial and venous blood. The secondary objectives include a correlation of pulse oximetry and arterial pO2 along with subgroup analyses of specific patient populations such as congestive heart failure, chronic obstructive pulmonary disease, diabetic ketoacidosis, pneumonia, overdose, and trauma.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older Signed consent Patient in the ED or ICU Have a disease state that necessitates obtaining an ABG Have a disease state that necessitates pulse oximetry monitoring

Exclusion Criteria:

* Any contraindication to arterial or venous blood draw Prior enrollment in the study during the current hospitalization Pregnancy Prisoners
THD Versus Open Haemorrhoidectomy

A randomised study comparing Transanal Haemorrhoidal Dearterialization (THD) and Open Haemorrhoidectomy (OH) for the treatment of prolapsing haemorrhoids. The primary aim of the study is to evaluate the long-term effect on haemorrhoidal symptoms one year postoperatively.

Secondary endpoints are postoperative pain, complications, effect on anal continence, recovery and return to normal activity, quality of life and health cost analysis.


Eligibility Criteria:
Inclusion Criteria:

* The patient has Grade III-IV haemorrhoids or Grade II haemorrhoids with bleeding resistant to rubber band ligation or sclerotherapy
* The patient has a Haemorrhoidal Symptom Score of 4 or more
* The patient has an American Society of Anaesthesiologists (ASA) score I-II
* The patient's age is 18-85 years at inclusion
* The patient has had a colonoscopy, sigmoidoscopy or rigid rectoscopy within 3 months before inclusion

Exclusion Criteria:

* The patient has had previous operation for haemorrhoids within the last 2 years
* The patient has had previous operation for anal incontinence
* The patient has an active anal fistula
* The patient has an active anal fissure
* The patient has anal incontinence for solid stools
Safety and Effectiveness Study of Prodisc to Spinal Fusion Surgery

The objective of this clinical investigation is to compare the safety and effectiveness of ProDisc total disc replacement to spinal fusion surgery in the treatment of discogenic pain associated with DDD in the lumbosacral spine. There will be separate study arms for one and two level cases.


Eligibility Criteria:
Inclusion Criteria:

* Degenerative Disc Disease (DDD) in one or two adjacent vertebral levels between L3 and S1. Diagnosis of DDD requires: a)Back and/or leg (radicular) pain; and b)Radiographic confirmation of any 1 of the following by CT, MRI, discography, plain film, myelography and/or flexion/extension films: Instability (greater than or equal to 3mm translation or 5° angulation); Decreased disc height \>2mm; Scarring/thickening of annulus fibrosis; Herniated nucleus pulposus; or Vacuum phenomenon.
* Age between 18 and 60 years.
* Failed at least 6 months of conservative treatment.
* Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%)(Interpreted as moderate/severe disability).
* Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
* Signed informed consent.

Exclusion Criteria:

* No more than 2 vertebral levels may have DDD and all diseased levels, either one or two, must be treated.
* Patients with involved vertebral endplates dimensionally smaller than 34.5mm in the medial-lateral and/or 27mm in the anterior-posterior directions.
* Known allergy to titanium, polyethylene, cobalt, chromium, or molybdenum.
* Prior fusion surgery at any vertebral level.
* Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma.
* Radiographic confirmation of facet joint disease or degeneration.
* Lytic spondylolisthesis or spinal stenosis.
* Degenerative spondylolisthesis of grade \>1.
* Back or leg pain of unknown etiology.
* Osteopenia or Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients to determine if a DEXA scan is required. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score less than
* 1.0. The World Health Organization defines osteoporosis as a DEXA T score less than or equal to -2.5.
* Paget's disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed above).
* Morbid obesity defined as a body mass index \>40 or a weight more than 100 lbs. over ideal body weight.
* Pregnant or interested in becoming pregnant in the next 3 years.
* Active infection - systemic or local.
* Taking medication or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).
* Rheumatoid arthritis or other autoimmune disease.
* Systemic disease including AIDS, HIV, Hepatitis.
* Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years.
SecuraTM ICD Clinical Evaluation Study

The purpose of the Secura clinical study is to evaluate the overall system safety and clinical performance of the Secura DR Implantable Cardioverter Defibrillator (ICD)

The Secura ICD is an investigational dual chamber ICD that provides atrial and ventricular tachyarrhythmia detection and therapy, cardioversion, defibrillation, dual chamber rate-responsive bradycardia pacing and diagnostics.

The study will be a prospective, non-randomized, multicenter clinical study, conducted in approximately 15 centers.

To allow for sufficient experience with the device, a maximum of 80 subjects may be implanted with the Secura device. Data will be collected at baseline (enrollment), implant, 1-, 3-, and 6- months post implant and every 6 months thereafter or until study closure (whichever occurs first), Unscheduled Follow-up visits, System Modifications, Technical Observations, Study Deviations, Study Exit, upon notification of new or updated Adverse Events and in case of death.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have an ICD indication.
* Patients who are geographically stable and available for follow-up at the study center for the duration of the study.
* Patients who have signed a Medical Ethics Committee (MEC) approved Informed Consent form.

Exclusion Criteria:

* Patients with a life expectancy less than the duration of the study.
* Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients.
* Patients with mechanical tricuspid heart valves.
Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent, locally advanced, or metastatic soft tissue sarcoma.

OBJECTIVES: I. Determine the efficacy of flavopiridol in terms of response rate in patients with previously untreated metastatic or locally advanced soft tissue sarcoma. II. Determine the toxicity of this regimen in these patients. III. Determine the time to progression, early progression rate, and response duration in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive flavopiridol IV over 1 hour daily on days 1-3. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks and then every 3 months until disease progression or death.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study over 12-18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed previously untreated metastatic or locally advanced soft tissue sarcoma not amenable to standard curative therapies Measurable disease At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan Bone lesions are not considered measurable Must have measurable disease outside irradiated area unless evidence of progression or new lesions inside irradiated area No carcinosarcoma, Kaposi's sarcoma, soft tissue Ewing's sarcoma, or embryonal rhabdomyosarcoma

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST no greater than 2.5 times ULN Renal: Creatinine no greater than ULN Cardiovascular: If history of cardiac disease, cardiac ejection function greater than 50% No clinically significant cardiac symptomatology Pulmonary: If history of symptomatic pulmonary disease, FEV1, FVC, and TLC greater than 60% predicted and DLCO greater than 50% predicted No clinically significant pulmonary symptomatology Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other concurrent serious disease

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior stem cell transplantation Chemotherapy: No prior chemotherapy for metastatic or locally advanced disease No prior high dose chemotherapy and stem cell transplantation Prior adjuvant chemotherapy allowed At least 6 months since prior chemotherapy No other concurrent cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No more than 25% of functioning bone marrow irradiated No concurrent radiotherapy to sole site of measurable disease Surgery: At least 4 weeks since prior major surgery Other: No other concurrent anticancer therapy
Phase II Study of Tin Mesoporphyrin vs Phototherapy for Hyperbilirubinemia in Premature Newborns

OBJECTIVES: I. Compare the effectiveness of a single dose of tin mesoporphyrin and special blue light phototherapy in controlling hyperbilirubinemia in premature newborns in Greece.

II. Evaluate the dose of tin mesoporphyrin sufficient to alleviate the need for phototherapy without adverse effects in these newborns.

PROTOCOL OUTLINE: Patients are randomly assigned to a clinical group within 96 hours of birth. Patients are stratified by gestational age, clinical status, and age at treatment.

One group receives tin mesoporphyrin. Patients are crossed to phototherapy if the plasma bilirubin concentration reaches the treatment threshold.

The second group receives phototherapy with Special Blue fluorescent lamps for at least 24 hours. Patients receive a second phototherapy course if the plasma bilirubin concentration reaches the treatment threshold within 24 hours of the first course.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Premature infants of gestational age 210 to 251 days
* No blood group isoimmunization (direct Coombs' positive), e.g., rhesus or ABO
* No glucose-6-phosphate dehydrogenase deficiency

--Prior/Concurrent Therapy--

* No maternal phenobarbital in last month of pregnancy

--Patient Characteristics--

Renal: No congenital renal abnormality

Cardiovascular: No congenital heart abnormality

Pulmonary: No asphyxia requiring assisted ventilation at delivery

Other: No other major congenital abnormality, i.e.:

* Central nervous system
* Chromosomal
* Gastrointestinal

No evident or suspected congenital infection, i.e.:

* Cytomegalovirus
* Herpes
* Rubella
* Syphilis
Safety and Feasibility of a New Neuromuscular Monitoring Device

The aim of the study is to compare, during general anesthesia using neuromuscular blocking agent, the feasibility of a new mechanographic device (ITF handle and Visual ITF software) with a standard acceleromyographic device (TOF Watch SX) and also to assess its safety during the first 24 hours after surgery.

The two devices will be studied simultaneously in each patient.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients,
* ASA class 1 to 3,
* Scheduled for elective surgery requiring general anesthesia and muscle paralysis

Exclusion Criteria:

* Age inferior to 18 years,
* ASA class 4,
* Emergency surgery,
* Prone position on the operating table