cyrilzakka/clinical-trials huggingface dataset:
A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.

This study will evaluate the efficacy and safety of sequential administration of Tarceva and gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer. Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4 week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The anticipated time on study treatment is until disease progression or unacceptable toxicity.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* histologically documented advanced or recurrent stage IIIB or IV non-small cell lung cancer;
* measurable disease;
* no previous chemotherapy for non-small cell lung cancer.

Exclusion Criteria:

* unstable systemic disease;
* any other malignancies in the last 5 years.
RIPC and Platelet Activation on Platelet Activation During Cardiopulmonary Bypass

In this study, the investigators are going to investigate the effects of remote ischemic preconditioning on platelet activation in patients undergoing cardiac surgery with cardiopulmonary bypass.

Previous studies reported that remote ischemic conditioning reduce platelet activation in patients with coronary artery disease or patients undergoing ablation for atrial fibrillation. Cardiac surgery with cardiopulmonary bypass has been associated with platelet activation. In this randomized study, investigators are going to compare the effects of remote ischemic preconditioning (RIPC) on platelet activation using flow cytometry in patients undergoing cardiac surgery with cardiopulmonary bypass.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Preoperative left ventricle ejection fraction \< 30%, mechanical ventricular support
* Peripheral vascular disease
* Poorly controlled diabetes mellitus
* NSAIDs within 3 days
* iv heparin within 6 h
* low molecular weight heparin within 24 h
* platelet inhibitor within 24 h
* known thrombocytopenia
* End stage renal disease / hemodialysis
* Active infection
* Pregnancy
Investigation of Low-intensity Focused Ultrasound for Human Pain Management

This project examines the effects of noninvasive brain stimulation on pain. The investigators believe this study will help to better understand possible treatments for chronic pain patients. Participants undergo structural imaging, a functional Magnetic Resonance Image (fMRI) and computed tomography (CT). These images are used to align the low-intensity focused ultrasound (LIFU) device which uses sound waves to temporarily change brain activity. Pain testing is done using a small device that will increase/decrease the temperature of the skin. Brain signals are collected using electroencephalography (EEG). Heart rate, blood pressure, and skin moisture will be monitored as well.


Eligibility Criteria:
Inclusion Criteria:

* Understand and speak English

Exclusion Criteria:

* MRI/CT/EEG contraindications.

  1. Claustrophobia
  2. Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
  3. Contraindications to CT: pregnancy
  4. Active medical disorder or treatment with potential CNS effects
  5. History of neurologic disorder
  6. History of head injury resulting in loss of consciousness for \>10 minutes.
  7. History of alcohol or drug dependence
  8. Failure to provide Social Security Number or Tax ID number. This is required for tax purposes or payment cannot be processed.
Prediction of Weaning Outcomes by Using Rate of Change of Rapid Shallow Breathing Index

This trial examines weaning outcomes using the rapid shallow breathing index rate.

We hypothesize that the trend of the Rapid Shallow Breathing Index or RSBI rate, is a better predictor of weaning outcome than the RSBI as a single value during the weaning trial. patients are recruited during a weaning trial on t-piece and the RSBI during what the RSBI is measured periodically. The outcome is ventilatory status at 24 hours after the weaning trial.

Eligibility Criteria:
Inclusion Criteria:

* Requires need of mechanical ventilation for \> 48 hours with a tube size no smaller than 7.5

Exclusion Criteria:

* Healthy volunteers
Neuroprotection During Open Heart Surgery

Millions of individuals with coronary artery, or valvular heart disease have been given a new chance at life by heart surgery, but the potential for neurological injury is a great risk .Neural complications - including neurocognitive dysfunction and ischemic complications are complications of cardiac surgery that can restrict the improved quality of life.

Propofol is one of the most popular agents used for induction of anesthesia. propofol reduces cerebral blood flow but maintains coupling with cerebral metabolic rate for oxygen and decreases intracranial pressure, allowing optimal intraoperative conditions.

Ketamine is a non-competitive antagonist of NMDA receptors that has well documented neuroprotective effects against ischemic brain injury and glutamate-induced brain injury. ketamine has neuroprotective effects against oxygen-glucose deprivation injury

The aim of the study is to evaluate neuroprotective effect of mixture of propofol and ketamine (ketofol) as compared to propofol after open heart surgery.

Induction;

* Pre-oxygenation with100% O2 for 3 min.
* Morphine 0.1-0.15 mg/kg
* Fentanyl, dose 3-5 mcg/kg.
* hypnotic agent differs for each group:
* Propofol group: Propofol, dose 0.5-2 mg/kg.
* Ketofol group: Ketofol,( dose 0.25-1 mg/kg propofol plus 0.25-1 mg/kg ketamine diluted in normal saline with maintained 1:1 ratio between propofol and ketamine. )

Catheterization:

1. Central venous catheter: A suitable central venous catheter will be inserted into Right subclavian vein under complete aseptic technique using seldinger technique.
2. Jugular bulb catheterization: Patients is placed in supine position with mild neck extension. The head is placed in neutral position with mild tilt to the opposite side of insertion. Under complete aseptic conditions, the anatomical landmarks for the right internal jugular vein will be identified (at the level of cricoid cartilage, medial to the sternomastoid muscle and lateral to a palpable internal carotid artery). The internal jugular vein will be then cannulated by retrograde insertion of a catheter for sampling of the jugular venous bulb blood. Catheter will be advanced till resistance of the skull base is reached then withdrawn about 1 to 2 mm.

Position of the catheter will be confirmed by antero-posterior and lateral neck C-arm x-ray to verify the correct placement of the catheter tip in the will be sutured to the skin and dressed with sterile gauze

Eligibility Criteria:
Inclusion Criteria:Age between 30 and 70 years of either sex.

* Patients scheduled for elective cardiac surgery using cardiopulmonary bypass (CPB) either valve surgery or coronary artery bypass surgery

Exclusion Criteria:

* Patient refusal.
* Morbidly obese patients.
* Patients with uncontrolled diabetes.
* Patients with pre-existing neurological disease or using anti-psychotics. Severe or uncontrolled renal, hepatic or endocrinal diseases.
* Pregnancy, post-partum or lactating females
* Allergy to one of the agents used.
* Emergency cardiac surgery.
* Re-do surgery.
Respiratory Capacity and Swallowing Function in Spinal Disorders: A Pilot Study

This study is part of a larger grant, for which the overall goal is to collect measurements of liquid flow through the oropharynx (i.e., mouth and throat) during swallowing.The focus of this study is to evaluate the flow of liquids of varying consistency in the spinal disorder population.

Thickened liquids are commonly used as an intervention for dysphagia (swallowing impairment). However, the field lacks a clear understanding of how liquids of different consistencies behave during swallowing. In order to improve understanding of the effectiveness of altered liquid consistency for improving dysphagia, the investigators are studying liquid flow through the oropharynx. This study explores this question in individuals with spinal cord injury. Participants will swallow 20% w/v barium thickened to different consistencies (thin, slightly thick, mildly thick, moderately thick and extremely thick). Swallowing will be observed under videofluoroscopy. Simultaneous measures of airflow via nasal cannula will be used to study respiratory-swallow coordination in this study sample.

Eligibility Criteria:
Inclusion Criteria:

Spinal cord injury at the cervical or thoracic level (T6 or higher)

Exclusion Criteria:

* Prior history of swallowing, motor speech, gastro-esophageal difficulties, chronic sinusitis or taste disturbance.
* Neurological difficulties unrelated to spinal disorder (e.g. Stroke, Parkinson disease, etc).
* Cognitive communication difficulties that may hinder ability to participate.
* Current use of mechanical ventilation
* External instrumentation around the head/neck that would obstruct the field of view during the videofluoroscopy exam (e.g. cervical collar).
* Type 1 Diabetes (due to the requirement to swallow stimuli containing starch based thickeners, which carry a significant carbohydrate load).
* Known allergies to latex, food coloring or dental glue (due to the probability that these items will come into contact with the oral mucosa during data collection).
* Children and pregnant women (due to the use of radiation during the videofluoroscopic examination).
Ultrasound Guided Versus Surgical Rectus Sheath Block Versus Local Anesthesia Infiltration for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy

The aim of this work is to compare the efficacy and safety of the effectiveness and safety of ultrasound-guided surgical rectus sheath block and local anesthetic infiltration for postoperative analgesia in patients undergoing total abdominal hysterectomy.

Total abdominal hysterectomy (TAH) is a commonly performed major surgical procedure that results in substantial postoperative pain and discomfort.

Local anesthetic infiltration (LAI) at the end of surgery is one of the most common technique employed in laparotomies for postoperative analgesia.

Rectus sheath block (RSB) has been used as a part of multimodal analgesia, especially when neuraxial techniques are unsuitable.The RSB was used to achieve peri-operative relaxation of the anterior abdominal wall.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years old.
* American Society of Anesthesiologists (ASA) physical status I - II.
* Patients scheduled for elective total abdominal hysterectomy under general anesthesia.

Exclusion Criteria:

* Hepatic, renal or cardiac disease.
* Any known allergy to local anesthetic.
* Physical or mental conditions which may vaguely measure postoperative pain following surgery.
* History of chronic use of analgesic as nonsteroidal anti-inflammatory drugs (NSAIDs) or central nervous system (CNS) depressants as antiepileptic, and bleeding disorders.
Stem Cell Fistula Plug in Perianal Crohn's Disease

The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore® Bio-A®; Fistula Plug) in a Phase I study using a single dose of 20 million cells. Twenty adult patients (age 18 years or older) with refractory, complicated perianal fistulizing Crohn's disease will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton with continuation of pre-existing anti-Crohn's therapy. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore® Bio-A® fistula plug as per current clinical practice. The subjects will be subsequently followed for fistula response and closure for 24 months. This is an autologous product derived from the patient and used only for the same patient.


Eligibility Criteria:
Inclusion Criteria

* Males and females 18-65 years of age.
* Residents of the United States.
* Crohn's disease with single or multiple draining complex perianal fistulae (definition as below) for at least three months despite standard therapy (definition below).
* Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted.
* All patients should have undergone a colonoscopy in last 12 months to rule out malignant or premalignant condition
* Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
* Ability to comply with protocol
* Competent and able to provide written informed consent
* Must have failed standard medical therapy including anti-TNF agents

Exclusion Criteria

* Inability to give informed consent.
* Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
* Specific exclusions: Evidence of hepatitis B, C, or HIV
* History of cancer including melanoma (with the exception of localized skin cancers)
* Investigational drug within thirty (30) days of baseline
* A resident outside the United States
* Pregnant or breast feeding.
* History of clinically significant auto-immunity (other than Crohn's disease) or any previous example of fat-directed autoimmunity
* Previous allergic reaction to a perianal fistula plug.
* If liposuction is not technically feasible
* Allergic to local anesthetics
* Pregnant patients or trying to become pregnant.
* Non-enterocutaneous tracts (ie recto-vaginal, entero-vesicular)
Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae

This prospective, global, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Lutonix 035 AV Drug Coated Balloon PTA Catheter compared to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥21 years;
2. The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF);
3. Arteriovenous fistula located in the arm;
4. Native AV fistula was created ≥30 days prior to the index procedure and has undergone one or more hemodialysis sessions;
5. Venous stenosis of an AV fistula with the target lesion located from the anastomosis to the axillosubclavian junction and an abnormality attributable to the stenosis as defined by K/DOQI guidelines.;
6. Successful pre-dilation of the target lesion with a percutaneous transluminal angioplasty (PTA) balloon;
7. Intended target lesion.

Exclusion Criteria:

1. Women who are pregnant, lactating, or planning on becoming pregnant during the study;
2. Hemodialysis access is located in the leg;
3. Subject has more than two lesions in the access circuit;
4. Subject has a secondary non-target lesion that cannot be successfully treated;
5. Target lesion is located central to the axillosubclavian junction;
6. The subject has a secondary lesion located in the central venous system (central to the axillosubclavian junction);
7. A thrombosed access;
8. Surgical revision of the access site planned;
9. Recent prior surgical interventions of the access site;
10. Other planned treatment during the index procedure;
11. Known contraindication (including allergic reaction) or sensitivity to iodinated contrast media, that cannot be adequately managed with pre-and post-procedure medication;
12. Known contraindication (including allergic reaction) or sensitivity to paclitaxel.
13. Subjects who are taking immunosuppressive therapy or are routinely taking

    ≥10mg of prednisone per day;
14. Subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be noncompliant with the protocol or confound the data interpretation;
15. Subject has a life expectancy \<12 months;
16. Anticipated for a kidney transplant;
17. Anticipated conversion to peritoneal dialysis;
18. Subject has a stent located in the target or secondary non target lesion;
19. Subject has an infected AV access or systemic infection;
20. Currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study.
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems

Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) marketed in the European Union (EU) . These types of studies are required by regulatory authorities for all THA devices that do not have clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.

Total hip arthroplasty (THA) has been performed since the early 1920s and is generally considered to be one of the most successful orthopedic surgeries performed. The 8th Annual Report from the National Joint Registry of England and Wales reported 95.3% component survivorship at 7 years for over 300,000 THA implantations. MicroPort Orthopedics, Inc. (MPO) currently markets several THA components throughout the world, including the European Union (EU). As part of the process for gaining approval to market in the EU, MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of these THA components. The objectives of this study are to evaluate component survivorship and total functional outcome scores of implanted subjects at out to 10 years follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Has undergone primary THA for any of the following:
* Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;
* Inflammatory degenerative joint disease such as rheumatoid arthritis; or
* Correction of functional deformity
* Subject is implanted with the specified combination of components
* Subject is willing and able to complete required study visits or assessments

Exclusion Criteria:

* Subjects implanted with DYNASTY® BIOFOAM® Acetabular Shells
* Subjects implanted with a metal-on-metal articulation
* Subjects implanted with non-MicroPort Orthopedics components (femoral heads, acetabular shells, acetabular liners) in the enrolled THA
* Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
* Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
* Subjects unwilling to sign the Informed Consent document
* Subjects with substance abuse issues
* Subjects who are incarcerated or have pending incarceration
Health Literacy As a Mediator Between Gender, Illness Identity, and Self-Efficacy

The goal of this observational study is to understand the role of health literacy in shaping the relationship between gender differences, illness identity, and self-efficacy in geriatric patients with cardiac diseases. The main question it aims to answer is:

Does health literacy mediate the relationship between gender, illness identity, and self-efficacy in elderly cardiac patients?

Participants with diagnosed cardiac conditions, will complete online surveys assessing their health literacy, illness identity, and self-efficacy over a one-year period. Structural Equation Modeling (SEM) will be used to analyze the relationships among these variables.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 30 years or older.
* Diagnosed with a cardiac disease (e.g., heart failure, coronary artery disease, arrhythmia).
* Able to provide informed consent.
* Sufficient health literacy to complete surveys in the study language.
* Currently under regular medical care for their cardiac condition.

Exclusion Criteria:

* Individuals with a cognitive impairment or diagnosis of dementia that could interfere with survey participation.
* Patients with co-morbid terminal illnesses that significantly impact life expectancy (e.g., advanced cancer).
Internet-delivered CBT for NCCP-patients - a Pilot Trial

This pilot randomized controlled trial (RCT) aims to test the feasibility and effectiveness of a guided internet-delivered cognitive behavioural therapy intervention in the treatment of cardiac anxiety and fear of body sensations in patients with non-cardiac chest pain. The control group will receive care-as-usual.

Despite reassurance, many patients with non-cardiac chest pain (NCCP) think they have an undetected cardiac disease and avoid activities that they think might be harmful to their heart. These patients need help and support to evaluate the way they perceive and handle their chest pain. Therefore, we have developed a 4 session guided intervention based on cognitive behavioural therapy that will be delivered via internet.

The intervention consists of psychoeducation, exposure to physical activity, and a breathing-based relaxation exercise. The goal with the intervention is to help the participants modify their beliefs about chest pain, change their cognitive and behavioural strategies, and give them tools to handle chest pain to prevent them from relapse.

Eligibility Criteria:
Inclusion Criteria:

* recurrent chest pain that has been diagnosed as non-cardiac at least twice during last 6 months
* patients screened positive for avoidance of physical activity due to cardiac anxiety and/or fear of body sensations

Exclusion Criteria:

* no regular access to a computer/tablet computer with internet connection
* language difficulties
* not able to perform physical activity/exercise test due to physical constraints
* patients with severe depressive symptoms
* patients with acute ischemic heart disease
The Use of Visual Feedback in Airway Clearance

Cystic Fibrosis (CF) patients perform airway clearance incorporating various breathing strategies, to clear secretions from their lungs. Hand held devices may aid mucus expectoration, and also motivate the patient to manage by themselves. Our aims was to study if resistive expiration through "volumetric incentive spirometer" (VISex) can improve lung function in the short term in Cystic Fibrosis (CF) patients.


Eligibility Criteria:
Inclusion Criteria:

* cystic fibrosis patients

Exclusion Criteria:

* i.v. antibiotic therapy during the experiment day