cyrilzakka/clinical-trials huggingface dataset:
Perception of Cure Among Patients With Metastatic Cancer

This study collects information about perception of cure among patients with cancer that has spread to other places in the body (metastatic). This study aims to determine patients' perception (knowledge) before starting immunotherapy and if differences exist in understanding of treatment to stimulate or restore the ability of the body's immune (defense) system to fight infection and disease (immunotherapy) based on social and economic factors or on race/ethnicity.

PRIMARY OBJECTIVE:

I. To assess the proportion of patients with metastatic cancer who anticipate cure before starting immunotherapy.

SECONDARY OBJECTIVES:

I. To determine if expectations of cure are associated with quality of life and distress.

II. To determine if patients' perceptions differ by gender, age, and ethnicity.

OUTLINE:

Patients complete surveys over 30 minutes about sociodemographic information and perception of immunotherapy, over 10 minutes about expectations of cure, over 10 minutes about anxiety, over 10 minutes about depression, and over 30 minutes about physical well-being. Patients' medical records are reviewed.

Eligibility Criteria:
Eligibility Criteria:

1. Patients must be aged 18 and over
2. Patients sufficiently fluent in English
3. Patients must have a cytologically or pathologically verified diagnosis of cancer
4. Patients must have measurable metastatic disease
5. Patients must be initiating immunotherapy
6. Patients must be undergoing evaluation and treatment at City of Hope Cancer Center
ROTEM in Sepsis Trauma Outcome in Intensive Care

This prospective observational study aims to investigate the ability of advanced ROTEM analysis using Principal Component Analysis (PCA) to detect early signs of disseminated intravascular coagulation (DIC) and trauma-induced coagulopathy (TIC) in hospitalized patients with sepsis or trauma. Standard coagulation tests and ROTEM measurements will be collected and analyzed in relation to clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

Trauma patients:

Trauma alarm activated at hospital admission New Injury Severity Score (NISS) \> 15 Transfer to hospital within 7 days of trauma with NISS \> 15

Sepsis patients:

Meeting Sepsis-3 criteria Receipt of intravenous beta-lactam or aminoglycoside antibiotics within 48 hours of admission

Control group:

Patients undergoing elective surgery without expected coagulopathy

Exclusion Criteria:

Trauma patients:

Isolated chronic subdural hematoma No underlying traumatic event despite trauma alarm Age \<18 years

Sepsis patients:

Age \<18 years

Control patients:

Ongoing anticoagulant treatment Life-threatening illness (ASA IV-V) Age \<18 years
Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS)

The purpose of this randomized study is to determine whether a type of mesh derived from a layer of pig small intestine (SIS) is of benefit in treating paraesophageal hernias versus standard surgical suture repair.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Documented symptomatic paraesophageal hernia
* Ability to participate in follow-up evaluation
* Has a telephone
* Free of cognitive or speech impairment

Exclusion Criteria:

* Patients requiring intra-operative conversion to an open procedure
* Unable to close the crura primarily
* Short esophagus that requires the surgeon to perform a lengthening procedure
* Previous operation of the esphagus or stomach
* Associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of like assessment
* Intraoperative full-thickness perforation of the esophagus
* Emergent operation for acute volvulus
* Ineffective peristalsis defined as average amplitude of peristalsis less than 30 mmHg or \< 70% propagation of peristaltic waves in the distal esophagus
Piezoelectric Vibrations and Tissue, Cellular and Molecular Mechanisms of Oral Wound Healing After Third Molar Surgery

The aim of this clinical trial is to investigate and compare the effect of piezoelectric surgery on tissue, cellular and molecular level of oral surgical wound healing and postoperative outcomes (pain, swelling, trismus) after lower third molar surgery in healthy patients


Eligibility Criteria:
Inclusion Criteria:

* bilaterally symmetrically impacted lower third molars

Exclusion Criteria:

* presence of intraoral infection
* chronic orofacial pain
* pregnancy/ lactation
* heavy tobacco smokers
* alcohol/ drug abuse
* allergic reaction to medicaments used
Fish Oil and EPO in Breast Cancer

Recent literature data suggest beneficial effects of dietary fats in patients with cancers, in particular polyunsaturated fatty acids (PUFAs). Fish oil and evening primrose oil provide a high amount of PUFAs and a desirable n-6/n-3 PUFAs ratio.

Breast cancer (BC) is leading cancer in women. As most of the cancers, it is characterized by inflammation and alternations in lipid and fatty acid metabolism. Patients with BC have impaired fatty acid profiles, low level of PUFAs, and high n-6/n-3 PUFAs ratio. Moreover, these changes are related to clinical outcome.

Fish oil is the richest source of anti-inflammatory n-3 PUFAs. Evening primrose oil (EPO) is rich in 18:3 n-6, the only n-6 fatty acid with an anti-inflammatory effect. Dietary intake of fish oil or EPO has been shown to decrease inflammation and improve PUFAs status in patients with cancers. However, it is not known what is the effect of combined EPO and fish oil in BC patients.

The study design is double-blind, controlled, randomized nutritional intervention. The participants are randomly assigned into intervention and control group before starting chemotherapy. All patients receive nutritional counseling to achieve a daily energy and protein intake according to recommended dietary allowances, with (intervention) or without (control) of milled seed mix.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed breast cancer,
* Clinical Stadium III and IV,
* Patients able to understand requirements of the study and provide written informed consent-

Exclusion Criteria:

* Previous radio- or chemotherapy
* Other serious chronic diseases
* Statin therapy
* Use of fat-based dietary supplements (such as fish oil, evening primrose oil etc) 3 months prior to study
Impact of Splenic Artery Ligation in LDLT for Patients With Portal Hypertension

In this study, the investigators aim to prove that performing splenic artery ligation in living donor liver transplantation for patients with portal hypertension is beneficial for early graft function postoperatively. The investigators will be analyzing trend of LFT's (liver function tests) after surgery, time for normalization of bilirubin, INR (international normalised ratio) and decrease in ascites, morbidity, mortality, ICU (intensive care unit) and total hospital stay.

Liver transplantation (LT) is the principal treatment for end-stage liver diseases and selected cases of liver neoplasms . Living donor liver transplantation (LDLT) serves as a sole source of liver graft in some countries that do not allow donation from deceased donors for cultural, social, or religious reasons.

Hyperperfusion plays an important role in liver regeneration after LDLT, but it may induce injury in the graft . After the reperfusion of a partial graft, there is a significant increase in the portal flow, but Hepatic artery flow remains constant . Excessive portal vein flow may induce injuries in grafts and may contribute to poor graft function.

For satisfactory graft function early after LT, the portal vein pressure (PVP) value after reperfusion should be \<15 mm Hg. PVP is the most important hemodynamic factor influencing the functional status of the liver and graft regeneration after LT.

The use of Splenic Artery Ligation (SAL) as a simple and safe method to modulate portal flow has been reported .

The investigators will evaluate that Splenic artery ligation in living donor liver transplantation for patients with Portal hypertension is feasible and efficient technique to improve early graft function and to decrease morbidity and hospital stay and improve outcomes .

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing Living Donor Liver Transplantation(LDLT) accepted according to hospital protocol.
* Patients who have Portal Venous Pressure (PVP) \> 15 mm Hg after reperfusion .

Exclusion Criteria:

* Patients who have Portal Venous Pressure (PVP) \> 15 mm Hg after reperfusion.
* Patients who had splenectomy.
* Patients who have splenic artery aneurysm.
A Pharmacokinetic (PK) Study of Extended-Release Epidural Morphine in Upper Abdominal Surgery

The primary purpose of this study is to evaluate the effects of lidocaine/epinephrine test dose administration on the PK profile of a single epidural dose of DepoDur (extended-release epidural morphine) in patients undergoing major upper abdominal surgery. A secondary objective was to evaluate the safety and efficacy profile.


Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years of age at Screening
* Negative pregnancy test in females of childbearing potential
* Scheduled for major upper abdominal surgery via an upper midline incision under general anesthesia
* American Society of Anesthesiology (ASA) Physical Class 1, 2, or 3
* Willing and able to use a PCA pump
* Willing to receive only IV fentanyl for 72 hours post-dose to control post-operative pain
* Capable of providing written informed consent and responses to pain assessment scales and neurological assessment questionnaires

Exclusion Criteria:

* Morbid obesity, defined as a body mass index (BMI) ≥ 40
* Scheduled to undergo surgery under regional anesthesia
* Usage of analgesic medications containing morphine or codeine within three days prior to study drug administration
* Chronic opioid medication usage (defined as daily opioids for more than 7 days prior to enrollment)
* Suspected or documented history of sleep apnea, narcolepsy, or excessive daytime sleepiness
* Female who was pregnant or lactating
* History of hypersensitivity or idiosyncratic reaction to opioid medications, local anesthetics, or epinephrine
* Any contraindication for the epidural administration of study drug (e.g., coagulopathy, local infection)
* Administration of an investigational drug within 30 days prior to Screening
* Suspected or documented history of substance abuse and/or alcoholism
* Any contraindication to frequent blood PK sampling (such as significant anemia) or other barrier to obtaining timely PK samples
Zoledronic Acid in Rheumatoid Arthritis

The progression of structural joint damage is the leading cause of disability and socioeconomic costs associated with rheumatoid arthritis (RA). Remission and low clinical activity not always imply absence of progression of structural damage. The main objective of this study is to evaluate the progression of radiological damage in early RA patients currently treated with disease modifying anti-rheumatic drugs (DMARDs) and low disease activity to which treatment with zoledronic acid is added.

The investigators propose a randomized clinical trial in 94 patients with RA of less than 2 years of evolution that, being treated with DMARDs, present criteria of low disease activity (DAS28 \< 3.2).

Patients will be randomized into two branches: zoledronic acid and no treatment. The primary study endpoint is the progression of radiological damage assessed in a blinded way by the difference in the Sharp-van der Heijde index (SHI) in radiographs of hands and feet after two years; the secondary variables: radiographic progression after one year, serum bone biomarkers (OPG, RANKL, DKK-1 and sclerostin) and adverse effects. In a subgroup of patients, the investigators shall evaluate the change in the size of hand erosions by multislice computed tomography and the evolution of periarticular osteoporosis and systemic bone mass by dual X-ray absorptiometry (DXA).


Eligibility Criteria:
Inclusion Criteria:

1. Age equal or greater than 18 years
2. Patients with RA of less than 2 years of evolution
3. DMARD therapy (methotrexate alone or methotrexate, leflunomide or methotrexate within COBRA strategy) on stable dose for at least 6 weeks prior to study entry
4. Patients not treated with glucocorticoids or under stable dose of prednisone up to 5 mg / day or equivalent dose of another glucocorticoid
5. Low disease activity (DAS28 \<3.2)
6. In case of premenopausal women, commitment to make contraceptive treatment up to 3 years after the last dose of zoledronic acid
7. Signed informed consent

Exclusion Criteria:

1. Previous or current treatment with biological drugs used for the treatment of RA (infliximab, adalimumab, etanercept, certolizumab, golimumab, rituximab, abatacept, tocilizumab)
2. Pretreatment with:

   1. Bisphosphonates in the 5 years prior to the onset of RA
   2. Calcitonin, raloxifene, bazedoxifene, strontium ranelate, teriparatide and denosumab in the year before the onset of RA
3. Contraindication to treatment with zoledronic acid:

   1. Hypersensitivity to bisphosphonates
   2. Hypocalcemia
   3. Glomerular filtration rate \<35 mL / min
   4. Pregnant (negative pregnancy test) and lactating women
   5. Poor oral hygiene
   6. Pending invasive dental procedure
4. Serum levels of calcidiol lower than 25 nmol/L (10 ng/mL).
5. Simultaneous participation in another clinical trial
Conversational Hypnosis for Peripherical Veinous Access (HYPNACESS)

The peripherical veinous catheterization is required for anesthesia. However, it's a painful procedure and causes stress or even phobia.

Hypnosis can be seen as an interesting tool. Conversational hypnosis needs no training. It is used by script, which makes it easier.

The working hypothesis for study is that the conversational hypnosia script reduces pain during the set up of peripherical veinous access.

The main objective is the analgesia assessment of conversational hypnosis script for peripherical veinous catheter set up versus standard script in operating room. A nurse anesthetist is reading the conversational script or standard script during the procedure. The nurse anesthetist is untrained for hypnosis.

The secondary objective are the level of anxiety, patient satisfaction within the perioperative period (EVAN G questionnaire), the heart rate and the evaluation how nurse anesthetist feels about using the script after each use.


Eligibility Criteria:
Inclusion Criteria:

* Digestive endoscopy procedure under general anesthesia in one of the participating centers
* Patient speaking and understanding French
* Patient affiliated or entitled to a social security scheme
* Patient who received enlightened information about the study and who co-signed, with the investigator, a consent to participate after a minimum period of reflection

Exclusion Criteria:

* Patient with deafness
* Patient with cognitive impairment
* Pregnant and / or breastfeeding patient
* Patient with dissociative disorders (contraindication to hypnosis)
* Patient suffering from a pathology which can cause chronic pain
* Patient receiving analgesia or anxiety drug
* Patient under justice, curatorship or tutorship
* Patient deprived of liberty by judicial or administrative decision
Prospective Randomized Pilot Study Comparing Inferior Versus Superior Conjunctival Autografts for Primary Pterygia

The purpose of this study is to determine if there is any difference in the surgical time when the surgery is performed with a graft taken from under the upper lid versus lower lid. The investigators will also be recording the level of pain felt by patients after surgery, any difficulties during or after surgery, and if the pterygium grows back.


Eligibility Criteria:
Inclusion Criteria:

* Primary pterygium (no previous surgeries or radiotherapy) requiring excision due to ocular discomfort or disruption in vision
* Ability to understand the nature of the procedure and to complete all measurement requirements
* Patients must be eligible for either the superior or inferior conjunctival autografts (they must not meet any of the following exclusion criteria)
* Adults (age \>18)

Exclusion Criteria:

* Ocular surface disease apart from pterygium (such as severe dry eye, corneal disease, scarring from previous infection, radiotherapy, inflammatory diseases or trauma)
* Patients who have had previous ocular surface surgery
* Patients with glaucoma or those who may need glaucoma surgery in the future
* Contraindications to local anesthetics (such as known allergy)
* Pregnancy (as the risk to the fetus with the use of topical antibiotic drops and local anesthetics are not known)
Scapholunate Ligament Partial Tears; Tear Localization, Extrinsic Ligament Injury Association and Conservative Treatment Responses Prior to Instability

The purpose of this study is to investigate scapholunate ligament partial tears regarding tear localization, extrinsic ligament accompaniment in stable wrist and accordingly to scrutinize conservative treatment response.

Patients admitted with radial sided wrist pain without carpal instability were retrospectively evaluated. Scapholunate interosseous ligament (SLIOL) tear localization, grade of injury and associated extrinsic ligament injuries were examined on MRI. Patients treated conservatively and recalled at their first year for re-evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Scapholunate ligament Injury
* Wrist Extrinsic Ligament Injury

Exclusion Criteria:

* Scapholunate Dissociation
* Radiological and clinical instable wrist
* Carpal bone fracture
* MRI imaging artefact
A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)

Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.


Eligibility Criteria:
Inclusion Criteria:

* Patient-reported history of Dry Eye Disease in both eyes.
* Use of over the counter artificial tears within the past 30 days.
* A negative urine pregnancy test for females and willingness to use adequate birth control throughout the study.
* Able and willing to comply with all study procedures.

Exclusion Criteria:

* Presence of an ocular condition that could affect the study parameters such as active ocular infections, ocular inflammation, glaucoma, or diabetic retinopathy;.
* Unwilling to stop wearing contact lenses during the study.
* LASIK or other ocular surgical procedures within 12 months prior to or during the study.
* Use of prohibited medications
* Significant medical conditions that could affect the study parameters.
Drug Combination on Exercise Performance at High Altitude

This study is being conducted to determine the effectiveness of using two FDA approved medications in concert to reduce the likelihood of sickness due to low oxygen levels and to reduce the decrement in physical performance at higher elevations. The investigators hypothesize that this drug combination will reduce the symptoms of acute mountain sickness and improve exercise performance at high altitude compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* healthy males

Exclusion Criteria:

* VO2max below 45ml/kg/min
* currently taking any medication
A Composite Assay for HER2-positive Early-stage Breast Cancer Management

The goal of this observational study is to assess the prognostic value of a genomic classifier (S18) and its refined version (S\*) in women with early-stage HER2-positive breast cancer. The study aims to determine whether these tools can predict event-free (EFS) and disease-free survival (DFS) in patients treated with neoadjuvant and/or adjuvant trastuzumab-based therapies.

The population includes women aged 18 or older with stage I-III HER2-positive breast cancer who received trastuzumab ± pertuzumab. Data and tumor tissue samples from this population have been collected prospectively from Istituto Nazionale dei Tumori IRCCS Fondazione Pascale, Naples (cohort A), and from Ospedale "Di Summa-Perrino", Brindisi (cohort B). The study integrates clinical-pathological and genomic data to refine and validate the prognostic capabilities of the S18 classifier.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Operable breast cancer (stage I-III)
3. Any status of hormone receptor in the primary tumor, according to institutional guidelines
4. HER2-positive primary tumor, according to ASCO guidelines, i.e., HER2-positive phenotype by immunohistochemistry (IHC) 3+ or 2+ with a positive result for ERBB2 gene amplification analysis using ISH techniques (CISH, SISH, FISH)
5. Neoadjuvant and/or adjuvant therapy based on trastuzumab ± pertuzumab
6. Written informed consent from patients

Exclusion Criteria:

1. Patient in follow-up for less than 3 years after surgery
2. A prior diagnosis of invasive cancer before the diagnosis of breast cancer
Studying Malnutrition And Sarcopenia In Older Adults With Acute Myeloid Leukemia

This study will explore how malnutrition (poor nutrition/diet) and sarcopenia (a condition that causes a loss of muscle and bone mass) affects study participants over the age of 60 with acute myeloid leukemia (AML) who will receive induction chemotherapy (chemotherapy given as the first treatment to help cancer go into remission) and/or cancer drugs as part of standard care for AML. By studying how these nutritional and skeletal factors, doctors leading this study hope to learn how malnutrition and sarcopenia may be able to predict certain outcomes --such as how long study participants with poor nutrition and muscle loss can live after chemotherapy- for older (age 60+) individuals with AML.


Eligibility Criteria:
Inclusion Criteria:

* Older Adult patients (greater than or equal to 60 years of age)
* New diagnosis of acute myeloid leukemia (AML)
* Receiving induction therapy (intensive or low intensity therapy)
* Willing and able to provide written informed consent

Exclusion Criteria:

* Presence of a pacemaker or defibrillator.
* Participants who are pregnant at the time of enrollment.
* Anyone unable/unwilling to follow protocol requirements
Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study

The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies at high risk of RDS:

1. Early stabilization on nCPAP
2. Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery, and rapid extubation to nCPAP.

The data obtained from this comparison will be applied to test the hypothesis that preterm neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need for MV when compared to infants who receive nCPAP alone.


Eligibility Criteria:
Inclusion Criteria:

* Preterm neonates with a gestational age (GA) of 25+0 - 28+6 completed weeks.
* Inborn neonates.
* In case of twins, both neonates will be included in the same treatment arm.
* Parental written informed consent for participation in the study obtained on admission into the hospital or prior to delivery.

Exclusion Criteria:

* Evidence of severe birth asphyxia, that is an APGAR score below 3 at 5 minutes of age.
* Need for endotracheal intubation for cardiopulmonary resuscitation or insufficient respiratory drive.
* Known genetic or chromosomal disorders.
* Delivered to mothers with ruptured membranes of more than 3 weeks duration.
* Potentially life-threatening conditions unrelated to immaturity.
* Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.