cyrilzakka/clinical-trials huggingface dataset:
Gabapentin in Reducing the Need for Pain Medication in Patients With Bladder Cancer Undergoing Radical Cystectomy

This randomized phase II/III trial studies gabapentin in reducing the need for pain medication in patients with bladder cancer undergoing surgery to remove the bladder and nearby tissue and organs. Gabapentin may reduce the amount of pain medicine required after surgery, improve pain after surgery, and/or reduce the length of hospital stay after surgery.

PRIMARY OBJECTIVES:

I. To assess if perioperative gabapentin will decrease post-operative analgesic requirements within the first 48 hours after radical cystectomy (RC) in patients undergoing RC as measured morphine equivalents.

SECONDARY OBJECTIVES:

I. To assess patient self-assessment of postoperative pain on Numeric Pain Scale (NPS) at 24 and 48 hours.

II. To assess time to return of bowel function (ROBF).

III. To assess length of stay (LOS) following RC.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive gabapentin orally (PO) thrice daily (TID) for 48 hours after surgery.

ARM II: Patients receive placebo PO TID for 48 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bladder cancer
* Anticipated radical cystectomy with ileal conduit or orthotopic neobladder

Exclusion Criteria:

* Presence of spinal cord injury including any form of paraplegia or quadriplegia
* Allergy to gabapentin
* Active alcohol dependence, defined as 2 or more positive questions on the CAGE alcoholism questionnaire
* Illicit drug use (excluding recreational marijuana)
* Chronic kidney disease with glomerular filtration rate \< 30 ml/min
* Pregnancy: All female patients \< 55 years old (yo) will be administered a urine pregnancy test prior to enrollment
* Non-English speaking patients
* Chronic gabapentin, or the similar drug pregabalin, use
* Chronic narcotic use (daily or near daily use for \> 90 days)
Pulmonary Hypertension in Interstitial Lung Disease

HYPID study is an observational and prospective study of patients with interstitial lung disease and pre capillary hypertension diagnosed by right heart sided catheterization. The primary aim of the study is to identify prognostic factors.

Pre capillary pulmonary hypertension (PH) may be present in patients with diffuse interstitial lung disease.

In this context, PH represents an important factor of morbidity and mortality for these patients.

One of the purposes of HYPID is to determine predictive factors of mortality within this cohort of patients.

In order to reach that aim,the study includes an evaluation based on exams conducted for the routine follow-up of patients. Each patient will be followed during 2 years at least.

Eligibility Criteria:
Inclusion Criteria:

* pre capillary pulmonary hypertension at right heart sided catheterization with: mPAP \> or = 25 mmHg,PCWP \< or = 15 mmHg
* interstitial lung disease with diffuse infiltrative opacities on chest CT scan

Exclusion Criteria:

* pulmonary hypertension related to a thromboembolic disease
* respiratory disease other than diffuse interstitial lung disease
* any etiological factor of pulmonary arterial hypertension based on DANA POINT classification other than diffuse interstitial lung disease
* any progressive disease associated to a life expectancy less than 6 months other than pulmonary hypertension, diffuse interstitial lung disease and respiratory insufficiency
Effect of Omega 3 Supplementation on the Heart Rate Variability in Obese Children

Evidence shows that omega-3 fatty acids lower blood triglyceride levels, lower blood pressure, enhance insulin sensitivity, and improve heart rate variability (HRV) measures, all of which may be indicators of cardiovascular health.As a result, omega-3 fatty acid supplementation may be a low-cost strategy with little adverse effects for obese youngsters, perhaps delaying the development of chronic cardiovascular illnesses.

This is a two-armed study , the interventional group will be given omega 3 and the control group will be given a placebo and both will be examined for the heart rate variability

Eligibility Criteria:
Inclusion Criteria:

* Children (5-12 years) whose parents or caregivers will agree to be enrolled in the study
* Obese Children (Simple obesity )
* Both males and females

Exclusion Criteria:

* Patients are known to have cardiac disease
* Patients with associated chronic systemic illness
* Patients with 2ry obesity : (endocrine /metabolic/genetics/drug intake)
* Patients on medications affecting heart rate :structural or arrhythmic
Validation of Electrical Cardiometry Versus Fick Method in Cardiac Output Measurement

The investigators would like to find out if AESCULON®, a new device that non-invasively and continuously measures cardiac output using electrical cardiometry, works as well as one existing method--Fick method in patients undergoing cardiopulmonary exercise testing.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 yd;
* Level 3 cardiopulmonary exercise testing.

Exclusion Criteria:

* Proven or suspected disease involving severe aortic regurgitation;
* Implanted with a rate-responsive cardiac pacemaker;
* Pneumothorax or pleural effusion;
* Skin lesion(s) at the place where the electrode is supposed to be applied;
* Allergic to adhesive of ECG electrodes.
Acute Feasibility Investigation of a New S-ICD Electrode

This is an early-stage feasibility study. This study seeks to characterize the performance of the new electrode shock configuration with the S-ICD

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD, EMBLEM®, Boston Scientific Corp) delivers 80 J shocks from an 8 cm left-parasternal coil (LPC) to a 59 cc left lateral pulse generator (PG). A system that defibrillates with lower energy could significantly reduce PG size. Computer modeling and animal studies suggest a 2nd shock coil either parallel (P) to LPC or transverse (T) from xiphoid to PG pocket would significantly reduce shock impedance and defibrillation threshold (DFT).

Objective: Acutely test defibrillation efficacy of P and T configurations in patients receiving an S-ICD.

Methods: Testing was performed in patients receiving a conventional S-ICD system (C) for standard indications. Patients at risk for conversion failure, stroke or infection were excluded. A 65 J success with the conventional S-ICD was required prior to investigational testing. A second electrode was temporarily inserted from the xiphoid incision using the same introducer and sheath tools and connected to the PG with an investigational Y-adapter (Model 3598, Boston Scientific). Phase 1 (n=11) tested only P at a starting energy of 50 J with subsequent tests at 65 or 30 J then 40 or 20 J depending upon outcome. Phase 2 (n=21) tested both P and T in random order, starting at 30 J then either 40 or 20 J.

Eligibility Criteria:
Key Inclusion Criteria:

1. Subject is scheduled to receive a de novo S-ICD system implant per labeled indication.
2. Passing S-ICD screening ECG performed per applicable user's manual.
3. Subject is willing and capable of providing informed consent specific to local and national laws.
4. Subject is age 18 or above, or of legal age to give informed consentspecific to local and national law.

Key Exclusion Criteria:

1. Subject has an unusual chest anatomy (eg. pectus excavatum and pectus carinatum) that might impede the ability to temporarily insert a second S-ICD electrode.
2. Subject has a left ventricular ejection fraction ≤ 20% within 3 months prior to enrollment.
3. Subject has NYHA Class IV or unstable Class III heart failure.
4. Subject that, in the opinion of the investigator, cannot tolerate the DFT testing required by this protocol.
5. Subject is morbidly obese, defined as BMI ≥ 35.
6. Subject has an active infection or has been treated for infection within the past 30 days.
7. Subject that, in the opinion of the investigator, has an increased risk of infection.
8. Subject is currently requiring/receiving dialysis.
9. Subject has insulin-dependent diabetes.
10. Subject had/has any prior or planned other surgical procedure within ±30 days of enrollment.
11. Subject that, in the opinion of the investigator, has an increased risk for thromboembolic event.
12. Subject that, in the opinion of the investigator, has an increased risk of excessive bleeding.
13. Subject is currently on an active heart transplant list.
Study to Evaluate Safety, Tolerability, PK and the Food Effect on PK of ASC11/RTV Tablets in Healthy Subjects

This is a randomized, double-blind, placebo-controlled phase I clinical study evaluating the safety, tolerability, and pharmacokinetics of ASC11 plus ritonavir tablets in healthy subjects and an open-label, cross-over study evaluating the effect of food on the pharmacokinetics of ASC11 plus ritonavir tablets


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects aged 18-60 years (including boundary values)
* If a woman has no planned pregnancy within 6 months after signing the informed consent, and is willing to use effective contraception (e.g. condom, uterine cap, non-hormonal intrauterine device \[IUD\]) for at least 3 months from the first administration of the study intervention to the last administration of the study intervention; Or not fertile (e.g. surgical sterilization \[bilateral oophorectomy, tubal ligation, or hysterectomy\] or natural sterilization \[continuous \> 12 months without menstruation\])
* If male, agree to use effective contraception throughout the study intervention and for at least 3 months after the last dose of the study intervention, and do not donate sperm.
* General good health based on history, physical examination (screening and check-in assessment), vital signs and other screening assessments.
* Able to understand the research content, comply with the research protocol, and voluntarily sign the informed consent.

Exclusion Criteria:

* Pregnant and lactating women.
* Patients with acute or chronic diseases, including but not limited to cardiovascular, digestive, respiratory, urinary, nervous, endocrine, immune, musculoskeletal, and skin conditions, were judged by the investigator.
* Any previous or existing hematological disorders or disorders, major liver disease, family history of bleeding/platelet disease.
* Previous or existing cancer (other than basal cell carcinoma or squamous cell carcinoma of the skin), or hygrosis.
* Have an autoimmune disease, immunosuppression, or any form of immune deficiency.
Influence of Gemcitabine Treatment on Immunological and Serological Profile in Patients With Pancreatic Cancer

Observational study of influence of gemcitabine treatment on serological and immunological status and gene expression profile in patients with pancreatic tubular carcinoma after tumor resection.


Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status 0-2 at the time of inclusion
* Following R0 or R1 pancreatic tubular adenocarcinoma resection

Exclusion Criteria:

* Pregnancy
* Serious comorbidity
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease

The purpose of the study is to determine the effect and optimum dose and evaluate the safety of ferric citrate, administered three times daily (TID) immediately after meals for a total daily dose of 4 or 6 grams for 56 days, on serum phosphate (PO4) levels in subjects with end stage renal disease (ESRD).


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years and has a diagnosis of ESRD
* On a three-times per week hemodialysis regimen
* On a stable dose of a phosphate-binding agent for at least one month prior to study entry.
* If on vitamin D supplementation or calcitriol, must be on a stable dose for at least one month prior to study entry.
* Hct \>= 20%
* Serum Ca level of 8 mg/dL to 10.5 mg/dL

Exclusion Criteria:

* Is pregnant or lactating
* Clinically significant GI disorder
* Has tertiary hyperparathyroidism or is immediately post-operative from a parathyroidectomy (within the first 3 months post-op or the plasma Ca is \<7 mg/dL)
* ferritin\>800 ng/mL
* Unstable medical condition unsuitable for the study in the opinion of investigator
* Has been treated with an investigational agent within 30 days of enrollment
* Has a history of documented iron allergy or hemochromatosis
Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle

Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved.

The Echotip Procore (Cook Medical) core biopsy needle (ETP), has been demonstrated to provide excellent efficacy for core biopsy samples. Final diagnostic yield using this needle ranges from 80-90% and appears to be significantly greater than EUS-FNA for lesions requiring histology for diagnosis. However, there is currently only limited data from prospective studies comparing EUS-FNA to EUS-FNB with the ETP needle. The investigators propose a randomized, prospective, cross-over study comparing diagnostic accuracy of EUS-FNA to EUS-FNB.

Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved.

We will compare tissue samples obtained by standard FNA to FNB with a sample size of 140 patients with the primary outcome being diagnostic yield. Each patient will be randomized to FNA or FNA. If after 3 passes the on-site evaluation remains inadequate, the endoscopist will crossover to the other arm.

Eligibility Criteria:
Inclusion Criteria:

- 3.1.1 All patients referred for EUS tissue sampling who provide informed consent

Exclusion Criteria:

* 3.2.1 Coagulopathy which is not corrected

3.2.2 Diagnostic EUS determines lesion is not amenable to FNA or FNB
Dexmedetomidine Versus Lidocaine in Attenuating Airway Reflexes During Recovery of Thyroidectomy Patients

It is widely believed that most of the patients experience a cough upon emergence from general anesthesia, due to many causes including the presence of an endotracheal tube, uncleared secretions and anesthetic gas. Cough during tracheal extubation may lead to several complications, such as hypertension, tachycardia and postoperative bleeding.

In this study the investigators are going to compare the effectiveness of intravenous Dexmedetomidine and intravenous lidocaine in attenuating the air way reflexes and coughing during recovery of thyroidectomy patients.

Intubation and extubation process are associated with cardiovascular and various airway responses leading to tachycardia, hypertension, arrhythmia, myocardial ischemia, cough induction, bronchospasm, increased bleeding, increased intracranial and intraocular pressure. Causes possibly include the presence of an endotracheal tube, uncleared secretions, and anesthetic gas.

Furthermore, postoperative bleeding in thyroid surgery is still significant and is often associated with severe complications including cervical hematoma, reoperation and cardiac arrest.

Extubation under deep anesthesia decreases cardiovascular stimulation and reduces the incidence of coughing and straining on the tube. Intratracheal local anesthetic instillation, I.V lidocaine, short acting opioids such as fentanyl and remifentanil, esmolol, labetalol, diltiazem and verapamil have been used to attenuate these hemodynamic and respiratory responses during extubation in the past but with certain limitations.

Also "no stimulation" extubation technique avoids extubation under light anesthesia and ensures extubation only when consciousness is returned. It requires absolutely no stimulation during emergence and performing extubation only when the patient wakes up spontaneously and opens his eyes.

Recently dexmedetomidine, a potent α2-adrenoreceptor agonist has been used to facilitate extubation in surgical intensive care unit, but its role in the attenuation of hemodynamic and airway reflexes during extubation in general anesthesia is still under study.

In this study the investigators are going to compare the effects of intravenous lidocaine and dexmedetomidine in inhibiting cough reflex during the recovery period after thyroid surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective thyroidectomy surgery.
* Age: patients between 18-and 65-years old from both sexes.
* Classified as either American Society of Anesthesiologists (ASA) class I or II.

Exclusion Criteria:

* Refusal of procedure or participation in the study.
* Patients suffering from asthma, chronic cough, preoperative upper respiratory infection symptoms.
* Current smoker.
* Medication involving angiotensin-converting-enzyme inhibitors (ACE-I).
* Classified as either American Society of Anesthesiologists (ASA) class III or IV.
* Sinus Bradycardia (\<60/min) or history of any type of heart block or Beta-Blockers medication.
Problems With Immune Recovery in the Gut Tissue

The aim of this study is to find out if the process of HIV replication in the lymph tissue and gut tissue of people taking HIV drugs causes long-term damage to the ability of the gut to protect you from other infections and health problems.


Eligibility Criteria:
Inclusion Criteria:

HIV+ individuals

* Seropositive for HIV
* On ART for at least 12 months
* Seropositive for Herpes Simplex Type 2 and Cytomegalovirus
* Age ≥ 18 years
* Negative pregnancy test for eligible women of childbearing potential

HIV- individuals

* Seronegative for HIV
* Seropositive for Herpes Simplex Type 2 and Cytomegalovirus
* Age ≥ 18 years
* Negative pregnancy test for eligible women of childbearing potential

Exclusion Criteria:

* Taking daily suppressive therapy for Herpes Simplex Type 2
* Contraindication to surgical \& endoscopic procedures (as judged by PI)
* Psychiatric or psychological illness that would make adherence to protocol procedures unlikely
* Pregnancy
Repeatability and Reproducibility of Cirrus HD-OCT Macular Retinal Pigment Epithelium Elevation

The objective of this study is to determine the repeatability and reproducibility of the Cirrus HD-OCT measurements of drusen area and volume.

This is a prospective, single site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. The study will be divided into two phases. In Phase 1, the inter-device variability of Cirrus HD-OCT measurements of drusen area and volume will be determined. In Phase 2, the inter-operator variability of Cirrus HD-OCT measurements of drusen area and volume will be determined. In each of these phases, the Macular Cube 200 x 200 scan and the Macular Cube 512 x 128 scan will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females 50 years of age or older diagnosed to have dry AMD with macular drusen.
2. Drusen should not be combined with other lesions such as geographic atrophy (GA) or choroidal neovascularization.
3. Able and willing to make the required study visits.
4. Able and willing to give consent and follow study instructions.

Exclusion Criteria:

1. History of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye.
2. Evidence of other retinal diseases of the eye, including wet AMD, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction.
3. Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
4. Concomitant use of hydrochloroquine or chloroquine.
5. Unable to make the required study visits.
6. Unable to give consent or follow study instructions.
Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

The main purpose of this study was to evaluate the safety and immunogenicity of Immunogenicity of Inactivated and Live Attenuated Hepatitis A Vaccines for healthy Chinese people.


Eligibility Criteria:
Inclusion Criteria:

* Only subjects fulfilling all of the following criteria will be eligible for the study:
* People aged from 18 months to 65 years old.
* The subjects or subjects' guardians are able to understand and sign the informed consent
* The subjects or subjects' guardians allow to comply with the requirements of the protocol
* Subjects with temperature \<=37.0°C on axillary setting
* The subjects have signed informed consent already

Exclusion Criteria:

* Subjects will not be eligible for the study if any of the following criteria is met:
* Subject who has a medical history of serious disease including Tumor, autoimmune disease, progressive atherosclerosis diseases or complications of diabetes, chronic obstructive pulmonary disease (copd), kidney disease, congestive heart failure etc.
* Have a history of neurological symptoms or signs
* Have medical history or family history relating to allergies, seizures, epilepsy, brain and spirit etc.
* Suffering from serious chronic diseases
* Suffering from known or suspected of diseases including respiratory diseases, acute infection , mothers have HIV infection, cardiovascular disease, severe hypertension, skin diseases, malignant tumor
* Allergic to any ingredient in research, history of allergies to any vaccination (always), especially for people allergic to high protein food like eggs and milk
* Any prior known or suspected damage or abnormal immune function. As for patients who are treated with immune inhibitors or immune enhancer medicine, accept with immunoglobin, blood products and plasma extraction within 3 months
* Any prior diseases including human immunodeficiency virus infection or related
* Bleeding constitution or prolong bleeding time situation
* Accept hepatitis A vaccination within a month
* Received vaccines, other immune globulin, any research drug injections in the past 4 weeks
* People who had any acute illness, needed systemic antibiotics or antiviral treatment in the past 7 days
* Caught a fever with axillary temperature 38°C or higher in past 3 days
* Take part in another clinical researchers
* Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
* Pregnancy test result is positive