cyrilzakka/clinical-trials huggingface dataset:
The Effect of Transcutaneous Electrical Nerve Stimulation on Pain During Venous Cannulation

The purpose of this study was to investigate whether transcutaneous electrical nerve stimulation (TENS) could reduce pain during cannulation of vein.

One hundred patients were allocated randomly to two groups: In the active TENS group TENS was delivered via two electrodes on the venous cannulation site (radial side of the wrist of dominant forearm) 20 min prior to venous cannulation and control group received placebo (no current) TENS. Venous cannulation with a 22 gage cannula was performed. During venous cannulation the pain intensity (0 = no pain, 10 = worst pain imaginable) was measured. Any side effects during study periods were recorded

Eligibility Criteria:
Inclusion Criteria:

* outpatients who underwent plastic surgery

Exclusion Criteria:

* concomitant sedative or analgesic medication,
* neurological disease.
* all patients with potentially dangerous internal diseases (American Society of Anesthesiologists' physical status \> 3).
68Ga-FAPI-RGD PET/CT for Dual Integrin αvβ3 and FAP-targeted Imaging in Patients With Various Types of Cancer and Compared With 18F-FDG

As a new dual receptor (integrin αvβ3 and FAP) targeting PET radiotracer, 68Ga-FAPI-RGD is promising as an excellent imaging agent applicable to various cancers. In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-RGD in healthy volunteers. Moreover, we evaluate the potential usefulness of 68Ga-FAPI-RGD positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, and compared with 18F-FDG PET/CT.

As a new dual receptor (integrin αvβ3 and FAP) targeting PET radiotracer, 68Ga-FAPI-RGD is promising as an excellent imaging agent applicable to various cancers. In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-RGD in healthy volunteers. Moreover, Subjects with various types of cancer underwent contemporaneous 68Ga-FAPI-RGD and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of 18F-FDG and 68Ga-FAPI-RGD PET/CT were recorded by visual interpretation. The diagnostic accuracy of 68Ga-FAPI-RGD were calculated and compared to 18F-FDG PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (aged 18 years or order);
* patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
* patients who had scheduled both 18F-FDG and 68Ga-FAPI-RGD PET/CT scans;
* patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* patients with non-malignant lesions;
* patients with pregnancy;
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Safety and Efficacy Clinical Study of KL-HIV-Tri01 in the Treatment of HIV Infected Subjects

This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL-HIV-Tri01 injection solution in HIV infected subjects treated with HAART.

This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL-HIV-Tri01 injection solution expressing triple targets antibodies with broad HIV-1 neutralizing activity in HIV-1 infected adults on anti-retroviral therapy (ARV). Nine subjects will be enrolled and administered with three different doses of KL-HIV-Tri01. Subjects will provide informed consent and then undergo screening assessments up to 1 month prior administration of KL-HIV-Tri01. All subjects will undergo 52 weeks safety observation and will be encouraged to enroll in an extension study to evaluate long- term safety of KL-HIV-Tri01 for total 5 years.

Eligibility Criteria:
Inclusion Criteria:

1.18 (not inclusive) to 80 (inclusive) years of age, both male and female.

2. Conform to the Chinese AIDS Diagnosis and Treatment Guidelines (2021), HIV positive, and received HAART treatment for ≥ 3 months before enrollment.

3. CD4+T cell count≥500 cells/μl.

4. On a stable antiretroviral regimen before enrollment and viral load less than 40 copies/mL in two consecutive tests one year prior to enrollment.

5. Willing to fully understand the purpose, nature, method, and potential adverse reactions that may occur during the discontinuation period of the experiment, voluntarily participate in this experiment and sign an informed consent form.

Exclusion Criteria:

1. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
2. Active viral infections, such as HBV, HCV, CMV, or other viruses that the investigator believes will affect clinical research.
3. Any opportunistic infection in the past one year, such as tuberculosis, cryptococcosis, which is not cured after treatment.
4. Currently treated with Immunosuppressive medications or steroids.
5. Previous receipt of HIV vaccine, antibody or gene therapy.
Vorasidenib Expanded Access Program

This is an expanded access program to provide vorasidenib for treatment of patients 12 years or older with IDH1- or IDH2-mutated glioma.

This expanded access program is designed to provide access to vorasidenib for patients with IDH1- or IDH2-mutated glioma who are not eligible for other vorasidenib clinical trials, and who in the opinion of the treating oncologist would potentially benefit from treatment with vorasidenib.

Safety assessments (including vital signs, hematology, and serum chemistry) occur every two weeks for the first two cycles (28 day each cycle), then monthly for the duration of treatment. Treatment with vorasidenib will continue until, in the clinical judgement of the treating physician, the patient is no longer benefiting from the treatment, vorasidenib is approved and available by prescription, or the study is terminated.

Requests by treating physicians to file a single patient investigational new drug application as part of the expanded access program for vorasidenib will be considered on a case-by-case basis.

Eligibility Criteria:
Inclusion Criteria:

1. Male and females; ages ≥ 12 years old.
2. IDH-mutant oligodendroglioma or astrocytoma with the IDH1 or IDH2 gene mutation confirmed by tissue-based diagnosis.
3. At least 1 prior surgery for glioma (including biopsy).
4. Adequate bone marrow function as evidenced by:

   * Absolute neutrophil count ≥ 1.5 X 109/L
   * Hemoglobin ≥ 9 g/dL
   * Platelets ≥ 100 X 109/L
5. Adequate hepatic function as evidenced by:

   * Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN)
   * Aspartate aminotransferase and alanine aminotransferase: at or below the ULN
   * Alkaline phosphatase ≤ 2.5 X ULN
6. Adequate renal function as evidenced by a creatinine clearance (CrCl) ≥ 40 mL/min

   Exclusion criteria:
7. Patient is eligible for a clinical trial with vorasidenib.
8. Patients who are enrolled in a Servier-sponsored clinical trial and have completed all requirements of the trial may be eligible if the patient continues to benefit from vorasidenib and does not meet criteria for discontinuation of treatment.
9. Pregnant or breastfeeding.
10. Patients who require or who cannot withhold strong inhibitors of CYP1A2 (ciprofloxacin and fluvoxamine). Consider alternative therapies that are not strong CYP1A2 inhibitors.
Human Papillomatosis Genotyping of Children in Thailand

The purpose of the present study was to identify risk factors for more severe juvenile Recurrent Respiratory Papillomatosis (RRP) through prospective evaluation of a pediatric population in Thailand by the employing a protocol that includes staging of disease severity using above mentioned staging system at the time of each endoscopic debridement, as well as human papilloma virus (HPV) genotyping.

Recurrent respiratory papillomatosis is caused by human papilloma virus and is the most common benign laryngeal neoplasm in children. Although RRP is rarely fatal, the disease requires prolonged, extensive medical and surgical treatment, and causes physical and emotional suffering in affected children and their families. Although recurrent respiratory papillomatosis is a relatively unusual problem, it accounts for significant health are expenditures.The goal of management of RRP is control of the disease, preservation of the voice and prevention of major complication .The purpose of study will identify risk factors for more severe juvenile RRP through prospective evaluation of a pediatric population in Thailand by the employing a protocol that includes staging of disease severity , as well as HPV genotyping.

Objective:

* To identify the genotypes of HPV isolated from Thai RRP patients
* To compare staging and severity with HPV genotypes
* To correlate the following characteristics of the Thai RRP patients with the HPV genotypes

Eligibility Criteria:
Inclusion Criteria:

* Patients have active laryngeal papillomatosis .
* Patients have developed this infection before the age of 18 years old.

Exclusion Criteria:

* Children whose families do not sign an informed consent to enter into study.
* Children whose families anticipate discontinuing care at a participating institution during the study period.
Effect of Increased Protein Intake on Colonic Metabolism

The purpose of this study is to modulate the protein fermentation and to investigate the effect on colon toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Regular eating pattern (3 meals/day)
* Age between 18 and 45 years old
* BMI between 18,5 and 30 kg/m²

Exclusion Criteria:

* Intake of antibiotics in the last month before the study
* Abdominal surgeries in the past (accept appendectomy)
* Consulting a dietician/following a diet
* Vegetarian
* Intake of pre- and/or probiotics
* Exposure to radioactivity in the year proceeding the study
The Enzen Trial: Comparison of Evar Endoprosthesis: Endurant Versus Zenith

A prospective, non-randomized trial of patients submitted to EVAR for aortoiliac aneursym using Endurant II (Medtronic) or Zenith (Cook).

A prospective, non-randomized trial of patients submitted to EVAR for aortoiliac aneursym using Endurant II (Medtronic) or Zenith (Cook).

The patients will be evaluated in a follow-up, regarding overall mortality rate, perioperative mortality rate and outcomes, such as Endoleaks and reinterventions.

Eligibility Criteria:
Inclusion Criteria: Aortoiliac infra-renal aneurysms.

-

Exclusion Criteria: Thoracoabdominal aortic aneurysms, pararenal and supra-renal aortic aneurysms

* Patients not suitable for EVAR.
Empirical Rescue Therapies of Helicobacter Pylori Infection

The increase of antibiotic resistance to H. pylori causes failure of treatment. Furazolidone, amoxicillin and tetracycline are good candidates for rescue therapy since resistance to these three antimicrobials was rare. It is necessary to assess the efficacy and safety of these four bismuth-containing quadruple regimens with above antibiotics as empirical rescue therapies for H. pylori eradication.


Eligibility Criteria:
Inclusion Criteria:

* H. pylori -positive patients with functional dyspepsia and scarred peptic ulcers who had previously failed one or more eradication regimens containing clarithromycin, metronidazole and/or amoxicillin.

Exclusion Criteria:

* less than 18 years old, never receiving eradication treatment before, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks
Enhanced Housing Photoscreeners 2WIN and GoCheckKids Compared in Burma and Alaska

"Adaptica" (Padova, Italy) designed a fixed-distance, dark portable tube with power and remote control for the "2WIN: photoscreener. GoChecksKids designed a flash-concentrating case for the iPhone 7+ to more quickly achieve two-axis photoscreen. These devices were compared to confirmatory exams in children and young adults in a remote Burma clinic and in an Alaskan pediatric ophthalmology practice.

Photoscreening with follow up confirmatory exams for referred and passed interpretations were offered to children and young adults at a remote clinic in the Karen State of eastern Burma (Myanmar). The clinic had intermittent 220 Volt power generator, but no internet or cell phone coverage.

Consecutive patients in a "WiFi-equipped" pediatric ophthalmology practice in Anchorage, Alaska had photoscreening before confirmatory examination.

Each patient had photoscreening with the "2WIN" photoscreener installed in the "Kaleidos" housing. In Anchorage, the devise was controled by the wireless tablet computer. In Burma, however, despite a "WiFi router" not connected to internet, the tablet computer would not connect to the 2WIN and therefore the "Kaleidos" read-trap door was opened so the 2WIN could be activated and controlled manually. The" 2WIN" stored results on an "micro-SD" memory card which was eventually downloaded to computer.

Each patient also had photoscreening with GoCheckKids (GCK) on an "iPhone 7 Plus" using the enhanced, flash-concentrating cell-phone case. In Anchorage, in addition to on-site smart-phone interpretation, images were uploaded to the central reading center for secondary interpretation. In Burma, all images were retained on the smart phone and eventually uploaded for GoCheckKids central secondary analysis after return to urban internet availability. In Burma, a portable, light-wieght tent was used to provide a dim screening environment with less distraction.

Confirmatory exams were performed consistent with 2003 and 2013 American Association for Pediatric Ophthalmology and Strabismus (AAPOS) uniform guidelines. Cycloplegic refractions were performed 20-40 minutes after cyclopentolate 1% instillation. Visual acuity was checked with patched, surround "HOTV" at 3 meters threshold with at least 3 of 4 optotypes correct. Validation was performed with conventional 2 x 2 screen-exam matrix, and also with Alaska Blind Child Discovery (ABCD) 3 x 3 matrix including inconclusive results (no instrument interpretation or unable to gain a reading) with inconclusive interpretations considered a referral.

Eligibility Criteria:
Inclusion Criteria:

* at least one eye

Exclusion Criteria:

* bilateral enucleation
Phase II Trial of Allovectin-7® for Head and Neck Cancer

The purpose of this clinical trial is to determine if Allovectin-7®, an experimental gene-based immunotherapy, can shrink head and neck tumors. The trial will also examine if treatment can boost the immune system and if this treatment can improve the time to disease progression.

Treatment - If you take part in this trial you will be treated for about four weeks. You will receive an injection of Allovectin-7® by needle, directly into your tumor. This will be repeated 14 days later. The injections may be given in a doctor's office. A week later, you will undergo surgery to remove the tumor. Your tumor will be measured before Allovectin-7® treatment and before surgery to see if Allovectin-7® was effective in shrinking it. This will be done by general physical exams and scans (such as X-ray scans). There will also be tests on the removed tumor to see if Allovectin-7® helped to boost the immune system to attack the cancer.

Eligibility Criteria:
In order to be in this trial, you must meet the enrollment criteria. Below is a list of some of the enrollment criteria.

* You have been diagnosed with head and neck cancer (also called squamous cell carcinoma of the mouth)
* You have Stage I or Stage II disease (a single mouth tumor which has not spread to other areas of the body)
* Surgery to remove your tumor is recommended
* You have not received any prior therapy for head and neck cancer (e.g. radiation or chemotherapy)
* You are able to carry out your normal daily activities
Lung Cancer Case Registry and Tissue Resource

Potential participants in the Lung Cancer Case Registry will be all patients diagnosed or evaluated for possible treatment of lung cancer at the Cancer Research and Treatment Center (CRTC) and New Mexico Veterans Health Care System (NMVHCS).

Lung cancer is the most common cause of cancer death in the US in both men and women. This research study will enroll lung cancer patients into a registry to study changes in DNA (or genetic material) that may be associated with development of lung cancer or other lung diseases such as chronic obstructive pulmonary disease (COPD). We will also study the role of eating habits on lung cancer diagnosis and treatment, as well as the effects of the disease and treatment on quality of patient's lives.

Eligibility Criteria:
Inclusion Criteria:

* Potential participants in the Lung Cancer Case Registry will be all patients diagnosed or evaluated for possible treatment of lung cancer at the CRTC and NMVHCS. Recruiting will primarily be performed through the Multidisciplinary Chest Clinics held weekly at each hospital. These clinics are staffed by the Principal Investigator (PI) and Reza Mehran, MD, a thoracic surgeon at both hospitals and a co-investigator on this submission. Approximately 90% of all lung cancer cases diagnosed at the NMVHCS, and a somewhat smaller proportion of cases treated in the Cancer Center, are seen in these clinics. Additional cases will be identified through review of new patient visits to each hospital with a diagnosis of lung cancer; Drs. Crowell and Mehran also maintain weekly contact with pathology and oncology services at both facilities, which will facilitate case identification at NMVHCS and University Hospital. Finally, patient contact records will be correlated with tumor registry records at both hospitals, which will identify any cases not captured through the above mechanisms. Although these cases may be identified several weeks after initial diagnosis, all attempts will still be made to contact the patient and family for enrollment into the registry. Most Spanish-speaking patients served by the CRTC and the NMVHCS are bilingual, and a language barrier has not been a problem in other similar studies conducted by the PI. However, Spanish-speaking personnel are available to obtain consent and answer any questions if necessary.

Exclusion Criteria:

* Patients will be excluded if they cannot provide written informed consent.
Study of Metastatic Ocular Melanoma

This study evaluates treatment with combination versus monotherapy for patients with metastatic ocular melanoma.

Treatment of patients with metastatic ocular melanoma with combination chemotherapy Gemcitabine and Treosulfan versus monotherapy with Treosulfan as first-line chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic ocular melanoma

Exclusion Criteria:

* Prior treatment with chemotherapy
* Active 2nd malignancy
* Cerebral metastasis
Syringes Replacement for Insulin Application for Pens Device in a Population of Elderly Patients With Type 2 Diabetes: Multifactorial Intervention to Improve Glycemic Control

This is a prospective, intervention, randomized, phase IV study. Patients will be included with 60 years or older, both sexes, with HbA1c \>8.5% using oral antidiabetics agents and insulin and then we will be randomized by use syringe or pens device to use insulin NPH and regular. All patients will receive a blood glucose monitor, lancet tapes, capillary blood glucose tests (3 tests/day). HbA1c will be measured at baseline, 3 and 6 months. Patients will see monthly.


Eligibility Criteria:
Inclusion Criteria:

* Sixty years or older
* Diabetes type 2 with Glycated Hemoglobin higher than 8.5%
* Using or necessity to use insulin
* Using syringe to insulin
* Using at least one oral antidiabetic
* Accept to participate

Exclusion Criteria:

* Glomerular Filtration Rate lower than 30
* Considering unfit for self administration of insulin
Determinants of Balance Recovery After Stroke - Retrospective Study

Retrospective cohort study of consecutive patients investigated in a neurorehabilitation ward after a first hemispheric stroke. Postural and gait disorders in relation to referential of verticality have been analyzed in routine care.

300 consecutive patients, admitted in our department for neurorehabilitation after a first hemispherical stroke, have been enrolled retrospectively. During their hospitalisation, all patients have been routinely evaluated with clinical scales, evaluating motor and cognitive deficits. Postural and visual vertical (VV) assessments have been performed 1 to 4 times during in-patient-stay.

The objective was to analyse the determinants of balance recovery after stroke, in particular the impact of wrong referential of verticality.

Data collection was performed by means of medical records. Observation period covered from january 2012 to february 2018.

Eligibility Criteria:
Inclusion Criteria:

first hemispheric stroke patient non-opposed to inclusion

Exclusion Criteria:

history of neurological disorders interfering with balance history of vestibularly disorders interfering with balance unstable medical conditions history of cognitive disorders
Uncalibrated Pulse Contour to Assess Fluid Responsiveness in Off Pump Cardiac Surgery

The goal of this observational study is to Compare the performance of uncalibrated pulse wave contour analysis compared with transesophageal echocardiography (TEE) to assess response to a vascular filling test during beating-heart coronary artery bypass surgery, in people over age of 18; hospitalized for scheduled beating heart bypass surgery The aim question is to evaluate the ability of a less invasive cardiac output monitor (uncalibrated pulse wave contour analysis) compared with a reference cardiac output measurement (transesophageal echocardiography) to enable optimization of vascular filling by good assessment of the response to vascular filling in a high-risk perioperative patient population.

As part of hemodynamic monitoring, every patient undergoing beating-heart coronary bypass surgery is fitted with a radial arterial catheter immediately after induction of anesthesia, enabling continuous measurement of blood pressure. Hemodynamic optimization in these patients also involves fitting a transesophageal ultrasound probe to optimize cardiac output using the various therapies available (vascular filling, vasopressors, inotropes).

A specific sensor (FloTrac°, Hemosphere, Edwards°) will be connected to the arterial pressure line to obtain a systolic ejection volume value by analyzing the contour of the uncalibrated pulse wave.

The hemodynamic management of the patient, and the decision to perform a vascular filling test, will be left to the discretion of the practitioner in charge of the patient in the operating room.


Eligibility Criteria:
Inclusion Criteria:

Patient :

* 18 years of age and older
* Hospitalized for scheduled beating-heart coronary bypass surgery
* Beneficiary of a social security plan
* Not opposed to participating

Exclusion Criteria:

* Patients undergoing surgery with extracorporeal circulation
* Patients with a history of surgery or intra-esophageal pathology contraindicating TEE
* Patient refusing to participate in the study
* Unavailability of TEE or uncalibrated pulse-wave contour device
* Minors
* Protected adults, adults unable to give consent and not under protective supervision
* Persons deprived of liberty, hospitalized without consent
* Pregnant women, parturients and nursing mothers
* Patients not affiliated to the social security system
* Emergency situations