cyrilzakka/clinical-trials huggingface dataset:
UVA Brain and Aortic Aneurysm Study

The purpose of this study is to examine the percentage of patients who present with abdominal aortic aneurysms (AAA) will also have intracranial aneurysms (IA) and conversely; to examine the percentage of patients who present with intracranial aneurysms will also have abdominal aortic aneurysms.

The investigators have previously generated estimates for cost effectiveness of each arm of this reciprocal screening protocol based on literature dervied estimates of coprevalence and other key factors in a decision tree model to compare costs and outcomes. They measured expected outcomes using quality-adjusted life years (QALY) and the incremental cost-effectiveness ratios (ICER). The current study will involve establishment of the true co-prevalence and recalculation of the ICERs and QALYs. Based on their literature derived models we previously found an ICER of $34.01/QALY for AAA screening in IA patients and an ICER of $6,401.91/QALY for IA screening in AAA patients. Both of these are well below the societal accepted threshold of $60,000/QALY. However, both models were sensitive to co-prevalence. In the current study the investigators will therefore determine the actual cost-effectiveness of performing additional radiographic procedures and genetic counseling. The investigators will also bank DNA and RNA for future research.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Clinical and radiographic diagnosis of either abdominal aortic aneurysm (AAA) or intracranial cerebral aneurysm (IA). Aneurysm may be symptomatic (s/p rupture or mass effect) or asymptomatic (detected as part of screening or incidentally discovered. Aneurysms int he brain may be multiple. AAA will be defined as \>= 3 cm by any imaging modality. IA will be defined as \>= 3 mm on any imaging modality.
* Able to provide a valid informed consent (self or legally authorized representative)

Exclusion Criteria:

* Contra-indication for MRI/A (embedded metal, intractable claustrophobia, pacemaker, etc.)
* Intracranial aneurysm associated with arteriovenous malformation
* Clinical or radiographic diagnosis of mycotic aneurysm
* Substantial pre-existing neurological or psychiatric illness that would confound neurological assessment or other outcome assessment.
* Other serious conditions that make the patient unlikely to survive long enough to benefit from the screening program.
* Inability to follow the protocol or return for screening test or genetic counseling.
* Unwilling to have reports from imaging and genetic counselor sent to a clinician (PCP, testing surgeon, etc)

Note: Pregnancy is not a reason to exclude, but imaging done for the study will be postponed until after the subject has given birth.
Health Related Quality of Life and Multidimensional Evaluations of Prostate Cancer Subjects Aged ≥ 60 Years Initiating Gonadotropin-Releasing Hormone (GNRH) Agonist Therapy

The objective of the study is to compare the evolution over 6 months of Health-Related Quality of Life (HRQOL) among different age groups in subjects with prostate cancer treated with GnRH agonist therapy.

Relevant data collected as part of routine medical care will be captured on an electronic Case Report Form (eCRF). Investigator-subject questionnaires and subject self-questionnaires answers will be collected in a paper booklet. This study is non-interventional, thus if some assessments, are not routinely performed by the investigator, he/she will not complete the corresponding sections in the eCRF.

Eligibility Criteria:
Inclusion Criteria:

* Subject presenting with histologically confirmed prostate cancer
* Subject of 60 years and older
* Subject eligible to start GnRH agonist therapy, either as monotherapy or adjuvant therapy, and for whom one of these treatments was selected voluntarily by the investigator, prior to the start of the study
* Subject giving his written consent to participate in the study
* Subject able to complete questionnaires

Exclusion Criteria:

* Subject simultaneously participating in a clinical trial
* Subject who previously received a hormonal therapy during the last 6 months before inclusion
Fundal Block in Pre-menopausal Women to Reduce Pain During Outpatient-based Endometrial Ablation (FUNDAL-PAIN)

The objective of this study is to assess the efficacy of a fundal block in reducing women's perception of pain during NovaSure endometrial ablation (EA) in an outpatient-based setting.

The researchers aim to determine whether participants receiving the paracervical and fundal block (experimental group) achieve clinically and statistically significant reductions in self-reported pain during NovaSure EA, as compared to those receiving paracervical block (control group). All women will obtain concurrent procedural sedation. Women's perception of pain will be recorded on a scale from 0 to 10 using the visual analogue scale (VAS).

The researchers hypothesize that the participants receiving combined paracervical and fundal block will experience less pain during the active procedure, as compared to those receiving paracervical block alone.

Eligibility Criteria:
Inclusion Criteria:

* Abnormal uterine bleeding
* Pre-menopausal as determined by the presence of menstrual cycles
* Must have completed their family or have no desire to preserve fertility
* Uterus and cervix must meet eligibility criteria; based on hysteroscopy exam performed by the physician prior to the ablation procedure
* Must be a female participant 25-55 years of age

Exclusion Criteria:

* Any uterine characteristics that preclude performing EA
* Past allergic reactions to local anaesthetic
* Weight \<50kg
* Submucous fibroids requiring myomectomy
* Lack of patient consent
A Comparative Analysis of Ray-Tech Sponge and Ice Bag Techniques in Kidney Transplantation

Warm ischemia during kidney transplantation is one of the important factors that negatively affect kidney function in the recipient. The investigators aimed to examine the effects of two techniques (Ray-Tech sponge technique and Ice bag technique) applied to protect the kidney from warm ischemia during kidney transplantation on long-term kidney function.

A prospective, randomized clinical trial was conducted at Istanbul Okan University Hospital, Istanbul, Turkey. All participants were selected from those who underwent kidney transplantation between January 2020 and January 2023.

Eligibility Criteria:
Inclusion Criteria:

-Underwent kidney transplantation surgery

Exclusion Criteria:

- Deceased donor transplantation
Safety and Efficacy of Vanoxerine for the Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm

LGN-VN-003 is a prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a single oral dose of vanoxerine for the conversion of subjects with recent onset atrial fibrillation (AF) or atrial flutter (AFL) to normal sinus rhythm. Up to 625 subjects will be randomized in a 2:1 fashion so at least 400 vanoxerine and 200 placebo subjects receive study drug.


Eligibility Criteria:
Inclusion Criteria:

* Subject has been informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines.
* Able to return for Day 8 follow up.
* Male or female 18 years of age or greater.
* Onset of AF/AFL within the 7 calendar days preceding randomization, based on symptoms.
* AF/AFL documented by ECG during the screening period.
* Adherence to local clinical standards or the ACC/AHA or ESC practice guidelines for AF/AFL regarding thromboembolic event prevention and treatment.

Exclusion Criteria:

* Previous exposure to vanoxerine HCl.
* Women of childbearing potential (neither surgically sterilized nor post-menopausal defined as cessation of menses for over one year)
* Systolic blood pressure \<110 mmHg (unless documented to be usual value).
* Average heart rate \<60 bpm documented by screening ECG.
* Average QTc \>440 msec documented by screening ECG.
* QRS interval \>140 msec documented by screening ECG.
* Paced atrial rhythm on screening ECG.
* History of receiving another Class I or Class III antiarrhythmic drug within 3 days prior to randomization. Excluded Class I antiarrhythmic drugs include quinidine, procainamide, disopyramide, lignocaine, mexilitine, flecainide, and propafenone. Excluded Class III drugs include dofetilide, sotalol, dronedarone, and ranolazine.
* History of amiodarone (oral or IV) within the 90 days prior to randomization.
* Native or prosthetic aortic or mitral stenosis with aortic valve area ≤1.0 cm2 or mitral valve area of \<1.5 cm2 or any other valvular diseases for which surgery is indicated.
* Treatment with any loop diuretic (e.g., furosemide, bumetanide, torsemide, ethacrynic acid, etc.) in the 30 days prior to randomization.
* Ejection fraction of \<35% within the 3 months prior to randomization (most recent measure if more than one).
* AF/AFL as a result of surgery (postoperative AF/AFL) within 30 days prior to randomization.
* History of electrical cardioversion within the 7 calendar days prior to randomization.
* History of any polymorphic ventricular tachycardia including torsades de pointes.
* History or family history of long QT syndrome or other inherited arrhythmia syndrome.
* History of ventricular tachycardia requiring drug or device therapy.
Combination Chemotherapy in Treating Patients With Acute B-Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have acute B-lymphoblastic leukemia or recurrent non-Hodgkin's lymphoma.

OBJECTIVES: I. Improve the survival of children and adolescents with poor-risk nonlymphoblastic lymphoma and acute B-lymphoblastic leukemia using an intensive, short-course regimen of combination chemotherapy. II. Assess the toxicity of the regimen.

OUTLINE: Nonrandomized study. Induction: 7-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy (TIT). Cyclophosphamide, CTX, NSC-26271; Thiotepa, TSPA, NSC-6396; Vincristine, VCR, NSC-67574; Daunorubicin, DNR, NSC-82151; Dexamethasone, DM, NSC-34521; Etoposide, VP-16, NSC-141540; Methotrexate, MTX, NSC-740; with Leucovorin calcium, Citrovorum Factor, CF, NSC-3590; plus TIT: IT MTX; IT Cytarabine, IT ARA-C, NSC-63878; IT Hydrocortisone, IT HC, NSC-10483. Consolidation: 6-Drug Combination Chemotherapy with Leucovorin Rescue plus TIT. ARA-C; VP-16; Asparaginase (E. coli), ASP, NSC-109229; MTX; VCR; Methylprednisolone, MePRDL, NSC-19987; with CF; plus TIT. Reinduction: 7-Drug Combination Chemotherapy with Leucovorin Rescue plus TIT. CTX; TSPA; VCR; DNR; DM; VP-16; MTX; with CF; plus TIT.

PROJECTED ACCRUAL: A maximum of 30 patients, accrued from 4 institutions, will be entered. If at any time more than 3 patients are not "event free", the trial will be terminated early, with patients considered event free if they enter remission, do not die as a result of treatment toxicity, and do not experience progression within 1 year from the start of therapy.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Newly diagnosed undifferentiated nonlymphoblastic non-Hodgkin's lymphoma (Burkitt's or non-Burkitt's) Newly diagnosed large cell lymphoma with CNS involvement Recurrent non-Hodgkin's lymphoma L-3 and B-cell leukemia included At least 1 of the following required: LDH at least 500 IU/liter (old method) or 2,000 IU/liter (new method) Bone marrow involvement (greater than 5% lymphoblasts) CNS involvement (lymphoblasts on CSF cytospin or intracranial mass on CT or MRI scan)

PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Prior therapy allowed for non-Hodgkin's lymphoma No prior therapy for all other diseases
Study of Circular RNA Treatment in Patients with Radiation Induced Xerostomia-1

This is a first-in-human clinical study to evaluate the safety, tolerability and efficacy of RXRG001 administered in the ducts of the parotid glands in adult patients with radiation-induced xerostomia (dry mouth) and hyposalivation (reduced saliva production).

In Part 1 of the study (open-label, single-arm), patients will receive unilateral administrations of RXRG001 in 3 single ascending dose cohorts and in 3 multiple ascending dose cohorts.

Part 2 of the study has a randomized, double-blind, placebo-controlled design. Patients will receive bilateral administrations of RXRG001 in 3 multiple ascending dose cohorts.


Eligibility Criteria:
Inclusion Criteria\*

1. At least 18 years of age
2. History of radiation treatment or chemoradiotherapy for head and neck cancer for stage 2 or higher
3. Free from recurrence of your cancer and never have had another form of cancer for at least 2 years
4. Suffering from xerostomia and/or hyposalivation and have xerostomia symptoms which were not resolved after treatment for at least 3 months
5. Both parotid glands on imaging examination

Exclusion Criteria\*

1. Any active infection
2. Heart failure, reduced kidney function or uncontrolled diabetes (Hemoglobin A1c \>8%)
3. History of autoimmune diseases known to potentially affect the salivary glands
4. Any malignancy, other than head and neck cancer within the past 3 years except for certain skin and cervical cancers
5. Active smoker or use tobacco products or have a history of substance or alcohol abuse

   * Other criteria apply
Perineal Massage and Pelvic Floor Exercise in the Antenatal Period

This study aimed to determine the effect of perineal massage and pelvic floor exercise in the antenatal period on sexuality and urinary and fecal incontinence in the postpartum period. This study will be conducted in a pregnant school at a state hospital in Turkey. An active control group will be formed as the control group. The control group will be given the "Pelvic Floor Dysfunction Prevention Training" booklet prepared by the researchers. Experimental 1 group will receive perineal massage training in addition to the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group. Experimental 2 group will receive pelvic floor exercises in addition to perineal massage training and the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group.

The research was conducted as a randomized controlled trial. The simple randomization method will be used for the assignment to groups. The data of the research; will be collected using the Preliminary Evaluation Form, Personal Information Form, Female Sexual Function Index, The International Consultation on Incontinence Questionnaire-ICIQ-SF (Turkish Version), and Fecal Incontinence Severity Index. The research will start at the 34th week of pregnancy and the questionnaires will be administered in the 3rd month after delivery. There will be 3 groups in the research.An active control group will be formed as the control group. The control group will be given the "Pelvic Floor Dysfunction Prevention Training" booklet prepared by the researchers. Experimental 1 group will receive perineal massage training in addition to the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group. Experimental 2 group will receive pelvic floor exercises in addition to perineal massage training and the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group.

Eligibility Criteria:
Inclusion Criteria:

* being over 18 years old,
* being 32-34th pregnancy weeks,
* being not experiencing any complications in the mother and fetus during pregnancy (gestational diabetes, hypertension, preeclampsia, intrauterine growth retardation, congenital anomaly, etc.),
* having a singleton pregnancy,
* being primiparous
* being volunteer to participate in the study

Exclusion Criteria:

* elective cesarean section planning,
* having a history of chronic constipation,
* having a previous history of urinary or anal incontinence,
* having genital infection with lesions (HSV, HPV, Syphilis, Candida Albicans, Chancroid)
Study to Assess the Safety of Treatment of Articular Cartilage Lesions With CartiLife®

The purpose of this study is to assess the safety and efficacy of implanting bead-type autologous chondrocytes (CartiLife®) obtained by culturing expanded costal chondrocytes of the patient with a chondral defect in the knee. The patients will be assessed clinically using clinical, biochemical and IKDC (International Knee Documentation Committee) outcomes preoperatively as well as 4, 8, 24 and 48 weeks postoperatively to assess the relief of symptoms and joint function.


Eligibility Criteria:
Inclusion Criteria:

* Patients at least 19 years old
* Defect size: 2 to 10 ㎠ on the unilateral knee cartilage (up to 4 ㎤ in volume)
* Defect: isolated ICRS (International Cartilage Repair Society) grade III or IV single defect chondral lesion on articular cartilage
* The joint space is maintained over 50% relative to baseline
* Patients that are able to walk without aid
* Patients that agree to abide by strict rehabilitation protocols and follow-up programs
* Patients who provide written consent to the participation of the clinical trial

Exclusion Criteria:

* Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis
* Patients with arthritis associated with autoimmune disease
* Patients hypersensitive to bovine protein
* Patients with Haemophilia or markedly reduced immune function
* Patients hypersensitive to antibiotics such as gentamicin
* Patients with arterial bleeding and severe venous bleeding
* Patients with other diseases including tumors except for cartilaginous defects of joints
* Patients with a history of radiation treatment and chemotherapy within the past two years
* Patients who are pregnant, nursing a baby or likely to get pregnant
* Patients who participate in concurrent clinical trials or previous clinical trials within 30 days of administration
* Other cases where the investigator deems the patient ineligible for participation
Risk Level of Suffering From Traffic Injury in Primary Health Care: LESIONAT Project

Main objectives:

* To know the distribution of risk elements of traffic injuries

Secondary objectives:

* To study the distribution of risk elements related with the possibility of suffering from a TI in relation to medication, chronic health problems, and consumption of psychoactive substances (alcohol and others).
* To know the relation between levels of perception of risk of suffering from a TI and the presence of chronic problems, medications, or consumption of psychoactive substances.

Methodology:

Design: Observational, transversal, and multicentric research

Field of study: 20 PHC users from urban areas

Population of study: random consecutive sampling of ≥ 16 years old drivers with open medical history.

Measure's tools: Two means for data collection: survey among health professionals with medical history and structured telephonic survey about behaviours and risk perceptions in drivers.

Variables: Sociodemographic data, chronic pathologies related to TI, consumption of medications ,Alcohol consumption (AUDIT-C test), Psychoactive substances consumption (self declared), Level of perception of risk according to professionals.

Telephone survey: Class and age of driving license, Type of roads, Weekly driving time, Safety behaviours, Record of collisions/injuries in last year,Self perception of health level(SF-12) andSelf perception of risk level.

An descriptive analysis of population will be performed, a distribution of risk elements associated to TI will be described through bivariant analyses, and for describing the factors associated to perceived risk levels a linear regression multiple model will be built.

Eligibility Criteria:
Inclusion Criteria:

* 16 years old or more
* Catalan and/or spanish language speakers
* Drivers with driver license
* Participation accepted by the patient

Exclusion Criteria:

* Patients who do not have contact phone number.
* Patients who do not answer up to 3 phone calls
* Patients with severe mental or physical health disorder
Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate

The purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study.
* A male or female 60 years or older at the time of the first vaccination.
* Free of obvious health problems

Exclusion Criteria:

* Use of non-registered products
* Administration of immune-modifying drugs.
* Administration of vaccine 30 days before enrolment in study.
* Immunosuppressive or immunodeficient condition.
* Hypersensitivity to a previous dose of influenza vaccine
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
* History of confirmed influenza infection within the last 12 Months.
* Acute disease at the time of enrolment/vaccination.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine