cyrilzakka/clinical-trials huggingface dataset:
Assessing the Impact of a Patient Education Platform to Augment the Informed Consent Process for Obstetrics and Gynecology Procedures

Over the past few decades, there has been a shift in the informed consent process, whereby the focus is centered on patient comprehension, preparedness and satisfaction. When comparing interactive informed consent processes, such as the use of educational pathways, videos, written communication, and the traditional conversational based process, the results are conflicting. Some studies report improved patient comprehension, satisfaction and preparedness with the informed consent interventions, while others found no difference. The purpose of this study is to determine whether the use of a preoperative interactive patient education pathway improves patient comprehension, preparedness and satisfaction prior to undergoing a hysteroscopic procedure.

Informed consent is dependent on three criteria; the patient must be competent, relevant information including risks, benefits and alternatives must be clearly communicated, and the acceptance of treatment must be voluntary. The consent process usually occurs in the office setting through physician-led verbal communication. Despite satisfying the three criteria of informed consent, many patients leave the office with an inadequate understanding of the treatment they have consented to.

The purpose of this study is to use an interactive patient education pathway as an adjunct to the informed consent process for patients undergoing hysteroscopy. This will be done using a randomized controlled trial design.

Patients will be randomized to the control group (standard consent process) or the education group (standard consent process augmented by access to an interactive hysteroscopy teaching platform).

All patients will undergo the standard physician-led informed consent process. Patients from both groups will be asked to complete a post-informed consent questionnaire to assess their understanding of their upcoming procedure, preparedness for the procedure, and satisfaction with the informed consent process, be that through the traditional method or the interactive patient education portal.

Eligibility Criteria:
Inclusion Criteria:

* Women planning on undergoing a hysteroscopy procedure

Exclusion Criteria:

* Women NOT planning on undergoing a hysteroscopy procedure
Utilizing the Michigan Neuropathy Screening Instrument for Early Detection of Diabetic Neuropathy

The study aims to Compare the diagnostic accuracy of the Michigan Neuropathy Screening Instrument (MNSI) (using MNS questionnaire, ,Inspection, vibratory sensation, Ankle reflexes Exam, 10 g monofilament needle examination), routine NCS, and the U/S of the median, posterior tibial, and sural nerves in identifying diabetic peripheral neuropathy in patients recently diagnosed with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* ü Age: 30-55 y

ü Type of diabetes: Type 2

ü Duration of diabetes: Within 1Year of diagnosis of Type 2 diabetes mellitus according to World Health Organization 1999 criteria

Exclusion Criteria:

* Patients who had known conditions that could present with neuropathy such as hereditary sensory neuropathy, vitamin B12 or folate deficiency, paraneoplastic conditions, autoimmune diseases, uremia, hypothyroidism, and ethanol abuse.
Digital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries

Knee pain is one of the most prevalent musculoskeletal disorders in the United States. Conservative treatments generally consist of pharmacological agents and physical therapy. Unfortunately, such conservative care is often mismanaged, and little data is collected on clinical outcomes. The proposed investigation utilizes a novel and state-of-the-art mobile application (DETP) to guide an at-home exercise therapy program for non-operative knee pain. The purpose of this study is conducting a single-blind randomized, controlled, superiority study to compare the DETP to conventional physical therapy (PT). The investigators will seek to determine improvement in pain and function in PROMIS measures as the primary outcome. The investigators will also evaluate satisfaction with the application as a secondary outcome.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75, inclusive.
* Diagnosis of knee injury. For participants enrolled from the Mayo healthcare system database, knee injury identified from electronic medical records.
* Pain Numerical Rating Scale score of 4 or greater on a 0-10 scale (0 = no pain, 10 = pain).
* Participants must be diagnosed with a knee injury and the next step of care is either a home exercise program or external physical therapy ordered at the academic center.
* Prescribed external physical therapy (i.e., therapy not completed at Mayo Clinic in Rochester/Minneapolis).

Exclusion Criteria:

* No access to android or iPhone smartphone
* BMI greater than or equal to 35
* Previously completed series of physical therapy visits for knee injury within the past 12 months for the same injury (received one introduction PT session as seen in executive program will not be considered an exclusion).
* Recommended by a physician for consideration of total knee replacement.
* Diagnosis of rheumatoid arthritis, fibromyalgia, gout in the knee, or other systemic rheumatic disease.
* Hospitalization for a stroke, heart attack, heart failure, or had surgery for blocked arteries in the past 12 months.
* Total joint replacement knee surgery, bucket-handle meniscus tear, ACL tear, or other knee surgery in the past 12 months.
* Unable to speak English.
* Active diagnosis of psychosis.
* Fall history deemed by a physician to impose risk for potential injury with participation in a home-based exercise program.
* Severely impaired hearing or speech.
Immunogenicity and Safety of AdimFlu-S, Formulation 2010-2011, in Infants Aged Between 6-12months Old

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the seasonal flu vaccine(AdimFlu-S), as measured by hemagglutination inhibition (HAI) at 4 weeks after two doses of study vaccine, 4 weeks apart, in infants between 6 and 12 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Boys or girls and aged \>= 6 months old to \<= 12 months old on the day of first vaccination;
* Subject's parent(s) or legal guardian(s) must be willing to comply with planned study procedures and be available for all study visits;
* Subject must be in good physical health on the basis of medical history, physical examination;
* Subject's parent(s) or legal guardian(s) must read and signed the study-specific informed consent prior to initiation of any study procedure.

Exclusion Criteria:

* Subjects had received influenza vaccine;
* History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
* Personal or family history of Guillain- Barre' Syndrome;
* An acute febrile illness within 1 week prior to vaccination;
* Current upper respiratory illness (URI), including the common cold or nasal congestion within 72 hours;
* Subjects with influenza-like illness as defined by the presence of fever (temperature \>= 38'C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
* Immunodeficiency, immunosuppressive or significant chronic illness not suitable for inactivated influenza vaccination;
* History of wheezing or bronchodilator use within 3 months prior to study vaccine;
* Receipt of live virus vaccine within 1 month prior to study vaccine or expected receipt vaccination before the last blood sampling for immunogenicity evaluation;
* Receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt vaccination before the last blood sampling for immunogenicity evaluation;
* Receipt of any blood products, including immunoglobulin in the prior 3 months;
* Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.
European CML Blast Crisis Register

Multicentric prospective and retrospective register collecting patient with CML blast crisis diagnosed in Germany and Europe

Since the advent of treatment with tyrosine kinase inhibitors (TKI), the incidence of blast crises has significantly decreased. Nevertheless, about 5% of patients diagnosed with chronic myeloid leukemia (CML) will evolve into a blast phase at some point during the course of their disease. Furthermore, despite the advances made in CML treatment, outcome of patients with blast crises are still dismal. Due to the rarity of this condition clinical trials are challenging, and collaboration between researchers both at national and international level is needed to collect a meaningful number of data.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Diagnosis of BCR-ABL positive CML blast crisis according to the WHO criteria:

  * Blasts 20% or more of peripheral blood white cells or bone marrow cells or
  * Extramedullary blast proliferation or
  * Large foci or clusters of blasts in bone marrow biopsy

Exclusion Criteria:

* Lack of informed consent
Comparison in the Treatment of Acute Cystitis Using Cephalosporin and Norfloxacin (CECI)

This study is to assess if the efficacy of cephalosporin is similar to the efficacy of norfloxacin in the acute cystitis treatment.


Eligibility Criteria:
Inclusion Criteria:

* Sign, initialize and date the informed consent form
* Age ≥ 18 years
* For urinary infection diagnosis, the following parameters must be considered in the urine I test:
* Leukocyturia: ≥ 15,000 leukocytes
* Epidermal cells: \< 20,000/mL
* Presence of bacteriuria
* Presence of nitrite (positive results)
* To have a 2 points score (from 12 points) regarding the following symptoms of acute cystitis:
* Dysuria
* Urinary urgency
* Frequent urination
* Pain in the upper area of pubis

Each symptom must be scored according to the classification below. Total score may range from 0 to 12 points.

Severity Value Absent 0 Mild 1 Moderate 2 Severe 3

Exclusion Criteria:

Research subjects that meet any of the criteria below will not be eligible for the study:

* Asymptomatic urinary infection or infection in any organ
* Documented incidence of UTI in the last year
* Symptoms of pyelonephritis (cystitis symptoms plus fever, lower back pain or chills)
* History of complicated urinary tract infection (congenital abnormalities, urinary tract distortion or obstruction, formation of calculus in the urinary tract)
* Use of catheter in the urinary tract
* Chronic renal or hepatic disease
* Seizure-related diseases
* Neurological deficits that interfere in the urinary flow and tract defense
* Decompensated diabetes mellitus (fasting blood glucose ≥ 150 mg/dL);
* Immunodepression:
* Subjects with the human immunodeficiency virus (HIV)
* Chronic use of corticosteroids in a dose ≥ 5 mg/day of prednisone for over 30 days
* Any diseases related to immune dysfunction
* Severe comorbidities (at the investigator's discretion)
* History of allergy to penicillins, cephalosporines or quinolones
* Subjects on medications such as antibiotics, amiodarone, antacids or sucralphate, tricyclic antidepressants, antipsychotics, cyclosporine, cisapride, didanosine, erythromycin, fembufeno, gliburide (a sulphonilurea), nitrofurantoin, probenecid, procainamide, quinidine, sotalol, teophylline, warfarin
* Treatment due to UTI two weeks before entering study, or on antimicrobial treatment at least 3 times within the last 12 months
* Use of phenazopyridine 7 days before entering the study
* Hospitalization 30 days before study enrollment
* Female research subjects that are pregnant, breastfeeding, or women with childbearing potential that deny to use at least two safe contraceptive methods during study
* Participation in another clinical trial in the last 12 months
PET/MRI and PET/CT in Diagnosing Younger Patients With Cancer

This pilot clinical trial studies how well positron emission tomography (PET)/magnetic resonance imaging (MRI) works compared to PET/computed tomography (CT) in diagnosing younger patients with cancer. PET/MRI and PET/CT are procedures that combine the pictures from a PET scan and an MRI scan or a CT scan. The PET and MRI scans or PET and CT scans are done at the same time with the same machine. The combined scans give more detailed pictures of areas inside the body than either scan gives by itself. It is not yet known whether PET/MRI works better than PET/CT in diagnosing younger patients with cancer.

PRIMARY OBJECTIVES:

I. Determine the diagnostic accuracy of PET/MRI as compared to the standard of reference PET/CT in lesion detection and lesion characterization.

SECONDARY OBJECTIVES:

I. Obtain quantitative measurements in various body regions of standardized uptake values (SUV) in normal tissue and foci of pathologic tracer uptake in PET/MRI of pediatric patients with oncologic disease using various magnetic resonance attenuation correction (MRAC) methods and compare those to respective SUV based on CT attenuation correction.

II. Assess the potential for radiation dose reduction with PET/MRI when eliminating CT radiation dose.

III. Assess time efforts and workflow improvement with PET/MRI compared to sequential PET/CT plus MRI.

OUTLINE:

Patients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are referred by their physician for clinically indicated diagnostic fludeoxyglucose F 18 (18F-FDG) PET/CT (with or without clinically indicated diagnostic MRI)
* Subjects with malignancies including hematologic disorders
* Subjects NOT requiring sedation or anesthesia
* Stable physical medical conditions (patients conscious and comfortable, scheduled for an elective diagnostic imaging)

Exclusion Criteria:

* Subjects who are unable or unwilling to give their assent to both examinations if \> 7 years old
* Subjects requiring general anesthesia or sedation in order to undergo PET/CT or MRI
* Subjects unable to undergo magnetic resonance (MR) scanning due to exclusion by University Hospitals-Case Medical Center restriction policies for Magnetic Resonance Imaging (UHCMC MRI restriction policies) as mentioned in the standard UHCMC MRI informed consent form
* Previously known allergies against MRI contrast agents (exclusion criterion only for contrast enhanced MRI)
* Pregnant or breast feeding subjects, as determined by standard questionnaire administered prior to scanning
Treating Gnathic Form of Mesial Occlusion in Early Adolescence Patients

The primary purpose of this study was to evaluate the immediate and previous results of the effectiveness of non-surgical orthopedic treatment in children aged 12-14 years with gnathic forms of mesial occlusion by the method of dentoalveolar compensation using a permanent apparatus with a palatal expanding screw.


Eligibility Criteria:
Inclusion Criteria:

patients with a gnathic (skeletal) mesial occlusion patients age 12-14 years patients who underwent orthopedic treatment

Exclusion Criteria:

change of residence severe form of gnathic mesial occlusion congenital anomalies of the dento-maxillo-facial area
Interest of Automated Oocyte Freezing

In the space of a few decades, oocyte cryopreservation has become established in the world of reproductive biology with the authorization of oocyte vitrification. This ultra-fast manual freezing technique (authorised in France since 2011) is mainly used to preserve oocytes in women who have to undergo a treatment that could potentially cause sterility. A clear improvement in survival rates since the early stages of slow freezing has been observed with vitrification but with fairly heterogeneous results Indeed, manual vitrification remains an operator-dependent technique with a long learning curve and which does not allow an oocyte survival rate of more than 70-80%.

The recent marketing of an automatic vitrification machine would make it possible to standardise the whole vitrification process from the contact/exchange of fluids to the sealing of the units, and thus potentially increase the oocyte survival rate. It seems to be in the best interest of women that their ability to conceive be preserved (probably for several years) with the technique that offers the best survival and reproducibility rates.

However, no studies have been conducted to assess the impact of such automation on oocyte survival.

For this reason the investigators wish to set up a comparative study between the routine, manual technique, and an automated technique (GAVI system), using immature oocytes, not suitable for fertilization, and usually discarded.


Eligibility Criteria:
Inclusion Criteria:

Patient must be:

* Adult
* Affiliated to a National Health System
* Informed about the study and having given consent
* Receiving an in vitro fertilization attempt with microinjection (ICSI, IntraCytoplasmic Sperm Injection) or having agreed to donate oocytes after approval by the Multidisciplinary Committee
* Having more than two immature, non-fertile oocytes on the day the oocytes are retrieved,
* Having at least two mature oocytes at the end of a 24-hour maturation in vitro.

Exclusion Criteria:

* Protected patient, under guardianship or trusteeship
* In Vitro Fertilization (IVF) Attempts
* Attempts at IVF or ICSI performed in the context of viral risk (both systems will be frozen in the same nitrogen tanks in the assisted reproduction laboratory)
Self Medication in Odontology (AUDE)

To describe and understand the self-medication behaviours of a population of adults coming to the Clermont-Ferrand dentistry department for acute pain of pulpal origin and of a population of adults coming to the specific care unit of the Clermont-Ferrand dentistry department or the Riom hospital for treatment under general anaesthesia.

Self-medication behaviour will be studied by means of a questionnaire. Questionnaires on insecurity, anxiety about dental care, items related to the ingestion function of the International Classification of Functioning, Disability and Health (ICF), a visual analogue pain assessment scale and the PCS-CF pain dramatisation scale will also be used.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient, male or female, coming to consult in the Clermont-Ferrand or Riom Hospital for acute pain of pulp origin and periapical OR eligible for dental treatment under general anesthesia in a context phobic.
* Understanding and practicing French
* giving informed consent to participate in research.
* Affiliation to a Social Security scheme.

Exclusion Criteria:

* Patients under guardianship.
* Patient's refusal to participate in the study.
Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B

This study is being conducted to compare the safety and effectiveness of switching treatment from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Results from patients who were taking lamivudine and then switched to telbivudine will be compared with the results from patients who continued on lamivudine alone.


Eligibility Criteria:
Inclusion Criteria:

* Documented clinical history compatible with chronic hepatitis B
* Patient has compensated liver disease
* Patient has received previous treatment with lamivudine for a duration of at least 3 months and not more than 12 months

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient is co-infected with hepatitis C, hepatitis D or HIV
* Patient previously received antiviral treatment for hepatitis B other than lamivudine in the preceding 12 months

Other protocol-defined exclusion criteria may apply.
STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

This single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma. Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Metastatic or locally advanced basal cell carcinoma considered inoperable or that surgery is contraindicated and radiotherapy is contraindicated or inappropriate
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

Exclusion Criteria:

* Concurrent anti-tumor therapy
* Completion of the most recent anti-tumor therapy less than 21 days prior to the initiation of treatment
* Uncontrolled medical illness
A Trial of Fosfomycin vs Ciprofloxacin for Febrile Neutropenia

Randomized phase 3 trial to compare efficacy and safety of oral fosfomycin versus ciprofloxacin to prevent febrile neutropenia in patients with acute leukemia or recipients of hematopoietic stem cell transplant.

Multicenter, prospective, randomized, open label phase III trial to assess the efficacy and safety of oral fosfomycin vs. oral ciprofloxacin in the prevention of febrile neutropenia in patients with acute leukemia who are treated with intensive chemotherapy and/or are recipients of a hematopoietic stem cell transplant.

Non-inferiority design.

156 patients will be recruited: 78 in each arm

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are able to understand study procedures, comply with them, and provide written informed consent before any study-specific procedure.
2. Adult subjects ≥ 18 years of age with acute leukemia diagnosis who are going to receive their first intensive chemotherapy cycle or adult subjects ≥ 18 years of age who are candidates to receive a first stem cell transplant.
3. Expected neutropenia 100x109/L lasting at least seven days. In case of expected neutropenia range 100-500x109/L lasting seven days or more, at least one of the following risk factors for infection must be present:

   1. Performance status (Eastern Cooperative Oncology Group, ECOG) ≥2.
   2. Expected mucositis grade 3-4.
   3. Age ≥65 years.
   4. Comorbidity Index (HCTI) ≥3.
   5. Serum albumin\< 35 g/L.
   6. Total dose of etoposide \> 500 mg/m2
   7. Total dose of cytarabine \> 1 g/m2
   8. Active or refractory neoplasia at the moment of stem cell transplant.
4. Performance status (Eastern Cooperative Oncology Group, ECOG) of 0 to 3.
5. Adequate organ function defined as:

   Liver: bilirubin, alkaline phosphatase, or SGOT \< 3 times the upper normal limit (unless it is attributable to tumor activity).

   Renal : creatinine ≤ 250 μmol/l (2.5 mg/dL) (unless it is attributable to AML activity).
6. Life expectancy higher than 3 months.
7. Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of child-bearing potential and men with female partners of child-bearing potential must agree to practice 2 highly effective contraceptive measures of birth control and must agree not to become pregnant or father a child while receiving any study therapy and for at least 3 months after completing treatment.

Exclusion Criteria:

1. Hypersensitivity to fluoroquinolones or fosfomycin.
2. Treatment with broad spectrum antimicrobial therapy within 4 weeks of first study treatment.
3. Prior Intensive chemotherapy or stem cell transplant. Treatment with hydroxyurea or corticosteroids used to control white blood cell counts are permitted.
4. Fever of infectious origin or documented infection within 4 weeks of first study treatment.
5. Presence of any severe psychiatric disease or physical condition that, according to the physicians criteria, contraindicates the inclusion of the patient into the clinical trial.
6. Subjects that have participated previously in this study