cyrilzakka/clinical-trials huggingface dataset:
Magnetic Resonance Imaging-Based Radiation Therapy and Cisplatin in Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer

Rationale: Computer systems that allow doctors to create a 3 dimensional (3-D) picture of the tumor may help in planning radiation therapy and may result in more tumor cells being killed. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as cisplatin, may make tumor cells more sensitive to radiation therapy.

PURPOSE: This clinical trial is studying magnetic resonance imaging-based radiation therapy and cisplatin in treating patients with stage I, stage II, stage III, or stage IV cervical cancer.Detailed DescriptionPRIMARY OBJECTIVES:

I. To evaluate the feasibility of using MRI based treatment planning for intracavitary brachytherapy treatment planning.

SECONDARY OBJECTIVES:

I. To evaluate the incidence of early toxicities, specifically genitourinary and gastrointestinal.

II. To evaluate the incidence of late toxicities, specifically genitourinary and gastrointestinal.

III. To evaluate local, regional, and distant recurrence rates. IV. To evaluate disease-free and overall survival rates. OUTLINE: Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.

After completion of study treatment, patients are followed at 6 weeks, every 4 months for 2 years, and then every 6 months for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have histologically confirmed squamous cell, adenosquamous or adenocarcinoma of the cervix
* Subjects must have non-metastatic FIGO Stage Ia-IVa cervical cancer
* Claustrophobic subjects must agree to be sedated during MRI procedures
* ECOG performance status of 0-2

Exclusion Criteria:

* Subjects with an inability to tolerate MR imaging
* Subjects who have had prior surgery for treatment of disease other than exploratory laparotomy or biopsy
* Study subjects who have contraindication to MRI scanning such as but not limited to subjects with pacemakers, metal fragments in the eye or certain metallic implants
* Women of childbearing potential who have a positive result on screening serum pregnancy test
Adjuvant Whole Breast Radiotherapy (RT) With Intensity Modulated Radiotherapy (IMRT) and a Simultaneous Integrated Boost Versus Conventional RT and a Sequential Boost

The IMRT-MC2 study is a prospective, two armed, multicenter, randomized phase-III-trial comparing intensity modulated radiotherapy with integrated boost to conventional radiotherapy with consecutive boost in patients with breast cancer after breast conserving surgery. 502 patients will be recruited and randomized in two arms: patients in arm A will receive IMRT in 28 fractions delivering 50.4 Gy to the breast and 64.4 Gy to the tumor-bed by an integrated boost, while patients in arm B will receive conventional radiotherapy of the breast in 28 fractions to a dose of 50.4 Gy and a consecutive boost in 8 fractions to a total dose of 66.4 Gy. Primary aim of the study is the assessment of the cosmetic outcome and local control after breast radiotherapy. The study hypothesis is that intensity modulated radiotherapy (IMRT) is, in spite of the reduced treatment duration, at least equivalent to conventional therapy.


Eligibility Criteria:
Inclusion Criteria:

* All patients aged \>18 years and \< 70 years after breast conserving surgery.
* Patients aged ≥ 70 years with following risk factors:

  * Tumor stadium ≥ T2
  * Multifocal disease
  * Lymphangiosis
  * Extended intraductal component
  * Resection margin ≤3mm

Exclusion Criteria:

* Refusal of the patients to be included in the study
* Karnofsky Performance Score ≤ 70%
* Metastatic disease (M1)
* Other malignancies
* Previous radiotherapy of the breast
* Pregnancy
Development and Validation of a Novel Functional Eye-Tracking Software Application for Alzheimer's Disease

This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.

This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by Alzheimer's Disease and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. The study data will be used to develop machine learning algorithms and validate a software application intended to track the progressive component of Alzheimer's Disease and associated cognitive changes.


Eligibility Criteria:
Inclusion Criteria:

* For all participants:

  1. Able to provide informed consent
  2. Aged 18 years or older at the time of enrollment
  3. Able to read in either French or English
  4. Visual acuity of 20/100 in at least one eye (corrective glasses, contact lenses, surgery etc. are permitted)
* For patients only:

  1. Confirmed diagnosis of AD based on the NIAAA diagnostic criteria of probable AD
  2. Having undergone a full neuropsychological evaluation within the last 6 months or having a planned full neuropsychological evaluation within the next 6 months.
  3. AD diagnoses supported by FDG-PET scan or amyloid biomarkers (CSF or amyloid PET)

Exclusion Criteria:

* For AD participants:

  1. Diagnosed with one of the following dementia subtypes: Fronto-temporal dementia, Lewy-body dementia, or Creutzfeldt-Jakob disease.
  2. Incapacity to provide informed consent or inability to adequately understand the task instructions.
* For all participants:

  1. Evidence or medical history of psychiatric issues, which are known to also affect movements and oculomotor control.
  2. Presence of comorbid neurological conditions to avoid eye movement anomaly confounds (strabismus, cranial nerve palsy, stroke-causing hemianopsia).
  3. Diagnosis of macular edema or other pre-existing ocular conditions (e.g., glaucoma, cataracts) that would prevent from performing the eye movement assessments.
  4. Unstable medication use: recent (less than one month from enrollment) start of, change of dose, or irregular use of, new prescription drugs known to have an effect on ocular motor visual function, such as benzodiazepines, antipsychotics and anticonvulsants. Occasional use of benzodiazepines for medical procedures is permitted, at the investigator's discretion, but should not occur within a short time period of an eye movement assessment.
  5. Diagnosed with an active substance use disorder.
  6. History of stroke.
  7. Recent traumatic brain injury (within the last 6 months).
* For healthy controls only:

  1. Evidence or history of significant neurodegenerative disorder affecting brain function (e.g., MS, PD, ALS, Non-AD Dementia)
Clinical Observation of the Transscleral Suture Fixation of Posterior Chamber Intraocular Lens in Eyes With Inadequate Capsule Support

To present the follow-up outcomes of transscleral suture fixation of posterior chamber intraocular lens (PCIOL) in eyes with inadequate capsule support.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent transscleral suture fixation of PCIOL
2. Time between the primary surgeries was at least 3 months

Exclusion Criteria:

1. Active intraocular inflammation
2. The intraocular pressure (IOP) was higher than 25 mmHg
3. The endothelial cell count (ECC) was more than 1,200 cells/mm2
Slow Gait Speed as an Indicator of Overweight, Dynapenic Obesity and Sarcopenic Obesity in Elderly People in the Community

The goal of this observational study is to evaluate the relationship of gait speed with dynapenic or sarcopenic obesity in community-dwelling older people. The main questions it aims to answer are:

* Is slow walking speed related to overweight in older people in the community?
* Is slow walking speed related to dynapenic obesity in older people in the community?
* Is gait speed related to sarcopenic obesity in older people in the community?

Participants will answer a clinical interview to obtain sociodemographic data and will perform the following clinical tests: (1) 10-meter walk test, (2) Anthropometric measurement; (3) Handgrip dynamometry test, (4) Standing dynamometry test and (5) Physical functionality questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Subjects over 60 years of age
* Female and male
* Self-sufficient in the instrumental activities of daily living
* Subjects with or without drug consumption, capable of carrying out the activity of walking independently or dependent on technical aids.

Exclusion Criteria:

* Subjects with acute musculoskeletal injuries of the lower extremity.
Prevention After Stroke - a Nurse-led Physician-supervised Model

The study evaluates the effect of early follow up in a preventive clinic with stepwise treatment of high blood pressure and lowering blood cholesterol. Half the participants were randomized to the preventive clinic group and the other half to control group with the usual treatment: one visit to the outpatient clinic three months after discharge with a diagnosis of stroke or transient ischemic attack (TIA)

Hypertension is the most important modifiable risk factor for recurrent stroke. Several studies have shown that less than 40% of stroke survivors are treated to target one year after stroke The investigator performed a feasibility study to test a model of treating this important risk factor in a hospital setting The investigator used a stepwise escalation of treatment of both blood pressure and blood cholesterol to individual targets according to patients' diagnosis of stroke, comorbidity and age

Eligibility Criteria:
Inclusion Criteria: Patients diagnosed with a stroke during stay in the stroke unit of Herlev Hospital

Exclusion Criteria: Severe stroke giving a modified Rankin Scale score \>4, severe cognitive deficits or dementia, discharge to a nursing home
Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination

Some research suggests that administration of oxytocin with oxycodone may reduce its abuse liability and improve its ability to reduce pain. In a 6-session laboratory study, the investigators will be evaluating the effects of oxycodone and oxytocin (combined and separately, across sessions) on experimentally-induced pain, subjective effects, decision-making, and activation of different neural substrates.

The overall project goals are to determine oxytocin effects on oxycodone's subject-rated abuse liability, experimental pain, and to describe the neurobehavioral mechanisms underlying interindividual differences in these effects. Generally healthy individuals (determined via medical history review and a screening session) will, after informed consent, self-administer intranasal oxytocin (or placebo, containing the same ingredients but no oxytocin) shortly after oral oxycodone or placebo in a non-residential, double-blind, randomized, placebo-controlled, within-subjects laboratory study. Prescreening will assure MRI eligibility and drug application safety and, using a validated, comprehensive pain history interview, determine previous or existing chronic pain conditions, including current pain medication use.

Eligibility Criteria:
Inclusion Criteria:

* Individuals fluent in English will participate.
* Must report recreational use of opioids.
* Be within 20% of their ideal body weight.
* Are not currently experiencing chronic pain (pain on most days during the past 3 months)
* Have a systolic blood pressure of \<=140 and diastolic blood pressure of \<= 90, and a heart rate \<= 90 beats per minute.
* Participants must also have a normal electrocardiogram (EKG) reading and bloodwork indicating no major health contraindications.

Exclusion criteria:

* Significant current physical disease or major psychiatric disorder.
* No self-reported current interest in drug abuse treatment.
* Women who are pregnant or nursing.
* Any comorbid illicit substance use disorders or current clinically significant withdrawal for any abused drug excluding nicotine and caffeine.
* Any conditions that preclude safety in the MRI scanner, such as: implanted electrical devices (e.g., cardiac pacemaker, neurostimulator); implanted metallic clips or pins (e.g., aneurysm clip); a history of working with metal (unless able to demonstrate participant is MRI safe), and claustrophobia.
Application of Integrated MR-PET in Patients With Gynecologic Cancers

In this prospective cohort study, patients with newly diagnosed gynecologic cancers (including cervical, endometrial, and ovarian cancers) and patients with suspicious recurrent gynecologic cancers will be enrolled. The study period is two years and the estimated patient number is about 220. Patients will undergo image study before and after treatment. The diagnostic accuracy of MR-PET in cancer staging and the potential image biomarkers to monitor treatment response and predict treatment outcome will be investigated.


Eligibility Criteria:
Inclusion Criteria:

1. Group 1: Patients with newly diagnosed gynecologic cancers (including cervical, endometrial, and ovarian cancers).
2. Group 2: Patients with suspicious recurrent gynecologic cancers (including cervical, endometrial, and ovarian cancers).
3. Group 3: Patients with ovarian cancer who had debulking surgery and are going to receive adjuvant chemotherapy.

Exclusion Criteria:

1. Age \<20 or \>90 years old
2. Contraindication for MRI:
3. Contraindication for MR contrast medium (Cre \> 2.0)
4. History of other malignancy
5. Prior arthroplasty of hip or pelvic bone surgery with metallic fixation (may cause artifacts on MRI)
6. Pregnant or lactating women
Women's Responses to a Mindfulness-Based Body Scan: A Pilot Study

PTSD develops after trauma and is marked by intrusive memories, avoidance of reminders, negative changes in mood and cognitive processes, and dysregulated physical and emotional stress reactivity. PTSD disparately affects twice as many women as men (8.0% vs. 4.1%), and finding effective treatments for these women is critical to reduce poor health outcomes associated with PTSD. Mind-body therapies (MBT), using the mind in combination with the body to facilitate healing hold promise to enhance PTSD treatment by improving stress regulation. While MBT reduce PTSD symptoms long-term, women with PTSD may initially experience distress, leading to treatment avoidance. This pilot study will explore women's initial responses to MBT, the prevalence of adverse responses, and which women are at risk for adverse responses in a sample of participants with a history of trauma and varying levels of PTSD symptoms. Study participants will attend one virtual study visit via one-on-one videoconference with the PI, where they will complete self-report measures of stress and affect before and after one session of a MBT exercise. A subset of the sample will complete a semi-structured individual videoconference interview with the PI within two weeks following completion of the MBT exercise and quantitative measures.

The proposed single-group study will use a pre-post design to assess participants' responses to one exposure to a mindfulness-based body scan in a sample of women with a history of trauma and varying levels of PTSD symptoms. Quantitative measures will assess self-reported state positive affect, negative affect, and anxiety before and after the body scan, and psychosocial characteristics expected to influence responses. Individual semi-structured interviews will be conducted with a subsample of women to learn about their subjective experiences related to the body scan.

Eligibility Criteria:
Inclusion Criteria:

1. Previously experienced a traumatic event as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) \>6 months prior,
2. self-identify as a woman and were assigned female sex at birth,
3. \>18 years of age,
4. fluency in English,
5. access to computer or smartphone to complete REDCap surveys and videoconference study visit.

Exclusion Criteria:

1. active suicidal thoughts with a plan,
2. unable to abstain from drugs or alcohol for \>48 hours prior to study videoconference,
3. current or history of psychosis with auditory and/or visual hallucinations,
4. meditated or practiced yoga \>1 time(s) per month over past 6 months.
Short-term Oral Prednisone for Acute Subjective Tinnitus

The goal of this clinical trial is to investigate the efficacy of oral steroids in the acute tinnitus population. Participants will receive appropriate dosages of short-term prednisone and/or oral Ginkgo Biloba tablets.

Researchers will compare the intervention group and placebo-control group to see whether short-term systemic steroid therapy is effective for acute tinnitus.

Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years old;
2. a primary complaint of frequent occurrences of subjective tinnitus lasting at least 5 minutes within the past 3 months ;
3. a definition of normal hearing in line with the World Report on Hearing (2021), of which the average value of hearing threshold at 500, 1000, 2000, 4000 Hz in better ear was less than 20 decibels;
4. a score of more than 16 points on the Tinnitus Handicap Inventory (THI), which indicates that the level of tinnitus exceeds mild severity;
5. a state of good general condition.

Exclusion Criteria:

1. had previous history of middle ear pathology, apparent history of noise exposure, noise trauma or head injury;
2. had received treatment for their current condition before the study;
3. taken oral steroids within 3 months before randomization;
4. had hearing implants;
5. had participated in other clinical trials and have not terminated the trials;
6. had a history of known corticosteroid contraindications (including osteoporosis, peptic ulcers, poorly controlled hypertension, diabetes, chronic liver or renal insufficiency, tumorous condition, alcohol abuse, pregnancy, or taking estrogen-containing oral contraceptive steroids);
7. auditory hallucinations or other conditions deemed inappropriate for inclusion by the investigator.
Relationship Between Computed Tomography Manifestation and Histopathological Classification of Thymic Epithelial Tumors

the World Health Organization (WHO) has proposed a classification of histopathological thymic tumor and it significance in prognosis. Chest computed tomography (CT) is the most common method to evaluate thymic epithelial tumors before operation. Therefore, the question is to predict the histopathological type of thymic epithelial tumors before surgery based on CT-scan images , to help determine treatment strategy and prognosis. In Vietnam, there are no published literature on this issue.

1. Introduction: the World Health Organization (WHO) has proposed a classification of histopathological thymic tumor and it significance in prognosis. Chest computed tomography (CT) is the most common method to evaluate thymic epithelial tumors before operation. Therefore, the question is to predict the histopathological type of thymic epithelial tumors before surgery based on CT-scan images , to help determine treatment strategy and prognosis. In Vietnam, there are no published literature on this issue.
2. Materials and methods:

   2.1. Cross-sectional descriptive study on 53 patients with diagnosed of thymoma by CT and had postoperative histopathology results as thymic epithelial tumors

   2.2. Time and Place: in Departement of CTVS, Military Hospital 103, Vietnam from 10/2013 to 7/2017.

   2.3. methods:
   * study in chest CT scan:

     * Measure the maximun diameter of the tumor
     * The contour: smooth contour or irregular contour
     * The shape: round, oval and plaque base on the ratio between long axis and short axis of the tumor
     * Some other characteristics: Degree of enhancement, Level of drug absorbed, Calcification, Invasion the local organs and Capsular destruction.
   * Histopathological study: based on the 2004 WHO classification:

     * Thymoma: type A, AB, B1, B2, B3
     * Thymic carcinoma
   * Data processing: use software Epi Info 2000.
3. Expectation of results

   * Relationship between the size and histopathological type of thymic epithelial tumors.
   * Comparison of some characteristics of the tumor on preoperative chest CT scans and histopathological type of thymic epithelial tumors

Eligibility Criteria:
Inclusion Criteria:

* All of patient have a chest CT scan pre-operation and a result of thymic epithelial tumors postoperative histopathology

Exclusion Criteria:

* Incomplete or loss the CT and postoperative histopathology
Post Operative Pain of Partial Pulpotomy Using a Bioceramic Material in Patients With Symptomatic Irreversible Pulpitis

The goal of this clinical trial is to assess post-operative pain of partial pulpotomy using a newly introduced Bioceramic material in young patients with symptomatic irreversible pulpitis at 24, 48, 72 hours postoperatively using visual analogue scale (VAS). The main question\[s\] it aims to answer are:

• In patients with symptomatic irreversible pulpitis does the use of bioceramic material in partial pulpotomy decrease amount of post operative pain in comparison to conventional root canal treatment?

Participants will record the intensity of pain at 24,48, 72 hours postoperatively.


Eligibility Criteria:
1. Inclusion criteria :

   1. Subject's age between 9-14 years.
   2. Both male and female subjects.
   3. Medically free and healthy subjects.
   4. Mandibular molar teeth.
   5. Teeth with symptomatic irreversible pulpitis.
   6. Teeth with mature closed apices.
2. Exclusion Criteria:

   1. Teeth with acute dentoalveolar abscess.
   2. Subjects having more than one tooth that require root canal treatment.
   3. Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment.
   4. Subjects with systemic diseases who have endocrine diseases, Infectious diseases or Psychological disturbance.
   5. Teeth with periodontal disease or pulp calcification.
   6. Subjects taking chronic pain medications.
Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Minimal Encephalopathy

The study aimed to assess the effectiveness and safety of L-ornithine-L-aspartate in the management of hepatic encephalopathy.

Hepatic encephalopathy continues to be a major clinical problem in cirrhosis. Patients with minimal hepatic encephalopathy are at risk for accidents, had a decline in work performance, or complain of cognitive symptoms, with poor health-related quality of life. This study will compare L-ornithine-L-aspartate with placebo for 60 days to assess the effectiveness, safety and health-related quality of life of this drug.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis and diagnosis of minimal hepatic encephalopathy using psychometric tests and critical flicker frequency

Exclusion Criteria:

* Hepatic encephalopathy grade 1 to 4
* Use of drugs to treatment of hepatic encephalopathy (lactulose, neomycin)
* Psychoactive substance use within 72 hours
Study of the Metabolism of Pyruvate and Related Problems in Patients With Lactic Acidemia

OBJECTIVES: I. Study the metabolism of pyruvate and related problems in patients with lactic acidemia.

II. Define the nature of the metabolic defect.

PROTOCOL OUTLINE: Patients fast for 6 hours. Glucagon IM is administered after the 6 hour fast. Glucose level is measured at 0, 15, 30, 45, 60, and 90 minutes.

In children of sufficient size, alanine and lactic acid should also be measured at each or most of these time points.

Fasting continues for at least 18 hours. Glucagon IM is administered again at end of fast. Glucose level is measured at time 0, 15, 30, 45, 60, and 90 minutes.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

* Diagnostically documented elevation in lactate, pyruvate, and/or alanine levels in lactic acidemia patients