cyrilzakka/clinical-trials huggingface dataset:
Plastic Stents Compared With Metal Stents in Treating Patients With Malignant Dysphagia Caused by Esophageal Cancer or Gastroesophageal Junction Cancer

RATIONALE: Placing a stent in the esophagus may lessen swallowing difficulties and improve quality of life in patients with malignant dysphagia caused by esophageal cancer or gastroesophageal junction cancer.

PURPOSE: This randomized clinical trial is studying self-expanding plastic stents to see how well they work compared with self-expanding metal stents in treating patients with malignant dysphagia caused by esophageal cancer or gastroesophageal junction cancer.

OBJECTIVES:

Primary

* Assess differences from baseline in health-related quality of life of patients with malignant dysphagia due to cancer of the esophagus or gastroesophageal junction palliated with self-expanding plastic stents (SEPS) compared to those who receive self-expanding metal stents (SEMS).

Secondary

* Perform a cost-effective analysis of each type of stent by independent evaluation of the rates of SEPS-related and SEMS-related morbidity that necessitates repeat endoscopic interventions and/or additional healthcare costs in these patients.
* Analyze effective palliation (degree and duration of improvement of dysphagia) in these patients.
* Determine the individual rates of complication associated with each type of esophageal stent in these patients.

OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo placement of a self-expanding metal stent on day 1.
* Arm II: Patients undergo placement of a self-expanding plastic stent on day 1. Health-related quality of life is assessed at baseline, 30 days, and 3 months.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed primary cancer of the esophagus or gastroesophageal junction

  * Squamous cell or other type
* Diagnosis of malignant dysphagia
* Disease deemed surgically inoperable, but may be any of the following:

  * Locally contained
  * Locally advanced
  * Metastatic
  * Unresponsive to previous chemoradiotherapy
  * Recurrent despite previous surgical resection
* Must be either an inpatient OR outpatient at Johns Hopkins Hospital
* No known tracheal compression by tumor burden

PATIENT CHARACTERISTICS:

* Karnofsky performance status 50-100%
* Life expectancy ≥ 6 months
* Platelet count \> 50,000/mm³
* INR \< 1.5

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Prior surgery, chemotherapy, biologic therapy, or radiotherapy allowed
* No concurrent surgery, chemotherapy, biologic therapy, or radiotherapy
Influence of Beverage Choice on Hydration Status Cognition and Learning in Children

The main aim of this clinical trial is to compare the beverage hydration index of three different beverages in primary school-aged children.The Beverage Hydration Index (BHI), compares the hydration value of beverages against plain water. This study will explore the fluid retention capabilities of semi-skimmed milk, milk permeate, and water.

This study will also investigate:

* Identify the most effective beverage for hydration and the potential cognitive and mood benefits.
* To test if these beverages have any effect on gastric emptying
* To test if these beverages have any effect on appetite.
* To test the acceptability and palpability of semi-skimmed milk, milk permeate, and water in primary school-aged children.

Participants will:

* Take part in three study days (one for each beverage)
* Study day will take part between 9:00AM-12:30PM
* Participants will also record their food and fluid consumption the day before and consume a standardised breakfast before each trial.
* The beverage hydration index will be calculated as the mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment.
* Blood and urine samples will be taken to measure hydration
* Breath samples will be taken for gastric emptying rate
* COMPASS (Computerised Mental Performance Assessment System), fNIRS (Functional Near Infrared Spectroscopy) and visual analogue scales (VAS) measures will be obtained to assess cognition/mood
* An ad libitum pasta meal will be consumed after the trial to measure appetite, along with blood glucose and GLP-1 and further VAS to measure self reported hunger and fullness.
* A focus group will be held following completion of all three beverage trials, to gather participants opinion of each drink.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 9-11
* Healthy

Exclusion Criteria:

* Psychiatric, neurological or mental disorder.
* Children with any morbidity that might influence hydration status (i.e., renal/cardiovascular/metabolic disease), blood-borne illness, or if they were taking any medications that may impact fluid balance.
* Children that are lactose intolerant
* Children that have any food allergies
Web-based Resource for Children and Adolescents About Clinical Research

The overall aims of this project are to: 1) create a developmentally appropriate interactive educational website for adolescents called DigiKnowIt News: Teen, and 2) examine the feasibility of DigiKnowIt News: Teen in a small randomized control trial with adolescents.

Youth (N=30) will be recruited to participate in the feasibility study. Parent permission and youth assent will be sought. Participants will be randomized into one of two study arms: intervention and wait-list control. All participants will complete a web-based pre-test questionnaire. Youth in the intervention group will then receive access to DigiKnowIt News: Teen for one week. Approximately one week after completing the pre-test questionnaire, all participants will complete a web-based post-test questionnaire (the post-test for youth in the intervention group will also include Consumer Satisfaction Questions). Youth in the wait-list control group will then receive access to DigiKnowIt News: Teen for one week. After one week, they will complete a Consumer Satisfaction Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be between the ages of 12 and 17 years.
* Participants must have access to a computer or tablet with Internet connection.
* Participants must be able to read and write in English fluently.

Exclusion Criteria:

* Participants must NOT have previously participated in a clinical trial.
Effect of Orthodontic Treatment on Periodontally Compromised Dentition- Randomised Control Trial

The main aim of this prospective, randomized controlled clinical study is to:

• To evaluate and compare the effect of a combined orthodontic -periodontal treatment protocol versus periodontal treatment alone on osseous and non -osseous parameters in periodontally compromised patients.

All the patients of both the groups will receive a detailed periodontal evaluation and then therapeutic management of patients will be done as per their periodontal requirement. This will include oral hygiene instruction, scaling and root planning and re-evaluation after 2 weeks and periodontal surgical treatment if indicated will be re-evaluated 4-6 weeks. After an observation period of 2 months confirming patient cooperation and their ability to maintain good oral hygiene as well as stability of the periodontal results orthodontic treatment will be started in the test group whereas the control group will be kept on monthly recall for the first 3 months and then every 3 months as per the oral hygiene status requirement of the patient.periodontal charting will be done at every 3 months till finish of treatment and supra gingival scaling will be provided as per requirement in both the groups.Changes in periodontal status in terms of clinical and radiographic parameters will be compared between the groups. cone beam Computed tomography will be taken at the baseline T0 and study end point T2 for assessment of changes in the bone level around maxillary and mandibular teeth

Eligibility Criteria:
Inclusion Criteria

.• Patient age criteria 20-40 years.

* Periodontally Compromised dentition with moderate to severe periodontitis ≥2 teeth with pocket depth (PD) ≥5 mm and loss of clinical attachment level (CAL) ≥ 4mm. and radiographic bone loss
* Good general health status.
* Malocclusion that needs orthodontic treatment

Exclusion Criteria:

* Systemic illness known to affect the periodontium or outcome of periodontal and orthodontic therapy.
* Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy.
* Pregnant or lactating women.
* Smokers(≥5 cigarettes∕ day).
* Noncompliance to oral hygiene measures after Phase I therapy.
* Presence of trauma from occlusion (TFO).
* Patients with aggressive periodontitis
Mind Your Heart-II

This projects studies the role of mindfulness training (MT) to improve self-care among patients with heart failure and cognitive impairment.

Stable outpatients patients with co-morbid heart failure (HF) and mild cognitive impairment (MCI) (n=176) will be randomly assigned to phone-delivered MT (a weekly, 30-minute session for 8 weeks integrated with 20-min daily guided individual practice via digital recordings) plus enhanced usual care (EUC) or to EUC alone. Per current recommendations, usual care will be enhanced in both groups with self-care education materials. At baseline, 3 months (end of treatment), and 9 months since baseline participants will undergo comprehensive assessments of cognitive function, psycho-behavioral factors, cardiac vagal control, and HF biomarkers.

This study has the following objectives:

1. To study the role of MT in improving cognitive function and HF self-care in patients with co-morbid HF and MCI. We hypothesize: 1a) Cognitive function will improve in MT vs. EUC at end of treatment (3 months); 1b) Improvements in cognitive function at end of treatment will mediate effects on self-care and HF biomarkers at follow-up (9 months since baseline).
2. To study the role of MT in improving interoceptive awareness and HF self-care in patients with co-morbid HF and MCI. We hypothesize: 2a) Interoceptive awareness will improve in MT vs. EUC at 3 months, and 2b) Changes in interoceptive awareness at end of treatment will mediate improvements in self-care and HF biomarkers at 9 months follow-up.
3. To study the mechanistic pathway linking MT, vagal control and cognitive function. We hypothesize: 3a) Vagal control will improve in MT vs. EUC at end of treatment (3 months); 3b) Changes in vagal control will mediate improvements in cognitive performance at 9 months of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* A documented diagnosis of HF
* Access to a telephone
* Mild cognitive impairment (MoCA score \< = 26)
* Ability to understand and speak English or Spanish

Exclusion Criteria:

* Unwillingness/inability to provide informed consent
* Reversible causes of HF (e.g., takotsubo syndrome; myocarditis)
* Severe hearing impairment not allowing phone delivery
* Suicidal ideation or plan
* Current (at least once a month) mind/body practice
* Planning to move out of the area during the study period
* Severe cognitive impairment (MoCA scores \< 15)
* New York Heart Association (NYHA) class IV heart failure or clinically unstable
* Ongoing psychiatric or neurologic conditions
* Current enrollment in another study
An Exploration of the Relationship Between Serum Cytokine Levels and the Clinical Efficacy of Vedolizumab

It is uncertain the relationship between serum cytokine levels and the clinical efficacy of vedolizumab in the treatment of ulcerative colitis. The effects of cytokines on the efficacy of vidrecizumab in Chinese UC patients were retrospectively analyzed. Methods: Patients with UC were recorded. These patients were detected the levels of cytokines.


Eligibility Criteria:
Inclusion Criteria:

* UC patients Treated with Vedolizumab

Exclusion Criteria:

* pregnant
* had cognitive/developmental disorders that affected their ability to complete the study procedures
* had medical illness or therapies potentially affecting bone, nutrition or growth status
A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer

This study will evaluate the efficacy and safety of pertuzumab in combination with carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian cancer. The anticipated time on study treatment is 3-12 months.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed ovarian, primary peritoneal, or fallopian tube cancer;
* only 1 previous regimen, which must be platinum-based;
* platinum-sensitive disease which is defined by a progression-free interval of greater than 6 months after completion of platinum-based chemotherapy.

Exclusion Criteria:

* previous radiotherapy;
* previous treatment with an anti-cancer vaccine or any targeted therapy;
* major surgery or traumatic injury within 4 weeks of study;
* history or evidence of central nervous system metastases.
4D CBCT and Intrafractional Imaging for the Determination of the Most Representative 4D Simulation Planning Technique for Lung SBRT Technique Patients

The researchers plan to investigate two ways of visualizing and planning to account for the respiratory motion which takes place while treating lung tumors with radiation therapy. The researchers will determine if a traditional snapshot (free-breathing) CT or a longer-lasting CT encompassing the breathing cycle better matches a patient's breathing during treatment.

As part of this study the patient will receive the standard of care treatment of Stereotactic Body Radiation Therapy (SBRT) approach for treatment of lung cancer. The study will compare whether the quick snapshot or longer-last image is more representative of breathing motion. The standard of care way to verify breathing is to use the Cone Beam Computerized Tomography (CBCT) before each treatment. For this study the researchers will use two other standard of care ways to verify breathing motion during treatment only during the first and last radiation treatment sessions. During the other radiation treatment sessions the CBCT alone will be used. These two other methods are FDA approved, but not routinely being used at the Mays Cancer Center. One method is called 4D-CBCT and is conducted immediately prior to treatment. This will create an image taken over a longer time of the patient's lungs which will be compared with the images from the CT Simulation used to plan the radiation. The other way is called Intrafractional CBCT and is imaging that is done at the same time as the radiation treatment delivery. This will show the researchers how the tumor is moving while the radiation treatment is taking place. These two methods require a longer treatment time, approximately 10 minutes during the first and last treatments.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Ability to provide informed written consent in either English or Spanish.
* Patients with cancer or presumed cancer involving the lung (primary or secondary) planned to undergo lung SBRT technique or IMRT technique with an SBRT setup in 10 or fewer fractions.

Exclusion Criteria:

* Current pregnancy, as this is a contraindication to receiving radiation therapy.
* Patients to be treated to multiple targets concurrently.
* Any condition or history as evidenced by patient record and/or self-report that, in the opinion of the investigator, would interfere with adherence to the prescribed pattern of radiation therapy.
* Poor lung function, as judged by the prescribing radiation oncologist, sufficiently limiting to make the patient not a candidate for 4D imaging (for example major differences between the 4D and free-breathing CT scan).
Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fasted Conditions

The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone hydrochloride extended-release tablets (Sandoz) with Opana extended release oxymorphone hydrochloride tablets.

Bioequivalence based on FDA Criteria.

Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on physical exam, medical history or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C
* Treatment for drug or alcohol dependence
Specific Screw Holes Locating Surgical Guide and Pre-bent Plates

The aim of the current study was to evaluate the accuracy of computer-guided mandibular fracture reduction versus the classical work flow

Research question:

Does the use of screw holes locating surgical guide \& pre-bent plates osteosynthesis accurately reduce class III mandibular fractures regarding segments integrity and occlusion more than the classical reduction and fixation?

Statement of the problem:

Mandibular fractures are the most frequently occurring fractures within the maxillofacial injuries. The evaluation, diagnosis, and management of these fractures remain challenging despite improved imaging technology and fixation techniques. Depending on the type and location of the fractures, various open and closed surgical reduction techniques can be utilized. There are several critical and inherent limitations to the current ,standard approach of mandibular fracture reduction and fixation includes : (improper alignment of segments ,malocclusion ,nerve affections and related teeth roots injury).

There is a possibility to overcome these limitations with the help of computer-guided surgery . The introduction of CAD/CAM software has provided surgeons with an opportunity to perform virtual manipulations of CT datasets preoperatively and production of corrected mandibular model for plate pre-bending and fabrication of plate locating surgical guide which provide accurate segment reduction and fixation with accurate post-operative occlusion and minimal post-operative complication . The aim of the current study was to evaluate the accuracy of computer-guided mandibular fracture reduction versus the conventional work flow

Rationale for conducting the research:

Through computer guided mandibular fracture reduction investigators can provide proper segment alignment with subsequent accurate post-operative occlusion in addition reduce intra-operative time , post-operative pain and edema

Eligibility Criteria:
Inclusion Criteria:

* Patients with delayed and isolated mandibular class III fracture needs open reduction and internal fixation.
* Patients with medical history that did not hinder plate placement (uncontrolled diabetes) and adequate proper oral hygiene.
* Both genders males and females will be included.

Exclusion Criteria:

* • General contraindications to surgery.

  * Patients with fresh fractures (mobile segments).
  * Patients with unfavourable nor comminuted fractures.
  * Subjected to irradiation in the head and neck area less than 1 year before fixation.
  * Untreated periodontitis.
  * Poor oral hygiene and motivation.
  * Uncontrolled diabetes.
  * Pregnant or nursing.
  * Substance abuse.
  * Psychiatric problems or unrealistic expectations.
  * Severe bruxism or clenching.
  * Immunosuppressed or immunocompromised.
  * Treated or under treatment with intravenous amino-bisphosphonates.
  * Patients participating in other studies, if the present protocol could not be properly followed.
Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis

To evaluate the safety and efficacy of liposomal amphotericin B and amphotericin B deoxycholate with or without flucytosine followed by fluconazole for the treatment of cryptococcal meningitis.

Subjects who meet all eligible requirements will be randomized into study group （Lipo-AB）or control group（Amphotericin B deoxycholate） in 2:1 ratio. Subjects will be treated with induction therapy in study group or in control group with flucytosine for at least 14 days, and followed by consolidation therapy for another 56 days after CSF sterilization.

Eligibility Criteria:
Inclusion Criteria:

1. Adults with age of at least 18 years.
2. Within 7 days prior to, or at the time of screening visit, patient with cryptococcus meningitis, diagnosed by :

   1. CSF India ink staining positive OR
   2. CSF cryptococcal antigen test positive OR
   3. CSF culture positive
3. Patient or his/her legally acceptable representative has signed the written informed consent form.

Exclusion Criteria:

1. Patients have laboratory abnormalities within 3 days prior to screening visit :

   1. ALT \> 5x UNL,
   2. AST \> 5x UNL,
   3. Creatinine \> 2mg/dl
2. Patient is pregnant or lactating.
3. Patient participate other investigational drug trial within 1 month before entering this study.
4. Patient has some indications that another systemic antifungal drug would be needed in addition to assigned drugs in study.
5. Patient had contraindication of amphotericin B or azole.
6. Patient is not available for lumbar puncture.
7. Patient with life expectancy less than 5 days.
Comparison of New and 3-Month-Old Toothbrush in the Removal of Plaque in Children

This study aimed to validate or invalidate non-inferiority in the plaque removal efficacy of old versus new toothbrushes in the hands of 7-9 year old children. This study was conducted in 93 Iranian students aged between 7-9 year old.

At baselines, each student is given a new toothbrush which they will use for 3 months. The amount of wearing the 3-month-old brushes will determine by measurement of brushing surface areas using NIH imaging software. The outcomes will be measured after 3 month. The tooth brush which used in this study is "Jordan" with the following specifications: Length: 128 mm, 9 rows of bristles, 27 tufts, 24 monofilaments per tuft, height of monofilaments 10 mm and diameter of filaments 0.3 mm. The students will attend on two occasions following 48 hour periods of no oral hygiene. Following plaque scoring, students will brush with a new tooth brush at one visit and with a brush that they had used previously for 3 months at the other visit. Brushing time was 60 seconds. Plaque then will be re-scored and the percentage reduction in plaque score will be calculate using the Turesky plaque index. All plaque scoring will be performed by one examiner who is blind with the groups allocations.

Eligibility Criteria:
Inclusion Criteria:

1. subjects should be have central and lateral incisors, first permanent molar in each quadrant of maxilla and mandible
2. they should be without restoration on facial, lingual surfaces
3. subjects should be healthy without any disabilities

Exclusion Criteria:

1. subjects who wearing oral prosthesis,orthodontic brackets or removable appliances
2. subjects using mouthwashes which improve the oral hygiene
Digital Design for Maxillofacial Prosthetics

This study will use a 3D scanner to print a 3D model or mold for each patient's prosthesis. The goal of this study to provide patients with a new, faster method of imaging and creating prostheses that preserves the quality of the current method while reducing time spent by both the patient and providers. Patients that are eligible will have a non-invasive 3D scanner (Artec Space Spider) to image the indicated areas of their head and face to help create their new prosthesis. Patients will come in for visits as needed to fit and adjust their prosthetic. Additionally, patients will be asked to complete questionnaires and have follow-up visits at certain time -points pre and post prosthetic completion.


Eligibility Criteria:
Inclusion Criteria:

* Maxillofacial anatomic defect or anomaly that limits function or cosmesis (including facial and/or intraoral)
* Stable defect (no clinically active tumor or plans for major reconstructive surgery)
* The patient (or family) have elected to pursue a prosthetic reconstruction of a craniofacial anomaly
* The patient is amenable to 3D surface scanning rather than facial molding

Exclusion Criteria:

* Known allergy to silicone
* Poor candidate for prosthetic reconstruction
* Developmental concerns regarding aspiration risk