cyrilzakka/clinical-trials huggingface dataset:
Proactive Automatized Lifestyle Intervention

Background: The co-occurrence of health risk behaviors (HRBs), namely of tobacco smoking, insufficient physical activity, unhealthy diet and at-risk alcohol use, more than doubles the risk of cancer, other chronic diseases and mortality; and applies to more than half of adult general populations. However, preventive measures that target all four HRBs and that reach the majority of the target populations and particularly those persons most in need and hard to reach (e.g. with low socio-economic status), are scarce. Electronic interventions may help to efficiently address multiple HRBs in whole populations, such as health care patients. The aim is to investigate the acceptance of a proactive and brief electronic multiple behavior change intervention among general hospital patients with regards to reach, retention, equity in reach and retention, satisfaction and subsequent trajectories of behavior change motivation, HRBs and health.

Methods: A pre-post-intervention study with four time points will be conducted at a general hospital in Germany. Patients admitted to participating medical departments (internal medicine, general surgery, trauma surgery, ear-nose-throat medicine) and aged 18-64 years will be systematically approached and invited to participate, irrespective of reason for admission and HRB profile. Based on HRB profile and on psychological behavior change theory, participants (n=175) will receive individualized computer-generated feedback concerning all four HRBs and motivation-enhancing feedback for up to two HRBs; directly on the ward and 1 and 3 months later. Intervention reach and retention will be determined by the proportion of participants among eligible patients and participants, respectively. Equity in reach and retention will be measured with regards to school education and other socio-demographics. To investigate satisfaction with the intervention and trajectories of motivational measures, HRBs and health measures, a 6-month follow-up will be conducted. Descriptive statistics, multivariate regressions and latent growth modelling will be applied.

Discussion: This study will be the first to investigate the acceptance of a proactive, electronic and brief multiple behavior change intervention among general hospital patients. If reach is high and efficacy established by a randomized controlled trial, the intervention has potential for public health impact in terms of primary and secondary prevention of diseases.


Eligibility Criteria:
Inclusion Criteria:

- General hospital patients admitted to participating wards of four medical departments (internal medicine, surgical medicine, trauma medicine, ear-nose-throat) at the University Medicine Hospital Greifswald in northeastern Germany

Exclusion Criteria:

* Cognitively or physically incapable
* Presence of a highly infectious disease
* Discharge or transferral within the first 24 hours
* Already asked for participation during previous hospital stay
* Insufficient language skills
* Employed at the conducting research institute
* Neither telephone nor email
Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus

The study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo controlled clinical trial. Subjects will receive hydroxychloroquine or placebo and close monitoring for progression of T1D.

This study is testing a medication, called hydroxychloroquine (HCQ) to assess safety and effectiveness to prevent individuals at risk of type 1 diabetes (T1D) from progressing to type 1 diabetes.

HCQ is approved by the U.S. Food and Drug Administration as a treatment for malaria, lupus, and rheumatoid arthritis. HCQ has been used extensively for treatment of autoimmune disease in adults, children, and during pregnancy. This medication has not previously been studied as a treatment to prevent T1D.

The goal of this study is to learn if HCQ can help prevent or delay progression from normal glucose tolerance (Stage 1) to abnormal glucose tolerance (Stage 2) or type 1 diabetes (Stage 3).

The study involves 5 visits in the first 6 months, then 1 visit every 6 months for the remainder of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Participant in TrialNet Pathway to Prevention Study (TN01)
2. Age 3 years or greater at the time of randomization
3. Willing to provide informed consent
4. Normal glucose tolerance by OGTT within 7 weeks (no more than 52 days) of baseline
5. Two or more diabetes-related autoantibodies present on two separate samples
6. Weight of 12 kg or greater at screening
7. If a female participant with reproductive potential, willing to avoid pregnancy and undergo pregnancy testing prior to randomization and at each study visit
8. Anticipated ability to swallow study medication.

Exclusion Criteria:

1. Abnormal Glucose Tolerance or Diabetes
2. History of treatment with insulin or other diabetes therapies
3. Ongoing use of medications known to influence glucose tolerance
4. Ongoing or anticipated future use of medications known to have untoward interactions with hydroxychloroquine
5. Known hypersensitivity to 4-aminoquinoline compounds
6. G6PD deficiency
7. History of retinopathy
8. Have an active infection at time of randomization
9. Have serologic evidence of current or past HIV, Hepatitis B (positive for Hepatitis B core antibody or surface antigen), or Hepatitis C infection
10. Deemed unlikely or unable to comply with the protocol or have any complicating medical issues, including prolonged QT interval, a disease previously or likely in the future to require immunosuppression, or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.
11. Deemed unlikely or unable to comply with the protocol or have any complicating medical issues, including prolonged QT interval, a disease previously or likely in the future to require immunosuppression, or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.
12. Be pregnant or breastfeeding.
The Utility of PET/CT in the Planning of Stereotactic Body Radiotherapy for Non-small Cell Lung Cancer

The trial evaluates the utility of 18FDG-PET/CT scan in the target definition process when SBRT is planned for stage I NSCLC.

The trial aims to evaluate the utility of 18FDG-PET/CT in SBRT planning for NSCLC with particular emphasis on the definition of macroscopic and microscopic boundaries of malignant growth. Studies indicate that the definition of the gross tumor volume may gain in quality when CT and 18FDG-PET are combined. In about 30-60% of NSCLC patients considered for radiotherapy, alteration of CT-based treatment volumes is the consequence of a supplementary 18FDG-PET scan. Studies examining the effect of combined PET/CT scans on the delineation of the GTV generally show reduced intra- and inter-clinician variability. Whether this higher degree of consistency is an actual improvement remains to be proven. Pathological specimens from operated NSCLC patients may serve as a gold standard in this respect. To meet the need for tight margins, the clinical target volume in SBRT planning is generally presumed to correspond to the GTV. Whether this clinical practice rests on firm ground is also an issue that can be addressed in a PET-CT-pathology correlation study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or above
* Histologically or cytologically verified NSCLC
* Disease stage I (T1-2 N0 M0)
* Referred from the multi-disciplinary lung cancer conference at Aarhus University Hospital for operation at Skejby Hospital, Aarhus University Hospital
* Oral and written informed consent

Exclusion Criteria:

* Medically treated diabetes mellitus
* Fasting blood-glucoses above 6,7 mM
* Blood-creatinin above normal
* Allergies to intravenous contrast
* Detention according to the Danish laws on psychiatrics that does not comply with participation in a clinical trial
* Employment at the Dept. of Oncology, Aarhus University Hospital
* Pregnancy
* Lactation
Computer-assisted Diagnosis System Based on Linked Colour Imaging

Linked color imaging (LCI)，a new endoscopy modality, creates clear and bright images by using short wavelength narrow band laser light. LCI can make red area appear redder and white areas appear whiter. Thus, it may be possible to distinguish adenoma and non-adenoma polyps based on color evaluation of LCI images. This study aimed to assess the correlation between histology results and LCI images. Moreover, the investigators conducted a pilot study to explore the clinical potential of LCI to distinguish adenoma and non-adenoma polyps and the accuracy of an automatic computer-aided diagnosis system using LCI imagine to predict histology polyps when compared to human experts physicians.

This study consists of a retrospective analysis and a pilot study. In the retrospective study, the investigators tried to find out an correlation between LCI images and histology results for polyp lesions. And a computer-aided analysis of the images was conducted to demonstrate the correlation objectively. Thereafter,a pilot study was performed to explore whether the previous correlation could be easily learned to distinguish adenoma and non-adenoma polyps by comparing the results of experts diagnosis of LCI image and non-experts. Also, in the pilot study, the investigators assessed the accuracy of an automate histology diagnosis method for polyp LCI images using the computer-aided system when compared to human experts physicians. Throughout the entire research, histology results are regarded as gold standard.

Eligibility Criteria:
Inclusion Criteria:

- at least one polyp found during colonoscopy examination.

Exclusion Criteria:

- poor quality of bowel preparation which impedes histology evaluation; previous resection of colon; inflammatory bowel disease; familiar adenomatous polyposis; Peutz-Jeghers syndrome or other polyposis syndrome.
Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant 3 Months Post-activation

This study aims to collect data in newly implanted cochlear implant-recipients to inform future development of fitting methods to optimally and efficiently program a cochlear implant.

Firstly, it aims to collect data to investigate if the new fitting method gives a good fit of MAP for newly implanted CI-recipients in terms of performance outcomes, compared to the standard streamlined behavioural fitting after 3 months of use. Secondly, it aims to collect data to further refine the new fitting method beyond what is evaluated within this study.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older (no upper age limit).
2. Post-lingually deafened defined as severe or greater sensorineural hearing loss onset after the age of 2 years as reported by the subject
3. Unilaterally implanted with the CI600 Series (CI612, CI622, CI632) or CI500 series (CI512, CI522, CI532) cochlear implant.
4. Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
5. Willingness to participate in and comply with all requirements of the protocol.
6. Willing and able to provide written informed consent

Exclusion Criteria:

1. Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire.
2. Subject who will be programmed with an acoustic component in the implanted ear.
3. Pure tone average (average of unaided thresholds at 0.5, 1, 2 and 4 kHz) less than or equal to 30 dB HL and aided word score of more than 80% in the contralateral ear.
4. Diagnosis of auditory neuropathy.
5. Additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues.
6. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
7. Investigator site personnel directly affiliated with this study and/or their immediate families: immediate family is defined as a spouse, parent, child, or sibling.
8. Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
9. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation). -
Preoperative Pain, Function, and Activity for Total Hip and Knee Arthroplasty Patients

This study wish to show if the preoperative level of pain, function or activity for hip and knee arthroplasty patients has any predictive value of the time it takes to fulfill the well-defined discharge criteria.

The investigators would like to be able to identify those patients, for whom it will take longest time to fulfill the discharge criteria. With this knowledge the investigators will be able to initiate sufficient treatment already before operation.

Eligibility Criteria:
Inclusion Criteria:

* Total hip arthroplasty patients
* Total knee arthroplasty patients

Exclusion Criteria:

* Inability to speak and understand Danish
* Inability to perform the functional measurements due to other conditions
Impact of AI on Trainee ADR

Adenoma detection rate (ADR) is a validated quality metric for colonoscopy with higher ADR correlated with improved colorectal cancer outcomes. Artificial intelligence (AI) can automatically detect polyps on the video monitor which may allow endoscopists in training to improve their ADR. Objective and Purpose of the study: Measure the effect of AI in a prospective, randomized manner to determine its impact on ADR of Gastroenterology trainees.

Our objective is to determine the impact of AI on the adenoma detection rate of Gastroenterology trainees. The secondary aim of this quality improvement study is to determine the impact of AI based endoscopy on the rate of recording of quality improvement metrics versus historical performance in our program.

Fellows will undergo educational session prior to the start of study, describing commonly used metrics for assessing quality of colonoscopy and how to use the artificial intelligence software. Gastroenterology fellows will be consented for the study prior to initiation. The fellows will be randomized on a daily basis to perform colonoscopies in a room. Outcomes will measure the effects of AI in fellows

Eligibility Criteria:
Inclusion Criteria:

* All Gastroenterology fellows at USC performing Endoscopies will be included in the study.

Exclusion Criteria:

* If fellows refuse informed consent they will be excluded.
* Procedures performed in the intensive care unit or the operating room will not be counted toward the study metrics as the AI system will only be available in the endoscopy unit.
* If procedures are performed only by faculty, in which the fellow is not the primary operator, they will not be used for study metrics.
Pain in Neonates During Screening for Retinopathy of Prematurity Using Two Methods

Retinopathy of prematurity screening is painful. Wide field digital retinal imaging (WFDRI) and binocular indirect ophthalmoscopy (BIO) are being used for screening examinations. The aim of Edinburgh, UK based study is to compare the pain experienced by infants using both examination techniques.

Infants undergoing routine eye screening at Edinburgh Royal Infirmary Neonatal Intensive Care Unit are to be recruited. Infants will be excluded if they require mechanical ventilation or analgesic medication or if they have moderate/severe neurological impairment. The first screening examination for each baby was included. Infants' eyes will be examined by both WFDRI and BIO with eyelid speculum by 2 experienced pediatric ophthalmologists in random order. Observations will be video-recorded during examinations to generate a pain score (premature infant pain profile) for both WFDRI and BIO. The pain scores, heart rates, oxygen saturations and time taken for WFDRI and BIO will be compared using paired t tests.

Eligibility Criteria:
Inclusion Criteria:

* Infants born at less than 32 weeks gestation and/or birth weight of less than 1500g.

Exclusion Criteria:

* Infants requiring mechanical ventilation
* Infants requiring analgesic medication
* Infants with moderate/sever neurological impairment
KingVision Video Laryngoscopy vs Direct Laryngoscopy - Equivalence Trial

The purpose of this study is to determine whether the Ambu KingVision videolaryngoscope performs as well as direct laryngoscopy for intubating small children and infants.

The goal of this prospective randomized study is to compare the Ambu KingVision Video Laryngoscope and direct laryngoscopy using the Miller Blade Laryngoscope.

The primary outcome of the study will be time to successful intubation. Other outcomes of clinical relevance such as first attempt success rates of intubation, grade of laryngeal view, percentage of glottic opening, number of insertion attempts, hemodynamic responses, and complications will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients at Lurie Children's Hospital undergoing surgery/procedure where intubation is indicated
* American Society of Anesthesiology Class I-III patients

Exclusion Criteria:

* Children with an expected difficult airway
* A bleeding or blood clotting disorder
Effect of Acetazolamide and Methazolamide on Hypoxic Exercise Performance

A single-centered randomized doubled blinded placebo-controlled cross-over trial comparing two the effect of two carbonic anhydrase inhibitors on exercise performance in acute hypoxia. Participants will be young (under 40 years of age), healthy males and females who are regularly physically active.


Eligibility Criteria:
Inclusion Criteria:

* Consent provided
* Between ages of 18-40 years old
* In good general health as evidences by medical history
* Perform at least 150 mins of aerobic exercise per week, and engage in physical activity \>2 days a week
* Completed in an endurance event in the last 12 months
* Ability to take oral medication, and be willing to adhere to the drug regimen
* Be willing to have blood samples taken

Exclusion Criteria:

* Weigh 49kg or less, or are Obese (BMI \>30 kg/m2)
* Presence of chronic health condition (s), being investigated and/or taking prescription medications for the following disorders:

  1. Cardiovascular - e.g., hypertension
  2. Metabolic - e.g., type 1 or 2 diabetes
  3. Respiratory - e.g., chronic obstructive pulmonary disease, asthma
  4. Digestive - e.g., ulcerative colitis
  5. Arthritis
  6. Cancer
* Presence of any disorder or condition listed in the health screening questionnaire (see section 12.1)
* Current use of Lonafarnib, Methenamine, Topamax, or steroids/corticosteroids
* Known allergic reactions/hypersensitivity to carbonic anhydrase inhibitors or sulfonamides
* Presence of bleeding or clotting disorders
* Current smoker or cannabis user
* Pregnant, suspect to be pregnant, currently planning a pregnancy, or nursing
* Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk
The Effect of Osseodensification on Implant Stability in Posterior Maxilla

Implants will be placed in posterior maxilla using two drilling methods; the osseodensification technique and conventional drilling protocols. Implant stability will be measured after implant placement , 1,2,3,4,6 and 8 weeks and 3 months later. Insertion torque will be evaluated at the termination of implant placement and crestal bone loss will be measured post-implant insertion, after 3 months and after 6 and 12 months of loading. Post-operative pain and patients' satisfaction will be assessed as well. implant survival will be assessed at the end of the follow up period


Eligibility Criteria:
Inclusion Criteria:

* Age: \>18 years; medically free,
* Partially edentulous patients in maxillary posterior area (premolar-molar area)
* Sufficient ridge height
* Sufficient ridge width
* Adequate soft tissue biotype.
* Patients with adequate inter-arch space for placement of implant prosthetic part.
* Cooperative patients with good oral hygiene
* Patients who accept to sign an informed consent.

Exclusion Criteria:

* Active periodontal diseases
* Parafunctional habits.
* History of radiation therapy to the head and neck
* Bone augmentation to implant site
* Smoking
* Pregnant females
Veritas in Non-Bridging Ventral Hernia Repair

The main study objective is to determine the frequency of hernia recurrence following use of Veritas Collagen Matrix.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older
* Ability to understand and read English
* Must be scheduled for open abdominal surgery for repair of primary ventral hernia or first recurrence of a ventral hernia with the Veritas Collagen Matrix using the underlay technique, with our without component separation
* Must be of ambulatory status
* Primary closure can be obtained during surgery
* Repair is such that one piece of Veritas can be used to reinforce the repair

Exclusion Criteria:

* Hernia is undetectable on physical exam
* There is evidence of existing cancer
* BMI ≥ 40
* Use of chronic immunosuppressive therapy, including steroids or cytotoxic agents
* Any condition that product labeling indicates would adversely affect participant safety, including sensitivity to bovine products
ALIMTA (Pemetrexed) Alone or in Combination With Cisplatin for Patients With Malignant Mesothelioma.

This study is to evaluate the effects (good and bad) of ALIMTA and Cisplatin or ALIMTA alone on you and your malignant pleural mesothelioma as well as make ALIMTA available to patients who qualify for treatment.


Eligibility Criteria:
Inclusion Criteria:

* Have a proven diagnosis of malignant mesothelioma in patients not candidates for curative surgery
* Prior chemotherapy for your disease is allowed
* Measurable lesion is not required
* Have a adequate performance status
* Sign an informed consent form

Exclusion Criteria:

* You are excluded from this trial if you have received any investigational agent within 4 week before enrolling in this study
* You are excluded from this trial if you have received radiation within the previous 2 weeks
* You are excluded from this trial if you are a candidates for curative surgery