cyrilzakka/clinical-trials huggingface dataset:
A 3D Printed Assistive Technology Intervention

The purpose of this study is to understand the feasibility of using a 3D printer to create tailored assistive technology rehabilitation devices. Specifically, we are investigating if a tailored 3D printed pillbox is safe, acceptable, and effective compared to an off-the-shelf generic pillbox. In this study, approximately 20 people with chronic health conditions who use pillboxes will describe their satisfaction and medication adherence with their current pillbox using a series of surveys and interviews. Then they will partake in an interview about their pillbox, medications, and routines. Based on the interview, the research team will 3D print a new pillbox tailored to the participant's preferences, abilities, and medication regimen. Then the participant will use the pillbox for 2-8 weeks. At the end, the participant will answer the same questions describing their satisfaction and medication adherence with the new pillbox using a series of surveys and interviews. This research will reveal important knowledge about the potential of 3D printing in the clinic and effectiveness of customized assistive technology.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Adults (ages 18+ years)
* Use a pillbox at least weekly
* Prescribed 2+ medications
* Willing to try a new 3D printed pillbox

Exclusion Criteria:

* Have significant cognitive impairment evidenced by a score of 10+ on the short blessed test
* Unable to meet with the research team in person and by phone
Lateralization of the Inferior Alveolar Nerve After Repositioning of the Bone Window Versus Sticky Bone Augmentation

Rehabilitation of edentulous posterior mandibular regions with severe ridge atrophy using implants is subject to anatomical, surgical, and biological difficulties. In many cases, the bone is severely atrophied that sufficiently long fixtures cannot be placed without encroaching on the inferior alveolar nerve (IAN). IANL is defined as the lateralization of inferior alveolar neurovascular bundle posterior to the mental foramen, with preservation of the incisive nerve; exposure and traction are used to deflect the IAN laterally while the implants are placed.

This prospective randomized clinical trial will enroll 20 patients with posterior mandibular ridge atrophy. Ten of which will undergo computer guided nerve lateralization with subsequent implant placement and repositioning of the osteomotized bone window and ten patients will undergo computer guided nerve lateralization with subsequent implant placement and sticky bone grafting.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from unilateral posterior mandibular edentulism and having \< 8 mm of bone above the mandibular canal.
* The width of the ridge should be \> 4mm.
* The patient should be psychologically accepting the implant and the involved procedures.
* The patients should have adequate oral hygiene and adequate bone quality.

Exclusion Criteria:

* Any absolute contraindication for implant surgery such as uncontrolled diabetes mellitus, blood and/or bleeding disorders, serious osseous defects...etc.
* Any relevant systemic disease directly affecting bone metabolism and healing.
* Any habits that might reduce the blood flow and retard healing such as heavy smoking and alcoholism.
* A history of any grafting procedure at the designated area.
* Patient with thick cortical bone buccally and a thin neurovascular bundle.
Immunological Mechanisms of Oralair® in Patients With Seasonal Allergic Rhinitis

Allergic diseases represent a major health issue worldwide and epidemiological studies in Melbourne, Australia, have reported a high prevalence of rhinitis (hayfever) and atopy (genetic tendency to make allergy antibody) in Asian and Caucasian subjects. Mainstay treatment of allergic rhinitis is allergen avoidance and pharmacotherapy for symptom relief. Allergen immunotherapy offers the advantages of specific treatment with long lasting efficacy, and can modify the course of disease. However, use of this treatment is restricted by the high risk of adverse events especially in asthmatics. Other, better tolerated, routes of allergen administration than the current conventional subcutaneous route (SCIT) have been investigated including the sublingual route (SLIT) and recently sublingual tablets for pollen allergy immunotherapy became available. The tablets are safe and easy to use and contain pollen extracts from 5 of the most common allergy-causing European grasses but include ryegrass (Lolium perenne), the major seasonal pollen for allergy in Melbourne and south-eastern Australia. The immunological mechanisms of sublingual immunotherapy are not fully understood. The investigators propose conducting a longitudinal open label study to investigate the immunological changes that occur with the 5 grass pollen sublingual immunotherapy tablet (Oralair®) in a cohort of Chinese and non-Chinese background subjects. The investigators will investigate the induction of relevant T cell regulatory immune mechanisms and changes in serum allergen-specific immunoglobulin (Ig) E and IgG4. Immunoregulatory cytokine synthesis and T cell phenotype (Bio-plex and flow cytometry) will be examined. This project will provide important fundamental knowledge on which to inform decisions for the greater application of this treatment for subjects with moderate and severe allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of Chinese heritage or non-Chinese heritage
* Clinical diagnosis of moderate to severe seasonal allergic rhinitis
* Ryegrass-specific IgE : CAP-Pharmacia score \> 1

Exclusion Criteria:

* Ongoing immunotherapy or previous immunotherapy (within last 5 years)
* Continuous oral corticosteroids
* Moderate, severe or unstable asthma
* Standard contraindications for allergen immunotherapy
* Ongoing treatment with β-blockers
* Immunodeficiency diseases
* Malignancy
* Significant inflammatory condition or disease in the oral cavity
Feasibility Study of Cavity Radiofrequency Ablation in ex Vivo Mastectomy Breast Tissue

The purpose of this study is to build a device that will consistently ablate (destroy or remove) cavitary breast tissue after a formal breast cancer resection in order to mimic the tissue that is now irradiated after breast cancer lumpectomy. The device would be easier to handle, perform the ablation in less time and by so ablating this margin would avoid the need in many for reoperation to obtain negative margins and based on preliminary data avoid the need for radiation. This would be especially important in poor and rural patients and would lead to decreased costs of treatment in patients with favorable breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age greater than or equal to 18 years.
* Receiving bi-lateral mastectomy due to tumor in the breast, or by choice (prophylactic mastectomy). Only non-cancerous breast tissue will be included in the study.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Those determined by the study investigator to have mental, physical, or medical conditions that would indicate that they should not participate.
* Because there is no patient contact with the device no medical contraindications are foreseen.
MetAbolism vaRiability of VEnLafaxine

Regarding the direct costs and the social value of depression, the decision of an antidepressant treatment prescription must be optimized as much as possible. The development of a personalized medicine in psychiatry may reduce treatment failure, intolerance or resistance, and hence burden and costs of affective disorders.

There is hope that biomarkers will be found to guide treatment selection. It might be of decisive interest to be able to assess an individual's metabolism activity. We propose here to explore the relationship between the activity of drug-metabolizing enzymes (DME) and transporters- assessed by a phenotypic approach and the efficacy of antidepressants. We will focus on venlafaxine (V) that provides a reasonable second-step choice for patients with depression and is used extensively in psychiatric practice, and the metabolism of which involves several cytochromes (CYP) P450 enzymes and the transporter P-gp.

Thus, the primary objective of this study is to study the correlation between the concentration of V and its metabolite ODesmethylV (V+ODV) and drug metabolism variability assessed by a phenotypic approach, in patients with major depressive disorder and MADRS ≥ 20 despite 4 weeks of V at 150mg or less


Eligibility Criteria:
Inclusion Criteria:

* Patient (Hospitalized or outpatient) with major depressive disorder and MADRS ≥ 20 at visit of selection
* Patients non responders to V after 4 weeks of V at 150mg or less
* Decision of the psychiatrist to increase the dose of V at visit of selection
* Understanding of French language and able to give a written inform consent.
* Informed consent signed to participate to the study
* Individuals covered by social security regimen

Exclusion Criteria:

* Patients treated by more than one antidepressant
* Patients currently treated with one of the drug substrate of the cocktail
* Sensitivity or contra-indication to any of the substrate drugs used
* Current pregnancy, desire to get pregnant, or breastfeeding
* Bipolar disorder and schizophrenia
Development of a Personalized Growth Hormone Treatment Profile (PGTP) Report for Pediatric Endocrinology

The goal of this observational study is to learn how to make growth hormone treatment more personalized for children. The main questions it aims to answer are:

* How can information about treatment adherence and patient experiences help improve care?
* What insights can help doctors create treatment plans that are more tailored to each child?

The study will include 40 families of children who are using a connected injector device for their growth hormone treatment. These devices track how often the treatment is taken, and families will also share their experiences through surveys. The information will be used to develop a new tool, similar to tools used in diabetes care, to help doctors create better, personalized treatment plans for children with growth hormone needs.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients (up to 18 years old) diagnosed with growth hormone deficiency or disorders requiring growth hormone treatment.
* Patients are currently undergoing growth hormone therapy. Includes both naive patients (those newly starting weekly treatment) and those already on treatment.
* Families willing to use connected injector devices and participate in mobile-based psychometrics for the study duration.
* Families are able and willing to regularly provide patient-reported outcomes (PROs) and adherence data through the Adhera®️ Caring Digital Program.
* Participants willing to sign the informed consent form, confirming their understanding of the essential aspects of the study, including the potential risks, benefits and rights as participants.

Exclusion Criteria:

* Families/patients already enrolled in other study protocols, including the use of connected injector devices and participation in mobile-based psychometrics.
* Patients with other significant medical conditions that could interfere with growth hormone treatment or the study's data collection processes.
* Inability to understand or communicate in the language used for data collection and study participation, unless appropriate translation services are available and can be consistently utilized.
Radiographic Migration Analysis of the ATTUNE Cementless CR Fixed-Bearing Total Knee Replacement

This is a multi-centre, single cohort trial of patients undergoing cruciate-retaining total knee arthroplasty with the Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System.

All patients will undergo post-operative radiostereometric analysis (RSA) and computed tomography (CT) to quantify and characterize the in vivo migration pattern of the Attune AFFIXIUM Cementless Tibial Baseplate and the Attune POROCOAT Cementless Femoral Component up to 24 months. Patient health and functional outcomes will be recorded at pre- and post-operative intervals for all patients. Peri-operative adverse events and other clinical complications will be captured as encountered.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
* Patients aged 21 years or older
* Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
* Patients willing and able to comply with follow-up requirements and self-evaluations
* Ability to give informed consent

Exclusion Criteria:

* Active or prior infection of ipsilateral extremity
* Medical condition precluding major surgery
* Inflammatory arthropathy
* Posterior cruciate ligament (PCL) deficiency
* Major coronal plane deformity
* Conditions that are cautioned against or contraindicated, as listed in the product monograph and/or instruction for use
* Bone defects requiring augments, cones and/or stemmed implants
Clinical Trial of Transtek Body Fat Analyzer (GBF-835-N2 & Other 7 Models)

The clinical protocol of the clinical testing of this device:

1. Objective of the test: To verify the functions and efficiency of devices.
2. Test methods and procedures: Comparison Test.
3. Device Under Test (DUT): Transtek Body Fat Analyzer, Model: GBF-835-N2, GBF-835-N2 Plus, LS202-B1, LS202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1 Plus.
4. Comparison device: TRANSTEK GBF-1251-B and Tanita BC-533.
5. Study endpoints: DUT and the comparison device are substantial equivalence.
6. Statistical methodology used: Description of statistical methods.

1. Test Purpose:

   The aim of clinical test is to collect BMI, body fat, total body water, muscle mass, bone mass, calorie, and visceral fat reading value which measured by DUT and reference device.
2. Target Subject:

   The subject database shall contain at least 30 male and 30 female subjects and all above 10 years old.
3. Test procedures:

   1. Record the name, age, gender, and height of each subject.
   2. Let subject seated calmly for two minutes before test, dry the feet.
   3. Use device to measure weight, body fat, total body water, bone mass, and muscle mass; record reading value.
   4. For each subject, repeat 3) to get 3 pairs measurements.
   5. Repeat step 1) to 4) for every device (DUT: GBF-835-N2, GBF-835-N2 Plus, LS202-B1, LS202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1 Plus; and reference device: GBF-1251-B and BC-533).
   6. Repeat step 1) to 5) for each subject.
4. Note:

   1. No motion and speaking are allowed during the measurement.
   2. All DUT use the same algorithms and contact the patient at the same body locations (feet), and operate on the same frequency.
   3. Test environment: Temperature: 22±1℃; Relative humidity: 40\~70%.

Eligibility Criteria:
Inclusion Criteria:

* Male, female

Exclusion Criteria:

* Below 10 years old
Electrical Impedance Tomography in Guiding Early and Precise Rehabilitation of Patients with Difficult Ventilator Weaning

Diaphragm dysfunction, ineffective chest wall and respiratory muscle function are frequently observed in critically ill patients with difficult weaning from mechanical ventilation(MV).It is the leading cause of retention of airway secretions and insufficient airway clearance.Thechest physiotherapy (CPT) of critically ill patients can reduce secretion retention. We designed a protocol to investigate the feasibility and efficacy of CPT guided by electrical impedance tomography (EIT) in Difficult-to-Wean patients.


Eligibility Criteria:
Inclusion Criteria:

* mechanical ventilation patients who are ≥18 years old, are received to invasive mechanical ventilation more than 96 hours before randomization, are meted the preconditions for the machine to be withdrawn, and at least have one failed attempt to withdraw the ventilator (re-need ventilator support within 48 hours after extubation),
* willing to participate in the study and sign the informed consentsent.

Exclusion Criteria:

* Malignant arrhythmia or acute myocardial ischemia
* Pneumothorax, pulmonary bulla and barotrauma and other lung diseases
* Hemorrhagic disease or abnormal coagulation mechanism with bleeding tendency
* Chest skin trauma
* Pulmonary hypertension and pulmonary embolism
* With a permanent or temporary pacemaker
* There is malignant tumor
* Present and previous history of neuromuscular diseases affecting respiratory muscle
* Participated in another clinical study related to mechanical ventilation withdrawal
* Can not cooperate with the study for any reason or the researcher thinks that it is not suitable to be included in this experiment.
Evaluation of the Efficacy of Preoperative Ketamine Nebulization on Postoperative Sore Throat Due to Tracheal Intubation for Adult Patients Under General Anesthesia, A Prospective Randomized Controlled Study

Sore throat includes specific symptoms such as dysphagia, dysphonia, hoarseness, continuous throat pain, and pharyngeal dryness. Patients rated postoperative sore throat (POST) as the eighth most undesirable outcome in the postoperative period POST has a reported incidence of up to 62% following general anesthesia (GA). The incidence of POST is more common in GA with tracheal intubation than in GA with the supraglottic airway Ketamine is an N-methyl-D-aspartate (NMDA) receptor antagonist and has been used as a gargle for reducing the incidence and severity of POST due to its anti-nociceptive and anti-inflammatory effects


Eligibility Criteria:
Inclusion Criteria:

1. Age 16-60 years.
2. Of both sex.
3. American Society of Anesthesiologists Physical Status (ASA PS) I-II.
4. Undergoing general anesthesia with endotracheal intubation with surgery duration less than two hours.

Exclusion Criteria:

* a- History of chronic obstructive History of sore throat or upper respiratory tract infection.

  b- Intraoral and intrapharyngeal surgery. c- airway disease or Asthma. d- Mallampati grade more than II. e- Known allergic to study drug. f- More than one attempt is required for intubation. g- Hypertensive patients. h- Epileptic patients. i- cerebral palsy or any neurological disorders. j- Psychiatry patients. k- Cardiac patients. l- Perioperative use of anti-inflammatory drugs (Non-steroidal anti-inflammatory drug or steroids).
Functional ImaGing of Heterogeneity in Head and Neck Tumors - Validation From Surgical Specimens

The purpose of this study is to investigate if heterogeneity in head and neck squamous cell carcinoma as seen in functional imaging with PET/MR can be correlated to biologic heterogeneity in surgical specimens.

The following is a presentation of a prospective protocol, named FIGHHT, including patients with squamous cell carcinoma of the head and neck (HNSCC) who are referred for surgery.

This is a prospective imaging/biomarker expression study where patients referred for surgery for HNSCC will be included. The purpose of the study is to investigate if heterogeneity in HNSCC as seen in functional imaging with PET/MR can be correlated to biologic heterogeneity in surgical specimens.

Multiparametric imaging(MPI) is performed before surgery using a PET/MR system (Siemens Biograph mMR) with a 3 T magnet using a head and neck coil. The scan protocol includes diffusion weighted MRI, dynamic contrast enhanced perfusion MRI and FDG-PET (4 MBq/kg). Morphometric imaging is performed with a 3D T2 weighted sequence (SPACE, voxel size 1.0 mm isotropic in vivo and 0.5 mm isotropic for specimens).

The scans are evaluated by a radiologist and a specialist in nuclear medicine and regions of interest and reference areas (anatomical landmarks) are marked. The tumor and if indicated lymp nodes are removed en bloc and per-operatively the reference areas and other anatomical landmarks are marked in the specimen with intravenous tubes. The specimen is fixed to a corkboard and scanned morphometric (as described) using a knee coil before and after formalin fixation within 1 hour after surgery. The whole surgical specimen is sectioned for histological processing.

Tissue blocks will undergo microscopic pathological evaluation and IHC staining. The specific selection of cancer related IHC biomarkers is based on their relationship with tumor cell metabolism, radiotherapy resistance (proliferation and hypoxia), association with FDG accumulation and institutional experience from a previous study.

The quantified measurements from the FDG PET, DWI and DCE scan will be correlated to the expression of IHC biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age above 18
* Primary or recurrent squamous cell carcinoma in the head and neck area
* Referred to surgery
* Primary tumor \> 1.5 cm and or neck metastasis of more than 1 cm.

Exclusion Criteria:

* Patient refusal
* Contraindications for FDG-PET/MR scan

  * Pacemaker
  * Severe claustrophobia
  * Magnetic metal in the body that is not MR compatible
Heart Rate and Respiratory Rate Measurements by a Novel, Radar-based Device

A single center, single blinded, prospective validation (including extension0 study for the accuracy and safety evaluation of Neteera 130H, a novel, radar-based contact-free device for heart and respiratory rate measurements.

This is a single-blinded, prospective validation study for the accuracy and safety evaluation of Neteera 130H, a novel, radar-based contact-free device for heart and respiratory rate measurements compared to reference devices.

Each subject will have a single study visit in which the subjects will be screened and upon eligibility confirmation, will undergo HR and RR measurements using the investigational device as well as the reference devices. In a previous clinical trial (NET-MED-002) 100 subjects were measured in the sitting position. In the extension study part (NET-MED-002-EXT), 70 eligible subjects, 18 years old and above, suffering from chronic medical conditions, will be enrolled. In this extension part, 70 of the subjects will be measured while randomly assigned into one of two groups - 35 subjects in group A (sitting position) and 35 subjects in sleep posture//group B (lying in bed/sleeping posture position) in a ratio of 1:1. Data from the previous study and the Extension study will be pooled for final analysis.

Eligibility Criteria:
Inclusion Criteria (NET-MED-002):

* Age ≥ 18 years

Inclusion Criteria (NET-MED-002-EXT):

* Age ≥ 18 years
* One (or more) chronic medical condition/s

Exclusion Criteria (NET-MED-002):

* Children under the age of 18 years
* Pregnant or lactating women - as confirmed by a home pregnancy test kit
* Current irregular heart rate (e.g. Atrial fibrillation) - as assessed by a targeted physical examination during screening
* Current shortness of breath, respiratory distress, or other clinical signs of hemodynamic instability - as assessed by a targeted physical examination during screening
* Prior major surgical and/or orthopedical and/or trauma in the thorax
* Participation in an investigational trial within 30 days of the screening visit
* Subjects that will not be able to complete the trial, according to the PI or SI evaluation

Exclusion Criteria (NET-MED-002-EXT)

* Children under the age of 18 years
* Prior major trauma in the thorax
* Participation in an investigational trial within 30 days of the screening visit
* Subjects that will not be able to complete the trial, according to the PI or SI evaluation