cyrilzakka/clinical-trials huggingface dataset:
DD Assessment With Diaana #2

Single-center, unblinded, 1:1 parallel pseudo-randomized efficacy trial.

In the intervention group only, resident physicians will be assisted by the automated medical history-taking device "Diaana" during their consultations in outpatient ambulatory unit of the Geneva University Hospital.

In both groups, the differential diagnosis of the resident physician will be compared to the gold-standard differential diagnosis of the senior physician.

Automated medical history-taking devices (AMHTD) are emerging tools with the potential to increase the quality of medical consultations by providing physicians with an exhaustive, high-quality, standardized anamnesis and differential diagnosis. In this study, the investigators aimed to establish whether an AMHTD of interest, "Diaana", allowed the physician to establish a more precise differential diagnosis.

A single-center, unblinded, 1:1 parallel pseudo-randomized efficacy trial will be performed. No follow-up is necessary, because patients are seen once and all data are collected on this time. The study will take place in the emergency outpatient unit of Geneva University Hospital and include patients suffering from symptoms covered by Diaana.

Patients in the intervention group will fullfil Dianna. Then, the resident physician will read Diaana summary, perform his consultation, and fullfil case report form, including his differential diagnosis. Then, the senior physician will see the patient and establish the gold-standard differential diagnosis. In the control group, the residents will directely establish a differential diagnosis, without the help of Diaana.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to the emergency outpatient unit of Geneva University Hospital
* Patients suffering from symptoms localized to the superior or inferior member, the back, hand the chest wall.

Exclusion Criteria:

* Strictly dermatologic concerns
* Toes and inversion ankle trauma (because the diagnosis of those conditions is generally obvious)
* Medical condition considered as urgent
* Inability to complete de digilatized Diaana form (sight problems, language, inability to use a tablet computer)
Effect of HIgh-flow Therapy in Long-term Oxygen Therapy

This is a registry-based, randomized, controlled clinical trial of the effect of added high-flow oxygen therapy (using the device Lumis HFT) during one year in people with long-term oxygen therapy (LTOT) for chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).

This is a registry-based, randomized, controlled clinical trial of patients with LTOT for COPD or ILD recruited using the Swedish National Registry for Respiratory Failure (Swedevox) in collaboration with a research network within the Swedish Respiratory Society. The trial evaluates the effect of added high-flow oxygen therapy nighttime to the regular low-flow oxygen therapy compared with regular low-flow oxygen therapy alone up to one year.

The purpose of this project is to improve evidence-based treatment of people with chronic respiratory failure, currently about 2000 patients annually in Sweden, who have high risk of adverse events and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 years or older
* Ongoing LTOT: prescribed for at least 15 hours per day; and since at least 28 days as registered in Swedevox
* COPD or ILD as main underlying reason for LTOT
* Oxygen concentrator as stationary oxygen source in the home including night-time
* Body mass index (BMI) \< 35 kg/m2

Exclusion Criteria:

* Current or previous treatment with home HFOT
* Current treatment with home mechanical ventilation
* Current treatment with home CPAP
* Hospitalized during the last 2 weeks
* Current smoking or contact with flames
* Self-reported average use of the LTOT \< 15h per day (24 hours)
* PaCO2 (breathing air at rest) \> 8 kPa
* Strong clinical suspicion of obstructive sleep apnea (OSA) or obesity-related hypoventilation syndrome (OHS) (as judged by the responsible staff)
* Inability to participate in the study procedures (as judged by the staff)
* Not eligible for continuing LTOT due to other reason (as judged by the staff)
* Expected survival less than 3 months (as judged by the staff)
Fluorescence Cystoscopy and Optimized MMC in Recurrent Bladder Cancer (FinnBladder 9)

Bladder cancer (BC), the second most common urological malignancy, is an important public health issue. One of the main challenges in the treatment of bladder cancer if the prevention of recurrences of non-invasive tumors, which is also associated with significant costs.

The current study will investigate optimal treatment of patients with bladder cancer with high risk of tumor recurrence but low risk of progression. The main interest is comparison of photodynamic (PDD) bladder tumor resection (TUR-BR)to traditional TUR-BT. Also the efficacy of adjuvant optimized mitomycin-C is compared to patients with no adjuvant treatment.


Eligibility Criteria:
Inclusion Criteria:

- Primary papillary bladder cancer at high risk for further recurrence as defined as follows:

Number of primary tumors ≥2, OR Size of solitary primary tumor ≥ 3 cm, OR Recurrent papillary tumors

* Histologically proven Ta bladder cancer
* Histological grade 1-2 (WHO 1973 grading system) or papillary urothelial neoplasm of low malignant potential (PUNLMP) or low grade (WHO 2004 grading system) bladder cancer
* Written informed consent is required from every eligible patient

Exclusion Criteria:

* Grade 3 tumors (WHO 1973 grading system), or high grade tumors (WHO 2004 grading system)
* CIS (carcinoma in situ)
* Suspicion or evidence of papillary tumors or CIS of the upper urinary tract
* Non-TCC (transitional cell carcinoma, i.e. urothelial carcinoma) bladder cancer
* Suspicion or previous history of the patient not tolerating intravesical instillations
* Known allergy to MMC or hexaminolevulinate (HAL, Hexvix®)
* Urethral stricture, stone disease, chronic urinary tract infection or any other urological condition that may compromise study participation (as judged by treating physician)
* Pregnancy or lactating patient
* Other non-cured malignancy (excepting skin basalioma or cancer in situ of the cervix uteri or any other malignancy in remission ≥5 years)
* Age \< 18 years
* Expected survival time less than one year
* Expected poor compliance (e.g. some severe psychiatric disorders, antisocial behaviour, or dementia)
Intercultural Adaptation and Validation of the "Orebro Musculoskeletal Pain Questionnaire"

The aim of this study is to adapt and translate the Orebro Musculoskeletal Pain Questionnaire into German.

Participants will fill out all questionnaires at baseline and again after three days. If the questionnaires have not been returned by day four the participant receives a reminder telephone call. Patients that do not return the questionnaires by day seven are dismissed. The baseline measurement is done at the practice the second measurement will be done by the patient at home. To send the questionnaire back the participant receives a prepaid envelope.

Eligibility Criteria:
Inclusion Criteria:

Acute:

* Recently diagnosed with neck pain (\< 30 days)
* Must be able to speak, read and write German

Chronic:

* Neck problems for a longer period of time (\> 90 days)
* Must be able to speak, read and write German

Healthy volunteers:

* No neck pain
* Must be able to speak, read and write German

Exclusion Criteria:

* Does not speak, read and write German
* "Red Flags" e.g. acute trauma
* Medical knowledge
Pharmacokinetics of Morphine and Oxycodone in Frail Elderly Undergoing Cardiac Surgery

* Single centre observational cohort study.
* 20 older patients undergoing cardiac surgery who receive standard of care pain treatment.
* Postoperative ICU: blood sampling to determine morphine and metabolite (M3G, M6G, noroxycodone and oxymorphone) pharmacokinetics
* After ICU discharge on general ward: blood sampling to determine morphine, oxycodone and metabolite (M3G, M6G, noroxycodone and oxymorphone) pharmacokinetics
* During study monitoring of pain scores, total opioid consumption, side effects (e.g. nausea, vomiting, pruritus), sedation and delirium scores.

Postoperative pain after cardiac surgery in elderly patients is common and leads to postoperative complications. Opioids play an important role in treatment of postoperative pain after cardiac surgery. In frail elderly after cardiac surgery however dosing schemes for opioids are still unknown, potentially leading to inadequate treatment of pain and/or safety issues.

* Single center observational cohort study
* The study population includes frail patients ≥70 years undergoing elective cardiac surgery.
* Primary endpoints of this study is the concentration of morphine, oxycodone and metabolites in blood over time on behalf of pharmacokinetic modelling.
* Secondary endpoints of this study are the pharmacodynamic parameters of morphine, oxycodone and metabolites (M3G, M6G, noroxycodone and oxymorphone) in blood in frail patients; such as pain scores, postoperative opioid consumption, vital signs, side effects of opioids and the influence of covariates such as frailty, serum creatinine, Glomerular Filtration Rate (GFR) on the pharmacokinetics and pharmacodynamics of morphine and oxycodone.

Eligibility Criteria:
Inclusion Criteria:

* ≥70 years undergoing elective cardiac surgery.

Exclusion Criteria:

* Patients undergoing transcatheter aortic valve replacement or mitral valve repair
* Contra-indication for morphine and/or oxycodone
HS2 US Liver Reader Study

The purpose of this study is to to assess the ability of 5 Gastro-Intestinal (GI) surgeons, within liver surgery, the readers, to identify pre-defined anatomical landmarks in liver images processed by HS2, and assessment of landmark distance between CT and Holographic visualization (HV).

This is a retrospective investigation of Computer Topographies (CTs)/ Holographic visualization based on CTs retrieved from patients with metastases in the liver from colorectal cancer.

The study consists of:

* Preparations at Day 0. The reader is not involved in the preparation
* Using of HS2 and evaluation at Day 1-2
* Calculation at Day 3.

The study will enroll eligible subject's images.

Eligibility Criteria:
Inclusion Criteria:

1. Livers with colorectal cancer liver metastasis
2. CTs from individuals 22 years or older
3. CTs retrieved from US hospitals
4. CTs from patients treated in the US
5. At least 1 visible liver lesion to complete detection of L1

Exclusion Criteria:

No exclusion criteria
A Study to Determine the Absorption, Metabolism, and Routes of Excretion of (14C) Radiolabeled Ibrutinib in Healthy Male Participants

The purpose of this study is to investigate the absorption, the metabolic pathways and the excretion of ibrutinib in healthy male adult participants after administration of a single oral dose of 50 mg to 140 mg (5 mg/mL solution) of unlabeled ibrutinib admixed with 14C ibrutinib.

This is an open-label (all people know the identity of the intervention), single-center, single-dose study in healthy male participants. Six men will be enrolled to allow a minimum of 4 participants to complete the study. All participants will receive a single oral solution dose of 50 to 140 mg ibrutinib containing 1480 kBq (40 µCi) of 14C labeled ibrutinib, constituting a total radiation burden of approximately 0.916 mSv (ICRP risk category IIa). The duration of the study is approximately 73 days including screening period of 28 days, treatment period of 15 days, and follow-up period of 30 days. Safety will include adverse events, laboratory safety, 12 lead electrocardiogram, physical examination, and vital signs.

Eligibility Criteria:
Inclusion Criteria:

* Participant must sign an informed consent document indicating they understand the purpose of and procedures required for the study, including DNA analysis, and are willing to participate in the study
* Must agree to use an adequate contraception method as deemed appropriate by the investigator (eg, vasectomy, double-barrier, partner using effective contraception) during the study and for 3 months after receiving the study drug
* Must agree to not donate sperm during the study and for 3 months after receiving the study drug
* Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
* Non-smoker (not smoked for 6 months prior to screening)

Exclusion Criteria:

* History of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease
* Clinically significant abnormal values for hematology, coagulation and platelet function, clinical chemistry or urinalysis at screening as deemed appropriate by the investigator
* Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ECG) at screening as deemed appropriate by the investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to β-lactam antibiotics or sulfonamides
* Known allergy to heparin or history of heparin induced thrombocytopenia
Use of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula

The objective of this pilot study is to evaluate the feasibility, safety and efficacy of 3M™ Cavilon™ Advanced Skin Protectant when used in the management of damaged skin exposed to caustic body fluids from an ostomy, drain site or fistula.

This is a pilot study evaluating the product, 3M™ Cavilon™ Advanced Skin Protectant, for the management of skin around an ostomy, drain and/or fistula. All subjects will receive the product for up to 14 days. The primary site must have red skin with breakdown (i.e. skin erosion and denudation or denudation of skin alone). Secondary sites can have red skin with or without breakdown. Product will be applied twice/week or more frequently if additional applications are needed due to leakage, skin irritation or standard of care. Skin assessments (including photography) will be completed at baseline and at all follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

1. Is the subject 18 years of age or older?
2. Does the subject have red skin with breakdown (i.e. skin erosion and denudation or denudation of skin alone) at the primary site of an ostomy, drain and/or fistula?
3. Is the subject willing to have photographs taken of their skin and permit use of photographs in potential publication?
4. Is the subject willing to release rights to 3M for the use of the photos?
5. Is there a reasonable expectation that the subject will be in the hospital or available for follow-up visits during the 14 day study period?
6. Has the subject signed an Institutional Review Board-approved informed consent/assent document and authorized the use and disclosure of protected health information?

Exclusion Criteria:

1. If female, is the subject pregnant or breast feeding or has she given birth within the 3 weeks preceding the screening visit?
2. Does the subject have a known allergy to acrylates or cyanoacrylates?
3. Does the subject have a preexisting skin disease on the areas affected that may make skin assessments for this study difficult?
4. Does the skin area affected require treatment with a concomitant medication or product?
5. Has the subject received antifungal powders in the area affected within 24 hours prior to enrollment?
6. Has the subject received cyanoacrylate based skin protectant (such as Marathon) within 72 hours prior to enrollment?
7. Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study?
8. Has the subject been enrolled in any investigational study where product was applied to proposed study sites within 30 days of the screening visit?
Information Extraction and Database Construction for Emergent Patients Based on Voice and Image Recognition Technology

Video and audio data of the triage process of emergency department (ED) patients will be collected to build a database. Clinical information retrieved from the database with voice and image technology will be used to determine the triage level of each patient and will be compared with the actual triage level.

Study Objectives:

1. To develop a platform to record video and audio data of the ED triage process.
2. To retrieve clinical information using voice and image technology.
3. To develop a tool to determine ED triage level using voice and image technology.
4. To build a clinical database using video and audio data using voice and image technology.

Study design: Single center observational study (tertiary hospital emergency department in Korea).

A platform to record video and audio data of the ED triage process will be developed. The camera and microphone will be installed at an optimal location to retrieve video and audio data in the ED triage area.

Voice and image technology will be used to retrieve clinical information including demographic information, chief complaint, type and onset of symptoms, past medical history, and physical examination results to build a database. Clinical information including examination notes, diagnosis, patient vital signs, test results, and ED results will be retrieved from the hospital database.

Eligibility Criteria:
Inclusion Criteria:

* Age 19 years or older
* Visited the emergency department of the study hospital

Exclusion Criteria:

* Patients who do not agree to enroll to this study
* Without a family
* Foreign patients
SAPLAI : Assessing the faiSAbility of a Peer-to-peer Contraceptive Education Program on Social Networks Aimed at 15- to 19-year-old High School Students in GuAdeloupe and La RéunIon

The goal of this clinical trial is to evaluate the feasibility of a contraception education program delivered by peers via social networks to high school students.

Our primary hypothesis is that the implementation of a peer-led contraceptive education program via social networks is a feasible approach in high schools on Reunion Island and Guadeloupe, as part of a before-and-after study.

Our secondary hypotheses concern the evaluation of adoption, exploratory efficacy (on knowledge, attitudes and practices), acceptability and fidelity of the peer-led education program via social networks among high school students in La Réunion and Guadeloupe.

Participants will :

* Participate in a focus group to explore their views and experiences regarding the value of a peer educator as a source of sexual and reproductive health information.
* answer questionnaires on their knowledge of sexual health
* A selected group (peer influencers): Create educational content (after a training period) on sexual health, and particularly contraception, to be broadcast on social networks.
* Take note of the program distributed on the networks by the peer influencers (for 3 months)
* Fill in questionnaires on their knowledge of sexual health, after the program.


Eligibility Criteria:
Inclusion Criteria:

* HIGH SCHOOL STUDENTS
* Young men and women aged between 15 and 19
* Living in La Réunion or Guadeloupe
* Enrolled in one of the selected vocational high schools and whose school principal agrees to take part in the program
* Who have agreed to take part in the study
* Who have received written consent from a parent or guardian.

PEER INFLUENCERS

* Young men and women aged between 15 and 19
* Living in La Réunion or Guadeloupe
* Enrolled in one of the selected vocational high schools and whose school principal agrees to participate in the program
* Selected in seconde class and admitted to première class
* Have been chosen as a peer
* Have a sense of self-efficacy in the use of computers
* Have good communication skills
* Possession of a video-capable smartphone
* Having agreed to take part in the study
* Written consent from a parent or guardian

Exclusion Criteria:

- Involved in other similar programs
Nutritional Supplements in Improving Quality of Life During First-Line Chemotherapy in Patients With Metastatic Gynecological Cancer

RATIONALE: Learning about the effect of nutritional supplements on quality of life in patients receiving chemotherapy for cancer may help doctors plan the best treatment.

PURPOSE: This randomized phase II trial is studying nutritional supplements to see how well they work in improving quality of life during first-line chemotherapy in patients with metastatic gynecologic cancer.

OBJECTIVES:

Primary

* Measure quality of life (QLQ-C30) at week 18 in patients with metastatic gynecological cancer receiving systematic nutritional supplements during first-line chemotherapy.

Secondary

* Study the maintenance or improvement of intake and nutritional status.
* Study the quality of life during chemotherapy.
* Evaluate tolerance and compliance to treatment with nutritional supplements.
* Evaluate the feasibility of and the tolerance to chemotherapy.
* Measure the overall survival over 18 weeks.
* Analyze the cost-effectiveness of different strategies of nutritional care.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients are monitored via standard follow-up assessments every 3 weeks.
* Arm II: Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks.
* Arm III: Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks with additional biweekly assessments completed at home by a service provider.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed gynecological cancer

  * Currently receiving first-line chemotherapy for metastatic disease

PATIENT CHARACTERISTICS:

* WHO performance status (PS) 0-2 or Karnofsky PS 70-100%
* Not pregnant or nursing
* Intake \< 75% of theoretical need
* Weight loss ≥ 5% within the past 6 months
* No patients with dementia or altered mental status
* No psychological, familial, social, or geographic situations that preclude clinical follow up

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent radiotherapy
A Study to Assess Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Knee Osteoarthritis

Knee-osteoarthritis (OA) is a common and disabling problem, that represents a global health issue since none of the current therapies are truly disease modifying. The use of mesenchymal stem cells (MSCs) in OA-preclinical models has been associated with a reduction in cartilage degradation, the attenuation of bone sclerosis and an effective anti-inflammatory response. Investigators have designed a randomized phase I/II placebo controlled trial of UC-MSCs in knee OA. Outcomes will be evaluated at 12 months, comparing monodosis versus double intra-articular injection, re-randomized at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic Knee OA, Kellgren and Lawrence grade I, II, III on plain Rx films.
* Chondromalacia patella grade I-III on knee MRI. With or without meniscal tear.
* Stable knee and normal clinical exam of involved extremity
* Written informed consent for patients.

Exclusion Criteria:

* Bilateral symptomatic knee OA
* Local or systemic infection.
* Active neoplasia or immunosuppressive state
* Pregnancy or Breastfeeding
* Body Mass Index ≥ 30
* Presence of Pacemaker or Lower extremity metal implant
* Anticoagulant treatment other than aspirin.
* Recent use of oral (previous month) or intra-articular (previous 3 months) corticosteroids
* Concomitant inflammatory joint disease (cristal, connective tissue disease)
* Valgus (\>10o) or Varus (\>5o) deformity of involved extremity
* Condilar or Tibial plateau Generalized Bone Marrow edema on MRI
* Significant symptomatic hip or spine disease
* Significant abnormality in baseline lab tests