louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05162495: Breath Samples Collection Clinical Trial, for Development of the TERA BioStation T101, Intended for CoV-19 Exhalation Products Detection.
Official title: A Single Center, Two Arms, Non-interventional, Breath Samples Collection Clinical Trial, for Development of the TERA Bio Station T101, Intended for SARS-CoV-2 Exhalation Products Detection.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Lead sponsor: Tera Group
Sponsor class: INDUSTRY
First posted: 2021-12-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The participant's breath sample is taken by blowing preferably three times into a disposable TeraTube. Thereafter, the tube is sealed, sterilized, and scanned by the BioSafety Station for analysis of its bio-chemical spectral signature. This will take place once during the study.
Primary purpose: DIAGNOSTIC

Brief summary: The Sponsor has developed a rapid screening tool intended to determine if the subject tested has COVID-19.

Detailed description: According to recent scientific literature, the virus infection occurs mainly through the nasal cavity, and therefore, samples of nasal and pharyngeal fluids are expected to be high viral load samples.

The proposed clinical trial is to test the mentioned for potential dominant virus particles absorbance frequencies according to which, it will be possible to perform a statistical analysis of spectral data of infected subjects' samples compared to healthy ones and to examine whether a statistical significance between 'Infected' and 'Healthy' can be demonstrated in terms spectroscopic measurements.

Indication for Use: Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples.

The study is aimed to collect data in order to assess whether a patient's COVID -19 status can be identified by a unique spectrophotometric pattern.

Eligibility criteria: Inclusion Criteria:

General:

1. Male or female subject aged 18 years and above
2. Subject is able and willing to provide informed consent
3. Subject is able to complete the breath test.

   Arm A:
4. Requiring a diagnostic or screening RT-PCR test for COVID-19.

   Arm B:
5. Positive to COVID-19 in RT-PCR test performed up to 48 hours before screening.

Exclusion Criteria:

1. Male of female subject under the age of 18.
2. Subject is unable to provide and informed consent, for any reason.

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: The collection of an additional samples requiring COVID 19 diagnostic evaluation will take approximately 1 minute from initial collection of the sample
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04557995: Clinical Efficacy of Erythropheresis in High Altitude Polycythemia
Official title: The Clinical Study on the Efficacy and Safety of Erythropheresis in High Altitude Polycythemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Altitude Polycythemia
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical study is aimed to explore the efficacy and safety of erythropheresis in high altitude polycythemia.

Detailed description: The clinical study is aimed to explore the efficacy and safety of erythropheresis in high altitude polycythemia. People reside in highland diagnosed as high-altitude polycythemia were included and randomly divided into two groups. In one group, routine therapy including oxygen inspiration would be performed, while in another erythropheresis would be added. Symptom relief, blood oxygenation, and 6-minute walk test would be assessed and compared in the above two groups.

Eligibility criteria: Inclusion Criteria:

1. \>=18 years old;2.High altitude polycythemia; 3.Han nationality who have been in highland for over 12 months; 4. No other complications indicated by general examinations such as chest X-ray, electrocardiogram; 5. patients who are informed and informed consent form are acquired.

Exclusion Criteria:

1. Hypoxemia caused by other respiratory or cardiac diseases or polycythemia vera; 2. Acute or subacute mountain sickness ; 3. Acute or chronic infections and medication history ; 4. Psychiatric disorders or severe neurosis; 5. Malignant myeloproliferative disease; 6. Any contraindications to erythropheresis.

Primary outcomes:
measure: 6-Minute Walk Test
timeFrame: Within 24 hours after treatment is completed
measure: Arterial partial pressure of oxygen
timeFrame: Within 24 hours after treatment is completed
Secondary outcomes:
measure: Activated partial thromboplastin time
timeFrame: Within 24 hours after treatment is completed and during follow-up period
measure: Prothrombin time
timeFrame: Within 24 hours after treatment is completed and during follow-up period
measure: Oxygen saturation Oxygen saturation
timeFrame: Within 24 hours after treatment is completed and during follow-up period
Other outcomes:
Locations:
city: Shigatse
country: China
facility: NO.953 Hospital
state: Tibet
Study officials:
affiliation: Third Military Medical University
name: Ye Fan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04383795: Change of Gut Microbiome in the Treatment of Graves' Disease
Official title: A Prospective Study Analyzing the Change of Gut Microbiome With Antithyroid Drug Treatment of Graves' Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graves' Disease
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 29
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients first diagnosed with Graves' disease, aged more than 19 years and lesser than 70 years. Eligible for treatment of graves' disease with antithyroid drug. Consented for collection of stools in 6-month interval

Brief summary: Graves' disease is the main cause of hyperthyroidism. Graves' disease has a prevalence of 0.5% in the general population. As a non-surgical treatment, antithyroid drug (ATD) and radioactive iodine treatment have been proposed and ATD is the first-line treatment in Korea. However, ATD has a rare but fatal side effect of agranulocytosis. Furthermore only half of its users maintain long-term remission and frequent recurrence is a problem to this disease. Therefore it is essential to distinguish between patients who respond well to ATD and those who resist it. The aim of this study is to verify the changes in gut microbiome in Graves' disease patients before and after six-month treatment with ATD. Patients first diagnosed with Graves' disease will participate in the study. The study design is a prospective longitudinal trial. The patients are asked to have their gut microbiome analyzed before and after the treatment of Graves' disease with ATD. Primary endpoint is the changes of analyzed gut microbiome before and after ATD treatment. Secondary outcome is to find species that can be used as a biomarker to differentiate the patients refractory to ATD.


Eligibility criteria: Inclusion Criteria:

* More than 19 years and lesser than 70 years
* First diagnosed as Graves' disease and planned to have antithyroid drug

Exclusion Criteria:

* Pregnancy and lactating women
* Inflammatory bowel disease
* Active malignancy
* Autoimmune disease
* Immune-deficiency patients

Primary outcomes:
measure: Change of gut microbiome in the treatment of Graves' disease
timeFrame: 6 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary hospital
Study officials:
affiliation: the Catholic Univerisity of Korea
name: Dong-Jun Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02245295: The Role of Sedation Technique in EBUS-TBNA
Official title: Impact of Sedation Technique on the Diagnostic Accuracy of Endobronchial Ultrasound-guided Needle Aspiration (EBUS-TBNA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Bronchial endoscopy
ultrasound
EBUS
anesthesia
lung cancer
diagnosis including staging
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-09-19
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with enlarged or suspicious mediastinal and/or hilar lymph nodes, in whom EBUS-TBNA is indicated

Brief summary: There is a paucity of data concerning the impact of the sedation technique used for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) on diagnostic accuracy. The aim of this retrospective study is to compare diagnostic accuracy of EBUS-TBNA in deep and moderate sedation, and to investigate other possible determinants of diagnostic accuracy in three lymph node locations (mediastinal, subcarinal, and hilar).

The first consecutive patients at the University Hospital Zurich undergoing EBUS-TBNA for selective sampling in deep sedation are compared with the first consecutive patients in moderate sedation between 2006 and 2014. Diagnoses based on EBUS-TBNA were compared with those on surgical or radiological follow-up.

Detailed description: Between September, 2007 and January 31, 2014, all consecutive patients who undergo EBUS-TBNA at the University Hospital Zurich for selective assessment of enlarged (≥ 1 cm by CT or ultrasound) or suspected (enhanced fluorodeoxyglucose (FDG) activity in PET/CT) lymph nodes were enrolled. Demographic and clinical data, procedural reports and cytological findings were collected from medical records. Computed tomography (CT) or PET/CT scans were prospectively reviewed to gather the size and standardized uptake value (SUV) of FDG of each sampled lymph node. The cytological findings obtained with EBUS-TBNA were verified by histological examination, if a surgical biopsy (mediastinoscopy, thoracoscopy, or thoracotomy) was carried out following EBUS-TBNA, or alternatively by clinical and radiological follow-up data.

Eligibility criteria: Inclusion Criteria:

* EBUS-TBNA

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 1-6 months
Secondary outcomes:
measure: Lymph node morphology
timeFrame: 1-6 months
measure: EBUS technique
timeFrame: 1-6 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Division of Pulmonology
name: Daniel Franzen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Pulmonology
name: Malcolm Kohler, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT02641795: Robotic Assisted Cochlear Implantation Feasibility Study
Official title: Robotic Assisted Cochlear Implantation Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sensory Hearing Loss
Keywords: cochlear implantation
robotics
image guidance
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2015-12-29
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A first in man clinical trial to asses the the use of am image guided robotic system to safely and effectively create a minimally invasive access tunnel to the middle ear cavity to allow access to the round window for cochlear implant electrode insertion.

Detailed description: A first in man feasibility study of an image guided robotic system for performing a key-hole approach to the middle ear cavity.

Eligibility criteria: Inclusion Criteria:

* Geographically and physically able to attend scheduled evaluations and follow-up appointments
* Indicated for cochlear implantation
* Age 18 years or older
* Fluent in German or French
* Sufficient facial recess size ( \> 2.5 mm between the facial nerve and chorda tympani)

Exclusion Criteria:

* Pregnancy
* Anatomical malformation of the middle or inner ear or unusual facial nerve course
* Lack of compliance with any inclusion criteria

Primary outcomes:
measure: Drilling accuracy
timeFrame: Image data acquired during the procedure
Secondary outcomes:
measure: Number of successfully completed robotic procedures
timeFrame: The procedure (day 0)
measure: The number of successful cochlear implant electrode array insertions
timeFrame: The procedure (day 0)
measure: Registration accuracy
timeFrame: The procedure (day 0)
measure: Time of the robotic procedure and its subparts
timeFrame: The procedure (day 0)
measure: Adverse events
timeFrame: day 0-30
measure: Blood loss
timeFrame: The procedure (day 0)
measure: Postoperative pain
timeFrame: day 0-30
measure: Invasiveness of the intervention
timeFrame: The procedure (day 0)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital University Hospital Bern
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Marco Caversaccio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02094495: Pilot Study About Tamoxifen Therapy for Breast Cancer Patients
Official title: Pilot Study to Evaluate the Knowledge and Understanding on Tamoxifen Therapy for Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Tamoxifen
Breast cancer
Knowkedge
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2014-03-21
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: breast cancer patients who take tamoxifen at National Cancer Center

Brief summary: The aim of this study are to to evaluate the knowledge and understanding on tamoxifen theraphy for breast cancer patients and examine the decision conflict scale and satisfaction with decision scale while making decision to take tamoxifen.

Detailed description: The knowlege questionnaire about tamoxifen was developed by the medication guides that provide for patients taking tamoxifen and hormone therapy for breast cancer fact sheet from National Cancaer Institute. Several experts in the field of breast cancer and gynecologic cancer are going to review and indicate the questionnaire.

Eligibility criteria: Inclusion Criteria:

* The breast cancer patients who take tamoxifenExclusion Criteria:

Exclusion criteria

* The patients who do not agree to participate in this study
* The paitents who have trouble with understanding and reading Korean.

Primary outcomes:
measure: The knowledge questionnaire about tamoxifen
timeFrame: The study outcome measure will be assessed by face-to-face, one time.
Secondary outcomes:
measure: Decision Conflict Scale
timeFrame: The study outcome measure will be assessed by face-to-face , one time.
Other outcomes:
measure: 1. Satisfaction with Decision scale
timeFrame: The study outcome measure will be assessed by face-to-face , one time.
measure: Quality of life (EQ-5D, VAS)
timeFrame: The study outcome measure will be assessed by face-to-face, one time.
measure: Female Sexual Function Index - 6 items, Korean version
timeFrame: The study outcome measure will be assessed by face-to-face, one time.
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Center for Breast Cancer, National Cancer Center
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center, Korea
name: Eun Sook Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01111695: Evaluation of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs
Official title: Open Label Study (Phase 2) to Evaluate the Safety, Tolerance and Efficacy of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leg Ulcer
Keywords: wound healing
granulation tissue
Varicose Ulcer
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Haute école de santé - Genève
First posted: 2010-04-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this open study, the primary objective is to study the efficacy and clinical outcome of the chronic wounds treated with this preparation for 8 weeks on 30 adults. Evaluation will be based on standardised photographs and clinical data.

The secondary objectives are to evaluate the tolerance and side effects of the honey based preparation in the management of chronic wounds.


Eligibility criteria: Inclusion Criteria:

* Adult
* Chronic wounds due to arterial or venous insufficiency stages 1 to 3 and difficult to heal with the usual treatments and
* Written informed consent

Exclusion Criteria:

* Refuse to give written informed consent.
* Patient suffering from mental disorder that may interfere with the treatment.
* Known allergy or intolerance to any of the products used in the formulation.
* Having received systemic antibiotics within 7 days of starting treatment with honey based formulation.
* Arterial insufficiency stage IV of the lower limbs.

Primary outcomes:
measure: Granulation and /or epithelial tissue progression
timeFrame: 8 weeks
Secondary outcomes:
measure: Tolerance
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Home Care Service of the canton of Geneva
Study officials:
affiliation: University Hospital, Geneva
name: Denis Salomon, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04824495: Evaluation of Inflammatory Cytokines During COVID-19
Official title: Evaluation of Inflammatory Cytokines During COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed acute SARS-CoV2 infection

Brief summary: The aim of this study is to evaluate pro-inflammatory cytokines as well as microvesicles during the course of SARS-CoV2 infection in the context of clinical parameters.

Detailed description: In this prospective trial, 100 patients with an acute SARS-CoV2 infection are enrolled. After confirmation of COVID-19, blood samples are taken for evaluation of various inflammatory cyokines and microvesicles at day 1, 5, 9 and 13 during hospitalisation and are interpreted in the context of clinical parameters.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Confirmation of acute SARS-CoV2 infection
* Ability to provide informed consent

Primary outcomes:
measure: Cytokine level in context with clinical parameters
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Daniela Gompelmann
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04255095: Early Intervention of High Tension in the Pancreatic Duct on the Outcome of Severe Biliary Pancreatitis
Official title: Application of Negative Pressure Suction in Nasopancreatic Duct in Patients With Severe Biliary Pancreatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ERCP
Keywords: Pancreatic duct negative-pressure suction
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesized that naso-pancreatic duct suction could benefit for patients with severe biliary pancreatitis undergoing ERCP. So, the investigators designed this experiment to verify it.

Detailed description: This project intends to conduct treatment based on different interventions for enrolled subjects according to international and domestic standardized treatment procedures, including 1.ERCP stone extraction, duodenal papillary pressure measurement, bile duct pressure measurement, and nasal bile duct placement; 2.ERCP+ duodenal papillary pressure measurement, biliopancreatic duct pressure measurement + nasopancreatic duct + determine whether nasopancreatic duct negative pressure attraction.Compare the advantages of two different treatment methods.This paper attempts to explore new treatment methods that are more conducive to the rehabilitation of patients and provides an important preliminary research basis for the future clinical application of standardized treatment.

Patients from the people's hospital of Wuhan university were recruited and selected into groups. The incidence, recurrence rate, operation time and hospital stay of the two independent samples will be compared.

Eligibility criteria: Inclusion Criteria:

Ages 16 to 75. Apach-ii score of patients diagnosed with pancreatitis was greater than 8 points.

Liver function can be damaged. Elevated indicators of pancreatitis (hematuria amylase, lipase). Identify patients with biliary tract infection or obstruction.

Exclusion Criteria:

Older than 75 or younger than 16. The duration of admission was more than 72 hours. Gastrointestinal obstruction endoscopy cannot be operated. Patients with duodenoscopy contraindications.

Primary outcomes:
measure: Rehabilitation
timeFrame: 2 months
measure: complication rate
timeFrame: 1 months
Secondary outcomes:
measure: LOS(length of stay)
timeFrame: postoperative period（1 month ）
measure: death rate
timeFrame: postoperative period（1 month ）
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
References: