louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03864705: Compliance of Diabetic Patients Treated With Metformin
Official title: Compliance of Diabetic Patients Treated With Metformin
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
First posted: 2019-03-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with type 2 diabetes mellitus on metformin therapy for at least 3 months.

Brief summary: Metformin is the 1st line treatment in all subjects with type 2 diabetes without a contraindication to its use. The compliance with the use of metformin is not optimal mainly owing to relatively frequent gastrointestinal side effects. However, hard data about the real compliance are currently not available.

In this trial we aim at assessing the compliance with metformin intake using a combination of serum metformin measurement and a specific questionnaire. We will further evaluate the impact of different pharmacological forms of metformin (standard vs. XR - extended release) on its compliance and try to identify common characteristics associated with reduced compliance.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus on metformin therapy for at least 3 months

Exclusion Criteria:

-

Primary outcomes:
measure: Plasma metformin levels
timeFrame: At the time of measurement
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine
Study officials:
affiliation: Institute for Clinical and Experimental Medicine
name: Martin Haluzik, Prof. DSc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06143605: Clinical Relevance of the Salvage Treatment for Colorectal Neuroendocrine Tumors
Official title: Clinical Relevance of the Salvage Treatment for Colorectal Neuroendocrine Tumors Based on the Pathological Evaluation Following Initial Endoscopic Resection: A Multi-center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Neoplasms
Neuroendocrine Tumors
Keywords: endoscopic resection
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 527
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with rectal neuroendocrine tumors following initial endoscopic resection

Brief summary: we evaluated all related clinical and pathologic data of rectal NET cases, including the resection margin status, NET grading, and lymphovascular invasion status. Finally, the present study was aimed at (1) determining the risk factors for LN and distant metastases in colorectal NETs (2) clarifying the clinical significance of the salvage treatment for colorectal neuroendocrine tumors following initial endoscopic resection with positive resection margin status and (3) compare different salvage treatment of this uncommon disease through conducting a large, multi-center cohort study.


Eligibility criteria: Inclusion Criteria:

* within the age range of 18 to 65 years, diagnosed with rectal neuroendocrine tumors. Furthermore, patients were required to have a palpable tumor as determined by digital rectal examination or accessible through proctoscopy, with the distal border situated within 12 cm from the anal verge.

Exclusion Criteria:

* (1) muscularis propria invasion or NET grading = 3, (2)regional LN or distant organs metastasis at the time of diagnosis, (3) incomplete follow-up information, (4) the patient had multiple primary tumors, (5) patients with surgical excision or inappropriate methods such as forceps removal, and (6) the patient had a history of malignant tumors.

Primary outcomes:
measure: DFS
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06325605: Efficacy and Safety of Bifidobacterium Combined With High-frequency Transcranial Magnetic Stimulation in the Treatment of Adolescent Depression
Official title: Medical Practitioner
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Depression
Lead sponsor: Tangshan Worker's Hospital
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A total of 100 patients with adolescent depression who were admitted to our hospital between March 2022 and October 2022 were selected. On the basis of double blinding, these patients were randomly divided into the observation group(n=50) and the control group(n=50) using a random number table. 5S management method was used in the whole process of treatment to improve the hospital environment, increase the work efficiency and reduce the occurrence of cross infection through the effective implementation of the five steps of sort(Seiri), set in order(Seiton), shine (Seiso), standardize(Seiketsu) and sustain(Shitsuke).


Eligibility criteria: Inclusion Criteria:

* aged 13-18 years old;
* met the diagnostic criteria for depression in the International Classification of Disease-10 (ICD-10);
* with a total score of the Hamilton Rating Scale for Depression (HAMD-24) ≥20 in the initial assessment;
* who were right-handed

Exclusion Criteria:

* with a definite diagnosis of other mental disorders in the past;
* with a past or current history of manic episodes;
* with a past or current history of severe physical diseases;
* who used antidepressants, mood stabilizers, steroids, anti-inflammatory drugs, antibiotics, and immunomodulators in the past 1 month;
* who used lactic acid bacteria products for ≥7 days in the past 1 month;
* with a history of alcohol or psychoactive substance abuse within the last 3 months;
* with contraindications for rTMS, including but not limited to intracranial metal foreign bodies, cardiac pacemakers, and ear hearing aids;
* complicated with organic brain diseases, epileptic diseases, and severe physical diseases

Primary outcomes:
measure: HAMD-24 scores
timeFrame: 4 times a week, for 8 consecutive weeks
measure: TNF-α
timeFrame: 7 consecutive days
measure: IL-1β
timeFrame: 7 consecutive days
measure: IL-6
timeFrame: 7 consecutive days
measure: DA
timeFrame: 7 consecutive days
measure: 5-HT
timeFrame: 7 consecutive days
measure: COR
timeFrame: 7 consecutive days
measure: Serum miR-16
timeFrame: 7 consecutive days
measure: Serum miR-195
timeFrame: 7 consecutive days
Secondary outcomes:
Other outcomes:
Locations:
city: Tangshan
country: China
facility: Tangshan Workers' Hospital
state: Hebei
Study officials:
References:
Clinical trial NCT03394105: Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer
Official title: Pilot Study to Evaluate the Effect of Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pleural Effusion, Malignant
Non-small Cell Carcinoma
Keywords: Pleurodesis
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 4
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this trial, the effect of intrapleural docetaxel administration using medical pleuroscopywill be evaluated in Lung Cancer patient with malignant effusion.

Detailed description: This study is designed to be pilot, single-center, open-label, single-arm, prospective, phase II trial of patient with NSCLC with pleurla effusion. Approximately 40 patients will be enrolled into the trial, and study will be performed to 31Dec2018 from IRB and Korea: MFDS approval date.

Docetaxel will be administed to interpleural space using medical pleuroscopy in malignant effusion with lung cancer. Response evaluation will be done until confiramtion of disease progression.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 20, and NSCLC patients with malignant pleural effusion and related symptoms
* ECOG ≤ 2
* Blood test ANC≥ 1500/mm3, Hb ≥ 8.0g/dl, platelet count ≥ 100000/mm3 Serum creatinine ≤ 1.8mg/dl, Total bilirubin within normal limits, Transaminases ≤ 1.5 x UNL, Alkaline phosphatase ≤ 2.5 X UNL BUN ≤ 25mg/dl, Creatinine clearance ≥ 50ml/min
* Negative serum or urine pregnancy test for women for childbearing age
* Patients who provide written informed consent for the study

Exclusion Criteria:

* Age \< 20
* Patients who were previously perfomed pleurodesis
* Patients who were previously treated with thoracic radiosurgery
* Patinet with bilateral pleural effusion
* Age ≥ 80yrs
* Patients with histories of hypersensitivity to Docetaxel
* Patients with cardiovascular, respiratory, hepatic, renal, gastrointestinal, neunological disease, asthma, MI, stroke, arrhythmia, uncontrolled hypertionsion, etc. that would effect absorption, distribution, and metabolism of IP or be risk factors during IP administrion.
* Patients who could not understand the study procedure

Primary outcomes:
measure: Overall respose rate(ORR)
timeFrame: through study completion (2.5 years)
measure: Complete resonse (CR) rate
timeFrame: through study completion (2.5 years)
Secondary outcomes:
measure: Time to progression(TTP)
timeFrame: through study completion (2.5 years)
measure: Overall survival(OS)
timeFrame: through study completion (2.5 years)
measure: Adverse Event
timeFrame: through study completion (2.5 years)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: CHANG-MIN CHOI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06919198: The Dreamy Jet Study
Official title: Procedural Sedation for Minor Procedures Using Jet-Injected Subcutaneous Ketamine
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Sedation
Blood Drawing Procedure
Immunization
IV Placement
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to see if a device known as a jet-injection system can help deliver a single dose of a sedating medication with less pain and stress than current methods.

Participants will receive a dose of the sedative in their arm or thigh before their procedure at the sedation clinic.

Detailed description: This study will evaluate whether jet-injected ketamine can provide adequate sedation to perform minimally invasive procedures in children with heightened procedural sensitivity in a pediatric sedation clinic environment. Minimally invasive procedures include, but are not limited to, blood draws, IV placement, and immunizations.

Eligibility criteria: Inclusion Criteria:

* Referred to UW Health American Family Children's Hospital Pediatric Sedation Clinic for minimally invasive procedures such as blood draw, IV placement, or immunization
* Age 2-15 years
* Weight \<40kg

Exclusion Criteria:

* Participants with elevated intracranial pressure
* Participants with uncontrolled hypertension
* Participants who are pregnant or possibly pregnant (i.e., people of child bearing potential unable to provide a negative pregnancy test)
* Participants who received a dose of medication within 2 hours of their appointment with the intention of sedation (i.e., benzodiazepines, opioids, alpha-2 agonists, 1st generation antihistamines)
* Participants who are receiving medications which might enhance the sympathomimetic effect of ketamine (i.e., theophylline, aminophylline, amphetamine, or pseudoephedrine)
* Participants who are receiving medications that might interfere with the expected pharmacokinetics of ketamine (i.e., ketoconazole, clarithromycin, rifampin, or carbamazepine)
* Participant's parent/legal guardian requires a translator for communication about the patient's medical care

Primary outcomes:
measure: Feasibility of procedural success
timeFrame: Up to 3 hours
Secondary outcomes:
measure: Rate of procedural success
timeFrame: Up to 3 hours
measure: Time it takes to achieve target PSSS score
timeFrame: Up to 20 minutes
measure: Rate of adverse events
timeFrame: Up to 3 hours
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Megan Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03142698: Evaluation of 4 MRI Methods (PDFF 3, 6 and 11 Gradient Echoes and Spectroscopy) Compared to the Reference Method (Liver Biopsy) in Quantification of Hepatic Steatosis
Official title: Evaluation of 4 MRI Methods (PDFF 3, 6 and 11 Gradient Echoes and Spectroscopy) Compared to the Reference Method (Liver Biopsy) in Quantification of Hepatic Steatosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatic Steatosis
MRI
Liver Biopsy
Quantification
Keywords: hepatic steatosis
MRImaging
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of 4 MRI methods (PDFF 3, 6 and 11 gradient echoes and Spectroscopy) compared to the reference method (liver biopsy) in quantification of hepatic steatosis

Detailed description: Hepatic steatosis is an increasingly frequent pathology, which can lead to severe complications (Cirrhosis, Hepatocellular Carcinoma).

The poor quantification of steatosis by ultrasound or scanning and the invasiveness of the reference method (liver biopsy) make MRI a measurement tool of choice.

Recent techniques such as proton density measurement with several echoes or spectroscopy are increasingly used for the measurement of steatosis.

At the time of the development of therapeutics to reduce fatty liver disease, the use of MRI seems an interesting alternative for longitudinal follow-up in these patients.

Our study aims to ensure the reliability of these different MRI techniques for accurate quantification of liver steatosis and to compare them.

* Measurement and influence of hepatic fibrosis
* Measurement and influence of intrahepatic iron
* Influence of intercurrent liver disease
* Comparison of the fat measurement of the different hepatic segments
* Reproducibility by measurement of inter-observer concordance

Eligibility criteria: Inclusion Criteria:

* patients undergoing hepatic biopsy (trans-parietal or trans-jugular) in the context of liver disease
* signature of written consent

Exclusion Criteria:

* Contra-indications to MRI
* Refusal of protocol
* underage patients and protected adults

Primary outcomes:
measure: Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.
timeFrame: at day 1
Secondary outcomes:
measure: Measurement of intrahepatic iron
timeFrame: at day 1
measure: Measurement of intrahepatic fibrosis
timeFrame: at day 1
measure: Measurement of fat in different hepatic segments
timeFrame: at day 1
measure: Concordance between observers
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Louis BOYER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04902898: Safety and Efficacy of the Sterile Single-use Circular Stapling Device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China)
Official title: Evaluation of the Safety and Efficacy of the Sterile Single-use Circular Stapling Device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China) in Adult Patients Suffering From Pathologic Foreskin (Phimosis, Stenosis, Redundant Prepuce): A Prospective Randomised Comparative Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Phimosis
Foreskin; Tightness
Redundant Prepuce
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 100
Sex: MALE
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the safety and efficacy of the sterile single-use circular stapling device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China) in comparison with circumcision in adults patients with pathological foreskin (phimosis, stenosis, redundant prepuce)


Eligibility criteria: Inclusion criteria :phimosis, stenosis of foreskin, redundant prepuce

Exclusion criteria : active inflammation of foreskin

Primary outcomes:
measure: Bleeding
timeFrame: Intraoperatively
measure: Postoperative hematoma
timeFrame: First postoperative day
measure: Postoperative hematoma
timeFrame: Seventh postoperative day
measure: Postoperative oedema
timeFrame: Twenty first postoperative day
measure: Duration of procedure
timeFrame: Intraoperative (Measurement begins at the time of the beginning of the sterilisation of the surgical field and ends at the time of the completion of the bandeage of the wound)
Secondary outcomes:
measure: Postoperative oedema
timeFrame: First postoperative day
measure: Postoperative oedema
timeFrame: Seventh postoperative day
measure: Aesthetic result
timeFrame: Nineteenth postoperative day
Other outcomes:
measure: Pain feeling
timeFrame: Intraoperatively
measure: Anaesthesia
timeFrame: Immediately preoperatively
measure: Used sutures
timeFrame: Intraoperatively
Locations:
city: Larissa
country: Greece
facility: Urology Department, University of Thessaly, University Hospital of Larissa
state: Larissa/Thessaly
Study officials:
affiliation: Urology Department, University of Thessaly, University Hospital of Larissa, Greece
name: Vasileios Tzortzis, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02075398: Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0
Official title: Evaluation of Respiration Rate Parameters During Motion in Healthy Volunteers Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Monitoring Arterial Oxygen Saturation
Keywords: Portable pulse oximeter
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2014-03-03
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the available Covidien Boulder Clinical Laboratory subject data base.

Brief summary: To validate the Respiration Rate Version 2.0 algorithm, housed in the Nellcor Bedside Respiratory Patient Monitoring System, for performance during motion conditions.


Eligibility criteria: Inclusion Criteria:

* Male or Female subjects 18 years or older (inclusive)
* Subject is able to participate for the duration of the study
* Subject is willing to sign an informed consent

Exclusion Criteria:

* Subject with abnormalities that may prevent proper application of the devices
* Physiologic abnormalities that prevent proper application of pulse oximetry sensor
* Severe contact allergies that cause a reaction to standard adhesive materials such as those fund in medical sensors and electrodes
* Subjects with significant arrhythmia, as determined by subject self-report during screening and I/E criteria assessment at study start. (Three events of irregularities in radial pulse with thirty seconds).

Primary outcomes:
measure: To determine the respiration rate performance in healthy adult volunteers during motion when compared to established technologies for measuring parameters related to respiration.
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Boulder Clinical Laboratory
state: Colorado
Study officials:
affiliation: Medtronic - MITG
name: Kelley Scott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05942898: When the Alarm Goes Off, You're Already Awake
Official title: When the Alarm Goes Off, You're Already Awake!
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Keywords: Behavioral Medicine
Anticipatory anxiety
Alarm
Work
Experiencing self
Remembering self
Lead sponsor: International Institute of Behavioral Medicines
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Workers (any kind)

Brief summary: This is a behavioral observational study aimed at evaluating the impact that anxiety exerts on working people at the moment of awakening in the morning. It consists of a short self-administered questionnaire which will be given to workers to complete. Relationships between workers' answers and anxiety will be evaluated.

Detailed description: This is a behavioral observational study aimed at evaluating the impact that anxiety exerts on working people at the moment of awakening in the morning. Literature found out that anticipatory anxiety plays a key role as for awakening quality (experiencing self). This evaluation could change at the end of the working day due to biased memory effects (remembering self).

In Literature there are not studies which investigate the relationships between time to awakening before the alarm sounds and anxiety.

The study consists of a short self-administered questionnaire which will be given to workers to complete. In more details, the survey is made of five questions collecting information on type of work, people who use an alarm, time of awakening before the alarm goes off, feelings on the moment of awakening, and feelings as for the working day spent. Further, participants will have to complete an anxiety self-administered questionnaire on anxiety, and namely the Zung Self-Rating Anxiety Scale.

Descriptive statistics will be presented by taking into account the characteristics of the sample being investigated. Statistical correlations between workers' answers and anxiety will be also evaluated.

This study's usefulness relies on detecting on advance mood disorders (like anxiety is) and maladaptive behaviors, in order to build persons' positive routines (i.e. well-being) and improve their productive quality at work.

Eligibility criteria: Inclusion Criteria:

* Being workers (any type)
* Adult age
* Ability to understand the Italian language

Exclusion Criteria:

* People who do not use the alarm clock to wake up in the morning
* Refuse to adhere to the study

Primary outcomes:
measure: Zung
timeFrame: At the specific time of the scale assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Calosso
country: Italy
facility: Barbara Rocca
Study officials:
References:
citation: Dunstan DA, Scott N. Norms for Zung's Self-rating Anxiety Scale. BMC Psychiatry. 2020 Feb 28;20(1):90. doi: 10.1186/s12888-019-2427-6.