louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02417831: Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fasted Male.
Official title: Single Center, Single Dose, Open-label, Randomized, Two-way Crossover Study to Determine Bioequivalence of Two Formulations Containing Tamsulosin HCl 04.mg MR Capsules in at Least 30 Healthy Male Subjects Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostatic Hyperplasia
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-04-16
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A bio-equivalence of 2 different capsule formulations in fasted subjects


Eligibility criteria: Inclusion criteria:

Healthy male volunteers 18 years and older

Exclusion criteria:

History of hypersensitivity or allergy to the IPM or its excipients or any related medication

Primary outcomes:
measure: Cmax
timeFrame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.
measure: AUC0-tz
timeFrame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.
measure: (AUC0-inf)
timeFrame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.
Secondary outcomes:
measure: Tmax
timeFrame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.
measure: λz
timeFrame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.
measure: t1/2
timeFrame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.
Other outcomes:
Locations:
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT06658431: Study on Music Intervention of Non-clinical College Students
Official title: Study on Music Intervention of Non-clinical College Students
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression Anxiety Disorder
Keywords: music therapy
Lead sponsor: Central University of Finance and Economics, China
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to understand whether a mindfulness-integrated volleyball team sports program can effectively intervene in the mental health of college students. The main questions it aims to answer is:

Does the music group effectively intervene in the participants' mental health levels, including indicators such as anxiety and depression?

Participants will:

Attend a music group once a week for 1.5 hours each session, for a total of 6 weeks.

Complete a psychological questionnaire every 3 weeks and a follow-up questionnaire every 2 weeks after the program concludes for twice.


Eligibility criteria: Inclusion Criteria:

* Participants aged 16 years or older.
* Able to communicate in Mandarin and voluntarily participate in the study.
* Agree to consistently participate in each session.

Exclusion Criteria:

* Disagree to consistently participate in each mindfulness-integrated volleyball course.
* Individuals unable to commit to participating in each mindfulness-integrated volleyball course.

Primary outcomes:
measure: depression
timeFrame: From enrollment to 4 weeks after the end of treatment.
measure: anxiety
timeFrame: From enrollment to 4 weeks after the end of treatment.
measure: perceived stress
timeFrame: From enrollment to 4 weeks after the end of treatment.
Secondary outcomes:
measure: sleep
timeFrame: From enrollment to 4 weeks after the end of treatment.
measure: positive and negative affective
timeFrame: From enrollment to 4 weeks after the end of treatment.
measure: life satisfaction
timeFrame: From enrollment to 4 weeks after the end of treatment.
measure: burnout
timeFrame: From enrollment to 4 weeks after the end of treatment.
measure: emotion regulation
timeFrame: From enrollment to 4 weeks after the end of treatment.
measure: loneliness and social anxiety
timeFrame: From enrollment to 4 weeks after the end of treatment.
measure: self acceptance
timeFrame: From enrollment to 4 weeks after the end of treatment.
measure: perceived support
timeFrame: From enrollment to 4 weeks after the end of treatment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Central University of Finance and Economics
state: Beijing
Study officials:
References:
Clinical trial NCT06852131: Carpal Tunnel Syndrome Treatment: Surgery Vs. Injections
Official title: Comparison of Surgical Treatment for Carpal Tunnel Syndrome with Corticosteroid Injection and Platelet-Rich Plasma Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome (CTS)
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective randomized controlled study included 68 patients (aged 18-70) with mild to moderate carpal tunnel syndrome (CTS), randomized into three groups: surgical treatment (25 patients, 25 wrists), corticosteroid (CS) treatment (20 patients, 32 wrists), and platelet-rich plasma (PRP) treatment (23 patients, 35 wrists). Diagnosis was confirmed through clinical evaluation and electrodiagnostic (EDX) testing, with assessments including the Visual Analog Scale (VAS), Boston Carpal Tunnel Questionnaire (BCTQ), ultrasonographic median nerve cross-sectional area (CSA) and flattening ratio (FR), and sensory/motor conduction parameters. Treatments were ultrasound-guided CS (1 mL triamcinolone, 40 mg/mL) or PRP (1 mL extracted from centrifuged venous blood) injections, while surgical treatment involved standard open carpal tunnel release using the WALANT (Wide Awake Local Anesthesia No Tourniquet) technique. Follow-ups were conducted at 1, 3, and 6 months, and the study was ethically approved with informed patient consent.


Eligibility criteria: Inclusion Criteria:

minimum of 3 months duration of symptoms and mild to moderate CTS

Exclusion Criteria:

* 1) Patients with severe CTS diagnosed with EMG or the presence of thenar atrophy, 2) Polyneuropathy, 3) Previous injection therapy for CTS, 4) Previous CTS surgery, 5) Pregnancy or lactation.

Primary outcomes:
measure: Electrophysiological studies
timeFrame: 1-3-6 months
measure: ultrasonography
timeFrame: 1-3-6 months
measure: Boston carpal tunnel Questionnaire
timeFrame: 1-3-6 months
measure: Visual Analog Scale
timeFrame: 1-3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
References:
Clinical trial NCT00879931: Influence of Corticoids on Renal Function in Cardiac Surgery
Official title: Influence of Corticoids on Renal Function in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Elective Cardiac Surgery
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2009-04-13
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Corticoid treatment in cardiac surgery works renal protective.

Study design: Randomized, double blind trial in which one group of patients will receive methylprednisolone and the other group (control) will receive placebo NaCl 0.9%.


Eligibility criteria: Inclusion Criteria:

* age between 20-80 year
* patients scheduled for elective cardiac surgery.
* preoperative creatinine levels of \< 2mg/dl
* no corticoid treatment

Exclusion Criteria:

* non-elective surgery
* patiënts with renal dysfunction: creatinine \> 2mg/dl
* patiënts treated with corticoids

Primary outcomes:
measure: Renal dysfunction and renal failure postoperatively in cardiac surgery
timeFrame: within 48 hours after cardiac surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Stefaan Bouchez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02183831: Comparison of Clinical Outcomes After Cataract Surgery With and Without Capsular Tension Ring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-07-08
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients who were planned to undergo the cataract surgery in Department of Ophthalmology, Yonsei University College of Medicine

Brief summary: This study was set up to identify clinical outcomes including a refractive shift or change in IOL calculation accuracy and optical quality after Ophtec® capsular tension ring in the eyes without zonular instability.


Eligibility criteria: Inclusion Criteria:

1. age between 40 and 79 years
2. no history of eye surgery or glaucoma
3. a transparent central cornea
4. pupil dilation at the preoperative examination of at least 6.0 mm
5. absence of biomicroscopic signs of pseudoexfoliation
6. normal fundus examination

Exclusion Criteria:

1. presence of ocular disease that might affect the visual outcome (e.g., color vision disturbance, chronic uveitis)
2. presence of ocular disease that might affect contrast sensitivity function (e.g., glaucoma, maculopathy, high myopia)

Primary outcomes:
measure: Best corrected visual acuity
timeFrame: 1 month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
measure: refractive error
timeFrame: 1 month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
measure: Anterior chamber depth
timeFrame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
measure: Ocular aberrations
timeFrame: 1month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
Secondary outcomes:
measure: constrast sensitivity
timeFrame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
measure: posterior capsular opacity grades
timeFrame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
measure: Best corrected visual acuity
timeFrame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
measure: refractive error
timeFrame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
measure: Ocular aberrations
timeFrame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04873531: Feasibility of Neostigmine for Intraoperative Neuromonitoring in Thyroid Surgery
Official title: Feasibility of Neostigmine as a Reversal Agent of Neuromuscular Blockade for Intraoperative Neuromonitoring During Thyroid Surgery: a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Diseases
Surgical Injury
Nerve Monitoring
Keywords: thyroid surgery
recurrent laryngeal nerve
neostigmine
intraoperative neuromonitoring
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2021-05-05
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomized controlled trial
Primary purpose: PREVENTION

Brief summary: For successful intraoperative neuromonitoring (IONM), adequate reversal of neuromuscular blocking agent is a prerequisite in thyroid surgery with .

The aim of this study is to investigate the feasibility of neostigmine just after tracheal intubation on the IONM in thyroid surgery.

Detailed description: For successful intraoperative neuromonitoring (IONM), adequate reversal of neuromuscular blocking agent is a prerequisite in thyroid surgery with .

The aim of this study is to investigate the feasibility of neostigmine just after tracheal intubation on the IONM in thyroid surgery.

This study will be performed as a randomized controlled trial with two groups (N group: neostigmine group and NS group: normal saline group).

For the N group, neostigmine (0.03 mcg / kg) and glycopyrrolate with a 5:1 ratio will be administered just after tracheal intubation.

For the NS group, normal saline with a same volume of the N group will be administered just after tracheal intubation.

For all patients of two groups, investigators evaluate the quality of signal of IONM during the surgery.

Eligibility criteria: Inclusion Criteria:

* open thyroid surgery with intraoperative neuromonitoring

Exclusion Criteria:

* refusal to participate in the study
* rocuronium should not be used (e.g. renal dysfunction patient)

Primary outcomes:
measure: Time to recovery of cricothyroid muscle twitching
timeFrame: perioperative
Secondary outcomes:
measure: amplitude of EMG for V1
timeFrame: During surgery
measure: amplitude of EMG for R1
timeFrame: During surgery
measure: amplitude of EMG for R2
timeFrame: During surgery
measure: amplitude of EMG for V2
timeFrame: During surgery
measure: number of patients with involuntary movements disrupting surgery
timeFrame: During surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Jung-Man Lee, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04240431: Level of Lacrimal Passage Obstruction
Official title: Symptomatic Acquired Lacrimal Passage Obstruction: Clinical Evaluation of the Level of Obstruction in Adult Patients of Upper Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lacrimal Apparatus Diseases
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were divided into four main groups according to site of narrowing or obstruction Punctal group, Canalicular group, NLD group and Mixed group who had 2 or more levels of narrowing or obstruction

Brief summary: Detect anatomical level of acquired lacrimal passage obstructions among patients with epiphora. They were evaluated and divided into four groups Punctal, Canalicular, Nasolacrimal duct and Mixed groups according to level of obstruction

Detailed description: In a 3 years period adult patients with obstructive epiphora were evaluated clinically by Probing /irrigation of lacrimal passages to detect anatomical level of obstruction.

The main site of obstruction was the common canaliculus where 2/3 of patients had canalicular problems. The second common site of obstruction is nasolacrimal duct followed by the puncti.

Eligibility criteria: Inclusion Criteria:

* Watering of the eye
* Acquired lacrimal obstructions
* Adult patients with

Exclusion Criteria:

* No previous lacrimal surgery
* Congenital lacrimal obstructions

Primary outcomes:
measure: Level of obstruction of lacrimal system
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medicine
state: Minia
Study officials:
affiliation: Minia University
name: Mohamed F Ibrahiem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03444831: Buspirone Plus Omeprazole for Functional Dyspepsia
Official title: Buspirone Plus Omeprazole for Functional Dyspepsia: A Randomised Placebo Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyspepsia
Keywords: Functional Dyspepsia
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a double-blinded Randomised clinical trial aim to compare buspirone plus omeprazole with placebo plus omeprazole.


Eligibility criteria: Inclusion Criteria:

* being over 18-year-old, Rome III criteria for FD
* normal upper endoscopy within five years
* negative Urease test for H-pylori
* acceptance informed concept form.

Exclusion Criteria:

* denied to get these medications
* taking other drugs for FD
* patients with the organic gastrointestinal disorder

Primary outcomes:
measure: 70 patients With functional dyspepsia symptoms, Change From Baseline by asking about symptoms at 4 Weeks after using buspirone or placebo
timeFrame: 4 weeks taking buspirone plus omeprasole or taking placebo plus omeprasloe
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03738631: Cardiac Biomarkers After Marathon Running and Coronary Atherosclerosis
Official title: Association of Cardiac Biomarker Elevation After Marathon Running and Coronary Atherosclerosis - the MaraCat Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 43
Sex: MALE
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male participants of the Paavo Nurmi Marathon 2018

Brief summary: This study evaluates cardiac biomarkers and their association to coronary artery disease in marathon runners.

Detailed description: The MaraCat study is an observational prospective study evaluating the association between cardiac biomarkers and coronary artery disease in 43 runners participating in the 2018 Paavo Nurmi Marathon. The study participants were recruited according to two age criteria - under 35 years and over 44 years of age. Comprehensive laboratory samples were collected immediately after the run, while the control workup was done in a separate visit with no significant physical excercise in the preceding two weeks. In the under 35 years -group, the control workup included an echocardiography, ecg and blood samples. In the over 44 years group, the control studies included coronary CT, echocardiography, ecg and laboratory tests.

Eligibility criteria: Inclusion Criteria:

* Age under 35 years or over 44 years
* Participant of Paavo Nurmi Marathon 2018
* Informed consent signed

Exclusion Criteria:

* No informed consent
* existing coronary artery disease

Primary outcomes:
measure: Cardiac Troponin-T level after marathon
timeFrame: 0-30minutes after finishing the Paavo Nurmi Marathon
measure: Association Cardiac troponin-T level and coronary CT findings
timeFrame: Cardiac Troponin-T 0-30 minutes after finishing the Paavo Nurmi Marathon. Control Troponin-T levels and coronary CT angiography at control visit (>30days after marathon).
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital, Heart Center
Study officials:
References:
Clinical trial NCT04343131: Different Dietary Interventions and Glycemia in T1DM
Official title: The Effect of Three Different Types of Diet on Glycemia Assessed by Continuous Glucose Monitoring in Patients With Type 1 Diabetes on Multiple Daily Insulin Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes Mellitus, Type 1
Glycemia
Continuous glucose monitoring
Diet
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to compare the effects of three different dietary patterns on glycemia in individuals with type 1 diabetes (T1D).

Detailed description: The aim of the present crossover study was to compare the effects of three different dietary patterns on glycemia in individuals with type 1 diabetes (T1D).

Three different isocaloric diets, namely, a Mediterranean style diet, a low-carbohydrate diet and a reference diet were provided to patients with T1D for three separate weeks, in a random order, and with 7-day washout periods in-between. Glycemia was assessed during each 7-day period using a continuous glucose monitoring system. Participants were recruited from the outpatient diabetes clinic of a University Hospital in Athens, Greece.

The primary outcome was time spent in euglycaemic range (TIR: 70-140mg/dl) during the diet period. Secondary outcomes were: (a) time spent below euglycaemic range (TBR: \<70mg/dl); (b) time spent above euglycaemic range (TAR: \>140mg/dl); (c) glycaemic variability and (d) insulin needs.

Eligibility criteria: Inclusion Criteria:

* Adults with T1D receiving MDI therapy
* Sufficient education and knowledge on carbohydrate counting
* Motivation to follow a specific dietary schedule
* Frequent (7 times a-day) self-monitoring of blood glucose (SMBG)
* Willingness to wear a CGM system

Exclusion Criteria:

* HbA1c \>8%
* Lack of severe diabetic complications, such as cardiovascular disease, proliferative retinopathy, nephropathy with estimated glomerular filtration rate (eGFR) ≤ 60 or gastroparesis

Primary outcomes:
measure: Percentage of time spent with glucose levels between 70-140 mg/dl
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical School, National and Kapodistrian University of Athens, Laiko Hospital
name: Alexandros Kokkinos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: