louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05106530: Arrhythmogenic Risk Assessment in Coronary Artery Ectasia Patients
Official title: Arrhythmogenic Risk Assessment in Coronary Artery Ectasia Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Ectasia
Keywords: Coronary artery ectasia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include consecutive eligible patients recruited in Assiut University Heart Hospital

Brief summary: The investigators thought to explore arrhythmias outcome - hidden arrhythmias, ECG features: Tp-Te interval and Tp-Te/QTc ratio, fQRS among patients with coronary artery ectasia as compared to normal coronary artery patients.

Detailed description: All patients will be subjected to:

A. Full history taking:

- Including age, sex, history of DM, HTN, dyslipidemia and Body surface area.

B. Holter monitoring for 24 hours:

* Heart rate variability
* Hidden arrhythmias
* Hidden ischemia by monitoring ST segment changes

C. Twelve lead ECG:

* fQRS in baseline ECG
* QT dispersion.
* Tp-Te interval and Tp-Te/QTc ratio
* Tp-Te dispersion

Eligibility criteria: Inclusion Criteria:

* Subjects with suspected CAD who are referred for elective coronary angiography and/or interventions

Exclusion Criteria:

1. Patients with a history of cardiomyopathy and myocardial infarction (MI), left ventricular hypertrophy (LVH), pathological Q wave on ECG, typical left bundle block or right bundle block, incomplete right bundle block, or paced rhythm on ECG.
2. Patients with severe renal impairment
3. Post CABG patients
4. Patients of acute coronary syndrome

Primary outcomes:
measure: Precence of arrhythmias in 24 hours Holter monitoring
timeFrame: 1 year
Secondary outcomes:
measure: • Heart rate variability in Holter monitoring
timeFrame: 1 year
measure: • Silent ischemia as detected by Holter
timeFrame: 1 years
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine Assiut University
Study officials:
affiliation: Assiut University
name: Tarek Abd El Hameed, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01811030: Evaluation of the 755nm Alexandrite Laser for the Treatment of Scars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scars
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-14
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and efficacy of removing unwanted scars using a 755nm Alexandrite laser.


Eligibility criteria: Inclusion Criteria:

1. Is a healthy male or female between 18 and 85 years old.
2. Has unwanted scars (including atrophic, hypertrophic, hyper or hypo pigmented, erythematous )and wishes to undergo laser treatments to remove or improve them.
3. Is willing to consent to participate in the study.
4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits

Exclusion Criteria:

1. Is hypersensitive to light exposure.
2. Has active localized or systemic infection.
3. Is taking medication(s) for which sunlight is a contraindication.
4. Has a history of squamous cell carcinoma or melanoma.
5. Has a history of keloid scarring.
6. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
7. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
8. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
9. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
10. Has any other reason determined by the physician to be ineligible to participate in the study.

Primary outcomes:
measure: Photographic Evaluation of Scar Clearance
timeFrame: 1 Month Post Last Treatment
measure: Photographic Evaluation of Scar Clearance
timeFrame: 3 Months Post Last Treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Laser & Skin Surgery Center of New York
state: New York
Study officials:
affiliation: Cynosure, Inc.
name: Patricia Krantz
role: STUDY_DIRECTOR
References:
Clinical trial NCT02535130: Evaluation of Nebulization and Positive Expiratory Pressure Combination
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystic Fibrosis
Healthy Subjects
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-08-28
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficiency of nebulization and positive expiratory pressure combination


Eligibility criteria: Inclusion Criteria:

* Stable cystic fibrosis patients older than 16 y.o.
* Healthy subjects

Exclusion Criteria:

* Kidney failure
* No pregnancy

Primary outcomes:
measure: Urinary excretion of amikacin
timeFrame: 24 hours after the nebulization
Secondary outcomes:
measure: breathing pattern
timeFrame: participants will be recorded for the duration of the nebulization, an expected average of 15 minutes
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT03395925: Evaluation of the Thyroid Volume After Radiofrequency Ablation of Thyroid Nodules and Recurrent Thyroid
Official title: Evaluation of the Thyroid Volume After Radiofrequency Ablation of Thyroid Nodules and Recurrent Thyroid
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Thyroid Nodule
Keywords: Thyroid Nodule
Bipolar coagulation electrode
radiofrequency ablation
Lead sponsor: Olympus Surgical Technologies Europe
Sponsor class: INDUSTRY
First posted: 2018-01-10
Enrollment: 0
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: Thyroid nodules are among the common alterations of the thyroid. Depending on the detection method the prevalence is between 20% and 50%, whereas the incidence increases with improvement of ultrasonic technology. The CelonPro Surge bipolar coagulation electrode operated with the compatible power control unit and compatible tube pump is indicated for ablation and coagulation of soft tissue, including thermal inactivation and/or volume reduction of locally defined tissue areas, such as tumors and metastases.

The primary objective of the study is to assess the influence of radiofrequency ablation due to thyroid volume after 24 hours, 3 months, 6 months and 1 year.


Eligibility criteria: Inclusion Criteria:

* The patient must have given written (personally signed and dated) informed consent before completing any study-related procedures (i.e. any assessment or evaluation that would not have formed part of their normal medical care).
* The patient must be aged 18yrs or older.
* The patient must be able to understand, and be willing to comply with the requirements of the protocol
* The patient is not pregnant
* The patient has the diagnosis of benign thyroid nodules, struma diffusa, struma uninodosa, struma multinodosa, struma per magna, Thyroidea nodosa or Thyroidea multinodosa
* The patient rejected surgery The patient rejected sole radioiodine therapy

Exclusion Criteria:

* Malign nodules
* Pregnancy
* Pacemaker near the target issue (\<4cm)
* Nerve stimulating device
* High fever
* Prosthesis for the inner ear

Primary outcomes:
measure: The primary objective of the study is to demonstrate reduction of thyroid volume following radiofrequency ablation of thyroid tissue
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Johann-Wolfgang Goethe University
Study officials:
affiliation: Goethe University
name: Hüdayi Korkusuz, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00768625: Cardiovascular Risk Stratification in Patients With Obstructive Sleep Apnea
Official title: Cardiovascular Risk Stratification in Patients With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Obesity
Lead sponsor: Associacao Fundo de Incentivo a Psicofarmcologia
Sponsor class: OTHER
First posted: 2008-10-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1000 OSA patients and 1000 controls enrolled from Instituto do Sono database 500 subjects with body mass index less than 25

Brief summary: The purpose of this study is:

1. To determine the frequency of cardiovascular diseases in patients with OSA, obese, overweight, and lean (BMI\<25)
2. To analyze the CPAP treatment over the clinical evolution of OSA patients
3. To determine if OSA is a independent predictor of cardiovascular risk

Detailed description: Obstructive Sleep Apnea (OSA) is a condition with important cardiovascular repercussions. However, the association between OSA, cardiovascular diseases, and obesity has not been totally clarified. We hypothesized that the cardiovascular consequences of OSA are due to obesity.

Eligibility criteria: Inclusion Criteria:

* Men and women with OSA (apnea-hypopnea index higher than 5 events/hour)

Exclusion Criteria:

* Body mass index higher than 40

Primary outcomes:
measure: Cardiovascular events
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Sono/AFIP
Study officials:
affiliation: Associacao Fundo de Incentivo a Psicofarmcologia
name: Fatima D Cintra, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associacao Fundo de Incentivo a Psicofarmcologia
name: Dalva Poyares, PhD
role: STUDY_CHAIR
affiliation: Associacao Fundo de Incentivo a Psicofarmcologia
name: Sergio Tufik, PhD
role: STUDY_DIRECTOR
References:
citation: Feres MC, Fonseca FA, Cintra FD, Mello-Fujita L, de Souza AL, De Martino MC, Tufik S, Poyares D. An assessment of oxidized LDL in the lipid profiles of patients with obstructive sleep apnea and its association with both hypertension and dyslipidemia, and the impact of treatment with CPAP. Atherosclerosis. 2015 Aug;241(2):342-9. doi: 10.1016/j.atherosclerosis.2015.05.008. Epub 2015 May 23.
citation: Cintra FD, Tufik S, Paola Ad, Feres MC, Melo-Fujita L, Oliveira W, Rizzi C, Poyares D. Cardiovascular profile in patients with obstructive sleep apnea. Arq Bras Cardiol. 2011 Apr;96(4):293-9. doi: 10.1590/s0066-782x2011005000030. Epub 2011 Mar 18. English, Portuguese, Spanish.
citation: Rizzi CF, Cintra F, Risso T, Pulz C, Tufik S, de Paola A, Poyares D. Exercise capacity and obstructive sleep apnea in lean subjects. Chest. 2010 Jan;137(1):109-14. doi: 10.1378/chest.09-1201. Epub 2009 Oct 3.
Clinical trial NCT05702125: Chronic Pain After Cardiothoracic Surgery
Official title: Chronic Pain After Cardiothoracic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Thoracic
Chronic Pain Syndrome
Keywords: chronic pain
thoracotomy
sternotomy
cardiothoracic surgery
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 96
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: Patients undergo elective sternotomy and/or thoracotomy using general anesthesia in Cipto Mangunkusumo hospital during January 2023 until March 2024

Brief summary: This is a prospective cohort study to estimate prevalence of chronic pain after cardiothoracic surgery

Detailed description: This is a prospective cohort study of all patients undergo cardiothoracic elective surgery in Cipto Mangunkusumo Hospital using general anesthesia. Patients with emergency surgery, history of psychologic and neurologic disease which cannot reliably state their pain score, cannot communicate well, and disagree to follow the research will be exempted. The pain score will be recorded one week after surgery during walk-in consultation, followed by 3 months and 6 months after surgery via telecommunication.

Eligibility criteria: Inclusion Criteria:

* Patients undergo elective sternotomy and/or thoracotomy using general anesthesia
* Patients agree to follow the study

Exclusion Criteria:

* Patients undergo emergency sternotomy or thoracotomy
* Patients with pyschological and neurological disorder, that it is not reliable to determine the pain intensity
* Patients who cannot communicate
* Patients disagree to follow the study

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 1 week after surgery
measure: Visual Analog Scale
timeFrame: 3 months after surgery
measure: Visual Analog Scale
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Indonesia University
name: Ratna F Soenarto, Consultant
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06956625: Cleansing Efficacy of Cosmetic Product
Official title: Cleansing Efficacy of Cosmetic Products - Particular Matter Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Skin
Lead sponsor: Amazentis SA
Sponsor class: INDUSTRY
Collaborators: name: SGS proderm GmbH
First posted: 2025-05-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two test areas will be defined on both forearms. Area 1 will be located on the right forearm; Area 2 will be located on the left forearm. Treatments will be randomly and balanced assigned to the test areas.
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate the cleansing effect of one cosmetic product containing Mitopure against a particular matter model pollutant in comparison to an untreated control.


Eligibility criteria: Inclusion Criteria:

* Written informed consent to participate in the study
* Willingness to actively participate in the study and to come to the scheduled visits
* Female and/or male
* From 18 to 70 years of age
* Healthy skin in the test area
* Skin type on Fitzpatrick scale: I, II or III

Exclusion Criteria:

* Female subjects: Pregnancy or lactation
* Drug addicts, alcoholics
* AIDS, HIV-positive or infectious hepatitis
* Conditions which exclude a participation or might influence the test reaction/evaluation
* Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
* Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
* Active skin disease at the test area
* Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
* Any topical medication at the test area within the last 4 weeks prior to the start of the study and during the study
* Documented allergies to cosmetic products and/or ingredients

Primary outcomes:
measure: Luminosity (L)
timeFrame: Before pollutant application (t0), immediately after evaporation of the applied pollutant (t1), and 20 minutes after product rinse-off (t2)
Secondary outcomes:
Other outcomes:
Locations:
city: Schenefeld
country: Germany
facility: SGS proderm GmbH
Study officials:
affiliation: SGS proderm GmbH
name: Dr Katrin Unbereit
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05758025: A New Surgical Strategy to Protect the Inferior Parathyroid
Official title: Dissection of Thyroid and Central Lymph Nodes Based on "Layer of Thymus-blood Vessel-inferior Parathyroid Gland" Complex for Preserving the Inferior Parathyroids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Cancer
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 506
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: The incidence of temporary hypoparathyroidism after thyroid surgery is 14%-60%, and the incidence of permanent hypoparathyroidism is 4%-11%. The protection of parathyroids has always been the focus and difficulty of thyroid surgery. The anatomical position of the superior parathyroids is relatively fixed, and can be preserved in situ easily; while the anatomical position of inferior parathyroids varies greatly between patients. It is always difficult to look for, identify, and protect them. Concepts such as thyro-thymic ligament and "thymus-vascular-inferior parathyroid plane" were raised to help identify the inferior parathyroids. We found that this surgical strategy can protect inferior parathyroids in situ effectively in our retrospective studies. Thus, we are going to carry out a prospective study to compare the new method and the traditional method of thyroidectomy, to see if more inferior parathyroids can be protected in situ through the new surgical strategy.


Eligibility criteria: Inclusion Criteria:

* initial thyroid surgery; thyroidectomy with/without central lymph node dissection

Exclusion Criteria:

* coexisting parathyroid disease; need lateral neck dissection; history of radio-iodine ablation treatment

Primary outcomes:
measure: Primary outcome
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Secondary outcome
timeFrame: Postoperative day 1
Other outcomes:
measure: Other outcome
timeFrame: 3 weeks after surgery, then every 3 month during the first year after surgery until 12 months after surgery
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital Zhejiang University School of Medicine
name: Qunzi Zhao, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang JB, Wu K, Shi LH, Sun YY, Li FB, Xie L. In situ preservation of the inferior parathyroid gland during central neck dissection for papillary thyroid carcinoma. Br J Surg. 2017 Oct;104(11):1514-1522. doi: 10.1002/bjs.10581. Epub 2017 Aug 7.
Clinical trial NCT05271825: Broadband Amplification as Tinnitus Treatment
Official title: Broadband Amplification as Tinnitus Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus, Subjective
Lead sponsor: Technical University of Denmark
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: * The effect of broadband amplification was tested in a double-blinded crossover study
* Its effect was compared to an active placebo treatment
* An improvement in tinnitus distress was found after use of broadband amplification
* No effect was found on the tinnitus loudness

Detailed description: This study investigated the effect of broadband amplification (125 Hz to 10 kHz) as tinnitus treatment for participants with high-frequency hearing loss and compared these effects with an active placebo condition using band-limited amplification (125 Hz to 3-4 kHz). A double-blinded crossover study. 23 participants with a high-frequency (≥ 3 kHz) hearing loss and chronic tinnitus were included in the study and 17 completed the full treatment protocol. Two different hearing aid treatments were provided for 3 months each: broadband amplification that provided gain in the frequency range from 125 Hz to 10 kHz and band-limited amplification that only provided gain in the low frequency range (≤ 3-4 kHz). The effect of the two treatments on tinnitus distress was evaluated with the Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI) questionnaires. The effect of the treatment on tinnitus loudness was evaluated with a visual analog scale (VAS) for loudness and a psychoacoustic loudness measure. Furthermore, the tinnitus annoyance was evaluated with a VAS for annoyance. The tinnitus pitch was evaluated based on the tinnitus likeness spectrum.

Eligibility criteria: Inclusion Criteria:

* Chronic tinnitus
* hearing thresholds (\<=25 dB HL) up to 2000 Hz and hearing loss at frequencies above 2 kHz
* inexperienced hearing aid user

Exclusion Criteria:

* objective or pulsatile tinnitus
* Ménière's disease, otosclerosis, stapedectomy, stapedotomy or tympanoplasty

Primary outcomes:
measure: Tinnitus Handicap Inventory
timeFrame: 3 months
measure: Tinnitus Functional Index
timeFrame: 3 months
Secondary outcomes:
measure: Tinnitus loudness
timeFrame: 3 months
measure: Tinnitus spectrum
timeFrame: 3 months
measure: Visual Analog Scale - annoyance
timeFrame: 3 months
measure: Visual Analog Scale - loudness
timeFrame: 3 months
Other outcomes:
Locations:
city: Kongens Lyngby
country: Denmark
facility: Technical University of Denmark
Study officials:
affiliation: Technical University of Denmark
name: Mie Jørgensen
role: PRINCIPAL_INVESTIGATOR
References: