louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05250466: A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia
Official title: A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vulvar Lichen Sclerosus
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was designed as a prospective, multicenter, randomized, open-label, parallel-controlled clinical trial. The study population was patients with vulvar leukoplakia, and compared the efficacy and safety of AI temperature-controlled radio frequency technology and electrical stimulation in the treatment of vulvar leukoplakia. According to the research purpose, the sample size was calculated and determined to be 120 cases, and they were randomly assigned to the observation group and the control group according to the ratio of 1:1, namely 60 cases in the radio frequency observation group and 60 cases in the electric stimulation control group.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed by pathological examination, meeting the diagnostic criteria for leukoplakia;
2. 18 to 60 years old;
3. Agree to sign the informed consent;

Exclusion Criteria:

1. Patients with severe liver and kidney dysfunction;
2. Combined with HIV, syphilis infection, acute vaginitis, cervical cancer;
3. Patients with cardiovascular disease;
4. People with hematological diseases;
5. Patients with hypertension and diabetes;
6. People with mental illness;
7. Pregnant and lactating women.

Primary outcomes:
measure: Efficacy index
timeFrame: 6 month after treatment
Secondary outcomes:
measure: Recurrence rate
timeFrame: 6 month after treatment
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Wuhan University
name: Yuanzhen Zhang, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01616966: Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Sevoflurane and Propofol
Official title: Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Anesthesia With Sevoflurane and Intravenous Anesthesia With Propofol A Randomized, Prospective, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vocal Cord; Injury, Superficial
Keywords: hoarseness
sore throat
vocal cord injuries
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Vocal cord injuries occur not only during tracheal intubation, but also during surgery and during removal of tracheal tube. Volatile anesthetics increase neuromuscular block of muscle relaxants. Thus, the investigators tested the hypothesis, that sevoflurane would cause less vocal cord injuries than a total intravenous anesthesia with propofol.

Detailed description: Volatile anaesthetics increase neuromuscular block of neuromuscular blocking drugs. We tested the hypothesis, that sevoflurane would cause less vocal cord injuries than an intravenous anaesthesia with propofol. Sixty five patients were randomly assigned to the SEVO group (anaesthesia with sevoflurane) or TIVA group (anaesthesia with propofol). Vocal cord injuries were examined by stroboscopy before and 24 and 72 h after surgery; hoarseness was assessed up to 72 h.

Eligibility criteria: Inclusion Criteria:

* orotracheal intubation
* surgery of the ear
* written consent
* ASA I-III

Exclusion Criteria:

* preexisting pathologies of the vocal cords
* obesity
* difficult airway

Primary outcomes:
measure: incidence of vocal cord injuries
timeFrame: 24h after surgery
Secondary outcomes:
measure: incidence of hoarseness
timeFrame: 24h after surgery
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: University of Rostock
state: Mecklenburg/Vorpommern
Study officials:
References:
Clinical trial NCT00540566: Optical Biopsy of Human Skin in Conjunction With Laser Treatment
Official title: Optical Biopsy of Human Skin in Conjunction With Laser Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Melanoma
Merkel Cell Carcinoma
Basal Cell Carcinoma
Squamous Cell Carcinoma
Atypical Nevi
Congenital Nevi
Seborrheic Keratosis
Paget's Disease
Dermatofibroma
Kaposi's Sarcoma
Port Wine Stain
Hemangioma
Tattoos
Scleroderma
Burns
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2007-10-08
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic, community sample

Brief summary: This study is to compare the ability of optical biopsy. Research can use light enters the skin, collected, analyzed by the computer, and a picture created for the pathologist to conventional histologic examination compare with the pathologist looking at the piece of tissue through a microscope makes the diagnosis.

Detailed description: The Optical measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development. Each measurement requires less than 5 minutes to execute. The measurements will be taken before and after skin treatment.This non-invasive, non-contact technique has great potential as a means to diagnose different skin problems without the need to obtain a piece of tissue from the skin.

Eligibility criteria: Inclusion Criteria:

* Male or female age \> 18 years

Exclusion Criteria:

* current participation in any other investigational drug evaluation
* inability to understand and carry out instructions

Primary outcomes:
measure: normal skin
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute, Unversity of California Irvine
state: California
Study officials:
affiliation: Beckman Laser Institue, University of California Irvine
name: John S Nelson, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04202666: The Role of Convex Skin Barrier in Prevention of Peristomy Skin Complication-Randomized Controlled Trial
Official title: The Role of Convex Skin Barrier in Prevention of Peristomy Skin Complication-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stoma Colostomy
Stoma Ileostomy
Keywords: peristomy skin complication
convex skin barrier
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: ConvaTect, Taiwan
First posted: 2019-12-17
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The incidence of peristomy skin complication ranges from 15% to 65%. It is a serious issue and problem for patients care.The type of skin barrier is associated with peristomy skin complication. How to choose suitable skin barrier is important.


Eligibility criteria: Inclusion Criteria:

* Age\>20
* Receive colostomy or ileostomy
* Agree to join the trial and sign the informed consent form

Exclusion Criteria:

* Liver cirrhosis
* Renal insufficiency
* Severe malnutrition
* Unstable vital sign
* Not suitable after evaluation by Principal Investigator

Primary outcomes:
measure: peristomy skin complication rate
timeFrame: one month
Secondary outcomes:
measure: (2) life quality stomy care questionnaire
timeFrame: one month
measure: (3) stomy appliance satisfaction questionnaire
timeFrame: one month
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital,Kaohsiung
Study officials:
References:
citation: Colwell JC, Beitz J. Survey of wound, ostomy and continence (WOC) nurse clinicians on stomal and peristomal complications: a content validation study. J Wound Ostomy Continence Nurs. 2007 Jan-Feb;34(1):57-69. doi: 10.1097/00152192-200701000-00010.
citation: Bosio G, Pisani F, Lucibello L, Fonti A, Scrocca A, Morandell C, Anselmi L, Antonini M, Militello G, Mastronicola D, Gasperini S. A proposal for classifying peristomal skin disorders: results of a multicenter observational study. Ostomy Wound Manage. 2007 Sep;53(9):38-43.
citation: Beitz J, Gerlach M, Ginsburg P, Ho M, McCann E, Schafer V, Scott V, Stallings B, Turnbull G. Content validation of a standardized algorithm for ostomy care. Ostomy Wound Manage. 2010 Oct;56(10):22-38.
citation: Meisner S, Lehur PA, Moran B, Martins L, Jemec GB. Peristomal skin complications are common, expensive, and difficult to manage: a population based cost modeling study. PLoS One. 2012;7(5):e37813. doi: 10.1371/journal.pone.0037813. Epub 2012 May 24.
citation: Hoeflok J, Purnell P. Understanding the role of convex skin barriers in ostomy care. Nursing. 2017 Sep;47(9):51-56. doi: 10.1097/01.NURSE.0000516224.24273.88. No abstract available.
citation: Steinhagen E, Colwell J, Cannon LM. Intestinal Stomas-Postoperative Stoma Care and Peristomal Skin Complications. Clin Colon Rectal Surg. 2017 Jul;30(3):184-192. doi: 10.1055/s-0037-1598159. Epub 2017 May 22.
Clinical trial NCT01600066: Erectile Dysfunction in Severe Obstructive Sleep Apnea: Effects of CPAP Therapy
Official title: Erectile Dysfunction in Severe Obstructive Sleep Apnea : Effects of CPAP Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Erectile Dysfunction
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2012-05-16
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male patients with untreated severe sleep apnea (apnea-hypopnea-index \> 30/h)

Brief summary: Obstructive sleep apnea has been linked to erectile dysfunction. Furthermore, small studies suggest that treatment of sleep apnea by continuous positive airway pressure (CPAP) may reverse erectile dysfunction in affected patients. The present study aims to investigate in a larger cohort if severe sleep apnea is independently associated with erectile dysfunction and if 6-12 months of CPAP therapy lead to an improvement of erectile dysfunction.


Eligibility criteria: Inclusion Criteria:

* apnea-hypopnea-index \> 30/h
* no CPAP therapy
* male gender
* 18-80 years of age
* having or attempting to have regular sexual intercourse

Exclusion Criteria:

* apnea-hypopnea-index \< 30/h
* already treated by CPAP
* female gender
* age \< 18 or \> 80 years
* not having or not attempting to have regular sexual intercourse

Primary outcomes:
measure: Change of erectile function in severe sleep apnea after 6-12 months of CPAP therapy
timeFrame: at the time of diagnosis of sleep apnea and after 6-12 months of CPAP therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Giessen Lung Center, Germany
name: Richard Schulz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04771065: Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Intractable Epilepsy
Official title: Microendoscopic Transventricular Deep Brain Stimulation of the Anterior Nucleus of the Thalamus as a Safe and Efficient Treatment in Intractable Epilepsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Refractory Epilepsy
Keywords: epilepsy
deep brain stimulation
thalamus
endoscopy
stereotaxy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients extracted from our prospective database, who have been surgically treated between 2010 and 2019 for refractory epilepsy by deep brain stimulation (DBS) of the anterior thalamic nucleus using microendoscopy. All patients had a minimum follow up of 1 year. Refractory epilepsy was defined as failure of at least 3 anti-epileptic drugs (AEDs) to produce adequate seizure control

Brief summary: Deep Brain Stimulation (DBS) of the anterior nucleus of the thalamus (ANT) has been proposed in patients with severe intractable epilepsy. When used, the transventricular approach increases the risk of bleeding due the anatomy around the entry point in the thalamus. To avoid such a complication, the investigators used a transventricular microendoscopic technique.


Eligibility criteria: Inclusion criteria:

* adult patients
* treated between 2010 and 2019 for refractory epilepsy by DBS of the anterior nucleus os the thalamus using microendoscopy
* minimum follow-up of 1-year
* refractory epilepsy defined as failure of at least 3 antiepileptic drugs

Exclusion criteria:

- age \< 18 years

Primary outcomes:
measure: Absence of hemorraghic complication
timeFrame: 1 day
Secondary outcomes:
measure: responder rate
timeFrame: 1 year
measure: responder rate
timeFrame: 2 years
measure: responder rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Gaëtan Poulen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00126165: Short-course Hypofractionated Radiotherapy for Localized Prostate Cancer
Official title: A Phase I/II Study of Escalated-dose Short-course Hypofractionated Radiotherapy (55 Gy/16 Fractions/4 Weeks) for Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer
radiotherapy
hypofraction
radiosensitivity
image-guidance
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Calgary Health Region
First posted: 2005-08-03
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is aimed at providing further clinical evidence to support or refute the current understanding of biological sensitivity of prostate cancer to fractionated radiotherapy. Determining the morbidity and cancer control provided by a 4-week course of treatment will greatly influence future radiotherapy services for patients with localized prostate cancer.

Detailed description: This study is aimed at providing further clinical evidence to support or refute the current understanding of biological sensitivity of prostate cancer to fractionated radiotherapy. Determining the morbidity and cancer control provided by a 4-week course of treatment will greatly influence future radiotherapy services for patients with localized prostate cancer.

Eligibility criteria: Inclusion Criteria:

* Stage T1 and T2 prostate cancer
* Prostate specific antigen (PSA)\>=20 and Gleason score\<=6
* PSA\<=15 and Gleason score 7
* Signed informed consent

Exclusion Criteria:

* No hip prosthesis, pins or screws
* No previous pelvic radiotherapy
* No inflammatory bowel disease

Primary outcomes:
measure: rectal morbidity
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Jackson Wu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu JS, Brasher PM, El-Gayed A, Pervez N, Tai PT, Robinson J, Skarsgard D, Joseph K, Sia MA, Pearcey RG. Phase II study of hypofractionated image-guided radiotherapy for localized prostate cancer: outcomes of 55 Gy in 16 fractions at 3.4 Gy per fraction. Radiother Oncol. 2012 May;103(2):210-6. doi: 10.1016/j.radonc.2011.12.020. Epub 2012 Jan 24.
Clinical trial NCT01394965: Electrocardiographic Mapping and Imaging
Official title: Electrocardiographic Mapping and Imaging
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Cardiac Arrhythmia
Keywords: ECG
Mapping
ecg mapping
arrythmias
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: University of Minnesota
First posted: 2011-07-15
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: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate a novel non-invasive cardiac electric imaging methodology for localizing and imaging cardiac electrical activity from body surface electrocardiographic recordings in patients with ventricular tachycardia (VT). Using non-invasive means will increase our ability to correctly diagnose cardiac abnormalities, and aid ablation of cardiac arrhythmias, offering enhanced performance to what currently exists.

Detailed description: Specific Aims

1. Use non-invasive cardiac electric imaging to provide information as to the sites of origin of arrhythmias and sequence of cardiac activation and repolarization.

Methods and Procedures Approximately 8 patients with recorded Premature Ventricular Contractions (PVC), Wolff-Parkinson-White (WPW) or other ventricular tachycardia cases which need Ensite/Carto endocardial mapping and radiofrequency ablation treatment will be enrolled.

One day before catheterization and ablation, patients will undergo approximately 30 minutes of Body Surface Potential Mapping (BSPM) recordings with about 200 surface electrodes arranged in 20 strips, attached on his/her front and back. BSPMs will be recorded in the baseline resting rhythm.

On the day of ablation, before catheterization in the surgical room, the BSPM recording procedure will be carried out with the patient using the same technique used during the first BSPM study.

Clinical endocardial mapping data may also be obtained concurrently with BSPM recordings before the ablation procedure.

Another BSPM recording will be made 30-60 minutes after successful ablation with the patient still in normal sinus rhythm if possible. Patients will be followed up 1 month after ablation with the same method of BSPM recorded at the baseline resting rhythm.

Eligibility criteria: Any patient undergoing ablation.

Primary outcomes:
measure: Results of ECG Mapping
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Samuel Asirvatham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04316065: Bioequivalence Study Between YHP1906 Tab. 5 mg and YHR1902 Tab. 5 mg
Official title: A Randomized, Open-label, Single-dose, 2-sequence, 2-period, Crossover Clinical Trial to Investigate the Bioequivalence Between YHP1906 Tab. 5 mg and YHR1902 Tab. 5 mg in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics
Bioequivalence
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
Collaborators: name: Metro Hospital
First posted: 2020-03-20
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP1906 Tab. 5 mg and YHR1902 Tab. 5mg in healthy volunteers

Detailed description: 30 healthy subjects will be randomized to one of the 2 groups in the same ratio.

Subjects in group 1 will be administered "comparator" and "YHP1906 Tab. 5 mg" by cross-over design on day 1, 8.

Subjects in group 2 will be administered "YHP1906 Tab. 5 mg" and "comparator" by cross-over design on day 1, 8

Eligibility criteria: Inclusion Criteria:

1. Healthy adults aged 19 and above with body mass index(BMI) between 18.5 and 30.0 kg/m2
2. Acceptable medical history, physical examination and laboratory tests during screening
3. Subjects who has signed a written informed consent voluntarily, prior to any procedure, using a form that is approved by the local Institutional Review Board after detailed explanation of the purpose, contents, and characteristic of the drug

Exclusion Criteria:

1. History of clinically significant disease
2. Administration of ETC(ethical-the-counter drug) within 2 weeks or OTC(over-the-counter drug) within 1 week prior to the first dosing
3. Have AST(GOT) and/or ALT(GPT) and/or GGT(γGT) and/or Total Bilirubin \> 1.5 times of normal upper limit
4. Volunteers considered not eligible for the clinical trial by the investigator
5. Administration of other investigational products within 6 months prior to the first dosing

Primary outcomes:
measure: Area under the plasma drug concentration-time curve [AUCt]
timeFrame: 0-36 hours
measure: Maximum plasma concentration [Cmax]
timeFrame: 0-36 hours
Secondary outcomes:
measure: Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]
timeFrame: 0-36 hours
measure: Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]
timeFrame: 0-36 hours
measure: Time of peak concentration [Tmax]
timeFrame: 0-36 hours
measure: Terminal phase of half-life [t1/2]
timeFrame: 0-36 hours
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Metro Hospital
state: Gyeonggi-do
Study officials:
affiliation: Metro Hospital
name: Sungdae Kwon
role: PRINCIPAL_INVESTIGATOR
References: