louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01200745: Efficacy of Topical Capsaicin on Chronic Neck Pain
Official title: Efficacy of Topical Capsaicin on Chronic Neck Pain ; Double-blinded Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Neck Pain
Keywords: neck pain
capsaicin
dermal patch
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2010-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether topical capsaicin patch can effectively reduce chronic neck pain.

Detailed description: * Design: This is a double-blind, randomized, controlled study. Participants: Sixty participants with chronic neck pain are recruited and randomly assigned to two groups.
* Intervention: Over an four-week period, the treatment group (n=30) uses capsaicin patch (100 mcg/3cc) at the tender point of neck for 12 hours a day; the control group (n=30) receives Hydrogel patch instead of capsaicin patch.

Eligibility criteria: Inclusion Criteria:

* Korean participants with Chronic neck pain are enrolled in our study

Exclusion Criteria:

* Participants with coagulation deficiencies, infections, hypertension, diabetes, heart disease, renal disease, liver disease, cancer, myelopathy, hypersensitivity of drugs, other skeletomuscular disease, allergic response to capsaicin, pregnancy and nursing are excluded

Primary outcomes:
measure: Pain Scores on the Visual Analogue Scale(VAS)
timeFrame: 4 week
Secondary outcomes:
measure: Neck disability index
timeFrame: 4 week
measure: Beck depression inventory
timeFrame: 4 week
measure: SF-36
timeFrame: 4 week
measure: EQ-5D(EuroQol-5 dimension)
timeFrame: 4 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyunghee University East West Neo Medical Center
Study officials:
affiliation: Department of Oriental Rehabilitation Medicine/College of Oriental Medicine/Kyung Hee University
name: Mi-Yeon Song, OMD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06697145: Assessment of the Durability of Cardioneuroablation Using Physiological Indices of Heart Rate Reactivity
Official title: Assessment of the Durability and Clinical Effectiveness of Parasympathetic Denervation Following Cardioneuroablation Using Physiological Indices of Heart Rate Reactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syncope, Vasovagal, Neurally-Mediated
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cardioneuroablation is a novel treatment option for reflex-mediated syncope. It involves thermal destruction of neural tissue in the close proximity of heart using catheter introduced to the heart through vein in the groin. Effectiveness of the procedure is satisfactory, however, in some cases there is a possibility of the re-growth of previously ablated tissue. We aim to investigate whether this process could be traced by measurement of various physiological parameters related to heart rate reactivity. Additionally we intend to reveal whether changes in those parameters over time could influence clinical effeciveness of the procedure.


Eligibility criteria: Inclusion Criteria:

* signed informed consent
* sinus rhythm
* clinical indications for cardioneuroablation for the treatment of vagally-mediated syncope

Exclusion Criteria:

* pregnancy
* known atropine hypersensitivity

Primary outcomes:
measure: Change in degree of parasympathetic denervation (%)
timeFrame: 12 months
Secondary outcomes:
measure: Change in heart rate (beats/min)
timeFrame: 12 months
measure: Change in heart rate variability (ms)
timeFrame: 12 months
measure: Change in cardiac barosensitivity (ms/mmHg)
timeFrame: 12 months
measure: Change in hypoxic heart rate response (beats/min SpO2)
timeFrame: 12 months
measure: Time to recurrence of syncopal event (days
timeFrame: 12 months
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Wroclaw Medical University
state: Dolnoslaskie
Study officials:
References:
Clinical trial NCT00838045: Evaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens
Official title: A Prospective, Multi-Center Clinical Investigation to Evaluate the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL (Model MI60) Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Aphakia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2009-02-06
Enrollment: 125
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety and effectiveness of the Bausch \& Lomb Akreos TL (thin lens) intraocular lens (IOL) following implantation in adults requiring cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction.
* Subjects must be undergoing primary intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
* Subjects must require a lens power from 15 to 30 diopters.
* Subjects must have a visual potential of 20/40 or better in the study eye.

Exclusion Criteria:

* Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
* Subjects with any inflammation or edema (swelling) of the cornea.
* Subjects with uncontrolled glaucoma or glaucoma under current treatment in the study eye or with ocular hypertension.
* Subjects with previous retinal detachment.
* Subjects with diabetic retinopathy (proliferative or non-proliferative).
* Subjects with rubella, bilateral congenital, traumatic, or complicated cataract.
* Subjects who have had previous ocular surgery in the planned operative eye, excluding ocular adnexa surgery.
* Subjects who have already received an Akreos TL IOL in the fellow eye.

Primary outcomes:
measure: Bast Corrected Visual Acuity
timeFrame: 24 months
Secondary outcomes:
measure: Uncorrected Visual Acuity
timeFrame: 24 months
measure: Manifest Refraction
timeFrame: 24 Months
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Klinikum der J.W. Goethe-Universität
Study officials:
affiliation: Klinikum der J.W. Goethe-Universität
name: Thomas Kohnen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03213145: Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers
Official title: A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics and Safety of EDP-305 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: NASH - Nonalcoholic Steatohepatitis
Keywords: drug-drug interaction
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2017-07-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 2-Part Single Group study.
Primary purpose: BASIC_SCIENCE

Brief summary: This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of itraconazole or rifampin on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.


Eligibility criteria: Inclusion Criteria:

* An informed consent document signed and dated by the subject.
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
* Female subjects must be of non-childbearing potential.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease.
* Pregnant or nursing females.
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
* A positive urine drug screen at screening or Day -1.
* Current tobacco smokers or use of tobacco within 3 months prior to screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
* History of regular alcohol consumption.
* Participation in a clinical trial within 30 days prior to the first dose of study drug.

Primary outcomes:
measure: Cmax of EDP-305 with and without coadministration with itraconazole
timeFrame: Up to 19 days
measure: AUC of EDP-305 with and without coadministration with itraconazole
timeFrame: Up to 19 days
measure: Cmax of EDP-305 with and without coadministration with rifampin
timeFrame: Up to 17 days
measure: AUC of EDP-305 with and without coadministration with rifampin
timeFrame: Up to 17 days
Secondary outcomes:
measure: Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).
timeFrame: Up to 19 days
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Pharmaceutical Research Associates, Inc.,
state: Kansas
Study officials:
affiliation: Enanta Pharmaceuticals, Ind
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References:
Clinical trial NCT02989545: The Use of an "Anal-Tape" in Patients With Fecal Incontinence
Official title: The Use of an "Anal-Tape" in Patients With Fecal Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2016-12-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Fecal incontinence (FI), defined as the involuntary passage of stool for more than 3 months and is a devastating disease. The negative impact on quality of life has been consistently demonstrated. The prevalence of FI is probably underestimated in most studies. Currently conservative treatment is only modestly effective and surgical treatment is complex and expensive with less than optimal efficacy.

The investigators developed an "anal tape" using a commercially available elastic band with a special adhesive that is approved for use in the skin. A special design of the tape can be applied to the skin surrounding the anus providing support and additional pressure forces to the anal sphincter.

This is a 4 week, prospective, non blinded, cross-over study to explore the efficacy and safety of this device in patients with FI. The primary endpoint will be improvement in quality of life.


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* Fecal incontinence for more than 6 months
* Willing to participate
* Understand the study procedures
* Is able to apply and remove the "anal tape" without significant assistance of others.
* Have done sigmoidsocopy or colonoscopy and anal manometry within five year of screening visit

Exclusion Criteria:

* Advanced full thickness rectal prolapse.
* Injured, inflamed or any significant disease in the peri-anal skin.
* Allergy to any component of the device, either known or developed during testing in the screening visit.
* Moderate to severe proctitis of any etiology.

Primary outcomes:
measure: Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs)
timeFrame: 2 weeks
Secondary outcomes:
measure: A 50% Reduction in the Number of Episodes of FI Per Week
timeFrame: 4 weeks
measure: Mean Wexner Score
timeFrame: 2 weeks
measure: Mean Redction in Wexner Scale Compared to Baseline
timeFrame: 2 weeks
measure: General Satisfaction
timeFrame: 2 weeks
measure: Willingness of the Patient to Continue Using the Anal Tape After the Study.
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Livovsky DM, Koslowsky B, Goldin E, Lysy J. External kinesiology tape for improvement in fecal incontinence symptom bother in women: a pilot study. Int Urogynecol J. 2022 Oct;33(10):2859-2868. doi: 10.1007/s00192-021-05050-z. Epub 2022 Jan 18.
Clinical trial NCT04773145: Osseointegration of Hydroxyapatite-coated Femoral Stems in Femoral Neck Fractures Over 80 Years
Official title: Osseointegration of Hydroxyapatite-coated Femoral Stems in Femoral Neck Fractures Over 80 Years
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Femoral Neck Fractures
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 140
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients over 80 with femoral neck fracture

Brief summary: This study aimes to prove that osseointegration of hydroxyapatite coated stem is possible for patients over 80 years with femoral neck fracture, without the risks of cemented stems.

The hydroxyapatite has a local effect which can improve cortical index.


Eligibility criteria: Inclusion Criteria:

* 80 years
* 1 year follow-up
* femoral neck fracture

Exclusion Criteria:

* bad-realized radiographs

Primary outcomes:
measure: Engh and Massin score
timeFrame: 1 month
Secondary outcomes:
measure: CBR
timeFrame: 1 month
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHU Hôpital Central
state: Lorraine
Study officials:
References:
Clinical trial NCT06109545: Doppler Ultrasound and CT Versus Laparoscopy in Assessment of Ovarian Malignancy
Official title: Validation of Doppler Ultrasound, CT Parameters Versus Laparoscopic Scoring in Assessment of Suspicious Ovarian Malignancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Keywords: Ovarian cancer, Doppler, CT, Laparoscopy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with suspicious ovarian malignancy

Brief summary: The aim of this study is to assess validation of ultrasound (± Doppler) parameters in the diagnosis of suspicious ovarian malignant tumors and laparoscopic assessment of these findings according to Fagotti score evaluation of suspicious malignant tumors

Detailed description: The aim of this study is to asses validation of ultrasound (± Doppler) parameters in the diagnosis of suspicious ovarian malignant tumors and laparoscopic assessment of these findings according to Fagotti score evaluation of suspicious malignant tumors

Eligibility criteria: Inclusion Criteria:

1. all patients with clinical or radiological suspicion of ovarian cancer.
2. at least one of clinical presentation of suspected or advanced ovarian cancer and performed ultrasound or CT or MRI that detect a pelvic mass and CA125 is more than 200 UL/ML.
3. patients with eastern Cooperative Oncology Group status from 0 to 3.

Exclusion Criteria:

1. the women outside the age group in our study.
2. any known malignancy at other sites.
3. uncompliant patients who have severed uncontrolled infection or any other medical problem.
4. any previous major surgery.
5. patients who refuse to give an informed consent to do laparoscopy.
6. pregnancy and its complications.

Primary outcomes:
measure: Fagotti score
timeFrame: Al time of laparoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sarah Madany, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05208645: The Place of Men in Arrested Pregnancies
Official title: The Place of Men in Arrested Pregnancies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arrested Pregnancies
Keywords: arrested pregnancies
Cardiac Arrest
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male adult who is progenitor of the pregnancy and whose partner is affected by an aborted pregnancy

Brief summary: An terminated pregnancy is defined as the cessation of cardiac activity before 14 weeks of amenorrhea. This early interruption of gestation can be induced by pathological, traumatic or idiopathic causes. In any case, it remains a physically and psychologically trying event for the woman, the couple as well as for the man.

Indeed, the loss of this embryo, which measures only a few millimeters, corresponds to the loss of a child for the triad: woman, man, couple. The termination of this pregnancy is experienced as a bereavement for the future parents.

The stopped pregnancy has always been a taboo in the society. The proof being that it was not until the 1980s that this was considered mourning and its psychological consequences were studied.

Following these studies, psychological follow-ups are democratized and are thus offered to women. However, when is it men? The investigators have always put the woman at the center of the care process. Which is legitimate. However, the man is often seen as "the person who influences the woman". This default categorization marginalizes the man who would like to be an actor in the care of his partner. In fact, men are increasingly asking to support women in their gynecological care procedures. Unfortunately, for lack of measures put in place. The men are more than abandoned.


Eligibility criteria: Inclusion criteria:

* Age ≥18 years old
* male
* Speaking French
* The progenitor of the pregnancy and whose partner is affected by an aborted pregnancy

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject under safeguard of justice
* Subject under guardianship or guardianship
* Subject under guardianship, curatorship or safeguard of justice

Primary outcomes:
measure: Identify the role of the men's place during an aborted pregnancy of their partners
timeFrame: up to 1 month post-arrested pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
name: Luisa ATTALI, Midwife
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02959645: Assessment of Brain Activities in Cervical Dystonia
Official title: Assessment of Cortical Network Activities in Cervical Dystonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Dystonia
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cervical dystonia will be recruited from the University of Minnesota's Movement Disorders Clinic.

Brief summary: To address joint position sense in cervical dystonia patients and how it affects the brain activity.


Eligibility criteria: Inclusion Criteria:

* patients having cervical dystonia and aged matched healthy control group

Exclusion Criteria:

* cervical dystonia patients with severe head tremor will be excluded

Primary outcomes:
measure: Hand Joint Position Sense
timeFrame: 30 minutes
Secondary outcomes:
measure: Brain Signals Recorded via Non-Invasive Surface Electromyography
timeFrame: 2 hours
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Elliott Hall-MSP Lab
state: Minnesota
Study officials:
References:
citation: Khosravani S, Buchanan J, Johnson MD, Konczak J. Effect of Neck Botulinum Neurotoxin Injection on Proprioception and Somatosensory-Motor Cortical Processing in Cervical Dystonia. Neurorehabil Neural Repair. 2020 Apr;34(4):309-320. doi: 10.1177/1545968320905799. Epub 2020 Feb 26.
Clinical trial NCT06638645: Prolonged Hospital Stay After Thoracoscopic Anatomical Lung Resections
Official title: Reasons for Prolonged Hospital Stay After Thoracoscopic Anatomical Lung Resections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Minimally Invasive Surgical Procedures
VATS
RATS Surgery
Pulmonary Lobectomy
Pulmonary Segmentectomy
Air Leakage
Postoperative Complication
Pain Postoperative
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: AZ Sint-Lucas Brugge
First posted: 2024-10-15
Enrollment: 140
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 scheduled for thoracoscopic anatomical lung resection. An estimated 136 patients should be included after power calculation

Brief summary: In this study, the reasons for prolonged hospital stay after thoracoscopic (video- or robot-assisted) anatomical lung resections are investigated. Currently, whenever possible, these anatomical lung resections are performed thoracoscopically, as they offer significant improvements in terms of postoperative pain, number of postoperative complications, rehabilitation, tolerance for adjuvant chemotherapy, and length of hospital stay. The development of an 'Enhanced Recovery After Surgery' (ERAS) protocol for lung surgery has further reduced hospital stay and the need for opioids for analgesia. Despite the optimal implementation of the ERAS protocol, there are still patients who need to stay in the hospital longer than the median. The aim of this research is to investigate the reasons for this.


Eligibility criteria: Inclusion Criteria:

* Patients referred for elective minimally invasive (uniportal or multiportal video- or robot-assisted) anatomical lung resection (lobectomy or segmentectomy)
* Informed consent obtained pre-operatively
* Age 18 years or older

Exclusion Criteria:

* Patients younger than 18 years old
* Traumatic event as indication for lung resection
* Non-anatomical lung resections
* Thoracotomy
* Patients already hospitalized for other pathologies, pre-existent and not related to the lung surgery
* Urgent/emergency procedures

Primary outcomes:
measure: Length of hospital stay (days)
timeFrame: immediately after surgery until hospital discharge (1 week on average), up to 3 months
Secondary outcomes:
measure: Reasons for delayed discharge (more than 2 days postoperatively) identified through daily questionnaires and review of medical records.
timeFrame: immediately after surgery until hospital discharge (1 week on average), up to 3 months
measure: Number, frequency and severity of postoperative complications during hospital stay.
timeFrame: immediately after surgery until hospital discharge (1 week on average), up to 3 months
Other outcomes:
Locations:
city: Bruges
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende AV
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
References: