louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04001426: Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device
Official title: Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Bladder, Overactive
Keywords: Overactive Bladder
Women
Neuromodulation
Bioelectronic Medicine
Lead sponsor: FemPulse Corporation
Sponsor class: INDUSTRY
First posted: 2019-06-28
Enrollment: 2
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will wear a device and will be monitored non-invasively during activation of the device.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this feasibility clinical investigation is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.

Detailed description: The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.

Eligibility criteria: Inclusion Criteria:

* Normal healthy women ≥ 21 years old
* Using contraception if of reproductive age

Exclusion Criteria:

* Pregnant, recently pregnant or actively trying to conceive
* Prior hysterectomy
* Current or recent urinary tract or vaginal infection

Primary outcomes:
measure: Autonomic nervous system response
timeFrame: Up to 6 hours
measure: Evoked Potential response
timeFrame: Up to 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin Healthcare
state: Minnesota
Study officials:
References:
Clinical trial NCT04321226: Femtosecond Laser-assisted Astigmatism Treatment
Official title: Femtosecond Laser-assisted Astigmatism Treatment (FLAAT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Age Related Cataracts
Astigmatism
Keywords: Laser Cataract Surgery
Arcuate Keratotomy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective interventional case series
Primary purpose: TREATMENT

Brief summary: The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure including arcuate incisions (AI) correcting astigmatism, also referred to as arcuate keratotomy (AK). The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery and additionally perform arcuate keratotomy in individuals with more than 1.0 Diopter (dpt) of astigmatism. Cataract surgery will be performed in subjects who have signed an informed consent form.

Postoperative examinations will be implemented in accordance with the approved Investigational Plan on subjects and includes: postoperative refraction, visual acuity, slitlamp examination, and corneal topography


Eligibility criteria: Inclusion Criteria:

* Age-related cataract necessitating lens extraction and posterior IOL implantation
* Regular corneal astigmatism between 1.0 and 2.5 DPT
* Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)

Exclusion Criteria:

* Corneal abnormality
* Preceding ocular surgery or trauma
* Uncontrolled glaucoma
* Proliferative diabetic retinopathy
* Iris neovascularization
* History of uveitis/iritis
* Microphthalmus
* Recurrent intraocular inflammation of unknown etiology
* Blind fellow eye
* Uncontrolled systemic or ocular disease

Primary outcomes:
measure: Corneal Astigmatism one year after the intervention
timeFrame: 1 year follow-up
Secondary outcomes:
measure: Precision and reproducibility of corneal cut depth
timeFrame: 1 year follow-up
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT04800926: Xavier Electromyographic Wheelchair Control for Limited Mobility Patients
Official title: Xavier Electromyographic Wheelchair Control for Limited Mobility Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: University of Central Florida
First posted: 2021-03-16
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to assess the functional mobility and self-reported satisfaction with the Xavier electromyography hands-free wheelchair control system in comparison with a standard joystick.


Eligibility criteria: Inclusion Criteria:

* ALS diagnosis by revised el Escorial criteria (definite, probable or probable laboratory supported)
* Age 18-89
* Limited mobility with use of motorized wheelchair at screening-time
* Impairment of hand function limiting the use of a standard joystick control
* Caregiver willing to assist with transfers into wheelchair and application of controllers
* Ability to attend study visits with a motorized wheelchair
* Ability to communicate and answer patient reported outcome measure questions

Exclusion Criteria:

* Cognitive impairment prohibiting safe independent mobility as defined by an ALS-Cognitive Behavioral Screen (ALS-CBS) score of \<10 or the opinion of the investigator
* A sensory impairment prohibiting safe independent mobility in the opinion of the investigator
* Allergy to adhesives or electrode gels (required for EMG electrodes)
* Skin breakdown over the temporalis muscle that would predispose to further breakdown and/or infection with electrodes
* Severe loss of facial muscle functionality or control that would preclude EMG electrode efficacy
* Subjects who do not have the capacity to consent

Primary outcomes:
measure: Wheelchair Skills Test (WST)
timeFrame: approximately 3 days
Secondary outcomes:
measure: Drive test
timeFrame: approximately 3 days
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Bjorn Oskarsson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manero AC, McLinden SL, Sparkman J, Oskarsson B. Evaluating surface EMG control of motorized wheelchairs for amyotrophic lateral sclerosis patients. J Neuroeng Rehabil. 2022 Aug 14;19(1):88. doi: 10.1186/s12984-022-01066-8.
Clinical trial NCT01710826: A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Genz-682452 in Healthy Volunteers
Official title: A Single-center, Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending 14-day Repeated Oral Doses of Genz-682452 in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-10-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To assess in healthy adult subjects:

* The tolerability and safety of ascending repeated oral doses of Genz-682452.
* The pharmacokinetic parameters of Genz-682452 after ascending repeated oral doses.
* The pharmacodynamics of Genz-682452 after ascending repeated oral doses.


Eligibility criteria: Inclusion Criteria:

* Body weight between 50.0 and 95.0 kg, inclusive, if male and between 40.0 and 85.0 kg inclusive, if female, body mass index between 18.0 and 30.0 kg/m\^2, inclusive.
* Certified as healthy by a comprehensive clinical assessment.

Exclusion Criteria:

* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
* Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
* Blood donation, any volume, within 2 months before inclusion.
* Symptomatic postural hypotension.
* History or presence of drug or alcohol abuse.
* Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, antihepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
* Positive result on urine drug screen.

Primary outcomes:
measure: Participants with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 1 through Day 14
Secondary outcomes:
measure: Pharmacokinetics as measure by plasma parameters
timeFrame: Day 1 through Day 14
measure: Pharmacodynamics as measure by Plasma concentrations of Glucosylceramide (GL-1), Globotriaosylceramide (GL-3) and GM3 ganglioside (GM3)
timeFrame: Day 1, through Day 14
measure: Pharmacokinetics Urine parameter as measure by assessment of Genz-682452 in Urine, Ae0-t, fe0-t (Exploratory)
timeFrame: Day 1 through Day 14
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Peterschmitt MJ, Crawford NPS, Gaemers SJM, Ji AJ, Sharma J, Pham TT. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Oral Venglustat in Healthy Volunteers. Clin Pharmacol Drug Dev. 2021 Jan;10(1):86-98. doi: 10.1002/cpdd.865. Epub 2020 Aug 26.
Clinical trial NCT04811326: Latanoprost Plus NB-UVB Versus Each Alone in Non-segmental Vitiligo: Clinical and Laboratory Evaluation
Official title: Latanoprost Plus NB-UVB Versus Each Alone in Non-segmental Vitiligo: Clinical and Laboratory Evaluation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Non-segmental Vitiligo
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the efficacy of different lines of therapies on the TWEAK serum level in patients with non-segmental vitiligo.

Detailed description: the study is to evaluate the efficacy of NB-UVB, latanoprost, and combination of them on the TWEAK serum level in patients with non-segmental vitiligo.

Eligibility criteria: Inclusion Criteria:

* Patients with non-segmental vitiligo of any age and gender.

Exclusion Criteria:

* History of vitiligo treatment with topical, systemic or biological agents prior to the study for at least 3 weeks.
* Pregnancy and lactation.
* Infections
* Patients with other autoimmune diseases.
* Patients with chronic diseases: cardiac diseases, hepatic disorders, hematologic disease, chronic renal failure or malignancies.

Primary outcomes:
measure: serum TWEAK in vitiligo
timeFrame: 3months
Secondary outcomes:
measure: treatment of vitiligo
timeFrame: 3 months
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: faculty of medicine, Aswan University
state: Aswan Governorate
Study officials:
affiliation: Prof. and Head of Dermatology, Venereology and Andrology department, Aswan University, Egypt
name: Moustafa A El Taieb, prof.
role: STUDY_CHAIR
References:
Clinical trial NCT03737526: Impact of Anaesthesia Mode on Evaluation of LEEP Specimen Dimensions
Official title: Impact of Anaesthesia Mode on Evaluation of LEEP Specimen Dimensions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: loop electrosurgical excision procedure
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators conducted a prospective non-randomized controlled study at the Amiens University Hospital (France). The study took place between January and December 2015. The investigators included every patient who underwent a first conization procedure, regardless of indication. The only exclusion criterion was the patient's refusal to participate.Written consent was obtained before procedure. Data was gathered using questionnaires, pre-, per- and post-procedure.

Brief summary: To study the influence of anaesthesia (local by cervical block vs. general or spinal anaesthesia) on height and volume of resection specimens in case of conization treatment for cervical intraepithelial neoplasia (CIN).

Prospective observational study of all patients who underwent a first treatment by loop electrosurgical excision procedure (LEEP) for CIN. Height of fresh resection specimens was first measured by the operator and then by the pathologist after formaldehyde fixation. Volume of fresh specimens was measured in a measuring cylinder by fluid displacement.

Detailed description: Measure of conization specimens can be done in the operating theatre on fresh specimen or by pathologist after fixation. Methods and conditions of specimen measurement are rarely, if ever, described in published studies.

To study the influence of anaesthesia (local by cervical block vs. general or spinal anaesthesia) on height and volume of resection specimens in case of conization treatment for cervical intraepithelial neoplasia (CIN).

Prospective observational study of all patients who underwent a first treatment by loop electrosurgical excision procedure (LEEP) for CIN. Height of fresh resection specimens was first measured by the operator and then by the pathologist after formaldehyde fixation. Volume of fresh specimens was measured in a measuring cylinder by fluid displacement.

Eligibility criteria: Inclusion Criteria:

* every patient who underwent a first conization procedure
* regardless of indication

Exclusion Criteria:

* patient's refusal to participate.

Primary outcomes:
measure: Impact of anaesthesia on height of resection specimens.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU AMIENS
name: Jean Gondry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06012526: The Study of Sleep Disordered Breathing in Patients With Interstitial Lung Diseases
Official title: Study of the Prevalence and Predictive Factors of Sleep Disordered Breathing in Patients With Interstitial Lung Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea-hypopnea
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 69 patients with interstitial lung diseases of both sexs and older than 18 years

Brief summary: This was a cross-sectional observational study to evaluate the prevalence and predictive factors of SDB in ILD and to analyze the relationship between polysomnography (PSG) findings, pulmonary function, disease severity, parenchymal involvement, and sleep questionnaires ESS and SBQ. This study included 69 patients who were diagnosed with diffuse parenchymal lung diseases by high-resolution computed tomography (HRCT) chest. All patients were subjected to clinical examination, HRCT, spirometry, full-night polysomnography, and echocardiography.


Eligibility criteria: Inclusion Criteria:

* Both sexes of clinically stable ILD patients older than 18 who met the ATS/ERS criteria for an ILD diagnosis were included in the study.

Exclusion Criteria:

* Patients who have any anatomic upper airway obstructions such as significant nasal septal deviation, nasal polyps, conchae hypertrophy or tonsillar hypertrophy.
* Patients with neurological diseases or severe psychiatric disorders.
* Patients who have history of administration of any drug that has a major effect on sleep e.g. benzodiazepine, narcotic drugs ....etc.
* Patients with any chronic pulmonary disease except ILD.
* Total sleep time less than 4 hours on PSG.

Primary outcomes:
measure: Measurements of apnea hypopnea index
timeFrame: 1and half years
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni suef university
state: Beni Suef
Study officials:
affiliation: Head of chest department in BeniSuef university
name: Nabila Ebrahim Laz, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT05194826: Using Fascia Lata Membrane Versus Connective Tissue Graft in Immediate Implants
Official title: Vestibular Socket Therapy Using Fascia Lata Membrane Versus Connective Tissue Graft in Immediate Implants of Aesthetic Zone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Connective Tissue Graft
Anterior Aesthetic Zone
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate and compare the Vestibular Socket Therapy (VST) technique using fascia lata membrane versus connective tissue graft both with xenogenic lamina membrane in immediate implants of anterior aesthetic zone.


Eligibility criteria: Inclusion Criteria:

* Class II socket according to Elian et al, described as facial soft tissue is present but the buccal plate is partially missing following extraction of the tooth in the maxillary anterior region.
* Thin gingival phenotype.
* Bone quality ranges from D2-D3 as gained from preoperative cone-beam computed tomography.
* Presence of at least 3 mm of keratinized gingiva.
* Optimal compliance as evidenced by no missing treatment appointments and a positive attitude towards oral hygiene

Exclusion Criteria:

* Medically compromised patients and systemic conditions precluding implant and periodontal surgery.
* Smokers, diabetics, pregnant or lactating women.
* History of chemotherapy, radiotherapy in head and/or neck region.
* Bisphosphonate therapy.

Primary outcomes:
measure: Changes in peri-implant mucosal level
timeFrame: at baseline, 6 months and 12 months
measure: Changes in gingival phenotype
timeFrame: at baseline, 6 months and 12 months
measure: Chaneg in height of labial (facial) plate of bone
timeFrame: at baseline, 6 months and 12 months
measure: Chaneg in thickness of labial (facial) plate of bone
timeFrame: at baseline, 6 months and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
Study officials:
References:
Clinical trial NCT05994326: Perioperative Care and Short-term Outcomes of Colorectal Surgery in Addis Abeba
Official title: Perioperative Care and Short-term Outcomes of Colorectal Surgery: A Prospective Study From Tikur Anbessa Specialized Hospital in Addis Abeba Ethiopia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Disorders
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (≥18 years) with willingness and ability to give informed consent, who were admitted to the surgical department at TASH (elective or in an emergency) and operated for a colorectal condition

Brief summary: Observational cohort study of adult patients undergoing colorectal surgery at Tikur Anbessa Specialized Hospital in Addis Abeba for 3 months.

Detailed description: Observational prospective cohort study, including all adult (≥18) patients undergoing colorectal surgery at Tikur Anbessa Specialized Hospital in Addis Abeba for 3 months. Variables are patients' characteristics, risk factors, investigations, types of operations, level of training of surgeon, and postoperative management. The data collection is conducted at admission, day of surgery, and discharge. The primary outcomes are in-hospital complications and length of stay, and the secondary outcomes are perioperative management.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Willingness and ability to give informed consent
* Admitted to the surgical department at TASH (elective or in an emergency) and operated for a colorectal condition

Exclusion Criteria:

-Emergency conditions usually managed in general surgery, e.g., perianal conditions and adhesive small bowel obstruction

Primary outcomes:
measure: Proportion postoperative complications
timeFrame: From date of surgery to date of discharge from hospital or maximun 30 days postoperatively
Secondary outcomes:
measure: Mean length of stay
timeFrame: From admission to date of discharge from hospital, up to 30 days
measure: Type of surgery performed
timeFrame: From admission to date of discharge from hospital, up to 30 days
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Tikur Anbessa Specialized Hospital
Study officials:
affiliation: Karolinska Institutet
name: Åsa Everhov, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05301426: Neural Glide Technique on the Sciatic Nerve and the Passive Stretching Technique in the Short Hamstring Muscles
Official title: Differences Between the Effects of the Neural Glide Technique on the Sciatic Nerve and the Passive Stretching Technique in the Short Hamstring Muscles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hamstring Muscles
Sciatic Nerve
Flexibility
Keywords: Hamstring muscles
Sciatic nerve
Flexibility
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 50
Sex: MALE
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two intervention groups. One control group.
Primary purpose: TREATMENT

Brief summary: The project consists of studying the differences between neural gliding techniques of the sciatic nerve and passive stretching of the hamstring muscles in football players.

Detailed description: Study of hamstring shortening in football players through passive muscle stretching and the use of the neurodynamic technique of longitudinal sliding of the sciatic nerve.

Eligibility criteria: Inclusion criteria:

* Footballers with shortening of the hamstring musculature.
* Age between 16 and 18 years.
* Subjects who agree to participate in the study.

Exclusion criteria:

* Subjects with significant nerve involvement.
* Subjects with scars or wounds affecting the assessment.
* Subjects with muscle injuries in the lower limb.
* Subjects with herniated discs or chronic acute low back pain.
* Subjects with pain or paresthesia in the lower limbs.

Primary outcomes:
measure: Differences between passive stretching of the hamstring muscles and longitudinal sliding of the sciatic nerve.
timeFrame: One month.
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Campo de Fútbol de Archena
Study officials:
affiliation: Universidad de Murcia
name: Angel Martínez Carrasco, PhD
role: STUDY_DIRECTOR
References: