louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03780530: Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair
Official title: Comparison of Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Episiotomy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 207
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study aims to assess the efficacy and the safety of various cosmetic techniques (subcuticular, surgical glue, adhesive tapes) for perineal skin closure during mediolateral episiotomy repair


Eligibility criteria: Inclusion Criteria:

* Women aged above 18 yrs.
* Primiparous.
* Undergoing spontaneous vaginal delivery of a single full-term fetus.
* Vertex presentation.
* Having mediolateral episiotomy.

Exclusion Criteria:

* Body mass index ≥ 35 kg/m2
* Complicated delivery by any tears other than episiotomy or postpartum hemorrhage.
* Any risk factor causing increased stretch of the perineum; Operative vaginal delivery, fetal macrosomia.
* The use of epidural anesthesia.
* Previous perineal surgeries, local infection or lesions.
* Any medical condition that can cause excessive bleeding or impair wound healing; (cardiovascular disease, diabetes, anemia, coagulopathy, collagen disease or Immunosuppression).
* Contraindication or Hypersensitivity to any of materials used in the study.

Primary outcomes:
measure: Short -term postpartum pain
timeFrame: six hours postpartum
measure: Short -term postpartum pain
timeFrame: 10 days postnatal
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00092430: Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016)
Official title: A Comparison of the Safety, Tolerability, and Immunogenicity of a Refrigerator-Stable Measles, Mumps, Rubella, and Varicella Combination Vaccine V221 (Refrigerated) Versus V221 (Frozen) in Healthy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Measles
Mumps
Rubella
Varicella
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-27
Enrollment: 1200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to demonstrate that an investigational refrigerated vaccine with measles, mumps, rubella, and varicella is well tolerated and has similar immune response when compared to a frozen vaccine with measles, mumps, rubella, and varicella.


Eligibility criteria: Inclusion Criteria:

* Healthy children 12-23 months of age

Exclusion Criteria:

* Previously had measles, mumps, rubella, or varicella
* Compromised immune system

Primary outcomes:
measure: Percent of patients demonstrating adequate antibody titers 6 weeks following administration
Secondary outcomes:
measure: Geometric mean titers (GMT) 6 weeks post vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Bernstein HH, Eves K, Campbell K, Black SB, Twiggs JD, Reisinger KS, Conti RM, Flodmark CE, Rombo L, Klopfer S, Schodel F, Hartzel J, Kuter BJ; Refrigerator-Stable Formulation Study Group for ProQuad. Comparison of the safety and immunogenicity of a refrigerator-stable versus a frozen formulation of ProQuad (measles, mumps, rubella, and varicella virus vaccine live). Pediatrics. 2007 Jun;119(6):e1299-305. doi: 10.1542/peds.2006-2283. Epub 2007 May 14.
Clinical trial NCT04253730: Characterization of Corticospinal Excitability During Progressive Skin Cooling
Official title: Characterization of Corticospinal Excitability During Progressive Skin Cooling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia Due to Cold Environment
Keywords: Body Temperature, Skin Temperature, Cooling
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Repeat Measures
Primary purpose: BASIC_SCIENCE

Brief summary: This study characterizes the changes in corticospinal excitability that accompany basic cold stress via skin cooling that result in reduced skin or core temperature and shivering.

Detailed description: Cold stress is known to impair both fine and gross motor movement. Reductions in performance may have life threatening consequences in survival situations where maintenance of muscle control is necessary. Much of the effects cooling has on muscle performance is directly due to its effects on muscle tissue itself, whereas less is known about the effects on the central nervous system. Therefore, the purpose of the study was to characterize corticospinal excitability that accompanies basic cold stress via progressive skin cooling, resulting in reductions in skin (Tsk) or core (Tco) temperature and shivering.

Eligibility criteria: Inclusion Criteria:

* Healthy adult
* Right Handed
* Pass Magnetic Stimulation Safety Checklist
* Pass Medical Screening Questionnaire

Exclusion Criteria:

* Left Handed
* Any adverse responses to cold exposure (Raynaud's Syndrome)
* Cardiorespiratory Disease

Primary outcomes:
measure: Change in Corticospinal Excitability
timeFrame: at 0, 20, 40, 60 and 90 minutes
Secondary outcomes:
measure: Change in Spinal Excitability
timeFrame: at 0, 20, 40, 60 and 90 minutes
measure: Change in Skin Temperature
timeFrame: at 0, 20, 40, 60 and 90 minutes
measure: Change in Core Temperature
timeFrame: at 0, 20, 40, 60 and 90 minutes
measure: Change in Metabolic Heat Production
timeFrame: at 0, 20, 40, 60 and 90 minutes
Other outcomes:
measure: Change in Peripheral nerve excitability
timeFrame: at 0, 20, 40, 60 and 90 minutes
measure: Change in Maximal Voluntary Contraction of Elbow Flexors
timeFrame: at 0, 20, 40, 60 and 90 minutes
Locations:
city: Winnipeg
country: Canada
facility: 211 Max Bell Centre, University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Gordon Giesbrecht, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hurrie DMG, Talebian Nia M, Power K, Stecina K, Gardiner P, Lockyer E, Giesbrecht GG. Spinal and corticospinal excitability in response to reductions in skin and core temperatures via whole-body cooling. Appl Physiol Nutr Metab. 2022 Feb;47(2):195-205. doi: 10.1139/apnm-2021-0370. Epub 2021 Sep 28.
Clinical trial NCT06360848: Surgical Treamtment of Pseudarthrosis of the Humerus (Study of a Series of 53 Cases)
Official title: Surgical Treamtment of Pseudarthrosis of the Humerus (Study of a Series of 53 Cases)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Humerus Fracture
Keywords: humerus
pseudarthrosis
screwed plate
external fixator
Lead sponsor: Ibn Jazzar Hospital
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 53
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 53 cases. of pseudarthrosis of the humeral shaft collected at the surgery department orthopedic and traumatology

Brief summary: Pseudarthrosis of the humerus is a serious complication of humerus fractures, of particular interest to subjects young working people with pseudoarthrogenic risk factors (tobacco++). It represents a real problem therapeutic given the long period of treatment, its disabling socio-professional repercussions and the cost which resulting.

The aim of our work is to evaluate the anatomical and functional results of different surgical techniques. used.

Detailed description: The management of pseudarthrosis of the humerus remains a subject of controversy. Given our results, the investigators think that osteosynthesis by plate associated with bone grafting and/or decortication remains the most suitable for the treatment of aseptic pseudarthroses of the humeral shaft while treatment with Ilizarov is most appropriate in septic pseudarthrosis.

However, the best treatment for pseudarthrosis of the humerus remains that of treating the initial fracture. and better control of pseudoarthrogenic risk factors (tobacco++).

Eligibility criteria: Inclusion Criteria:

* - Adult men and women \&gt; 18 years old with pseudarthrosis of the post-fractured humeral diaphysis treated in the orthopedic surgery and traumatology department.

Exclusion Criteria:

* - Unusable files.
* Patients lost to follow-up.
* Patients who did not accept therapeutic treatment.

Primary outcomes:
measure: Distribution of atrophic pseudarthrosis according to technique surgical procedure used (in Number of patients)
timeFrame: a minimum follow-up of 10
measure: Distribution of hypertrophic pseudarthrosis according to technique surgical procedure used (in Number of patients)
timeFrame: a minimum follow-up of 10 months
measure: Time to consolidation depending on the type of pseudarthrosis (in months)
timeFrame: a minimum follow-up of 10 months
measure: Average Constant score postoperatively according to the means of restraint
timeFrame: a minimum follow-up of 10 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05592548: Rosacea Treatment Using Non-thermal (cold) Atmospheric Plasma Device
Official title: Open Label Split Face Pilot Study to Assess the Safety and Efficacy of Cold Atmospheric Plasma (non-thermal Plasma) for the Treatment of Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rosacea, Papulopustular
Lead sponsor: The Skin Center Dermatology Group
Sponsor class: INDUSTRY
First posted: 2022-10-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: split face study
Primary purpose: TREATMENT

Brief summary: 10-13 patients will be enrolled to receive split face treatment: the control side will be treated with metronidazole cream, the intervention side will be treated with a cold atmospheric plasma device


Eligibility criteria: Inclusion Criteria:

* Papulopustular rosacea of the cheeks
* Ability to complete six weeks of twice-weekly treatments

Exclusion Criteria:

* substantial asymmetry of disease distribution
* previous failure of topical ivermectin treatment
* presence of any other facial dermatoses
* presence of any photosensitizing disorders
* systemic tetracycline, systemic or topical ivermectin treatment within 6 weeks of start date
* current or within prior 3 months treatment with systemic immune-suppressive medication

Primary outcomes:
measure: Efficacy - Investigator global assessment
timeFrame: 6 weeks
measure: RosaQoL change
timeFrame: 6 weeks
measure: Demodex count change
timeFrame: 6 weeks
measure: Efficacy - National Rosace Society Expert Committee grading system
timeFrame: 6 weeks
Secondary outcomes:
measure: Tolerability - Incidence of Treatment-Emergent Adverse Events as assessed by patient review
timeFrame: 6 weeks
measure: Tolerability - pain as assessed by NRS scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New City
country: United States
facility: The Skin Center Dermatology Group
state: New York
Study officials:
affiliation: The Skin Center Dermatology Group
name: Peter Friedman, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Malik S, Gill M, Fridman G, Fridman A, Friedman PC. Cold atmospheric plasma reduces demodex count on the face comparably to topical ivermectin, as measured by reflectance confocal microscopy. Exp Dermatol. 2022 Sep;31(9):1352-1354. doi: 10.1111/exd.14584. Epub 2022 May 11. No abstract available.
Clinical trial NCT01577030: Hypotensive Effects of Conventional Dairy Products: Role of Arterial Stiffness
Official title: Hypotensive Effects of Conventional Dairy Products: Role of Arterial Stiffness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prehypertension
Stage-1 Hypertension
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2012-04-13
Enrollment: 49
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Elevated systolic blood pressure is by far the largest single contributor to cardiovascular risks in middle-aged and older adults. Lifestyle modifications, including dietary modifications, are the first line approach for treating and preventing hypertension. The general aim of the proposed study is to address the efficacy of conventional dairy products as part of the normal routine diet for lowing arterial blood pressure in middle-aged and older adults with elevated blood pressure. The investigators hypothesize that the dietary intervention including dairy products will induce significant decreases in arterial blood pressure in this population. A secondary aim will be to test the hypothesis that these reductions in systolic blood pressure will be associated with increases in arterial stiffness/compliance and endothelial vasodilatory function.


Eligibility criteria: Inclusion Criteria:

* Prehypertension or stage-1 hypertension

Exclusion Criteria:

* Consume \> 3 servings of dairy or fruit per day
* Strenuous physical activity \> 3 time per week
* Lactose intolerance, pregnancy, lactation, and/or alcohol abuse
* Taking cardiovascular-acting drugs
* Overt cardiovascular disease, metabolic disease, GI disorders and/or renal disease

Primary outcomes:
measure: Seated blood pressure
timeFrame: 4 weeks
Secondary outcomes:
measure: 24-hour ambulatory blood pressure
timeFrame: 4 weeks
measure: Carotid arterial compliance
timeFrame: 4 weeks
measure: Arterial stiffness
timeFrame: 4 weeks
measure: Flow mediated dilation
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin, Cardiovascular Aging Research Laboratory
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Hirofumi Tanaka, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Machin DR, Park W, Alkatan M, Mouton M, Tanaka H. Effects of non-fat dairy products added to the routine diet on vascular function: a randomized controlled crossover trial. Nutr Metab Cardiovasc Dis. 2015 Apr;25(4):364-9. doi: 10.1016/j.numecd.2015.01.005. Epub 2015 Jan 31.
citation: Machin DR, Park W, Alkatan M, Mouton M, Tanaka H. Hypotensive effects of solitary addition of conventional nonfat dairy products to the routine diet: a randomized controlled trial. Am J Clin Nutr. 2014 Jul;100(1):80-7. doi: 10.3945/ajcn.114.085761. Epub 2014 May 7.
Clinical trial NCT01563848: Cryoablation in Patients With Atrial Flutter
Official title: Cryoablation in Patients With Atrial Flutter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Atrial Flutter
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2012-03-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesized that revealing the incidence of AF following RFA of the CTI and cryoablation PVI reduces incidence of AF following RFA of the CTI.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* ECG documented paroxysmal or persistent AFL
* No prior documented history of AF
* Patient undergoing RFA of the CTI for AFL.
* No indication (other than AFL) for continued anticoagulation with warfarin.
* No existing implantable cardiac device (pacemaker, defibrillator, cardiac resynchronization therapy device)
* Availability of an analog phone line.

Exclusion Criteria:

* a history of atrial fibrillation
* Previous AF ablation procedure
* Congestive heart failure
* Left Ventricle ejection fraction less than 35%
* Unwillingness to participate

Primary outcomes:
measure: Percentage of AF burden
timeFrame: 3 years
Secondary outcomes:
measure: All-cause death
timeFrame: 3 years
measure: thromboembolic events
timeFrame: 3 years
measure: hospitalizations
timeFrame: 3 years
measure: procedural complications
timeFrame: 3 years
measure: drug adverse effects
timeFrame: 3 years
measure: number of crossovers
timeFrame: 3 years
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
affiliation: State Research Institute of Circulation Pathology
name: Evgeny A Pokushalov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Romanov A, Pokushalov E, Bayramova S, Ponomarev D, Shabanov V, Losik D, Stenin I, Elesin D, Mikheenko I, Steinberg JS. Prophylactic pulmonary vein isolation during isthmus ablation for atrial flutter: Three-year outcomes of the PREVENT AF I study. J Cardiovasc Electrophysiol. 2018 Jun;29(6):872-878. doi: 10.1111/jce.13485. Epub 2018 Apr 6.
Clinical trial NCT03055130: HPV Infection and Cervical Neoplasm in Women With Inflammatory Bowel Disease: a Cross-sectional Study
Official title: HPV Infection and Cervical Neoplasm in Women With Inflammatory Bowel Disease: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HPV-Related Cervical Carcinoma
Inflammatory Bowel Diseases
Cervical Neoplasm
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 160
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive female adult patients betwween 20-60 year old were recruited from July 2015 to July 2017. Female persons who performed physical examination in our hospital with the same age were recuited as control. All of the received HPV DNA testing and TCT. The case and control were matched 1:3

Brief summary: The associations between female inflammatory bowel disease (IBD) patients and human papilloma virus (HPV) infection and cervical neoplasia (dysplasia or cancer) were unclear. Especially there was no data for Chinese IBD population. So we investigated the incidence and risk factors of HPV infection and cervical neoplasia (dysplasia or cancer) in female IBD patient.


Eligibility criteria: Inclusion Criteria:

1. between 20-60 years old;
2. Patients diagnosed as IBD according to previously established international criteria

Exclusion Criteria:

1. Patients refuse to participating

Primary outcomes:
measure: The different infection rate of HPV between controls and patients by detecting HPV-DNA using reverse dot-blot method.
timeFrame: July 2015 to July 2017
measure: The different incidence of cervical neoplasm between controls and patients by performing Thinprep Cytology Test
timeFrame: July 2015 to July 2017
Secondary outcomes:
measure: Find drugs relating to HPV infection of IBD patients
timeFrame: July 2015 to July 2017
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Gastroenterology
state: Guangdong
Study officials:
affiliation: The sixth affiated hospital of Sun-Yat sen University
name: Xiang Gao, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05997030: Low-Intensity Focused Ultrasound (LIFU) Neuromodulation
Official title: Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients with Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 15
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with mild cognitive impairment ( MCI) due to Alzheimer's disease.

Detailed description: The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for MCI due to AD

Eligibility criteria: Inclusion Criteria:

* Males and non-pregnant females, aged 45-85 years
* Able and willing to give informed consent
* Must meet the clinical criteria for MCI due to Alzheimer's disease
* If receiving concurrent treatment with an AChEI and/or memantine, has been on a stable dose for at least 45 days
* Able to communicate sensations during the LIFU procedure

Exclusion Criteria:

* Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small spaces (have claustrophobia).
* Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain.
* Participants with a history of seizure disorder.
* Participants with clinically significant chronic pulmonary disorders e.g., severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area.
* Participant does not speak English
* Participant is pregnant or planning to be pregnant

Primary outcomes:
measure: Occurrence of Treatment Emergent Adverse Events
timeFrame: baseline and 7 and days after study procedure
measure: Cognitive Change
timeFrame: baseline and 7 days after procedure
Secondary outcomes:
measure: Imaging Changes
timeFrame: baseline, 7 and 30 days
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Rockefeller Neuroscience Institute at West Virginia University
state: West Virginia
Study officials:
affiliation: WVU Rockefeller Neuroscience Institute
name: Ali Rezai, MD
role: PRINCIPAL_INVESTIGATOR
References: