louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05823610: Intrapartum Ultrasonography in Evaluation of the Progress of Labor
Official title: Intrapartum Ultrasonography in Evaluation of the Progress of Labor
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Progress pf Labor
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: women presented in labor

Brief summary: The optimal management of the second stage of labor is a subject of an ongoing debate. It is well established that prolonged second stage of labor is associated with increased maternal and neonatal morbidity.

Diagnosing the onset of labour is one of the most critical and complex judgments made by care providers in the delivery room. Measurement of cervical dilatation is considered the most crucial parameter for labour progress during childbirth and the main reason for doing digital vaginal examination (DVE) in women with signs of labour onset.

DVE was the most common method for measuring cervical dilatation in the past and has been the gold standard for assessing labour progress. However, it can be subjective, inaccurate, and uncomfortable for women. Also, only 50% of assessments are accurate, and there is an increased risk of infection with frequent DVE. Therefore, vaginal examination cannot be a correct scale for measuring cervical dilatation, mainly when done by different examiners. Because of the poor reliability and pain associated with DVE, the use of intrapartum ultrasound to measure cervical dilation has been suggested as an alternative method. Abdominal, vaginal, trans-labial, and trans-perineal 2D and 3D ultrasounds have been used to measure cervical dilatation during labour.


Eligibility criteria: Inclusion Criteria:

* Primigravida patients
* At the onset of active phase
* Cephalic vertex presentation
* Estimated Fetal Weight 3Kg - 4Kg
* Gestational Age ≥37 weeks

Exclusion Criteria:

* Multiple Pregnancy
* Patients refused to participate in our study
* Induced labor
* Any Obstetrical Complication or Disease
* Malpresentation

Primary outcomes:
measure: compare the intrapartum sonographic parameters between women who had spontaneous vaginal delivery (SVD) vs those who required CS
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05444010: Mandala Intervention on Mental Distress in Nurses Working With Terminally Ill Patients
Official title: Mandala Intervention on Mental Health Problems of Nurses Caring for Terminally Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Keywords: mental health, anxiety, depression
Lead sponsor: Istanbul Sabahattin Zaim University
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is an experimental study with pre-test and post-test control grups
Primary purpose: PREVENTION

Brief summary: Mandala application intervention of mental distress in nurses working with terminally ill patients

Detailed description: Questionnaires were applied to the control and experimental groups. Mandala painting was done to the experimental group. Questionnaires were applied to the control and experimental groups again. Distress, anxiety, depression, death anxiety, death depression and psychological well-being of the experimental and control groups were evaluated.

Eligibility criteria: Inclusion Criteria:

volunteer

* active employee
* year of study

Exclusion Criteria:

* paint allergy
* use of psychiatric drugs Loss of loved one in the last six months

Primary outcomes:
measure: Beck depresion scale
timeFrame: 4 week
Secondary outcomes:
measure: STAI-trait anxiety scale
timeFrame: 4 week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: SZU
state: İSTANBUL/halkalı
city: Istanbul
country: Turkey
facility: SZU
state: İ̇stanbul
Study officials:
affiliation: SZU
name: RUKİYE PINAR BÖLÜKTAŞ
role: STUDY_DIRECTOR
References:
Clinical trial NCT00002210: A Study of Delavirdine Mesylate in Combination With Other Anti-HIV Drugs in HIV-Infected Children and Babies
Official title: Phase II Study of the Safety, Tolerance, Pharmacokinetics, and Antiviral Effect of Delavirdine Mesylate (Rescriptor), in Combination With Nucleoside Reverse Transcriptase Inhibitors, in HIV-1-Infected Neonates, Infants, and Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
Delavirdine
Reverse Transcriptase Inhibitors
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to give delavirdine mesylate (Rescriptor) plus two nucleoside reverse transcriptase inhibitors (NRTIs) to HIV-infected children and babies. This study also examines how the body processes Rescriptor when taken with 2 NRTIs.


Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV infection.
* Plasma HIV-1 levels greater than 10,000 copies/ml.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Peapack
country: United States
facility: Pharmacia & Upjohn
state: New Jersey
Study officials:
References:
citation: Willoughby R, Watson D, Welliver R. Early use of RESCRIPTOR (delavirdine) in children with HIV. 39th Intersci Conf Antimicrob Agents Chemother. 1999 Sept 26-29 (abstract no 1995)
Clinical trial NCT06354010: Cross-sectional and Prospective Study to Characterize Early-onset Presbycusis
Official title: Cross-sectional and Prospective Study to Characterize Early-onset Presbycusis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sensorineural Hearing Loss, Bilateral
Keywords: Adulthood-onset bilateral sensorineural hearing loss
GJB2
Presbycusis
hearing impairement
Deafness
Connexin 26
SONG
Genetic deafness
Adult deafness
Lead sponsor: Sensorion
Sponsor class: INDUSTRY
First posted: 2024-04-09
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female participants aged ≥30 and ≤55 years old with bilateral hearing loss first noticed after the age of 16 years old.

Brief summary: The purpose of this study is to characterize and assess the evolution of hearing impairment of patients with adulthood-onset bilateral sensorineural hearing loss carrying mutations on GJB2 gene.

Detailed description: This study aims to characterize patients with adulthood-onset bilateral sensorineural hearing loss not due to any underlying medical condition (likely due to a genetic cause) and to assess the evolution of hearing impairment of those carrying mutations in GJB2 gene.

Patients who present with adulthood-onset bilateral sensorineural hearing loss will be screened for the presence of mutation involved in hearing impairment. Patients with GJB2 mutations will be proposed to continue in a follow-up period.

Eligibility criteria: Inclusion Criteria:

1. Female or Male patients ≥30 and ≤55 years old
2. Bilateral hearing loss first noticed after the age of 16 years old
3. Documented genotyping results showing mutations in GJB2 gene.

Exclusion Criteria:

1. Deafness with a known, non-genetic cause
2. To the opinion of the investigator, unable and/or unwilling to comply with all the protocol requirements and/or study procedures

Primary outcomes:
measure: Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene.
timeFrame: 2 years
measure: Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene
timeFrame: 2 years
Secondary outcomes:
measure: Genetic characteristics of adult patients with early-onset presbycusis
timeFrame: Unique visit
measure: Audiological characteristics of adult patients with early-onset presbycusis
timeFrame: Unique visit
measure: Mood evaluation in adult patients with early-onset presbycusis carrying mutations in GJB2 gene
timeFrame: 2 years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: The University of South Florida Board of Trustees
state: Florida
city: Montpellier
country: France
facility: CHU Gui de Chauliac
Study officials:
affiliation: CHU Montpellier - Hôpital Gui de Chauliac
name: Frederic Venail, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02465710: Comparisons of Clinical Outcomes Between Novel Tailored Transvaginal Mesh Surgery and Vaginal Native Tissue Repair Surgery for Pelvic Organ Prolapse
Official title: Comparisons of Clinical Outcomes Between Novel Tailored Transvaginal Mesh Surgery and Vaginal Native Tissue Repair Surgery for Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Organ Prolapse
Keywords: pelvic organ prolapse
pelvic floor reconstruction surgery
transvaginal mesh surgery
Women
Surgical treatment
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 350
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women who underwent surgical treatment of pelvic organ prolapse were enrolled in this study.

Brief summary: The issue of whether utilizing the mesh in the surgical treatment of pelvic organ prolapse remained undetermined.Thus, the aim of this study is to analyze clinical outcome of women who underwent pelvic organ prolapse surgeries with and without mesh implantation in the Department of Obstetrics \& Gynecology of National Taiwan University Hospital.

Detailed description: Hypothesis / aims of study:

The use of mesh for women with pelvic organ prolapsed (POP) remains under debate, despite a recent randomized trial reported a favourable anatomic outcome of transvaginal mesh (TVM) surgery for cystocele, compared with anterior colporrhaphy. Besides, the issue of preserving uterus or not in women with POP during operation is still undetermined. Thus, the aim of this study is to compare clinical outcomes of the novel tailored TVM surgeries and conventional transvaginal native tissue repair (NTR) surgeries for POP.

Study design, materials and methods:

Between November 2011 and September 2014, the medical records of all consecutive women who underwent POP surgeries in a medical centre were reviewed. The choice of surgery method was according to the surgeons' preference. Clinical characteristics and intraoperative data and postoperative clinical outcomes were recorded. Wilcoxon rank-sum test was used to compare the data between two groups. Kaplan-Meier survival analysis was used to compare the recurrence rate between two groups.

Eligibility criteria: Inclusion Criteria:

* All women who underwent surgical treatment of pelvic organ prolapse were enrolled in this study.
* ≥ 20 years old female.

Exclusion Criteria:

* Healthy women
* Without underwent surgical treatment of pelvic organ prolapse

Primary outcomes:
measure: Recurrence rate of pelvic organ prolapse
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Obstetrics & Gynecology, National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT01724710: To Study the Effect of Organic Light Emitting Diodes (OLED) on Cultured Fibroblast
Official title: To Study the Effect of Organic Light Emitting Diodes (OLED) on Cultured Fibroblast
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-pressure Chronic Ulcer of Skin, Not Elsewhere Classified
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-11-12
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. The process of collecting chronic ulcer skin: When the patient accept wound debridement surgery, visiting staff will take 1x1cm2 skin of chronic ulcer.
2. The process of collecting normal skin: When the patient accept skin-grafting surgery, visiting staff will take 1x1x0.1cm3 skin.

Brief summary: Chronic ulcers is a common clinical problem. Diabetes or peripheral vascular occlusion is major reason leading to chronic wound healing.

The investigators's previous animal experiments have confirmed that OLED can promote burn wound healing and fibroblast proliferation in normal Wistar rat.

In order to find the time point and dosage of the effective light therapy. The investigators further use cultured human fibroblasts in vitro to study light therapy to promote fibroblast proliferation mechanisms.

Expect clinical application of light therapy in the future is more accurate and effective.

Detailed description: Chronic ulcers is a common clinical problem. Diabetes or peripheral vascular occlusion is major reason leading to chronic wound healing.

Therapeutic methods to promote wound healing are hyperbaric oxygen therapy, vacuum assisted therapy and photostimulation.

Although there are many treatments but no one has been widely accepted. The clinical effects of uncertainty, high cost and inconvenience of use is the main reason.

Each year amputation of the population due to chronic ulcers has not decreased. In order to break the current medical difficulties, We refer to the new light therapy technology.

Look forward to shorten the healing time and reduce medicine costs. The investigators's previous animal experiments have confirmed that OLED can promote burn wound healing and fibroblast proliferation in normal Wistar rat.

In order to find the time point and dosage of the effective light therapy. The investigators further use cultured human fibroblasts in vitro to study light therapy to promote fibroblast proliferation mechanisms.

Expect clinical application of light therapy in the future is more accurate and effective irradiative time points and dosage.

Eligibility criteria: Inclusion Criteria:

* chronic ulcer
* normal skin
* age 50\~80 years,
* chronic skin ulcer patient
* skin-grafting patient

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: NTUH Burn lab
name: Kean Eng Yeong, college
role: STUDY_CHAIR
References:
Clinical trial NCT01943110: Evaluation of the Performance and Safety of Two Intradermal Delivery Devices.
Official title: A Clinical Trial to Evaluate the Performance and Safety of Two Intradermal Delivery Devices.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injections, Intradermal
Keywords: Intradermal injections
Vaccine delivery devices
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: SID Technologies
First posted: 2013-09-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate whether two intradermal (ID) vaccine delivery devices can safely and precisely inject liquid into the intradermal layer of the skin in three different injection locations

Detailed description: This study is a preliminary device safety and performance evaluation in healthy adult volunteers (ages 18-55 years).

Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:

* Upper deltoid with the side-load ID adapter
* Upper deltoid with the autodisable (AD) ID adapter
* Suprascapular (behind the shoulder) with the side-load ID adapter
* Suprascapular with the AD ID adapter
* Forearm with the side-load ID adapter
* Forearm with the AD ID adapter

Intradermal administration of each injection will be assessed:

* The liquid remaining on the surface of the skin will be blotted with absorbent paper and the amount of liquid present will be recorded.
* The formation of an intradermal wheal will be observed, and the diameter of the wheal measured using a ruler or similar measurement tool.
* A photo of the injection site will be taken.

Injections will be assessed for safety by observation of injection sites for any local adverse events.

Eligibility criteria: Inclusion Criteria:

* Female and male participants ages 18 to 55 years.
* Healthy enough to participate in the clinical trial per site investigator assessment.
* Healthy skin on the upper deltoid, suprascapular, and forearm regions (both sides of the body).
* Able to provide signed informed consent and understand study procedures per ICH/GCP guidelines.
* Literate in English.
* Available by telephone 48 hours after the study visit.

Exclusion Criteria:

- Skin abnormalities on upper deltoid, suprascapular, and forearm regions of either side of the body (scars, rash, infection), tattoo at the injection site, or other skin conditions that would interfere with the ability to visualize an intradermal injection in the opinion of the investigator.

Primary outcomes:
measure: Proportion of Injections Delivered to the Intradermal Layer of the Skin
timeFrame: 1 day
Secondary outcomes:
measure: Proportion of Injections With Safety Events
timeFrame: Within 30 minutes and within 48 hours of injection
Other outcomes:
Locations:
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
affiliation: Rainier Clinical Research Center
name: Leslie Klaff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06217510: Pilot Project on the Automatic Design and 3D Printing of Adolescent Idiopathic Scoliosis Braces (Phase 1)
Official title: Pilot Project on the Automatic Design and 3D Printing of Adolescent Idiopathic Scoliosis Braces (Phase 1)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Scoliosis
3D printing
Finite Element Analysis
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Modulate Technologies
First posted: 2024-01-22
Enrollment: 15
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study with a single group of 15 patients
Primary purpose: TREATMENT

Brief summary: The goal of this pilot clinical trial is to validate a 3D printed brace designed automatically for patients with Adolescent Idiopathic Scoliosis. The main question it aims to answer is: which parameters leads to a efficient and comfortable brace.

Participants will try the brace for a period of 30 minutes, measurement and feedback will be obtained.


Eligibility criteria: Inclusion Criteria:

* Diagnostic of Adolescent Idiopathic Scoliosis
* Risser 0-2
* Cobb Angle between 20 and 40 degrees
* Prescription for a brace
* Able to understand French or English

Exclusion Criteria:

* Grade II or higher Spondylolisthesis
* Neuromuscular disease
* Past spinal surgery

Primary outcomes:
measure: Participant Questionnaire
timeFrame: 30 minutes
measure: Orthotist Adjustment Questionnaire
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01349010: Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia
Official title: A Randomized, Double Blind, Placebo Control, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Imported Probucol in Hyperlipidemia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia
Keywords: hyperlipidemia
Lead sponsor: Otsuka Beijing Research Institute
Sponsor class: INDUSTRY
First posted: 2011-05-06
Enrollment: 264
Sex: ALL
Minimum age (years): 20
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 evaluate the efficacy and safety of imported Probucol in hyperlipidemia patients.

Detailed description: This is a randomized, double blind, placebo control, multi-centre clinical study in hyperlipidemia patients.

Enrolled subjects will be randomized to the treatment group or control group, and receive Probucol or placebo continuously for 8 weeks; Treatment group: Imported Probucol 250 mg (1 tablet) bid. p.o Control group: Placebo 1 tablet bid. p.o

Eligibility criteria: Inclusion Criteria:

1. Signing Informed Content Form;
2. Age \>= 20 (the age at the time of signing ICF; both gender);
3. hyperlipidemia patients who meet the following criteria:

   * 4.14 mmol/L (160mg/dL) =\< LDL-C (Serum low density lipoprotein-cholesterol) \< 6 mmol/L (232mg/dL)
   * TG (Serum triglycerides) \< 4.5 mmol/L (398mg/dL);
4. Framingham: Coronary Heart Disease 2-year risk probabilities \< 10%.

Exclusion Criteria:

1. Subjects who receive antilipemic agents within 1 month prior to the pre-screening period;
2. Subjects who receive Probucol within 6 months prior to the pre-screening period;
3. Coronary Heart Disease subjects;
4. Subjects being treated with cyclosporine;
5. Subjects with a history of hypersensitivity to Probucol;
6. QTc interval \> 450ms (male); QTc interval \> 470ms (female);
7. Subjects with impaired hepatic and renal function, who meet any of the following abnormal value:

   * AST \>= 100IU/L
   * ALT \>= 100IU/L
   * Serum creatinine \>= 1.5mg/dL
8. Female subjects who are pregnant, lactating, or who plan to conceive;
9. Subjects who are considered by the investigator to be inappropriate to participate in this trial.

Primary outcomes:
measure: TC and LDL-C
timeFrame: 8-week
Secondary outcomes:
measure: oxLDL and MCP-1
timeFrame: 8-week
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Sencond Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: The Sencond Xiangya Hospital of Central South University
name: Shuiping Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References: