louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04331210: Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain
Official title: Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Episiotomy Wound
Keywords: Episiotomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 1024
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Current study aims to compare oral diclofenac sodium with it's rectal form for analgesia of pain after episiotomy.

Detailed description: * Episiotomy is a surgical incision of the perineum and the posterior vaginal wall.
* it can be done at a 60 degree angle from the vulva towards the anus or at an angle from the posterior end of the vulva.
* usually under local anesthetic and is sutured after delivery.
* It is done during second stage of labor to enlarge the opening for the baby to pass through to avoid soft-tissue tearing which may involve the anal sphincter and rectum.
* Perineal pain after episiotomy has immediate and long-term negative effects for women and their babies. These effects can interfere with breastfeeding and the care of the infant.
* Usually women undergo episiotomy need a good analgesic to overcome pain resulting from the analgesic.
* Previous study by Faiza shafi, Shazia sayed, Naheed bano, Rizwana chaudhri, Holy family hospital, Rawalpindi, Pakistan, The study was published in journal of Rawalpindi medical college and concluded that rectal diclofenac should be further promoted , for pain relief, in women following episiotomy.

Eligibility criteria: Inclusion Criteria:

1. age: 20:35 years.
2. Primigravidae as elective procedure.
3. face to pubis delivery.
4. Big baby.
5. Narrow pelvic arch.
6. Elderly primigravida.
7. old perineal scar as episiotomy or perineorrhaphy.
8. Manipulative delivery.
9. To cut short second stage cases such as pre eclampsia.
10. Premature baby.
11. Fetal distress.

Exclusion Criteria:

1. more than 35 years.
2. pelvic inflammatory disease.

Primary outcomes:
measure: Post episiotomy pain relief
timeFrame: First three days after delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: women health hospital assiut university
name: Diaa eldin Mohammed, Professor
role: STUDY_CHAIR
affiliation: women health hospital assiut university
name: Osama Saber, Lecturer
role: STUDY_DIRECTOR
References:
Clinical trial NCT03390010: Misoprostol Versus Active Management of Labour in CS
Official title: Intrauterine Misoprostol With Active Management of Labour Versus Active Management of Labour for Prevebtion of Postpartum Hemorage in Cesarean Section ,Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cesarean Section
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2018-01-04
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Several treatment strategies are emplemented to prevent post delivery hemorage and decreasing maternal morbidity and mortality .

Detailed description: Many approved drugs are used in prophylaxis against postpartum hemorage from these medications are the (syntocinon combined with methergine ) that are known as active management of labour drugs .

Moreover there is misotac , that also guards against postpartum hemorage .

All these medications act in a different way to cause uterine contraction post delivery to prevent uterine atony .

-Here we are comparing the additive value of misotac intrauterine to syntocinon and methergine in comparison to the usually used syntocinon plus methergine .

Eligibility criteria: Inclusion Criteria:

* • All patients included in this research were aged 18-42 years, pregnant 37 weeks till 42 weeks

  * no medical disorders with pregnancy e.g DM, HTN. All patients were subjected to full history taking, examination.

Exclusion Criteria:

* Exclusion Criteria:

  * The following patients were excluded , GA before 37 weeks or after 42 weeks , medical disorders with pregnancy eg. DM with pregnancy, HTN with pregnancy

Primary outcomes:
measure: The number of participants who passed cesarean section without postpartum hemorage
timeFrame: within 2 days post CS
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt )
name: Mahmoud Alalfy, M.s.c
role: STUDY_CHAIR
affiliation: kasraliny hospital- Aljazeerah hospital
name: yossra Lasheen, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05200910: The Effect of Transcatheter VSD Closure on Children's Appetite, Hormones and Growth
Official title: Nutritional, Hormonal and Anthropometric Evaluation of Children After Transcatheter VSD Closure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Septal Defect
Appetite Loss
Growth Delay
Keywords: ventricular septal defect
appetite
growth
interventional therapy
Lead sponsor: Kayseri City Hospital
Sponsor class: OTHER_GOV
First posted: 2022-01-21
Enrollment: 46
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients who underwent transcatheter VSD closure in our institute and whose growth was followed for 6 months as patient group.

Healthy children without appetite or growth retardation were included in the study as a control group.

Brief summary: In this study; Changes in appetite, hormones and growth of ventricular septal defect patients treated with non-surgical method were evaluated.

Detailed description: The study included 20 patients whose ventricular septal defect closed percutaneously and 26 children as control group. The symptoms, anthropometric measurements and laboratory tests of patient group were recorded at initial, 1st month and 6th months after closure.

Anthropometric measurements; weight for age (WFA), height for age (HFA), body mass index (BMI) and their z scores, triceps skinfold thickness (TSF) and mid-upper arm circumference (MUAC) were recorded on admission. Patients with weight for height z score less than -2 were defined as malnutrition.

Questions about the symptoms like appetite, weight gain, frequency of illness, rate of breathing, fatigue were asked to all parents at initial. These questionnaires15 and visual analogue scale (for appetite) were repeated at 1st and 6th month visits.

During the initial evaluation, approximately 6 ml of venous blood samples were taken between 9:00-10:00 am after an average of 10 hours fasting. On the same day, IGFBP-3, Ghrelin and leptin,fasting blood glucose, insulin, IGF-1, IGFBP-3, aspartate aminotransferase (AST) and alanine aminotransferase (ALT), total protein, and albumin were measured.

Anthropometric measurements and laboratory tests were repeated at 1st and 6th month visits.

Eligibility criteria: Inclusion Criteria:

Pediatric patients who underwent transcatheter VSD closure

Exclusion Criteria:

* Chromosomal abnormalities
* Additional systemic disease
* Systemic infections

Primary outcomes:
measure: Weight Z score
timeFrame: 6 months
measure: Height Z score
timeFrame: 6 month
measure: Body mass index Z score
timeFrame: 6 month
measure: Ghrelin
timeFrame: 6 month
measure: Leptin
timeFrame: 6 month
measure: Visual analogue scale
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Süleyman Sunkak
state: Kocasinan
Study officials:
affiliation: TC Erciyes University
name: Onur Tasci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04982510: Accuracy of 3D Printed Complete Dentures Using Two Impression Techniques: RCT
Official title: Retention of 3D Printed Bases Using Prefabricated Thermoplastic Trays and Conventional Custom Impression Trays: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulism Nos
Keywords: digital dentures, definitive impression, thermoplastic trays, printed denture, 3D, rapid prototyping
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 11
Sex: MALE
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: the aim of this crossover randomized controlled clinical trial is comparing retention of 3D printed maxillary complete dentures produced from thermoplastic impression trays and conventional acrylic impression trays.

The research hypothesis is that there is no difference in patient satisfaction and retention of dentures constructed from definitive impression using the conventional tray and the prefabricated thermoplastic tray


Eligibility criteria: Inclusion Criteria:

* Male edentulous patients.
* Cooperative and highly motivated patients.
* Patients with well or moderately developed ridges and healthy attached mucosa of appropriate thickness free from inflammation

Exclusion Criteria:

* Patients with recent extraction less than 3 months ago
* Patients with Parkinson's disease
* Patients with xerostomia.
* Patients with allergy to resins.
* Pathological changes of residual ridges.
* Patient with sever undercuts, or irregular bony exostosis.
* Patients with flabby and flat ridges.
* Patients with medical or psychological conditions that hinder co-operation.
* Patients with class II or III jaw relation.

Primary outcomes:
measure: Maxillary complete denture base retention
timeFrame: 2 weeks after denture insertion
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Cairo University
Study officials:
References:
Clinical trial NCT05211310: Validity and Reliability of High-Activity Arthroplasty Score
Official title: Turkish Validity and Reliability of High Activity Arthroplasty Score After Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthroplasty Complications
Keywords: Knee Arthroplasty, Total
Validation Study
Questionnaire
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have undergone primary total knee arthroplasty surgery at least 6 months ago in the Orthopedics and Traumatology Outpatient Clinic will be included. Participants will be contacted via telephone.

Brief summary: Patient-reported Outcome Measures (PROMs) used in total knee arthroplasty focus more on quality of life and pain. For this reason, individuals who can perform activities of daily living normally can get full points. There is a need for PROMs used in the assessment of higher functional skills. This study aimed to translate The High-Activity Arthroplasty Score (HAAS) into Turkish and to conduct a validity and reliability study of the Turkish version.

Detailed description: Studies show that TKA practice has increased in the young population in recent years. Patient-reported Outcome Measures (PROMs) used in total knee arthroplasty focus more on quality of life and pain. For this reason, individuals who can perform activities of daily living normally can get full points. There is a need for PROMs used in the assessment of higher functional skills. This study aimed to translate The High-Activity Arthroplasty Score into Turkish and to conduct a validity and reliability study of the Turkish version. The adaptation of the questionnaire to Turkish in the study will be made according to the COSMIN and Reliability and Agreement Studies Reporting Guide. The construct validity, concurrent validity, reliability, and floor and ceiling effects of the questionnaire will be evaluated.

Eligibility criteria: Inclusion Criteria:

* To have undergone primary total knee arthroplasty for osteoarthritis at least 6 months ago,
* To be between the ages of 18-65.

Exclusion Criteria:

* Having orthopedic, neurological, cardiovascular, or cognitive problems that may affect physical performance,
* Presence of previous lower extremity surgery

Primary outcomes:
measure: High-Activity Arthroplasty Score (HAAS)
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Science University
city: Afyonkarahisar
country: Turkey
facility: Emel Taşvuran Horata
Study officials:
affiliation: AFSU
name: EMEL TAŞVURAN HORATA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03965910: Importance of Early Rehabilitation in Stroke Patients
Official title: Demonstration the Importance of the Early Rehabilitation in Stroke Patients Based on Diffüsion Tensor Imaging Data
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
rehabilitation
diffusion tensor imaging
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 28
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is one of the leading health problems in the community and it is the most common life-threatening neurological disease impairing the quality of life. Early rehabilitation of stroke is very important. The purpose of our study was to evaluate, through clinical examination, whether there was any difference between patients who underwent early rehabilitation and those who underwent late rehabilitation in terms of improvements in motor and functional impairment after rehabilitation, and also to evaluate this difference objectively by analyzing white-matter pathways (corticospinal tracts) using DTI.

Detailed description: Methods: Twenty-eight (28) adults (12 women, 16 men, average age 58 years) with first-time stroke who met the study criteria were divided into two groups depending on the duration of their stroke at the time of their presentation to our facility. Group 1 consisted of patients who underwent rehabilitation program within the first 1-4 weeks after stroke, whereas Group 2 consisted of patients who underwent rehabilitation program within 5-8 weeks after stroke. Both groups were evaluated using the BRS, FMA scale, FAC and BI scales. For cranial imaging, DTI was obtained 1 day before and 1 day after treatment. FA and ADC values of corticospinal tracts were performed using DTI.

Intervention: Patients were enrolled in a rehabilitation program, which was designed for a total of 4 weeks, with daily sessions lasting a total of 1 h on 5 days of a week.

Eligibility criteria: Inclusion Criteria:

* Patients suffering cerebrovascular accident (CVA)-associated stroke for the first time with a cortical or subcortical unilateral ischemia or hemorrhage
* The patients aged 35-75 years
* Patiients with ability to understand and follow the instructions
* Patients with the absence of serious cognitive deficits.

Exclusion Criteria:

* Patients who had spinal-cord lesion
* Patients who had history of traumatic brain injury,
* Patients who had accompanying neurological disease (multiple sclerosis, Parkinson's disease, dementia)
* Patients who had tumor
* Patients who had history of convulsions

Primary outcomes:
measure: Change in Cranial diffusion tractography
timeFrame: performed 1 day before and 1 month after treatment
measure: Change in Fugl-Meyer Assessment Scale score(FMA)
timeFrame: performed 1 day before the end of the second week of the treatment and 1 day after the completion of the treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03539510: Effectiveness of the HF-ACP Website Study
Official title: Randomized Controlled Trial of an Interactive Website for Heart Failure Advance Care Planning
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Advance Care Planning
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: will be conducted using a single center, double-blind randomized controlled trial with 2 groups; an intervention group using the HF-ACP website and control group receiving usual care.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates the effectiveness of an interactive website on advance care planning for patients living with heart failure (HF-ACP website). The investigators will randomize patients to either the HF-ACP website or usual care to determine if the participants who use the HF-ACP website have higher advance care planning completion rates than participants assigned to usual care.

Detailed description: Advance care planning is a process that supports adults at any age or stage of health to understand and share their personal values, life goals and preferences in order to prepare for future decisions regarding medical care. Public awareness campaigns to promote ACP have been taking place for about 10 years without significant improvements in ACP completion rates. Content intended for use by the general public may be too vague for those living with a chronic illness. Framing ACP within the context of a specific disease may provide the impetus for a person to engage in ACP. The investigators believe the HF-ACP website will improve patient understanding of the life-limiting nature of HF, the ACP process and the need to plan ahead to help ensure the care they receive matches their treatment preferences.

Eligibility criteria: Inclusion Criteria:

* over the age of 18,
* a regular patient in our clinic,
* able to read and write English,
* familiar with the use and have access to a personal computer, email and the internet.

Exclusion Criteria:

* ineligible for participation in the trial if they do not meet the inclusion criteria described above.

Primary outcomes:
measure: Advance care planning completion rates
timeFrame: 6 months
Secondary outcomes:
measure: advance care planning knowledge
timeFrame: 6 months
measure: The 5-level European Quality of Life scale
timeFrame: 6 months
measure: Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: 6 months
measure: The Readiness to Change Scale (RCS)
timeFrame: 6 months
measure: The Patient Health Questionnaire (PHQ-9)
timeFrame: 6 months
measure: The Perceived Stress Scale
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: UHN Toronto
name: Jane Maciver, RN PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02558712: Technology-based Eye Care Services (TECS) Compare
Official title: Prospective Comparison of Technology-based Eye Care Services (TECS) With and Without OCT Assessment Versus Standard Face to Face Ophthalmologic Exam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Macular Degeneration
Glaucoma
Keywords: screening
tele-ophthalmology
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the Technology-based Eye Care Services (TECS) protocol to the standard face to face ophthalmologic exam.

Detailed description: Patients will sign informed consent to enter the one visit study. They will undergo the study protocol and then see the face to face physician on the same day.

Eligibility criteria: Inclusion Criteria:

* Patient at the Atlanta VA Medical Center (VAMC) New Comprehensive eye clinic

Exclusion Criteria:

* Known acute or chronic ocular issues

Primary outcomes:
measure: Number of patients with accurate diagnosis of eye diseases from TECS protocol versus face to face eye exam with and without OCT
timeFrame: Evaluation Visit (Day 0)
Secondary outcomes:
measure: Number of patients appropriately referred from the TECS protocol
timeFrame: Evaluation visit (Day 0)
measure: Number of participants with an accurate diagnosis for anterior segment disease
timeFrame: Evaluation visit (Day 0)
measure: Inter-reader variability of the TECS protocol
timeFrame: Evaluation visit (Day 0)
measure: Intra-reader variability of the TECS protocol
timeFrame: Evaluation visit (Day 0)
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
Study officials:
affiliation: Emory University
name: April Maa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04744012: Modified Periostal Pocket Flap Technique
Official title: Modified Periostal Pocket Flap Technique: a Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Regeneration
Keywords: Periostal Pocket Flap Technique
PPFT
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients included in this case series were collected from Clinica Dental Alcalá, were operated on by the same surgeon and fullfilled the inclusion and exclusion criteria.

Brief summary: The aim of this study is to propose a modification of the original periostal pocket flap technique consisting in replacing the xenograft by a conglomerate which contains autologous bone obtained from the future implant site through biological drilling technique and PRGF (Plasma Rich in Growth Factors)

Detailed description: Materials and methods: 8 patients referred for implant placement and with a slight bucco-lingual (BL) width deficiency in alveolar bone were included in the study. Patients were placed dental implants and bone width was augmented by using the conglomerate mentioned above.

Eligibility criteria: Inclusion Criteria:

* Patients with a favorable bone density and favorable bone length but insufficient bone width that could compromise implant placement

Exclusion Criteria:

* Smokers (\>10 cigarettes per day) and patients with severe systemic disease ( ASA III or IV - American Society of Anaesthesiology)

Primary outcomes:
measure: Volume of bone augmentation
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Complutense de Madrid
name: Jesús Torres, Associate
role: PRINCIPAL_INVESTIGATOR
References: