louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04712708: Role of Rebound Therapy in the Rehabilitation of Children With Spastic Cerebral Palsy
Official title: Role of Rebound Therapy in the Rehabilitation of Children With Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 32
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cerebral palsy (CP) is a group of disorders of movement and posture, causing several body impairments. CP is caused by non-progressive disturbance that occurred in the fetal or immature brain. CP symptoms include several motor disorders such as disturbances in sensation, coordination, cognition, communication and behavior in addition to disturbances in postural stability, balance and coordination.

Balance is the ability to maintain the center of body mass over the base of support. CP causes balance impairment which results in decrease in the child's mobility functions and causing activity limitation and participations restrictions.

Motor coordination is the registration of two or more things such as body movements , timing or sensory feedback into a harmonious relationship.

CP causes disturbances in motor coordination such as difficulties in the routine gross movements as running and jumping, and disturbances in common fine movements like buttoning, clothing or brushing hair Rebound therapy is an exercise therapy which uses mini trampolines, rebounders , Springfree Trampoline and Swiss balls, to provide opportunity to perform recreational movements for individuals with different body structural and functional impairments.


Eligibility criteria: Inclusion Criteria:

* Spastic cerebral palsy was determined according to the sample size calculation, was selected from the outpatient's clinic of the faculty of Physical Therapy Cairo University.
* Level I according to the Gross Motor Function Classification System (GMFCS). Chronological age ranged from 5 to 11 years.
* Height was above 1 meter.
* Understand verbal command.
* The degree of spasticity ranged from 1 to 1+ according to Modified Ashworth' Scale.

Rebound therapy using trampoline was used as the method of management in the study group in addition to the selected physical therapy program that was used in both groups, and the treatment sessions was provided in the out-patient clinic of the faculty of Physical Therapy Cairo University.

Exclusion Criteria:

* Vertigo or dizziness.
* Epilepsy.
* Osteoporosis.

Primary outcomes:
measure: Balance
timeFrame: 12 Weeks
measure: Gross Motor Function
timeFrame: 12 Weeks
measure: Gross Motor Coordination
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy Cairo University
Study officials:
References:
Clinical trial NCT05448508: The Effects of Manual and Automatic Lancets on Pain and Stress in Newborn Capillary Heel Blood Collection
Official title: The Effects of Manual and Automatic Lancets on Pain and Stress in Newborn Capillary Heel Blood Collection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn
Pain
Stress
Lead sponsor: Ataturk University
Sponsor class: OTHER
Collaborators: name: MSc Meral Güven
name: MSc Reyhan YALÇIN
name: PhD Adem ASLAN
First posted: 2022-07-07
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Heel blood sampling is a routine but painful procedure for newborns. A limited number of international studies have shown that automatic lancets are more effective with less pain and tissue damage than manual lancets.

In line with this information, this study was planned to investigate the effects of manual and automatic lancets on pain and stress in newborn capillary heel blood collection.


Eligibility criteria: Inclusion Criteria:

* Postnatal age zero day
* Term newborn
* No congenital anomalies
* No advanced medical intervention at birth
* Infants not receiving oxygen or respiratory support

Exclusion Criteria:

* Legal guardian not giving consent to research

Primary outcomes:
measure: The neo pain assessment scale
timeFrame: 12 week
measure: Crying time in second
timeFrame: 12 week
Secondary outcomes:
Other outcomes:
Locations:
city: Yakuti̇ye
country: Turkey
facility: AtaturkU
state: Erzurum
Study officials:
References:
Clinical trial NCT02678208: The Effect of Tranexamic Acid on Uterine Blood Flow After Vaginal Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postpartum Hemorrhage
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postpartum hemorrhage is the most common cause of maternal death across the world, responsible for more than 25% of maternal deaths annually. Although effective tools for prevention and treatment of are available, most are not feasible or practical for use in the developing world where many births still occur at home with untrained birth attendants . primary postpartum hemorrhage is excessive bleeding from or in the genital tract within 24 hours of delivery of the fetus which affects the general condition.

Postpartum hemorrhage is responsible for around 25% of maternal mortality worldwide , reaching as high as 60% in some countries. Postpartum hemorrhage can also be a cause of long-term severe morbidity, and approximately 12% of women who survive postpartum hemorrhagewill have severe anemia.

Tranexamic acid is an antifibrinolytic compound which is a potent competitive inhibitor of the activation of plasminogen to plasmin. At much higher concentrations it is a non-competitive inhibitor of plasmin. The inhibitory effect of tranexamic acid in plasminogen activation by urokinase has been reported to be 6-100 times and by streptokinase 6-40 times greater than that of aminocaproic acid.


Eligibility criteria: Inclusion Criteria:

* pregnant women (37-42 weeks),
* with spontaneous labor
* Women who were expected to normal vaginal birth.
* women with a live fetus.

Exclusion Criteria:

* multiple gestations
* polyhydramnios
* macrocosmic baby
* grand multipara
* women with hypertensive disorders
* previous history of postpartum hemorrhage
* abnormal placentation (placenta previa or placental abruption)
* history of any uterine scarring (including cesarean section)
* history of blood/liver/renal/heart diseases.

Primary outcomes:
measure: The changes in Doppler indices of uterine artery after use of tranexamic acid
timeFrame: 6 months
measure: The changes in Doppler indices of intramyometrial blood vessels after use of tranexamic acid
timeFrame: 6 months
measure: The changes in Doppler indices of subendomterial blood vessels after use of tranexamic acid
timeFrame: 6 month
Secondary outcomes:
measure: The volume of blood loss after delivery (mL)
timeFrame: 6 months
measure: Number of patients needed for blood transfusion
timeFrame: 6 months
measure: The hematocrit values (%)
timeFrame: 6 months
measure: The hemoglobin concentration
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT06376708: Comparison Between PEEK With Platelet-rich Fibrin and PEEK Alone in Maxillary Sinus Augmentation
Official title: Comparison Between PEEK With Platelet-rich Fibrin and PEEK Alone in Maxillary Sinus Augmentation: Histomorphometric and Clinical Analysis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Sinus
Keywords: maxillary sinus elevation and PEEK
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: use of platelet rich fibrin after maxillary sinus elevation using PEEK
Primary purpose: TREATMENT

Brief summary: comparison between the resulted bone during maxillary sinus elevation by PEEK with and without platelet rich fibrin

Detailed description: Histomorphometric and clinical analysis of the bone formed after 6 months after the maxillary sinus elevation using PEEK in the 2 groups : the study group (PEEK with platelet rich fibrin) and the control group (PEEK alone ) .

Eligibility criteria: Inclusion Criteria:

* • Posterior edentulous ridges with pneumatized maxillary sinus and remaining bone height less than 4 mm.

  * ASA physical status I and II.
  * Patients willing to be a part of the study and ready to give their consent in writing for the same.
  * Patient not complain from maxillary sinusitis
  * Patient with good oral hygiene.
  * Both males as well as females without any active periodontal disease.
  * The edentulous ridges are covered with optimal thickness of mucoperiosteum with no signs of inflammation, ulceration or scar tissue.
  * Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.

Exclusion Criteria:

* • General contraindications to implant surgery.

  * Untreated gingivitis, periodontitis.
  * Subjected to irradiation in the head and neck area less than 1 year before implantation.
  * Untreated periodontitis.
  * Pregnant or nursing.
  * Unable to open mouth sufficiently to accommodate the surgical tooling.
  * Patients participating in other studies, if the present protocol could not be properly followed.
  * Patient who could/would not participate in the follow-up period.

Primary outcomes:
measure: Bone quantity
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Bone quality
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Cairo University
Study officials:
References:
Clinical trial NCT05742308: The Effect of Laughter Yoga on Hope and School Burnout
Official title: The Effect of Laughter Yoga on Hope and School Burnout Among Secondary School Students: A Parallel Group Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laughter Therapy
Laughter Yoga
Hope
School Burnout
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aimed to evaluate the effect of laughter yoga on hope and school burnout among secondary school (8th Grade) students. The study hypothesized that laughter yoga would have an effect on hope and school burnout scores among secondary school students

Detailed description: Purpose: The aim of the research was to examine the effects of laughter yoga on life hope and school burnout among secondary school (8th Grade) students.

Methods: The study was conducted with 60 (30 in the intervention group, and 30 in the control group) students. The study population consisted of 8th grade students. Laughter yoga sessions were applied to the intervention group twice a week for 6 weeks. No intervention was offered to the control group. Data were collected by a socio-demographic questionnaire, school burnout inventory and Children's Hope Scale.

Results: After laughter yoga, the intervention result showed a significant decrease in burnout (d=0.129; p \< 0.001) and increase hope scores (d=0.556; p \< 0.001) compared to the control group.

Conclusion: The study reveals that laughter yoga affects students' burnout and hope levels. It is recommended to organize laughter yoga activities in schools to decrease burnout and increase hope of students.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria of the study were determined as being an 8th-grade student, speaking and understanding Turkish, and being able to perform daily life activities.

Exclusion Criteria:

* having severe hearing or perceptual deficits that impaired communication; having dementia, Alzheimer's disease, depression, uncontrolled diabetes, hypertensive disease and surgical operations with the risk of bleeding.

Primary outcomes:
measure: Children's Hope Scale scores
timeFrame: up to 6 weeks
Secondary outcomes:
measure: School Burnout Inventory score
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Associate professor
name: Nilgun Kuru Alici, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06001008: Validity of the Turkish Version of "Perception of Quality in Anesthesia": A Prospective Observational Cohort Study
Official title: Validity of the Turkish Version of "Perception of Quality in Anesthesia": A Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patient Satisfaction
Keywords: Anesthesia
Perioperative complications
PQA
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing electiveinguinal or umbilical hernia surgery under general or regional anesthesia in Samsun University Hospital

Brief summary: The aim of this study is to test the validity of the Perception of Quality in Anesthesia (PQA) and language compatibility.

Detailed description: The Perception of Quality in Anesthesia (PQA) scale was developed by Hocking et al. in 2013 to measure the quality of anesthesia service received by patients who underwent surgery under anesthesia. The survey consists of 16 questions. Researchers ask patients undergoing surgery to complete the PQA questionnaire 24 hours after surgery. The researcher visits patients in hospital rooms or makes phone calls the day after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective inguinal or umbilical hernia surgery under general or regional anesthesia
* Age between 18 and 80 years
* Ability to understand the content of surveys
* Native speaker of Turkish

Exclusion Criteria:

* Emergency operation
* The need for postoperative intensive care
* Existence of mental disability
* Pregnancy

Primary outcomes:
measure: Construct Validity of PQA (Perception of Quality in Anesthesia)
timeFrame: 24 hours after the surgery
Secondary outcomes:
measure: Response success rate of the PQA
timeFrame: 24 hours after the surgery
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Dilan Akyurt
Study officials:
affiliation: Samsun University
name: Mustafa SÜREN
role: STUDY_DIRECTOR
References:
citation: Hocking G, Weightman WM, Smith C, Gibbs NM, Sherrard K. Measuring the quality of anaesthesia from a patient's perspective: development, validation, and implementation of a short questionnaire. Br J Anaesth. 2013 Dec;111(6):979-89. doi: 10.1093/bja/aet284. Epub 2013 Aug 28.
Clinical trial NCT02007408: Comparison of Lidocaine Spray and Paracervical Block Application for Pain Relief During First-trimester Surgical Abortion: a Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Score
Keywords: abortion
analgesia
paracervical block
lidocaine spray
Lead sponsor: Kayseri Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2013-12-10
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: The investigators sought to investigate the analgesic efficiency of lidocaine spray, paracervical block (PCB) with lidocaine and PCB with lidocaine plus lidocaine spray combination in patients undergoing first-trimester surgical abortion.

Methods: A randomized, double-blind, placebo-controlled clinical trial was conducted on 108 women with the request of pregnancy termination.The subjects were randomly assigned into four groups: PCB (n=27), lidocaine spray (n=27), PCB plus lidocaine spray (n=27) and placebo(n=27).Intraoperative and postoperative pain scores were measured with a standard Visual Analog Scale (VAS).


Eligibility criteria: Inclusion Criteria:

Age \>18 years Single Pregnancy \<7 weeks of gestation

Exclusion Criteria:

Incomplete abortion Early pregnancy failure Acute cervicitis Untreated pelvic inflammatory disease Cervical stenosis

Primary outcomes:
measure: Pain Scores on the Visual Analog Scale
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Gökhan Açmaz
Study officials:
References:
Clinical trial NCT01943708: Novel Auto-continuous Positive Airway Pressure (CPAP) Validation
Official title: A Study to Validate a Novel Auto Continuous Positive Airway Pressure Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sleep Apnea, Obstructive
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2013-09-17
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This single-blind randomised crossover trial aims to compare the efficacy of a novel Auto-CPAP algorithm (SPAP) to conventional CPAP. Up to 50 patients will be recruited from an OSA population, aged over 18.

Detailed description: Auto-CPAP devices change therapeutic pressure based on the needs of the patient. Algorithms differ from machine to machine. This single-blind randomised crossover trial aims to compare the efficacy of SPAP (a novel Auto-CPAP algorithm) to conventional CPAP.

Up to 50 patients will be recruited from an OSA population, aged over 18. Participants will consist of male and female patients diagnosed with moderate-severe OSA (Apnea Hypopnea Index (AHI) greater than or equal to 15 per hour. Eligible participants, according to the protocol approved by the Northern X Region Ethics Committee, providing written informed consent will be enrolled into the study. Patients will be enrolled sequentially according to the randomisation list. Patients will be randomised to CPAP or SPAP.

The therapeutic pressure will be based on the most recent titration night of each patient. Comparisons between data will be made using a one-tailed t-test for non-inferiority of the SPAP algorithm compared with conventional CPAP therapy.

Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years with mild-to-severe OSA (Apnea Hypopnea Index equal to or greater than 5 per hour).

Exclusion Criteria:

* Any medical condition which contraindicates (see Appendix A) the use of CPAP or AutoCPAP.
* Unstable cardiovascular disease (untreated or resistant hypertension acceptable).
* Unstable psychiatric disease.
* Other significant sleep disorder.
* Inability to tolerate CPAP due to nasal obstruction or claustrophobia, as determined by the investigation investigator.
* Any known factor or disease that might interfere with treatment compliance, investigation conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with investigational requirements.
* Participation in another clinical trial in the previous month.
* Less than 2 hours recorded sleep in either arm

Primary outcomes:
measure: AHI
timeFrame: one post study night (once PSG is scored)
Secondary outcomes:
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher and Paykel Healthcare Sleep Lab
Study officials:
References:
Clinical trial NCT05049408: Verification of Saliva MMP-1 as a Diagnostic Marker of Oral Cavity Cancer
Official title: Verification of Saliva MMP-1 as a Strong Diagnostic Marker of Oral Cavity Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Squamous Cell Carcinoma
Keywords: Mouth Neoplasms
Head and Neck Neoplasms
Lead sponsor: S&T Biomed Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-20
Enrollment: 1160
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Randomly selected samples whose donors meeting the eligibility criteria from tissue bank

Brief summary: The study is designed to measure salivary matrix metalloproteinase-1 (MMP-1) using the enzyme-linked immunosorbent assay (ELISA) we developed previously in patients with oral potentially malignant disorders (OPMD), oral squamous cell carcinoma (OSCC), and healthy participants. The purpose of this study is to evaluate the potential of the newly developed salivary MMP-1 ELISA as an adjunctive tool to aid in diagnosis of OSCC.


Eligibility criteria: Inclusion Criteria:

* Group OSCC: patients with lesions of OSCC
* Group OPMD: patients with lesions of OPMD
* Group HC: healthy subjects who are not suffering from any oral lesions and having behaviors of smoking, and/or betel nut chewing

Exclusion Criteria:

* Subjects having personal history of other cancers or severe diseases

Primary outcomes:
measure: Sensitivity and Specificity (both range from 0 to 1, the higher the better) of salivary MMP-1 levels as a diagnostic marker for OSCC
timeFrame: 30 days from initial sample obtained for this study
Secondary outcomes:
measure: ROC analysis of non-cancer group versus OSCC patients to find the optimal cutoff as the maximum of Youden's index (calculated as sensitivity + specificity - 1 and ranges from 0 to 1, the higher the better)
timeFrame: 30 days from initial sample obtained for this study
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Tainan
country: Taiwan
facility: Chi-Mei Medical Center
Study officials:
References:
citation: Chang YT, Chu LJ, Liu YC, Chen CJ, Wu SF, Chen CH, Chang IY, Wang JS, Wu TY, Dash S, Chiang WF, Chiu SF, Gou SB, Chien CY, Chang KP, Yu JS. Verification of Saliva Matrix Metalloproteinase-1 as a Strong Diagnostic Marker of Oral Cavity Cancer. Cancers (Basel). 2020 Aug 13;12(8):2273. doi: 10.3390/cancers12082273.