louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06921200: Effect of Perineal Cryotherapy on Episiotomy
Official title: Effect of Perineal Cryotherapy on Episiotomy- Associated Pain Among Postpartum Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Normal Vaginal Delivery
Perineal Episiotomy
Keywords: Episiotomy
Pain
Perineal cryotherapy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The present study aims to evaluate the effect of perineal cryotherapy on episiotomy- associated pain among postpartum women.

The study hypothesis: Post-partum women who apply perineal cryotherapy have lower level of episiotomy- associated pain than those who don't apply.

Detailed description: The present study included postpartum mothers who are in a good health immediately after giving delivery, having an episiotomy and a normal vaginal birth of a single, full term, healthy baby with normal weight and vertex presentation.

Eligibility criteria: Inclusion Criteria:

* Postpartum mothers who are in a good health immediately after giving delivery.
* Having an episiotomy and a normal vaginal birth.
* Having a vaginal birth at full term.
* The delivery of a healthy single fetus having normal weight and vertex presentation.

Exclusion Criteria:

* Women who are experiencing labor or complications after giving birth, such as hemorrhage, a tear, or a cut in the perineum.

Primary outcomes:
measure: Level of episiotomy-associated pain
timeFrame: from enrollmet until four hours after delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01498900: An Observational Study Evaluating Efficacy, Safety and Convenience of NovoNorm® in Treatment of Type 2 Diabetes in Routine Clinical Practice
Official title: A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoNorm® in the Treatment of Type 2 Diabetic Patients in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 30554
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes, newly diagnosed or not adequately controlled on their current therapy, who are treated repaglinide by their physicians in accordance with the approved labeling

Brief summary: This study is conducted in Africa and Asia. The aim of this study is to evaluate the efficacy, safety and convenience of using repaglinide (NovoNorm®) in type 2 diabetes management in routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Newly diagnosed or not adequately controlled with current therapy

Primary outcomes:
measure: HbA1c (glycosylated haemoglobin)
Secondary outcomes:
measure: Fasting Plasma Glucose (FPG)
measure: Postprandial glucose values
measure: Incidence of hypoglycaemia
measure: Adverse drug reactions (ADR)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03377400: Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer
Official title: Phase II Trial of Durvalumab (MEDI4736 )/Tremelimumab Combined With Definitive Concurrent Chemo-radiotherapy for Inoperable Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single arm phase II study, in which 2 cycles of chemotherapy (5FU/CDDP) and immunotherapy (durvalumab and tremelimumab) are administered every 3 weeks with concurrent radiotherapy for inoperable locally advanced esophageal squamous cell carcinoma. Four weeks after completion of CCRT combined with immunotherapy, 2 cycles of durvaluma and tremelimumab will be administered every 4 weeks and thereafter durvalumab monotherapy Q4W will be maintained until unacceptable toxicity or disease progression, or for maximum 2 years after enrollment.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed squamous esophageal cancer
* The clinical stage T2-3N0M0 or T1-3N1-3M0
* Inoperable case: it refers to medically inoperable status and/or patient's refusal to surgery and/or cervical location and/or locoregionally recurrent tumor after primary surgery
* ECOG PS of 0 to 1

Exclusion Criteria:

* clinical T4 disease (for example, invasion to aorta, vertebral body, or trachea/bronchus) or distant metastasis (M1)
* previously received radiotherapy for esophageal cancer

Primary outcomes:
measure: Progression-free survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: MA
Study officials:
affiliation: Samsung Medical Center
name: Jong-Mu Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05631600: Manuka Honey as an Adjunct to Non-surgical Periodontal Therapy: Clinical Study
Official title: Manuka Honey as an Adjunct to Non-surgical Periodontal Therapy: Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Periodontal Diseases
Periodontal Pocket
Periodontal Bone Loss
Periodontal Attachment Loss
Keywords: Periodontitis
Manuka honey
Periodontal pocket depth
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Split-mouth study
Primary purpose: TREATMENT

Brief summary: The goal of this split-mouth clinical trial is to evaluate the effects of Manuka honey applied into periodontal pockets after initial periodontal therapy (NSPT) in the treatment of stage 3 periodontitis.

The main question it aims to answer is:

• does the adjunct of Manuka honey improve the outcome of the non-surgical periodontal treatment.

The intervention in this study was conducted in a split-mouth design, meaning that after completing the NSPT for each subject, Manuka honey was administered as an adjunct to the periodontal treatment in two randomly selected quadrants of the oral cavity around the teeth with a specially designed cannula.

This was followed by oral hygiene instructions and training. The home-performed oral hygiene procedures were focused on interdental cleaning using dental floss and toothbrushing with regular fluoride-containing toothpaste. The subjects were also instructed not to use any form of oral antiseptic (e.g., chlorhexidine) or antibiotic during the follow-up period.


Eligibility criteria: Inclusion Criteria:

* Patients of both genders with good systemic health;
* Non-smokers;
* Presence of at least 20 teeth;
* Untreated moderate to advanced generalized chronic periodontitis according to the 1999 Classification 199 , i.e., generalized stage III periodontitis according to the 2007 Classification

Exclusion Criteria:

* Pregnant and nursing women;
* Antibiotics prescribed for dental or non-dental diseases 6 months before the start of the research;
* Systemic diseases or the use of drugs known to affect periodontal tissues, bleeding parameters;
* Acute oral or periodontal inflammation or infection (pericoronitis, necrotizing periodontal diseases, etc.).

Primary outcomes:
measure: Periodontal pocket depth
timeFrame: Baseline; 12 months
measure: Clinical attachment level
timeFrame: Baseline: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: School of Dental Medicine
Study officials:
References:
Clinical trial NCT03469700: General Anesthesia vs Paravertebral Block With General Anesthesia For Laparoscopic Sleeve Gastrectomy
Official title: General Anesthesia vs Paravertebral Block With General Anesthesia For Post-Operative Pain Post Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Makassed General Hospital
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The incidence of obesity is steadily rising. Laparoscopic sleeve gastrectomy (LSG) is an innovative approach to the surgical management of morbid obesity.

We will be discussing the effect of adding paravertebral block (PVB) in addition to general anesthesia (GA) vs. GA alone for post operative pain after laparoscopic sleeve gastrectomy.

Detailed description: This is a prospective, randomized, double-blind controlled clinical trial. Written informed consent will be obtained from patients. Patients will be randomly assigned using the sealed envelope technique into 2 equal groups: Group 1 will be patients who receive general anesthesia with paravertebral block, whereas group 2 will be patients who receive general anesthesia with placebo block.

Eligibility criteria: Inclusion Criteria:

* Patients with body mass index (BMI) greater than or equal to 30
* American Society of Anesthesiologist (ASA) score greater than or equal to 2
* Undergoing laparoscopic gastric sleeve surgeries

Exclusion Criteria:

* Patients with ASA score less than 2 and greater than 4
* Patients with any type of allergy to local anesthesia
* Patients refusing to be part of the study (refusal to sign consent)
* Any complication during surgery or anesthesia

Primary outcomes:
measure: postoperative pain
timeFrame: within 1 week postoperatively
Secondary outcomes:
measure: ambulation
timeFrame: within 1 week postoperatively
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Makassed General Hospital
Study officials:
affiliation: Makassed General Hospital
name: Saleh Kanawati, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01406600: Optimal rhCG(Ovidrel®) Dose in Poor Responder During IVF and ICSI Cycles
Official title: Optimal rhCG(Ovidrel®) Dose for Final Oocyte Maturation Triggering in Poor Responder During IVF and ICSI Cycles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: in Vitro Fertilization
Poor Responder
Keywords: recombinant hCG
poor responder
oocyte maturity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-08-01
Enrollment: 70
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Choriogonadotropin alfa (Ovidrel®) is a recombinant hCG (rhCG) preparation derived from genetically engineered Chinese hamster ovary cells, which is widely used for final oocyte maturation triggering in assisted reproductive technology (ART).Recombinant hCG has been investigated about its safety and efficacy comparing with urinary hCG, but still the optimal dose of rhCG is questionable. From former studies, there only have been proven that high dose of hCG can make ovarian hyperstimulation syndrome (OHSS) in usual condition. On the other hand, we hypothesize that high dose of hCG may improve oocyte maturity in poor responders who cannot easily provoke OHSS. Hence, this study will assess the comparative efficacy and safety of 250mcg and 500mcg of rhCG in ART treatment cycle.

Detailed description: Randomized prospective clinical study that compare the two doses of rhCG (250mcg vs. 500mcg).

Eligibility criteria: Inclusion Criteria:

* poor response in prior IVF cycle (≤ 4 oocyte retrieved)
* women's age ≥ 40 years
* FSH ≥ 10mIU/mL or AMH ≤ 1.1ng/mL
* Antral follicle count \<6

Exclusion Criteria:

* patient without informed consent

Primary outcomes:
measure: oocyte maturity
timeFrame: Up to the ovum pick up day. At the point of ovum pick-up, we can count how many mature or immature oocytes were retrived. Therefore, in one hour after ovum pick-up, outcome measurement will be possible.
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: After confirming fetal heart beat via transvaginal ultrasound. Usually 2 to 4 weeks after ovum pick-up day.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT05057000: Effect of Aerobic Exercises and Nutrition In Adolescent Girls With Anorexia
Official title: Effect of Aerobic Exercises and Nutrition on The Activities of Daily Living and Estrogen Level in Adolescent Girls With Anorexia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anorexia in Adolescence
Keywords: anorexia
adolescent girls
areobic exercises
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized control study used to identify the effect of aerobic exercises on the activity of daily living and estradiol serum level in young girls with anorexia

Detailed description: Control group will receive diet program while the study group received the same diet program given to control group in addition to AEROBIC exercise program.

Inclusive criteria

* Thirty girls with anorexia
* BMI ≤ 18 kg/m2
* Age ranged from (14-17 years).
* Exclusive criteria:
* Girls did not receive any exogenous steroid and other treatment which could affect plasma levels of estrogen hormone.
* Exclude any other eating disorders

Data analysis and statistical design:

The collected data will be statistically treated using:

Descriptive statistics.

Inferential statistics using:

Paired t-test.

Eligibility criteria: Inclusion Criteria:

* Thirty girls with anorexia
* BMI ≤ 18 kg/m2
* Age ranged from (14-17 years).

Exclusion Criteria:

Girls did not receive any exogenous steroid and other treatment which could affect plasma levels of estrogen hormone.

Primary outcomes:
measure: Estradiol level
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Badr University
Study officials:
References:
Clinical trial NCT03849300: Impacts of Aquatic vs Land Walking on Vascular Health and Exercise Tolerance in Patients With Peripheral Artery Disease
Official title: The Impacts of Aquatic Walking and Land-based Walking Exercise Therapy Programs on Vascular Function, Cardiorespiratory Capacity, Exercise Tolerance, Muscular Strength, and Physical Function in Patients With Peripheral Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Vascular Function
Exercise Tolerance
Peripheral Arterial Disease
Keywords: arterial stiffness
cardiorespiratory capacity
exercise tolerance
VO2max
Lead sponsor: Pusan National University
Sponsor class: OTHER
Collaborators: name: Marymount University
name: Dong-Eui University
First posted: 2019-02-21
Enrollment: 147
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: aquatic walking exercise intervention group 1 vs. control group; aquatic walking exercise intervention group 2 vs. land-based walking exercise group
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study was to examine the impacts of a 12-week aquatic walking exercise program on body composition, vascular function, cardiorespiratory capacity, exercise tolerance, muscular strength, and physical function in patients with peripheral artery disease (PAD). The effects of the 12-week aquatic walking exercise program were also compared to the effects of a 12-week land-based walking exercise program.


Eligibility criteria: Inclusion Criteria:

* Peripheral artery disease (ankle-brachial index between 0.6 and 0.9)
* 50-85 years of age
* Sedentary (less than 1 hour of regular exercise participation per week within the previous year)

Exclusion Criteria:

* current smoker (smoking within previous 6 months)
* psychiatric conditions
* pulmonary disease
* renal disease
* thyroid disease

Primary outcomes:
measure: Peripheral Arterial Stiffness
timeFrame: 12 weeks
Secondary outcomes:
measure: Body Composition
timeFrame: 12 weeks
measure: Resting Heart Rate
timeFrame: 12 weeks
measure: Systolic Blood Pressure
timeFrame: 12 weeks
measure: Resting Metabolic Rate
timeFrame: 12 weeks
measure: Cardiorespiratory Capacity
timeFrame: 12 weeks
measure: Exercise Tolerance - Walking Capacity
timeFrame: 12 weeks
measure: Upper Body Strength
timeFrame: 12 weeks
measure: Lower Body Strength
timeFrame: 12 weeks
measure: Lower Body Flexibility
timeFrame: 12 weeks
measure: Medical Outcomes Study Short-Form 36 General Health Survey for Physical Function
timeFrame: 12 weeks
measure: Diastolic Blood Pressure
timeFrame: 12 weeks
measure: Systemic Arterial Stiffness
timeFrame: 12 weeks
measure: Time to Onset of Claudication
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06627400: Association of Urinary Incontinence With Depression, Insomnia, Frailty and Falls in Older Adults
Official title: Association of Urinary Incontinence With Depression, Insomnia, Frailty and Falls in Older Adults: a Cross-sectional Comprehensive Geriatric Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence,Stress
Urinary Incontinence, Urge
Depressive Disorder
Insomnia
Frailty
Fall
Lead sponsor: Kastamonu University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 635
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study was conducted using the electronic records of patients aged 60 and over who presented to the outpatient geriatric clinic from January 2024 to July 2024. The patients with comprehensive geriatric assessment data were included in the study. Patients with dementia, those who experienced cerebrovascular occlusion with resulting neuromuscular paralysis, individuals with active infections, schizoaffective disorder, epilepsy or other neuromuscular disorders, as well as those who were wheelchair or bed-bound, and patients with advanced chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) were excluded from the study.

Brief summary: The aim of our study is to provide a holistic analysis of the geriatric syndromes associated with urinary incontinence, which can result in significant adverse outcomes in the elderly, and to explore the gender-specific relationships within these associations. The study revealed that urinary incontinence is highly prevalent among the older adults, particularly in women, and is associated strongly with depression, insomnia, frailty, and falls. Moreover, while older women with urinary incontinence exhibited more depressive symptoms than men, urinary incontinence was associated with similar frequencies of insomnia in both sexes. Considering the negative outcomes of depression, insomnia, frailty, and falls in older adults, as well as a decline in functionality, cognitive impairment, and prolonged hospitalizations and even mortality they cause, it becomes evident that urinary incontinence must be routinely assessed and treated by clinicians.


Eligibility criteria: Inclusion Criteria:

* The patients with comprehensive geriatric assessment data

Exclusion Criteria:

* dementia,
* those who experienced cerebrovascular occlusion with resulting neuromuscular paralysis
* active infections,
* schizoaffective disorder,
* epilepsy
* neuromuscular disorders
* those who were wheelchair or bed-bound,
* advanced chronic obstructive pulmonary disease (COPD)
* advanced chronic heart failure (CHF)

Primary outcomes:
measure: depression
timeFrame: Baseline
measure: frailty
timeFrame: Baseline
measure: insomnia
timeFrame: Baseline
measure: fall history
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Kastamonu
country: Turkey
facility: Kastamonu University
Study officials:
References:
Clinical trial NCT03463200: KT on Low Back Pain Patients
Official title: The Influence of Kinesio Taping on Back Muscle Fatigue of Low Back Pain Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: bandage
low back pain
muscle fatigue
electromyography
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aim evaluates the effect of Kinesio Taping (KT) on back muscle fatigue of low back pain patients, analysing the electromyography activity of longissimus muscle (median frequency) and the sustained time during a fatigue test (Ito test).

Detailed description: Individuals with low back pain usually have poor back muscles endurance, which may be improved with the application of Kinesio Taping. The aim of this study is evaluate the effect of Kinesio Taping on back muscle fatigue of low back pain patients. Sixty-four women, between 18 to 50 years old, with chronic nonspecific Low Back Pain will attend this study. They will be randomly assigned in four different groups: control group (CG), KT with tension group (KTT), KT no tension group (KTNT) and Micropore® group (MP) and submitted to three evaluations: pre, three and ten days after intervention, analysing the electromyography activity of longissimus muscle and the sustained time during a fatigue test. The variables analysed during the evaluations will be median frequency (MP) slope of longuissimus muscle and sustained time during the Ito test.

Eligibility criteria: Inclusion Criteria:

* Female between 18 and 50 years of age with chronic nonspecific low back pain for more than three months.

Exclusion Criteria:

* Serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as ankylosing spondylitis);
* Nerve root compromise (disc herniation and spondylolisthesis with neurological compromise, spinal stenosis, and others);
* Fibromyalgia
* Corticosteroid treatment in the previous two weeks;
* Antiinflammatory treatment in the previous 24 hours;
* Contraindications to the use of Kinesio Taping (allergy or intolerance);
* Score of two or less on Visual Analogue Scale of the first day;
* Pregnancy;
* Previous Kinesio Tape therapy on lumbar.

Primary outcomes:
measure: Median frequency
timeFrame: Change from baseline median frequency at three days after the application of the tape.
Secondary outcomes:
measure: Median frequency
timeFrame: Change from baseline median frequency at ten days after the application of the tape.
measure: Sustained muscle fatigue time
timeFrame: Change from baseline sustained time at three days after the application of the tape.
measure: Sustained muscle fatigue time
timeFrame: Change from baseline sustained time at ten days after the application of the tape.
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Federal University of Rio Grande do Norte
state: RN
Study officials:
References: