louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04937023: Ursodeoxycholic Acid (Udca) as a Local Drug Delivery Agent in the Treatment of Intra-bony Defects
Official title: Assessing the Clinical Efficacy of Ursodeoxycholic Acid (Udca) as a Local Drug Delivery Agent in the Treatment of Intra-bony Defects: A Clinico-radiographic Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Regeneration
Lead sponsor: SVS Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy of ursodeoxycholic acid as local drug delivery agent in intra- bony defect to achieve bone regeneration.

Detailed description: Experimental: Main treatment group the prepared UDCA gel will be injected using a syringe with blunt cannula into the defect site.

Comparator: In patients allocated to control group, placebo gel will be injected in to the defect site using a syringe with blunt cannula.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy male and female patients of age\>18 years with intrabony defects - two wall or three wall defects and probing pocket depths (PPD) of \>3mm will be included

Exclusion Criteria:

* Medically compromised patients, pregnant women, heavy smokers, and patients who underwent radiotherapy or chemotherapy will be excluded.

Primary outcomes:
measure: Evaluation of bone regeneration
timeFrame: Baseline to 6 months
measure: Evaluation if clinical attachment level
timeFrame: Baseline to 6 months
measure: Evaluation of probing pocket depth
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Evaluation of gingiva
timeFrame: Baseline to 6 months
measure: Evaluation of gingival bleeding
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: SVS Institute of Dental Sciences
state: Telangana
Study officials:
References:
Clinical trial NCT02247323: Ovarian Malignancy Incidence in Moderate Risk Women With Low CA 125
Official title: Ovarian Malignancy Incidence in Premenopausal Women Who Were at Moderate Risk for Malignancy by Risk of Malignancy Index With Low CA 125.(Retrospective Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 200
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premenopausal who had complex ovarian mass with low CA125 and at moderate risk for malignancy by RMI.

Brief summary: The investigators are assessing the incidence of ovarian cancer in premenopausal women who were at moderate risk of malignancy with low CA125.

Detailed description: About 10% of premenopausal women may have a surgery for ovarian masses. In premenopausal women the incidence of ovarian malignancy is 1:1000 in case of symptomatic ovarian cyst.1 CA125 is unreliable in differentiating benign from malignant ovarian mass in premenopausal women due to many false positive results and reduced specificity.1 pelvic vaginal ultrasonography is the most effective tool in evaluating ovarian masses due to increased sensitivity over abdominal US.1 An estimation of risk of malignancy index is essential in evaluating an ovarian mass.26 /2 Risk of malignancy index combines presurgical features serum including CA125, menopausal status and ultrasound findings. RMI=Ux Mx CA125 in which each feature takes a score and after calculation score less than 25 is mild, from 25-250 moderate and more than 250 has a severe risk of malignancy needing oncologist.44/3

Eligibility criteria: Inclusion Criteria:

* Women with complex ovarian cyst
* Abdominal pain
* Menometrorrhagia

Exclusion Criteria:

* Significant weight loss
* Cachexia
* History of ovarian or other malignancy
* Family history of ovarian Cancer

Primary outcomes:
measure: Incidence of ovarian malignancy
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Beni-Suef University
Study officials:
affiliation: Beni-Suef University
name: Nesreen A Shehata, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05276323: Medihoney® Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children Study
Official title: Medihoney® Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children: an Open-label Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: eczema
atopic dermatitis
Medihoney dermacream
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: We conducted a randomized trial comprising children aged 2-18 diagnosed with mild to moderate AD, with an IGA of 2-3 and BSA of 1%-10%, including 30 patients, 20 using Med-D-Cream and 10 as controls using Hydrocortisone 1% cream. Patients applied creams for 2 weeks and were then followed for two weeks to measure clinical responses.
Primary purpose: TREATMENT

Brief summary: A randomized, open-label trial comparing Medihoney Derma Cream to Hydrocortisone 1% cream. Children between the ages of 2-18 years old diagnosed with mild to moderate atopic dermatitis with an IGA (Investigator Global Assessment) score of 2-3, and a BSA (Body Surface Area) score of 1%-10% were included.

Detailed description: A randomized trial comprising children aged 2-18 diagnosed with mild to moderate AD, with an IGA of 2-3 and BSA of 1%-10%, including 30 patients, 20 using Med-D-Cream and 10 as controls using Hydrocortisone 1% cream. Patients applied creams for 2 weeks and were then followed for two weeks to measure clinical responses and pruritus change.

Eligibility criteria: Inclusion Criteria:

* 2-18 years old
* mild to moderate atopic dermatitis
* an IGA score of 2-3
* BSA score of 1%-10%.

Exclusion Criteria:

* participation in any clinical trial less than 28 days before the enrollment
* AD-related systemic therapy or phototherapy within 28 days prior to the enrollment
* topical corticosteroids, calcineurin inhibitors, or PDE4 inhibitors use within 7 days prior to the enrollment

Primary outcomes:
measure: response rate
timeFrame: 1 month
Secondary outcomes:
measure: VAS (Visual Analogue Scale) pruritis score
timeFrame: 1 month
measure: SCORAD - (SCORing Atopic Dermatitis)
timeFrame: 2 weeks
measure: The Eczema Area and Severity Index (EASI)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
Study officials:
References:
Clinical trial NCT05635123: A Cohort Study of Uterine Malignancies
Official title: A Cohort Study of Uterine Malignancies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Endometrial Cancer
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 6200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators establish a population cohort of 6200 women including patients with cervical cancer or endometrial cancer, and women attending to a health check-up.

Brief summary: The purposes of current study were to explore the relationship between cervical cancer/endometrial cancer and demographic information, behavior and life style, pregnancy-related factors, and disease history, and to study the factors affecting the prognosis of cancers. In addition, omics tests were performed on the biological specimens to identify the diagnostic markers and prognostic biomarkers.

Detailed description: After being informed about the study and potential risks, all patients who meet the eligibility requirements will be enrolled.

Eligibility criteria: Inclusion Criteria:

* Age 20-75 years;
* Women with cervical cancer or endometrial cancer with a definite pathological diagnosis for the first time;
* Women attending a health check-up;
* Obtain informed consent and sign an informed consent form.

Exclusion Criteria:

* Patients who are unable to cooperate with the investigations such as mental disorders or cognitive impairment；
* Patients with cancer other than cervical cancer or endometrial cancer;
* Women who have received hysterectomy or pelvic radiation therapy previously.

Primary outcomes:
measure: progression free survival (PFS)
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's hospital school of medicine zhejiang university
state: Zhejiang
Study officials:
affiliation: Women's Hospital School Of Medicine Zhejiang University
name: Hui Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06719323: Long-term Effects of Family WISH Program for Adolescents with Congenital Heart Disease
Official title: Long-term Effects of Family WISH Program for Adolescents with Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Defects, Congenital
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 104
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn the long-term effects of "Family Walking Instruction with Support by Heart" (Family WISH) on frailty state, quality of life and family functioning among adolescents with congenital heart disease (CHD).

Researchers will compare the 12-week Family WISH program, based on self-efficacy theory, to a comparison group receiving a family walking health education sheet to evaluate the long-term effectiveness of the Family WISH program.

Participants will:

* Walk with family members for 20-30 minutes daily, at least 5 times per week, totaling 150 minutes per week.
* Keep a diary to record the frequency of their walks and any symptoms experienced.
* Complete questionnaires at baseline, and at 6, 12, and 24 weeks.


Eligibility criteria: Inclusion Criteria:

* being between 12 and 18 years old;
* having received a diagnosis of CHD by a physician before age 2;
* having received a diagnosis of CHD with New York Heart Association (NYHA) functional class I, II, or III;
* having parents or guardians who were able to communicate in Mandarin, and being able to communicate in Mandarin themselves;
* not having cognitive impairments, and;
* voluntarily signing informed consent forms.

Exclusion Criteria:

* undergoing heart transplant surgery within the past year;
* receiving cardiac catheterization intervention or open-heart surgery within the past 6 months;
* having CHD with NYHA functional class IV; and
* having other congenital diseases

Primary outcomes:
measure: frailty state
timeFrame: at baseline, and at 6, 12, and 24 weeks
Secondary outcomes:
measure: quality of life and family functioning
timeFrame: at baseline, and at 6, 12, and 24 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: College of Nursing, National Yang Ming Chiao Tung University
Study officials:
References:
Clinical trial NCT00823823: Randomized Trial of Casting Techniques for Displaced Forearm Fractures
Official title: Randomized Trial of Bivalved and Circumferential Casting for Displaced Forearm Fractures in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Displaced Forearm Fractures
Keywords: Casting techniques
Bivalved cast
Circumferential cast
Displaced distal radius fracture
Children
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2009-01-16
Enrollment: 202
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is recognized that fractures of the distal radius and forearm occur in approximately one in 100 children and adolescents every year. Though closed manipulation and cast immobilization of displaced injuries is the mainstay of treatment in the majority of cases, the optimal type of cast remains debatable. Though well-molded casts theoretically provide the best ability to maintain fracture alignment, risks of circumferential immobilization in acute injuries include neurovascular compromise. Splitting, or bivalving, casts may reduce these risks, but the effect on fracture stability is unknown. The proposed investigation seeks to address the simple question of whether circumferential or bivalved casts provide the best outcomes.


Eligibility criteria: Inclusion Criteria:

* Displaced distal radius or mid-diaphyseal forearm fracture
* fracture requires closed reduction and cast immobilization
* Age 4-16 years
* Skeletally immature

Exclusion Criteria:

* Failed closed reduction
* Acute fracture \> 1 week old
* Refracture injury
* Fracture requires surgical treatment
* Significant soft tissue swelling
* Associated neurovascular compromise
* Plastic deformation injuries

Primary outcomes:
measure: Loss of Radius Fracture Reduction
timeFrame: 4 weeks post-randomization
Secondary outcomes:
measure: Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations
timeFrame: Up to 4 weeks post-randomization
Other outcomes:
Locations:
city: Boston
country: United States
facility: Childrens Hospital Boston
state: Massachusetts
Study officials:
affiliation: Childrens Hospital Boston
name: Donald Bae, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05538923: Oral Health in Children With Inflammatory Bowel Disease
Official title: Dental Caries, Dental Erosion and Periodontal Disease in Children With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Health in Children With Inflammatory Bowel Disease
Keywords: inflammatory bowel disease, children, permanent dentition, nutritional habits
Lead sponsor: Marmara University
Sponsor class: OTHER
Collaborators: name: Saglik Bilimleri Universitesi
First posted: 2022-09-14
Enrollment: 64
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population with inflammatory bowel disease in the remission period.

Brief summary: In adults with inflammatory bowel disease (IBD), a higher prevalence of dental caries and periodontal disease has been reported compared with healthy control subjects, but similar data on children are missing in the literature.We aimed to evaluate the prevalence of dental erosion, dental caries and periodontal disease in children with IBD.

Detailed description: In this age- and gender-matched prospective case-control study, detailed questionnaires including nutritional habits and oral examinations were completed for 32 IBD patients aged 11 to 18 (15,53±2,00 yr) and 32 healthy controls based on the established criteria of the World Health Organization by the same pediatric dentist.

Eligibility criteria: Inclusion Criteria:

* 11-18 years of age
* Study population with IBD in the remission period of disease
* Permanent dentition stage

Exclusion Criteria:

* Those who refused or whose families refused participation in this study
* Study population with IBD in the active period of disease
* Primary or mix dentition stage
* Systemic conditions, or medications with impact on periodontal tissues and previous orthodontic or periodontal treatment within the last year.
* Smoking

Primary outcomes:
measure: Dental caries
timeFrame: In one year
measure: Dental erosion
timeFrame: In one year
measure: Periodontal disease
timeFrame: In one year
measure: Oral extraintestinal manifestations (EIMs)
timeFrame: In one year
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Marmara University
Study officials:
References:
Clinical trial NCT03231423: Effect of Drainage on Laparoscopic Gastric Bypass Surgery
Official title: Effect of Drain Usage on Patient Comfort on Laparoscopic Gastric Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Keywords: Obesity
VAS
Pain
Laparoscopy
Bypass
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method. The purpose of this study is to determine the use of drain, which closely affects these criteria; And the effect on patient comfort.

Detailed description: Question the necessity of routine use of drain in RYGB surgeon

Eligibility criteria: Inclusion Criteria:

* Morbid obese patients

Exclusion Criteria:

* Cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries during LRYGBP and those who had previously undergone obesity surgery (revision surgery) were excluded

Primary outcomes:
measure: 3-Item Pain Intensity measyre (P3)
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04007250: FENIX™ Continence Restoration System Registry
Official title: FENIX™ Continence Restoration System Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fecal Incontinence
Faecal Incontinence
Keywords: Magnetic Anal Sphincter Augmentation
FENIX™ continence restoration system
Magnetic Anal Sphincter
Lead sponsor: Torax Medical Incorporated
Sponsor class: INDUSTRY
First posted: 2019-07-05
Enrollment: 94
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic fecal incontinence patients who have failed or are not candidates for more conservative therapy.

Brief summary: The FENIX Registry is a multi-center, observational database designed to collect data regarding the FENIX™ Continence Restoration System in everyday clinical practice, evaluate the clinical course of patients from pre-operative assessment through five years post-surgery and Track and monitor effectiveness and safety through the use of a bowel diary, fecal incontinence quality-of-life measures and adverse event reporting. Up to 25 sites will participate in the Registry. Sites to enroll consecutive eligible patients into the Registry. Registry will enroll approximately 200 FENIX patients.


Eligibility criteria: Inclusion Criteria:

* Individuals being treated with the FENIX™ Continence Restoration System
* Individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the FENIX Registry.
* Individuals willing to complete a 14-day bowel diary, questionnaires and comply with all required follow-up.

Exclusion Criteria:

* Known circumstances that would make it unlikely for an individual to complete the five-year follow-up (e.g. life expectancy \<5 years)

Primary outcomes:
measure: Change in fecal incontinence (FI) episodes
timeFrame: Evaluate at 6 months and then annually at 12 months through 60 months post implant
measure: Change in fecal incontinence days
timeFrame: Evaluate at 6 months and then annually at 12 months through 60 months post implant
measure: Adverse events related to the FENIX system
timeFrame: assessed up to last follow up [max 60 months]
measure: Change in Fecal Incontinence Quality of Life: Fecal Incontinence Quality of Life (FIQOL) score.
timeFrame: Evaluate at 6 months and then annually at 12 months through 60 months post implant
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Hospital of Nantes
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
Study officials:
References:
Clinical trial NCT02093650: Black Cohosh Extract for Treatment of Moderate to Severe Menopausal Symptoms
Official title: Black Cohosh Extract for the Treatment of Moderate to Severe Menopausal Symptoms: a Randomized-placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Menopause
Quality of Life
Keywords: Menopausal symptoms
menopause related quality of life
black cohosh
cimicifuga racemosa
MENQOL
Kupperman index
KI
liver function tests
Lead sponsor: Navamindradhiraj University
Sponsor class: OTHER
First posted: 2014-03-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare the treatment efficacy of black cohosh extract 80 mg daily and placebo for moderate to severe menopausal symptoms

Detailed description: Compare the treatment efficacy of black cohosh extract 80 mg/day an placebo for moderate to severe menopausal symptoms with Kupperman menopausal index and MENQOL

Eligibility criteria: Inclusion Criteria:

* Age at least 40 years
* Peri or post menopause
* Moderate to severe menopausal symptoms (Kupperman index at least 20)

Exclusion Criteria:

* Use hormonal treatment or other treatments within 4 weeks
* Use atorvastatin azathioprine or cyclosporin within 4 weeks
* BMI at least 30 kg m2
* Allergic to drug or components
* Liver disease or abnormal liver function test
* Psychiatric disease
* Alcoholic or drug abuse
* Vegetarian

Primary outcomes:
measure: The changes in Kupperman Index
timeFrame: baseline, week 4, week 8 and week 12
Secondary outcomes:
measure: A change in MENQOL
timeFrame: baseline and week 12
measure: The changes in daily hot flushes frequency
timeFrame: baseline, week 4, week 8 and week 12
measure: Global satisfaction
timeFrame: week 12
measure: A change in liver function test
timeFrame: baseline and week 12
measure: adverse events
timeFrame: week 4, week 8 and week 12
Other outcomes:
Locations:
city: Dusit
country: Thailand
facility: Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
state: Bangkok
Study officials:
affiliation: Faculty of Medicine Vajira Hospital
name: Patsama Vichinsartvichai, MD
role: PRINCIPAL_INVESTIGATOR
References: