louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00394758: A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia
Official title: Comparison of Surgical Procedures in Vulvar and Vaginal Dysplasias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vulvar Dysplasia
Vaginal Dysplasia
Keywords: ultrasonic surgical aspiration
CO2 laser surgery
vulvar dysplasia
vaginal dysplasia
recurrence
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2006-11-01
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 1. To compare the recurrence rate between the use of laser vaporization and ultrasonic surgical aspiration in the treatment of vulvar and vaginal dysplasias
2. To compare healing related complications, post-operative pain, and scarring between the two procedures.

Detailed description: First line of treatment for vulvar intraepithelial neoplasia (VIN) and vaginal intraepithelial neoplasia (VAIN) is not well defined. Laser vaporization and ultrasonic surgical aspiration are both accepted surgical modalities used in the treatment of vulvar and vaginal dysplasias, however no prospective study has been done to compare the two procedures. The specific aims of this research study include:

1. To compare the recurrence rate between the use of laser vaporization and ultrasonic surgical aspiration in the treatment of vulvar and vaginal dysplasias in a prospective, multi-institutional, randomized clinical trial.
2. To compare healing related complications, post-operative pain, and scarring between the two procedures.

Eligibility criteria: Inclusion Criteria:

* Patients who present with vulvar or vaginal dysplasias or condylomas that require surgical intervention will be informed of the study by the treating physician
* Pre-operative biopsies to confirm presence of dysplasia / condyloma. Patients with dysplasias of grade 3 / CIS will be included at the discretion of the treating surgeon and will have had invasion confidently excluded by clinical exam and biopsy.

Exclusion Criteria:

* Patients under the age of eighteen or who are pregnant will be excluded

Primary outcomes:
measure: recurrence rate
Secondary outcomes:
measure: pain
measure: side effects
measure: complications
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Vivian von Gruenigen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: von Gruenigen VE, Gibbons HE, Gibbins K, Jenison EL, Hopkins MP. Surgical treatments for vulvar and vaginal dysplasia: a randomized controlled trial. Obstet Gynecol. 2007 Apr;109(4):942-7. doi: 10.1097/01.AOG.0000258783.49564.5c.
Clinical trial NCT03504358: A New Prognostic Scoring System for Spontaneous Ruptured Hepatocellular
Official title: A New Prognostic Scoring System for Spontaneous Ruptured Hepatocellular Carcinoma: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rupture, Spontaneous
Keywords: surgery
scoring system
hepatocellular carcinoma
homogeneity and discriminatory ability
survival
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 129
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ten year HCC rupture patients who received partial hepatectomy at Tongji Hospital of the Huazhong University of Science and Technology

Brief summary: Develop a new scoring system for HCC patients with tumor rupture.

Detailed description: There has been no special prognostic scoring system for HCC patients with tumor rupture in the literature. In this work, we obtained all survival risk factors of ruptured HCC patients who underwent partial hepatectomy using multivariable Cox regression analysis. Furthermore, we develop and validate a new postoperative scoring system for patients with spontaneous HCC rupture based on the these results.

Eligibility criteria: Inclusion Criteria:

* Received partial hepatectomy; with Child A or B liver function.

Exclusion Criteria:

* Without complete data；loss of follow-up; had reveived repeated transcatheter arterial chemoembolization before rupture; received non-radical resection.

Primary outcomes:
measure: Overall survival
timeFrame: 3 years
Secondary outcomes:
measure: Disease-free survival
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Huazhong University of Science and Technology
name: Bi-xiang Zhang, Prof, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT04406558: Psychological Impact of the Health Measures Generated by the COVID19 in Adolescents
Official title: Psychological Impact of the Health Measures Generated by the SarsCov-2 Pandemic in Adolescents (COVADO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Adaptation
Psychology, Social
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 50
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be proposed to all the adolescents followed in the Centre hospitalier Intercommunal de Creteil for a chronic disease or not.

Brief summary: The lockdown of the French population is a health measure put in place in response to the pandemic linked to a new coronavirus, SARS-CoV-2 (Covid-19). After a health campaign to recommend hygienic "barrier gestures" and social distancing, the decision to confine the population at the national level was decided by the executive from Monday 16 March to Monday 11 May 2020. The national confinement implies the restriction of movement to the strict necessary, outings near the home and the closure of schools and communities. These decisions have led to an unprecedented state of stress for the entire French population, the consequences of which are unknown in the short, medium or long term. The objectives of this study are to evaluate the psychological impact of the confinement on adolescents with or without chronic disease and also the difficulties and fears engendered by deconfinement .


Eligibility criteria: Inclusion Criteria:

* Adolescents aged 11 to 18 years old
* Previous consultation in the Centre Hospitalier intercommunal de Creteil
* Agree to participate

Exclusion Criteria:

* Lack of computer equipment or internet connection

Primary outcomes:
measure: Anxiety score from the Generalized Anxiety Disorder 7 (GAD-7) questionnaire
timeFrame: At inclusion
Secondary outcomes:
measure: Depression score from the Adolescent Depression Rating Scale (ADRS) questionnaire
timeFrame: At inclusion
measure: Post traumatic score questionnaire: Children's Revised Impact of Events Scales -CRIES13
timeFrame: At inclusion
measure: Presence or absence of difficulty in falling asleep, sleeping
timeFrame: At inclusion
measure: Presence or absence of feeding difficulty
timeFrame: At inclusion
measure: Presence or absence of difficulty performing physical activity
timeFrame: At inclusion
measure: Presence or absence of toxic consomption (drug, acohol) during the lockdown
timeFrame: At inclusion
measure: Mean duration time in front of screen (hours per day)
timeFrame: At inclusion
measure: Presence or absence of difficulties with social interactions
timeFrame: At inclusion
measure: Presence or absence of difficulties with familial interactions
timeFrame: At inclusion
Other outcomes:
Locations:
city: Creteil
country: France
facility: Camille JUNG
Study officials:
References:
Clinical trial NCT05928858: Clinical And Radiographic Evaluation Of Premixed Bio-ceramic MTA In Indirect Pulp Capping Of Young Permanent Molars
Official title: Clinical And Radiographic Evaluation Of Premixed Bio-ceramic Mineral Trioxide Aggregate Versus Calcium Hydroxide In Indirect Pulp Capping Of Young Permanent Molars: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Indirect Pulp Capping
Keywords: neoputty
premixed bioceramic MTA
young permanent teeth
calcium hydroxide
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The present study aims to evaluate the clinical and radiographic success of premixed bio-ceramic MTA versus calcium hydroxide in indirect pulp capping of young permanent molars.

Detailed description: Researchers are still in search of an ideal material for pulp capping, and they evaluated numerous dental materials. For many decades, calcium hydroxide has been the 'gold standard' material for maintaining pulp vitality. Both clinically and histologically, it has been found to produce satisfactory results in indirect and direct pulp capping because it can stimulate the formation of tertiary dentine by the pulp and it has antimicrobial properties.

Due to the drawbacks of calcium hydroxide, several materials have been developed, such as NeoPUTTY which is premixed bio-ceramic Mineral Trioxide Aggregate (MTA) that triggers hydroxyapatite. Its firm, non-tacky consistency, wash-out resistance, and bioactivity make it a pediatric dentists' preferred material for every pulp need. It also delivers ready-to-use material for immediate placement with zero waste, saving cost and chair time.

Eligibility criteria: Inclusion Criteria:

* Patients who have young permanent molars with deep carious lesions.
* Restorable young permanent molars with no clinical symptoms of irreversible pulpitis.
* Permanent molars with no clinical or radiographic signs of pulp necrosis including swelling, fistula, pain on percussion,pathologic tooth mobility, thickening of the periodontal ligament space, radiolucency at the periapical area.

Exclusion Criteria:

* Medically compromised patients who have systemic disease.
* Uncooperative patients who refuse treatment
* Permanent molars that were previously restored
* Children whose parents or caregivers refuse to participate in the study.

Primary outcomes:
measure: Immediate Postoperative pain
timeFrame: one week
Secondary outcomes:
measure: The thickness of newly formed dentin
timeFrame: 3,6,9,12 month
measure: Soft tissue pathology
timeFrame: 3,6,9,12 month
measure: Radiographic changes
timeFrame: 3,6,9,12 month
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Aya Ad Hamza, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02126358: Gemigliptin-Rosuvastatin Fix-dose Combination Phase 3(BALANCE)
Official title: A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of the Fix-dose Combination Therapy With Gemigliptin 50mg and Rosuvastatin 20mg With Type 2 Diabetes and Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Dyslipidemia
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2014-04-30
Enrollment: 290
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of the fix-dose combination therapy with Gemigliptin 50mg and Rosuvastatin 20mg with type 2 diabetes and dyslipidemia


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus with Dyslipidemia
* Adults who are at least 19 years old

Exclusion Criteria:

* Patients with type 1 diabetes, diabetic ketoacidosis, diabetic coma and pre-coma
* Patients with gestational diabetes or secondary diabetes
* Patients with NYHA Class III, IV congestive heart failure or arrhythmias requiring treatment
* Patients with thyroid gland dysfunction deviating from the normal TSH range
* Patients with pituitary insufficiency or adrenal insufficiency

Primary outcomes:
measure: HbA1c change
timeFrame: Baseline(Day 0) to Treatment (last visit, w24)
measure: LDL-C change rate
timeFrame: Baseline(Day 0) to Treatment (last visit, w24)
Secondary outcomes:
measure: HbA1c
timeFrame: Baseline(Day 0) to Treatment (last visit, w24)
measure: LDL-C change rate
timeFrame: Baseline(Day 0) to Treatment (last visit, w24)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT00550758: Spirometry and Methacholine Challenge Test in Asthmatic Children Age 3-6years
Official title: The Effect of Singular (Montelukast) 4mg on Hypersensitivity of the Airways in Children 3-5 Years Old. + Extended Study Hyprsensitivity of the Airways in Asthmatic Children Age 3-6years
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Asthma
Recurrent Cough
Keywords: Methacholine challenge; Spirometry, Early childhood
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2007-10-30
Enrollment: 84
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Rational: The possible contribution of methacholine challenge test via spirometry to the clinical diagnosis of young children with various respiratory symptoms, the most appropriate spirometry index, and the proper cutoff point concentration that will define airway sensitivity have not yet been explored. Objectives: To assess airway reactivity by spirometry in a large group of children aged 3-6years with various respiratory symptoms.

Detailed description: We aimed to gather information concerning methacholine challenge test performed in children previously diagnosed with asthma (asthmatics) and 48 had prolonged cough (coughers) from the pediatric clinic at Meyer Children's Hospital.

Tests were performed by inhalation of triple-concentration increments (0.06 to13.9mg/ml/methacholine).

Spirometry was determined at baseline and after each inhalation in duplicate sets. End of test was defined by a fall of 20%FEV1 baseline (PC20-FEV1). PC20-FEV1\<4.0mg/ml was considered positive). Results from the challenge were related to data from questionnaires concerning respiratory symptoms were analyzed at the end of the studies.

Eligibility criteria: Inclusion Criteria:

* age 3- to 6-years
* respiratory diseases who were highly indicative of asthma diagnosis according to GINA guidelines \[9\]
* cough duration of more than 4 weeks
* normal chest auscultation and baseline FEV1\>75% predicted for healthy preschool children, on the day of testing.

Exclusion Criteria:

* presence of other chronic respiratory conditions
* emergency room visit or the presence of respiratory infection within the last month
* oral or inhaled steroids or other anti-inflammatory medication taken in the last two weeks
* bronchodilator taken within 24-hours prior to the test.

Primary outcomes:
measure: Determination of a Fall of 20% FEV1 from baseline values (PC20FEV1)
timeFrame: after intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Lea Bentur, MD
role: STUDY_DIRECTOR
affiliation: Rambam Health Care Campus
name: Daphna Vilozni, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01061996: Basiliximab Maintenance in Ulcerative Colitis
Official title: An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Lead sponsor: Cerimon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-02-04
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective Safety: assess the safety of basiliximab 40 mg, given every 4 weeks, in subjects with ulcerative colitis who completed previous basiliximab studies.

Secondary Objectives: evaluate the efficacy and assess the immunogenicity of this multiple-dose maintenance regimen in this population


Eligibility criteria: Inclusion Criteria:

1. Previously met eligibility criteria in the previous basiliximab UC study
2. Must have a total Mayo score at entry consistent with clinical response or clinical remission.
3. Signed a current IRB/IEC-approved informed consent form
4. Females of childbearing potential must use an effective birth control method, and be willing to continue birth control during the study, and for 4 months after the last dose of study drug.
5. Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months before study entry, hysterectomy, or bilateral oophorectomy at least 2 months before study entry) or post-menopausal for at least 2 years.

Exclusion Criteria:

1. Subject is severely ill, as evidenced by more than 6 episodes of loose stools, all of them bloody, during a 24-hour period within the prior 7 days, concurrent with any of the following systemic features:

   * Heart rate \> 90 beats/min at rest
   * Temperature \> 37.8 degrees C
   * Hemoglobin \< 10.5 g/dL
2. Subject is currently receiving a restricted/prohibited concomitant medication
3. Subject has undergone colectomy (total, or subtotal)
4. Subject is pregnant or breast-feeding
5. Prior noncompliance with previous study visit schedule and requirements

Primary outcomes:
measure: Assess the safety of basiliximab in subjects with ulcerative colitis
timeFrame: 1 year
Secondary outcomes:
measure: Evaluate the efficacy and assess the immunogenicity of t his multiple-dose maintenance regimen in this population
timeFrame: 1 year
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
Study officials:
affiliation: Cerimon Pharmaceuticals
name: Shaily J. Reichert
role: STUDY_DIRECTOR
References:
Clinical trial NCT02005796: Bioavailability of Anthocyanins of Blue Potatoes as Compared With Bilberries
Official title: Bioavailability of Anthocyanins of Blue Potatoes as Compared With Bilberries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Glycemia
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, the postprandial glycemia and insulinemia caused by boiled potato with blue-fleshed or yellow-fleshed tubers, or a gel prepared with bilberries and potato starch, is studied in healthy males. Additionally, the appearance and metabolism of the flavonoids and their metabolites is studied in plasma and urine.


Eligibility criteria: Inclusion Criteria:

* Age 18-45
* Male
* No regular medication
* No participation in a drug trial or blood donation within 2 months
* Non-smoker
* Signs informed consent
* Body mass index 18.5-27 kg/m2
* Fasting plasma cholesterol \< 5.5 mmol/l
* Fasting plasma triacylglycerols \< 2.6 mmol/l
* Fasting plasma glucose 4-6 mmol/l
* blood pressure \<140/80 mmHg
* hemoglobin\>130 g/l
* Fasting plasma alanine amino transferase (ALAT) \<60 U/l (normal liver function)
* Fasting plasma thyroid-stimulating hormone (TSH) 0.4 - 4.5 mU/l (normal thyroid function)
* Fasting plasma creatinine \<118 µmol/l (normal kidney function)

Exclusion Criteria:

* Regular smoking
* Alcohol abuse
* Regular medication

Primary outcomes:
measure: Plasma glucose concentration
timeFrame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
measure: Plasma insulin concentration
timeFrame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
Secondary outcomes:
measure: Concentrations and quality of flavonoid color compounds or their metabolites in plasma and urine (HPLC-measurement)
timeFrame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
measure: Concentrations and quality of flavonoid color compounds or their metabolites in plasma and urine (NMR-measurement)
timeFrame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
Other outcomes:
Locations:
city: University of Turku
country: Finland
facility: Department of Biochemistry, University of Turku
state: Turku
Study officials:
References:
Clinical trial NCT00400296: A Study of R547 in Patients With Advanced Solid Tumors.
Official title: A Multiple Ascending Dose (MAD) Study of R547 Administered as an Intravenous Infusion on a Weekly Schedule in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-11-16
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will determine the maximum tolerated dose, and recommended dose for further development, of R547, in patients with advanced solid tumors. Groups of patients will receive ascending doses of R547 as weekly intravenous infusions administered over a) 90 minutes and b) 180 minutes, on days 1 and 8 of a 21 day cycle. In the absence of dose-limiting toxicity following the starting dose, incremental dose-escalations will be allowed in subsequent cohorts of patients until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* locally advanced or metastatic solid tumors;
* measurable or evaluable disease.

Exclusion Criteria:

* prior chemotherapy, radiotherapy or immunotherapy within 3 weeks of start of study;
* prior history of CNS metastases with disease progression;
* patients taking strong inhibitors and/or inducers of CYP3A4.

Primary outcomes:
measure: AEs, laboratory parameters.
timeFrame: Throughout study
Secondary outcomes:
measure: Pharmacokinetic and pharmacodynamic profiles of R547
timeFrame: Throughout study
Other outcomes:
Locations:
city: Aurora
country: United States
state: Colorado
city: New Brunswick
country: United States
state: New Jersey
city: Charlotte
country: United States
state: North Carolina
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Malumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66. doi: 10.1038/nrc2602.