louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00397410: Prevention of Hip Fractures With Soft and Hard Hip Protectors
Official title: Compliance With and Effect of Soft and Hard Hip Protectors in Norwegian Nursing Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Prevention
Keywords: hip protectors
uptake and adherence
Nursing home residents
efficacy
prevention
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: Oslo University College
First posted: 2006-11-09
Enrollment: 1236
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED

Brief summary: The aim of this study is to compliance with and effect of soft and hard hip protectors in Norwegian nursing homes.

Detailed description: Hip fractures are a major cause of disability and functional limitation. Hip protectors have shown to have the potential to lower the risk of a fracture by reducing the impact on the hip region during falls, but low uptake and adherence have been a problem.

Changing the hip protector's design might give a higher uptake and adherence. The aim of this study is to compare uptake, adherence and effect of soft and hard hip protectors in Norwegian nursing homes. Because a soft hip protector seems to be more comfortable, we expect a higher uptake and adherence with the soft hip protector, specially when it comes to 24 hour use. If the soft hip protector has the same protective quality as the hard hip protector, the soft hip protector will be a better alternative than the hard one.

This cluster randomized study is performed in 18 Norwegian nursing homes in 2 municipalities. The study started May 15. 2006 and will end November 30. 2006.

All permanent residents are invited to participate in the study either as a user of hip protector or as a non user.

Eligibility criteria: Inclusion Criteria:

* all permanent residents in the the participating nursing homes

Primary outcomes:
measure: Uptake and adherence with soft and hard hip protectors
measure: Effect of soft and hard hip protectors in protected and unprotected falls
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian Institute of public Health
Study officials:
affiliation: National Institute of public Health
name: Lisa Forsen, PHd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00723710: Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600)
Official title: Guidelines to the Intron A® Health Management Program II: A Nursing Support Program for Patients With High-Risk Melanoma Receiving High Dose Intron A Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 300 patients with malignant melanoma who are free of disease but at high risk for systemic recurrence. The study is conducted in Canada.

Brief summary: Patients with malignant melanoma who had undergone surgery will receive adjuvant treatment with high-dose Intron A for one year. The objective of this study is to maximize treatment compliance by proactive management of side effects in a day-to-day healthcare setting.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Age \> 18 years
* Confirmed melanoma
* Patient has been prescribed Intron A therapy for High-Risk Stage II \& III Melanoma
* Intron A therapy started within 70 days of surgery (additional 15 days may be granted by the sponsor upon written approval)
* Proper contraception in both male and female subjects and the female partner(s) of male study subjects

Exclusion Criteria:

* Metastatic disease at the time of diagnosis
* Other malignancies
* History of non compliance to other therapies
* Pregnancy or breast feeding
* Previous Intron A therapy

Primary outcomes:
measure: Number of Participants Who Completed Treatment
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Levesque N, Mitchinson K, Lawrie D, Fedorak L, Macdonald D, Normand C, Pouliot JF. Health management program: factors influencing completion of therapy with high-dose interferon alfa-2b for high-risk melanoma. Curr Oncol. 2008 Jan;15(1):36-41. doi: 10.3747/co.2008.200.
Clinical trial NCT02922010: A Follow-Up Survey of Oral Hygiene and Health Outcomes for Women Previously Enrolled in "OHMOM"
Official title: A Follow-Up Survey of Oral Hygiene and Health Outcomes of Women Enrolled in the "OHMOM" Clinical Trial at the University of Alabama Birmingham
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gingivitis
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2016-10-03
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants from the OHMOM study and offspring from that study (NCT01549587) at the University of Alabama Birmingham.

Brief summary: The objective of this study is to assess oral health, oral hygiene knowledge, and daily oral hygiene practices of women who participated in a randomized controlled trial (2011001) at University of Alabama Birmingham during the period 2012-2014. Additional objectives of the research include evaluation of possible cultural, biological or other mechanisms for outcomes observed in the OHMOM clinical trial, and oral health screening of children born to mothers during the study for the purposes of understanding possible multigenerational effects of oral hygiene education.


Eligibility criteria: Inclusion Criteria:

* be at least 18 years of age
* sign an informed consent form and be given a copy
* be a former subject in study 2011001 at University of Alabama Birmingham with a live birth outcome from that study.

Exclusion Criteria:

* any medical condition requiring pre-medication prior to dental procedures
* any diseases or conditions that might interfere with the subject safely completing the study
* inability to undergo study procedures

Primary outcomes:
measure: Löe-Silness Gingivitis Index
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Center for Women's Reproductive Health
state: Alabama
Study officials:
affiliation: Procter and Gamble
name: Robert W Gerlach, DDS, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT01044810: Effectiveness of Efavirenz-based Regimen in HIV-1-infected Patients With Nevirapine Hypersensitivity
Official title: Comparison of Virological and Immunological Results of Efavirenz-based Regimen in HIV-infected Patients With or Without Allergic Reactions to Nevirapine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Treatment Failure, HIV or AIDS
CD4 Cell Counts
Keywords: HIV
efavirenz
nevirapine
allergy
rash
Cohort Studies, Historical
Retrospective Study
exanthem
Antiretroviral Agents
Highly Active Antiretroviral Therapy
HAART
treatment failure
Lead sponsor: Bamrasnaradura Infectious Diseases Institute
Sponsor class: OTHER_GOV
Collaborators: name: Thai Red Cross AIDS Research Centre
name: Clinical Research Collaborative Network
First posted: 2010-01-08
Enrollment: 559
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected patients who started EFV-based regimens between January 2002 and December 2008 at Bamrasnaradura Infectious Diseases Institute

Brief summary: The primary objective of this study is to compare the effectiveness of EFV-based regimens in HIV-1-infected patients who; (1) were previously allergic to NVP and stopped all ARV simultaneously; (2) were previously allergic to NVP and continued the other NRTIs for a period of time, i.e. "staggered interruption"; and (3) started EFV-based regimens as an initial regimen (as controlled group).


Eligibility criteria: Inclusion Criteria:

* age 18-70 years old
* documented HIV infection
* started EFV-based regimens between January 2002 and December 2008 at Bamrasnaradura Infectious Diseases Institute

Exclusion Criteria:

* previously received non-HAART regimens such as dual NRTIs regimen, AZT monotherapy with single-dose NVP in pregnancy patients
* previously received protease inhibitor-based regimen
* diseases or conditions that significantly affected either kidney or liver functions such as decompensated liver cirrhosis, ESRD

Primary outcomes:
measure: Time to Virological failure
timeFrame: until end of study cohort
Secondary outcomes:
measure: Virological suppression
timeFrame: 24 months
measure: Median increase from baseline of CD4 cell count
timeFrame: 24 months
measure: Adverse events
timeFrame: until end of cohort
measure: Clinical outcomes such as death, major opportunistic infections, immune recovery syndrome, non-AIDS events
timeFrame: until end of cohort
Other outcomes:
Locations:
city: Nonthaburi
country: Thailand
facility: Bamrasnaradura Infectious Disease Institute
Study officials:
affiliation: Bamrasnaradura Infectious Diseases Institute
name: Krittaecho Siripassorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02142010: Weekly Paclitaxel Liposome Injection Plus Cisplatin in Preoperative Treatment of Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Nanjing Luye Sike Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-05-20
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pathological complete response (pCR) rate in breast cancer patients treated with weekly paclitaxel liposome injection plus cisplatin preoperative regimen.


Eligibility criteria: Inclusion Criteria:

* Women aged ≥ 18 years and \< 65 years,An estimated life expectancy of at least 12 months
* ECOG 0-1
* At least one measurable disease according to the RECIST. histologically confirmed invasive breast cancer, stage II and III, no prior systemic or loco-regional treatment of breast cancer
* Biopsy specimens are available for ER, PgR and Her2 analysis
* Adequate bone marrow function: Neutrophil ≥ 1.5\*109/L; Hb ≥ 100g/L; PLT ≥ 100\*109/L
* adequate liver function (bilirubin \> 1.0 times upper normal limit \[UNL\] and ALT and/or AST\> 1.5 UNL associated with alkaline phosphatase \> 2.5 UNL;
* Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
* No obvious main organs dysfunction
* patients must be accessible for treatment and follow-up and written informed consent

Exclusion Criteria:

* Patient is pregnant or breast feeding
* Inflammatory breast cancer and Metastatic breast cancer
* Patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitis, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
* History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP \> 180 mmHg or diastolic BP \> 100 mmHg)
* Has peripheral neuropathy
* Treatment with any investigational drugs within 30 days before the beginning of study treatment
* No psychiatric illness and other situations that would limit compliance of study
* With a history of other malignant tumor
* Known severe hypersensitivity to any drugs in this study

Primary outcomes:
measure: pathological complete remission (pCR) rate
timeFrame: after 4 months of preoperative treatment
Secondary outcomes:
measure: Adverse Events as a Measure of Safety and Tolerability
timeFrame: 4 months during neoadjuvant therapy
measure: clinical response rate
timeFrame: after 4 months of preoperative therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medicine, Renji Hospital
Study officials:
References:
Clinical trial NCT02977910: Treatment Strategy of Ankle Fracture Combined With Deltoid Ligament Rupture
Official title: Comparative Study for Ankle Fracture Combined With Deltoid Ligament Rupture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankle Fractures
Lead sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ankle fracture is very common which is often combined with deltoid ligament injury. Although the incidence of deltoid ligament injury is high, but there is no unified and effective diagnosis method. Even whether the ankle fracture with deltoid ligament rupture needs surgical repair is still controversial. There is no high-level, multi-center, large sample, long-term follow-up clinical evidence to prove whether the repair of deltoid ligament is necessary or not. The main content of the project: 1 Achieve accurate classification of deltoid ligament rupture with intraoperative exploration. 2 Study the surgical indications and treatment guidelines by comparative study.

Detailed description: Comparative study for ankle fracture combined with deltoid ligament rupture: with \& without repair of ligament

Eligibility criteria: Inclusion Criteria:

* ankle fracture with deltoid ligament rupture

Exclusion Criteria:

* ankle fracture without deltoid ligament rupture

Primary outcomes:
measure: AOFAS score
timeFrame: 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Fan J, Zhang X, Luo Y, You GW, Ng WK, Yang YF. Tibiotalocalcaneal (TTC) arthrodesis with reverse PHILOS plate and medial cannulated screws with lateral approach. BMC Musculoskelet Disord. 2017 Jul 24;18(1):317. doi: 10.1186/s12891-017-1666-2.
Clinical trial NCT02125110: PERINE : Effect of Prenatal Exposure to Neurotoxicants on the Developing Brain : an MRI Study
Official title: Effect of Prenatal Exposure to Neurotoxicants on the Developing Brain: an MRI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of Neurotoxicants on the Brain
Keywords: neurotoxicants
MRI
developing brain
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 112
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This project aims at evaluating the consequences of prenatal exposure to neurotoxicants (solvents, organophosphate pesticides) on the developing brain, in children aged from 10 to 12 years.


Eligibility criteria: Inclusion Criteria:

* Children included in the cohort PELAGIE
* Children participated in the study PEPSY
* Age between 10 and 12 years (pilot study)

Exclusion Criteria:

* Maternal smoking and or alcohol consumption during pregnancy (study group)
* Children with a health event affecting neurodevelopment
* Children treated with methylphenidate, psychotropic or anti-epileptics

Primary outcomes:
measure: Measurement of the brain activity and its functionality
timeFrame: day 1
Secondary outcomes:
measure: Measurement of the brain activity and its functionality
timeFrame: day 1
measure: Results of neuropsychological tests
timeFrame: day 1
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
References:
citation: Binter AC, Bannier E, Simon G, Saint-Amour D, Ferre JC, Barillot C, Monfort C, Cordier S, Chevrier C, Pele F. Prenatal exposure to glycol ethers and motor inhibition function evaluated by functional MRI at the age of 10 to 12 years in the PELAGIE mother-child cohort. Environ Int. 2019 Dec;133(Pt A):105163. doi: 10.1016/j.envint.2019.105163. Epub 2019 Sep 11.
Clinical trial NCT05096910: Comparison Of Suture Materials on Sectio Scars (COSMOSS)
Official title: COSMOSS Study, Comparison Of Suture Materials on Sectio Scars. A Multicenter Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Scar
Keywords: cesarean section
isthmocele
uterine scar
suture
Lead sponsor: Uludag University
Sponsor class: OTHER
Collaborators: name: Bursa Medicana Hospital
name: UMI Health Center
name: Ceylan Hospital
First posted: 2021-10-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This multicenter prospective randomized controlled trial aims to investigate the ishtmocele rates after c-section delivery depending on using different suture materials for the uterine closure.

Detailed description: The study involves 5 health centers (two universities, three private hospitals). Patients who will undergo their first cesarean section because of any etiology (except emergent cases) will be included in the study. Operation Nurse will randomize the patients into two groups depending on the monofilament or poly filament suture material. Patients will be checked by transvaginal ultrasound on a postoperative day one, postoperative first month, and postoperative sixth month. As the primary result, the istmocele rates will be compared between the study groups.

Eligibility criteria: Inclusion Criteria:

* 18-40 yrs women
* Primary elective cesarean section
* First delivery
* Without any systemic diseases

Exclusion Criteria:

* emergent delivery
* previous c-section history
* congenital uterine abnormality

Primary outcomes:
measure: Isthmocele Rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Uludag University Scholl of medicine
state: Turkey/bursa
Study officials:
affiliation: Bursa Uludag University Faculty of Medicine
name: Gurkan Uncu, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03237312: Serum Anti-mullerian Hormone and Polycystic Ovarian Syndrome
Official title: The Impact of Serum Antimullerian Hormone Level on Adjusting the Number of Ovarian Drills in Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In 1935 the polycystic ovary syndrome was a clinical diagnosis made on the morphological appearance of the ovaries in association with amenorrhoea, hirsutism and frequently obesity. At that time wedge resection of the ovaries was introduced on an empirical basis and proved a successful treatment for the associated anovulation and infertility. In the ensuing fifty years the limitations of a purely surgical approach to therapy have become recognized and the importance of the biochemical abnormalities appreciated. Prevalence of polycystic Ovary Syndrome: The prevalence of polycystic ovary syndrome in any specified population is dependent upon the diagnostic criteria used, but does have some regional and ethnic variation. While most reports on the prevalence of polycystic ovary syndrome range between 2 and 20%, the chosen diagnostic criteria are recognized to influence the determined prevalence. Anti-mullerian hormone which is a predictor of ovarian reserve is known to decrease after laparoscopic ovarian drilling. On the best of our knowledge no study had been done to use the level of anti-mullerian hormone as a factor for planning the number of ovarian drills in each ovary.


Eligibility criteria: Inclusion Criteria:

1. Infertility more than 2 years.
2. Age between 20-35 years.
3. clomiphene resistant patients: Patients received clomiphene 150 mg from day 3 to 7 of the menstrual cycle for 6 months and non-ovulatory (with failure of conception). They were followed up in the outpatient clinic.
4. No contraindications for laparoscopy.
5. Normal Hysterosalpingography

Exclusion Criteria:

1. Contraindications for laparoscopy e.g cardiac diseases, bad scared abdomen ect....
2. Women's age less than 20 years or more than 35 years.
3. Previous Laparoscopic surgery.
4. Previous ovarian surgery.
5. Women with Antimullerian hormone level less than 4 ng/ml.
6. Tubal factor infertility as diagnosed by Hysterosalpingography .

Primary outcomes:
measure: Size of ovarian follicle (mm)
timeFrame: 14 days
Secondary outcomes:
measure: Antimullerian hormone level (ng/dl)
timeFrame: 3 months
measure: Ovarian volume (ml)
timeFrame: 3 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT01868412: Resin Salve Versus Honey Treatment in Wound Care
Official title: Comparison of Resin Salve and Medical Honey in Wound Care in Vascular Surgery Patients - A Prospective, Randomized and Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Healing
Wound Infection
Keywords: Wound healing
Wound infection
Resin salve
Medical honey
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2013-06-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In recent years, salve prepared from Norway spruce (Picea abies) resin and refined honey from manuka myrtle (Leptospermum scoparium), has successfully been used in medical context to treat both acute and chronic surgical wounds. The objective of this prospective, randomized and controlled clinical trial is to investigate healing rate and healing time of surgical wounds in patients, who have undergone peripheral vascular surgery, and whose complicated wounds are candidate for topical treatment with the resin or honey. In addition, factors contributing with delayed wound healing, antimicrobial properties, safety and cost-effectiveness of the resin salve and medical honey will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Infected of non-infected acute or chronic wound after vascular surgery.
* Need for topical wound care.
* Need for wound healing follow-up at the surgical outpatient department.

Exclusion Criteria:

* Life expectancy less than 6 months.
* Advanced malignant disease.
* Need for extensive surgical wound revision or skin transplantation.

Primary outcomes:
measure: Wound Healing
timeFrame: 6 months
Secondary outcomes:
measure: Contributors for Wound Healing
timeFrame: 6 months
Other outcomes:
measure: Other Pre-specified Outcome Measure
timeFrame: 6 months
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Kuopio University Hospital
name: Tommi Auvinen, MD
role: PRINCIPAL_INVESTIGATOR
References: