louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01839942: Recurrence and Patient Satisfaction After Laparoscopic Hernia Repair With Intraperitoneal Onlay-mesh (IPOM)
Official title: Recurrence and Patient Satisfaction After Laparoscopic Hernia Repair With Intraperitoneal Onlay-mesh (IPOM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventral Hernia
Recurrent Ventral Hernia
Keywords: Hernia, Ventral
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after laparoscopic repair of a ventral hernia (including recurrent hernias)

Brief summary: For laparoscopic ventral hernia repair, the technique to close the hernia gap is not well established. Mainly three techniques are currently applied:

* no closure at all
* extracorporal suturing of the gap
* intracorporal suturing of the gap

All three techniques have been applied at our hospital. Patients who received laparoscopic hernia repair between 2006 and 2011 will be identified from the patient database and will be contacted by phone to inquire about the outcome and the satisfaction of the surgery.


Eligibility criteria: Inclusion Criteria:

* hernia repair between 2006 and 2011
* laparoscopic hernia repair using intraperitoneal onlay-mesh (IPOM)
* patient agrees to be surveyed by phone

Exclusion Criteria:

* Patient rejects participation in survey
* patient already rejected use of his/her data for research purposes at admittance to surgery

Primary outcomes:
measure: Recurrence rate
timeFrame: 7 years
Secondary outcomes:
measure: Time to recurrence
timeFrame: 7 years
measure: Patient satisfaction
timeFrame: 2 - 7 years after surgery
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Cantonal Hospital St.Gallen
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Sascha Müller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01468142: Pulmonary Pathophysiology and Inflammatory Response in Patients Treated With Ecmo for Severe Respiratory Failure
Official title: Pulmonary Pathophysiology and Inflammatory Response in Patients Treated With Ecmo for Severe Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Child
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2011-11-09
Enrollment: 6
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General hospitals, district hospitals, specialized hospitals,

Brief summary: The purpose of this study is the observation of the course of

* the mechanics of the respiratory system
* the endexpiratory lung volume
* and the inflammatory response in patients undergoing treatment with extracorporeal life support (ECLS) due to severe refractory respiratory failure at our department.


Eligibility criteria: Inclusion Criteria:

* patients accepted for extracorporeal life support at our department due to the most severe forms of ARDS/respiratory failure not responding to conventional therapy.

Exclusion Criteria:

* malignant disease with a poor prognosis
* massive intracranial bleeding

Primary outcomes:
measure: Course of inflammatory parameters and lung function
timeFrame: end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Solna
country: Sweden
facility: ECMO Centre Karolinska
state: Stockholm
Study officials:
affiliation: Karolinska University Hospital
name: Bernhard Holzgraefe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University, Uppsala, Sweden
name: Anders Larsson, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00004442: Study of Bile Acids in Patients With Peroxisomal Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infantile Refsum's Disease
Zellweger Syndrome
Bifunctional Enzyme Deficiency
Adrenoleukodystrophy
Keywords: Zellweger syndrome
adrenoleukodystrophy
bifunctional enzyme deficiency
inborn errors of metabolism
infantile Refsum's disease
peroxisomal disorders
pseudo-Zellweger syndrome
rare disease
sphingolipidoses
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
Collaborators: name: Children's Hospital Medical Center, Cincinnati
First posted: 1999-10-19
Enrollment: 25
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine the effectiveness of oral bile acid therapy with cholic acid, chenodeoxycholic acid, and ursodeoxycholic acid in patients with peroxisomal disorders involving impaired primary bile acid synthesis.

II. Determine whether suppression of synthesis of atypical bile acids and enrichment of bile acid pool with this regimen is effective in treating this patient population and improving quality of life.

Detailed description: PROTOCOL OUTLINE: Patients receive oral cholic acid and oral chenodeoxycholic acid on day 1. On day 4, patients receive oral cholic and ursodeoxycholic acids. Patients are assessed at 3 and 6 months for liver function response, neurologic status, and nutritional status.

Patients receive treatment until disease progression or unacceptable toxic effects are observed.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: Biochemically proven peroxisomal disorder, including:

* Zellweger syndrome
* Pseudo-Zellweger syndrome
* Neonatal adrenoleukodystrophy
* Bifunctional enzyme deficiency
* Infantile Refsum's disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Kenneth Setchell
role: STUDY_CHAIR
References:
Clinical trial NCT02066142: Tomosynthesis (TS) Versus Ultrasonography (US) in Women With Dense Breast
Official title: Tomosynthesis (TS) Versus Ultrasonography (US) in Screening Women With Dense Breast
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Genova
Sponsor class: OTHER
Collaborators: name: University of Sydney
First posted: 2014-02-19
Enrollment: 4000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Hypothesis The study aims to demonstrate at least equivalence, or non-significant difference between TS and US in women with dense breast screened negative at 2D Mammography.

If the equivalence between TS and US will be demonstrated, US may be substituted by TS with great benefits for the patients and for the healthcare resources.

Aims

1. Assess if TS may detect additional cancers in dense breast that approximate US detection capability but with less false positive findings than US.
2. If TS detects new cancers in dense breast similarly to US (approximate rate or marginally lower rate), evaluate the the true positive/false positive ratio.
3. Cost-analysis. In case of less false positives detected by TS, the true-positive / false positive trade-off might be strongly in favour of TS with a great potential of costs reduction.


Eligibility criteria: Inclusion Criteria:

* Asymptomatic subjects \<50 years of age presenting for mammography, with the exception of those that, on previous mammograms are found to have breast density 1-2 according to the Breast Imaging Reporting and Data System (BIRADS D1-2). - Asymptomatic subjects ≥ 50 years of age who request mammography and have breast density BIRADS 3-4.
* No history of breast cancer - Written informed consent

Exclusion Criteria:

* Pregnant and breast feeding women
* Unable to tolerate breast compression
* Breast implants
* Unable to understand or execute written informed consent
* Unable or unwilling to agree to follow-up during observation period

Primary outcomes:
measure: 1) Sensitivity of TS
timeFrame: up to 36 months
Secondary outcomes:
measure: 2) Specificity of TS
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Genova
country: Italy
facility: UNIGE
Study officials:
affiliation: UNIGE
name: Alberto S Tagliafico, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01671306: The Association Between Monocyte Subsets and Coronary Collateral Development in Diabetes Mellitus
Official title: The Association Between Monocyte Subsets and Coronary Collateral Development in Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Coronary collaterals
diabetes mellitus
monocyte subsets
Lead sponsor: Samsun Education and Research Hospital
Sponsor class: OTHER
First posted: 2012-08-23
Enrollment: 83
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of 83 consecutive type 2 diabetic patients who have undergone coronary angiography because of stable symptoms and signs of coronary artery disease. The main inclusion criterion was the presence of \>95% stenosis of at least one major coronary artery in their first coronary angiogram.

Brief summary: Monocyte heterogeneity in peripheral blood seems to be important in coronary collateral development in non-diabetic patients with stable coronary artery disease. Our aim in this study is to find out any possible relationship between the levels of circulating monocyte subsets and coronary collateral development in type 2 diabetic patients.

Detailed description: 83 diabetic patients with severe coronary artery disease were enrolled in the study. These patients were investigated according to their collateral development. Monocytes and their subtypes, namely CD14++CD16- and CD14+CD16+ cells were compared in 2 groups

Eligibility criteria: Inclusion Criteria:

* presence of \> 95% stenosis of at least one major coronary artery in their first coronary angiogram.

Exclusion Criteria:

* Patients experiencing acute coronary syndrome either with or without ST elevation in the last one month
* Evidence of ongoing infection and inflammation, known malignancy and chronic kidney disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Samsun Education and Research Hospital
name: Uğur ARSLAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01204606: Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)
Official title: Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA): A Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-09-17
Enrollment: 54
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * The purpose of this study is to compare the efficacy of periarticular injections consisting of ropivacaine, morphine, epinephrine, cefotetan, and hyaluronic acid with the efficacy of periarticular injections consisting of the same amount of placebo(isotonic saline) during arthroscopic rotator cuff repair.
* Adding of multimodal analgesia(MMA) to conventional rotator cuff repair, it was expected that could reduce postoperative pain and narcotic consumption.


Eligibility criteria: Inclusion Criteria:

* rotator cuff tear
* arthroscopic surgery

Exclusion Criteria:

* age\<45 or \>85
* allergies to the drugs used in the study
* acute trauma history
* history of renal disease
* history of hepatic disease
* osteoarthritis or rheumatic arthritis
* systemic condition with chronic pain
* history of infection
* could not understand the questions
* rotator cuff tear treated by the open technique, by debridement only

Primary outcomes:
measure: Visual Analogue Scale(VAS) for Pain
timeFrame: postoperative 5 hours
Secondary outcomes:
measure: Postoperative narcotic consumption
timeFrame: every 6 hours after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Joint and Spine Center; SMG-SNU Boramae Medical Center
Study officials:
affiliation: Seoul Metropolitan Government Seoul National University Boramae Medical Center; Joint and Spine Center
name: Chris H. Jo, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00957606: Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer
Official title: Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer: Symptoms, Risc Factors, and Prevention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Prostate Cancer
Androgen Deprivation Therapy
Osteoporosis
Keywords: Prostate cancer
androgen deprivation therapy
osteoporosis
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Zealand University Hospital
First posted: 2009-08-12
Enrollment: 100
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is

* to determine the rate of osteoporosis among patients with advanced prostate cancer.
* to propose an algorithm for early detection of patients with advanced prostate cancer who are at risk of developing osteoporosis.

Detailed description: Patients with advanced prostate cancer are included at the initiating of androgen deprivation therapy.

The patients are followed for 2 years after inclusion with blood sampling, DXA-scan, questionnaire, bone scintigraphy.

Eligibility criteria: Inclusion Criteria:

* Prostate cancer
* Initiation of androgen deprivation therapy
* Oral and written informed consent

Exclusion Criteria:

* They withdraw their consent
* Treatment for osteoporosis within the last year
* Other malignancy
* Other bone disease, bedbound, use of steroid

Primary outcomes:
measure: Osteoporosis, either T-score < -2,5 or osteoporosis fracture
timeFrame: 2½ years
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Urology, Odense University Hospital
city: Roskilde
country: Denmark
facility: Department of Urology, Roskilde Hospital
Study officials:
affiliation: Department of Urology, Odense University Hospital, Denmark
name: Mads H Poulsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Urology, Odense University Hospital, Denmark
name: Steen Walter, MD, DMSci, Professor
role: STUDY_CHAIR
affiliation: Department of Endocrinology, Odense University Hospital, Denmark
name: Morten MF Nielsen, MD
role: STUDY_CHAIR
affiliation: Department of Endocrinology, Odense University Hospital, Denmark
name: Kim Brixen, MD, PhD, Professor
role: STUDY_CHAIR
affiliation: Department of Urology, Roskilde Hospital, Denmark
name: Claus Dahl, MD
role: STUDY_CHAIR
affiliation: Department of Endocrinology, Køge Hospital, Denmark
name: Peter Eskildsen, MD, DMSci
role: STUDY_CHAIR
affiliation: University of Southern Denmark
name: Oke Gerke, PhD
role: STUDY_CHAIR
affiliation: Faculty of Health Sciences, University of Southern Denmark, Denmark
name: Bo Abrahamsen, MD, PhD, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT03028506: Meal Composition and the Influence on Pre-prandial Blood Glucose Values
Official title: Meal Composition and Frequency in Type 1 Diabetic Women and the Influence on Pre-prandial Blood Glucose Values and Fetal Weight.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes in Pregnancy
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant, all ethnic groups

Brief summary: The purpose of the proposed study is to assess the distribution of carbohydrates and fat in the diet of women with type 1 diabetes during pregnancy. More specifically, it will look at the distribution of carbohydrate in the diet during weeks 29-32 of pregnancy. The carbohydrate distribution and fat content of the meal will be compared to maternal glucose control, preprandial glucose levels, and the percentile for weight of the infant at birth. In addition, each meal and snack will be classified as low-moderate fat or high fat.

Detailed description: This is a retrospective chart review. Data will be collected on all patients seen whose blood sugar and food logs were at least 75% complete. By calculating carbohydrate amounts at meals and snacks, as well as classifying meals and snacks as high fat, we will examine the correlation to higher preprandial blood glucose values and large for gestational age infants. Preprandial glucose levels will be reviewed, questioning whether the biggest contributor is the composition of the previous meal or additional snacks between meals.

Eligibility criteria: Inclusion Criteria:

* Female, age 16-45, all ethnic groups,
* Type 1 diabetes
* Blood glucose logs at least 75% complete
* Food intake records during weeks 29-32 that are at least 75% complete

Exclusion Criteria:

* Maternal medical conditions:

  * Renal disease
  * Restrictive lung disease
  * Cyanotic heart disease (severe heart disease where mother is blue)
  * Antiphospholipid antibody syndrome
  * Collagen-vascular disease (lupus)
  * Substance use and abuse (drugs)
  * Multiple gestation
  * Genetic disorders
  * Severe malnutrition

Primary outcomes:
measure: large for gestational age infants
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St. Louis University
name: Rosemary Catanzaro, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01107106: Safety, Tolerability, and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Women
Official title: Prospective Observational Single Arm Open-Label Multicenter Study to Assess the Safety, Tolerability and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Adult Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: Contraceptive Methods
Female Contraception
Lead sponsor: HRA Pharma
Sponsor class: INDUSTRY
First posted: 2010-04-20
Enrollment: 579
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents and adult women seeking emergency contraception in family planning centers and youth clinics in Sweden

Brief summary: The purpose of this observational study is to assess the safety and tolerability of ellaOne® in routine conditions of use for emergency contraception in postmenarcheal adolescents and adult women who want to prevent pregnancy up to 5 days after unprotected sexual intercourse.


Eligibility criteria: Inclusion Criteria:

* Having received ellaOne® as emergency contraception at the clinical site
* Postmenarcheal adolescents or adult women
* Willing to provide information on bleeding, sexual intercourses, method of contraception, concomitant medications and adverse events for the next two menstrual periods and to complete the diary accordingly
* Willing to provide information on pregnancy outcome / delivery and newborn's health at delivery
* Able to provide written informed consent
* Willing to not participate in a clinical trial before the end of study participation

Exclusion Criteria:

* Currently participating in any interventional clinical trial (testing an Investigational Medicinal Product)

Primary outcomes:
measure: Frequency of adverse events after ellaOne® intake in routine conditions of use for emergency contraception
timeFrame: Two months (i.e. all along 2 menstrual cycles following ellaOne® intake)
Secondary outcomes:
measure: Pregnancy rate observed after taking ellaOne® in routine conditions of use for emergency contraception
timeFrame: Two months (i.e. during two menstrual cycles following ellaOne® intake)
Other outcomes:
Locations:
city: Denver
country: United States
facility: PPRM Central clinic
state: Colorado
city: Lakewood
country: United States
facility: PPRM Southwest clinic
state: Colorado
city: Philadelphia
country: United States
facility: Elizabeth Blackwell Health Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Locust Health Center
state: Pennsylvania
city: Stockholm
country: Sweden
facility: Dept of Women & Child Health - Karolinska University Hospital
city: Belfast
country: United Kingdom
facility: Brook clinic
Study officials:
References:
Clinical trial NCT02001506: Neoadjuvant Chemotherapy of 6 Cycles vs 8 Cycles in Node Positve Breast Cancer
Official title: A Randomized Phase III Trial of Neoadjuvant Chemotherapy With 3 Cycles of FEC Followed by 3 Cycles of Docetaxel Versus 4 Cycles of Adriamycin Plus Cyclophosphamide Followed by 4 Cycles of Docetaxel in Node-positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: breast cancer
neoadjuvant
different number of chemotherapy cycles
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 250
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Various regimens and schedule as neoadjuvant chemotherapy regimens were investigated and sequential treatment of anthracyclines followed by taxanes, which has shown superior pathologic complete respone (pCR) rate (NSABP-B27 study) is widely used until now. Considering the proven efficacy and tolerable toxicity of 3 cycles of FEC followed by 3 cycles of Docetaxel (FEC3-D3) compared to FEC 6 cycles in adjuvant chemotherapy (PACS 01 trial), use of FEC3-D3 regimen in neoadjuvant setting will be feasible with acceptable efficacy and further reduce the duration of neoadjuvant chemotherapy.

Detailed description: To investigate feasibility of FEC3-D3 regimen in neoadjuvant setting in terms of comparable efficacy and shorter duration across all subtypes.

Eligibility criteria: Inclusion Criteria:

* Performance status 0 or 1
* Clinically stage 2 or 3 with histologically proven lymph node involvement
* Tumor or lymph node greater than 1.5 cm

Exclusion Criteria:

* Pregnancy or lactation
* Prior chemotherapy or radiotherapy for any malignancy
* Documented history of cardiac disease contraindicating anthracyclines
* Currently active infection

Primary outcomes:
measure: pathologic complete response (pCR) between two arms
timeFrame: within the first 30 days (plus or minus 3 days) after surgery
Secondary outcomes:
measure: 3 year-disease free survival between two arms
timeFrame: 3 year after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Sung-Bae Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: