louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01085669: Infection Rate of Vertical Expandable Prosthetic Titanium Rib Implants (VEPTR)
Official title: Infection Rate of VEPTR-Implants in Children With Severe Spinal and Thoracic Deformities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection
Keywords: Infection rate of VEPTR-Implants
VEPTR. Vertical Expandable
Prosthetic Titanium Rib
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: University Children's Hospital Basel
First posted: 2010-03-12
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with severe spinal or throacic deformities treates with VEPTR-implants. In these patients the implant has to be revised every half a year due to grow and achieved correction.

Brief summary: The study is conducted to analyse the infection rate in children treated with VEPTR-Implants for severe spine or thoracic deformities.

Detailed description: Spinal and thoracic deformities in children can be treated with vertical expandable prosthetic titanium ribs (VEPTR©, Synthes GmbH®) to stimulate thoracic and spinal growth. With these implants children's symptoms and conditions can be slowed, halted or even reversed. Because of the dynamic character of the deformity and the growth of the children, the implants have to be lengthened about every half a year. With each operation there is a small risk of infection, which might increase with number of previous surgeries. Implant associated infections are often not clinical apparent and only found in microbiological analysis. To objectify the infection rate, identify potential precursors of infections and the relevance of asymptomatic infections in children with these implants a prospective study is conducted.

Eligibility criteria: Inclusion Criteria:

* all patients admitted at the University Children's Hospital Basel in whom a VEPTR©-implant or parts of it will be removed.

Exclusion Criteria:

* obvious contamination of an explanted component occurred in the operating room.

Primary outcomes:
measure: Infection rate of VEPTR Implants
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Orthopaedic Department, University Children´s Hospital Basel
Study officials:
References:
Clinical trial NCT03371069: Use of Methylphenidate in Children and Adolescents in France
Official title: Use of Methylphenidate in Children and Adolescents in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Use of Methylphenidate in Children and Adolescents
Keywords: methylphenidate
drug utilisation study
pediatrics
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 1
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolesents who are users of methylphenidate

Brief summary: The use of methylphenidate in children and adolescents in France from 2010 to 2015

Detailed description: To describe the use of methylphenidate in children and adolescents in France from 2010 to 2015

Eligibility criteria: Inclusion Criteria:

* children and adolescents (0-17 years)
* registered in the French Health Insurance Database from 2012-2015

Primary outcomes:
measure: use of methylphenidate over time
timeFrame: 6 years
Secondary outcomes:
measure: Describe methylphenidate patterns of use over time
timeFrame: 6 years
measure: Co-prescription of methylphenidate and non-psychostimulant psychotropic drugs
timeFrame: 6 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Robert Debré, APHP
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Florentia Kaguelidou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01218269: U-clip Pilot Study in Plastic Surgery
Official title: A Prospective Evaluation of U-clips for Arterial Microvascular Anastomoses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Microvascular Anastomoses
Keywords: anastomoses
Lead sponsor: Scott and White Hospital & Clinic
Sponsor class: OTHER
First posted: 2010-10-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the nitinol U-clip as an alternative to conventional microsurgical suture for arterial anastomoses in free tissue transfer.

Detailed description: Within Scott \& White, a total of 25 free flaps will be performed using U-clips for microvascular anastomoses in lieu of traditional suturing techniques. Each of these free flaps may be in individual patients or two anastomoses may be included in one patient. Historical controls will be used for comparison of complication rates of U-clip versus sutured anastomoses. Postoperatively, the study participants will be evaluated at 2 weeks (+/- 1 week) and at 3 months (+/- 1 month) follow up.

Eligibility criteria: Inclusion Criteria:

* either gender
* any ethnicity
* patient requiring free tissue transfer for complex wound coverage or reconstruction
* patient having arterial anastomotic diameter of at least 2 mm
* patient capable of giving informed consent

Exclusion Criteria:

* less than 18 years of age
* allergy to nitinol or any of its components (nickel or titanium)
* pregnancy
* known coagulopathy

Primary outcomes:
measure: Flap failure rate compared to published rate for conventional suture anastomoses
timeFrame: will be measured 3 months postoperative (+/- 2 weeks)
Secondary outcomes:
measure: Rapid, reproducible, sutureless microvascular arterial anastomoses in free flaps without compromising patient outcomes.
timeFrame: data collected at 3 months postoperative (+/- 2 weeks)
Other outcomes:
Locations:
city: Temple
country: United States
facility: Scott and White Hospital and Clinic
state: Texas
Study officials:
affiliation: Scott & White
name: Raman C Mahabir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06176469: Renal Colic and Urolithiasis in Poland
Official title: Population-level Prevalence, Effect on Quality of Life, and Treatment Behavior for Renal Colic and Urolithiasis in Poland
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Renal Colic
Urolithiasis
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A representative pool of men and women in Poland

Brief summary: The aim of this study is to analyze the prevalence, effect on quality of life, and treatment-related behaviors for renal colic and urolithiasis in a population-representative sample of Poles. We will be using an Internet interview format for renal colic and urolithiasis evaluation. The study will include respondents representative for age and place of residence with adequate proportions of respondents from urban and rural areas.


Eligibility criteria: Inclusion Criteria:

- consent to participate

Exclusion Criteria:

- lack of consent to participate

Primary outcomes:
measure: Prevalence of renal colic and urolithiasis in Poland
timeFrame: December 2023 - December 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Department of Urology, Jagiellonian University
Study officials:
References:
Clinical trial NCT01396369: Flaxseed Lignan (Brevail)
Official title: Impact of Flaxseed Lignan (Brevail) on Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Polycystic Ovarian Syndrome
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2011-07-18
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PCOS is a disorder which is characterized by hyperandrogenism (high serum male hormone levels), ovulatory dysfunction, and polycystic ovaries (multiple follicles-over 12- in the ovary). There is no universally accepted definition for PCOS. The Rotterdam criteria require 2 of 3 criteria for diagnosis, including hyperandrogenism (clinical hirsutism or serum hormone measurement), oligomenorrhea/amenorrhea, and ultrasound findings of polycystic ovaries.

This study is a prospective randomized pilot study designed to evaluate the effects of flaxseed supplementation (with Brevail) on hormonal and lipid metabolism balance in polycystic ovarian syndrome (PCOS) patients.


Eligibility criteria: Inclusion Criteria:

* Must be 18 to 40 year old female with:
* Diagnosis of PCOS by menstrual irregularity (fewer than 9 menses annually/interval over 40 days), Ferriman-Galleway score \>8, and/or hyperandrogenemia defined as total testosterone \>80ng/dl or bioavailable testosterone \>8.4 ng/dl.
* Mentally competent.

Exclusion Criteria:

* Use of oral contraceptives, spironolactone, or insulin-sensitizing agents within the past 2 months.
* Long-term or chronic use of oral antibiotics.
* Hysterectomy.
* FSH \>15.
* Pregnancy/lactation.
* Consumption of flaxseed within the last month.
* Diagnosis of thyroid disease, nonclassical adrenal hyperplasia, and hyperprolactinemia.
* Use of any dietary fiber supplements which are newly started (within the past 6 months) and agreement not to use any new fiber supplements during the study period.

Primary outcomes:
measure: Primary outcomes to assess are the changes of testosterone levels and hirsutism.
timeFrame: up to 6 months
Secondary outcomes:
measure: Secondary outcomes to assess are the lipid profile and estrogen levels.
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: The University of Kansas Medical Center
name: Sam Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02529969: Effects of Curcumin Supplementation on Lipid Profile and Inflammatory Markers of Patients With Type 2 Diabetes
Official title: Curcumin Supplementation and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Non Insulin Dependent Diabetes
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetes mellitus is the most common endocrine disorder, causes many complications such as micro- and macro-vascular diseases. Various kinds of antidiabetic drugs have been developed, but most of them have side effects. Recently, the use of natural plant products has gained more attention among scientists in order to prevent diabetic vascular complications. Curcumin is a natural yellow product derived from the turmeric rhizome which has shown to be non-toxic and exhibits various bio¬logical activities such as anti-oxidant, anti-inflammatory, anti-carcinogenic, and anti-diabetic effects. Curcumin is effective in reducing glycemic index and hyperlipidemia in rodent models and is relatively inexpensive and safe. Most of the studies conducted on animal model, and just a few of them are on human model. The present study was planned to evaluate the effects of curcumin supplementation on serum levels of lipid profile and inflammatory markers in patients with type 2 diabetes


Eligibility criteria: Inclusion Criteria:

1. Tendency to participate
2. Age range of 40-65
3. Suffering from diabetes type 2 ( between 1 to 10 yeares)
4. BMI 18/5-30
5. Patients with diabetes who administer oral hypoglycemic agents and do not use

Exclusion Criteria:

1. patients with liver diseases
2. patients with kidney diseases
3. patients with inflammatory diseases
4. patients with liver diseases
5. Administering herbal agents
6. Administering multivitamins and minerals in past 3 months

Primary outcomes:
measure: Triglyceride
timeFrame: 12 weeks
Secondary outcomes:
measure: C-Reactive Protein
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: NNFTRI clinic
Study officials:
References:
Clinical trial NCT03231969: A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model
Official title: A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2, Dose Ranging Evaluation of the Effectiveness of Bilastine Ophthalmic Solution (0.2%, 0.4%, and 0.6%) Compared to Vehicle for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora-CAC®) Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Conjunctivitis
Lead sponsor: Faes Farma, S.A.
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2017-07-27
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis


Eligibility criteria: Key Inclusion Criteria:

* be at least 18 years old
* be willing and able to avoid all disallowed medications and contact lenses
* must have a pregnancy test if of childbearing potential
* must be able to read an eye chart from 10 feet away

Key Exclusion Criteria:

* must not have any allergies to the study medications
* must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
* must not have used immunotherapy in the last 2 years
* must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial

Primary outcomes:
measure: Ocular Itching
timeFrame: The outcome measure was assessed at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment).
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Ora Clinical Research Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT01727869: Study of REGN1400 Alone and in Combination With Erlotinib or Cetuximab in Patients With Certain Types of Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-11-16
Enrollment: 56
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 is an open-label, multicenter, ascending multiple dose study of REGN1400 alone and in combination with erlotinib or cetuximab administered to patients with certain types of cancer.


Eligibility criteria: Inclusion Criteria include, but are not limited to, the following:

1. Confirmed diagnosis of certain unresectable or metastatic cancers
2. Adequate Eastern Cooperative Oncology Group (ECOG) performance status
3. Adequate hepatic, renal and bone marrow function
4. Resolution of toxicity from prior therapy to grade less than/ = to 1

Exclusion Criteria include, but are not limited to, the following:

1. Active brain metastases
2. Thromboembolic events \< 6 months prior to study
3. Patients with a recent history (within 5 years) of another malignancy.
4. Investigational or any antitumor treatment with a maximum of 4 half-lives or administered 30 days prior to the initial administration of REGN1400
5. Patients who are pregnant or nursing
6. Prior treatment with ErbB3 inhibitors

Primary outcomes:
measure: The primary objective of the study is to characterize the safety profile of REGN1400 alone and in combination with erlotinib or cetuximab
timeFrame: Day 1 - Day 28
Secondary outcomes:
measure: Recommended Phase 2 Dose (RP2D)
timeFrame: Day 1 to Day 28
Other outcomes:
Locations:
city: Santa Monica
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: Detroit
country: United States
state: Michigan
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT04778969: Kor PCI - CAD Patients Treated With PCI: Analysis of the Korean Nationwide Health Insurance Database
Official title: Coronary Artery Disease Patients Treated With Percutaneous Coronary Intervention: Analysis of the Korean Nationwide Health Insurance Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Drug-eluting Stents
Drug-coated Balloon
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 200000
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: All coronary artery disease patients wih Korean NHIS (National Health Insurance Service)-listed PCI Patients are selected based on the registered treatment insurance code.

Brief summary: Current Status and Prognosis of Coronary artery disease patients treated with coronary intervention - Analysis of the Korean Nationwide Health Insurance Database

Detailed description: This is a retrospective study and is conducted for all patients who received percutaneous coronary intervention among cohorts registered with the National Health Insurance Service.

Primary outcome is all cause of mortality. Secondary outcomes are cardiovascular death, ischemic stroke, cerebral hemorrhage, admission due to gastrointestinal bleeding, and admission due to major bleedings.

Eligibility criteria: Inclusion Criteria:

* All coronary artery disease patients wih Korean NHIS (National Health Insurance Service)-listed PCI

Exclusion Criteria:

* non-specified

Primary outcomes:
measure: All cause of death
timeFrame: 10 years
Secondary outcomes:
measure: Cardiovascular death
timeFrame: 10 years
measure: ischemic stroke
timeFrame: 10 years
measure: Cerebral hemorrhage
timeFrame: 10 years
measure: Admission due to gastrointestinal bleeding
timeFrame: 10 years
measure: Admission due to major bleeding
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02585869: Efficacy and Safety of Gemcabene in Patients With Low HDL-C and Either Normal or Elevated Triglycerides
Official title: A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Determine the Efficacy and Safety of CI-1027 in Patients With Low HDL-C and Either Normal or Elevated Triglycerides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Hypertriglyceridemia
Keywords: Lipid Regulator
TG
Lead sponsor: NeuroBo Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-23
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 evaluate the effect of gemcabene on HDL-C, LDL-C, TG, and other lipid levels in patients with low HDL-C


Eligibility criteria: Inclusion Criteria:

* Men or naturally postmenopausal or surgically menopausal women
* 18 to 80 years of age
* Baseline HDL-C \<35 mg/dL (0.9 mmol/L)

Exclusion Criteria:

* Creatine phosphokinase (CPK) \>3 × the upper limit of normal (ULN)
* Body Mass Index (BMI) \>35 kg/m2
* Uncontrolled Hypertension \>95 mm Hg
* Uncontrolled diabetes mellitus (HbA1c \>10%)
* Renal dysfunction (blood urea nitrogen \[BUN\] or creatinine \>2 × ULN);
* Hepatic dysfunction (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \>2 × ULN)
* Uncontrolled hypothyroidism (TSH \>1.5 × ULN)
* Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous 3 months

Primary outcomes:
measure: HDL-C - percent change from baseline
timeFrame: 84 days
Secondary outcomes:
measure: Plasma lipids (eg, LDL-C, VLDL-C, TG)- percent change from baseline
timeFrame: 84 days
measure: Adverse Events
timeFrame: 84 days
measure: Clinical Laboratory - hematology, chemistry, urinalysis
timeFrame: 84 days
Other outcomes:
Locations:
Study officials:
References:
citation: Bays HE, McKenney JM, Dujovne CA, Schrott HG, Zema MJ, Nyberg J, MacDougall DE; Gemcabene Study Group. Effectiveness and tolerability of a new lipid-altering agent, gemcabene, in patients with low levels of high-density lipoprotein cholesterol. Am J Cardiol. 2003 Sep 1;92(5):538-43. doi: 10.1016/s0002-9149(03)00721-5.