louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00787878: Long Term Metabolic Safety of Norditropin® Treatment of Small for Gestational Age (SGA) Subjects
Official title: Comparison of Safety in Small for Gestational Age (SGA) Subjects Treated With Norditropin® (Somatropin) 5 Years Ago With Untreated SGA Subjects and With Normal Average for Gestational Age (AGA) Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Foetal Growth Problem
Small for Gestational Age
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-11-10
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: GH treated SGA and controls of non-treated SGA and AGA

Brief summary: The study is conducted in Europe. The primary aim of this observational study is to compare the insulin sensitivity in small for gestational age (SGA) subjects treated with Norditropin® with untreated small for gestational age (SGA) subjects and with average for gestational age (AGA) subjects.


Eligibility criteria: Inclusion Criteria:

* Norditropin® treated small for gestational age (SGA) group: Treated with Norditropin® for at least three years in the IUGR-1 or IUGR-2 trials
* Untreated small for gestational age (SGA) group: Birth length and/or weight less than -2 SDS for gestational age
* Average gestational age (AGA) group: Birth length and/or weight larger than -2 SDS for gestational age

Exclusion Criteria:

* Growth hormone deficiency defined as a peak growth hormone (GH) less than 20 mU/l
* Insulin like growth (IGF)-1 level less than -2 SDS
* Receipt of any investigational drug within four weeks prior to the trial

Primary outcomes:
measure: Insulin sensitivity
timeFrame: Index 5 years after end of GH treatment compared to controls
Secondary outcomes:
measure: Disposition index, glucose effectiveness and acute insulin response compared to controls
timeFrame: 5 years after end of Norditropin treatment
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: van Dijk M, Bannink EM, van Pareren YK, Mulder PG, Hokken-Koelega AC. Risk factors for diabetes mellitus type 2 and metabolic syndrome are comparable for previously growth hormone-treated young adults born small for gestational age (sga) and untreated short SGA controls. J Clin Endocrinol Metab. 2007 Jan;92(1):160-5. doi: 10.1210/jc.2006-1073. Epub 2006 Oct 24.
Clinical trial NCT04899778: Do Oral Contraceptives Protect Against ACL Injuries in Female Athletes
Official title: Do Oral Contraceptives Protect Against Anterior Cruciate Ligament Injuries in Female Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ligament Injury
Keywords: anterior cruciate ligament
birth control
oral contraceptive
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to examine the impact of one type of commonly used birth control pill on blood levels of relaxin and measure changes in knee movement to determine whether there are changes in joint instability (indicating the knee is less stable) that may predispose female athletes to injury. Women not on hormonal birth control will also be enrolled to analyze differences between athletes on and not on birth control and to evaluate typical relaxin levels and knee laxity when birth control pills are not used.


Eligibility criteria: Inclusion Criteria:

* Female
* 18 years of age or older
* Currently playing basketball, soccer, or volleyball at Loyola Marymount or Pepperdine
* If not currently on COC, regular menstrual cycle occurring every 21-35 days

Exclusion Criteria:

* Previous ACL injury
* Underlying neuromuscular disease
* Medical contraindication to COC use
* History of pregnancy
* Desire to conceive in the next year

Primary outcomes:
measure: Injury
timeFrame: over the course of 1 year
Secondary outcomes:
measure: Serum Relaxin Level
timeFrame: baseline, 4 month visit
measure: Anterior Knee Laxity
timeFrame: baseline, 4 month visit
measure: Hip Rotation During a Single-legged Drop
timeFrame: baseline, 4 month visit
measure: Knee Rotation During a Single-legged Drop
timeFrame: baseline, 4 month visit
measure: Joint Hypermobility
timeFrame: baseline, 4 month visit
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
References:
Clinical trial NCT02373878: Telecoaching Plus a Portion Control Device for Weight Management in the Primary Care Setting
Official title: Telecoaching Plus a Portion Control Device for Weight Care Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the impact of telecoaching conducted by a counselor trained in motivational interviewing paired with a portion control device for obese patients receiving care in a certified patient-centered medical home. The investigators will conduct a randomized, controlled clinical trial evaluating the effectiveness of a telecoaching intervention with a portion control device.

Detailed description: The intervention will be provided during a 3-month period with follow-up through 6 months after randomization. Body mass index (BMI) and waist circumference measurements will be collected at baseline and at 6, 12, 18, and 24 weeks. Participants will also complete measures assessing eating behaviors and physical activity at baseline and at 12 and 24 weeks.

Eligibility criteria: Inclusion Criteria:

* Men or women ≥ 18 years and ≤ 55 years of age
* A BMI of ≥ 30 and ≤ 44.9 kg/m2
* Motivated to lose weight
* Able to participate fully in all aspects of the study;
* Have been provided with, understand, and have signed the informed consent.

Exclusion Criteria:

* Unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia
* A history of a gastric bypass procedure or planned gastric bypass
* Baseline systolic blood pressure \> 180 or diastolic \> 100
* Another member of their household already participating in this study
* Current treatment with another investigational drug for obesity (within 30 days of study entry)
* Are pregnant or lactating
* History of anorexia or bulimia
* Current binge eating disorder as assessed by the Patient Health Questionnaire eating disorder module (PHQ-ED)
* Schizophrenia or bipolar disorder or have a PHQ-2 ≥ 337
* Have been diagnosed with cancer within the past 5 years
* Are currently participating in a program specifically to lose weight or are on a weight loss medication (last 30 days)

Primary outcomes:
measure: Change in Body Mass Index
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jon O Ebbert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huber JM, Shapiro JS, Wieland ML, Croghan IT, Vickers Douglas KS, Schroeder DR, Hathaway JC, Ebbert JO. Telecoaching plus a portion control plate for weight care management: a randomized trial. Trials. 2015 Jul 30;16:323. doi: 10.1186/s13063-015-0880-1.
Clinical trial NCT04166578: Analgetic Effect of Two Solutions of Intracameral Anesthesia During Cataract Surgery in Patients
Official title: Comparison of Analgetic Effect of Two Solutions of Intracameral Anesthesia During Cataract Surgery: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Analgesia
Ophthalmological Disorder
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 70 patients was initially scheduled to participate in this study. However, 8 patients did not attend the postoperative visits and were excluded. As a result, only 62 patients were included in the analysis. The mean age (±SD) of patients was 73.95 (±7.82) years. Female to male ratio was 55/45 in Mydrane group and 53/47 in the control group.

Brief summary: Purpose: The aim of the study was to compare the analgetic effect of two solutions of intracameral anesthesia in patients undergoing cataract surgery and assess the factors influencing the patients' postoperative activities.

Methods: In this prospective, single-blind, randomized study, a group of 62 patients undergoing cataract surgery received Mydrane (Mydrane group) or a combination of 1% solution of lignocaine and 0.025% solution of adrenalin (reference group) as an intraocular anesthetic. The analgetic effect of these two anesthetic methods was evaluated using psychological tools - Visual Analog Scale for Pain (VAS Pain) and Brief Pain Inventory-short form (BPI) on the next day after the surgery.


Eligibility criteria: Inclusion Criteria:

* age above 18 years
* best corrected visual acuity (BCVA) of 0.2 logMAR or worse
* and agreement for taking part in the study

Exclusion Criteria:

* depressive disorder or expected compliance problems (known psychiatric disease)
* epilepsy
* ongoing treatment with hypnotics or psychotropic drugs (including opioids) within a week before admission
* daily analgesic treatment
* intake of additional rescue medications due to the pain after surgery
* omitting postoperative visit
* no consent to complete the survey
* The patients who later needed additional medications for pain relief

Primary outcomes:
measure: The mean pain score measured with VAS Pain
timeFrame: preoperatively
measure: The mean pain score measured with VAS Pain
timeFrame: postoperatively (the next day after surgery- 24 hours)
measure: The range of pain was measured on the next day after surgery with BPI-short
timeFrame: the next day after surgery (24 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: General Department of Ophthalmology in Lublin
Study officials:
References:
Clinical trial NCT00859378: Cemented vs Non-cemented Semiendoprosthesis in the Treatment of Proximal Femoral Fractures
Official title: A Prospective, Randomized Study Comparing Cemented and Non-cemented Semiendoprostheses in the Treatment of Proximal Femoral Fractures in the Elderly Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fracture
Proximal Femoral Fracture
Keywords: Hip
Hip endoprosthesis
Hip fracture
Femoral fracture
Bone cement
Non-cemented
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: The Finnish Research Foundation for Orthopaedics and Traumatology
First posted: 2009-03-11
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hip semiendoprosthesis is an acceptable method to treat the proximal femoral fractures. Traditionally, the cemented version of the semiendoprosthesis has been used for this indication. However, the cementing carries a risk of fat embolism during the pressurization of the cement. The fat embolism can be avoided when using the non-cemented semiendoprosthesis. In this study we want to find out whether there are any differences in the treatment results between the cemented and non-cemented semiendoprostheses when treating the proximal femoral fractures.


Eligibility criteria: Inclusion Criteria:

* A proximal femoral fracture

Exclusion Criteria:

* Rheumatoid arthritis
* Pathologic fracture
* Severe dementia (preventing the informed consent)

Primary outcomes:
measure: Primary mortality
timeFrame: 3 months
Secondary outcomes:
measure: Prosthetic complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Joensuu
country: Finland
facility: Central Hospital of North Carelia
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
References:
Clinical trial NCT06302478: 5E Program for Preventing Venous Thromboembolism in Patients With Spinal Cord Disorders
Official title: Effects of a Venous Thromboembolism Prevention Program on the Occurrence of Venous Thromboembolism in Patients With Spinal Cord Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Venous Thromboembolism
Spinal Cord Diseases
Spinal Cord Injuries
Nurse's Role
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A quasi-experimental research (two group pretest-posttest design)
Primary purpose: PREVENTION

Brief summary: The goal of this quasi-experimental study is to examine the effects of a venous thromboembolism prevention program, or "5E" program, on the rates of venous thromboembolism in patients with spinal cord disorders. The main questions it aims to answer are:

* Will participants receiving the 5E program have lower rates of venous thromboembolism compared to those receiving the usual care?
* Will participants receiving the 5E program have lower scores of venous thromboembolism signs and symptoms compared to those receiving the usual care?
* Will the average thigh and calf circumferences of participants before and after receiving the 5E program be different?

Participants in the intervention group will receive the 5E program, including

* Education: health education regarding venous thromboembolism prevention
* Elevation: leg elevation of 10-20 degrees
* Exercise: ankle exercises
* Enough fluid: adequate fluid uptake
* Early application of intermittent pneumatic compression (IPC): IPC use within 48 hours after admission


Eligibility criteria: Inclusion Criteria:

* Caprini scores of 5-8 and \>8
* Able to communicate in the Thai language
* Willing to participate in this study

Exclusion Criteria:

* Alteration of consciousness
* Experiencing complications, including neurogenic shock and autonomic dysreflexia
* Being pregnant
* Having fluid restriction

Primary outcomes:
measure: The rate of venous thromboembolism
timeFrame: The day before implementing the intervention and at 7 days after implementing intervention
Secondary outcomes:
measure: Signs and symptoms of deep venous thrombosis and pulmonary embolism
timeFrame: The day before implementing the intervention and Day 1 - Day 7 after implementing intervention
measure: Thigh and calf circumference
timeFrame: The day before implementing the intervention and Day 1 - Day 7 after implementing intervention
Other outcomes:
Locations:
city: Chaiyaphum
country: Thailand
facility: Chaiyaphum Hospital
Study officials:
References:
Clinical trial NCT00770978: Open Label Study of Ceftobiprole to Evaluate Pharmacokinetics in Adults Hospitalized in the ICU
Official title: Open-Label, Parallel Group, Multiple-dose Study of Ceftobiprole to Evaluate the Plasma Pharmacokinetics in Adults in Intensive Care Units
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: ICU
Keywords: ICU
Lead sponsor: Basilea Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2008-10-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to measure the levels of ceftobiprole in the blood and urine during and after administration of four doses of ceftobiprole. Safety of the drug will also be evaluated.

Detailed description: Patients will receive an intravenous dose of ceftobiprole infused over 4 hours. Multiple blood samples will be obtained to determine the concentration of ceftobiprole in the plasma. Pharmacokinetic parameters such as clearance and volume of distribution will be calculated. 1000mg every 8hours or every 12 hours

Eligibility criteria: Inclusion Criteria:

* Informed Consent
* Between 18 and 75 years of age inclusive
* BMI 18 - 35 inclusive
* Albumin \< 3.3 g/dL or clinical evidence of edema
* Negative Pregnancy test
* Expected survival of at least 7 days

Exclusion Criteria:

* Known drug allergy (including penicillin, cephalosporin, carbapenems, or other beta-lactams)
* Renal impairment (CrCl \< 50 mL/min) or dialysis
* History of seizures
* ALT or AST \> 5 times upper normal limit
* Sustained shock, unresponsive to sympathomimetics
* Conditions that may have jeopardized adherence to the protocol (NYHA Class 4 cardiac disease, \>15% total body burn or significant third degree burn)

Primary outcomes:
measure: Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine) during dosing and 24 hours after last dose
timeFrame: 3 days
Secondary outcomes:
measure: Safety will be evaluated throughout the study.
timeFrame: 7 days
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Chicago
country: United States
state: Illinois
city: Beech Grove
country: United States
state: Indiana
city: Omaha
country: United States
state: Nebraska
city: Aalst
country: Belgium
city: Edegem
country: Belgium
city: Greenfield Park N/A
country: Canada
state: Quebec
city: Jerusalem
country: Israel
city: Gwangju
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Barcelona
country: Spain
city: Madrid
country: Spain
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT00501878: 2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides
Official title: 2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: phenylephrine
mydriasis
diabetes mellitus
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2007-07-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To compare the clinical efficacy and systemic side effects between 2.5% and 10% phenylephrine for mydriasis in diabetic patient with darkly pigmented irides.

Detailed description: One hundred patients with diabetes from Srinagarind Hospital Eye Clinic were enrolled and randomized into two groups by block randomization. In group I (50 patients), 1% tropicamide combined with 2.5% phenylephrine were administered to dilate pupil whereas 1% tropicamide combined with 10% phenylephrine were used in Group II (50 patients). Pupil diameter, blood pressure and heart rate were measured before and after eye drop instillations.

Eligibility criteria: Inclusion Criteria:

* diabetic patients

Exclusion Criteria:

* history of intraocular surgery or laser treatment,
* any ocular diseases that might affect pupil size such as glaucoma,uveitis,Horner's syndrome, Adies' pupil,
* history of allergy to any drug used, and
* hypertension

Primary outcomes:
measure: Pupil diameters were measured.
timeFrame: before and after phenylephrine eye drop instillations
Secondary outcomes:
measure: blood pressure and heart rate were measured
timeFrame: before and after phenylephrine eye drop instillations
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital Eye Clinic
Study officials:
affiliation: Khon Kaen University
name: Yosanan Yospaiboon, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suwan-Apichon O, Ratanapakorn T, Panjaphongse R, Sinawat S, Sanguansak T, Yospaiboon Y. 2.5% and 10% phenylephrine for mydriasis in diabetic patients with darkly pigmented irides. J Med Assoc Thai. 2010 Apr;93(4):467-73.
Clinical trial NCT00396578: Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation
Official title: Aerosolized Antibiotics in Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ventilator Associated Pneumonia
Respiratory Infection
Tracheobronchitis
Keywords: aerosolized antibiotics
ventilator associated pneumonia
clinical pulmonary infection score
bacterial resistance
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Nektar Therapeutics
First posted: 2006-11-07
Enrollment: 80
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: The purpose of this study was to determine the effect of aerosolized antibiotics on respiratory infection in mechanically ventilated patients.We hypothesize that aerosolized antibiotics , which achieve high drug concentrations in the airway, would more effectively treat respiratory infection, decrease the need for systemic antibiotics and decrease antibiotic resistance.

Detailed description: In patients requiring mechanical ventilation, signs of respiratory infection often persist despite treatment with powerful antibiotics given through the patient's vein. In this trial, patients with purulent secretions were assigned aerosolized antibiotics or placebo by a randomizing protocol. Neither the patients or their doctors knew what the patient was receiving.Need for a systemic antibiotic was determined by the clinical physician. Comparisons were made between placebo and study drug for their effects on pneumonia, respiratory signs of infection, ability to wean patients from the ventilator, systemic(given in the vein) antibiotic use and the development of organisms that were resistant to antibiotics.

Eligibility criteria: Inclusion Criteria:

* be on mechanical ventilation greater than 3 days
* greater than or equal to 18 years of age survival greater than 14 days
* greater than 2 ccs of tracheal secretions/4 hours

Exclusion Criteria:

* allergy to drugs, pregnancy

Primary outcomes:
measure: Ventilator associated pneumonia Systemic Antibiotic use Clinical pulmonary infection score
Secondary outcomes:
measure: Weaning from mechanical ventilation Bacterial resistance
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: University Hospital Medical Center
state: New York
Study officials:
affiliation: SUNY at Stony Brook
name: Lucy B Palmer, MD
role: PRINCIPAL_INVESTIGATOR
References: