louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05661279: Rhomboid Intercostal Block Versus Serratus Anterior Plane Block
Official title: Ultrasound Guided Rhomboid Intercostal Block Versus Serratus Anterior Plane Block for Analgesia After Thoracodorsal Artery Perforator Flap Following Partial Mastectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Keywords: rhomboid intercostal block -serratus anterior plane block - thoracodorsal artery perforator flap
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-12-22
Enrollment: 84
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: evaluate and compare the impact of ultrasound guided rhomboid intercostal block versus serratus anterior plane block for analgesia after thoracodorsal artery perforator flap following partial mastectomy

Detailed description: * To assess and compare quality of post- operative analgesia in each group.
* Time of performance of block in both groups.
* To assess and compare post-operative hemodynamics as well as anticipated adverse effects including nausea, vomiting, itching, hemorrhage, bradycardia, hypotension.

Eligibility criteria: Inclusion Criteria:

* Adult patients aged between 21 to 60 years
* Undergoing pedicled thoracodorsal artery perforator flap following breast conserving surgery -General anesthesia
* Informed consents
* ASA I \& II
* Body mass index 25-30 kg/m2.

Exclusion Criteria:

* patients on anti-platelet, anticoagulant or B blocker drugs
* Patients with acute decompensated heart failure, hypertension, heart block, coronary disease, Asthma, bleeding disorders, compromised renal or hepatic function
* history of allergy to local anesthesia or opioid analgesia,
* pregnancy.

Primary outcomes:
measure: tramadol consumption
timeFrame: at 24 hours postoperative
Secondary outcomes:
measure: Time of performance of block
timeFrame: time from positioning of ultrasound porbe till the end of block procedure.
measure: Time to first dose of rescue analgesia
timeFrame: during the first 24 hours postoperatively
measure: Anticipated side effect
timeFrame: at 24 hous post operative
measure: Post operative patient's satisfaction
timeFrame: at 24 hours post operative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Heba M Fathi
Study officials:
affiliation: faculty of human medicine ,zagazig university
name: Heba M Fathi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02108379: Compliance and Usability Study Evaluating RHINIX™ Nasal Filters
Official title: An Open-label Outpatient In-season Study Assessing Compliance and Usability of Rhinix™ Nasal Filters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Rhinix ApS
name: Astma-Allergi Danmark
First posted: 2014-04-09
Enrollment: 1073
Sex: ALL
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: This study will investigate usability and compliance related to rhinix nasal filters for the treatment of seasonal allergic rhinitis (hay fever) during the natural grass pollen season in Denmark.


Eligibility criteria: Inclusion Criteria:

* Motivated to try a different treatment approach to seasonal allergic rhinitis (documented by answering the call-out by Astma-Allergi Danmark)
* Indicates having seasonal allergic rhinitis to grass via online questionnaire
* Informed consent (by email acceptance after having received information on the trial)
* Assess to internet and email

Exclusion Criteria:

* Improper fit of the Rhinix™ device

Primary outcomes:
measure: Week 1 likelihood of continued use of RHINIX after study end.
timeFrame: 1 assessment at the end of the 1st week of use.
measure: Week 2 likelihood of continued use of RHINIX after study end.
timeFrame: 1 assessment at the end of the 2nd week of use.
Secondary outcomes:
measure: Week 1 Satisfaction with RHINIX
timeFrame: 1 assessment at the end of the 1st week
measure: Week 2 satisfaction with RHINIX
timeFrame: One assessment at the end of the 2nd week
measure: Week 1: RHINIX Control
timeFrame: One assessment at the end of the 1st week of use
measure: Week 2: RHINIX Control
timeFrame: One assessment at the end of the 2nd week of use.
Other outcomes:
measure: Week 1: Correlation of use and allergy severiy
timeFrame: One assessment at the end of the 1st week of use
measure: Week 2: Correlation between use and allergy severity
timeFrame: One assessment at the end of the 2nd week of use
measure: Week 1: Perceived decrease in medication
timeFrame: One assessment after the 1st week of use
measure: Week 2: Perceived decrease in medication
timeFrame: One assessment after 2nd week of use
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine
Study officials:
affiliation: Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine
name: Torben Sigsgaard, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kenney P, Hilberg O, Sigsgaard T. Clinical Application of Nasal Filters: An Observational Study on the Usability of Nasal Filters in Managing Seasonal Allergic Rhinitis. J Allergy Clin Immunol Pract. 2016 May-Jun;4(3):445-452.e4. doi: 10.1016/j.jaip.2016.01.003. Epub 2016 Feb 18.
Clinical trial NCT02598479: A Quality of Life Study Using Insulin Potentiation Targeted LowDose (IPTLD) Chemotherapy and Nutrition Therapy in the Treatment of Cancer
Official title: The IPTLD QoL Broad Study A Quality of Life Study Using Insulin Potentiation Targeted LowDose (IPTLD) Chemotherapy and Nutrition Therapy in the Treatment of Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cancer
Keywords: Cancer
Insulin Potentiation Low Dose Chemotherapy
IPT
IPTLD
Nutrition therapy
Lead sponsor: Best Answer for Cancer Foundation
Sponsor class: OTHER
First posted: 2015-11-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over the age of 18 who have chosen to receive IPTLD with nutrition therapy

Brief summary: The IPTLD QoL Broad Study.

Detailed description: A Quality of Life Study Using Insulin Potentiation Targeted LowDose (IPTLD) Chemotherapy and Nutrition Therapy in the Treatment of Cancer.

Eligibility criteria: Inclusion Criteria:

* diagnosis of cancer,
* age older than 18 years,
* requesting IPTLD and nutrition therapy

Exclusion Criteria:

* diagnosis other than cancer,
* age younger than 18 years,
* requesting conventional chemotherapy

Primary outcomes:
measure: Improvement in Quality of Life measured by questionnaires
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Center for Advanced Medicine
state: Arizona
Study officials:
affiliation: Arizona Center for Advanced Medicine
name: Martha M Grout, MD, MD(H)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01421979: Clinical Trial on the Effects of Caffeine and Taurine From Energy Drinks (EDs) to Parameters of the Cardiovascular System in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2011-08-23
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of this study is to examine the safety and the effects of EDs at high doses, either alone or in combination with other risk factors such as alcohol intake, physical exercise and sleep deprivation, on cardiovascular markers and subjective health.


Eligibility criteria: Inclusion Criteria:

* written informed consent
* healthy (no acute or chronic desease)
* BMI 20,0 - 25,9 kg/m2
* moderate and non-regular consumption of alcohol, EDs and coffee

Exclusion Criteria:

* pregnancy
* regular medication (oral contraceptives permitted)
* hypertension and other deseases of the cardiovascular system
* liver-deseases
* psychiatric deseases
* epilepsy
* other relevant deseases
* (former) alcoholics
* non-compliance to the study-protocol
* simultaneous participation in another clinical trial
* retraction of the written informed consent

Primary outcomes:
measure: Heart-rate-variability (HRV)
timeFrame: during 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: University of Hohenheim
state: Baden-Württemberg
Study officials:
References:
citation: Basrai M, Schweinlin A, Menzel J, Mielke H, Weikert C, Dusemund B, Putze K, Watzl B, Lampen A, Bischoff SC. Energy Drinks Induce Acute Cardiovascular and Metabolic Changes Pointing to Potential Risks for Young Adults: A Randomized Controlled Trial. J Nutr. 2019 Mar 1;149(3):441-450. doi: 10.1093/jn/nxy303.
Clinical trial NCT02095379: Oligosecretary Myeloma: Prevalence and Its Clinical Significance
Official title: Oligosecretary Myeloma: Prevalence and Its Clinical Significance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: oligosecretary multiple myeloma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-03-24
Enrollment: 390
Sex: ALL
Minimum age (years): 17
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: a subgroup of multiple myeloma (MM) characterized by low levels of serum and urine monoclonal (M) protein below thresholds of measurable disease (a serum M protein ≥ 1g/dL, a urine M protein ≥ 200mg/day)

Brief summary: In this study, the investigators aim to investigate the prevalence and clinical course of oligosecretary myeloma.

Detailed description: Oligosecretary myeloma is a subgroup of multiple myeloma (MM) characterized by low levels of serum and urine monoclonal (M) protein below thresholds of measurable disease (a serum M protein ≥ 1g/dL, a urine M protein ≥ 200mg/day). Patients with oligosecretary myeloma do not have established methods for disease monitoring and clinical informations regarding oligosecretary myeloma are still largely unknown.

In this study, we aimed to investigate the prevalence and clinical course of oligosecretary myeloma.

Eligibility criteria: Inclusion Criteria:

* a subgroup of multiple myeloma (MM) characterized by low levels of serum and urine monoclonal (M) protein below thresholds of measurable disease (a serum M protein ≥ 1g/dL, a urine M protein ≥ 200mg/day)
* available clinical data

Exclusion Criteria:

* patients without available clinical data

Primary outcomes:
measure: Number of patients with oligosecretary myeloma among multiple myeloma patients
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Kihyun Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05373979: Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale
Official title: Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale (PN-PROS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Narcolepsy
Obstructive Sleep Apnea
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Jewish Health
name: Geisinger Clinic
name: The Hospital for Sick Children
name: Stanford University
First posted: 2022-05-13
Enrollment: 212
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (and a parent/guardian) with an established narcolepsy type 1, narcolepsy type 2, or OSA diagnoses ages 9-17 years.

Brief summary: The purpose of this study is to test a pediatric narcolepsy patient reported outcomes tool to assess pediatric narcolepsy symptoms and their effect on daily functioning and quality of life. The goal is to develop a clinical survey that can improve the care of pediatric narcolepsy.

Detailed description: WHO IS ELIGIBLE?

* Children and adolescents with narcolepsy between the ages of 9-17 years
* Diagnosis must be verified by a signed letter from physician in order to participate
* Participants must be able to understand the purpose of the study

PARTICIPATION DETAILS

* Upon enrollment participants will receive an email containing a link to complete HIPAA compliant online surveys about narcolepsy symptoms, quality of life, and daily function. Surveys should take no more than 30 minutes.
* One week later, some participants will receive another email with a link to complete a 10-minute follow up survey

Eligibility criteria: Inclusion Criteria:

* Children and adolescents ages 9-17
* Have a diagnosis of narcolepsy type 1, narcolepsy type 2, or mild to moderate obstructive sleep apnea (OSA)

Exclusion Criteria:

* A history of visual or hearing impairment
* A co-morbid neurodevelopmental disorder such as autism or schizophrenia
* No access to computer/tablet/smart phone to complete questionnaires

Primary outcomes:
measure: Survey Validation
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Kiran Maski, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03693079: Investigation of Wet Cupping Therapy on Heavy Metal Levels of Steel Industry Workers
Official title: Investigation of Wet Cupping Therapy on Heavy Metal Levels of Steel Industry Workers: A Self Controlled Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heavy Metal Toxicity
Keywords: heavy metal
wet cupping therapy
steel industry worker
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This interventional study investigates the efficacy of Wet cupping therapy on heavy metal levels.The levels of the selected heavy metals will be measured in the blood samples obtained from the participants before and after the interventions

Detailed description: Wet cupping therapy (WCT) is a traditional therapy which was used for centuries especially for detoxifiying purposes.Current literature also points out its blood clarifiying capacity in order to illuminate the underlying mechanism of this ancient treatment.

Steel industry workers, different from the general population are exposed to heavy metals more often.Conducting a study in this special group where we will evaluate the levels of selected heavy metals in blood before and after the three sessions of WCT might let us know its detoxifiying capacity based on measurable parameters.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals
* Iron and Steel industry workers

Exclusion Criteria:

* having any chronic disorder
* being on daily medication
* wet cupping application in the last 6 months

Primary outcomes:
measure: Levels of the selected heavy metals in venous blood samples before and after the interventions
timeFrame: 3 months
Secondary outcomes:
measure: Levels of the selected heavy metals in cupping blood samples obtained during the first intervention
timeFrame: 1 month
Other outcomes:
Locations:
city: Safranbolu
country: Turkey
facility: Suleyman Ersoy
state: Karabuk
Study officials:
References:
Clinical trial NCT01633879: Addressing Proven Factors in HIV Prevention for Latino Youth
Official title: Health and Success: Addressing Proven Factors in HIV Prevention for Latino Youth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: HIV
Sexually Transmitted Infections
Keywords: parenting, prevention, HIV/AIDS, adolescents, Latino
Lead sponsor: Education Development Center, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-04
Enrollment: 3400
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study tests the effectiveness of the bilingual Health and Success program, which aims to support Latino parents and schools in their efforts to promote the academic success and healthy choices of youth, with the goal of reducing barriers that lead to elevated levels of HIV/AIDS in urban Latino communities.


Eligibility criteria: Inclusion Criteria:

* youth attend school selected as study site
* youth in 6-7th grade

Exclusion Criteria:

* parent/youth non-English or Spanish speakers

Primary outcomes:
measure: reduction in risk behavior
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03438279: Survival Study for Participants Treated With Ipilimumab-Nivolumab Combination Therapy
Official title: Projecting Survival for Patients Treated With First-Line Ipilimumab-Nivolumab Combination Therapy Using a Prognostic Model and Cost Per Responder Model of Ipilimumab-Nivolumab Combination Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-02-19
Enrollment: 600
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: Individual patient data (IPD) from the ipilimumab pooled analysis of clinical trials and observational studies will be used to construct the prognostic model for OS in advanced melanoma patients.

Brief summary: This study will review published trial literature and documents for Overall Survival (OS) to evaluate the association between the hazard of death and each baseline variable.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of melanoma

Exclusion Criteria:

* Age less than 18 years old

Primary outcomes:
measure: Prognostic Model of Overall Survival (OS)
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02032979: Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2
Official title: Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Dystrophy, Facioscapulohumeral
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators propose to conduct a comparative pilot cognitive and psychiatric profiles of 10 patients Facio-Scapulo-Humeral Dystrophy (= FHSD) type 1 and 10 patients with type 2 FSHD study. For this, the investigators relied on observational components: FSHD2 patients appear more often present with psychiatric comorbidities and seem to have lower cognitive performance compared to FSHD1 patients. This was confirmed by a preliminary study on a small sample population of patients. It seems to exist mainly executive dysfunction associated with attention disorders in patients FSHD2. Moreover, their performance in IQ tests would be low in relation to their socio-educational and compared with patients FSHD1 level.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years and \<75 years
* FSHD patients 1 or 2 with genetic confirmation

Exclusion Criteria:

* Phosphokinase creatine level \> 5 time of the normal
* Patient as medical history :

  * A history or active neurological disease likely to interfere with the interpretation of results
  * a history of head trauma
  * an infectious disease, hormonal, inflammatory or some deficiency may induce cognitive and / or psychiatric troubles
  * Patient with cons-indication for performing a brain MRI
* Pregnant, parturient and lactating (producing a serum pregnancy test)

Primary outcomes:
measure: Montgomery and Asberg Depression Rating Scale
timeFrame: One time at the inclusion
measure: Hamilton Depression Rating Scale
timeFrame: One time at the inclusion
measure: Hamilton Anxiety Rating Scale
timeFrame: One time at the inclusion
measure: Quick inventory of depressive symptomatology Self report
timeFrame: One time at the inclusion
measure: Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
timeFrame: One time at the inclusion
measure: Mini Mental Status Evaluation
timeFrame: One time at the inclusion
measure: Wechsler Adult Intelligence Scale
timeFrame: One time at the inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpital Pasteur
Study officials:
References:
Clinical trial NCT00092079: A Study of MK0217A and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)
Official title: A 15-Week, Double-Blind, Randomized, Active-Controlled, Multi-Center Study With 24-Week Extension to Evaluate the Safety, Tolerability, Efficacy of Alendronate 70 mg Plus Vitamin D3 2800 IU Combination Tablet in Men and Postmenopausal Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Vitamin D Deficiency
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-24
Enrollment: 652
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
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 test the safety, tolerability, and effectiveness of an investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and deficiency during treatment of osteoporosis in men and postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* Men or postmenopausal women who are osteoporotic

Exclusion Criteria:

* Vitamin D deficiency
* Other disease of bone or mineral metabolism
* Digestive disease causing malabsorption
* Other medical conditions that are not adequately treated

Primary outcomes:
measure: Safety and tolerability; primary parameter assessed is the proportion of patients who develop hypercalcuria
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitior
role: STUDY_DIRECTOR
References:
citation: Recker R, Lips P, Felsenberg D, Lippuner K, Benhamou L, Hawkins F, Delmas PD, Rosen C, Emkey R, Salzmann G, He W, Santora AC. Alendronate with and without cholecalciferol for osteoporosis: results of a 15-week randomized controlled trial. Curr Med Res Opin. 2006 Sep;22(9):1745-55. doi: 10.1185/030079906x120913.
citation: Binkley N, Ringe JD, Reed JI, Ljunggren O, Holick MF, Minne HW, Liu M, Lamotta A, West JA, Santora AC. Alendronate/vitamin D3 70 mg/2800 IU with and without additional 2800 IU vitamin D3 for osteoporosis: results from the 24-week extension of a 15-week randomized, controlled trial. Bone. 2009 Apr;44(4):639-47. doi: 10.1016/j.bone.2008.05.002. Epub 2008 May 15.