louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00706043: French Validation Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ) Questionnaire
Official title: Validation of a French Translation of the Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ): A Prospective One-year Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Low Back Pain
Chronic Low Back Pain
Keywords: Low back pain
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2008-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females 20-55 years old suffering from acute low back pain

Brief summary: Low back pain is a very common disease. Among the persons suffering of acute low back pain, about 10% are at risk of developping chronic pain. A screening questionnaire assessing this risk has been developed and validated in Swedish and English (Orebro Musculoskeletal Pain Screening Questionnaire, Linton, 2003). The aim of our study is to validate a french translation of this questionnaire. Patients suffering from acute low back pain will be asked to fill in several questionnaires at day 0, and 6 and 12 month later.


Eligibility criteria: Inclusion Criteria:

* all consecutive patients presenting at the clinical care setting with acute low back pain
* pain lasting for less than three months
* cumulated sick leave less thant six months

Exclusion Criteria:

* unability to sufficiently read and understand French
* presence of red flags as according to the New Zealand Acute Low Back Pain Guide

Primary outcomes:
measure: Pain
timeFrame: 6 and 12 month
Secondary outcomes:
measure: Professional status
timeFrame: 6 and 12 months
measure: functional status
timeFrame: 6 and 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02262143: Phase III Study of Rosuvastatin and Fenofibrate Versus Rosuvastatin in Mixed Dyslipidemia
Official title: Efficacy and Safety of Combination Therapy of Rosuvastatin and Fenofibrate Versus Rosuvastatin Monotherapy in Mixed Dyslipidemia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mixed Dyslipidemias
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2014-10-10
Enrollment: 362
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and safety of combination therapy of rosuvastatin and fenofibrate versus rosuvastatin monotherapy in mixed dyslipidemia patients: A randomized, multi-center, double-blind, phase 3 study


Eligibility criteria: Inclusion Criteria:

* 19 \~ 80 years old
* High risk patient to Coronary Heart Disease
* At Visit 1(Screening)

  1. Treated with Rosuvastatin 10mg monotherapy 4weeks prior to this study
  2. 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl
* At Visit 2 (Baseline), 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl

Exclusion Criteria:

* AST or ALT \> 2X ULN
* Patients with uncontrolled hyperthyroidism (TSH\>1.5X ULN)
* Patients with uncontrolled diabetes (HbA1c ≥ 9%)
* Patients with uncontrolled hypertension(SBP\>160mmHg or DBP\>95mmHg)
* Patients with congestive heart failure(NYHA class III\~IV) or uncontrolled arrhythmia within 6 months
* Patients treated with any investigational drugs within 3 months at the time consents are obtained
* Not eligible to participate for the study at the discretion of investigator

Primary outcomes:
measure: The mean percent change of Non-HDL Cholesterol
timeFrame: from baseline at week 8
Secondary outcomes:
measure: The mean change, percent change of Non-LDL-C
timeFrame: from baseline at week 4
measure: The mean change of Non-LDL-C
timeFrame: from baseline at week 8
measure: The mean percent change of LDL-C, HDL-C, VLDL-C, TG, TC, Apo-AI, Apo-B
timeFrame: from baseline at week 4, 8
measure: The achievement rate of Non-HDL-C<130mg/dl
timeFrame: from baseline at week 4, 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ildong Pharm.
Study officials:
affiliation: Kyunghee University Medical Center
name: Jeongtaeck Woo, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01466543: Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity
Official title: Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity in Normal and Subcortical Vascular Cognitive Impairment Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Vascular Dementia
Subcortical Vascular Dementia
Keywords: Vascular dementia
Subcortical vascular dementia
Phosphodiesterase 5
Udenafil
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Dong-A Pharmaceutical Co., Ltd.
First posted: 2011-11-08
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Zydena (Udenafil) has effect on cerebral blood flow and peripheral blood viscosity in normal and subcortical vascular cognitive impairment subjects.

Detailed description: Udenafil is a newly developed selective phosphodiesterase type 5 inhibitor (PDE5i). Since PDE5i is known to relax smooth muscle cells, it is suggested that PDE5i may dilate cerebral vessels and lead to an increase in cerebral blood flow. The main mechanism of subcortical vascular cognitive impairment are hypoperfusion of the brain. Therefore, in this study, the investigators will investigate whether Udenafil can increase cerebral blood flow and also lower peripheral blood viscosity in normal and subcortical vascular cognitive impairment subjects.

Eligibility criteria: Inclusion Criteria:

for Normal control group

* Normal cognition by detailed neuropsychological tests
* Brain MRI scan with no or minimal white matter hyperintensities

for Subcortical vascular mild cognitive impairment (svMCI)

* Clinical diagnosis of svMCI
* Brain MRI scan with severe white matter hyperintensities

Exclusion Criteria:

- Contraindications to phosphodiesterase type 5 (Zydena, Udenafil)

Primary outcomes:
measure: Cerebral blood flow
timeFrame: One hour after the administration of the medication
Secondary outcomes:
measure: Peripheral blood viscosity
timeFrame: One hour after the administration of the medication
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Duk L. Na, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05972343: COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients
Official title: COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients: A Prospective Observational Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Cancer of the Breast
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen at Siteman Cancer Center.

Brief summary: This is a subject registry study of patients who undergo cryoablation for their breast cancer after being determined not to be surgical candidates. Data collected as part of this registry will be used to assess the safety of percutaneous ultrasound-guided cryoablation in this population as well as provide long-term follow-up of subjects who received cryoablation.


Eligibility criteria: Eligibility Criteria:

* Diagnosis of breast cancer.
* Mass must be visible on ultrasound and \> 5 mm from skin.
* Not undergoing surgery, because:

  * Patient has a medical condition that would not allow sedation or general anesthesia
  * Surgery is not clinically indicated due to unresectable and/or metastatic disease
  * Surgery is not clinically indicated for another reason
  * Patient declines surgery
* At least 18 years old.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Primary outcomes:
measure: Proportion of patients who are free of serious treatment related complications per CTCAE v 5.0
timeFrame: Through 3 year follow-up
Secondary outcomes:
measure: Proportion of patients who demonstrate progression-free survival (PFS)
timeFrame: At 3 year follow-up
measure: Proportion of patients who demonstrate disease-free survival (DFS)
timeFrame: At 3 year follow-up
measure: Proportion of patients who demonstrate overall survival (OS)
timeFrame: At 3 year follow-up
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Heather Garrett, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06966843: Dantrolene in Statin-induced Myopathy
Official title: Dantrolene in Statin-induced Myopathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Statins Induced Myopathy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive either dantrolene or placebo for 4 weeks.
Primary purpose: TREATMENT

Brief summary: Statins are one of the most efficient drugs for the treatment of hypercholesterolemia which is considered as one of the main risk factors for atherosclerosis., and therefore they are frequently prescribed medications \[1-2\]. However, statins therapy is associated with myotoxicity. This effect of different severity ranges forms myopathy, myalgia, myositis, and rhabdomyolysis \[3\].

Different studies set a number of hypotheses to explain the pathophysiological events of statin-induced myopathy. These hypotheses include disturbance of mitochondrial function resulting in cytoplasmic Ca2+ overload as well as decreased level of the potent antioxidant and membrane stabilizer coenzyme Q10/ubiquinone \[4-5\] This study tries to introduce a complementary therapy that targets these molecular events. This therapeutic protocol includes dantrolene the muscle relaxant that acts as a ryanodine receptor (RYR) antagonist and thus decreases Ca release in cytoplasm.


Eligibility criteria: Inclusion Criteria:

Adults aged 18-75 years Currently receiving statin therapy for at least 4 weeks Clinical symptoms suggestive of statin-induced myopathy (e.g., muscle pain, weakness) Elevated serum creatine kinase (CK) ≥1.5x upper limit of normal Able and willing to provide informed consent Willing to discontinue statins during the study period (if protocol requires)

Exclusion Criteria:

Known hypersensitivity to dantrolene History of severe liver disease or abnormal liver function tests (ALT or AST \> 2x ULN) Use of interacting drugs that may increase dantrolene toxicity (e.g., calcium channel blockers like verapamil) Renal impairment (e.g., serum creatinine \>2.0 mg/dL) Diagnosed neuromuscular disorders unrelated to statins (e.g., ALS, muscular dystrophy) Pregnant or breastfeeding women Participation in another clinical trial within the past 30 days

Primary outcomes:
measure: Change in Creatine Kinase (CK) Level
timeFrame: Baseline and 4 weeks after intervention start
Secondary outcomes:
measure: Change in Muscle Pain Score (Visual Analog Scale)
timeFrame: Baseline and Week 4
measure: Change in Serum Lactate Dehydrogenase (LDH) Level
timeFrame: Baseline and Week 4
measure: Number of Participants With Adverse Effects Related to Dantrolene
timeFrame: Throughout the 4-week intervention period
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01051843: Orofacial Difficulties in Rooming-in
Official title: Orofacial Difficulties During the Maternal Breastfeeding in Rooming-in
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orofacial Difficulties in Newborns
Maternal Breastfeeding in Newborns
Newborns in Rooming-in
Keywords: Maternal Breastfeeding
Orofacial Difficulties
Rooming-in
Speech and Language Therapy
Lead sponsor: Fortaleza University
Sponsor class: OTHER
First posted: 2010-01-20
Enrollment: 29
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Cross-sectional study of 29 dyads in rooming-in. The data collection consisted in the detection of the main orofacial difficulties during the maternal breastfeeding in rooming-in.

Brief summary: The purpose of this study is to identify the orofacial difficulties during the maternal breastfeeding in rooming-in.

Detailed description: Cross-sectional and quantitative study with sample consisted of 28 dyad present in rooming-in of the Assis Chateaubriand School Motherhood during August and December of 2009.

Eligibility criteria: Inclusion Criteria:

* mothers of the newborns participating in the study, regardless of the gender, ethnic and/or age.

Exclusion Criteria:

* newborns who presented oropharyngelarynx structural abnormality, impossibility to feed by mouth and/or exposed in bilispot.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00700843: Long-Term Follow-up of Ohio State University Medical Center (OSUMC) Bariatric Patients
Official title: Long-Term Follow-up of Ohio State University Medical Center (OSUMC) Bariatric Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obesity
Keywords: bariatric surgery
long term follow up
gastric partitioning surgery
Roux-en-Y gastric bypass surgery
obesity
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2008-06-19
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who participated in the bariatric program at OSUMC ten or more years ago, including bariatric surgery.

Brief summary: Obtain long-term follow-up results for bariatric patients who underwent medical management or surgery for treatment of morbid obesity by Ohio State University Medical Center (OSUMC).

Detailed description: The purpose of this study is to obtain long-term follow-up results for bariatric patients who underwent medical management or surgery for treatment of morbid obesity by Ohio State University Medical Center (OSUMC) surgeons during the late 1970s, 1980s, and 1990s. Our hypothesis is that surgical intervention for treatment of morbid obesity leads to sustained weight loss and decreased obesity-related morbidity and mortality.

Eligibility criteria: Inclusion Criteria:

* Adult
* Treated by OSUMC physicians for obesity
* Informed Consent

Exclusion Criteria:

* Informed consent not given

Primary outcomes:
measure: Failure to lose and maintain loss of > or equal to 50% of excess body weight will be considered failure of the bariatric surgery.
timeFrame: 10 or more years after surgery
Secondary outcomes:
measure: The need for additional surgical or other intervention for treatment of morbid obesity following bariatric surgery will be considered failure of the surgery.
timeFrame: 10 or more years after surgery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Bradley J Needleman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00642343: Balance in Children With Cochlear Implants
Official title: Balance in Children With Cochlear Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Severe, Profound Deafness
Keywords: Balance
Severe, Profound deafness
Children
unilateral/bilateral cochlear implants
unilateral cochlear implant
bilateral cochlear implants
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: American Academy of Otolaryngology-Head and Neck Surgery Foundation
First posted: 2008-03-25
Enrollment: 66
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to test the balance of children with unilateral,bilateral cochlear implants and patients having unilateral implants before,bilateral implants after surgery,using the Bruininks-Oseretsky Test 2nd ed. to find out if the cochlear implants have an effect.

Detailed description: Hearing impairment has a significant impact on individual quality of life and stresses community resources. In the last two decades cochlear implantation has developed into the new standard of care for severe to profound haring loss. Recent studies have shown bilateral implantation improves sound localization and understanding of speech in noise. For children, this is seen as a significant benefit. As we begin to offer bilateral cochlear implants to a growing number of children it would be in our patient's best interest to evaluate whether or not this may cause balance impairment. We will evaluate the balance scores of children with bilateral cochlear implants, and compare their results to unilaterally implanted children and a hearing impaired population, with the Bruininks-Oseretsky Test 2nd ed (BOT2). In addition we will take a small group of unilaterally implanted patients and test them before and after a contralateral cochlear implant as a prospective study group.

Eligibility criteria: Inclusion Criteria:

* Children with cochlear implant(s) activated for at least two weeks before participation.
* Children with severe to profound deafness that have not received intervention.

Exclusion Criteria:

* Children with mental retardation, associated physical handicaps, or chronic sedative use prohibiting completion of the balance tests.

Primary outcomes:
measure: The specific aim will be to compare the balance of children with cochlear implants to profoundly deaf children using the BOT2.
timeFrame: no earlier than 2 weeks following activation of implants
Secondary outcomes:
measure: To evaluate the differences in balance function between children with bilateral cochlear implants compared to children with unilateral cochlear using implants the BOT2.
timeFrame: no earlier than 2 weeks after implant activation
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Wayne Berryhill, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01154543: Safety and Efficacy of Famciclovir in HIV1 Positive Adults With Recurrent Genital Herpes
Official title: A Single Center, Open Label, Longitudinal Single Arm Study to Compare the Efficacy and Safety of Prophylactic Famciclovir 500 mg b.d. in HIV Positive Adults With Recurrent Genital Herpes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Positive
Herpes Simplex, Genital
Keywords: Recurrent genital Herpes Simplex Virus
Lead sponsor: Holdsworth House Medical Practice
Sponsor class: OTHER
First posted: 2010-07-01
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50-60 patients attending Holdsworth House Medical Practice in Darlinghurst, Sydney, New South Wales with documented HIV-1 infection who are taking Famciclovir 500mg bd as suppressive therapy for management of genital HSV infection who agree to participate in this study will be enrolled after signing HREC approved informed consent.

Brief summary: To determine the efficacy of Famvir 500mg bd as suppressive antiviral therapy for acute genital Herpes simplex virus (HSV) outbreaks in HIV subjects.


Eligibility criteria: Inclusion Criteria:

* Able to provide signed informed consent
* Documented HIV infection
* In general good health, without other serious medical conditions as deemed by the investigator
* Male or female over 18 years of age
* Diagnosed genital HSV (clinical or laboratory)
* Life expectancy of 12 months or longer per investigator's judgment
* Stable on Famvir 500 mg bd for at least 30 days at time of screening

Exclusion Criteria:

* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\>5)mIU/mL).
* Women of childbearing potential who are unwilling to use reliable contraception for the duration of the study.
* History of hypersensitivity to Famvir, its constituents or penciclovir
* Current use of another antiherpetic medication
* Recent history of alcohol or drug abuse, which in the opinion of the investigator may interfere with their compliance with study requirements, or who have any other conditions which in the opinion of the investigator would interfere with the successful completion of study procedures
* Disorder or condition that could interfere with drug absorption, distribution, metabolism or excretion
* Known or suspected to have or past history of renal dysfunction requiring a dosage modification of Famvir 500 bd

Primary outcomes:
measure: To determine the incidence of acute genital HSV outbreaks whilst taking Famciclovir 500 mg bd during the study period (24 months)
timeFrame: 24 months
Secondary outcomes:
measure: To determine the acceptability of Famciclovir 500 mg bd as long term suppressive antiviral therapy
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Australian Health Practitioners Regulation authority
name: Mark T Bloch, MBBS
role: PRINCIPAL_INVESTIGATOR
References: