louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03846687: Validation of Patient Reported Outcome Measures for Use in Hallux Valgus
Official title: Validation of the Modified Foot Function Index (mFFI) for Use in Hallux Valgus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hallux Valgus
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2019-02-20
Enrollment: 21
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: Subjects referred by clinicians

Brief summary: The purpose of the study is to explore whether the mFFI is fit for purpose in adults with hallux valgus (HV).


Eligibility criteria: Inclusion Criteria:

* Male or female, of any race and, aged ≥ 18 years
* Clinical diagnosis of hallux valgus
* Fluent in reading/speaking US-English to read and understand informed consent form and to participate in the interview

Exclusion Criteria:

* Participation in another foot-based clinical trial in the last 90 days or in Ipsen's clinical trial D-FR-52120-237
* Current chronic drug or alcohol abuse problem

Primary outcomes:
measure: Concept elicitation (CE) of mFFI
timeFrame: 7 days
measure: Cognitive debriefing (CD) of mFFI
timeFrame: 7 days
measure: Usability testing of mFFI
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: University Foot and Ankle Institute
state: California
city: Youngstown
country: United States
facility: Ankle and Foot Care Centers
state: Ohio
city: McAllen
country: United States
facility: Futuro Clinical Trials, LLC
state: Texas
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03142087: The Effect of Virtual Reality Exercises on Balance in Children With Brain Tumors
Official title: The Effect of Virtual Reality Exercises on Balance in Children With Brain Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Balance
Keywords: balance
brain tumor
virtual reality
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 30 patients with brain tumor will be included in the study between the ages of 6 and 18 who have undergone surgery. Patients included in the study will be randomly assigned to two groups. The study group will be included in the Nintendo Wii Fit Plus Balance Game exercise program under the supervision of a physiotherapist for 2 days per week for 8 weeks. The control group will be taken to the conventional exercise program under the supervision of a physiotherapist for 2 days a week, 1 hour a day. The assessments will be made before the exercise program begins and at the end of the 8th week. Patients' physical measurements were assessed by anthropometric evaluations, muscle strength measurement, pain Visual Analogue Scale, walking Observational Walking Analysis, Balanced Pediatric Functional Range Test, Timed Up and Go (TUG) and one foot standing test and Nintendo Wii Fit Plus Balance Assessment, Functional capacity 2 min. With Walking Test, fatigue with PedsQL Multidimensional Fatigue Scale, daily life activities will be evaluated with WeeFIM.

Detailed description: In our pediatric rehabilitation policlinic we have seen that these children has problems in balance and coordination from cause muscle weakness and cerebral-sensory-proprioceptive problems. We have evaluated with all parameters belong the physiotherapy and rehabilitation measurements and then planning this study with study protocol.

Eligibility criteria: Inclusion Criteria:

* 6-18 years of children
* brain tumor

Exclusion Criteria:

* have any conditions with exercises
* neurological and musculoskeletal disorders

Primary outcomes:
measure: the effects of virtual reality exercises evaluating with Nintendo Wii Fit Plus on balance
timeFrame: change from baseline balance at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University
Study officials:
affiliation: Bezmialem Vakif University
name: Müberra Tanrıverdi, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02066987: The Effects of Two Volitional Interventions to Improve Oral Health Behaviour Among Iranian Adolescents
Official title: The Effects of Two Volitional Interventions to Improve Oral Health Behaviour Among Iranian Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Health Behavior Change
Keywords: Action planning, Implementation intention
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 1110
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: the present study had two main aims. First, due to the current underconsumption of dental brush adolescents, the investigators should apply a volitional intervention to increase oral health behvaiour in adolescents. Second, the investigators aim to compare the effectiveness of action planning intervention and implementation intention will improve oral health behavior in adolescents.

Detailed description: This is a study to explore the impact of two volitional interventions on brushing intentions , behaviors and clinical characteristics among a sample of adolescent students.

Eligibility criteria: Inclusion Criteria:

* 14 Years to 19 Years
* Ability to understand Persian language Adolescents attending high schools in Qazvin

Exclusion Criteria:

* participate in any kind of oral health education and promotion programs
* undergoing orthodontic treatment

Primary outcomes:
measure: changes in frequencies of dental brushing
timeFrame: changes from baseline, one month after the intervention and six months follow-up
Secondary outcomes:
measure: changes in psychological predictors of dental brushing (intention ,perceived behavioural control and Self-monitoring)
timeFrame: changes from baseline, one month after the intervention and six months follow-up
measure: Changes in Community Periodontal Index (CPI)
timeFrame: changes from baseline, one month after the intervention and six months follow-up
measure: Changes in Turesky Modification of the Quigley-Hein Plaque Index
timeFrame: changes from baseline, one month after the intervention and six months follow-up
measure: Oral health related quality of life
timeFrame: changes from baseline and six months follow-up
measure: The frequency of the use of planning
timeFrame: changes from baseline, one month after the intervention and six months follow-up
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: Department of Public Health, Qazvin University of Medical Sciences
Study officials:
References:
citation: Pakpour AH, Gholami M, Gellert P, Yekaninejad MS, Dombrowski SU, Webb TL. The Effects of Two Planning Interventions on the Oral Health Behavior of Iranian Adolescents: A Cluster Randomized Controlled Trial. Ann Behav Med. 2016 Jun;50(3):409-18. doi: 10.1007/s12160-015-9767-3.
Clinical trial NCT02094287: Placebo Effect in the Treatment of Atopic Dermatitis
Official title: Placebo Effect in Atopic Dermatitis - Increase the Pharmacological Effect of Itching Caused by Classical Conditioning and Expectancy Processes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: University of Hamburg-Eppendorf
First posted: 2014-03-21
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is initiated in the indication of atopic dermatitis to study the impact of placebo in the treatment of pruritus. Classical conditioning and expectation via instructions/anticipation maintain the effect of placebo.


Eligibility criteria: Inclusion Criteria:

* SCORAD-Score \< 50 points
* basic experimental pruritus \>= 3 points on a numeric rating scale
* no acute eczema on their forearms
* no systemic treatments for skin diseases for at least four weeks
* no topical treatment on their arms for at least two weeks

Exclusion Criteria:

* intake of antihistamines
* pregnancy and lactation
* serious dysfunctions of the liver, kidneys or thyroid
* prostatic hyperplasia
* patients with tumors, major cardiovascular diseases, immunosuppression
* glaucoma

Primary outcomes:
measure: Comparison of the experimental pruritus intensity on a 10-point-rating scale between the groups
timeFrame: assessed over a time frame of 2 days
Secondary outcomes:
measure: Change of the severity of atopic dermatitis (SCORAD) and comparison between the groups
timeFrame: assessed over a time frame of 2 days
measure: Changes of Wheal sizes experimentally provoked by skin prick test.
timeFrame: assessed over a time frame of 2 days
measure: Changes of clinical, atopic itch intensity on a 10-point-rating scale
timeFrame: assessed over a time frame of 2 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - University Medicine Berlin
city: Hamburg
country: Germany
facility: University of Hamburg
Study officials:
affiliation: Charite University, Berlin, Germany
name: Margitta Worm, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01377987: Predicting Successful Sleep Apnea Treatment With Acetazolamide in Heart Failure Patients
Official title: Physiological Study to Predict Successful Sleep Apnea Treatment With Acetazolamide in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failures
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: National Institutes of Health (NIH)
First posted: 2011-06-22
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The ultimate goal is to improve our understanding of the pathophysiology and resistance to effective treatment of sleep disordered breathing in patients with heart failure, with a focus on selecting patients that will benefit specifically from acetazolamide treatment.

The study addresses three primary hypotheses: 1) Acetazolamide treatment will reduce the apnea-hypopnea index and improve markers of heart-failure severity in heart-failure patients with sleep apnea. 2) Acetazolamide will provide the greatest improvement in patients with the most severe ventilatory control instability (strongest chemoreflex response to carbon dioxide; highest loop gain). 3) Acetazolamide will act primarily via stabilizing ventilatory control (reducing loop gain), rather than via improvement to upper airway anatomy, pulmonary congestion, and cardiac function.


Eligibility criteria: Inclusion Criteria (Heart failure patients)

* Left ventricular ejection fraction (EF) \<50%, or heart failure with preserved EF
* Age 18-89

Exclusion Criteria:

* severe obstructive respiratory disease
* unstable heart failure status
* recent use of positive airway pressure therapy
* current use of opioids, benzodiazepines
* severe kidney disease
* severe anemia

Primary outcomes:
measure: The Severity of Sleep Disordered Breathing (Apnea-hypopnea Index, AHI)
timeFrame: 1 week
Secondary outcomes:
measure: Ventilatory Chemoreflex Sensitivity, "Loop Gain" Using Carbon Dioxide Pulses
timeFrame: 1 week
measure: Sympathetic Activity (Urinary Norepinephrine)
timeFrame: 1 week
measure: Left-atrial Volume
timeFrame: 1 week
measure: Brain Natriuretic Peptide (NT-proBNP)
timeFrame: 1 week
measure: Pittsburgh Sleep Quality Index
timeFrame: 1 week
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Andrew Wellman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Atul Malhotra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01416987: A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)
Official title: A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Ltd.
First posted: 2011-08-15
Enrollment: 600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile participants

Brief summary: This prospective study collected safety information from more than 600 participants treated with Pergoveris®.

During the Post-Marketing Surveillance (PMS) period, data about the participant's background, participant's medical history, Pergoveris® indication, prior infertility medication, Pergoveris® treatment status, concomitant drugs, all adverse events (regardless of the causal relationship to Pergoveris®) and efficacy (follicular growth and clinical pregnancy) were collected for study purposes.The post marketing surveillance was based on all cases treated with Pergoveris®.


Eligibility criteria: Inclusion Criteria:

* Participants, who were eligible for Pergoveris® treatment according to the indication in the national label of Pergoveris®. The national label approved by Korea Food \& Drug Administration is "Pergoveris® in association with a follicle stimulating hormone(FSH) preparation was recommended for the stimulation of follicular development in women with severe Luteinizing Hormone (LH) and FSH deficiency. In clinical trials these participants were defined by an endogenous serum LH level less than (\<)1.2 International units per liter IU/L"

Exclusion Criteria:

* According to national label

Primary outcomes:
measure: Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR)
timeFrame: 2463 days
Secondary outcomes:
measure: Number of Participants With at Least One Follicle of More Than 17 Millimeter (mm) of Mean Diameter on Ultrasonography
timeFrame: 2463 days
measure: Number of Participants With Clinical Pregnancy as Per Safety Analysis Set
timeFrame: 2463 days
measure: Number of Participants With Clinical Pregnancy as Per Effectiveness Analysis Set
timeFrame: 2463 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Research site
city: Seoul
country: Korea, Republic of
facility: Research site
Study officials:
affiliation: Merck Ltd.
name: Medical Responsible
role: STUDY_DIRECTOR
References:
Clinical trial NCT05073887: A Comparison of Ultrasound Guided Genicular Nerve Blockade Using Current Versus Revised Anatomical Targets
Official title: A Comparison of Ultrasound Guided Genicular Nerve Blockade Using Current Versus Revised Anatomical Targets in Chronic Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Pain Chronic
Keywords: Osteoarthritis
Radiofrequency
Ultrasound
Anatomical landmarks
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2021-10-12
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: comparison of effectiveness of ultrasound guided genicular nerve blockades and radio frequency stimulation


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Coagulation disorders
* Rheumatoid disorders
* Infections

Primary outcomes:
measure: Numerical Rating Scale
timeFrame: Post injection sixth month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Training and Research Hospital
Study officials:
affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
name: Selin Guven Kose
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01433887: Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic Hepatitis C Genotypes 1 Versus 2/3 Versus 6
Official title: Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Keywords: Peginterferon alfa-2a
ribavirin
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2011-09-14
Enrollment: 535
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Chinese patients with chronic hepatitis C have a different genetic background, which had been demonstrated to significantly influence their responses to pegylated interferon and ribavirin. In this study, Chinese patients with Hepatitis C Virus genotype 1, 2/3, 6 infection were treated with pegylated interferon and ribavirin. Their response was compared amongst different genotypes.


Eligibility criteria: Inclusion Criteria:

* HCV RNA is positive
* Treatment naive
* Come from China

Exclusion Criteria:

* Active substance abuse
* Poorly controlled psychiatric disease
* HBsAg positive
* Anti-HIV positive
* Suffering from other significant concurrent medical conditions including chronic liver diseases

Primary outcomes:
measure: Sustained virological response (SVR)
timeFrame: 24 weeks after the end of treatment
Secondary outcomes:
measure: Change in health related quality as measured by short form 36 (SF-36) from baseline to 24 weeks after the end of treatment
timeFrame: 24 weeks after the end of treatment
measure: Sick leave in patients treated for 24 or 48 weeks treatment
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Eighth People's Hospital of Guangzhou
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affliated Hospital of Sun Yat-sen University
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan second people's hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT04475887: Treatment of Anemia With Intravenous Iron in Patients Listed for Orthotopic Liver Transplantation
Official title: Treatment of Anemia With Intravenous Iron in Patients Listed for Orthotopic Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liver Transplantation
Blood Loss
Keywords: liver
anemia
transplantation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 60
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 aim of this study is to investigate whether therapy with intravenous iron carboxymaltose in patients with iron deficiency anemia (IDA) listed for orthotopic liver transplantation (OLT) increases hemoglobin concentrations and reduces intraoperative transfusion of packed red blood cells (PRBCs). The investigators hypothesize that therapy with intravenous iron will increase hemoglobin concentrations and reduce intraoperative transfusion of PRBCs in patients with IDA listed for OLT.


Eligibility criteria: Inclusion Criteria:

* patients listed for OLT with positive screening for IDA

Exclusion Criteria:

* Age \<18 years
* Hemochromatosis
* Iron utilization disorders
* Non-IDA
* Therapy with erythropoietin-stimulating agents or intravenous iron within 4 weeks prior to screening
* Previous allergic reactions against intravenous iron formulations
* Transfusion within 2 weeks prior to screening
* Complete portal vein thrombosis
* High-urgency OLT
* Pregnancy
* Sepsis or severe infection
* Immunosuppressive therapy

Primary outcomes:
measure: Hemoglobin at OLT
timeFrame: 6 months
Secondary outcomes:
measure: Transfusion requirement
timeFrame: 6 months
measure: Hemoglobin after 4 weeks
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Surgery
Study officials:
affiliation: Department of Surgery
name: Georg P Gyoeri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology
name: David M Baron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03017287: Safety and Efficacy of the GlucoMe APP in Patients With Uncontrolled Diabetes Treated With MDI
Official title: Safety and Efficacy of the GlucoMe APP in Patients With Uncontrolled Diabetes Treated With MDI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 1 or 2
Keywords: Glucose blood measurements, glucometer, BGM, Diabetes App
Lead sponsor: GlucoMe
Sponsor class: INDUSTRY
First posted: 2017-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate the safety and efficacy of computerized GlucoMe App in patients with uncontrolled diabetes treated with MDI.

Detailed description: GlucoMe is an interactive system, which provides glucose management tools to both the patient and health care team (HCT). The system includes a decision support system to be used by the HCT aiming to aid clinical decision making with mathematical models. The system does not intend to replace clinical judgement and all recommendations are to be approved by the HCT.

Forty (40) diabetic patients on multiple daily insulin injection (MDI) with abnormal HbA1c and identified as potential end users of the device will be recruited to the study and screened according to the study inclusion and exclusion criteria. Patient's daily blood glucose will be measured and the GlucoMe App will give its recommendations for change in insulin dose, as well as recommendations for pre and post-meal carbohydrate and exercise. Patient's daily blood glucose levels will be followed by the HCT biweekly for 12 weeks and patients will be instructed to change their insulin doses according to the decision of the treating physician. At the end of the study, the HCT's recommendations for treatment adjustment will be compared to those of the system for both safety and efficacy. Study subjects and the HCT will be asked to complete a questionnaire regarding the GlucoMe system usability.

Eligibility criteria: Inclusion Criteria:

1. Both type 1 and type 2 diabetes
2. HbA1c 7-11%
3. Treated with MDI for at least 3 months
4. Ability to use the system at home, mobile phone

Exclusion Criteria:

1. Active CAD, CVA during last 6 months
2. Treatment with steroids or other glucose modifying drugs
3. Chronic infection/cancer/other severe disease

Primary outcomes:
measure: Hypoglycemic and Hyperglycemic Events
timeFrame: At 12 weeks of the study
measure: Correlation between GlucoMe and HCT recommendations
timeFrame: At 12 weeks of the study
Secondary outcomes:
measure: Target HbA1C/glucose achievement
timeFrame: At 12 weeks of the study
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Diabitic Unit of the Wolfson Medical Center
Study officials:
References: