louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00999037: FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease
Official title: FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Secondary Hyperparathyroidism
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Loma Linda University
First posted: 2009-10-21
Enrollment: 18
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: FGF-23 is a newly described protein that is an important regulator of phosphorus in the body. This protein increases in people with kidney disease and people who need dialysis have very high levels of FGF-23 in the blood. However, although some studies have indicated that FGF-23 levels go up with increased intake of phosphorus, no one knows if FGF-23 levels can be lowered in patients with kidney disease by preventing them from absorbing phosphorus from food. This study is designed to see what happens to levels of FGF-23 in the blood when patients with chronic kidney disease take medications to prevent phosphorus absorption. Since high levels of FGF-23 have been linked with increased rates of death in patients with advanced kidney disease, controlling the levels may, in the future, be a way to decrease heart disease in patients with kidney disease.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria include pediatric patients, between the ages of 2 and 21 years, with CKD stages 2-4 (GFR 15-90 ml/min/1.73m2).

Exclusion Criteria:

* Exclusion criteria include: the use of phosphate binder therapy within the past 3 months, treatment with 25(OH)vitamin D or 1,25dihydroxyvitamin D, underlying metabolic bone disease, or underlying renal phosphate wasting disorder.

Primary outcomes:
measure: Change in FGF-23 Level
timeFrame: 12 weeks
Secondary outcomes:
measure: 1,25(OH)2vitamin D Value
timeFrame: 12 week
measure: Serum Phosphate Concentration
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
References:
Clinical trial NCT03969537: Telemedicine Follow-up for Patients With Cervical Dystonia Treated With Neurotoxin Injections
Official title: Telemedicine Follow-up for Patients With Cervical Dystonia Treated With Neurotoxin Injections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Dystonia
Telemedicine
Keywords: Cervical Dystonia
Telemedicine
Telehealth
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: The Allergan Foundation
First posted: 2019-05-31
Enrollment: 27
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: The patients selected to participate in the study are cervical dystonia (CD) patients who receive treatment at Vanderbilt University Medical Center, where the study takes place.

Brief summary: Many cervical dystonia (CD) patients are limited in their ability to travel to the clinic for follow-up in between injection visits.

A telemedicine visit at the time of peak effectiveness of neurotoxin treatment may be valuable in informing the neurologist's choice of muscle selection and/or dose for the next injection visit. The primary objective of this study is to investigate both patient and physician satisfaction with the use of our telemedicine tool for this type of follow-up. After assessment of the subject, the neurologist will decide whether or not the telemedicine visit was informative to the upcoming injection visit. Subjects will answer questions at the end of the visit regarding their satisfaction with the follow-up and overall telemedicine communication. The principle investigator will complete a similar survey with additional questions about information gathered from the visit to assess the primary objective.

A secure video communications platform will be used for the visit, which will occur 2-4 weeks after the patient's last neurotoxin injection (around the time of peak effectiveness). The investigating neurologist will remotely assess the patient and make notes for the next injection visit.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects of any race, aged 18 and above
* Diagnosed with cervical dystonia and being treated with neurotoxin injections at Vanderbilt University Medical Center
* The subject, or if appropriate their medical decision maker, is willing and able to provide written informed consent.
* Email and internet access
* Personal computing device with audio/video capability

Exclusion Criteria:

* Subjects for whom participation in the study may cause medical harm

Primary outcomes:
measure: Patient Satisfaction with Telehealth
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: David Charles, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05533437: Effect of Different Duration of Dry Needling on Muscles Strength of Flexor Forearm Muscles of Dominant Hand in Healthy Subjects
Official title: Effect of Different Duration of Dry Needling on Muscles Strength of Flexor Forearm Muscles of Dominant Hand in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Needling
Keywords: dry needling
kinesio tapping
Healthy adults
Lead sponsor: Majmaah University
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 64
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dry needling is typically used to treat muscles, ligaments, tendons, subcutaneous fascia, scar tissue, peripheral nerves, and neurovascular bundles for the management of a variety of neuromusculoskeletal pain syndromes.However, there are contradictory research articles about the optimal duration of dry needling per session.

Detailed description: Dry needling is 'an invasive technique used by physical therapists to treat myofascial pain that uses a dry needle, without medication or injection, which is inserted into areas of the muscle known as trigger point defines dry needling as including both muscular and connective tissues, but not neural stimulation. The paper reads, 'dry needling is a skilled intervention that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points, muscular, and connective tissues for the management of neuromusculoskeletal pain and movement impairments.

The dry needling is reported to improve the level of pain, muscle strength, and flexibility. However, the optimal duration of dry needling to improve muscle strength is still Unknown.

Eligibility criteria: Inclusion Criteria:

Patient with osteoarthritis

Exclusion Criteria:

Patient with musculoskeletal disorders Metabolic disorders causing knee pain Surgery

Primary outcomes:
measure: Level of pain on pain scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: AIMHS
Study officials:
References:
Clinical trial NCT05434637: Somatosensory Tinnitus RCT
Official title: Developing Tools and a Care Path for Somatosensory Tinnitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tinnitus
Keywords: Tinnitus
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-06-28
Enrollment: 72
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 is to learn more about a type of tinnitus (ringing in the ears) known as "somatosensory tinnitus." This type of tinnitus is suspected when the tinnitus perception changes following head and/or neck movements. This study is also exploring a possible way to treat somatosensory tinnitus.

Detailed description: The purpose of this study is to: (1) develop a screening tool for somatosensory tinnitus and (2) perform a randomized clinical trial comparing different treatment approaches for somatosensory tinnitus. The investigators want to find out if individualized physical therapy, alone or in combination with audiology-based sound therapy, is beneficial for treating somatosensory tinnitus.

Eligibility criteria: Inclusion Criteria:

* Constant, chronic tinnitus (6-months in duration)
* bothersome tinnitus based on TFI score and self-reported loudness
* able to modulate tinnitus perception with head, neck, and/or jaw maneuvers

Exclusion Criteria:

* Middle ear pathology
* not a candidate for physical therapy
* injury to the temporomandibular area in past 3 months
* active pathology in the orofacial region

Primary outcomes:
measure: Change in TFI Score
timeFrame: Measured at at baseline; 8 and 12 weeks post-randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Sarah Theodoroff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03227237: Impact of Strained Interpersonal Relationship (IPR) With Parents on Juvenile Delinquency Among Children
Official title: Assess the Impact of Strained Interpersonal Relationship (IPR) With Parents on Juvenile Delinquency Among Children Residing in Selected Delinquent Home Ambala, Haryana"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interpersonal Relations
Keywords: Impact, Interpersonal Relationship, Juvenile delinquency
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 120
Sex: MALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample in the present study is Delinquent Children(case) in Govt. Delinquent Home, Ambala and Non Delinquent children (control) in Govt. Senior Secondary school of Barara, Haryana. sampling technique used was Total enumerative sampling for case group and convenience sampling based on matching (age) and homogenity (gender) for control group.

Brief summary: "Assess the impact of Strained Interpersonal Relationship (IPR) with parents on Juvenile Delinquency among Children residing in Selected Delinquent Home Ambala, Haryana"

Detailed description: The objectives of this study are:- To assess and compare IPR score with parents among case (delinquent children) and control (non delinquent children) group.

To determine the association of IPR score with selected variables among case (delinquent children) and control (non delinquent children) group.

Eligibility criteria: Inclusion Criteria:

children who were aged 13-18 years and residing in selected delinquent home, ambala (for case).

aged 13- 18 years, fulfils matching (age) and homogenity(gender) with case and studing in selected school, Barara (for control).

alert, oriented and able to read, comprehend and speak English/ hindi.

Exclusion Criteria:

children who were non-literate (for case) not willing to participate in study. not having both biological parents.

Primary outcomes:
measure: Interpersonal Relation
timeFrame: 40 minutes per group
Secondary outcomes:
Other outcomes:
Locations:
city: Yamunanagar
country: India
facility: Talwinder kaur
state: Haryana
Study officials:
affiliation: Maharishi Markandeshwar University
name: Talwinder Kaur, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herrenkohl TI, Maguin E, Hill KG, Hawkins JD, Abbott RD, Catalano RF. Developmental risk factors for youth violence. J Adolesc Health. 2000 Mar;26(3):176-86. doi: 10.1016/s1054-139x(99)00065-8.
citation: Mednick BR, Baker RL, Carothers LE. Patterns of family instability and crime: The association of timing of the family's disruption with subsequent adolescent and young adult criminality. J Youth Adolesc. 1990 Jun;19(3):201-20. doi: 10.1007/BF01537887.
citation: Hoeve M, Stams GJ, van der Put CE, Dubas JS, van der Laan PH, Gerris JR. A meta-analysis of attachment to parents and delinquency. J Abnorm Child Psychol. 2012 Jul;40(5):771-85. doi: 10.1007/s10802-011-9608-1.
Clinical trial NCT00237237: Vildagliptin Compared to Pioglitazone in Combination With Metformin in Patients With Type 2 Diabetes
Official title: Vildagliptin Compared to Pioglitazone in Combination With Metformin in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 588
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of pioglitazone in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.


Eligibility criteria: Inclusion Criteria:

* On a stable dose of metformin as defined by the protocol
* Blood glucose criteria must be met
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* History of type 1 diabetes
* Pregnancy or lactation
* Evidence of significant diabetic complications
* Serious cardiovascular events within the past 6 months
* Laboratory value abnormalities as defined by the protocol
* Known sensitivity to pioglitazone
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in HbA1c at 52 weeks
Secondary outcomes:
measure: Adverse event profile after 52 weeks of treatment
measure: Change from baseline in fasting plasma glucose at 52 weeks
measure: Change from baseline in body weight at 52 weeks
measure: Patients with endpoint HbA1c < 7% after 52 weeks
measure: Patients with reduction in HbA1c >/= to 7% after 52 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Nurnberg
country: Germany
facility: Investigative Centers
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Bolli G, Dotta F, Rochotte E, Cohen SE. Efficacy and tolerability of vildagliptin vs. pioglitazone when added to metformin: a 24-week, randomized, double-blind study. Diabetes Obes Metab. 2008 Jan;10(1):82-90. doi: 10.1111/j.1463-1326.2007.00820.x. Epub 2007 Nov 22.
Clinical trial NCT05677737: Women on Breast Cancer Health Belıefs and Screenıng Behavıors
Official title: The Effect of Educatıon Gıven to Women on Breast Cancer Health Belıefs and Screenıng Behavıors,Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Method: It was conducted in a randomized controlled experimental type. The population of the study consisted of 2426 women over the age of 20 living in a family health center in Erzurum between October 2021 and September 2022. The sample of the study consisted of 252 women with 0.05 margin of error and 95% confidence level, according to the sample size calculation formula used in cases where the universe is known. Within the framework of the exclusion criteria of the study, 52 women were excluded from the study and 200 women were included in the randomization.

Detailed description: Persons in the experimental group will be trained 6 times with an interval of 2 weeks via an online platform (zoom, etc.). No training will be given to the control group, and the post-test data will be collected by re-administering the two groups with the mid-test created via Google forms and containing the scales immediately after the training, and the "Health Belief Model Scale in Breast Cancer Screening" and "Breast Cancer Screening Beliefs Scale" two months later.

Eligibility criteria: Inclusion Criteria:

-Being over 18 years old

* Being literate,
* Computer can be used,
* Internet is accessible,
* Not getting breast cancer before,

Exclusion Criteria:

* Having received training on breast cancer before

  * Having a history of breast cancer in first degree relatives
  * Those who did not attend all of the online trainings in the experimental group

Primary outcomes:
measure: Breast Cancer Screening Beliefs Scale
timeFrame: two week
measure: Health Belief Model Scale in Breast Cancer Screening
timeFrame: Two week
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk Unıversity
state: Yakutiye
Study officials:
affiliation: Ataturk University
name: Aslı Sis Çelik, Assoc. Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT01184937: Effect of Patient Education on Kidney Recipients Knowledge, Coping and Quality of Life
Official title: Effect of Patient Education on Kidney Recipients Knowledge, Coping and Quality of Life. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Recipients
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2010-08-19
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: For patients with end-stage kidney disease, transplantation is the treatment of choice, offering improved quality of life by restored metabolism and freedom from dialysis. However, demands regarding the acquirement of knowledge in life post transplantation are high. In order to reduce rejection episodes, graft loss and the negative consequences of life-long immunosuppressive medication, it is essential for kidney recipients to possess knowledge about important aspects regarding immunosuppressive medication, graft surveillance and the benefit of specific lifestyle behavior. Consequently, patient education is required for this patient group. This randomized controlled trial is investigating the effect of a structured patient education program on kidney recipients' knowledge, coping and quality of life


Eligibility criteria: Inclusion Criteria:

* being over 18
* recently had a kidney transplant
* able to speak, understand and read Norwegian
* mentally able to participate in the study

Primary outcomes:
measure: Kidney recipients'knowledge level
timeFrame: 7-8 weeks post kidney transplantation
measure: Kidney recipients'knowledge level
timeFrame: 6 months post kidney transplantation
Secondary outcomes:
measure: Kidney recipients' coping
timeFrame: 7-8 weeks post kidney transplantation
measure: Kidney recipients' coping
timeFrame: 6 months post kidney transplantation
measure: Kidney recipients' quality of life
timeFrame: 7-8 weeks post kidney transplantation
measure: Kidney recipients' quality of life
timeFrame: 6 months post kidney transplantation
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
citation: Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
Clinical trial NCT03294837: Treatment of Ventilator Associated Pneumonia in Pediatric Intensive Care Unit
Official title: Treatment of Ventilator Associated Pneumonia in Pediatric Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventilator Associated Pneumonia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: to assess the degree of adherence of pediatric physicians of assiut university children hospital to the american guidelines of treatment of ventilator associated pneumonia in pediatric intensive care unit.

Brief summary: treatment of ventilator associated pneumonia in pediatric intensive care unit according to the American guidelines

Detailed description: to assess the degree of adherence of pediatric physicians of assiut university children hospital to the American guidelines of treatment of ventilator associated pneumonia in pediatric intensive care unit searching for defects,obstacles,or need to improve health service.

Eligibility criteria: Inclusion Criteria:

- Children of both sexes. - Aged from 1 month to 18 years. - The patients are fulfilling the diagnostic criteria of ventilator associated pneumonia.

Exclusion Criteria:

- Patients aged less than 1 month. - Patients who are intubated and mechanically ventilated for less than 48 hours.

Primary outcomes:
measure: treatment of ventilator associated pneumonia in pediatric intensive care unit
timeFrame: 9 month - 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Chang I, Schibler A. Ventilator Associated Pneumonia in Children. Paediatr Respir Rev. 2016 Sep;20:10-16. doi: 10.1016/j.prrv.2015.09.005. Epub 2015 Sep 25.
citation: Amanati A, Karimi A, Fahimzad A, Shamshiri AR, Fallah F, Mahdavi A, Talebian M. Incidence of Ventilator-Associated Pneumonia in Critically Ill Children Undergoing Mechanical Ventilation in Pediatric Intensive Care Unit. Children (Basel). 2017 Jul 3;4(7):56. doi: 10.3390/children4070056.