louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01050803: Effectiveness of the Farsi Diabetes Self-management Education (FDSME) Program for People With Type 2 Diabetes
Official title: Effectiveness of the Farsi Diabetes Self-management Education Program for People With Type 2 Diabetes: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus
Intervention studies
Program effectiveness
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-01-15
Enrollment: 280
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: To evaluate the effectiveness of the Farsi diabetes self-management education program on psychosocial, lifestyle, and clinical measures in people with newly diagnosed people with type 2 diabetes and those with already-diagnosed type two diabetes who had received little self-management education. The development of the program was guided by an innovative process of intervention planning: Intervention Mapping.

Detailed description: For designing the management program, we will use Intervention Mapping (IM) framework for systematically developing the theory and evidence based program.

Based on IM approach, this study will have seven phases:

Step 1: needs assessment (Development the problem analysis: health, quality of life, behavior, environment).

Step 2: We will develop proximal program objectives with a multidisciplinary expert panel of participants.

Step 3: After identification of the proximal program objectives, the next step will be to select theoretical methods and practical strategies based on evidence for alternative methods.

Step 4: The forth step of the program development will comprise of composing program materials and pre-testing these materials with a sample of patients at a diabetic outpatient clinic.

Step 5: By involving the future program facilitators (health care workers at outpatient clinics) a linkage system will be foreseen.

Step 6: planning for evaluation Step 7: Randomized Clinical Trial

Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes (according to the WHO criteria)
* Older than 18 years

Exclusion Criteria:

* Pregnancy
* Unable to participate in a group program (for example, housebound or unable to communicate in Farsi)
* Having reduced cognitive ability

Primary outcomes:
measure: HbA1c
timeFrame: within 2 years
measure: BMI
timeFrame: 2 years
Secondary outcomes:
measure: Audit of Diabetes-Dependent Quality of Life (ADDQOL)
timeFrame: two years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03718403: Effect of Theophylline in Pseudohypoparathyroidism
Official title: Effect of Theophylline in Pseudohypoparathyroidism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: PHP Ia
PHP IB
Php1C
Keywords: PHP
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label intervention study, off label use of theophylline
Primary purpose: OTHER

Brief summary: The study evaluates the effect of theophylline in 100 subjects with Pseudohypoparathyroidism.

Detailed description: It is an open label intervention study for the off-label use of theophylline in psuedohypoparathyroidism (PHP).Theophylline is a is non-specific phosphodiesterase inhibitor which increases the levels of secondary messenger,cAMP. PHP patients have end organ resistance to hormones involving cAMP signaling. Thus, theophylline has a potential to abrogate hormone resistance. Also, it may have a role in bone maturation, neurocognition and metabolism.

Eligibility criteria: Inclusion Criteria:

* Subjects with known diagnosis of PHP1A and PHP1B
* Age \>5 years

Exclusion Criteria:

* • Significant kidney disease, i.e. any CKD stage

  * Hypercalciuria
  * Kidney stones
  * Severe Heart disease
  * Uncontrolled seizure disorder
  * Peptic ulcer
  * Liver dysfunction
  * Bleeding disorder
  * Allergy to theophylline preparation
  * Muscle disorder
  * Infection
  * Any neurologic disease
  * Chronic drugs interacting with theophylline

Primary outcomes:
measure: Effect of Theophylline on Bone Age in PHP
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: AMITA SHARMA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02778243: Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Bladder Neoplasms
Prostate Hyperplasia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 107
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients followed in the Foch Hospital Urology Department (Suresnes): Patients justifying a prostatectomy.

* Patients justifying prostatectomy together with the bladder (radical cystectomy for bladder cancer).
* Patients with benign prostate hyperplasia who justified a prostatectomy. Compare serum sexual steroid concentrations and intra-tissue on healthy prostates and prostate adenoma, assess concentrations intra-tissue sex steroids on cancer metastasis prostate specific blood sample under study (30mL) will be performed preoperatively in Patients followed in Foch Hospital Urology Department (Suresnes), and a Removal of a fragment of prostate tissue or metastasis will be analyze.

Aim is to compare serum concentrations of sexual steroids and intra-tissue on healthy prostates and prostate adenomas compared to concentrations measured in patients operated for prostate cancer.

Detailed description: Steroids concentration will be determined using Gas chromatography-mass spectrometry. The analyzed steroids are :

FSH :Mul/ml LH: mUI/ml SHBG: µg/ml BT: ng/ml TT: ng/ml DHT: ng/ml DHEA: ng/ml D5: ng/ml D4: ng/ml E1: pg/ml E2 : pg/ml DHEA-S : µg/dl

Eligibility criteria: Inclusion Criteria:

* Men aged over 18 years
* Surgical indication justifying protatique prostatectomy, or complete prostatocystectomie, or removal of a metastasis of prostate cancer.
* Patients affiliated to a social security scheme or benefiting from such a regime.
* Patients who have given their consent to participate in writing

Exclusion Criteria:

* Patient received local therapy or hormonal treatment (LHRH analogue, therapy blocking androgen receptors) before surgery.
* Treatment reductase inhibitors 5ARI ongoing or stopped for less than 3 months before the intervention.
* Patient included in another clinical trial inconsistent with the conduct of this research.
* Patient receiving treatment that could interfere with hormone levels (Prednisone, Ketoconazole, Abiraterone, Finasteride, Dutasteride).

Primary outcomes:
measure: Serum concentrations of sexual steroids and intra-tissue on healthy prostates
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Urologie Hopital Foch
name: Henry Botto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03625843: Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing
Official title: Incorporation of Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Incontinence, Female
Overactive Bladder
Lower Urinary Tract Symptoms
Keywords: urodynamics
Lead sponsor: San Antonio Uniformed Services Health Education Consortium
Sponsor class: FED
First posted: 2018-08-10
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this pilot study the investigators attempt to answer the question, does mindfulness exercises before urodynamic testing reduce patient's perception of anxiety or pain?

Detailed description: The subjects are being asked to consider participation in this research study. The purpose of this study is to see if incorporating mindfulness exercises prior to urodynamic studies (UDS) results in less pain, anxiety and discomfort.

The participants will be guided through a mindfulness meditation exercise by a licensed professional. During this exercise participants will be asked to focus attention on breathing, physical sensations, and thoughts. This exercise will last for approximately 10 minutes in which participants will not be asked to engage in any physical activity other than sitting and breathing. The participants will be randomly assigned to one of 2 treatment plans. Randomization is a process like flipping a coin and means the chance of being assigned to either of the plans. One treatment plan includes undergoing mindfulness exercises prior to your UDS evaluation. The other treatment plan includes simply undergoing the UDS evaluation.

After the participants UDS evaluation, questions will be asked about the urodynamic procedure. The participants will be asked to answer questions on a UDS and anxiety questionnaire which pertain to emotional and physical experiences during the procedure.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of urinary symptoms requiring urodynamic testing

  * Stress incontinence
  * Mixed incontinence
  * Urge incontinence
  * Overactive bladder
  * Urinary retention
  * Lower urinary tract symptoms
* Are Department of Defense (DoD) beneficiaries

Exclusion Criteria:

* Neurogenic bladder
* Interstitial cystitis
* Chronic bladder pain
* Inability to have urodynamics performed
* Are Not DoD beneficiaries
* Pregnant
* Lack capacity to consent

Primary outcomes:
measure: Anxiety during urodynamics as measured the STAI-6.
timeFrame: Day 1
Secondary outcomes:
measure: Positive and negative emotions as measured by the urodynamic questionnaire
timeFrame: Day 1
measure: Pain as measured by the VAS
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: San Antonio Uniformed Services Health Education Consortium
name: Forrest C Jellison, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02008643: Health Related Quality of Life in Children With Food Allergy: Comparison to Controls and Other Chronic Diseases
Official title: Health Related Quality of Life in Children With Food Allergy: Comparison to Healthy Children and Children With Other Chronic Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children With Food Allergy
Keywords: Health related quality of life, food allergy, children, chronic diseases
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 861
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL

Brief summary: The number of studies concerning health related quality of life (HRQL) in children with food allergy is very limited.

Only one study to date has compared HRQL of a group of children with food allergy to data published on general population and other chronic diseases. This study concluded to lowest HRQL scores in food allergic children compared to type 1 diabetes mellitus with important impact on scores concerning social activities.

Detailed description: Primary aim:

To compare generic HRQL score in children with food allergy with other chronic diseases and with healthy chidren in an homogeneous socio-cultural context.

Secondary aims :

* To compare generic and specific HRQL scores in children with food allergy
* Identifify in chidren with food allergy, clinical factrors assocated with lowest scores in order to improve our management.

Methods

Generic HRQL questionnaire (CHQ-87) will be distributed :

* after hospital consultation for patients
* in schools for healthy children A specific HRQL questionnaire (FAQLQ-CF or TF) and the " Food Allergy Independent Measure " will also distributed to chidren with food allergy.

Eligibility criteria: Inclusion Criteria:

* Age between 8-18 year old
* IgE mediated food allergy diagnosed by a pediatric allergologist with following criteria:

Convincing history of allergic reaction with positive prick-test and specific IgE Or Open food challenge associated with positive prick-test and specific IgE

* Signed informed consent of the two parents
* Signed informed consent of the child
* Health insurance recipient

Exclusion Criteria:

* Association with another medical or psychiatric chronic disease (excepted for controlled asthma)
* Partially or not controlled asthma during last year
* No signed consent

Primary outcomes:
measure: comparison of12 scores of the generic health-related quality of life questionnaire CHQ-CF 87 between children with food allergy and healthy children scores.
timeFrame: Once at inclusion
Secondary outcomes:
measure: comparaison beetween all questionnary
timeFrame: once at inclusion
Other outcomes:
Locations:
city: Nice
country: France
facility: Service de Pédiatrie
Study officials:
affiliation: CHU de Nice-Lenval
name: Lisa GIOVANNINI-CHAMI, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04856943: Effectiveness of Smartconsent in Improving Understanding of Informed Consent
Official title: Evaluation of the Effectiveness of Smartconsent to Improve Understanding of Informed Consent in Prostate Laser Enucleation Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Bioaraba Health Research Institute
Sponsor class: NETWORK
First posted: 2021-04-23
Enrollment: 52
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The general objective of the study is to assess whether the new smartconsent tool improves patients' understanding of the intervention to be performed, compared to standard practice.

A randomized clinical trial will be conducted in 50 patients who will undergo LASER PROSTATIC ENUCLEATION.

Detailed description: Male patients aged between 50 and 70 years, belonging to the Hospital Universitario Araba who are going to undergo PROSTATIC LASER ENUCLEATION, and who attend urology consultation between December 2019 and December 2020, and who meet the inclusion criteria and none of the exclusion criteria.

Inclusion criteria:

* Patients willing to receive information via tablet.
* Patients who know how to and can read.

Exclusion criteria:

-Not applicable.

Main variable: score on the Multiple choice test questionnaire (designed specifically for each type of procedure, following the recommendations proposed by Kehoe, Jerard and Fathelrahman et al. and developed on the basis of the information that an informed consent should provide (1, 2), with 4 response options and only one correct answer. An average score will be calculated for each patient.

This test evaluates the comprehension of the information provided through the informed consent.

Eligibility criteria: Inclusion criteria:

* Patients willing to receive information via tablet.
* Patients who know and can read.

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Score in the Multiple choice test questionnaire
timeFrame: At the recruitment moment
Secondary outcomes:
measure: Satisfaction with the informed consent proccess
timeFrame: At the recruitment moment
measure: Ability to complete the informed consent form
timeFrame: At the recruitment moment
measure: Time required to complete the informed consent process (MIN).
timeFrame: At the recruitment moment
measure: Overall satisfaction with the informed consent process,
timeFrame: At the recruitment moment
measure: Score in the System Usability Scale
timeFrame: At the recruitment moment
Other outcomes:
Locations:
city: Vitoria Gasteiz
country: Spain
facility: Imanol Merino
state: Alava
city: Vitoria-gasteiz
country: Spain
facility: Bioaraba Health Research Institute
state: Alava
Study officials:
affiliation: Bioaraba Health Research Institute
name: IMANOL MERINO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00842543: Fruit and Vegetable Juice Concentrate Effects on RBP4 and Antioxidant Capacity in Lean and Overweight 6-10 Year Old Boys
Official title: Effects Of A Fruit And Vegetable Juice Concentrate (FVJC) In-Vivo On Retinol Binding Protein 4 And Antioxidant Capacity In Normal And Overweight Boys -A Pilot Randomized Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Nutrition
Oxidative Stress
Insulin Resistance
Whole Food Supplement
Pediatric
Retinoids
Antioxidants
Dietary Supplements
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: NSA, LLC
First posted: 2009-02-12
Enrollment: 39
Sex: MALE
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Our study aims to evaluate if the consumption of a Fruit and Vegetable Juice Concentrate (FVJC) vs. placebo can exert changes in the serum levels of Retinol Binding Protein 4 (RBP4), carotenoids, tocopherol, antioxidant capacity, pro-inflammatory markers, insulin sensitivity in conjunction with weight management in a cohort of lean as compared to overweight healthy six to ten year-old boys. The boys will undergo a detailed medical and family history and a complete physical examination during the screening visit. Careful anthropometric measures and body composition by DEXA will be performed. Nutritional and exercise counseling will be given at the start of the study. The outcome measures will include differences in serum RBP4, antioxidant levels, inflammatory markers and insulin sensitivity at baseline and six months after consumption of FVJC in a randomized double blind placebo control manner.


Eligibility criteria: Inclusion Criteria:

* 6-10 year old healthy boys
* Lean or overweight
* Have not started puberty

Exclusion Criteria:

* Chronic illness, asthma, or GI disorder
* Vegan Diet
* Use of routine medications or vitamins 4 weeks before study

Primary outcomes:
measure: Beta-carotene Levels Between Overweight and Lean Boys at Baseline
timeFrame: Baseline
measure: Percent Change From Baseline in Beta-Carotene in Overweight and Lean Boys
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
Study officials:
affiliation: Nemours Children's Clinic
name: Atilio Canas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Canas JA, Damaso L, Altomare A, Killen K, Hossain J, Balagopal PB. Insulin resistance and adiposity in relation to serum beta-carotene levels. J Pediatr. 2012 Jul;161(1):58-64.e1-2. doi: 10.1016/j.jpeds.2012.01.030. Epub 2012 Feb 28.
Clinical trial NCT03498443: Effect of Pelvic Organ Prolapse Surgeries on Female Sexual Function in Egyptian Women
Official title: Effect of Pelvic Organ Prolapse Surgeries on Female Sexual Function in Egyptian Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Female Sexual Dysfunction
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: females e prolapse ser

Brief summary: study on female sexual function after different prolapse surgeries


Eligibility criteria: Inclusion Criteria:

* sex active prolapse surgery

Exclusion Criteria:

* not sex active any psychiatric problem

Primary outcomes:
measure: sexual function after prolapse surgeries
timeFrame: month3
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Benisuef Uneversity Hospital
state: BeniSuef
Study officials:
References:
Clinical trial NCT02072343: The Effect of 10 cm Catheter Mount on Malfunction of Capnometers Under the Conditions of Water
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Resuscitation
Pulmonary Edema
Hemorrhage
Keywords: Capnography
Catheters
Intubation
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Capnometer has been used to assess the success of intubation and the quality of cardiopulmonary resuscitation. However, capnometers can malfunction under the conditions such as pulmonary edema and hemorrhage due to the vulnerability of capnometers for water. Investigators hypothesized that the use of 10cm catheter mount will reduce the malfunction of capnometers under the conditions of water.


Eligibility criteria: Inclusion Criteria:

* Healthy adults without underlying disease

Exclusion Criteria:

* Lung and heart disease
* Drinking carbonated beverages

Primary outcomes:
measure: the malfunction rate of capnograph
timeFrame: 1 day
Secondary outcomes:
measure: The cumulative survival rate of capnometers under the conditions of water
timeFrame: 1 day
measure: The consistency of ETCO2 between No-DCCM group and DCCM group under the water-free conditions
timeFrame: 1 day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University
Study officials:
References: