louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01941732: Motor Response to Sildenafil in PD
Official title: Motor Response to Acute Challenge to Sildenafil in Parkinsons Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinsons Disease
Erectile Dysfunction
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 8
Sex: MALE
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: Sildenafil (Viagra(R))is widely used by men with Parkinsons Disease (PD) and erectile dysfunction. A number of patients have reported that when they take Sildenafil, their need of anti-PD medication is reduced.

We hypotheses that sildenafil increases brain blood flow and hence improves the function of specific brain regions, improving motor function.

Motor function and cerebral blood flow of 8 patients will be tested before and after Sildenafil intake and before and after anti-PD medication.

Detailed description: Erectile dysfunction can be experienced by up tp 40% of men with Parkinsons Disease (PD). Sildenafil (Viagra(R))is widely used by men with PD and erectile dysfunction. A number of patients have reported that when they take Sildenafil, their need of anti-PD medication is reduced.

We hypotheses that sildenafil increases cerebral blood flow in basal ganglia and hence improves the function, improving motor function.

Motor function and cerebral blood flow (rCBF) of 8 patients will be tested before and after Sildenafil intake and before and after anti-PD medication.

rCBF will be measured by the Xe133 inhalation method and a fast-rotating, brain-dedicated, single photon emission computerized tomograph (SPECT, Tomomatic, 232, Medimatic, Inc., Denmark). Two scans will be perfomed, when patients are i)in normal medicated state and ii) in normal medicated state 1 hour after intake of 100 mg sildenafil.

Motor function will be measured i 4 conditions: i)in normal medicated state and ii) in normal medicated state 1 hour after intake of 100 mg sildenafil, iii) after 12 hours of discontiation of anti-PD mediciation and iiii) after 14 hours of discontiation of anti-PD mediciation and 1 hour after intake of 100 mg sildenafil.

Eligibility criteria: Inclusion Criteria:

* Men
* Parkinsons disease
* Erectile dysfunction
* previous tried sildenafil with beneficial effects on motor function

Exclusion Criteria:

* psychosis
* Heart disease

Primary outcomes:
measure: Motor function
timeFrame: 1 hour
Secondary outcomes:
measure: Cerebral Blood Flow (rCBF)
timeFrame: 1 hour
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept of Neurology, Bispebjerg Hospital
Study officials:
References:
Clinical trial NCT06997432: Endophenotyping for Plant-based Food Allergy Diagnosis, Tolerance Biomarkers, and Mechanisms in Microneedle Immunotherapy
Official title: Study of the Clinical and Immunological Implications of Maintaining in the Diet the Maximum Tolerated Dose Identified in a Controlled Food Exposure Test According to the Sensitization Profile to LTPs
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Food Allergies
Keywords: Vegetable food allergy
Allergy desensitization
Lipid Transfer Proteins
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 32
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women and men aged 14-65 years with peach allergy due to sensitization to LTP confirmed by skin tests and/or IgEe positive to Pru p 3.

Brief summary: In relation to the prognosis of vegetable FA (VFA), in contrast to other food allergies (FA), which disappear naturally with time, VFA tends to persist into adulthood and to the appearance of new sensitizations to other vegetables. The paradigm of early intervention in patients with risk factors for developing FA has changed in recent years, with evidence that maintaining a controlled diet with foods with potential allergic risk in a population of children at risk has shown efficacy in early intervention. An important aspect would be the selection of the dose of the food to be included in the diet. In this sense, recent studies on the standardization of the double-blind placebo-controlled oral challenge test (DBPCFC) in allergic patients to Lipid Transfer Proteins (LTP) with known amounts of Pru p 3 (peach LTP), have observed that the maximum tolerated dose (MTD) was equivalent to 40 grams of peach with skin. Based on these results and those obtained in the pediatric population, this study aims to evaluate whether the maintenance in the diet of a DMT evaluated in a DBPCFC could influence tolerance (desensitization) to the food at both clinical and immunological levels.


Eligibility criteria: Inclusion Criteria:

* Women and men
* 14-65 years-old
* Peach allergy due to sensitization to LTP confirmed by skin tests and/or IgEe positive to Pru p 3.
* Sign informed consent.

Exclusion Criteria:

* Pregnant of lactating women.
* Patients with immunological diseases, mental illness or severe atopic dermatitis.
* Patients treated with immunomodulators and/or β-blockers
* Patients with forced expiratory volume (FEV1)\<70%.

Primary outcomes:
measure: Changes in the distribution of immune cell populations after MTD exposure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
Study officials:
References:
Clinical trial NCT05430932: Effect Of Laparoscopic Sleeve Gastrectomy on Vitamin D, Parathormone and Calcium Levels
Official title: Effect Of Laparoscopic Sleeve Gastrectomy (LSG) on Vitamin D, Parathormone and Calcium Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Obesity, Morbid
Vitamin D Deficiency
Calcium Deficiency
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Obesity is likely to be the disease of the 21th century. The growth of obesity is worldwide, a pandemic, and has increased globally in the last 30 years. Developed countries were more affected, but developing countries have increasingly contributed to this epidemic as they continue to modernize. The national and global burden of obesity, with its public health and financial implications, is projected to increase markedly in the next two decades.

the study aimed to assess the effect of Vit D supplementation on preventing altered levels of calcium, Vit D, and parathormone after laparoscopic sleeve gastrectomy.


Eligibility criteria: Inclusion Criteria:

* Adult
* male or female
* from 18 to 60 ages
* BMI: 40 kg/m2 or \> 35 kg/m2
* comorbidities e.g., hypertension and DM
* conservative management for obesity failed in at least 2 years

Exclusion Criteria:

* BMI \> 60
* history of bariatric surgery
* symptomatic reflux oesophagitis
* stomach cancer
* active peptic ulcer disease
* alcohol or drug abuse
* major psychological disturbance
* major eating troubles
* risky anesthesia
* risky surgery.

Primary outcomes:
measure: Vitamin D level assessment
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafr Al Sheikh
Study officials:
References:
Clinical trial NCT00299832: SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction
Official title: A Multi-center, Open-label Study Assessing the Safety, Efficacy and Pharmacokinetics of 8 Week's Treatment of SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, aliskiren, blood pressure, rennin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-03-07
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assessing the safety, efficacy and pharmacokinetics of SPP100 (Aliskiren) regimen in hypertensive patients with renal dysfunction


Eligibility criteria: Inclusion Criteria:

* Age: 20 - 80 years old
* Gender: Male or female
* Status: Outpatients
* Elevated Serum Creatinine

Exclusion Criteria:

* Patients suspected of malignant hypertension
* Patients with a clinically significant allergy
* Patients who have received other investigational drug Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Adverse events after 8 weeks
Secondary outcomes:
measure: Change from baseline in mean sitting systolic blood pressure after 8 weeks
measure: Change from baseline in mean sitting diastolic blood pressure after 8 weeks
measure: Mean sitting systolic blood pressure is < 140 mmHg or a reduction of > 20 mmHg after 8 weeks
measure: Mean sitting diastolic blood pressure is < 90 mmHg or a reduction of > 10 mmHg after 8 weeks
measure: Blood pressure <140/90 after 8 weeks
Other outcomes:
Locations:
city: Japan
country: Japan
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
citation: Ito S, Nakura N, Le Breton S, Keefe D. Efficacy and safety of aliskiren in Japanese hypertensive patients with renal dysfunction. Hypertens Res. 2010 Jan;33(1):62-6. doi: 10.1038/hr.2009.175. Epub 2009 Nov 20.
Clinical trial NCT05323032: Multifocal Electroretinogram in Normal Egyptian Population
Official title: Normal Multifocal Electroretinogram in Egyptian Population.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinal Disease
Healthy Population
Keywords: normal
electroretinogram
delta population
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multifocal electroretinogram in normal population
Primary purpose: DIAGNOSTIC

Brief summary: Studying normal subjects to create unique normal database for multifocal electroretinogram (mf-ERG) in specific population.

Detailed description: Normal parameters for electroretinogram (ERG) is important in studying specific population, studying normal subjects is important to create specific normal database for each population. This will help in accurate differentiation for various ocular diseases and in research trials.

Eligibility criteria: Inclusion Criteria:

* Normal subjects seeking regular ophthalmic check-up at banha university hospital.

Exclusion Criteria:

* Any retinal diseases that may affects mf-ERG waves.
* Subjects with best corrected visual acuity less than 0.7 in decimal form at time of examination.
* Refractive errors more than 0.5 diopter as measured by autorefractometer.

Primary outcomes:
measure: Amplitude of waves in nv/deg2
timeFrame: immediately after mf-ERG diagnostic test for each eye.
measure: Latency of waves in msec.
timeFrame: immediately after mf-ERG diagnostic test for each eye.
Secondary outcomes:
measure: Difference between different age groups in mf-ERG readings.
timeFrame: immediately after mf-ERG diagnostic test for each eye.
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Ahmed Abdelshafy Tabl
state: Banha
Study officials:
affiliation: Benha University
name: Ahmed A Tabl, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05779332: Prevalence, Etiology and Effects on Oral Health and Life Quality of Molar Incisor Hypomineralization
Official title: Prevalence, Etiology and Effects on Oral Health and Life Quality of Molar Incisor Hypomineralization: A Comprehensive Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Molar Incisor Hypomineralization
Oral Health
Child, Only
Pediatric ALL
Dental Caries
Dental Plaque
Dental Diseases
Keywords: Molar Incisor Hypomineralization
oral health
MIH
Oral health related lif quality
Child Perceptions Questionnaire
OHRQoL
CPQ
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 655
Sex: ALL
Minimum age (years): 9
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 9-year-old children who were enrolled in the primary schools in the city of Rize, Turkey.

Brief summary: Molar incisor hypomineralization (MIH) can lead to many clinical conditions and affect oral health-related quality of life (OHRQoL).

Detailed description: Molar incisor hypomineralization (MIH) can lead to many clinical conditions and affect oral health-related quality of life (OHRQoL). The aim of this study was to determine the prevalence, etiology and impacts of MIH on oral health status and OHRQoL.

Six hundred and fifty-five parents and their children aged 9 years were included in the study. After parents completed the questionnaire about the etiology of MIH, children's OHRQoL was measured by the Child Perceptions Questionnaire (CPQ8-10). Children were evaluated for presence and severity of MIH, dental caries experience and oral hygiene status. Qualitative data were analyzed with the Pearson chi-square and Fisher's exact tests. For the quantitative data, if the normal distribution was not satisfied, Kruskal Wallis/Mann-Whitney U tests were used. Also, Binominal logistic regression analysis was performed and p\<0.05 was statistical significant.

.

Eligibility criteria: Inclusion Criteria:

* Being 9-year-old,
* Mentally and physically capable of completing the questionnaire,
* Presence of fully erupted 4 permanent molars and 8 permanent incisors.

Exclusion Criteria:

* Children were receiving orthodontic treatment during the examination,
* Children had enamel hypoplasia or developmental defects,
* Children had amelogenesis imperfecta or dental fluorosis.

Primary outcomes:
measure: To determine the prevalence and etiology of MIH.
timeFrame: up to four months
measure: To evaluate the impacts of MIH on oral health status.
timeFrame: up to six months
measure: To evaluate the impacts of MIH on OHRQoL.
timeFrame: up to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Sema Aydinoğlu
Study officials:
References:
Clinical trial NCT06654232: Patient-Reported Quality of Life in Patients With an Implantable-Cardioverter Defibrillator - A Cross-Sectional Observational Study
Official title: Patient-Reported Quality of Life in Patients With an Implantable-Cardioverter Defibrillator - A Cross-Sectional Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Implantable Cardioverter Defibrillator (ICD)
Keywords: implantable cardioverter defibrillator
quality of life
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with any type of implantable cardioverter-defibrillator followed at UZ Leuven.

Brief summary: Patients at risk for life-threatening arrhythmias are eligible for the implantation of an implantable cardioverter-defibrillator (ICD), which has repeatedly shown improved survival. However, living with an ICD may pose several challenges and affect quality of life (QoL). This prospective cross-sectional observational cohort studies will provide detailed insights in patient-reported QoL. The aim is to study the QoL perspective of patients who have an ICD, including physical and emotional health; ICD acceptance; concerns of ICD patients with regard to physical and sexual activity.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years of age
* Patients with any type of ICD followed in UZ Leuven
* Willing and able to provide signed written informed consent

Exclusion Criteria:

* Patients who are hospitalized
* Patients with a mental disability
* Patients already included in another interventional study

Primary outcomes:
measure: ICD acceptance assessed using the Florida Patient Acceptance Survey (FPAS)
timeFrame: Cross-sectional at time of inclusion
Secondary outcomes:
measure: - General QoL, including physical and emotional components, assessed using the Short Form Health Survey (SF-12)
timeFrame: Cross-sectional at time of inclusion
measure: - Cardiac-specific QoL assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12).
timeFrame: Cross-sectional at time of inclusion
measure: Florida Shock Acceptance score (FSAS)
timeFrame: Cross-sectional at time of inclusion
measure: Steinke Sexual Concerns Inventory
timeFrame: Cross-sectional at time of inclusion
measure: "Concept of a Good Death" questionnaire
timeFrame: Cross-sectional at time of inclusion
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT01361932: Using Online Videos to Supplement Emergency Department Discharge Instructions
Official title: Speak Fast, Use Jargon, and Don't Repeat Yourself: Using Online Videos to Supplement Emergency Department Discharge Instructions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergency Department Discharge Instructions
Instruction Videos
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2011-05-27
Enrollment: 133
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This project will evaluate the effectiveness of 38 videos of discharge instructions for patients seen in, and discharged from, the emergency department (ED). The investigators will (1) assess how many ED patients chose view the website, and (2) interview patients who viewed a video, as well as those who didn't view a video (and therefore received standard care), to determine whether patients who viewed a video understood their diagnoses and discharge instructions better.


Eligibility criteria: Inclusion Criteria:

* Age \> 16, or \< 16 and accompanied by a legal guardian
* Has one of 38 ED discharge diagnoses
* Fluent in English, or caregiver fluent
* Has access to a computer, with internet access, in the next 4 days
* Has access to a telephone

Exclusion Criteria:

* Age \< 16 when unaccompanied by a legal guardian
* Decreased level of consciousness at ED discharge (eg palliative patient)

Primary outcomes:
measure: Score out of 3 points on 3 key questions
timeFrame: 1 to 5 days after ED visit
Secondary outcomes:
measure: Quality rating of video of discharge instructions, Likert scale 1 to 5
timeFrame: 1 to 5 days after ED discharge
Other outcomes:
Locations:
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Clare L Atzema, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Atzema CL, Austin PC, Wu L, Brzozowski M, Feldman MJ, McDonnell M, Mazurik L. Speak fast, use jargon, and don't repeat yourself: a randomized trial assessing the effectiveness of online videos to supplement emergency department discharge instructions. PLoS One. 2013 Nov 11;8(11):e77057. doi: 10.1371/journal.pone.0077057. eCollection 2013.
Clinical trial NCT00190632: To Evaluate the Safety in Patients Taking Duloxetine for Stress Urinary Incontinence
Official title: Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stress Urinary Incontinence
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2005-09-19
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an on-going study to evaluate the long-term safety and maintenance of effect of duloxetine in patients suffering with stress urinary incontinence.


Eligibility criteria: Inclusion Criteria:

Have had symptoms of SUI for at least 3 months prior to study entry.

Have urine leakage most often associated with activity (such as coughing, sneezing, exercise).

Ambulatory and able to use a toilet independently and without difficulty.

-

Exclusion Criteria:

Subjects who participated or were discontinued from any previous studies investigating duloxetine.

Use of excluded medications within 14 days prior to study entry or at any time during the study.

Subjects who currently have or have had a history of urogenital cancer.

Primary outcomes:
measure: To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence (SUI)
Secondary outcomes:
measure: To collect data to demonstrate the maintenance of effect of duloxetine as measured by the Patient Global Impression of Improvement (PGI-I) questionnaire.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
state: Ohio
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: