louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03014661: Untersuchung Zur Erfassung Und Kontrolle Der Lebensqualität Unter Einer Therapie Mit Pollinex Quattro Bei Heuschnupfen
Official title: Untersuchung Zur Erfassung Und Kontrolle Der Lebensqualität Unter Einer Therapie Mit Pollinex Quattro Bei Heuschnupfen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis, Allergic, Seasonal
Keywords: pollinosis, quality of life, specific immunotherapy
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult persons with hayfever treated with a specific immunotherapy with Pollinex quattro plus (Allergens: birch/alder/Hazel or grass/rye or mugwort)

Brief summary: Questionnaire to measure and control the quality of life of patients with hay fever who are treated or were treated with Pollinex quattro

Detailed description: Questionnaire including 19 questions concerning the Quality of life of patients with hayfeyer under or after therapy with a specific immuntherapy with Pollinex quattro

Eligibility criteria: Inclusion Criteria:

* Pollinosis/seasonal Rhinitis based on an allergy against birch/alder/Hazel pollen OR grass/rye pollen OR mugwort
* Therapy with Polinex quattro

Exclusion Criteria:

* Age \<18 years.

Primary outcomes:
measure: Quality of life questionnaire (DLQI)
timeFrame: during year one, year two, year three of therapy or within 6 months after completion of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Saarland University Hospital. Department of Dermatology
state: Saarland
Study officials:
References:
Clinical trial NCT01892761: MPA Pharmacokinetics in Renal Transplantation
Official title: THE PROFILE OF MYCOPHENOLIC ACID IN CONSECUTIVE PHARMACOKINETICS AFTER RENAL TRANSPLANTATION:EFFECTS OF TIME AND CALCINEURIN-INHIBITORS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation Recipients
Keywords: mycophenolate mofetil
mycophenolic acid
MPA
MMF
Pharmacokinetics
renal transplantation
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2013-07-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Renal transplant recipients

Brief summary: Adequate exposure to mycophenolic acid (MPA) is associated with better outcomes in kidney transplantation. This study evaluated repeated, MPA pharmacokinetics (MPA-PK) according to post-transplant time-points and concomitant CNIs. Fifty-two patients, 33 allocated to tacrolimus (TCL) and 19 to CyA (all with mycophenolate mofetil (MMF) and steroids), had the full MPA area under the time-concentration curve (AUC0-12hrs) repeatedly evaluated at days 7, 14, 30, 60 and 180 post-transplant. MMF daily dose was lower in TCL group as per protocol. Dose-adjusted MPA-AUC0-12hrs progressively increased throughout the study period in both groups but profiles were different according to the CNI regimen and time. The majority of patients were underexposed to MPA on day 7 for both groups what reinforces the need of a higher dose in the first week. Dose-adjusted MPA-AUC0-12hrs was higher in TCL group, after day 7, due to both a diminished MPA clearance (for both groups) and higher AUC4-12hrs in the TCL group. There was a progressive overexposure to MPA in order that at day 180, 21-30% of the patients were overexposed to MPA what indicates a time for MPA monitoring and dose correction for long-term follow-up. These PK data suggest that changes in MPA profile occur according to time and CNIs used and suggests that MPA monitoring may be mandatory at specific time-points.


Eligibility criteria: Male and female patients aged 18-65 years, recipients of a non-HLA identical kidney allograft who presented a PRA \< 50% were eligible for the MoDIFY trial. Subjects were excluded if they received a non-renal organ, had current history of alcohol or illicit drug abuse, had liver enzymes more than two times the upper normal limit or received induction with anti-lymphocyte preparations.

Primary outcomes:
measure: To establish the dynamics of MPA-PK (AUC0-12hrs) during the first six months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Renal Transplantation Service
Study officials:
affiliation: Renal Transplantation Service - Hospital das Clínicas - University of São Paulo School of Medicine, Sao Paulo, Brazil
name: Elias David-Neto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06827561: The Effect of Presbyphagia on Urinary Incontinence and Quality of Life in Healthy Elderly People in Nursing Homes
Official title: The Effect of Presbyphagia on Urinary Incontinence and Quality of Life in Healthy Elderly People in Nursing Homes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Presbyphagia
Incontinence, Urinary
Quality of Life
Keywords: Presbyphagia
Urinary Incontinence
Quality of Life
Lead sponsor: Isparta University of Applied Sciences
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 73
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy elderly people living in a nursing home

Brief summary: Urinary incontinence in the elderly and health-related quality of life due to urinary incontinence is a common problem in nursing homes. Another problem that occurs in elderly individuals is swallowing disorder. Swallowing disorders that occur with aging are called presbyphagia. Additional health problems such as impaired fluid intake balance, fetal incontinence and sarcopenia may occur after presbyphagia. However, the effect of presbyphagia on urinary incontinence is not known. In this study, we aimed to determine the effect of presbyphagia on urinary incontinence and quality of life in healthy elderly individuals living in a nursing home.


Eligibility criteria: Inclusion Criteria:

* Individuals who have been living in the nursing home for at least 1 year and volunteer to participate in the study
* a mini metal test score of 24 and above

Exclusion Criteria:

* Those who cannot provide information on urinary function and quality of life,
* Those with a history of disease and surgery with mechanisms directly related to swallowing and urinary incontinence,
* Those with a mini mental test score of 23 or less were excluded

Primary outcomes:
measure: Determining the presence of urinary incontinence
timeFrame: 1 day
measure: Determining the presence ofquality of life
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Uluborlu
country: Turkey
facility: Haci Ahmet Şençopur Huzurevi Yaşli Bakim Ve Rehabilitasyon Merkezi
state: Isparta
city: Uluborlu
country: Turkey
facility: Uluborlu Gardenia Care Center
state: Isparta
Study officials:
References:
citation: Kakehi S, Wakabayashi H, Isono E, Takemura R, Sato Y, Otsuka Y, Nagai T, Nishioka S, Momosaki R. Association between sarcopenia and urinary dysfunction in patients with dysphagia. Arch Gerontol Geriatr. 2024 Dec;127:105577. doi: 10.1016/j.archger.2024.105577. Epub 2024 Jul 19.
Clinical trial NCT04171661: Self-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa
Official title: SASS 3: Self-Assembled Skin Substitute (SASS) for the Treatment of Epidermolysis Bullosa
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Epidermolysis Bullosa Dystrophica
Keywords: Dystrophic Epidermolysis Bullosa
Recessive Dystrophic Epidermolysis Bullosa
Tissue Engineering
Skin Substitute
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
First posted: 2019-11-21
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: n-of-one
Primary purpose: TREATMENT

Brief summary: Single patient study. Patient diagnosed with dystrophic epidermolysis bullosa presenting chronic open wounds that are not responding to dressings, topical preparations (antimicrobials, antibiotics) and systemic agents (anti-inflammatory antibacterials). The Self-Assembled Skin Substitutes will be used to cover wounds.


Eligibility criteria: This clinical trial was custom designed for one patient

Primary outcomes:
measure: Percent reduction in wound surface area
timeFrame: 2 weeks
Secondary outcomes:
measure: Graft failure
timeFrame: 2 weeks
measure: Number of subsequent re-transplantation
timeFrame: 3 years
measure: Time (in weeks) to 50% reduction in the surface area of the wounds;
timeFrame: 3 years
measure: Time (in weeks) to complete healing
timeFrame: 3 years
measure: Changes in pain scores
timeFrame: 3 years
measure: Changes in itch scores where 0 is none and 10 the worst itch
timeFrame: 3 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
Clinical trial NCT02157961: Doctor's Health - Health Behavior of Physicians in Germany
Official title: Doc's Health - Doctor as a Patient - An Observational Study on Health Behavior of Physicians in Germany
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Diseases
Chronic Illnesses
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicians in Germany

Brief summary: This is an observational study to assess the health behavior of Physicians from medical practices in Germany. Physicians will be asked by a questionnaire (self-report) on health behavior, self-diagnostics and self-medication in case of sickness. We will send the questionnaire to 1000 General Practitioners and to 300 medical specialists in Germany. We expect a response rate of 25-30 %. After electronically data-entry we will run a descriptive analysis for primary outcome. Results may provide a better understanding of the Physicians health behavior.


Eligibility criteria: Inclusion Criteria:

* Physicians in German ambulatory setting

Exclusion Criteria:

* any

Primary outcomes:
measure: Physicians health behavior
timeFrame: 1 day
Secondary outcomes:
measure: Physicians medication use
timeFrame: 1 day
measure: Physicians preventive care
timeFrame: 1 day
Other outcomes:
measure: Locus of internal control
timeFrame: 1 day
Locations:
city: Jena
country: Germany
facility: Institute of General Practice, University of Jena
Study officials:
References:
Clinical trial NCT04193761: TAURINE and HCC PATIENTS
Official title: COMPARISON BETWEEN SERUM TAURINE AND SPECIFIC TUMOR MARKERS FOR EARLY DETECTION AND DIAGNOSIS OF HCC IN EGYPTIAN PATIENTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Taurine in HCC
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Serum taurine level beside (AFP and AFU) are of great value in early diagnosis in HCC Egyptian patients and may have a rule in identifying end-stage liver disease (ESLD) patients candidate for LDLT.

Detailed description: Taurine has been demonstrated to have a direct and indirect antioxidant effect and to display antineoplastic activity by preventing angiogenesis and enhancing tumor cell apoptosis. Also it was suggested that measurement of serum taurine level in hepatic patients beside fibroscan is of great value in the early diagnosis of any fibrotic and cancerous liver changes.Aim of the work was to correlate serum taurine level with the levels of the specific tumor markers (α- fetoprotein and α-L-fucosidase ) for early diagnosis of different stages of HCC in Egyptian patients.

This observational case-control study was conducted in the Tropical Medicine Department, Ahmed Maher Teaching Hospital. Eighty hepatic patients were assigned to three groups (Chronic hepatitis, Cirrhosis and HCC). Twenty healthy subjects were enrolled as a control group. Serum levels of AFP, AFU, and taurine beside complete biochemical analysis and liver biopsies from all selected patients were done. Patients who accepted to be a candidate for living donor liver transplant (LDLT) were referred to Ain Shams University Specialized Hospital (ASUSH) liver transplant unit.

Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis
* Cirrhosis
* HCC patients

Exclusion Criteria:

* Patient refusal
* Bleeding tendency
* Tense ascites
* Inability to obtain a liver biopsy

Primary outcomes:
measure: Taurine level among patients groups
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hanaa El Gendy
state: Ain Shams University Specialized Hospital
Study officials:
References:
Clinical trial NCT06048861: Evaluation of Joint Position Sense in Carpal Tunnel Syndrome
Official title: Evaluation of Joint Position Sense With Two Different Electrogoniometers in Mild and Moderate Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: joint position sense
electrogoniometer
carpal tunnel syndrome
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 70
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study was to investigate the validity and reliability of the KForce Sens® for the evaluation of wrist joint position sense in individuals with CTS. Wrist joint position sense was assessed with KForce Sens® and Baseline® electrogoniometer. The validity and reliability of the KForce Sens® for wrist position sense evaluation were investigated by comparing the two data sets.


Eligibility criteria: Inclusion Criteria:

* mild to moderate CTS confirmed with EMG
* having symptoms for at least 3 months
* not receiving medical treatment and physiotherapy until 3 months before the study at the latest

Exclusion Criteria:

* having trauma in the affected extremity in the last 6 months
* having cervical radiculopathy
* having brachial plexopathy
* having cognitive problems
* having neurological problems
* being pregnant

Primary outcomes:
measure: Joint position sense
timeFrame: Day 1
measure: Joint position sense re-test
timeFrame: up to 1 week
Secondary outcomes:
measure: Function and symptom severity
timeFrame: Day 1
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References:
Clinical trial NCT02282761: A Trial to Assess the Antipsychotic Efficacy of ITI-007
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-04
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be conducted as a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.


Eligibility criteria: Inclusion Criteria:

* male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia
* experiencing an acute exacerbation of psychosis

Exclusion Criteria:

* any subject unable to provide informed consent
* any female subject who is pregnant or breast-feeding
* any subject judged to be medically inappropriate for study participation

Primary outcomes:
measure: Positive and Negative Syndrome Scale Total Score
timeFrame: 28 days
Secondary outcomes:
measure: Positive and Negative Syndrome Scale Subscales
timeFrame: 28 days
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Clinical Site
state: California
Study officials:
affiliation: Intra-Cellular Therapies, Inc.
name: Kimberly Vanover, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Correll CU, Davis RE, Weingart M, Saillard J, O'Gorman C, Kane JM, Lieberman JA, Tamminga CA, Mates S, Vanover KE. Efficacy and Safety of Lumateperone for Treatment of Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Apr 1;77(4):349-358. doi: 10.1001/jamapsychiatry.2019.4379.
Clinical trial NCT01179061: Investigating the Inotropic Potential of Apelin
Official title: Investigating the Inotropic Potential of Apelin in Healthy Volunteers and Patients With Chronic Stable Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Apelin
Heart failure
Pulmonary artery pressure
Inotropic
Diuretic
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2010-08-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The apelin-APJ system is a recently discover hormone system that has several important actions in the cardiovascular system. Apelin causes the heart pump with more force and also causes blood vessels to relax. Studies to date show that people with reduced pumping function of the heart have lower levels of apelin in the bloodstream compared to people with normal heart function. We have previously given apelin to healthy volunteers and people with reduced pumping function and this increases the heart's contraction. However, this has only been assessed over a short time period, around fifteen minutes, and we now want to know if this effect is seen over a longer period.


Eligibility criteria: Inclusion Criteria:

Healthy volunteers:

\>18yrs

Heart failure patients;

* New York Heart Failure class II-IV
* Ejection fractional \<35% or fractional shortening \<20% within previous 6months.

Exclusion Criteria:

All subjects,

* Females of child bearing age not on adequate contraception
* Lack of informed consent
* Age \<18yrs
* Current involvement in any other research study
* Systolic BP \>190 or \<100
* Malignant arrhythmias
* Renal or hepatic failure
* Haemodynamically significant aortic stenosis
* Severe or significant co-morbidity
* Pacemakers

Healthy volunteers

* Any regular medication
* Previous history of any cardiovascular disease

Primary outcomes:
measure: cardiac output
timeFrame: 6 hours
Secondary outcomes:
measure: Urine volume
timeFrame: 6 hours
measure: Pulmonary artery pressure
timeFrame: 1 hour
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc
city: Edinburgh
country: United Kingdom
facility: Gareth Barnes
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
Study officials:
References:
citation: Barnes GD, Alam S, Carter G, Pedersen CM, Lee KM, Hubbard TJ, Veitch S, Jeong H, White A, Cruden NL, Huson L, Japp AG, Newby DE. Sustained cardiovascular actions of APJ agonism during renin-angiotensin system activation and in patients with heart failure. Circ Heart Fail. 2013 May;6(3):482-91. doi: 10.1161/CIRCHEARTFAILURE.111.000077. Epub 2013 Mar 21.
Clinical trial NCT03584061: Treatment of Chronic Postherpetic Pain With Fat Grafting
Official title: Treatment of Chronic Postherpetic Pain With Fat Grafting - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Herpetic Neuralgia
Herpes Zoster
Keywords: Chronic Pain
Herpes Zoster
Pain
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The five patients included will all receive a fat graft in the area affected by PHN.
Primary purpose: TREATMENT

Brief summary: This study evaluates the possible beneficial effect of fat grafting for post herpetic neuralgia.

Detailed description: Herpes Zoster (HZ),is a condition caused by Varizella-Zooster virus (VZV), The disease is caused by reactivation of a latent VZV-infection in the sensory ganglia.

Clinically the condition is characterized by a painful, unilateral, vesicular rash. Pain is the most prominent symptom in around 90% of patients. In 10% of patients this pain remains and becomes chronic.

Post-herpetic neuralgia is a chronic pain syndrome that occurs after the dermal manifestations disappears.

Treatment is complex and mainly topical or systemic. For many patients this is not sufficient and they live with constant pain.

Fat grafting has shown promise in treating several different painful conditions such as post mastectomy pain syndrome, painful scars etc.

This study investigates is PHN can be treated by fat grafting.

Eligibility criteria: Inclusion Criteria:

* Age over 18
* Pain in area of former VZV-infection.
* Pain present over 3 months after reactivation of VZV and is present at least 4 days a week and of intensity \>3 on the VAS-scale.

Exclusion Criteria:

* Psychiatric illness that could potentially affect the study.
* Other indication for fat grafting than pain.

Primary outcomes:
measure: Neuropathic pain [LEVEL OF PAIN]
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life [QUALITY OF LIFE/ SATISFACTION]
timeFrame: 6 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Funen
Study officials:
affiliation: Professor
name: Jens A Sørensen, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sollie M, Thomsen JB, Sorensen JA. Autologous fat grafting seems to alleviate postherpetic neuralgia - a feasibility study investigating patient-reported levels of pain. J Plast Reconstr Aesthet Surg. 2021 Feb;74(2):350-356. doi: 10.1016/j.bjps.2020.08.038. Epub 2020 Aug 21.
citation: Sollie M, Sorensen JA. Treatment of chronic post-herpetic neuralgia with autologous fat grafts: a first-in-the-world case report. Br J Pain. 2019 Nov;13(4):239-243. doi: 10.1177/2049463718817570. Epub 2018 Nov 28.