louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04510961: Paraffin Bath Therapy for Chronic Hand Eczema
Official title: Beneficial Effects of Paraffin Bath Therapy as Additional Treatment of Chronic Hand Eczema: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eczema
Keywords: Paraffin bath therapy, Hand Eczema, SCORAD, DLQI, Itching
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sixty patients with moderate to severe Chronic Hand eczema (CHE) will participate in the study. They will be classified randomly into two groups of equal number; paraffin group and the control group.

Interventions: Paraffin group will receive Paraffin Therapy for 5 days per week for 12 weeks in addition to routine skin care program while the control group will received routine skin care program
Primary purpose: TREATMENT

Brief summary: Objective: Chronic Hand eczema (CHE) is a common inflammatory skin disease has a major medical psychological and socio-economic implications that affect quality of life (QoL)and work ability. This study, the first randomized controlled trial that will be conducted to evaluate the effect of paraffin bath therapy (PBT) in the treatment of CHE.

Detailed description: Design: The study design is a randomized controlled trial with measures at pre-and post-intervention.

Subjects: Sixty patients with moderate to severe Chronic Hand eczema (CHE) will participate in the study. They will be classified randomly into two groups of equal number; paraffin group and the control group.

Interventions: Paraffin group will receive Paraffin bath therapy for 5 days per week for 12 weeks in addition to routine skin care program while the control group will receive routine skin care program.

Outcome Measures:

Objective SCORing Atopic Dermatitis, subjective item score and dermatology life quality index (DLQI) will be assessed before, at 6th week and at 12th week of treatment.

Eligibility criteria: Inclusion Criteria:

* Age from 20-40 years
* Time elapsed from the beginning of the disease ; more than three months according to the Guideline of the German Dermatological Society

Exclusion Criteria:

* active eczematous lesions on other parts of the body;
* malignant or premalignant skin tumors

Primary outcomes:
measure: SCORAD ("SCORing Atopic Dermatitis
timeFrame: Change from Baseline at SCORAD score at 6th week and at 12th weeks of treatment
Secondary outcomes:
measure: Dermatology life quality index (DLQI)
timeFrame: Change from Baseline at 6th week and at 12th weeks of treatment
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Zizi Mohammed Ibrahim Ali
Study officials:
References:
Clinical trial NCT04815161: ASsessment of Adherence TO Medication in AtRIAl Fibrillation - an eMonitoring Drug Dispensing Device Study
Official title: ASsessment of Adherence TO Medication in AtRIAl Fibrillation - an eMonitoring Drug Dispensing Device Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adherence, Patient
Atrial Fibrillation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Pilloxa
First posted: 2021-03-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The ASTORIA study is a prospective cohort single-armed multicenter observational study that aims to assess adherence to rivaroxaban using a high technological electronical pillbox connected to a phone application in a group of atrial fibrillation patients with indication of long term anticoagulation treatment in routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* Female or male patient with age \> 18 years
* Patients with atrial fibrillation
* Patients initiated, continued on or switched to rivaroxaban for the indication atrial fibrillation with intended lifelong treatment (CHA2 DS2-VASc score ≥ 1).
* The patient must agree to the use of the electronic medication adherence monitoring device, the so-called Pilloxa box and need to have a sufficient understanding of the app and functionality in conjunction with the use of the Pilloxa box.
* Signed informed consent
* No participation in an investigational program with interventions outside of routine clinical practice
* No contra-indications according to the local marketing authorization

Exclusion Criteria:

* Participation in an investigational program with interventions outside of routine clinical practice
* Contra-indications according to the local marketing authorization

Primary outcomes:
measure: Rate of adherence
timeFrame: 2 years
Secondary outcomes:
measure: Persistence rate
timeFrame: 2 years
measure: Rates of risk factors
timeFrame: 2 years
measure: Rates of different patient experiences
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Univerity of Oslo, Oslo University Hospital
name: Dan Atar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03464461: Dosing of Ketorolac in the Emergency Department
Official title: Dosing of Ketorolac for Four Classes of Complaints in the Emergency Department
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Pain
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 groups with 3 different treatments
Primary purpose: TREATMENT

Brief summary: The optimal dose of ketorolac in the Emergency Department setting is no clear. We will compare 3 doses to determine the optimal dose.

Detailed description: Patients from 4 groups will be treated with 3 different doses of ketorolac. The groups are 1. headache 2. abdominal pain 3. musculo-skeletal pain 4. viral syndrome. The doses will be 0, 10, 30mgs of ketorolac to clarify the placebo effect and the optimal dosage as a function of condition.

Eligibility criteria: Inclusion Criteria:

\> 18 y/o

Exclusion Criteria:

pregnant allergic other contraindication

Primary outcomes:
measure: Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Any Pain Type
timeFrame: 30 minutes
measure: Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Abdominal Pain
timeFrame: 30 minutes
measure: Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Headache
timeFrame: 30 minutes
measure: Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Trauma/Musculoskeletal Pain
timeFrame: 30 min
measure: Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Viral Pain
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Matthew Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01778361: HIV UPBEAT: Understanding the Pathology of Bone Disease in HIV-infected Patients.
Official title: HIV UPBEAT: Understanding the Pathology of Bone Disease in HIV-infected. A Prospective Cohort Study of HIV-infected Patients and HIV-negative Subjects.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Keywords: Human immunodeficiency virus
low bone mineral density
osteopenia
osteoporosis
fracture
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: Health Research Board, Ireland
First posted: 2013-01-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV positive patients and HIV negative subjects

Brief summary: Despite the prevalence of osteopenia and osteoporosis in the HIV positive population, relatively little is known about the underlying pathology. This prospective cohort study aims to gain further understanding about a number of issues relating to low bone mineral density in HIV-infected subjects.

Detailed description: This study will follow HIV positive and negative subjects annually for 5 years. The aims of this study include:

* to describe the pathology underlying low bone mineral density
* to assess the relationship between low bone mineral density and antiretroviral therapy exposure
* to assess the relationship between low bone mineral density and vitamin D /PTH status and/or markers of bone metabolism
* to assess the relationship between osteopenia and subsequent changes in bone mineral density and markers of bone metabolism
* to assess the validity of the currently available fracture risk assessment tool in predicting fractures in HIV positive populations

Eligibility criteria: Inclusion Criteria:

* age \>18 years
* be able to provide written, informed consent
* be able to attend the research centre in a fasting state and undergo DEXA scanning

Exclusion Criteria:

* Subjects on bisphosphonate therapy at screening
* Pregnant or breastfeeding female subjects
* Subjects with a previous clinical history of primary hyperthyroidism or HIV negative subjects with elevated parathyroid hormone at screening
* HIV-negative subjects with a prior history of osteoporosis

Primary outcomes:
measure: Bone pathology
timeFrame: 3 years
Secondary outcomes:
measure: Rates of change in bone mineral density
timeFrame: 3 years
Other outcomes:
measure: Fracture incidence
timeFrame: 3 years
Locations:
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
Study officials:
affiliation: HIV Molecular Research Group, University College Dublin
name: Patrick WG Mallon, MB BCh, BSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01562561: Efficacy and Safety of Repaglinide Combined With Insulin NPH in Subjects With Type 2 Diabetes
Official title: Multi-centre, Multinational, Open-labelled, Randomised, Parallel, Controlled Trial in Type 2 Diabetic Subjects Inadequately Controlled on Repaglinide, to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime NPH Insulin Versus Twice Daily NPH Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-26
Enrollment: 213
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: This trial is conducted in Asia and South Africa. The aim of this trial is to compare the efficacy and safety of repaglinide plus insulin NPH (insulin Neutral Protamine Hagedorn) with insulin NPH alone in subjects with type 2 diabetes inadequately controlled on repaglinide.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* HbA1c (glycosylated haemoglobin): 7-13% (both inclusive)
* BMI (body mass index) maximum 35 kg/m\^2

Primary outcomes:
measure: HbA1c (glycosylated haemoglobin)
timeFrame: Week 0 (visit 5); week 26
Secondary outcomes:
measure: FPG (fasting plasma glucose)
timeFrame: Week 0 (visit 5); week 26
measure: 7-point blood glucose profile
timeFrame: Week 0 (visit 5); week 26
measure: Hypoglycaemic episodes
timeFrame: Week 0 (visit 5); week 26
measure: Adverse events
timeFrame: Week 0 (Visit 5); week 26
Other outcomes:
Locations:
city: Shatin, New Territories
country: Hong Kong
facility: Novo Nordisk Investigational Site
city: Kota Bharu, Kelantan
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Marikina City
country: Philippines
facility: Novo Nordisk Investigational Site
city: Pasig City
country: Philippines
facility: Novo Nordisk Investigational Site
city: Quezon City
country: Philippines
facility: Novo Nordisk Investigational Site
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Brits
country: South Africa
facility: Novo Nordisk Investigational Site
state: North West
city: Cape Town
country: South Africa
facility: Novo Nordisk Investigational Site
state: Western Cape
city: Alberton
country: South Africa
facility: Novo Nordisk Investigational Site
city: Tainan city
country: Taiwan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Panelo A, Wing JR; AGEE-1272 Study Group. Repaglinide/bedtime NPH insulin is comparable to twice-daily NPH insulin. Diabetes Care. 2005 Jul;28(7):1789-90. doi: 10.2337/diacare.28.7.1789. No abstract available.
Clinical trial NCT00223561: Methylphenidate and Driving Ability in Adult Patients With Attention-Deficit Hyperactivity Disorder
Official title: A Double Blind, Placebo-Controlled Crossover Study to Determine the Effects of Methylphenidate on Driving Ability in Adult Patients With Attention-Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ADHD
Keywords: adult
Lead sponsor: Utrecht Institute for Pharmaceutical Sciences
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to determine the effects of methylphenidate versus placebo on driving ability of adult ADHD patients.

Detailed description: This study was set-up to examine the controversial issue whether or not it is safe to drive a car or not when treated with methylphenidate.

On-the-road driving tests during normal traffic are conducted to determine the effects of methylphenidate versus placebo on driving ability of adult ADHD patients.In addition, two laboratory tests are conducted to examine memory functioning and inhibitory control.

Eligibility criteria: Inclusion Criteria:

* adult ADHD patient over 21 years old
* valid driver's license for at least 3 years
* treated with methylphenidate
* written informed consent

Exclusion Criteria:

* use of illicit drugs
* use of drugs or having medical conditions known to affect driving ability

Primary outcomes:
measure: Driving test:Standard Deviation of Lateral Position (SDLP, cm);i.e. the weaving of the car [single dose effects]
Secondary outcomes:
measure: Other Driving test parameters: Standard Deviation of Speed, mean speed, mean lateral position.
measure: Memory test: immediate & delayed word recall, delayed recognition.[single dose effects]
measure: Continuous Performance test: RT, %errors [single dose effects]
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Utrecht Institute for Pharmaceutical Sciences
Study officials:
affiliation: Utrecht Institute for Pharmaceutical Sciences
name: Joris Verster, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Utrecht Institute for Pharmaceutical Sciences
name: Edmund Volkerts, PhD
role: STUDY_DIRECTOR
References:
citation: Verster JC, Bekker EM, Kooij JJ, Buitelaar JK, Verbaten MN, Volkerts ER, Olivier B. Methylphenidate significantly improves declarative memory functioning of adults with ADHD. Psychopharmacology (Berl). 2010 Oct;212(2):277-81. doi: 10.1007/s00213-010-1952-2. Epub 2010 Jul 20.
Clinical trial NCT04249661: Differential Effects of Bacteria Colonising Venous Leg Ulcers on Pain and Healing Rates
Official title: Differential Effects of Bacteria Colonising Venous Leg Ulcers on Pain and Healing Rates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Leg Ulcer
Lead sponsor: University Hospital of Limerick
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Vascular patients with new and old venous ulcers to their lower limbs. As deemed suitable as per the inclusion/exclusion criteria. As deemed suitable by the P.I.

Brief summary: This Study aims to identify whether venous leg ulcers which are colonised by Pseudomonas Aeruginosa cause more pain than those which are not and if this bacteria affects healing time. This may determine how venous ulcer infections are treated in order to improve symtomatology and quality of life for patients with these chronic wounds.

Detailed description: Pseudomonas is a gram-negative bacillus which commonly colonises lower limb venous ulcers. It produces exotoxins and elastase as well as forming biofilms within chronic wounds.

Its effects on venous ulcer healing are debated. The objective of this study is to examine the effects on Pseudomonas Aeruginosa colonisation on the pain expereinces and healing rates of venous leg ulcers.

Eligibility criteria: Inclusion Criteria:

1. All patients age 18+ with lower limb venous ulcers as diagnosed on clinical history and examination.
2. Are willing and capable to voluntarily sign a statement of informed consent to take part in this study.
3. With an ABPI of \>/= 0.8 and/or palpable pedal pulses on clinical exam.
4. Without evidence (either clinical or diagnostic) of other causes of lower limb ulceration, namely vasculitis, local dermopathology, congenital syndromes or arterial insufficiency (see above).
5. If equipoise or disagreement between two independent clinicians exist, The ultimate decision as to inclusion/exclusion will be made by the P.I

Exclusion Criteria:

1. Patients unable to provide informed consent.
2. Patients under the age of 18
3. Patients with arterial insufficiency manifesting as ABPI's of \<0.8
4. Known or suspected alternate likely primary cause of lower limb ulceration (vasculitis, dermatological disease, underlying congenital syndrome).
5. Patients who are deemed unsuitable due to any circumstances as deemed appropriate by the P.I.

Primary outcomes:
measure: Pain burden of venous ulcers colonised by Pseudomonas Aeruginosa
timeFrame: 1 year
measure: Presentations and Admissions
timeFrame: 1 year
Secondary outcomes:
measure: Analgesia Requirements
timeFrame: 1 year
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University Hospital Limerick
Study officials:
affiliation: University Hospital of Limerick
name: Eamon Kavanagh, MD FRCSI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03668561: the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus
Official title: Evaluation of the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemiparesis
Varus Deformity of Equine Carpus
Keywords: stroke
hemiplegia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 30
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: To assess the benefit of an anti-varus ankle foot orthosis (CALIGALOC, Bauerfeind) on gait and balance parameters in hemiparetic patients.


Eligibility criteria: Inclusion Criteria:

* Hemiparesis at \> 3 months (whatever the etiology)
* varus or equinovarus foot disturbing the stance phase of gait
* Able to walk at least 10m, with or without assistive device

Exclusion Criteria:

* unable to walk 10m
* Botulinum toxin injection less than 3 months before inclusion
* history of neurological or locomotor pathology in addition to the etiology of hemiparesis
* Severe comprehension troubles
* Pregnancy

Primary outcomes:
measure: 10-meter walk test (in seconds)
timeFrame: comparison between baseline and 15 days
Secondary outcomes:
measure: Assessment of gait temporospatial parameters by GaitRite®
timeFrame: comparison between baseline and 15 days
measure: Posturographic analysis during static upright stance (center of pressure surface)
timeFrame: comparison between baseline and 15 days
measure: Baropodometric analysis during gait
timeFrame: comparison between baseline and 15 days
measure: Gait endurance (2-minute walk test)
timeFrame: comparison between baseline and 15 days
measure: Assessment of walking function
timeFrame: comparison between baseline and 15 days
measure: Tolerability of the wearing of the Caligaloc orthosis assessed by visual analog scale
timeFrame: at 15 days
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Swynghedau, CHI
Study officials:
affiliation: University Hospital, Lille
name: Etienne Allart, MD
role: PRINCIPAL_INVESTIGATOR
References: