louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03692208: Managing Diabetes to Gain Opportunities for a More Active Life
Official title: Managing Diabetes to Gain Opportunities for a More Active Life (My Diabetes GOAL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Geriatrics
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-10-02
Enrollment: 110
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this novel patient-facing disease management intervention is to develop and test a system embedded within the electronic medical record to engage patients in personalized goal setting and chronic disease management.

Detailed description: The purpose of this novel patient-facing disease management intervention, My Diabetes GOAL, is to develop and test a system embedded within the electronic medical record to engage patients in personalized goal setting and chronic disease management by: 1) establishing personalized goals of care based on comorbidities and preferences, 2) tracking diabetes measures against personalized goals, and 3) selecting the route and intensity of care management to help patients achieve their goals (e.g., telephonic care management, in-person care management, and self-care resources). This application can be used to individualize care, increase engagement with patient portals, and improve patient self-efficacy, as they take a more active role in their care.

Eligibility criteria: Inclusion Criteria:

* 65 years and older
* Diagnosis of Type 2 Diabetes
* Enrolled in MyChart (University of Chicago Patient Portal)
* Outpatient clinic visit in the prior year

Exclusion Criteria:

* Under 64 years of age
* No type 2 diabetes
* Not enrolled in MyChart
* No outpatient clinic visit in the prior year

Primary outcomes:
measure: Documentation of Diabetes Goal
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Personalized A1C Goals
timeFrame: Baseline, 6 months
measure: Patient Ability to Reach Personalized Goals
timeFrame: Baseline, 6 month
Other outcomes:
measure: Health Care Utilization
timeFrame: 1 year
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Elbert S Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05735808: VR Education in Arterial Hypertension
Official title: A Pilot Study of the Feasibility and Non-inferiority of Patient Education About Arterial Hypertension in Virtual Reality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arterial Hypertension
Keywords: virtual reality education
Lead sponsor: Poliklinika Agel, Dopravni zdravotnictvi a.s.
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to compare standard education with VR augmented education in patients with arterial hypertension

Detailed description: To demonstrate the technical and organizational feasibility of patient education about arterial hypertension in virtual reality. Demonstrate the non-inferiority of education conducted in virtual reality to traditional face-to-face education by a physician. To define the cost-effectiveness of education in virtual reality in the reality of progressing shortage of human resources.

Patients diagnosed with arterial hypertension as part of a routine examination in an internal medicine outpatient clinic will be randomized to education about the disease directly by a physician in one arm or using a 3D movie in VR glasses filmed by a physician in an identical outpatient clinic setting. It will be concluded by questionnaire method to compare the outcome of both education namely subjective satisfaction and objectively by using questions to evaluate the success of the education.

Eligibility criteria: Inclusion Criteria:

* all consecutive patients with arterial hypertension

Exclusion Criteria:

* visual impairment

Primary outcomes:
measure: Non-Inferiority of VR augmented education: physician assessment of objective patient understanding
timeFrame: 18 months
measure: Non-Inferiority of VR augmented education:subjective evaluation of education by the patient
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: Poliklinika Agel
Study officials:
affiliation: Nemocnice AGEL Trinec-Podlesi a.s.
name: Otakar Jiravsky
role: STUDY_CHAIR
References:
Clinical trial NCT00671008: Observational Study of Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes
Official title: Efficacy of Glycaemic Control of Biphasic Insulin Aspart (NovoMix® 30) or Insulin Detemir (Levemir®) in Patients With Type 1 or 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-05-02
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 and Type 2 Diabetes Mellitus

Brief summary: This trial is conducted in Europe.

The aim of this observational study is to evaluate the glycaemic control in patients with type 1 or 2 diabetes using NovoMix® 30 or Levemir® under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Patients with Type 1 or Type 2 diabetes, including newly diagnosed
* Age: Levemir® above 6 years
* Age: Novomix® above 18 years

Exclusion Criteria:

* Current treatment with NovoMix® 30 or Levemir®

Primary outcomes:
measure: Glycaemic control as measured by HbA1c
timeFrame: After 24 weeks
Secondary outcomes:
measure: Percentage of subjects to reach HbA1c below 7.0% and =6.5%
timeFrame: After 24 weeks
measure: Percentage of subjects on once vs twice daily injections of Levemir® or NovoMix® 30
timeFrame: After 24 weeks
measure: The effect on glycamic control as measured by FPG
timeFrame: After 24 weeks
measure: The effect on glycamic control as measured by PG profile
timeFrame: After 24 weeks
measure: Change in body weight
timeFrame: After 24 weeks
Other outcomes:
Locations:
city: Sarajevo
country: Bosnia and Herzegovina
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01430208: A New Alternative to Traditional Hysteroscopy
Official title: New Mini-resectoscope as Alternative to Traditional Hysteroscopy in the Treatment of Uterine Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrauterine Diseases
Myomas
Polyps
Keywords: endometrial pathology
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2011-09-08
Enrollment: 401
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hysteroscopy is a procedure designed for the diagnosis and the treatment of intra-uterine diseases. The development of smaller hysteroscopes allowed to change the approach to the intra-uterine lesions unifying the diagnostic and operative time. Recently Gubbini et al. developed a mini-resectoscope feasible for "see\&treat" hysteroscopy. The objective of the study is to compare the new 16 Fr mini28 resectoscope by Gubbini with Traditional 22 Fr resectoscope and Bettocchi 15 Fr hysteroscope for the treatment of uterine cavitary lesions. The investigators enrolled 401 women affected by endometrial polyps and/or G0 myomas, randomly allocated to receive the treatment with traditional resectoscope (127 women), with mini-resectoscope by Gubbini (142 women) and Bettocchi hysteroscope (132 women). Operating time, distension media delivered, dismiss time and discomfort experienced were recorded.


Eligibility criteria: Inclusion Criteria:

* women between 18-75 years of age
* endometrial polyps and/or G0 myomas smaller than 3 cm of diameter

Primary outcomes:
measure: efficacy of the treatment with mini-resectoscope in comparison with the traditional hysteroscopy in the whole group of 401 patients
timeFrame: sixteen months
Secondary outcomes:
measure: efficacy of the treatment with mini-resectoscope in comparison with the traditional hysteroscopy in the treatment of intrauterine lesions larger than 1,5cm in diameter
timeFrame: sixteen months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic university of Sacred Heart
Study officials:
References:
citation: Ricciardi R, Lanzone A, Tagliaferri V, Di Florio C, Ricciardi L, Selvaggi L, Guido M. Using a 16-French resectoscope as an alternative device in the treatment of uterine lesions: a randomized controlled trial. Obstet Gynecol. 2012 Jul;120(1):160-5. doi: 10.1097/AOG.0b013e31825b9086.
Clinical trial NCT01019408: Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan
Official title: Clinical Trial of Extended-dose Chloroquine Versus Standard Chloroquine Treatment for Resistant Falciparum Malaria Among Afghan Refugees in NWFP Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria, Falciparum
Keywords: Clinical Trial
Chloroquine
Refugees
Afghanistan
Pakistan
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: European Union
name: United Nations High Commissioner for Refugees
name: World Health Organization
First posted: 2009-11-25
Enrollment: 163
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to provide stronger evidence for extended-dose chloroquine treatment of falciparum-positive Afghan refugees in Northwest Frontier Province (NWFP), Pakistan or justification for discontinuation of the policy.

Detailed description: To determine whether extended-dose chloroquine provided better cure rates and fewer recrudescences than standard chloroquine treatment among Afghan refugees, 163 falciparum patients from three Afghan refugee camps were recruited into 3-day (CQ 25mg/kg) or 5-day (CQ 40mg/kg) treatment arms and followed for up to 60 days.

Eligibility criteria: Inclusion Criteria:

* slide-confirmed infection with P. falciparum only
* initial parasite density of 1000-100,000 asexual parasites/μl
* absence of severe malnutrition
* ability to attend stipulated follow-up visits and easy access to facility
* informed consent provided by patient or parent/guardian
* absence of history of hypersensitivity reactions to CQ

Exclusion Criteria:

* infants under six months old
* pregnancy or lactation
* underlying chronic severe illness
* patients with other febrile illnesses
* parasitaemia outside the range of 1000-100,000 asexual parasites/µl
* severe malaria

Primary outcomes:
measure: therapeutic and parasitological cure with no recrudescence
timeFrame: 60 days
Secondary outcomes:
measure: parasite clearance time
timeFrame: 28 days
measure: fever clearance time
timeFrame: 28 days
measure: gametocytaemia
timeFrame: 28 days
Other outcomes:
Locations:
city: Adezai
country: Pakistan
facility: Adezai Basic Health Unit
state: Nwfp
city: Baghicha
country: Pakistan
facility: Baghicha Basic Health Unit
state: Nwfp
city: Kagan
country: Pakistan
facility: Kagan Basic Health Unit
state: Nwfp
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Mark Rowland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05700123: Non-pharmacological Methods for the Control of Anxiety and Pain During Outpatient Hysteroscopy
Official title: Non-pharmacological Methods for the Control of Anxiety and Pain During Outpatient Hysteroscopy (Metodiche Non Farmacologiche Per il Controllo di Ansia e Dolore Durante Isteroscopia Ambulatoriale)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 198
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The administration of pharmacological and non-pharmacological aids during in-office hysteroscopic surgery is often used to both relieve the patient from discomfort and facilitate the operator in performing the procedure. The investigators aim to test the hypothesis that watching a video clip or listening to music would act as non-pharmacological relief for reducing anxiety and pain during in-office hysteroscopy.


Eligibility criteria: Inclusion Criteria:

* Premenopausal and postmenopausal women
* Indication for in-office operative hysteroscopy

Exclusion Criteria:

* Denied consent
* Use of analgesic drugs before the procedure

Primary outcomes:
measure: The anxiety, evaluated by means of State-Trait Anxiety Inventory (STAI) questionaries
timeFrame: 24 hours
measure: post-hysteroscopic pain, evaluated using a 1-10 Numeric Rating Scale (NRS)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: University of Bari
city: Cagliari
country: Italy
facility: University of Cagliari
city: Napoli
country: Italy
facility: University of Campania "Luigi Vanvitelli"
Study officials:
affiliation: Università della Campania Luigi Vanvitelli
name: Pasquale Franciscis, MD PhD
role: STUDY_CHAIR
affiliation: Università della Campania Luigi Vanvitelli
name: Gaetano Riemma
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01320423: Surgical Trial in Lobar Intracerebral Haemorrhage
Official title: Surgical Trial in Lobar Intracerebral Haemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracerebral Haemorrhage
Keywords: Intracerebral Haemorrhage
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To establish whether a policy of earlier surgical evacuation of the haematoma in selected patients with spontaneous lobar ICH will improve outcome compared to a policy of initial conservative treatment. The trial will also help to better define the indications for early surgery.

This will overcome two of the criticisms of STICH (timing was too late and sometimes location was too deep). The subgroup identified in STICH is clinically sensible and the hypothesis identified for STICH II is in line with current neurosurgical opinion.

Detailed description: STICH II is an international multicentre randomised parallel group trial comparing early craniotomy to evacuate the haematoma with initial conservative treatment, following spontaneous superficial intracerebral haemorrhage affecting the lobar region only. Only patients for whom the treating neurosurgeon is in equipoise about the benefits of early craniotomy compared to initial conservative treatment are eligible for the trial. Outcome is measured at six months via a postal questionnaire including the Glasgow Outcome scale, Modified Rankin Scale, EuroQol and Barthel. Six hundred patients will be recruited to the trial over thirty months. Follow-up will take six months with analysis and reporting taking one year.

Eligibility criteria: Inclusion Criteria:

* Evidence of a spontaneous lobar ICH on CT scan (1 cm or less from the cortex surface of the brain)
* Patient within 48 hours of ictus
* Best MOTOR score on the GCS of 5 or 6 and best EYE score on the GCS of 2 or more.
* Volume of haematoma between 10 and 100ml \[Calculated using (a x b x c)/2 method\]

Exclusion Criteria:

* Clear evidence that the haemorrhage is due to an aneurysm or angiographically proven arteriovenous malformation.
* Intraventricular haemorrhage of any sort
* ICH secondary to tumour or trauma.
* Basal ganglia, thalamic, cerebellar or brainstem haemorrhage or extension of a lobar haemorrhage into any of these regions.
* Severe pre-existing physical or mental disability or severe co-morbidity which might interfere with assessment of outcome.
* If surgery cannot be performed within 12 hours.
* If the haematological effects of any previous anticoagulants are not completely reversed.

Primary outcomes:
measure: Glasgow Outcome Scale/ Modified Rankin Scale
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Wen-Ta Chiu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01887223: Transconjunctival Needling Revision Versus Medical Treatment
Official title: Early Transconjunctival Needling Revision With 5-fluorouracil Versus Medical Treatment in Encapsulated Blebs: a 12-month Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Open Angle Glaucoma
Keywords: Encapsulated blebs
trabeculectomy failure
glaucoma
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2013-06-26
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: When the glaucoma filtering surgery failures (intraocular pressure rises again), the options is start to use the hypotensive eye drops again (medical treatment). However, in some cases (encapsulated blebs), there is a simple surgical revision that can revival the primary failure surgery. It calls transconjunctival needling revision. In this study, the investigators compare the efficacy of this revision versus medical treatment in 12-month follow up in eyes with encapsulated blebs.

Detailed description: To compare the efficacy of transconjunctival needling revision (TNR) with 5-fluorouracil versus medical treatment (MT) in glaucomatous eyes with uncontrolled intraocular pressure (IOP) due to encapsulated bleb after trabeculectomy Prospective, randomized, interventional study. A total of forty eyes of 39 patients with elevated IOP and encapsulated bleb diagnosed at maximum 5 months after primary trabeculectomy with mitomycin C were included. The eyes were randomized to either TNR with 5-fluorouracil or MT (hypotensive eyedrops). A maximum of two TNR per patient was allowed in the needling arm. All eyes were followed up for 12 months. Success of treatment was defined as IOP ≤ 18mmHg and 20% reduction from baseline at last follow up.

Eligibility criteria: Inclusion Criteria:

* Eyes with encapsulated blebs developed in 5 months or less following primary glaucoma filtering surgery (trabeculectomy) and intraocular pressure \>= 20mmHg

Exclusion Criteria:

* Previous other ocular surgery

Primary outcomes:
measure: Intraocular pressure
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo General Hospital
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Remo Susanna Jr., MD
role: STUDY_CHAIR
affiliation: University of Sao Paulo General Hospital
name: Ricardo Suzuki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Costa VP, Correa MM, Kara-Jose N. Needling versus medical treatment in encapsulated blebs. A randomized, prospective study. Ophthalmology. 1997 Aug;104(8):1215-20. doi: 10.1016/s0161-6420(97)30155-9.
citation: Suzuki R, Susanna R Jr. Early transconjunctival needling revision with 5-fluorouracil versus medical treatment in encapsulated blebs: a 12-month prospective study. Clinics (Sao Paulo). 2013 Oct;68(10):1376-9. doi: 10.6061/clinics/2013(10)14.
Clinical trial NCT00734123: Early Detection of Atherosclerosis: a Randomized Trial in the Primary Prevention of Cardiovascular Diseases.
Official title: Early Detection of Atherosclerosis in the Primary Care Setting: a Randomized Trial to Assess the Efficacy of a Novel Strategy in the Primary Prevention of Cardiovascular Diseases.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atherosclerosis
Cardiovascular Diseases
Keywords: Atherosclerosis
Cardiovascular Prevention
Carotid Intima-Media Thickness
Ankle-Brachial Index
Lead sponsor: Hospital Arnau de Vilanova
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-08-14
Enrollment: 2948
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The incidence of cardiovascular diseases is still high and further efforts should be done in primary prevention. The main objective is to quantify the burden of subclinical atherosclerosis using non-invasive techniques,and to study the impact of this assessment and consequent treatment in the progression of atherosclerosis and in the incidence of cardiovascular diseases.

Detailed description: We will perform non-invasive techniques (carotid Intima-Media Thickness, CAC score and ankle-brachial index) to individuals at intermediate cardiovascular risk.With these results, we will classify participants in: no atherosclerosis, mild, moderate and severe atherosclerosis, and therapeutic targets will be set according to pre-defined algorithms. The end-point will be the course of atherosclerosis measured by cIMT/CAC score (2 years) and the incidence of CVD at 5 years of follow-up.

Eligibility criteria: Inclusion Criteria

One or more of the following:

* Familiar History of early-onset cardiovascular disease (male \< 55 or female \< 65).
* Type 2 Diabetes mellitus or type 1 with microalbuminuria.
* Essential High Blood Pressure.
* Chronic Kidney Disease.
* Primary hyperlipidemia.

The presence of two or more of the following:

* Current smoker.
* Physical inactivity.
* High blood pressure (recently diagnosed).
* Abdominal perimeter: \> 102 cm. males; \> 88 cm. females.
* Total cholesterol \> 240 mg/dL.
* HDL cholesterol ≤ 40 mg/dL males, ≤ 50 mg/dL females.

Exclusion Criteria:

* Age \< 40 or \> 74 years old.
* Previous Cardiovascular Event.

Primary outcomes:
measure: Carotid Intima-Media Thickness progression/regression
timeFrame: 2 years
Secondary outcomes:
measure: Cardio and cerebrovascular eventS
timeFrame: 5 years
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
state: Catalunya
Study officials:
affiliation: Hospital Arnau de Vilanova
name: Elvira Fernandez, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: